This time, we look to New York for guidance on recognizing and treating monkeypox.

Dr. Eric Meyerowitz of Montefiore and Dr. Stephen Baum of Einstein will lead you through the monkeypox thicket in a 17-minute chat.

Included below is information for patients as well as links to some key articles of interest to clinicians.

LINKS:

For patients: Dr. Barry Zingman’s “Monkeypox — What you need to know”

For clinicians:

• NEJM article on monkeypox in 16 countries
• NEJM Case Records of the Mass. General Hospital on the state’s first case
• Stephen Baum’s summary of a paper in Emerging Infectious Diseases describing viral persistence on fomites

We’re back with another interview from this year’s IASLC conference.

This time, Christine Sadlowski and Dr. Julia Rotow interview Dr. Mariano Provencio about the survival outcomes from the NADIM II trial. In that trial, patients with resectable stage III AB non-small cell lung cancer received nivolumab plus chemotherapy versus chemotherapy alone.

Overall survival at 5 years in these patients has been roughly 30%, according to Provencio. With the addition of chemo-immunotherapy, patients who showed a complete pathological response were all alive at the 3-year mark. These results, according to Rotow, are “really quite exciting.”

INTERVIEW TRANSCRIPT

Christine Sadlowski:

This is part of the NEJM Group coverage of the IASLC’s 2022 World Conference on Lung Cancer. I’m Christine Sadlowski, and with me Dr. Julia Rotow, a clinical oncologist at Dana-Farber Cancer Institute in Boston. We’re here to interview Dr. Mariano Provencio, Chair of Medical Oncology at the Hospital Universitario Puerta de Hierro Majadahonda in Madrid in Spain. He is the lead author on NADIM II, a phase 2 trial of neoadjuvant nivolumab added to chemotherapy for resectable stage III AB non-small cell lung cancer. Welcome.

Dr. Mariano Provencio:

Thank you.

Christine Sadlowski:

So first, I’d like to ask you about the history of this research because these findings come after several previous studies, including NADIM nivolumab in this clinical setting. Can you refresh us briefly on what is known so far?

Dr. Mariano Provencio:

We studied the combination with nivolumab plus chemotherapy in NADIM I. It was a clinical trial focused on stage IIIA according to the 7th edition. It was a phase two trial. We obtained very exciting results: in overall survival, three times the historical series; in DFS [disease-free survival] around 77 percent at two years — almost double the historical series — and also early results in PCR, pathological complete response, almost 60 percent.

Then following that was the second clinical trial comparing nivolumab plus chemotherapy versus chemotherapy, and this is NADIM II.

Dr. Julia Rotow:

Thank you, Dr. Provencio. So, when you think about what we knew already in the field, could you take us through some of the key findings from the NADIM II study and what these might add to our current understanding of nivolumab in this setting?

Dr. Mariano Provencio:

In NADIM II, the primary objective was complete pathological response, and we obtained higher complete pathological response in the experimental arm. Nivo plus chemo versus chemo: Odds Ratio 7.88; p = 0.0068. We presented at the last lung cancer congress (IASLC) more progress, in PFS longer with hazard ratio of 0.48 and more overall survival hazard ratio of 0.40. And this is quite amazing results, in my opinion, comparing with chemotherapy arm.

Christine Sadlowski:

Can I go back a little bit and say in this particular presentation you’re showing primarily secondary outcomes, is that correct?

Dr. Mariano Provencio:

We presented the primary end point was a complete pathological response. It was positive and then we presented in this congress the secondary outcomes, survival outcomes, yes.

Christine Sadlowski:

And they were at 12 and 24 months, correct?

Dr. Mariano Provencio:

Correct.

Christine Sadlowski:

I was struck by the finding on overall survival. That’s obviously improved with adjuvant therapy.

Dr. Mariano Provencio:

We use adjuvant nivolumab therapy for six months. We think so, this is the first clinical trials who reported an increase in overall survival in this setting using immunotherapy plus chemotherapy and adjuvant.

Dr. Julia Rotow:

I was struck by these results. They were quite impressive. Are there any caveats we should take away from your status as secondary versus primary outcomes on the study?

Dr. Mariano Provencio:

In the first clinical trial, in NADIM I, the primary endpoint was progression-free survival. We saw pathological complete response was quite robust endpoint. I think these results are very significant in survival outcomes are very, very significant.

Christine Sadlowski:

So, what does that mean for clinical practice? I don’t actually know how nivolumab is currently used. I understand it’s approved for other cancers, not this one, but is it currently used?

Dr. Mariano Provencio:

Currently, we are using a chemo and then certainly in some cases immunotherapy, this subgroup of patients in stages 3A-B (N2) disease have poor prognostic and based on our results we can improve it. We have had the same results during last 30 years using chemotherapy and then these results are quite similar than the CM 816 specifically in stage 3A 3B. In some cases, these patients are considered with unresectable disease, and we obtain very high rate of surgery in these patients, more than 90 percent of patients underwent radical surgery is quite important to the clinical practice, in my opinion.

Our opinion, we should use chemo plus immunotherapy as standard of care in this group of patients as in the adjuvant setting.

Dr. Julia Rotow

You mentioned Checkmate 816, and I know this regimen involves a longer course of immunotherapy because of the adjuvant period. Is there anything that clinicians or patients should know about adverse effects that you saw with this regimen?

Dr. Mariano Provencio:

I think both trials are quite well tolerated results. In CM 816 we don’t use adjuvant therapy. I think maybe we have to have more results, more information about adjuvant period or adjuvant after chemo immunotherapy. Maybe in the future we’ll have to define with more detail this aspect. In any case, I think the most important part is use neoadjuvant chemo immunotherapy.

Dr. Julia Rotow:

I thought that it was great that you highlighted the surgical resection rate because it was quite a bit better with the combination chemo immunotherapy.

Dr. Mariano Provencio:

We have more than 92 percent of surgery. I mentioned before 70 percent of patients had N2 affectation. Half of them, multiple station. This is quite a high rate of radical surgery on more than 92 percent of R0 versus 60 percent in control arm. I think the surgery could be an important aspect to cure these patients.

Christine Sadlowski:

What would you need to do next to show that?

Dr. Mariano Provencio:

The next steps in this case, I think now this is a proof of concept introducing a new treatment in this group of patients. Very important this group of patients. We have almost the same survival within the last 30 years. Around 30 percent of overall survival at five years and no more than 12 or 16 months PFS. I think we have to analyze with more detail clinical trials analyzing pathological response and then in this case adjuvant treatment in these patients according to pathological response.

For example, in our study patients with PCR (complete pathological response) are 100 percent of disease-free and 100% alive at three years.

Dr. Julia Rotow:

Thank you for taking us through. I agree these are really quite exciting results and we’re so happy to have gotten to see them at the conference this year. We certainly look forward to seeing more of this sort of treatment strategy. So, thank you for joining us today.

Dr. Mariano Provencio:

Thank you.

Christine Sadlowski:

Thank you.

Interim results on overall survival in phase 3 of the IMpower010 trial were presented at this year’s meeting of the International Assosciation for the Study of Lung Cancer (IASLC). As part of the NEJM Group’s coverage of the conference, Christine Sadlowski interviewed the presenter, Dr. Enriqueta Felip. In a 15-minute interview, she discusses the implications for different patient groups and the past, present, and future of the IMpower trial, which tests adjuvant atezolizumab following platinum-based chemotherapy in patients with resected early-stage non–small-cell lung cancer. 

INTERVIEW TRANSCRIPT:

Christine Sadlowski:

This is coverage of the IASLC’s 2022 World Conference on Lung Cancer. I’m Christine Sadlowski of the NEJM Group. With me today is Dr. Enriqueta Felip, who is head of the thoracic cancer unit at the Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology in Barcelona, Spain. She is the presenting author for the overall survival interim analysis of IMpower010, which tested atezolizumab in patients with resected early stage non-small cell lung cancer following platinum-based chemotherapy.

Dr. Felip, thank you very much for joining me.

Dr. Enriqueta Felip:

Thank you. It’s a pleasure.

Christine Sadlowski:

So, last year I interviewed your colleague, Dr. Heather Wakelee, about the interim findings on progression-free survival from this same study. Can you briefly remind us what those findings were?

Dr. Enriqueta Felip:

So, IMpower010 is a randomized trial in patients with completely resected stage IB with a tumor size greater than four centimeters, II-IIIA according to the Seven TNM Classification, and patients received adjuvants, platinum-based chemotherapy, and then 1,000 patients were randomized to receive one year of atezolizumab or best supportive care. The primary endpoint in this trial was the disease-free survival, and the primary endpoint was presented by Dr. Wakelee during the ASCO last year and also published in Lancet.

So, in this trial, for those patients with stage II-IIIA and PD-L1-positive tumors, atezolizumab improved disease-free survival with a hazard ratio of 0.66. For those patients with stage II-IIIA, irrespective of PDL-1, disease-free survival was improved with a hazard ratio of 0.79, and in the whole group of patients, patients with a stage IB-IIIA, the hazard ratio for disease-free survival was 0.81, and the statistical significance boundary for disease-free survival was not met in this population.

So here, during the IASLC conference, we present the first prespecified interim analysis of overall survival and a safety analysis with a median follow-up of 45 months and with a clinical cutoff in April 2022. So, at this analysis with an event to patient ratio of 25% in the intention-to-treat population, the overall survival is not mature.

So, in this analysis, we presented the results of overall survival in this interim analysis for patients with stage II-IIIA and PD-L1-positive tumors. Overall, there is a trend towards an improvement in overall survival for those patients receiving atezolizumab. The median overall survival was not reached in either of the treatment arms. The hazard ratio was 0.71 with a 95% confidence interval between 0.49 to 1.03. So, at 60 months there is 76.8% of the patients alive in the atezolizumab arm, 67.5% of the patients in the control arm.

At this overall survival interim analysis, we observe no differences in overall survival when we analyze all randomized stage II-IIIA population, irrespective of PD-L1, with a hazard ratio of 0.95, and also no differences in overall survival was observed in an intention-to-treat population, including patients with a stage IB disease, with a hazard ratio of 0.995.

And also, we analyzed the overall survival in patients with stage II-IIIA based on PD-L1. So, as I mentioned, for those patients with PD-L1-positive tumors, there is a nonsignificant trend in favor of atezolizumab with a hazard ratio of 0.71. For those patients with PD-L1-negative tumors, the hazard ratio is 1.36, and for those patients with PD-L1 50% or higher, the hazard ratio for overall survival is 0.43. We analyzed also the hazard ratio for those patients with PD-L1 between 1-49%, that is 0.95. So, it’s important that for those patients with PD-L1 50% or higher, when we exclude those patients with EGFR and ALK, the hazard ratio for overall survival is 0.42, the median overall survival was not reached in both treatment arms, and at five years, there are 84% of the patients in the atezolizumab arm, 67% in the control arm.

I think it’s also important that we have updated the safety profile in this new data cutoff. Overall, the safety profile was consistent with the previous analysis and no new safety signals were seen.

So, what we have seen in this presentation is that we have observed an overall survival trend in favor of atezolizumab in those patients with stage II-IIIA and PD-L1-positive tumors. The hazard ratio is 0.71, 91% confidence interval between 0.49-1.03. For those patients with PD-L1 50% or higher and a stage II-IIIA, the overall survival hazard ratio is 0.43. After additional follow-up, the safety profile remains the same, no unexpected safety signals, and we will continue to the final disease-free survival analysis, and also with further overall survival follow-up.

Christine Sadlowski:

What is the distinction between the patients with PD-L1 1% or greater versus those with 50% or greater? I understand the drug has actually been approved through those two different populations. In the United States and some other countries, it’s approved for those with 1% or greater versus Europe, it’s 50% or greater. Why the difference?

Dr. Enriqueta Felip:

Yeah. The approval of atezolizumab in the adjuvant setting was based on the disease-free survival, published and presented at ASCO. As you mentioned, there are two different approvals. In the United States, the approval is in patients with PD-L1-postive stage II-IIIA, and in Europe, it’s for those patients with stage II-IIIA, PD-L1 50% or higher, excluding those patients with EGFR and ALK.

We have seen that the hazard ratio is different in the two populations, but it’s true that when we presented the prior results, the analysis in patients with PD-L1 between 1-49% was exploratory, so this was not the main endpoint of the trial. So, the trial was hierarchically designed, one, first for patients with stage II-IIIA and PD-L1-positive tumors, then for patients with stage II-IIIA, and if positive, in patients with stage IB-IIIA. The disease-free survival in patients with PD-L1 50% or higher is a secondary endpoint, but the analysis in patients with PD-L1 between 1-49% was a post hoc analysis.

Christine Sadlowski:

So, what is the implication here for those two different populations?

Dr. Enriqueta Felip:

I think this is the first time in the adjuvant setting, this was the first study with results. We have also now the KEYNOTE-091, presented also in ESMO Plenary, showing that adjuvant immunotherapy improves disease-free survival in patients with completely resected and stage II-IIIA.

In my opinion, the results are clear for patients with PD-L1 50% or higher, but even for those patients with PD-L1 between 1-49%, we cannot exclude a benefit. So, as I mentioned, this is a post hoc analysis, so probably we need to individualize the treatment in this group of patients with stage II-IIIA and PD-L1 between 1-49%.

What we have seen in the cohort is no benefit of adjuvant immunotherapy for those patients with PD-L1-negative tumors.

Christine Sadlowski:

So, what is the timing for the remainder of this overall survival analysis?

Dr. Enriqueta Felip:

Yeah. So, during this meeting, we have updated the overall survival as prespecified in the first interim analysis. There are remaining other analyses of overall survival in the future, and we have not updated the disease-free survival. So, this is important, there are not enough events for the final disease-free survival analysis, and we calculate that we will have these events probably late 2023.

Christine Sadlowski:

So, overall you’d say these are still very positive findings, right?

Dr. Enriqueta Felip:

Yes. I think so. So, for patients with stage II-IIIA, the hazard ratio for disease-free survival is 0.66 in PD-L1-positive tumors. For overall survival, I mentioned there is a trend that is not statistically significant, but we have in this group of patients a hazard ratio for overall survival of 0.71, and we analyzed the patients with PD-L1 50% or higher, the hazard ratio for disease-free survival and overall survival is 0.43.

I have to say that according to the statistical design, you know, the study has a hierarchical design, so to formally test the overall survival, we need to have a positive disease-free survival results in the intention-to-treat population, and this is not happening with the present analysis, but overall, I think these are positive findings in patients with early-stage disease.

Christine Sadlowski:

What would you tell your patients at this point? They are receiving this treatment now, right? What do you tell them about this?

Dr. Enriqueta Felip:

No. I think we need to test for PD-L1, also early-stage of disease specimens. I think testing is important, not only for PD-L1, but also probably for EGFR and ALK in this scenario, patients with resected tumors, and I think we need to discuss with our patients these results, the hazard ratio of 0.43 for disease-free survival in PD-L1 50% or higher, and also, as I mentioned, probably to individualize the treatment for those patients with resected stage II-IIIA and PD-L1 between 1-49%.

Probably, it’s not the same, a patient with a PD-L1 of 40% or a patient with a PD-L1 1%, so there are a number of…also, we need to analyze the possibility of disease recurrence in each individual case in this group, that are those patients with PD-L1 between 1-49% and pathologically stage II-IIIA.

Christine Sadlowski:

Is there anything else you think clinicians should know about this?

Dr. Enriqueta Felip:

I think immunotherapy, this is one trial. As I mentioned, the results presented of KEYNOTE-091, and importantly, we have also results with neoadjuvant strategies.

So, CheckMate 816 is a trial published in the New England Journal of Medicine in patients that perhaps are slightly different because the patients are clinically staged. So, in our trial, in IMpower, the patients were included with pathological staging after surgery. In the CheckMate 816, patients were included with clinical staging before surgery, but it’s also an important trial showing that preoperative chemo plus immunotherapy improves, increases the number of pathological complete responses and also is associated with longer event-free survival.

Probably the situation is that the CheckMate 816, I think 60% of the patients included had the stage IIIA disease that was, as I discussed, diagnosed pre-surgery, but you know, overall, we are seeing that immunotherapy will be part of the treatment of patients with early-stage disease, probably excluding those patients with EGFR and ALK, and we’ll have also positive trials with neoadjuvant strategies and with adjuvant therapy.

Christine Sadlowski:

Thank you very much.

Dr. Enriqueta Felip:

Thank you. Thank you, Christine.

In treating most exacerbations of chronic obstructive pulmonary disease (COPD) the usual regimen consists of prednisone plus 5- to 7-days of antibiotics. But what if a shorter course of antibiotic therapy would do? That would be both convenient for patients and less likely to promote antibiotic resistance.

A recent paper in Therapeutic Advances in Respiratory Disease describes just such a strategy: patients received prednisone plus either 2 or 7 days of levofloxacin. There was no substantive difference in clinical results between the groups. Summarized in NEJM Journal Watch General Medicine as “practice changing,” this research seems worth a closer look.

To that end we’ve invited two of the researchers and the Journal Watch editor who wrote the summary to discuss the issues raised.

Have a listen to this 14-minute Clinical Conversation.

(A note of no great consequence: We’ve called this “Podcast 298” because, while numbering the titles, your host negligently skipped from 297 to 299 in his haste to achieve 300 episodes.)

Therapeutic Advances in Respiratory Disease paper

Journal Watch summary

TRANSCRIPT

Joe Elia:

A recent summary in NEJM Journal Watch Journal General Medicine labeled a study about treating acute exacerbations of chronic obstructive pulmonary disease — or COPD — as practice changing, so it seems important to spread the news.

To do that, we’ve got Dr. Daniel Dressler, the summarizer of the study, Dr. Salma Messous, the study’s first author, and Dr. Semir Nouira, a senior author, to discuss it with us.

Dr. Dressler is a professor of medicine at Emory University in Atlanta. He is also deputy editor of NEJM Journal Watch General Medicine. Dr. Messous and Dr. Nouira are in the Emergency Department and the Department of Laboratory Research at Monastir University in Tunisia. Welcome to you both.

Dr. Semir Nouira:

Thank you very much. Welcome.

Dr. Salma Messous:

Thank you very much.

Dr. Daniel Dressler:

Thank you so much, Joe. Welcome, again, to Dr. Messous and Dr. Nouira.

I’ll just jump in and ask you if you would agree with this thumbnail description of your work: You randomized approximately 300 patients with acute exacerbation of COPD to one of two antibiotic regimens, either a two-day course of levofloxacin — or a seven-day course, which is the usual care, so I’ll ask you if that’s correct and if you can tell us briefly why you undertook this study, and essentially what you found.

Dr. Semir Nouira:

Thank you, Dan, for your choice of our study. I’m very proud to be here and to be with you to explain the background of our study and the results of our study.

Our study is probably the first that compares a short course of antibiotic — as short as two days — compared to seven days’ conventional duration. We found that there are similar results, and that the two-day is as effective as seven days.

You know, actually the objective of the study is not to show or to demonstrate the similarity between short course and conventional course of antibiotics, this was clearly shown many years ago — I can say at least since 2008, since the publication of the first analyses comparing the efficacy between short and a conventional course. So years ago it was shown, this evidence.

This was not our question, and as you can expect, this is very important as a result to know, it’s very important, it’s very relevant because this would lead to less consumption of antibiotics, less antibacterial resistance, less adverse effects, and perhaps more compliance.

So this was demonstrated many years ago, but the question of the present study is the following: What is the shortest course of antibiotics that we can accept for our patient, COPD patients with exacerbation. This is the main question of the study, and you know that according to a recent recommendation of the GOLD, it is recommended that antibiotic therapy should not exceed five days, and some studies demonstrate that even with three days, we can have similar results as conventional duration. So for us, the question is, could we decrease the duration to less than three days? And that’s why we performed this study because according to in vitro and animal studies, antibiotic therapy has its maximum effect during the first hours, so why not reduce antibiotic therapy to the least duration?

This was the background of our study, and fortunately, we demonstrate that we had similar clinical outcome with respect to clinical cure, to the need for additional antibiotic therapy, to the need for ICU admission, and to the duration of the exacerbation-free interval. So this is the background of our study, and these are the main findings of our study.

Joe Elia:

I wanted to ask you, Dr. Dressler, why you consider the research practice-changing or potentially so. Is the 5- to 7-day regimen baked into the current guidelines here?

Dr. Daniel Dressler:

Sure, and thank you, Dr. Nouira for that answer and response.

I also appreciate that there have been maybe some other studies that have suggested shortening the course for COPD is probably appropriate, and yeah, still the GOLD guidelines or the international guidelines for management of COPD and COPD exacerbation still are recommending even in 2022 this 5- to 7- day course of antibiotics, and so I applaud you for what you’ve done, which is trying to see, well, can we get even shorter than the 5 days, even shorter than a 3 day course. I think that you were able to demonstrate that in your patient population the equivalence in outcomes even with a 2- day course compared to a 7-day course, and so I find that really valuable, really impressive. And you say it can also really help clinicians feel comfortable that they can actually shorten the course. Maybe it will impact or influence guidelines in the future to help maybe suggest a shorter course. So I think that is why I consider it a value-added piece of medical literature and clinical literature, and something that we can practice on and maybe practice changing for many clinicians.

Joe Elia:

You also noted in your comment, Dr. Dressler, that the findings need to be confirmed and more work needs to be done in this area, but I can see the advantage of having a patient only taking two days and not trying to take a seven-day course.

Dr. Messous, your design was practical in nature. By that I mean, some patients remained in the hospital even while on the two-day course if it was considered clinically prudent to do so, and of course, everyone received prednisone intravenously or by mouth, if they were at home. Do you think you’ve got enough data to recommend two-day regimen as routine, and do your hospitals use the two-day regimen now?

Dr. Salma Messous:

So, it’s a bit early to make recommendations. We need larger studies. This may allow us to better target our recommendations for the duration of antibiotic therapy, for example, according to their age, the existence of pulmonary edema, comorbidity, biomarkers, et cetera. So maybe Professor Nouira can add a comment regarding this question.

Dr. Semir Nouira:

Thank you, Salma, for your answer. What I can add as to whether there is enough data to recommend two-day regimen as routine treatment, the answer, of course, is no, because I think there’s not enough data for that. With the available evidence, we can’t recommend two days, but in my opinion, there are two recommendations and two directions for future investigation.

First, we must have more investigation to select patients who need antibiotics for COPD exacerbation. This is the first step, and it’s a big challenge now. It’s very widespread to give antibiotics, and unfortunately, until now, we don’t know the best profile of patients who really need antibiotics, so this is the first step.

The second step and the second direction, once the first step is clearly answered, is to try to know what is the optimal duration of the antibiotic course. I think it can be two days. It can be more. It can be less. It probably depends, as said by Salma, on the patients. Probably we will recommend antibiotic duration according to the patient’s characteristics, biomarkers or clinical characteristics such as age, sex, or comorbidities or something like that. So I think it’s really early to recommend a two-day antibiotic therapy for acute exacerbation of COPD.

Dr. Daniel Dressler:

Thank you for those answers to Joe’s questions.

I will say also that I’m glad you brought up patient population and determining which patients need antibiotics at all for COPD exacerbation. I think you all did a nice job in trying to identify those patients and not including patients that did not meet the sort Anthonisen criteria for requiring antibiotic therapy or potentially needing antibiotic therapy, so I appreciate that, and because we have other data that suggests that, potentially, patients with COPD exacerbation that are low risk, you know, whether or not they need antibiotics at all, you may be getting to some of that. I think your study did a very nice job even with only about 300 patients and it’s still comparable to many studies in COPD in terms of size, and so I appreciate the work that you all have done.

I’m wondering what has been the reaction of your colleagues related to this research and these outcomes that you found?

Dr. Semir Nouira:

You know, it’s a very big challenge to translate scientific results into clinical practice, it’s not easy at all, even in the developed countries — and the examples are numerous. You know, despite the evidence that a short course of antibiotics is as effective as conventional course, I think more than half of the physicians continue to prescribe antibiotic for at least seven days, and this is evident, so it’s a very big change, and for the Tunisian physician, it’s the same issue, of course — there’s no reason to be different, you know.

Perhaps, we need to do more to make our results more visible, so it’s the future of our effort. We must not limit ourselves to recommendation, but we must follow this recommendation and try to translate these recommendations into clinical practice, and this is our job.

Dr. Daniel Dressler:

Greatly appreciated, as well, and hopefully, we’re helping do something with you.

Joe Elia:

I want to thank you, Dr. Messous and Dr. Nouira, and Dr. Dressler for this chat today.

Dr. Semir Nouira:

Thank you, Joe.

Dr. Salma Messous:

Thank you, Joe, very much.

Dr. Semir Nouira:

Thank you very much, Dan.

Joe Elia:

We will call that the 298th edition of clinical conversations all of which are available free at podcasts.jwatch.org. We come to you from the writers and editors of the NEJM Group. Our executive producer is Kristin Kelley, and I’m Joe Elia. Thanks for listening.

THE USUAL AUDIO FILE IS AVAILABLE BELOW

Steven Cummings has co-written a take-no-prisoners editorial in the New England Journal of Medicine. The topic? Vitamin D supplements. The conclusion? “…providers should stop screening for 25-hydroxyvitamin D levels or recommending vitamin D supplements, and people should stop taking vitamin D supplements to prevent major diseases or extend life.”

Dr. Cummings was commenting on research findings from the VITAL trial, also published in the journal, showing no fracture-lowering benefits of the supplements.

Allan Brett interviews Cummings to get the details on his pronouncement, and it takes just 13 minutes to dismiss vitamin D (which, by the way, is not a vitamin at all).

NEJM presentation of VITAL results

Cummings and Rosen editorial

THE USUAL AUDIO FILE IS AVAILABLE BELOW

Your host is old enough to remember when hospital corridors featured physicians with little black bags, scurrying around to see their patients.

That’s no longer true, of course. Most of the physicians seen in those corridors these days are white-coated employees.

The Annals of Internal Medicine reported a few months ago that “By 2018, 71% of newly certified general internists practiced as hospitalists, compared with only 8% practicing as outpatient-only physicians.”  In addition, between 2008 and 2018 mixed-practice physicians — those black-bag-carrying types — declined by over 50%.

To investigate this shift, we gathered five young internists for a roundtable discussion on the attractions of the hospitalist specialty.

Running time: 30 minutes

Annals of Internal Medicine article

In this edition, we address the question with a conversation between Dr. Allan Brett, NEJM Journal Watch‘s editor-in-chief, and Dr. Seemant Chaturvedi, a University of Maryland neurologist who serves on CREST-2’s executive committee.

[Running time: 16 minutes]

NEJM Journal Watch coverage of a recent JAMA paper on the topic.

In a small-cohort study presented at this year’s ASCO conference researchers used a PD-1 inhibitor — dostarlimab — every three weeks for 6 months against the disease. All patients had mismatch repair deficient tumors. No other treatments were needed however, since the 12 patients all attained complete response if they completed the regimen.

As part of the NEJM Group’s coverage of ASCO, Christine Sadlowski interviewed the study’s first author, Dr. Andrea Cercek of Memorial Sloan Kettering Cancer Centern about the study and its implications.

The study as published in the New England Journal of Medicine

However, Dr. Shanu Modi of the Memorial Sloan Kettering Cancer Center and a group of international collaborators explored the use of a monoclonal antibody–drug conjugate (trastuzumab–deruxtecan) in patients with disease they classify as HER2-“low.” Compared with “low” patients treated with one of several standard-of-care regimens, those receiving the conjugate therapy had greater median progression-free survival (roughly 10 months versus 5) and a longer overall survival (roughly 24 versus 18 months).

Christine Sadlowski of the NEJM Group interviewed Dr. Modi during the Group’s coverage of this year’s ASCO meeting, where Modi presented her results.

Have a listen.

Modi et al. as published in the New England Journal of Medicine.

In a fascinating 15-minute chat, two intensivists, Drs. Patricia Kritek and Robert Truog, discuss that question and another, larger one: what is death, anyway? Their back-and-forth was prompted by a recent debate, published in Chest, between two others —  a clinician and a law professor.

Have a listen, and please leave a comment to help guide future editions.

The Chest article

The New Yorker article mentioned by Dr. Truog

Listen to our 13-minute interview, which raises the question: Should you send your patients to non-unionized facilities?

Health Affairs article

This edition carries Brett’s advice on using the new guidelines in daily clinical practice.

Brett’s JAMA editorial

USPSTF recommendations in JAMA

[Running time: 15 minutes]

Patricia Kritek practices critical care medicine at the University of Washington. In this edition, she pilots a discussion with Todd Rice of Vanderbilt. He has studied the problem carefully, having published two studies in the New England Journal of Medicine in 2018; more recently, he’s written a meta-analysis of the problem in NEJM Evidence.

Listen in on a truly clinical conversation.

[Running time: 16 minutes]

This time, she relates how she lost a colleague in Russia’s attack on the Kramatorsk railway station and found another she’d feared lost in Mariupol. She told us that she’s impressed by her patients’ willingness to fight, despite their opioid dependence.

The narrative can be confusing at times, and following closely will require having a map of Ukraine handy. A technical glitch or two complicated things, but you’ll get the main idea: Ukraine needs help.

[Running time: 15 minutes]

Lipton’s group sought to characterize the impact of patients’ monthly headache days on their quality of life, especially the role of depression, allodynia, and anxiety. (Read the conference’s abstract here.)

[Listening time: 14 minutes]

Please leave a comment below to suggest how we can improve these interviews.

Dr. Natalia Shevchuk (pictured above) treats substance use disorders in Ukraine’s Donetsk region. Her face is candlelit because her town is under curfew, and people aren’t allowed to put on their room lights (if they have electricity) in the hours of darkness, lest Russian bombardments use the lights as guides.

She talked with Dr. Ali Raja and Joe Elia via Zoom about her work and her concerns for colleagues in Mariupol she’s not heard from for weeks. It’s wartime and nothing is running as usual.

But let her tell you all about that.

Here is a transcript.

[Running time: 20 minutes]

[Listening time: 24 minutes]

Journal Watch summary on the guidelines

American Journal of Gastroenterology containing the guidelines

Transcript of the discussion

A neurologist in Chernihiv, Serhiy Kareta, and a Ukrainian American trauma surgeon based in Philadelphia, Roxolana Horbowyj, join the Mass. General’s Ali Raja and NEJM Group’s Joe Elia in a conversation about the clinical situation in Ukraine and what listeners can do to help.

Here is a link to the Ukraine Ministry of Health’s humanitarian needs list

Transcript of the interview

[Running time: 20 minutes]

The views and opinions expressed in these blogs are not necessarily those of NEJM Journal Watch or NEJM Group.

Dr. Susan Hopkins, the senior author of the paper just published in the New England Journal of Medicine, explains SIREN’s results. The short version is that the vaccine was effective — up to 85% after the first dose — and its protection waned to about 50% some 6 months after a second dose. Among those who were seropositive before the arrival of the vaccine, vaccination showed a remarkable 90% effectiveness after the first dose, and that effectiveness remained high more than 18 months after their earlier infection.

New England Journal of Medicine study

[Running time: 11 minutes]

Transcript of the interview

About half the patients subsequently received at least one shot of the Pfizer-BioNTech vaccine, and all were followed over a period of some 9 months. Arbel’s group, using the patients’ health records, tracked how many became reinfected with Covid-19 — during that interval, the Delta variant was predominant. They found that reinfection was roughly fourfold higher among the unvaccinated; they also observed less benefit among patients aged 65 and older; in addition, the results from one or two shots were statistically the same.

Listen in to what this means for practicing clinicians.

[Running time: 15 minutes]

New England Journal of Medicine

TRANSCRIPT OF THE INTERVIEW 

Joe Elia:

We have all heard people say that they have had COVID-19 and as a result are immune, but would vaccination boost that naturally acquired resistance?

You’re listening to Clinical Conversations from the NEJM Group. I’m Joe Elia, and I’m joined by my co-host Doctor Ali Raja who is in the department of emergency medicine at Mass. General Hospital and a professor of emergency medicine at Harvard Medical School.

We’re about to interview Doctor Ronen Arbel on Zoom from Israel. His paper on the effectiveness of the Pfizer BNT vaccine among the recovered has just been published in the New England Journal of Medicine. Doctor Arbel does health outcomes research at Clalit Health Services and lectures on health systems management at the Ben-Gurion University of the Negev. Welcome Doctor Arbel.

Dr. Ronen Arbel:

Thank you for having me. It’s a great honor.

Dr. Ali Raja:

Thank you, Doctor Arbel. First of all, could you please for our listeners describe briefly the problem that you and the team investigated?

Dr. Ronen Arbel:

Okay. So, if you look around the U.S. CDC, European CDC, or the UK, each one has a different policy regarding when and how should I vaccinate the recovered subjects or patients for COVID-19, and they all say we don’t have any evidence. If we start with the…I think the most extreme is the United States. CDC said “We don’t have any evidence, so let’s ignore. We are ignoring your infection-induced immunity and you’re going to get vaccinated.”

Like all the others, the EU and other countries than the U.S. have other policies. The UK has a different policy. Israel has a different policy, and they all said “We don’t have evidence.” The only evidence actually that we found when we looked at this was a 600-patient study from Kentucky, which is probably not enough for significant evidence for the world. So, we thought this was a very important clinical issue. We always look what is the clinical question.

I’m a physician. I have a patient who recovered. Should we vaccinate? What would be the benefits? Of course, are there any safety issues? And that was the question. We had no clue what is the answer.

Dr. Ali Raja:

That makes perfect sense. And you mentioned the smaller study from Kentucky. It looks like you did this by reviewing the medical records of some 150,000 people in Israel who’d recovered from COVID-19. Is that right?

Dr. Ronen Arbel:

Yeah. Actually, we looked at all the patients in our healthcare organization [Clalit met the eligibility criteria. So, that was the number. It was for nine months, not just for a couple of weeks — a couple of months was done in Kentucky.

Joe Elia:

And the Clalit organization — you used their medical records. They ensure — or care for — I should say, about half the population in Israel. Is that correct?

Dr. Ronen Arbel:

Yes. 54 percent. And about two thirds of the patients above 65.

Joe Elia:

So, briefly, what did you find? Your primary and secondary findings, what were they?

Dr. Ronen Arbel:

So, the primary finding, first of all, we saw an interaction with age, so that’s why we recorded by two age groups. Up to 65 years old, we saw about 80 percent reduction in reinfection rates and the other rate was about 60 percent reduction.

Joe Elia:

In the older group.

Dr. Ronen Arbel:

Yeah. In the older group. That’s our main findings. What is very interesting we think, it’s only secondary, but very interesting, with one shot is enough. We didn’t see any benefit, any additional protection from a second shot. It was our hypothesis by the way. It’s very interesting that you said “boost natural immunity.” That’s the way we look at it. I mean, you can see there are a lot of studies that show the infection-induced immunity is at least as good as vaccine-induced immunity.

Of course, if you survive COVID and all the problems (long COVID), then the question, if it’s similar to a primary vaccination then it’s really reasonable that one shot will act with some kind of booster, which was your first word, right? How do you boost natural infection-induced immunity?

So, this is the biology that we saw. It was a nice study and it’s very similar to our results on the second one. I think it’s important because I think Eric Topol said, “You know, why does the CDC ignore [natural immunity]?” It’s like you’re already reading over our paper.

You want your patients to get vaccinated, it has to make sense. You cannot say “Ignore it; we don’t care that you are recovered.” I mean, the science says it does matter, but still, importance of study, you have a protection from your infection-induced immunity, but you can boost it and you should boost it by a vaccination, but a single one is enough.

Joe Elia:

And this work was done mostly, maybe even exclusively, among those who recovered from the Delta variant. Is that right?

Dr. Ronen Arbel:

No. Exposure was to the Delta variant. Some of them recovered from the original, the wild type and some from alpha. Okay. After Delta, by the way, there were very little reinfections. What we see now, we saw in Delta many more reinfections and you see in Omicron really much, much more reinfections. But after Delta, the numbers were really, really small. So, I think it was a very important to see what happens with the Delta.

Dr Ali Raja:

So, given the fact this was an exposure of the Delta variant, any thoughts about what this might mean with Omicron?

Dr. Ronen Arbel:

I was sure that you’d ask. Of course, it’s a great question. We don’t have a study on that yet. It’s probably too soon, but if we look at what…if we can learn from the past (which I’m not sure in COVID, right?) you see that in beta you didn’t see any reinfections. In Delta, you saw many more reinfections. In Omicron, you see many, many more reinfections.

Hopefully, we did not check this, we need to research this. We can hypothesize, I’m not sure what the results will be, but we’ll have I don’t know if a similar effect, but an effect of the vaccine on your reinfection risk. But the basic reinfection risk, that’s very clear.

The basic reinfection risk is going higher and higher. It was higher in Delta, and it was much higher in Omicron. So, if we assume…we’re not sure. If we assume that we have a similar effect and since the basic reinfection rates are much higher, the absolute effect should be higher assuming the same hazard ratio, but again, we did not research this yet. So, it’s just an assumption.

But we need to act all the time, and Israel is doing it, you can see like the fourth vaccination and the uncertainty. I mean, we don’t have evidence. We can just look at what we understand until now. That’s why Israel decided on a second booster, right? — a fourth vaccination — because the first booster was a huge success. Is the second booster a huge success?

We actually have some results on this, and our results are not published, but the minister in Israel published. It’s too soon to really tell but the decision was made. You don’t have time. Do we have the luxury to wait to see if vaccination helps in Omicron? No. It’s spreading like crazy.

Dr. Ali Raja:

That’s a great point. So, much of what public policy has been based on has had to be the data that we have available now even though we’re doing studies, and there will be more data in just a few weeks or months. You mentioned, Doctor Arbel, that the lack of a difference between one shot and two wasn’t a huge surprise for you because it makes sense given the modeling, were there any results that you did find surprising?

Dr. Ronen Arbel:

We actually did not know what would be the effect. I think 80 percent was probably higher than what we thought. We did not expect that in the older age group [vaccination would] have less of an effect. This age group interaction was discovered in the analysis, and we didn’t know. We don’t know when we go into the study what the results will be. I must point out here, it’s very important to say this is not in any way funded by Pfizer or any other company. All of our researchers are totally unbiased really and I think it’s very important.

So, we report what we find and don’t look at what will Pfizer…you know, they may like the first part. They probably don’t like the second part because you don’t need a second vaccination or a third vaccination. So, we are very strict not to get industry funding for these studies to make sure to really…I think it’s important to ensure that there is not even…of course, we are unbiased, but to make sure there is not even a suspicion of bias. Okay.

So, we can freely report what we see and be focused and that’s the advantage of our team that has all the clinical physicians who are leading this effort in Israel. They always push for the clinical question: “Should I vaccinate? How many vaccinations should I do?” These are really important clinical questions. That’s what we’re trying to answer.

Dr. Ali Raja:

So, let me actually ask you Doctor Arbel, I’m an emergency physician. I see patients every day, many of whom have had COVID, and they’re recovered. Some of those…fewer here in Massachusetts, but many still here and around the country look at me and say I just had COVID, I don’t need to get vaccinated. What does this mean in terms of the conversations I have with them, or a primary care doctor, or a pediatrician, what does this mean for the physicians who are actually seeing patients who have had COVID? What can we use this data to say?

Dr. Ronen Arbel:

So, the easy answer is, “You recovered from COVID, you have some coverage, but you can improve it significantly, dramatically, by one more vaccine.” I think it’s very simple.

Joe Elia:

Okay. Well, we want to thank you Doctor Arbel for your time with us today.

Dr. Ronen Arbel:

Thank you. It’s a great honor.

Joe Elia: The pleasure is ours, but what’s the next step? Are you going to be investigating Omicron and its effects?

Dr. Ronen Arbel:

So, right now, we are looking in I think some of the major clinical questions, a second booster. The real-world effect on this of oral medication. Especially Pfizer. Especially in the vaccinated because all these studies have been done in unvaccinated patients. Most of these patients are vaccinated. This is a big question. We don’t know from the RCTs [randomized trials], is it working on vaccinated patients? We should have the results soon.

Dr. Ali Raja:

Those are exciting. That is such an important question.

Joe Elia:

That was our 282nd Clinical Conversation. We come to you from the NEJM Group and the writers and editors of NEJM Journal Watch. Kristin Kelley is our executive producer. I’m Joe Elia.

Dr. Ali Raja:

And I’m Ali Raja. Thanks for listening.

In a capitalist democracy, many parties — the drug companies, medical associations, consumer groups — get to lobby their points of view. Is the problem intractable, or just an exercise in chaos?

Our three guests have written a book about the problem, “The Right Price: A value-based prescription for drug costs.” And although they don’t have a definitive answer, they do offer recommendations, interesting observations, and a way forward.

Listen in and let us know what you think.

[Running time: 26 minutes]

“The Right Price” (Amazon link)

TRANSCRIPT

Joe Elia:

The US has the highest drug prices around, right? And it threatens household as well as governmental budgets. Who sets those prices? What is their basis?

You’re listening to Clinical Conversations from the NEJM Group. I’m Joe Elia and I’m here with the authors of a book that came out last year titled, “The Right Price: A Value-Based Prescription for Drug Costs.” The authors are Drs. Peter Neumann, Joshua Cohen, and Daniel Ollendorf — all of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center.

Welcome.

Well, we could quickly drown in numbers here, so let’s get some out of the way, immediately.

One is that US prescription pricing amounts of some $500 billion a year. And the other that I’d like to cite is our per capita spending on those drugs, on those prescription drugs, is at least twice that in the United Kingdom.

So, there are more numbers, but let’s get around to your book. As the book’s first author, Dr. Neumann, you’ll get the first question, but anyone’s allowed to answer at any point. So, why did you write The Right Price and what has the reaction to it been?

Dr. Peter Neumann:

Well, thanks, Joe, for having us first of all.

We wrote this book because the conversation around drug prices is very important, but it tends to focus on the level of prices, not on the value that the drugs deliver. And we thought it very important to try to orient the debate around drug value and not drug prices.

Everyone wants lower drug prices, of course, we do too, but the really critical question is what value the drugs are delivering, and how do we think about that, and what’s an acceptable price, given the value? And so far the reaction to the book, I think, has been quite positive. We’ve spoken to many audiences and had a lot of positive feedback from people. And I think, and we hope, that it’s contributing in a constructive way.

Joe Elia:

People who read medical literature often come across the acronym QALY. Can somebody explain that in 10 seconds or less?

Dr. Joshua Cohen:

Maybe I’ll take a shot at it. So, a QALY is just a life year, but we scale it to also account for health. So, are you in pain — are you functional, and so on? A “one” corresponds to the hypothetical state of being in perfect health; “zero” is the equivalent of being dead, and the rest of us are in between; closer to 1 is better.

Joe Elia:

Thanks, Josh, that was close to 10 seconds. So, somebody who’s not feeling well a lot would probably score only maybe a 0.6 out of 1 or 60 percent of 100. And so, you would say a year in that person’s life would represent 0.6 QALY’s.

Dr. Joshua Cohen:

Yeah. I mean, actually, 0.6 would be really someone in quite a bit of discomfort or you know loss of function, but yes that’s the idea. Someone who’s, you know, in very poor condition would have a number like that.

Joe Elia:

Okay. So, one organization, the Institute for Clinical and Economic Review (or as I think of it as “ICER”) gets a lot of mention. And we should mention as well that Dr. Ollendorf worked there for about a decade, I think. What is ICER and what does it do?

Dr. Daniel Ollendorf:

So, ICER in the parlance of the day is known as a health technology assessment organization. So, it does its work along the same lines that many other agencies and organizations internationally, such as NICE in England or the Canadian Agency for Drugs and Technologies in Health or CADTH in Canada, do. Essentially, it’s an organization that is focused on understanding the clinical evidence on new and emerging technologies. So, to Josh’s point, what kind of benefit…or to Peter’s point, what kind of benefit the new treatments might bring? And also, to understanding questions about the cost-effectiveness and the impact on the budget that these new technologies might bring as well.

So, really using state-of-the-art scientific techniques to understand the value equation that we talk about in the book.

What kinds of clinical benefits are being brought by the drug? How is that balanced out against the possible harms that the drug or technology might be causing? And what’s the price? And does that price align using a QALY as a measure of benefit? Does that price align with the value that the drug or technology is bringing?

Joe Elia:

Now, it’s not a government organization is it?

Dr. Daniel Ollendorf:

It is not. So, the US is a bit of an outlier in comparison to other developed nations, because we have no formal step to do this work. So, ICER does this as a private organization and so is limited only to making recommendations to patients, clinicians, payers and others about what a price — a value-based price — might look like and what the evidence is saying about a new treatment.

Joe Elia:

And as you said the UK has got this organization called NICE, but we don’t have one in the United States. And as I read your book, and as I’ve been reading through my life about the politics of medicine, I have the sense that the lobbying of the drug companies of medical organizations, et cetera, have a lot to do with the fact that ICER can’t be a governmental agency because they’ve been lobbied out of the government. Is that fair?

Dr. Daniel Ollendorf:

Yeah, well it’s a bit of an interesting history. So, in fact, one of the ironies here is that organizations like NICE are using methods that were, in fact, pioneered here in the US. So, we used to have government entities who did this work: the Office for Technology Assessment, the National Center for Health Technology. These were not formal agencies in quite the same way. They were more Congressional advisory services, but they provided a lot of this information and information on health technology to decision-makers and policymakers.

I think those early efforts were scuttled in part due to lobbying, not necessarily from the pharmaceutical industry. In fact, the medical profession was quite concerned at the time about this kind of work being done outside of the profession itself. But recently, it has been the case that lobbying from patient advocacy groups and from the pharmaceutical industry has prevented any sort of formal step like a NICE to be taken here.

Dr. Peter Neumann:

And I would add, Joe, the politics of this are quite tricky. There’s ideological opposition to the federal government playing too strong of a role in many areas including health technology assessment. And the rhetoric you often hear is that — at least from some places — we don’t want the federal government to get between doctors and patients in their ability to make their own decision. So, in addition to the lobbying, which we suggest and is real, I think we shouldn’t underestimate that just ideological opposition.

Joe Elia:

As I read your book I realized how complicated. I was telling myself things like, well, it’s not brain surgery — it’s worse!

Because trying to figure this out, increasingly these days, I’m reminded of what Rudolf Virchow, the founder of cellular pathology, said about medicine, and he said this in the 19th century. He said that medicine is a social science. And it seems to me that drug pricing is kind of a proof of that, that every piece of society has a stake in this. And because it’s a democracy it becomes less tidy than it otherwise might be.

You know, you hear things about, well, you know the price is “what the market will bear” and the realization is that the pharmaceutical, the drug companies sell stock and so they’re interested in having good value in their stock. But there’s a tradeoff between the interests of society and the medical and the pharmaceutical industry. Are we looking at a situation that’s going to continue to evolve and we’ll never solve this equation? It’s not like algebra, there’s no, there’s no X equals something at the end of the day. Could you comment on that?

Dr. Peter Neumann:

Well, we emphasize in the book how complicated the market for prescription drugs is. And in many ways it’s just a reflection of how complicated the healthcare system in the United States is with so many different players. We talk about all kinds of issues on the requirements, let’s say, on the demand side of the market. We have insurance. We have third party payers. We have this phenomenon that when a patient takes a drug and benefits other people benefit. On the supply side we have patents, we have regulation, we have many, many players in between the drug companies and the ultimate consumer, the patient, and on and on.

These complexities to some extent, of course, will always exist, but we argue in the book that we can at least help things along by providing better information to the marketplace on the value of prescription drugs by measuring value and disseminating that information. We argue that this is something that individuals and even individual payers can’t do very well by themselves, but really in our view it takes an organization like ICER, or perhaps in the future some government organization, to help things along.

Joe Elia:

Yes.

Dr. Daniel Ollendorf:

I might add in that, so we know that the Build Back Better Act, which did have some discussion of drug price reform in it, is sitting dormant in Congress. But I think what gives us some hope that something may be done to better integrate value into this conversation is that there still is a lot of interest in doing something. Whether that is a slimmed down version of Build Back Better or whether there is something that CMS will do on its own is an open question, but I think that there is still some energy and some enthusiasm. What we don’t know from the discussions is what sort of approach to drug price reform will be taken. Will it be some kind of across the board price controls or will it be a value-based approach? And we, obviously, argued for the latter.

Dr. Joshua Cohen:

You know, I think it’s important to emphasize something. You know Peter was talking about this, but you know at some level its like, “Wait a minute, why are drugs so complicated?” You know it seems like they’re different from all the other products that we buy, you know, from the trivial — we mention toothpaste in our book. We don’t have a toothpaste technology assessment agency, you know, looking at what the price of toothpaste should be or, even more important, you know less trivial products like cars and houses, and things like that. So, you know, what is it about drugs?

And what Peter said gets at that, which is on the demand side, you know, consumers are not patients, they’re not really in a position to choose drugs in the same way that they choose their toothpaste, right? There have to be a lot of other parties involved. There are clinicians, primarily, and on the supply side we can’t just have the sort of normal competition where, you know, different companies compete and bring the costs down to, or the price down to the marginal costs of production. And that’s because you have to have patent protection on these products, because they’re so easy to copy.

And so, that means that we can’t have the normal, you know, individual producers and consumers just interacting with Adam Smith’s invisible hand, and everything works out great. Instead, we have to collectively figure out what the price should be. And that gets to what you said earlier, which is this becomes a social enterprise, and that’s what we’re talking about.

Joe Elia:

Yes. In the United States we have offered a monopoly to the drug companies, a limited monopoly, for some time. And the argument that’s adduced, and that you bring forward in your book as well, is that, well, without this monopoly the drug companies have got no incentive to innovate, which I found — okay, so what would those companies do if they didn’t have that incentive? Would they go out and make lawnmowers or you know toothpaste?

Dr. Joshua Cohen:

Well, I mean, I think what would happen is that those companies, the capital that is behind them, it’s not so much that, like, the companies would decide something, but the capital would move elsewhere and you know the people with those skills would move to do something else. And so, we would not have, you know, if a lot of these medications sold at their cost, their marginal cost of production, they could be pennies a pill and you just would never get the kind of resources you need to attract all the people you need and the risk that’s involved the many years. You know there’s so many drugs that are investigated, molecules that are investigated, that then go nowhere that, you know, you just would not get anywhere near the kind of innovation that we get.

Dr. Peter Neumann:

And Josh’s point raises just a question that gets back to the title of our book, The Right Price. That you know we worry a lot about too high prices, understandably, but there also is a problem if we have too low prices. And so, the right price, again, is the value-based price. The price that we hope delivers the value to the consumer, but also provides the right incentives to be producers to innovate and to innovate for the next products.

Dr. Daniel Ollendorf:

So, to be clear the right price can be very high. So, if you have a gene therapy that cures a universally fatal disease that occurs in childhood, and you’re allowing that child to live something close to a complete life, that therapy can be very expensive. A million dollars, 2 million dollars might not be too high.

Joe Elia:

Right. And so, there are ways of determining what a price might be, and you talk a lot about those in the book, and this is where we start swimming in the big pool of numbers, if you’re so inclined. I’m not so inclined, but if there is an example that you would like to bring forward about this I’d be happy to hear it. Is there an approach that you might use to illustrate this?

Dr. Joshua Cohen:

I don’t know. I mean, let me take a shot at it, you know? We tell the story of how…in the book of how these methods came about. And they came about, you know, not because someone sat down one day and said, you know, we should do health economics and let’s start writing down the theorems that underlie that science. Instead, they were trying to solve, you know, pretty straightforward problems of the day. And those involved like, you know, hey, if we can save some lives what’s that worth?

And so, at first people were like, well, what’s a life worth? And then the limitations of asking that question became apparent because it was like, well, are you talking about saving the life of someone who’s 85 or someone who’s much younger? And what about the quality of life? It’s not just about extending life it’s about the quality of life. And then it’s like all right, well, how are we going to estimate things like, you know, an extra year of life or an improvement in, you know, freedom from pain? These are not things that you can estimate by going to the marketplace and seeing what price people place on these things, because they’re not bought and sold explicitly.

But economists came up with different ways of imputing these values by looking at decisions people make, for example, you know tradeoffs between large cars and small cars. Now, there are a lot of reasons why people buy large cars versus small cars, but one of them is implicitly that the large car has more safety. So, they are implicitly buying health there. So, that’s one approach. Or you can actually ask people, you can hypothetical, you know, if there were a pill that could extend your life by this much, you know, what would it be worth to you? So, there are different ways of doing it. They all have limitations, but that’s the basic thumbnail sketch of how the science of estimating the value of health evolved.

Joe Elia:

Well, you end your book with some recommendations, and you gave a nice definition of the QALY early on, and I think the book says let’s stick with it because it’s, if nothing else, a standard measure. Even though, sometimes, people say, well, it’s not that standard, but it’s the closest one we’ve got to a standard. Is that right?

Dr. Peter Neumann:

Well, I think, and we say this in the book, that the QALY is imperfect, it has its own challenges and problems, but it is useful as a kind of benchmark for value. And it’s a starting point, as we say in the book, the cost per QALY ratio as a measure of value is a starting point, and we think a good one, for this conversation about value. Other things may certainly enter the equation.

Dr. Daniel Ollendorf:

And it’s important to realize that all health technology assessment organizations, ICER included, think of the cost per QALY equation, the value equation, as an input into decision or recommendation making, not the sole driver. So, you need to look at the clinical evidence. You need to understand how severe the condition is and what the level of unmet need is in that condition. What’s the public health burden associated with it? So, there are lots of other deliberative and ethical aspects that go into that conversation.

Joe Elia:

And one of your recommendations, and you are all fans of ICER or something that would evolve from ICER, you say that ICER should be more transparent in its analyses. So, in other words they should be giving people the wherewithal to reproduce the calculations that they make.

Dr. Joshua Cohen:

Yes. So, of course these issues are extremely controversial and the only way that we can, I think that we can really make progress towards some sort of consensus on what the price of a particular therapy should be is if at least we can agree on the analysis, the facts, so to speak. And the best way to do that is to lay bare what we’re doing. So, when ICER or another health technology assessment organization does their analysis the best way that they can convey what they’ve done is to say, look, here’s our model, here’s our computer code. You can look at it. You can change it and see how different assumptions affect the answer. Then, at least, we can argue about what the right assumption should be rather than, you know, just kind of not being able to reach any consensus. Because I can’t really tell what you’re doing and we’re stuck.

Dr. Daniel Ollendorf:

We also argue that everyone in the ecosystem needs to do this. So, a lot of these analyses are sponsored by pharmaceutical companies and they need to be open with their models too.

Joe Elia:

It’s a good book, I have to say. This is not a book review, but I’ve learned a lot reading it and I think that anyone who’s going to be a student of drug prices or clinicians who are taking a course in it would benefit from your book and I want to congratulate you. Is there a question that I have not asked that you wish I had?

Dr. Joshua Cohen:

You know, I think one thing that would be helpful is just even a simple explanation of what is a cost-effectiveness ratio, because, I think, especially you said that young clinicians are your audience. And so, you know, cost-effective ratio sounds really technical, but what a cost-effectiveness ratio is, is it’s the incremental cost per unit of benefit. Even that sounds complicated, but it’s really just a price. So, you know, if I go out and buy a gallon of milk, you know, 4 dollars per gallon of milk, the cost per unit of good thing, the milk, that is better than 5 dollars per gallon of milk.

So, we want low ratios, that’s good, and higher ratios are not as favorable. And to determine whether something…whether we’re paying too much for something we look at the ratio and we say, hey, you know if we’re paying 50,000 dollars for a quality-adjusted life year for this medication, if that’s what it’s giving us, is that a good price or does the price need to be lowered so that the cost-effectiveness ratio is lower, that is more favorable?

Dr. Peter Neumann:

I think the other problem we didn’t get to, and I think is important for your audience, is even if we get to value-based prices there’s still this affordability issue for many people that will remain. In other words, the value-based price, as Dan said, could be quite high. It could be a million, 2 million dollars for a gene therapy. There’s a separate problem of out-of-pocket costs rising for many, many patients and that needs to be dealt with as well through insurance reforms. And there’s legislation that’s being discussed to do things like that.

Joe Elia:

Okay.

Dr. Joshua Cohen:

And that’s something that is towards the end of our book. It might even be in chapter 11, I can’t remember. So the way to fix accessibility is not to say, “Well, let’s make the price really low,” because then you run into an innovation problem. You want to have the right price, but then as a society we need to figure out how can everyone get access to the therapies at that right price? And that’s insurance reform.

Joe Elia:

Okay. I want to thank you Dr. Neumann, Dr. Cohen, and Dr. Ollendorf for your time with me today. And I want to mention, once again, that your book, The Right Price, is available (for a right price, I hope) from the Oxford University Press.

That was our 281st Clinical Conversation. We come to you from the NEJM Group and the writers and editors of NEJM Journal Watch. Kristin Kelley is our executive producer, and I’m Joe Elia, thank you for listening.

CDC worked with several hospitals around the U.S. to discern whether vaccination in adolescents would lessen the likelihood of this outcome. A vaccine hadn’t yet been approved, as it now is, for kids between 5 and 11).

The bottom line is that vaccination with BNT162b2 (colloquially known as Pfizer-BioNTech) proved over 90% effective in preventing MIS-C.

Listen in as we discuss the work with CDC’s Laura Zambrano. The interview runs about 15 minutes.

The article in MMWR (free)

TRANSCRIPT

Joe Elia:

Multisystem Inflammatory Syndrome in Children or MIS-C is a troubling complication of COVID-19 infection. Does vaccination lower the risk?

You’re listening to Clinical Conversations from the NEJM Group. I’m Joe Elia, and I’m here with a principal co-author of a paper in MMWR published last week.

Dr. Laura Zambrano, the senior epidemiologist in the [Multisystem Inflammatory Syndrome] unit, which is a part of CDC’s COVID-19 Emergency Response Task Force, is here with us. Welcome, Dr. Zambrano.

Dr. Laura Zambrano:

Well, thank you. And thank you so much for having me.

Joe Elia:

You’ve been busy there at the CDC, I’ll bet. What prompted this research into MIS-C and how did you go about doing it?

Dr. Laura Zambrano:

MIS-C, as you mentioned, stands for Multisystem Inflammatory Syndrome in Children. And we understand it to be a post-acute hyperinflammatory syndrome that generally occurs between two and six weeks after a child tests positive for SARS-CoV-2. And it is a severe syndrome. It is characterized by fever, systemic inflammation and affects multiple organs throughout the body with a combination of severe cardiac, respiratory, gastrointestinal, mucocutaneous, hematologic, neurologic, or renal complications.

MIS-C was first described among patients in the United Kingdom and then in New York City in the spring of 2020. And since then, it has been reported worldwide. And higher MIS-C incidence really closely follows peaks of reported SARS-CoV-2 circulation, and it’s really a function of the number of infections reported among children. As of last week, we have received over 6,400 reports of children with MIS-C meeting our CDC case definition. And given the occurrence and recent surge of COVID we are anticipating, unfortunately, that a wave of MIS-C will soon follow, so we have our eyes on that.

So, all that to say we understand that severe outcomes related to COVID-19 can, and absolutely do occur in children, and MIS-C is one of them. And this is an outcome we are clearly hoping to avoid in children. We already have many studies that broadly show high vaccine efficacy and effectiveness against SARS-CoV-2 infection and severe COVID disease, but real-world effectiveness against MIS-C is a little bit trickier to assess. For one, MIS-C generally occurs after infection and can follow infections in children that are generally milder or even asymptomatic. And we felt we needed to quantify the degree of protection inferred by a vaccination against MIS-C in addition to some of these other analyses that have examined severe COID-related outcomes.

Joe Elia:

You describe the work as a test-negative case-control design, so could you oversimplify that for me?

Dr. Laura Zambrano:

Sure, of course. In any case-control study we’re looking to enroll patients who have a specific syndrome or outcome. And then we’re interested in exploring on a broad basis what exposures may have led to that outcome. And here, of course, the exposure is vaccination, really the protection. You know the exposure here is not being vaccinated, right, and development of MIS-C. So, what a test-negative case-control analysis involves, generally this is a standard study design used for other vaccine effectiveness studies: we take patients with a specific outcome, in this case MIS-C, and we match them to hospitalized controls.

In this case, these were hospitalized controls who fit into two categories: they either had a respiratory or COVID-like illness and actually tested negative for COVID-19 in the hospital generally by RT-PCR or possibly antigen, generally RT-PCR; or they could be syndrome-negative completely. And so, these could be children who are hospitalized for any other number of reasons, you know, they could be hospitalized, for example, as a trauma victim, but of course without any COVID-related symptoms. And so, we essentially pooled those together ultimately in our analysis, but one thing to note is that the vast majority, of course, of our syndrome-negative patients also tested negative for SARS-CoV-2 upon hospital admission.

Joe Elia:

Okay. And the way that you collected these cases, Dr. Zambrano — you had people across the country contributing these records. Can you talk a little bit about that?

Dr. Laura Zambrano:

Oh, yeah. So, this actually goes into this longstanding relationship that the CDC has had with Boston Children’s Hospital. And Boston Children’s Hospital has led a hospital network, and this is led by Dr. Adrienne Randolph who is really our principal investigator there, and the purpose of the original network was really to examine the effects of severe influenza in children. But early on in the pandemic we leveraged this network to create the Overcoming COVID-19 Network to better understand the clinical course of children hospitalized with severe COVID-19 and MIS-C.

We’ve used this platform to collect detailed clinical information on children hospitalized at over 70 hospitals across the United States. And one of these activities includes examining vaccine effectiveness against both hospitalization and critical COVID-19 illness in children and adolescents, and of course assessing vaccine effectiveness against MIS-C. In this particular study, we had 24 of these network hospitals that participated.

Joe Elia:

I see. Now, in terms of numbers of patients. You had, roughly speaking, and I’m going to talk in rough numbers here, you had roughly 100 patients with MIS-C.

Dr. Laura Zambrano:

One hundred and two, yeah.

Joe Elia:

These were all adolescents between the ages of 12 and 18.

Dr. Laura Zambrano:

Yes.

Joe Elia:

And then you had another, roughly, 200 hospitalized adolescents who were matched by various criteria. All right. So, what did you find?

Dr. Laura Zambrano:

Sure, I think really we had three overarching key findings.

Number one, the key finding here, I think, overall is that COVID-19 vaccination is highly effective in preventing MIS-C in adolescents. And how effective? We estimate 91 percent effective.

Number two, among the MIS-C patients we enrolled, 95 percent of them — 95 percent — were unvaccinated.

And number three (and while I still think it might be a little too early to tell for sure just because of the sample sizes that we were working with) overall, unvaccinated MIS-C patients appear to have more severe disease. This is really illustrated by the fact that nearly 40 percent of them required life support: they required some combination of invasive mechanical ventilation, vasoactive infusions to treat shock, and ECMO. But in contrast, none of the vaccinated patients included in the study required these treatments.

Those, I think, are the three overarching findings.

Joe Elia:

So, if I were to choose just one finding I would say ”Wow, only five percent of the MIS-C patients were fully vaccinated!”

Dr. Laura Zambrano:

Yes. Yes.

And you know one thing, I think, that is remarkable is we’ve seen that statistic highlighted time and time again regardless of almost whatever severe outcome we are looking at related to COVID-19. That, really, the overwhelming majority of patients exhibiting severe outcomes are unvaccinated.

Joe Elia:

So, the vaccination even among those children who came down with the syndrome, in that small group, their syndromes were less severe, that none of them required life support, or ECMO. And so, it seems, and as you calculated, the vaccine was roughly 90 – 91 percent effective in preventing MIS-C in those adolescents.

Dr. Laura Zambrano:

Yeah. And of course of note too, you know, one thing that we did notice is that ICU admissions also, I mean of course the sample size is small, but still, ICU admissions appear to be lower as well among the MIS-C patients. And so, we’ve seen consistently in our surveillance cohorts, for example, that the proportion (and this is looking at vaccination before or data from before vaccinations were available) that adolescents. requiring ICU admission has consistently ranged between 61 and 66 percent.

And again in this analysis we see among the unvaccinated patients about 63 percent of MIS-C patients required ICU admission, but among the five vaccinated patients only one — or really 20 percent — required ICU-level care. So, it’s still very early data. I don’t, you know, want to overinterpret it, but I do think it’s a promising sign.

Joe Elia:

And speaking of small samples, because you only had, I think, 81 or 84 or something like that cases, does this surveillance, does this research continue? Is it ongoing?

Dr. Laura Zambrano:

Sure. So, we have 102 cases, but absolutely the enrollment is continuing. And we really wanted to get this data out as soon as we felt like we had a sufficient sample size to get a reasonably precise estimate of vaccine effectiveness. But we absolutely are continuing to enroll patients. And you know specifically, I think, our next steps really are to look at the next-youngest age group, those 5 to 11 years old, who of course vaccination was just recommended for them starting back in November. And we didn’t have sufficient time, of course, to include them in this round of the analysis, but you know we are enrolling more of the 12- to 18-year-olds and we are enrolling the 5- to 11- year-olds right now.

Joe Elia:

And all the children who were vaccinated had received the Pfizer-BNT vaccine because that was the one that was available and had been approved by the FDA.

Dr. Laura Zambrano:

Yes, absolutely. And you know we set an exclusion criterion ahead of time that you know if a child had received another vaccine for some odd reason, even if they weren’t approved to do so, we would exclude them, but we actually did not see that. These children that were within this analysis all received the Pfizer vaccine.

Joe Elia:

Okay. Is there a question you wish I had asked you that I did not?

Dr. Laura Zambrano:

That’s a great question. You know one thing that I do want to emphasize, and of course this doesn’t have to go into the podcast this is just more me floating this by you, but this 5 to 11 age group is actually really important to us. And so, I would actually love to expand upon that a little bit more, mainly because the 5 to 11 year olds really appear to be the age group that’s disproportionately affected by MIS-C. And so, I’d love to just kind of talk about that age group a little bit more and the implications in this analysis for younger kids.

Joe Elia:

Sure, go ahead. And you’ve given a good introduction to the question, so I won’t ask it formally. Go right ahead.

Dr. Laura Zambrano:

The fact that the study here was focused on adolescents was really a function of timing. So, of course, the Pfizer-BioNTech vaccine was recommended for teens in mid-May, so we had this really nice window of time from July to December to study vaccine effectiveness in this group. But one thing that’s of real concern to us is that MIS-C is actually more common in younger kids. So, for example, the next age group eligible for vaccination, these 5- to 11-year-olds, are disproportionately more affected by MIS-C compared to other age groups.

So, as of last week, you know, when we posted this to our CDC website — to the CDC COVID Data Tracker, we have actually an MIS-C module there and I could direct your listeners to that webpage — but as of last week these 5- to 11-year-olds comprised 46 percent of all cases reported to the CDC. The Pfizer-BioNTech vaccine was only recommended for this age group back in November, you know, well that’s really the reason we weren’t really able to include them in this analysis, but we are currently investigating vaccine effectiveness in this group.

And one thing I want to emphasize is even though we don’t have a vaccine effectiveness estimate for the 5- to 11-year-olds yet, I don’t think there’s any reason to believe that vaccinations wouldn’t also protect these kids from developing MIS-C. So, we really want to use these findings from this study to encourage all parents to get their kids vaccinated to protect against the worst outcomes of this virus.

Joe Elia:

Okay. Well, I want to thank you for your time today, Dr. Zambrano.

Dr. Laura Zambrano:

Thank you so much for having me. And, Joe, one question that I would love to…or I do have a couple of statements I would love to make and you could sort of paste this or append this earlier in the podcast or where you see fit. But the one, I think, plea that I have for the public or for pediatric care providers in particular is truly, I mean, aside from being a public health professional and a scientist, I’m also the mom of a 4-year-old little boy and he is the light of my life. And so, this issue is extremely personal for me, and from that perspective I really view it as our responsibility to protect our kids and then really empower parents and pediatric providers with the information that will help them protect theirs.

Joe Elia:

Okay. I should emphasize that Dr. Zambrano’s views are her own and not necessarily those of the Centers for Disease Control and Prevention. That was our 280th Clinical Conversation. We come to you from the NEJM Group and the writers and editors of NEJM Journal Watch. Kristin Kelley is our executive producer, and I’m Joe Elia. Thank you for listening.

She and her colleagues found that older Black people (age 85+) show a survival advantage over whites, despite the fact that whites hold the advantage at every other age interval. There are several possible reasons for this, and Dr. Kershaw and my co-host Dr. Karol Watson offer a few.

This is probably the shortest Clinical Conversation ever, coming in at under 7 minutes. And it’s well worth your listening time.

Dr. Kershaw’s letter in JACC.

In this, the final entry in our four-interview exploration of race and clinical equity, Betancourt talks about the need for medical institutions to pay attention to what’s happening in their patients’ communities. To that end, MGH has a “bodega makeover” initiative to bring healthy food choices to local stores. (His grandfather’s bodega in Spanish Harlem likely served as an inspiration.)

Running time: 17 minutes

Listen in.

Running time: 20 minutes

She reminds us that tagging people as “non-compliant” would often be better expressed as “unable to afford.”

Let me know what you think, please, at jelia@nejm.org

Running time: 10 minutes

The conversations center not so much on their published research, but on the roles that these physicians take in their organizations and, in addition, the stories they tell about their own experiences.

Our first is with Dr. Kimberly Manning, who’s a professor of medicine at Emory.

Let us know what you think. Write to me at jelia@nejm.org.

Running time: 20 minutes

We present a brief, pre-conference chat in this edition. It was conducted just before the ASCO conference began, to get a sense of our guides’ expectations. Those guides — David Ilson, Ghassan Abou=Alfa, and Axel Grothey — are interviewed here and will be interviewed again at the end of the conference. The are expert, respectively, in cancers of the esophagus; stomach, liver, and pancreas; and the colon and rectum.

In forthcoming interviews, I will share several of the interviews done with hematologists for ASH. I hope you will find them as fascinating as I have.

Running time: 19 minutes

I asked him how COVID-19 has affected that journal, which has been around since the War of 1812 and seen its share of pandemics.

Listen in — it’s the first in a planned series of interviews with the editors of the principal clinical journals.

Running time: 19 minutes

NEJM’s Covid-19 resources page

TRANSCRIPT

Joe Elia: Welcome to Clinical Conversations. I’m your host, Joe Elia.

Dr. Eric Rubin, a specialist in infectious diseases, took over the reins of the New England Journal of Medicine as its editor-in-chief about a year ago. He had just enough time to settle in before — you know — the biggest pandemic in a century arrived.

He’s kindly agreed to take part in what’s planned as a conversational survey of the editors of the principal medical journals about their takes on COVID-19. These chats won’t focus so much on the clinical science of the pandemic as much as its broader effects.

In addition to editing the Journal, Dr. Rubin is an associate physician at Brigham and Women’s Hospital and a professor in the Department of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health.

Welcome to Clinical Conversations, Dr. Rubin.

Eric Rubin:: Thanks, Joe.

Joe Elia: These have been strange times for medical journals, haven’t they?

Eric Rubin::They sure have. I don’t have much of a basis for comparison, but as far as I can tell, this is pretty unusual.

Joe Elia: Yeah. I mean how is the journal doing? You’re all working in isolation? You’re not up in the top of the Countway Library on Shattuck Street, these days, are you?

Eric Rubin:: Yeah. That’s right. We’re all shut down, although I must say it’s worked out pretty well to have people working from home. I suspect that, like a lot of businesses, we’re going to find that we don’t have all that many people in the office when we finally do get back.

Joe Elia: I remember from years ago the kind of bustling newsroom feeling at the journal offices, and you would have these conversations in the corridor, like oh, you know, “This thing just came in, you should take a look at it,” but you really can’t do that over Zoom so readily, can you?

Eric Rubin:: Yeah, I think that’s right. It’s not as if we haven’t lost something.

Joe Elia: Yeah.

Eric Rubin:: It’s so much easier for people to walk in and out of each other’s offices with questions or ideas or “Here’s just something cool,” so we miss that, and I’m hoping that we recapture that, but on the other hand, there’s a lot of just get the work done stuff that people can do very efficiently at home, much more efficiently.

Joe Elia: Yeah. Yeah. When I was there, people would say, well, you know, “How often does the journal come out?” And I would say “Every damned week.” It’s relentless.

Eric Rubin:: That’s right. It’s kind of relentless.

Joe Elia: Yes. So, have you been inundated with research reports?

Eric Rubin: We have. I will say it’s gotten a lot better, but at its peak, we were getting more than 200 manuscripts a day, 7 days a week, for a while, just on COVID-19, on top of really a pretty normal volume otherwise.

Joe Elia: Yeah, my gosh. So, electronics have helped you distribute that workload, I guess, but that’s a lot of reviewers to find.

Eric Rubin: It is. We have to filter, before we send out for review, pretty severely, and finding reviewers is also problematic because the reviewers that we want to use are also quite busy. They’re the people taking care of the patients with COVID or setting the policy.

So, people, I think the reviewers have been very generous, but it did mean that we took a rather severe cut when things came in, thinking, you know, “This just is not likely to make it, and the authors are better off going somewhere else, where they can get a real serious look.”

Joe Elia: Yeah. You know journals have often been called universities without walls, but now, a lot of information, especially biomedical information, is being swapped around on social media, but they are kind of universities without constraints. What’s your feeling about this — this kind of swapping of information that’s going on?

Eric Rubin: You know I have mixed feelings. On one hand, I like the fact that information is being democratized and anyone can see it and comment on it, and that’s certainly true of COVID-19, where we and many of our fellow journals are making everything available immediately for free access right away, immediately, so that everyone can read the same things that the experts are reading.

When I look at social media, though, there’s a real mix. There’s really learned commentary, and there’s real misinformation, and it can be hard, I think, for people to sort out what’s real from what’s not.

Joe Elia: Can journals then offer a kind of healthy skepticism and peer review? Is that what they can bring to the table?

Eric Rubin: I think for sure. There’s no question that we make a lot of changes in every manuscript that comes to us. We work together with the authors, but the final product generally looks a lot different from what was submitted and different from the preprint that’s been posted.

And some of those changes — a lot of them — are cosmetic. A lot of them are messaging questions, making them more understandable or more accessible or being very clear about what the investigators did, but a lot of them are substantial.

For example, it’s not unusual to change the conclusions of a manuscript and sometimes change them to the opposite of what the authors had said originally, and that’s a pretty big change, and it is.

So, I think we’re still playing a role in communications that is very important, and we do that, certainly, with the very big help of our peer reviewers.

Joe Elia: So, those changes, Eric, are made with the — of course — with the consent of the authors. I mean they’re not just made and published. I just want our listeners to understand that.

Eric Rubin: Absolutely. This is a collaboration with our authors.

Joe Elia: Yeah.

Eric Rubin: When we accept a paper, we’re a little bit different from many scientific journals. We generally decide, after peer review, immediately, we’re going to take this or we’re not. It’s very unusual for us to send it back and say, “You know, if you did some more experiments, we’d reconsider.” Generally, we write a letter that says “We’d like to publish this, but as long as we can work with you to make the changes that we think are necessary,” and those are — can be — very extensive.

Joe Elia: This pandemic is an event that’s affecting culture, in some ways in the same way that the AIDS epidemic did, and by which I mean that, you know, human interactions and politics as much as creating an urge to solve the problem biomedically, but would you agree that the pandemic has become unusually politicized?

Eric Rubin: It is. It’s very strange but absolutely. I think the parallel that you point to with HIV is a good one, and back when HIV was in its heyday and treatments were not so good…not that HIV’s gone away. I don’t mean to suggest that.

Joe Elia: Right.

Eric Rubin: But back when there weren’t many therapies and there was a very strong advocacy movement, it was a very frustrating time, and that led — and people may not recall this — but that led to a lot of sort of crackpot theories that got propagated very widely in the community and were ascribed to by a lot of people, and that really undermined, I think, their confidence in the system.

Now, in the case of HIV, what brought confidence back was having effective therapies. It really was a technical fix. It wasn’t a political fix. Now, we’re in an even more difficult situation, I think, because our most effective means for controlling the virus are simple. They’re social engineering, in a way. They’re wearing masks and social distancing and all the standard sort of stuff, and yet we’re not really able to implement them, in the US at least, as widely as we should because of this politicization of the questions.

Joe Elia: You know Rudolf Virchow, back two centuries ago, said that medicine is a social science, and these simple, you know, measures that you mentioned are part of the social science — probably — that needs to be done.

Eric Rubin: Well, you know, and I think that goes back, again, back to HIV. I think it’s a really good point. In HIV, all we had originally were control measures, and those control measures meant people had to change their behavior in ways that they didn’t want to change, and it was very difficult. The uptake of that was difficult, very parallel to today, and what made the difference was actually not a social intervention but a technological fix, and I think, once again, we’ve come to rely on technology that we’re incredibly reliant, right now, on the idea that a vaccine will be successful.

Joe Elia: You know, speaking of HIV, when I was at the journal, a long time ago, at the Shattuck Street offices, we had a telephone call from Michael Gottlieb in Los Angeles in 1981, and I happened to be the senior person in the office at the time, I think Bud Relman was off on one of his trips, and he [Gottlieb] said, “Gee, I’ve got four cases of something, how soon can you publish an article?” and I said, “Well, you know, 3 to 5 months is what we’ve got.” So, I said “What is it?”

And he said, “Well, you know, it’s this kind of infectious thing that’s predominantly among gay men,” and I said “Do you think it’s a public health problem?” And he said, “I do,” and I said “Go to MMWR [Morbidity and Mortality Weekly Report (from the Centers for Disease Control)] and submit it there.” And he did.

And the next day, Bud Relman was back — the editor of the journal in those days — and he called Gottlieb and said, “Yeah, go to MMWR and we’ll publish the whole thing later.” And we did in, I think, December, like something like 6 or 8 months later, we published his article.

So, I mean, Randy Shilts and his book “And the Band Played On” says, “Oh, you know, Gottlieb went to the journal and the journal pooh-poohed it.” But it’s not true, but it makes it…

Eric Rubin: And the journal had the first report, I have to say, in a medical journal of HIV back then. Technology is better now so that we can publish things much more rapidly, and we can get them online instead of in print.

Joe Elia: Yeah.

Eric Rubin: Like we had to do back then but that it still requires people, and that is still the resource that’s most difficult for us. We put a lot of hours into every article, and we’re still putting in the same hours. They’re just compressed into a weekend.

Joe Elia: Yeah. Early in the pandemic, the journal published a letter about asymptomatic, or yes, presymptomatic transmission, for which it was…it got some criticism. Turns out that it was correct, that the letter was correct, but that.. You’re on the firing line, a lot, aren’t you, as the editor? You can be accused of saying, oh, you know, the journal is trying to be first, and it’s not always…that’s…

Eric Rubin: Yeah. I think that’s right, and I think we should be criticized when we make mistakes, and we should act to try to rectify those. In that case, we happened to be right, and we were vindicated by subsequent studies, but you know that was a case of politics as much as anything. That was a message that people didn’t want to hear and they were very resistant to at the time.

You know it’s no surprise that the biggest subsequent issues, in general, in medical journals have been about hydroxychloroquine, which has a very faithful following, and when anything gets published, we have a lot of people who object if it…and we would have people objecting on either side if the article suggested that it worked or it didn’t, and we’re also in the position, put in the position…we get a lot of people writing, saying “Why didn’t you do this?” We didn’t actually do the study, so it’s a little hard for us to…but they’ll criticize our characterization of the study as positive or negative, and I think we’re doing the best we can, and it’s very fair to second guess us. That’s part of the interchange, but it can get a little personal.

Joe Elia: So, when you think about your role, Dr. Rubin, do you see yourself as a teacher, a referee, a ringmaster? When you think about your audience, who is it?

Eric Rubin: Well, that’s a really good question. We like to think of our audience as clinicians, as people who are taking care of patients. The truth is that we publish a range of things, some of which are aimed at practicing clinicians and are very practical. They can be the videos in clinical medicine which show you how to intubate a patient or how to do any given procedure or the CPCs, the various clinical series we have where discussants develop a differential diagnosis and come up with management plans for patients. The research articles, we try to characterize, at least in summary, in ways that anyone, that any clinician could understand the message. Now, the truth is, we do have, and we have more and more of what I guess I’d call experimental medicine, which is something that’s not yet ready for primetime.

It can be phase I studies. It can be first-in-man studies, occasionally, of new drugs or new techniques, and I still think that’s important because a clinician can see what’s coming next, what do we have to look forward to? This may or may not be a breakthrough, but it could be, and we’d like to get those out to our audience.

Admittedly, some of what we publish is very technical and is aimed at a subspecialist or occasionally really a researcher community, but we’re trying to serve everybody to some extent. Our goal is to make a difference in how people are treated, and I think we try to think of the audience that matters for making that sort of impact.

Joe Elia: If you considered yourself a ringmaster, how do you get the lions and tigers to behave?

Eric Rubin: Well, so, I guess that requires a little description of the process we go through to make decisions on manuscripts. Essentially, all the editors sit in a room, at least until we shut down the office. Everyone shows up. There are 30 people in a room, and every manuscript that’s gone through peer review and has some chance of being accepted gets presented. Actually, it’s very old-fashioned. The editor who’s handling it Xeroxes all the figures, hands them around, and then presents the papers if it’s a journal club, and then there’s a very interesting discussion where the experts in the room or the people of opinions in the room, or of educated opinions in the room, will bring up any aspect of it, was the design correct, are the statistics correct?

We have several PhD professors of statistics sitting in the room. Was it ethical? Was there equipoise? Could you do this study? Almost any aspect of it gets discussed, and at the end, we make a decision. It is kind of a strange position to be in to be the final decision-maker because so many people in that room know more than I do, but it comes to a balancing act of what do we think people really need to know, and what’s going to move the needle? And I think that gets discussed all the time. In fact, one of the key questions that comes up repeatedly is, “If we publish this, is it going to help or hurt patients? Are people going to take this incorrectly and potentially do harm, or is this really going to make a difference?” And if it’s really going to make a difference, we’ll definitely publish it. So, it’s a fascinating process. You know it’s the world’s best journal club.

Joe Elia: Well, I want to thank you, so much, Dr. Rubin, for speaking with me today.

Eric Rubin: Thanks, Joe.

Joe Elia: That was our 273rd episode. We come to you from the NEJM group. Our executive producer is Kristin Kelly, and I’m Joe Elia. Thanks for listening.

He scours the ID literature (and we must include the social-media literature in that category) for interesting stuff to write about, seems to have a knack for summarizing whole conferences in 750 words, and often manages to give his readers a reason to smile in these fretful times.

We decided to catch up with him and ask him about his inspirations and for his advice. He doesn’t disappoint.

Running time: 10 minutes

Paul Sax’s latest “HIV and ID Observations” blog: “Carbapenems and Pseudomonas, Lyme and Syphilis Testing, a Bonus Point for Doxycycline, and Some Other ID Stuff We’ve Been Talking About on Rounds”

TRANSCRIPT:

Joe Elia: This is Clinical Conversations. I’m your host, Joe Elia. The current pandemic is leaving its mark all over the place, and one obvious area is in medical research. Clinicians are often hearing about new findings on their car radios on the way home or on social media. The credibility of that information is key.

Our guest, this time, is Dr. Paul Sax. He’s a contributing editor on NEJM Journal Watch Infectious Diseases, Clinical Director of the HIV Program, and Division of Infectious Diseases at Brigham and Women’s Hospital, and also a Professor of Medicine at Harvard Medical School.

Globally, he’s probably best known for his lively blog, “HIV and ID Observations,” which he posts almost every week on the NEJM Journal Watch site.

Welcome, Paul.

Dr. Paul Sax: Thanks, Joe, for inviting me.

Joe Elia: I’ve been reading your most recent blogs, which I’ll remind listeners are all available at Blogs.jwatch.org. One of the most recent is titled “Reaching Out to Infectious Disease Doctors in COVID-19 Hotspots: You must be truly exhausted.”

I get the sense that you’re talking more to working clinicians than policy makers or professors like yourself. Whom do you imagine is reading your observations?

Dr. Paul Sax: Well, I actually meant it for the entire infectious disease community. Kind of, if you think back a million years ago, to March 2020, we were starting to hear about this terrible thing that was coming our way. We all knew it was coming, but we didn’t know exactly when it was going to happen, and then it happened at different times in different parts of the country. So, while we were preparing here in Boston, and New York City was getting slammed, other parts of the United States were preparing, too, but they didn’t get hit the way we did in the Northeast.

So, you know, I have colleagues in Alabama and Atlanta and Florida and Texas and Arizona, and you know, things were pretty quiet there. They did have occasional cases, and what happened was that, unlike here, where we really got hit hard (and we fortunately, at least for now, knock wood, things are very quiet, for them,) they had a period of relative quiet and then, a large number of cases. So, they’ve had to sustain this intense involvement with COVID-19 response right from the beginning. Very tough.

Joe Elia: Yeah. You’ve been at this for just over 12 years, with the stated purpose, and I’ll quote, “Commenting on interesting HIV, infectious diseases, and other medical and not-so-medical news.”

Is that still your purpose and what has the reaction been over the 12 years?

Dr. Paul Sax: Well, it’s been really gratifying — and gratifying in a way that I never could have imagined. You know, I’ve always kind of imagined myself someday becoming a writer. I’m a frustrated comedy writer. Never quite made it to Hollywood, but I went to medical school and I went into this fascinating field, and I thought, you know, “Why not write about infectious diseases?” And I’ll tell you, my inspiration for the format really were some of the great blogging in the early 2000s, mid-2000s, where writing just exploded on the internet and I thought, “Wow, all this great writing available for free. Let me try my hand at it,” and I’ve got to thank Matt O’Rourke at NEJM Journal Watch for giving me the opportunity to do it.

Joe Elia: Well, in the not-so-medical department, you’ve been known to sprinkle in cartoons and lately, dog videos: “Olive and Mabel,” two Labradors. I’ll just say it’s British genius comedy, but what’s that got to do with infectious diseases, Paul?

Dr. Paul Sax: Well, you know, there’s this strategy that every infectious disease doctor does when you’re talking to patients — is you ask them about their exposures, and one of the ways we ask about exposures is you ask about pets, and of course, I wouldn’t probably be so fixated on the dog videos if I didn’t have a dog myself, which I truly love, but there is this sort of funny aspect of infectious diseases where you ask someone about their pet, and then they look at you like, are you out of your mind.

I remember one unfortunate person who had a motorcycle accident and we got to the point where we were asking about pets and he then acknowledged that, yes, he did have a new parakeet, and then our infectious disease fellow I was working with said, “What’s your parakeet’s name?” And he told us: Fruit Loop. And I thought, that’s a very funny name. Of course, it had nothing to do with his motorcycle accident, or why we were seeing him, but there are times when it is highly relevant, and you know, there have been many times when we’ve seen people, and for example, they’ve acquired an infection from their pet and sadly, sometimes it is their beloved dog.

Joe Elia: Now you’ve confessed, already in this interview, to wanting to be a comedy writer, perhaps, and maybe even a standup comic when you were younger. What deflected you from that noble cause and was there a book or an experience, an infection or something that deflected you?

Dr. Paul Sax: So, yeah, well, probably the thing that deflected me the most, and I’m going to say this because I’ve acknowledged this on the site, is my father. My father, who is a physician himself, comes from a long line of physicians, and his attitude, essentially, was, if you’re okay in science, then you become a doctor. And he could not understand why his son, who was okay in science (that’s me) would consider doing something like comedy writing. He basically said, “Just go to medical school and then after that, if you still want to be a comedy writer, see if you can make it work.”

So, thanks, Dad. I mean I really love my field. I find infectious diseases fascinating from A to Z and beyond, and it’s always challenging, never more so than today, and you know, I get to do somethings that are sort of vaguely related to comedy writing.

I do want to also say, that in college I had some truly outstandingly talented friends who became professional comedy writers and frankly, I don’t have their chops.

Joe Elia: You can drop some names if you’d like.

Dr. Paul Sax: Yes, well, he was very kind t let me interview him about his own experience with a life-threatening disease, but one of my friends was Andy Borowitz. Andy Borowitz, of course, is a prolific writer writer now for the New Yorker mostly, political satire, but he’s just an extraordinarily talented person. And then another brush with greatness is Conan O’Brien. Conan O’Brien was a college friend of mine, and his father actually is an infectious disease specialist, so it all comes round, eventually.

Joe Elia: Now you serve as a kind of medical-cultural reporter on rather mysterious viral infections — HIV and COVID-19. Information on these diseases — and especially now, COVID-19 — comes at us unremittingly. Is it a hopeless task to try to keep up, or is it essential to try to keep up, and how do you, as a reporter, keep up for other clinicians?

Dr. Paul Sax: Well, I would say it’s essential to keep up and the way that we keep up is different from the way it used to be. You know, it used to be, you would get your journal mailed to you every week or every month, depending on the frequency, and you would pore over the table of contents, and read the abstracts, and the interesting papers. You’d read the methods, et cetera, and then the results.

Now, rapid fire medical information comes at you really quickly. I want to say that there are some good things about Twitter. Twitter actually is a great place to see medical information very quickly, but it’s not adjudicated, so the next step, after seeing that information, is to try to look at it critically

And I think a really good example of that is the dexamethasone treatment for COVID-19. The first I head of that was, of course, on Twitter. This group in Britain was promoting their results and it was very exciting that they had a press release showing a randomized clinical trial had improved survival with dexamethasone, and I kind of made the point after seeing their summary, that it should become standard of care for people with COVID-9 and met the criteria that used in their trial. And as a result, practice-changing. Their study was practice-changing and now it has been given the blessing of the New England Journal of Medicine, and I think we can say without much risk of bias that that is very high praise indeed, to be accepted as a paper in that journal.

Joe Elia: Yes. I think you’re right. And finally, as a reporter yourself, is there a question you wished I’d asked that I didn’t?

Dr. Paul Sax: Well, you know, one thing I do on my blog, is I try to write in my own voice, and that is something that I feel like medical journals could use a bit more of, and if I were to give some feedback to some of the medical journals, it would be this, it would be that there is a role for the human beings voice in the august pages of these journals. It doesn’t all have to be edited to fit the house style. So, that’s one pitch for that.

Joe Elia: Okay. That’s good advice, I’ll pass it on.

Dr. Paul Sax: Please do. To my good friend, Dr. Eric Rubin.

Joe Elia: Thank you, Dr. Sax, for talking with us today.

Dr. Paul Sax: Thanks, very much, Joe.

Joe Elia: That was our 272nd episode. All of which are available free at podcast.jwatch.org. Our executive producer is Kristin Kelley, and we come to you from the NEJM Group. I’m Joe Elia. Thank you for listening.

The county’s cases jumped 100-fold, from about 600 to over 50,000. Just south of Broward, Miami-Dade has double that caseload.

We revisit Dr. Flores (who was sheltering from the rains of a coastal near-hurricane in his car). He confesses bewilderment and counsels skepticism — especially of one’s biases — in evaluating this thing we’re facing.

Running time: 16 minutes

Other interviews on Covid-19 in this series:

1. Dr. Anthony Fauci (NIAID, Bethesda, MD)
2. Dr. Susan Sadoughi (Boston, MA)
3. Dr. Matthew Young (suburban Delaware)
4. Dr. Julian Flores (Broward County, FL)
5. Dr. Kristi Koenig (San Diego, CA)
6. Dr. Renee Salas (Boston, MA)
7. Drs. Andre Sofair and William Chavey (New Haven, CT, and Ann Arbor, MI)
8. Dr. Comilla Sasson (volunteering in New York City)
9. Dr. John Jernigan (Centers for Disease Control, Atlanta, GA)
10. Dr. Ivan Hung (Hong Kong)
11. Dr. Steven Fishbane (metropolitan New York)
12. Dr. Michael Gonzalez (Houston, TX)

TRANSCRIPT:

Joe Elia:

Welcome to Clinical Conversations. I’m your host, Joe Elia, and I’m joined by co-host, Doctor Ali Raja, of the Mass. General Hospital, and Harvard Medical School.

Back in March, Ali and I interviewed an emergency medicine physician, from Broward County, Florida. Back then, Broward had just over 600 cases, and as of this afternoon, August 2nd, confirmed cases there stand at nearly 100-fold higher. It’s some 58,000, with some 750 dead.

So, we’re checking back in with Doctor Julian Flores, who is still working there, in Broward County, as an emergency medicine physician.

Welcome back, Julian.

Dr. Julian Flores:

Hi, guys. Thanks again, for having me.

Dr. Ali Raja:

Hi, again, Julian. Thank you for chatting with us today, especially on your day off. How are you doing? What are you seeing clinically there, right now?

Dr. Julian Flores:

So, I’m seeing a resurgence of cases, of COVID-related complications. Also, essentially, paired up with just volume of ER patients, in general, and you know, it is in the background of us, as a state, in Florida, pulling back the restrictions that, essentially we were, quote unquote, forced to put in the first place, after we were delayed, related to the rest of the country, in doing so, which makes it that much tougher to deal with.

Essentially, both situations, right? Because you know, you can only increase your staff, or your resources, or just sort of, your energy, so much, right, to meet those multiple needs. Hindsight’s 20/20, but it’s kind of hard to imagine the alternative, when we’re just so early, still, relatively, even if it’s been — what? since around January — that we’re dealing with this? It’s still relatively early for us to know what trend the virus is going take, as a virus in general, us as a society, the other things that are inevitably altered, as well, economics, the schooling system, familial structures, et cetera.

Joe Elia:

Back in March, I remember you telling us that although you were working Broward County — and I understand you’re also working in Miami, as well, now — you were living in Miami’s Financial District, and you told us that you saw many groups of people, together in the street, without masks. I’m guessing, and hoping, that things have changed, since then.

Dr. Julian Flores:

Yes. It’s essentially, it’s not the stark opposite of that. I’d say something at least in the middle of those two scenarios, right? Of no mask, versus everyone with masks. I will say that Miami-Dade County has implemented what I believe, a fee of sorts, or some sort of penalty, if you are seen in public, without a mask. We, at least, collectively, have seen that as an important measure, against, at least, the exposure to the virus, or you know, giving it to someone, and transmitting it.

Dr. Ali Raja:

That makes a lot of sense, and like the rest of the country, I think we’re seeing that shift. Let me take you back to March, again. When we spoke, you were using one N95 mask, per shift. So, what about now? What’s the availability of masks, of gowns, of other PPE, in your experience?

Dr. Julian Flores:

Well, because I feel like, or rather, I know that even as a country, in most states, we’ve seen sort of, I would say almost a bimodal peak, in that we saw a surge…speaking of ER volume, in general, we saw a peak of COVID-related cases. We then saw, generally speaking, a dip in just ER volume, in general, from what you can infer, most people just being scared to be at all associated with an environment that, in any shape or form, can expose you to a virus, just by you physically being there, to now, a resurgence of truly related, both primary complications, and secondary complications of COVID, with just volume, in general.

Thankfully, I feel like that sort of dip in volume, and in resource utilization has allowed us to, in a way, catch up, with PPE, at least, I can say, in my hospitals, and you know, speaking for other hospitals in the area, as well. So, I can say that the resources in the two shops I work for are thankfully there, but I can’t speak, you know, for every hospital in Florida.

Dr. Ali Raja:

That makes sense, and you just spoke about the hospitals. What about the hospitals, in total? How are ICU beds doing? Have they started bringing elective procedures back, or are they still holding out on them?

Dr. Julian Flores:

That’s also, from what I know, sort of, a hospital-by-hospital scenario. I know that as a state, that’s not a sort of, a uniform, now, limitation. My hospitals are allowing that to happen. Of course, there’s always, I can imagine, that back thought, in an interventionalist’s mind, that if it doesn’t need to happen now, and it doesn’t harm the patient, then maybe in the spirit of just limiting exposure in general, that it can be delayed, somewhat. At the very least, that’s being allowed to happen.

Joe Elia:

Do you have enough ICU beds? I mean, are…

Dr. Julian Flores:

Yeah. That’s also regional, when thinking about Florida. There are some ICUs that I know are at easily 90-something percent capacity.

Joe Elia:

Yeah. Okay.

Dr. Julian Flores:

And if not that, at the very least, we are holding more patients, in general. That’s something I feel like I can more easily generalize, to the state of Florida, that there are just more patients being held in the ER, secondarily, to just folks either in an ICU setting, or in what we call a PCU setting, taking a little bit more time to be discharged.

Joe Elia:

Okay. How are you keeping informed? There’s so much information, just bouncing off the walls about these things, and I don’t think that hydroxychloroquine was an issue, when we first talked. But I mean — and we don’t need to talk about that — but there are lots of advisories out there, and you had mentioned a private Facebook group, in our earlier chat. Are you still active in that, and finding it useful?

Dr. Julian Flores:

Definitely. I’m still a part of those, a couple of Facebook groups — private groups — I mentioned before, one of them being EM Docs, and the other one being the COVID-19 Physician Alliance. You know, there’s always going to be a lot of mixed messages, and comments that could be … in a way, you can say, they’re true. But there could also be another truth that’s mutually acceptable, right?, because as we all know, data can be presented — consciously, or subconsciously — how we want it to be presented, without altering numbers, or methods, as to how we acquired the data points, to begin with.

So, and of course, it’s hard to divorce the emotional sort of, drive, to be presenting that data, to begin with, right?, and to come up with a conclusion, whether you’re, you know, pro, or anti anything, really, in general, especially in regards to the pandemic, and how we’re handling it, and how the virus is going to be projected to continue affecting us.

Essentially, at least, what I do, is every time I look at, sort of, even a study that was well done, I try to think of if, in any way, the alternative could be true, right?, and if I’m already biasing myself pre-meditatedly, before I’m reading the study, because that’s going to color how I see it, going through. That’s going to color how I’m going to be spreading it to my colleagues, and to my friends, and family.

Again, we’re relatively pretty early into COVID-19. You know, and because of that, as much as you would like to, you can’t always make a study as diverse as possible, or as extrapolatable as possible, right? You can only do so much, when you’ve been in a pandemic for what?, eight months, or so, right? So, they may all come from a good heart, or a good, sort of, intention in mind, but I always try to read the opposite viewpoint, or a journal that would refute that.

So, you know, in many ways, in regards to things like hydroxychloroquine, or certain other related medications, sometimes the safer thing, I think, going into it, is to just have no opinion on it, because sometimes, we just don’t know, and we can’t apply every single patient, every single demographic, every single hospital to that end point, because I mean, for any study in general, for any medication, the number of days that you use it matters. If you use it at the beginning, during, or after, the height of, the peak of symptoms, et cetera.

So, it’s tricky, and I feel like we all, you know, reflexively want to have an answer, and we’re not going to convey it, always, that unambiguously, especially if we have an emotional drive to put that home.

Joe Elia:

Or a political drive, as well.

Dr. Ali Raja:

It could be either.

Joe Elia:

Yeah. Yeah.

Dr. Julian Flores:

And those are mutually not exclusive, either, right?

Joe Elia:

That’s true. That’s true. We want to believe what we want to believe, and so, I think we all face that, as human beings.

Have you been hearing from colleagues who haven’t faced a surge yet? There aren’t too many places in the country that aren’t, but have you heard from any, and do you have advice for them? We interviewed you in March, and now, here we are in August. And what was the big lesson that you’ve learned, over those months, if you had to give one?

Dr. Julian Flores:

Yeah. I would say to my colleagues, that haven’t been dealing with COVID-19 related symptoms, or complications, as much as the rest of us, to just keep your eyes peeled, because it’s hard to say that a specific ER, or a specific region, within Florida, or within any state, is going to be inherently immune to it, when we’re still allowing transportation within the state, across the states. And conversely, folks that have been dealing with only COVID-19 related, you know, pulmonary symptoms, or other organ system complications, not everything is COVID-19 related, either, right?

We’re still going to have our strokes that are just related to a vascular complication, independent of COVID, or heart attacks, or trauma-related complications. So, I think in either extreme, we just always have to, in these times, remember to just keep our eyes peeled.

Dr. Ali Raja:

That is a great way to look at things, and a good reminder for all of us. Let me ask you, Julian, we’ve been asking all the questions. So, do you have any questions that you wish that we had asked? Or, a point that you’d like to make, that we haven’t gotten the opportunity to do, yet. What’s on your mind, that we haven’t yet covered?

Dr. Julian Flores:

I have a lot of opinions, and ironically, on a lot of COVID-related topics, and the conclusion, in those opinions of mine, is that I have no opinion — if that makes any sense.

Joe Elia:

It does.

Dr. Julian Flores:

Or, no. I have no, sort of…I can’t say with legitimacy, or with, you know, pure confidence, that it’s one way or another, especially something like this virus, that again, is a specific strain of coronavirus. As we’re coming to know, it’s not only pulmonary-related complications. It sort of, evokes all your organ systems, and any of them could be altered short term, or long term, at any given time. We’re still, you know, trying to figure that out. And with the mindset of always trying to see what the opposite team is saying, it has sobered me quite a bit, when coming to terms with what I think I know, or what I want to know, and what I want to convey to the general public, all while trying to keep a word choice, a spirit of, per se, it doesn’t have to be the end of the world, and at the same, this is not something we’ve dealt with before, at any level that you want to talk about it.

At the medical level, at the societal level, political level. It’s just, it’s not, and I think we’d be lying to ourselves to say that it is, in either way.

And everything is relative. That’s a main point I would want to drive home, and we have to see what terms we’re talking with, what truth we’re believing, before we speak, and are we allowing room for that alternative explanation to be said? Because there’s a lot of common ground, that can be found, and sometimes, it can feel weak, or it can feel, sort of, in a way, insulting, especially to us physicians, or healthcare-related folks, that are the main, sort of, proponents to driving home knowledge, of any kind of sort, to sort of, quote unquote give in to the other side, and again, because these points touch on a lot of things besides just logic, right?

We cannot deny that sometimes, subconsciously, or consciously, there is a political side-motive. There is an inherently, sometimes, again an emotional cord that’s being strummed in some way or another. So, I would just like to advocate for us all, sort of, being honest with ourselves with what we’re reading, what we’re deciding to read, what we’re coming out of, you know, getting from these articles, from these posts, from the news channels. And are we leaving room for the alternative explanation? If so, are we deciding to paint one picture, or another, based on something else besides just the facts at hand of COVID-19.

Joe Elia: Julian, we’re very grateful to you, for doing this with us, today, and we want to extend our best to you, and your colleagues, and especially, to your patients. Thank you.

Dr. Julian Flores:

Thank you so much, and you know, as I finished, I believe, the last podcast we enjoyed, and collaborated in, together, you know, keep the hope. Keep the positivity. I think that’s, at least, what drives me, to keep reading, to keep wanting to know more for myself, and my peace of mind, and for our patients.

Trying to leave, you know, pride aside, and collaborating with, and you know, coming to terms with what could be the alternative of what we thought of, to now, in this, and just in medicine in general, because again, they’re not mutually exclusive, right? Especially in this sort of, wave of the virus where, especially as ER doctors, where we can’t afford to just see one thing, or another. I mean, we’re rolling the dice with every patient, with every, you know, clinical presentation. So, collaboration is what’s gotten us even this far.

Dr. Ali Raja:

That’s a great way to end this, Julian, to remind us, all of us, who are seeing patients right now, in this unprecedented time, to keep an open mind, and to be willing to collaborate, even when we might have initial doubts. That’s how we’re going to really move the treatment of this disease forward. So, thank you for that really important reminder.

Joe Elia:

That was our 271st episode. All are available, free, at podcast.jwatch.org. We come to you through the NEJM group, and our executive producer is Kristin Kelley. I’m Joe Elia.

Dr. Julian Flores:

I’m Julian Flores.

Dr. Ali Raja:

And I’m Ali Raja. Thanks for listening.

Every time you swipe your card to buy goodies at the supermarket (are you risking diabetes with all that ice cream?), or binge-watch that kinky series (how’s your mental health these days, really?), or let your step-tracker show you’ve fallen off the pace (can you afford those extra pounds?), there’s another little distinguishing feature added to your footprint.

This weeks’s guest, Dr. David Grande, and his associates asked a group of experts what they thought about all this accumulating personal data that’s outside HIPAA’s purview.

Listen in.

(Running time: 20 minutes)

Dr. Grande’s paper in JAMA Network Open

Franklin Foer’s Atlantic essay on the downside of Big Data’s help in the pandemic

New York Times‘s privacy project

TRANSCRIPT:

Joe Elia:  You’re listening to Clinical Conversations. I’m your host Joe Elia. This week’s chat isn’t about COVID-19 (or maybe it is really, but we’ll get back to that).

What we’re pursuing here is this: You know all that data you’re constantly contributing to what we call the “digital realm”?  You know, your Whole Foods discounts from your Amazon Prime account to your Netflix records from all that binge watching, the GPS navigation stuff? Well, who’s guaranteeing the privacy of all those data points? Not HIPAA. They’ve got your medical records covered, but what about the other stuff that points at your health status? The groceries, the streaming selections, the places you visit in your free time.

Our guest this week has concluded that you’re creating what he calls a “digital health footprint” with all that data — that, in fact, all data are health data. Dr. David Grande is the first author on a recent JAMA Network Open paper on all this. In it, his team surveyed a couple of dozen experts on privacy and data mining to gauge their thoughts and their concerns.

Dr. Grande is a physician at the Leonard Davis Institute of Health Economics at the University of Pennsylvania and in the Division of General Internal Medicine at the Perelman School of Medicine there. Welcome, Dr. Grande.

Dr. David Grande: Thank you.

Joe Elia:  I hope I didn’t overstate or sensationalize your conclusions in the introduction. What got you interested in this whole question?

Dr. David Grande:  You know going back years I’ve been interested in some of the ways in which marketing to doctors happens, marketing to patients happens; and what’s really happened over the last 10 years is all of that’s become supercharged by data. And a lot of it, when you’re talking about patients and consumers these days, marketing in health and healthcare is becoming supercharged by all those digital footprints that people are leaving behind. And while we may not necessarily think about our trip to the grocery store or the things we post on social media as being things that are fundamentally about health, when you talk to data scientists they’ll tell you oh it’s very much about health. Our ability to make inferences about health from all of that is extremely powerful today.

Joe Elia:  Can you tell us briefly how you went about interviewing a couple of dozen experts, as I’m recalling, and why you undertook the study?

Dr. David Grande:  Sure. Well, I think everybody — at some high level consumers have some level of awareness now of kind of the fact that people are being tracked in various ways. But frankly, it’s really hard to understand every time you sign up for something or use a new piece of technology it asks you to turn things on and off and you really don’t know what to make of it. And so we really wanted to talk to experts in the field to try to understand what is going on in the technology industry. And the data scientists and people who understand regulation and whatnot, like, how should we understand what’s going on out in the world in terms of data mining and the collection of people’s digital footprints?

And not surprisingly, you know, what we heard is it’s everywhere. It’s what we expected to hear to some extent.

But then the second part of that conversation was really focused on two things. One is, is it possible anymore to draw a line between health and non-health or has that become an artificial distinction? And then second, what are some of the, like, key big problems and challenges that we see that may need to be addressed by regulators? What is unique about this space? And that really was the focus of our conversation.

Joe Elia:  And you interviewed a variety of people. Can you give us a sense of what fields they came from?

Dr. David Grande:  Yeah. They’re certainly people who have been in the area of kind of thinking about privacy law and ethical issues around privacy. But then we also talked to people who are involved in digital technology and designing products in various ways. And trying to understand some of the decision-making that goes on and how those products are designed and engineered and where data comes into play. We talked to people who do sort of like predictive analytics in healthcare and how that world’s kind of vastly expanding now in terms of thinking about all the data inputs that go into predictive algorithms. We see that in healthcare delivery, but then of course we certainly see it in consumer products and advertising. So we tried to go pretty broad to really, you know, get a lot of perspectives.

Joe Elia:  So you talked with people dealing with ethics as well as data mining, so you got a wide range of expertise there. Having done all of that interviewing what were the principal conclusions that you arrived at?

Dr. David Grande:  Sure. So, that first question that I mentioned about can we draw a line anymore between health and non-health data? It was interesting. So even these experts in the field that we talked to, we actually had them answer some questions and kind of rating different kinds of sources of data and say how do you think about this one? Does it sound very health-related or not very much so? And actually [they] did rate some very high and some very low. So things like your Fitbit or food you buy at the grocery store people could say yeah I can see that’s health-related. And then, other things like your E-ZPass in your car or your other things with your travel habits or maybe things about your email or texting habits and things like that people were like “Maybe that’s not as health-related.”

But then when we actually dug into the conversation almost everyone we talked to was like “You really can’t draw a line.” I mean, when you think about modern data science today it’s really not about a single piece of data anymore. It’s not about just exactly what your language was on social media. But it’s linking that to a whole range of other things, which creates very powerful predictive capabilities. I mean now, we hear a lot of people talking about being able to make clinical diagnoses, you know? And so, I think one of the people said something like taking consumer grade data and turning it into a medical grade diagnoses and seeing that that’s quite possible now with a lot of data that people don’t really think of that way.

And so that was really an interesting part of the conversation. Again, I think if you ask consumers the same thing they would probably say yeah I can see these things as very health-related or not very health-related. But then again when you really look under the hood it’s really an artificial distinction.

Joe Elia: Let’s do a thought experiment. If I had enough data points, if you had enough data points about me and you knew my dietary habits, my exercise habits from my bicycle odometer, you had access to my travel through E-ZPass, et cetera, and you were a hospital administrator in the marketing department and you said “You know this guy Joe Elia? I’ve looked at his CVS records he’s not on any antidiabetic drugs, he’s sort of fallen off on his bicycling and he’s tending to drive himself places now. Maybe what we could market to him is a kind of a screening exercise for type 2 diabetes.”

And before I knew what was going on I’d have an email from David Grande saying “Joe, why don’t you come in for free screening?” I mean, that’s quite possible isn’t it?

Dr. David Grande: Oh, absolutely. I mean, again, there’s not a lot of transparency behind a lot of what’s going on in the companies who aggregate this data and use that to generate ads. But people are seeing it, you know, the output of that has become more evident, I think, to a lot of consumers. They say, “Hey it’s kind of weird I went on the internet yesterday, you know, looking for X, Y or Z and gee-whiz like suddenly I’m being approached today.” How else would that have happened? So, it’s becoming much more commonplace, I think, for people to have the experience that you just described.

I think what’s really hard to know is the accuracy of those analytics and those predictive models that are happening these days. We have some examples in research where people have validated ways of, for example, making a diagnosis of clinical depression. But we know very little in the advertising industry about how exactly they’re crunching data and deciding that you, Joe, have progressive diabetes or maybe a new diagnosis of diabetes. We don’t really know. All we know is that sometimes something shows up on a webpage you’re browsing or in your email inbox and you have to try to deduce why that happened.

Joe Elia:  One of your experts said something, commented something that I circled because I thought, “Oh this is so true.” And the quote is that “it would be very odd if someone followed you around making notes of everywhere you went and how much money you spent, and what you saw and who you interacted with. We would call it stalking, right? but in the digital world that’s accepted behavior.”

Dr. David Grande: Yeah, it’s commonplace and it is odd, right? You know there’s a level of surveillance in the marketplace now that I think no one ever would’ve dreamed was possible a decade or two ago. And I think if someone had told you that that’s what would be happening in the year 2020 — if we had this conversation in the year 2000 — they wouldn’t have believed you, probably, and secondly they would’ve said that’s outrageous we would never let that happen. But instead what we have seen happen is, because it’s so baked into all the things we use in the world it’s unavoidable now. Like, you would have to disconnect yourself from modern society at this point to really not be contributing data in this way. It’s not really a choice that consumers have anymore.

Joe Elia:  Yeah, it’s Orwellian. It’s actually infra Orwellian or super pro-Orwellian.

Dr. David Grande: Yeah.

Joe Elia:  We’ve gone beyond good old George.

And thinking back only seven years to the Snowden revelations in 2013 about how the government was, you know, it had access to all of our communications.

Actually, Snowden had a recent interview in which he said COVID-19 actually might be another way, another goad for the high tech companies to have more information about you. And in fact a couple of the high tech companies are getting together and saying “Yeah we’ll help contact tracing.”

Well, wait a minute. Okay, so when the pandemic goes away we’re going to have this method of tracing people’s contacts? And in a free society that’s not a problem. In the repressive society, and I’m thinking of you know facial-recognition technology in use in China, you know, North Korea, other places that can be dangerous. And so how is it that we can say okay you can use it for this purpose, for contact tracing in a pandemic, but you can’t use it for contact tracing politically?

Dr. David Grande:  Yeah, that’s a great question. I mean, I kind of look at this question and say that what we’re allowing to happen now in the private sector is complete Wild West. Like, the technology companies right now, at least in the American context, are largely unfettered — they can do almost anything. We really have no strong privacy regime around these questions in America. On the other hand we do apply a fairly, we apply a lot more scrutiny around these issues where government may be involved in some way that could actually have immense social benefits. So if we take COVID as an example I tend to believe that if we use these technologies responsibly we can make an enormous difference in the impact of the pandemic.

Now, the question is how do you avoid “mission creep”?, which is I think what you’re really asking. And I think for that to happen you need to write some pretty ironclad regulations about how you’re going to use these technologies so that they do get turned off.

Now, again, you have to maintain the kind of political energy when push comes to shove to actually turn them off. But you know what Google and Apple have done, and we can speak separately about what their motives might be for doing this, but what they have done is they’ve put forward a model that involves far more privacy protections around these COVID uses than what would be routine with other uses of technology.

So specifically, they are just making changes to their operating system and they are saying that for this to work a public health entity has to layer an app on top of that technology.

So the phone itself, there’s no app operating in the background of your iPhone that’s doing contact tracing. A public health agency has to put an app on top of that functionality in the operating system. But then they’re also saying we are not going to allow your phone to actually automatically transmit your personal information to the public health authorities it stays locally on your phone. And actually public health officials are not happy about that. Because one of the ways that contact tracing works is that you actually notify the public health authorities and you share data.

So there’s almost an odd paradox here but the world hasn’t faced a health crisis like this in a very long time. We have these digital tools that are now very powerful and it’s really public health that we’ve decided to take a firm stand on privacy about as opposed to all these other commercial applications where we seem to be a-okay with the status quo. So it’s a fine line to balance because, again, you get back to the mission-creep issue and it’s hard to turn that stuff off once you turn it on, but there are probably ways to do it.

Joe Elia:  Yeah. Well, you would think that there would be legislative ways to do it, except that the legislators are subject to lobbying. And so if you have the companies that are at risk from this legislation writing or helping to write the regulations then there could be backdoors left open. I mean, I don’t want to sound totally paranoid, but a little paranoia is a good thing, I think.

Dr. David Grande:  I do think though, back to that, I think the bigger issue of what’s going on is whether or not these technology companies are hopeful that by being seen as altruistic and responsible in some way that it will leave them in a better place in terms of what kinds of regulations they may face in the future. And that would be a mistake, like, we shouldn’t use a little bit of responsible behavior during the COVID pandemic to justify not taking actions at a later point.

Joe Elia:  So what would you like to see happen, Dr. Grande, as a result of your raising these issues?

Dr. David Grande:  Well, again, I’m actually not a legal expert by any means. But in talking to a lot of the folks that we did, I mean certainly the European Union has blazed a trail in this space. You know some of the people we interviewed who are really experts on international law and policy in this space talked about how the US really stands out in the world by taking this very sector-specific approach to privacy. So we have HIPAA, right, and we have GINA that protects genetic information. There is no place in the US federal government where anyone’s thinking about these issues across the economy.

You know, we’ve got people who think about health privacy at the Department of Health and Human Services, but it’s not the Department of Health and Human Services that can ultimately address this issue. And I think a lot of other countries around the world do specifically have privacy officers, agencies and whatnot to really come up with a more holistic way to think about these issues. Because we’ve moved far past, as I mentioned earlier, the idea that like health privacy can all be addressed through a health agency because it really is ubiquitous now.

And I think for many people and I think a lot of consumers — I don’t know this for sure — but I think if you asked them and said, “What do you worry more about, like, the privacy of the last blood pressure reading in your doctor’s visit or the social media posts and whether they reveal something about your mood?” And I think people would be more worried about their social media posts and their mood and people using that information in ways that they would rather not. So we have a lot to learn from the EU. I think we’re still seeing how that it’s relatively new, seeing how it’s going to play out in terms of the behavior of these companies. But we certainly need to start taking a similar direction here in the US.

Joe Elia:   And speaking of behaviors have you modified any of your own behaviors over time? Have you thrown away your GPS or your cell phone? Or have you stopped using Netflix or Amazon or going to Whole Foods?

Dr. David Grande:  I’ve tried. But I go back to my earlier point, which is it’s become almost impossible to be a modern day consumer and not leave these footprints behind. Even if you think about the basics of using a smartphone these days, God forbid you turn off all this functionality. Your phone’s going to tell you pretty much every day that you know you need to turn this thing back on or it won’t work properly. You know it’s like do you want to allow it once? Do you want to allow it always? And then when you know you allow it once is it really once? Is the app still operating in the background? You really have to become a computer scientist now to even interpret what you’re saying yes or no to anymore. And I think it’s asking a lot of consumers, but I’ve tried. I certainly have tried, but it’s a frustrating endeavor.

Joe Elia:  Well, I want to thank you, Dr. Grande, for talking about your work with me today.

Dr. David Grande:  Oh, absolutely, my pleasure.

Joe Elia:  That was our 270th podcast. They’re all available free at podcasts.jwatch.org. We come to you from the NEJM Group and our executive producer is Kristin Kelley. I’m Joe Elia. Thanks for listening.

How are his patients reacting to this surge? What does he do to prepare himself for a shift in the emergency department? Is there enough PPE to go around?

Listen in.

Running time: 25 minutes

Other interviews on Covid-19 in this series:

1. Dr. Anthony Fauci
2. Dr. Susan Sadoughi
3. Dr. Matthew Young
4. Dr. Julian Flores
5. Dr. Kristi Koenig
6. Dr. Renee Salas
7. Drs. Andre Sofair and William Chavey
8. Dr. Comilla Sasson
9. Dr. John Jernigan
10. Dr. Ivan Hung
11. Dr. Steven Fishbane

TRANSCRIPT 

Joe Elia:

You’re listening to Clinical Conversations. I’m your host Joe Elia.

Here we are still swimming in the sea of numbers generated by the COVID-19 pandemic: numbers of confirmed cases, numbers of tests, fatality rates per 100,000 population, et cetera.

With so many numbers you’d think your high school math teacher would suddenly appear and solve the equation — but there is no equation, only patients and clinicians. And that’s what Dr. Ali Raja, my cohost, and I are going to focus on this time. We’ll avoid numbers if we can.

We’ve invited a Houston emergency physician, Dr. Mike Gonzalez, to talk with us. As you’ve doubtless heard Houston and Texas in general have achieved the dubious achievement of being a new hotspot for COVID-19.

Welcome Dr. Gonzalez.

Dr. Michael Gonzalez:

Thank you. Great to be with you.

Dr. Ali Raja:

Hi, Mike. As a native Houstonian with lots of family still in town, I’ve got to ask, how are y’all doing down there?

Dr. Michael Gonzalez:

Yeah, thanks for asking. It is a challenge.

We are in the unfortunate position of sort of living the reality — of seeing the manifestations of what you know many of our colleagues, family members, brothers and sisters have gone through in other parts of the country. And you know it is disheartening to know that we’ve had months and months to prep, to learn and to now find ourselves in the situation of living through the very same problems.

So, you know, for a while there we were, I’ve got to tell you, somewhat optimistic that maybe we weren’t going to have the surge that everybody saw, that many of parts of the country kind of lived through. There was a lot of very hopeful optimism but many of us and I will fully admit to being one of the very sort of pessimistic “Hey we need to keep an eye on this and it’s not time to celebrate.”

So I think professionally, to break your question up into two parts, professionally I think like most emergency physicians who feel like, you know, we were built for this and this is our time to face the challenge head-on. My teams are ready. They have, you know like I said, been watching, waiting, learning, preparing. Professionally, I think we’re in about a good a place as we can be. Personally, for mostly the reason that I worry more about my family, friends, neighbors who are not medical and who have a really hard time, I think, parsing out the difference between what we know is the reality inside the four walls of the hospital and what they see on the news and what they hear in the community and what they see on the street. And I think one of the biggest struggles personally that I’ve faced is trying to get all of those things to align. And to really sort of get people to understand that this is serious, this is lethal, and it has longstanding implications that I think the world is still struggling with.

Dr. Ali Raja:

Right, we’re still figuring all this out. You mentioned being an emergency physician, and obviously you and I have known each other for a very long time. In addition to being an emergency physician you’re also an educator of other physicians, of paramedics, of EMTs. Can you tell us what it’s like for new residents, new paramedic students, new EMT students who are just starting in the journey? Can you tell us what it’s like for them — the ones you’re teaching right now?

Dr. Michael Gonzalez:

So I think I’ve honestly found that I pull, honestly, from my military training and really do sort of emphasize that this battle in many ways is fought on the front of preparation, and there is bedside care that we can certainly deliver optimally. Make sure we’re resuscitating, make sure we’re doing all the clinical things that as emergency physicians, like, as I said this is what we were built for and this is what we were trained for. But in many ways this battle, this virus is really confronted in all of the steps leading up to that in the form of the PPE that has, you know, become one of the major concerns, in terms of getting the rooms ready, in terms of getting enough hospital staff, enough, you know, equipment, enough gloves.

Like, all of those things that we for so long took for granted in the civilian world we are now facing. And the reason I say military training and from deployments where it was not an assumption that we had enough IV starting kits. It was not an assumption that we had the appropriate antibiotics. So all of that sort of training and background is really stuff that I had, in many ways, hoped to not face again [they] are right back on the forefront. And so for most of the time that I’ve spent with trainees at various levels it really is sort of reinforcing those lessons of preparation, right? And preparation, you know, in many clinical settings is one of the important P’s that we always emphasize, right?

Dr. Ali Raja:

Right.

Dr. Michael Gonzalez:

But in this setting it really is true and it’s down to the bedside level of “Do you have everything you need before you go in the room?” For the nurses, “Do you have all of your IV blood tubing starts, everything that you need before you walk in? Because you can’t come out again.” And so really I find myself, you know, going back to lessons that I learned way too long ago and really kind of reemphasizing basic important things like preparation and equipment.

Joe Elia:

Dr. Gonzalez, in this turmoil that you face it probably feels different now than it has recently. So has your routine changed over the past few weeks? How do you prepare for the clinical day?

Dr. Michael Gonzalez:

That’s a good question, Joe. I think that my routine probably hasn’t changed substantially in terms of getting ready for work. Getting ready is really, you know, unchanged I think for me. I think the only thing that probably has changed is, like for many of us, instead of wearing my own scrubs I change into hospital scrubs upon arrival in the clinical setting because I don’t want to take those things home. And so I find myself kind of, you know, still wearing scrubs generally into the department, but changing upon arrival. And then, again, kind of reminiscing back to military training and background in deployments, you know, I find myself [asking] “Do I have my scrub cap? Do I have my goggles?” And all those things have to be in place before I kind of get ready to go, you know, in the box or in the room or on the floor, depending on which part of the unit I’m working in.

And so I think a lot of that, again, is sort of familiar, to me at least, and for me it’s almost a warm blanket of “I know how to do this.” And I think I’ve heard it repeatedly from military colleagues that you know this is a very familiar setting in terms of facing an enemy that sometimes you can’t see, you don’t know where they’re coming from and it could be anywhere. It’s a sort of familiar feeling. The biggest thing, I think, is really afterwards. After a shift it is, you know, in a non-COVID time that you know I find myself sort of talking about now nostalgically, even though it was really only months ago. It’s really, you know pre-COVID you know you would get off shift, change quickly sometimes and go directly to meet family or friends for dinner, for a beer, or whatever the case might be. And now it’s truly sort of a more extended process.

And again I link it back to the checklist sort of mentality of, you know, “Did I take all that equipment off?” I’ve got my shoes off, I’ve got my scrubs off, I changed into you know whatever I wore into the hospital. In the car or once I get home certain things come off as I’m getting into the house. If my family members are awake, which I tend to work kind of a nightshift, you know, so that I don’t always cross over with my family — and that was even pre-COVID. So I don’t get a lot of the immediate need for hugs at the door, which I love, but in this time of COVID I think it’s really nice that I don’t have to deal with that. I get the dog barking sometimes when I get home, but otherwise it’s really more of I can kind of sneak into the house, get everything off and get immediately into the shower.

And then even before I get into the shower it’s a matter of getting the clothing bundled up separated from my family’s clothing so that I can make sure that we’re maintaining as many boundaries as we can from this thing. And again because having lived through a completely different world and a different environment it feels very much like the pre- and post-flight checklist of a previous world that I’ve done before and I can do. And I know, like, for me I know I can do it I’ve been through it. I see the struggles personally on my family and my spouse who is also a physician, but who is not in the emergency department.

And my kids, especially, like it’s really starting to wear on them. You know “Why can’t we go X, Y, Z? Why can’t we go to the movies? Why can’t we go to the arcade?” Like, that is getting hard.

Joe Elia:

This isn’t the question about whether you read the New England Journal of Medicine, so that’s not what we’re asking here. What I’d like to know is — and the information about this virus is changing all the time — is there a place that you’d go to just too brief yourself occasionally on “What’s the new stuff I should know about?”

Dr. Michael Gonzalez:

You know that’s a great question, Joe. I honestly read a variety of journals, the New England Journal one of them of course, and a couple of different emergency medicine sources. But really, honestly, lately because this has been moving so fast and, really, seems to be there was a period of time where I felt like it was changing by the hour, that honestly this is one of those times that social media has really come to the forefront. And I’m one of those people that’s fairly active on it. I absolutely have a group of trusted colleagues that we have formed both a public as well as a private discussion group to kind of update each other, follow-up on what’s going on and also provide the support that I think is just becoming more and more important as this thing seems to just morph and go from one area of the country to another. And I’m certainly hoping that we don’t, you know, send it back to other parts of the country but I have real fear and an anxiety about that, that this is going to just bounce back and forth as the fall and winter and more traditional infectious-like illness season comes back.

Dr. Ali Raja:

Let me ask. Taking it back a little bit to social media, because you and I have talked about this on Twitter and other places, you mentioned PPE recently and how it’s become a concern and you just talked about that. I understand that there’s a lot of connotations and background here, but let me just ask do you have enough PPE for your staff? And even if you do what’s the situation like in Houston? Are hospitals having to reuse it yet?

Dr. Michael Gonzalez:

I thank you for the question, Ali. I think that there has been a lot of work that has gone into making sure that we have the equipment that we need across multiple fronts, agencies, hospitals. I think that we, for now, and I always say that with excruciating care and in every meeting and every chance I get to express a concern or voice about this topic it’s always “for now” because it’s an important caveat that we are looking at what the numbers are doing. And they are constantly changing and they are looking worse than ever and so for me it is a constant. I do feel like as one of the leaders in various organizations, I do feel like that is my job. That is my responsibility to sort of speak up, make sure that people know that I really want to know what models are you using?

Because if you’re looking at a trend from the last two weeks that’s not going to work.

We’re in a completely different place now and so our modeling, our structures in terms of our supply chain, I think have been worked out. The single biggest thing that I worry about and this is true that we’ve heard from colleagues all over is the N-95 mask. I think we are good in terms of other very equally vital components but the N-95, as you know, is our unique sort of last line of defense before we inhale this virus. And so it is exceedingly important and I do worry that we are only okay in our supply status because of the reprocessing programs that are going on all over the country. And I certainly appreciate the people that worked that out and demonstrated it could be done safely. But I do have some anxiety and worry for my team about an instrument that was, as everybody knows, never designed to be reused. It was never designed to be reprocessed and so if you ask me about a single thing that keeps me up at night that’s it.

Dr. Ali Raja:

What about bed space? And I say that because earlier today I heard that, I don’t know if it’s level two or surge level two, but I’ve heard that Houston’s in the situation. I keep up with this because as I mentioned my parents live in town and if they get sick they’re going to need an ICU. I’ve heard that now you’ve reached ICU capacity and you’re starting to get creative around making new ICU space at least citywide, if not individual hospitals. How are things looking in terms of ICU and floor bed capacity?

Dr. Michael Gonzalez:

Yeah, we have attracted a lot of attention nationally and regionally for all the wrong reasons. I think that the bed capacity situation has certainly been on the radar for both myself and a variety of other leader’s way above me, right? And so this is something that we are closely monitoring for sure. The phases have been something that has been developed by the leadership out of the TMC organization that I don’t have direct links to. So it has been interesting to watch their messaging and how that has been perceived and understood or perhaps misunderstood. I do think that at a more local level and speaking to colleagues we are absolutely seeing adjustment inside the hospital of both elective surgery patterns, outpatient procedures, to make space available. As an emergency physician, right, we want our patients to get — once we’ve stabilized them —  diagnosed or at least [having] gotten the diagnostics done and we can hand off to our in-the-hospital colleagues. We want those patients to go upstairs as quickly as possible.

Because as has been well documented over multiple years of research and well proven that the single biggest obstacle of ED throughput is boarding time and how many patients are waiting. And so we, for the most part in the City of Houston, have hospitals that operate pretty darn efficiently. And so our board times are pretty limited in most facilities. We certainly have challenges here and there and you know different events, different periods of time where maybe due to staffing upstairs that there may be obstacles, but this is the first time that we’ve really been faced with a complete regional attack on those resources. And all of those resources are being demanded everywhere at the same time. So even during the closest other example is Harvey, which is not that long ago, and we had hospitals that were completely taken offline because of plumbing problems or disaster flooding — people couldn’t get in there or out.

But even then we are fortunate in the region to have 40 plus hospitals that we were able to flex and move patients around so that, for the most part, there was only a couple of days where certain facilities were really pushed to the limits on capacity. This as many of our colleagues from all over the country have already faced this, as you know better than anyone, right, this is an ongoing, slow-rolling, level six hurricane that just isn’t gonna go away. And more importantly, isn’t gonna tell us in advance when landfall is coming and when it’s gonna be over. And so, you know, there’s a dire need for the resources across the entire community. I know that many of our hospital partners and hospital colleagues all over the city are absolutely being creative in terms of freeing up existing bed space, both ICU, step-down, floor beds and freeing that space up from other procedural-type settings. And they are also looking at creating additional capacity.

So everyone in the medical community knows that capacity is one of those really difficult things to define because of how many patients move back and forth ICU to IMU, IMU to ICU and that is not always predictable. So I totally understand how difficult it is to put numbers — especially numbers reported to the public — around something that is so complicated. But at the same time I also feel like the public deserves to know that we are doing everything we possibly can and now including cancelling or postponing elective procedures to make room where I think there may have been some perceived resistance to do that from some of the hospitals in the Houston area.

Joe Elia:

Dr. Gonzalez, tell me about your patients. For instance, are they older or younger than you imagined that they would be and what’s their attitude? Do they come in surprised to find themselves in this “hurricane”?

Dr. Michael Gonzalez:

Yeah. So let me give you a little perspective on that, that early on I think there was a lot of surprise, so I’m talking very early April, May there was surprise: “I’ve heard about this and didn’t know it could happen to me.” And that was predominantly older, let’s say, over the age of 50.

And I think that, that has really dramatically changed to we are seeing a wider swath of age groups that are coming in because they feel terrible. And largely the people that we are seeing in the emergency department are not coming asking to be tested; they are coming because they feel awful.

And overwhelmingly, most of those people have now, at this stage in the past month, they know or they have an idea of where this came from. Either in the form of I’ve heard now that, “That person that I was with was positive” or “I went to this event, this party, this thing and it’s two weeks later or 17 days later and here I am. And I worried about it but I did it anyway.” I’ve heard it repeatedly and I can tell you that it is of course always an honor to take care of our patients and try and do the best we can to treat them medically, comfort them.

But this thing and because of the way this virus works it is a challenge to provide the same level of what I think all of us want to do. Because sometimes all you can is hold their hand and although we do that, we continue to do that, sometimes looking people in the eye, holding their hand, patting their shoulder and particularly not having family members available to help in the comfort and sometimes even, you know, providing just reassurance that we’re doing everything we can has been a real challenge. And that, I think, is taking a huge toll on healthcare providers all over and we are just sort of uncovering this raw nerve of we are really putting ourselves out there emotionally further than, I think, we’ve ever been asked to do because family members can’t be at the bedside. And so, back to your question, I think yes for sure we’re seeing a slightly skew younger over the past two weeks, let’s say, I’d use that as a timeline. But it is absolutely people come in who feel just awful and scared and you can see it in their faces when they arrive.

Dr. Ali Raja:

So, Mike, this is a really tough time but we know that like all things this will pass. And whether it’s a temporary lull or whether or not we finally get a handle on this we’re going to have a time at some point, weeks, months from now where things are better. Have you promised yourself a little bit of a reward after this? A new bicycle, a vacation in remote Canada far, far away from large medical centers? What are you going to do when all this calms down?

Dr. Michael Gonzalez:

I have given myself pause and freedom to think about that only because it has become a frequent topic around the dinner table. I told you my family and my kids have really sort of been struggling with this and as I have mentioned on social media I have become a Fortnite player with my kids.

Dr. Ali Raja:

Nice.

Dr. Michael Gonzalez:

Terrible, terrible, subpar they would tell you, Fortnite player. But that has been one of the things that you know we introduced them to, hesitantly, but now we enjoy playing together. And so that has been one of the joys of this thing, one of the small victories. They’ve admitted me to their team, so that’s a nice little…

Dr. Ali Raja:

That’s a win. That’s a dad win right there.

Dr. Michael Gonzalez:

Yes, exactly, a dad win. Exactly. But I think to your question, yes, we are really looking forward and are actively discussing and exploring options all the time about a vacation. And you know I am very mindful of my colleagues who both, you know, every team member in the hospital. And so I want to make sure that they’re obviously taken care of before I even think about taking my own time off. But there will be a long vacation at some point at the end of this, on the other side of this, let me say. And I am very optimistic, Ali, yes we will all get there.

Joe Elia:

Dr. Gonzalez, thank you very much for speaking with us today and good luck in the coming weeks.

Dr. Michael Gonzalez:

Thank you both. Thanks so much for giving me a chance to share our experience in Houston.

Joe Elia:

Of course.

That was our 269th podcast and they’re all available free at podcasts.jwatch.org. We come to you from the NEJM Group and our executive producer is Kristin Kelley. I’m Joe Elia.

Dr. Ali Raja:

And I’m Ali Raja. Thanks for listening.

Colorado showed an increase of roughly 75 additional traffic deaths per year, while Washington didn’t show any substantial effect. How can this be so, and what are the implications for states with legalization already in place or contemplating it?

Links:

JAMA Internal Medicine study

JAMA Internal Medicine editorial

Running time: 20 minutes

 Transcript:

Joe Elia: You’re listening to Clinical Conversations. I’m your host, Joe Elia.

Earlier this week, JAMA Internal Medicine published two reports and an editorial about the association of legalized recreational marijuana and its possible effect on traffic fatalities.

One report found an increased traffic fatality rate in four states that had legalized recreational use of the drug. The increase was measured relative to a control group of states that hadn’t legalized.

The other study examined the effect in two states, Colorado and Washington, and it found disparate results using a so-called synthetic control comparison.

Two authors of that paper have kindly agreed to discuss their results with me and Dr. Ali Raja, Editor-in-Chief of NEJM Journal Watch Emergency Medicine.

Our guests, Dr. Julian Santaella-Tenorio and Dr. Magdalena Cerda, are both with the Center for Opioid Epidemiology and Policy at New York University School of Medicine. Dr. SantaellaTenorio is also with Universidad del Valle in Cali Colombia. I’d like to welcome you both to Clinical Conversations.

Dr. Ali Raja: We both really enjoyed reading your study. For our listeners, can you give us a thumbnail sketch of your conclusions and findings?

Dr. Julian Santaella-Tenorio: We found that after controlling for all of these factors in generating a synthetic control for each one of the exposed states, which are Colorado and Washington state, we found that traffic fatalities were increasing in the post-law period — that’s from 2014 to 2017 — in Colorado but not in the synthetic control, but we didn’t see that in Washington state.

We just saw that in the post-law period the traffic fatality trajectories were the same for Washington state and for the synthetic control for that state.

Dr. Ali Raja: Were you surprised at the disparity between Washington state and Colorado?

Dr. Julian Santaella-Tenorio: It was surprising to see this kind of different effect. We were thinking that we’re going to see the same effect, right?, like increases in fatalities in both states that were enacting these laws. However, we thought that, after looking at the details, that the industry in Colorado is much bigger and it has many more dispensaries compared to Washington state. If you do that per capita, you see that it is much bigger in Colorado than in Washington state, and the other thing that we were trying to plot is for why this is the case in Colorado but not Washington is that we see that many of the states that are around Colorado don’t have these kind of laws and there could be a lot of kind of this tourism going into Colorado, but that’s not likely the case in Washington state.

Dr. Magdalena Cerda: And you also see, in Colorado, you see an increase in use of marijuana after the opening of legal retail sales and you don’t see the same in Washington. So, that also supports, I think, the focused increase in traffic fatalities in Colorado.

Joe Elia: Dr. Cerda, why did you choose synthetic controls which compared each state individually with a kind of, as I was thinking about it, a doppelganger state? You know, an identical state, but that state hadn’t implemented recreational cannabis laws. Why did you take that approach?

Dr. Magdalena Cerda: Yeah. That’s a great question, and so the reason is that we want to make sure –right?, because of the high policy relevance of this question — we want to make sure we get the answer right and we want to make sure that any kind of increase that we see in traffic fatalities after legalization is really due to the law and not to other things that might be different between Colorado, say, and other states, right?

Because we do know that states don’t randomly choose to legalize or not. In fact, there are many reasons why they do, and those reasons are different between states that choose to legalize or not, and it makes it difficult to figure out if it’s really the effect of the law.

So, the nice thing about synthetic control group approach is that we can use a data-driven procedure to figure out which states basically match what would have happened in Colorado, say, or what would have happened in Washington had the law not been passed, and that’s what we want to know, right? We want to figure out okay, well, what would have happened in Colorado had the law not been passed and what actually happened?

So, is what happened greater? Is their increase greater than what would have happened without the law? Yes or no, and that gives us a much better answer about whether it’s really the law and not something else. So, that’s why we chose to use that approach.

Joe Elia: I noticed that you have a table of the states that you used to synthesize the controls from, and Colorado’s state, I believe, the heaviest burden fell on New Jersey, I think, for Colorado, and for Washington, California was the closest comparison. Can you just give me a sense of why, for instance, California related more to Washington than say New Jersey did?

Dr. Magdalena Cerda: We used a range of different characteristics of these states and we combined them to figure out okay, given the combination of multiple characteristics that we think might be related to why certain states passed this law and why other states didn’t, which states were most similar to, say, Washington when you consider the combination of all of these laws together, and so it ended up that California was the best match for Washington and New Jersey was for Colorado, and so it’s not any one…the really nice thing actually about this approach is that it allows you to figure out, you know, not just the single isolated contribution of any one feature but account for the complexity of features, right? The complexity of factors that lead states to choose to enact this law or not, and it’s really a combination of factors that gives more weight to some states than others when you do the comparison.

Dr. Julian Santaella-Tenorio: And the good thing about this is that you’re not picking states to be the controls for your exposed state, for example, Colorado. The algorithm does it for you and it’s trying to find the best combinations of different states that will give the best match for that exposed state, for Colorado, for example. So, it’s an iteration process that will try to find the best combined group of states that will actually give you the synthetic Colorado that you want to use.

Dr. Ali Raja: Probably, hopefully many of our listeners will go back to JAMA Internal Medicine and read your article, but just because some of them may not have yet, let’s talk a little bit about the extent of the effect in Colorado, which we’ve mentioned a few times. You saw an uptick in motor vehicle deaths. What was your estimate of that uptick?

Dr. Julian Santaella-Tenorio: We saw that there was an average for the four years in the post-law period of 75 excess deaths, and if you look at each specific year you see that for 2014 there’s 37 excess deaths, and if you look into 2015, it’s 63 deaths. In 2016, it’s 78, and finally in 2017, it’s 123 excess deaths of the 648 that were reported by the CDC and by the four years’ data that we used. So, it’s an important proportion of the total deaths that were observed for Colorado in those years.

Joe Elia: Can we talk a little bit about, relative to death, are there offsetting benefits to be found in those 75 deaths? For instance, is there less crime surrounding illegal use of cannabis, or is there less driving under the influence of alcohol if you’ve legalized cannabis? Have these tradeoffs been studied?

Dr. Julian Santaella-Tenorio: So, we did a study back in 2016 trying to identify the effects of medical marijuana laws and traffic fatalities, and we did see that there was an overall reduction in traffic fatalities across these states that were enacting these laws.

The hypothesis that we had, and it was based also in another study by Anderson and collaborators showing the same effect, that perhaps marijuana was reducing alcohol use and was reducing the risk of people driving on roads being impaired by alcohol. However, that might be the case for medical marijuana laws, but might not be the case for recreational laws because it’s a totally different scenario.

You have dispensaries that are selling to anyone over the age limit. You have availability just skyrocket, and that could play different when you talk about like driving under the effects of marijuana and also the risk to driving. So, the thing is that marijuana competing with alcohol with medical marijuana laws could be one part of the study, but once you have such great availability of marijuana due to these new recreational laws, then the substitution effect might not be occurring, and you can have like a lot of people driving under the effects of both marijuana and alcohol, and we have different studies, like randomized controlled studies, showing that when you use both of these substances at the same time the risk for having a severe traffic event increases by a lot.

Dr. Magdalena Cerda: I would like to say though that at the same time, it is true that we just looked at one outcome, which is traffic fatalities, and so this doesn’t in any way mean that there aren’t very, you know, clear benefits of legalization in other areas. In no way does it mean that we are, you know, we’re trying to make a case against legalization. It’s just that we were focusing on this one particular outcome.

Joe Elia: You can be forgiven for defending it. However, I’m a bicyclist and I bike in Boston a lot, and I’ve noticed that I’m smelling a lot more marijuana coming out of car windows than I’m comfortable with smelling. So…

Dr. Ali Raja: As a bicyclist, I’m sure that’s of utmost concern. You’re right. It definitely has picked up.

Joe Elia: Dr. Cerda, what do you think are the next steps in your research?

Dr. Magdalena Cerda: So, I think, you know, one of the really interesting pieces of this paper is the fact that we found different effects in different states, right? Because that means that it’s not just legalization yes or no, it’s really about how legalization happens that probably makes a difference, and so I think one of the key questions that we need to figure out is what types of legalization approaches lead to increases in traffic fatalities and which type of legalization approaches don’t, right?

So, we need to figure out things like, you know, in terms of density of stores, taxation and the impact on pricing, advertising. So, really trying to identify the different aspects of legalization policy and figure out which ones are the ones that are driving or what combination of policies are really driving an increase in fatalities so that we can figure out potentially what are the types of legalization models that can avoid such unintended consequences.

Dr. Ali Raja: You know, on a little bit of a lighter note. All of us in academics went into our specific topic area for different reasons, and so if you imagine yourself at a family gathering for a holiday, and your friends and family ask you well, what do you do and why did you go into that, is there a story, or why do you tell them that you started researching this particular topic?

Dr. Julian Santaella-Tenorio: When I was doing my DrPH studies at Colombia University, I had this methods exam at the qualifying exams, right, and this was one of the questions that we were thrown at this exam, and I remember being really interested in answering this question, and then decided to start putting together databases and methods to be able to answer this question. So, to that I would say, like the first term paper that I had put together for passing this exam, and then continue and developed this nice paper that we published back in 2016, and I wanted to see the other effects of recreational marijuana laws, and I got Magdalena to be convinced that this was a good idea and to join in this effort.

Joe Elia: Dr. Cerda, what do you tell families at gatherings about why you’re doing what you do?

Dr. Magdalena Cerda: Well, you know, as a public health researcher I find this fascinating, and I feel like it’s my responsibility to figure out what the public health implications of these laws are. Particularly, I think what really fascinates me is not so much about what happens with legalization, but rather trying to figure out what types of models of legalization have been adopted across the United States and in different countries in the world to figure out: Are there ways that we can legalize safely? That is, are there ways that we can legalize and minimize public health consequences, and so to figure out and to use our capacity as researchers to figure out, you know, what are the unintended consequences and what do different experiences in different states and in different countries tell us about the best way to do it to protect public health?

Joe Elia: So, you’re both assuming, I think, that people are going to use cannabis, and your interest is in how do you make that possible and safe, as well as enjoyable or…

Your department encompasses both epidemiology and public policy, and so Dr. Cerda, what would you like to see change regarding that?

Dr. Magdalena Cerda: In terms of policy for marijuana, you mean?

Joe Elia: Yes.

Dr. Magdalena Cerda: I think it’s a good question. I think as…well, several things.

One is, as states legalize, I think there needs to be tight regulation around zoning of retail outlet stores, tight regulation and constraints on advertising of the product, investment in a lot of the taxes earned from sales in prevention, particularly in schools and targeted towards adolescents so that we can prevent unintended increases in early initiation of marijuana use.

Also, I think there needs to be use of those dollars for greater investment in treatment for people who are experiencing problems with cannabis use. So, I think it’s, you know, tighter regulation of access to marijuana and advertising, as well as investment in prevention and treatment.

Joe Elia: Okay, and just to be clear about the roles on the paper, Dr. Santaella-Tenorio, you’re the first author?

Dr. Julian Santaella-Tenorio: Yes.

Joe Elia: And Dr. Cerda was the senior author?

Dr. Julian Santaella-Tenorio: Yes.

Dr. Magdalena Cerda: Yes.

Joe Elia: Correct, and Dr. Cerda got the money together?

Dr. Magdalena Cerda: Yeah. Yeah. So, yes.

Joe Elia: Okay.

Dr. Magdalena Cerda: That’s part of what I did.

Joe Elia: All right. I just wanted to make the roles clear.

Dr. Julian Santaella-Tenorio: So, there’s something that I wanted to say, and is that so when we published our study on medical marijuana laws back in 2016, a lot of people complained about these results and it was kind of like we are saying that it’s safe to drive under the influence of marijuana, right? Because we saw reduction in fatalities, and we got a lot of emails and complaints like that, and I just want to point this out and is that it’s not that these findings at the population level when we were looking at states or say anything about the individual risk of marijuana use, right, but people sometimes get confused with that.

So, what we’re showing is not that if you smoke marijuana you have an increased risk of getting into an accident that will kill you. We’re saying is that, on average, states that passed these laws, such as Colorado, we see that at the population level there’s an increase in fatalities, which is totally different from the individual risk.

Joe Elia: Okay, and Dr. Raja, you’re an emergency department physician. Have you seen any effect? Do you see more people coming in with effects of having used recreational cannabis?

Dr. Ali Raja: It’s a good question, and, Dr. Santaella-Tenorio, you’re right. This is a very polarizing issue and people bring their own biases to it, and they take your conclusions and based on what they inherently believe, they’ll see them as either positive or negative, whereas you’re presenting data at a population level.

I’ll say individually, my patients…Massachusetts has always, at least that in the 12 years that I’ve been here, there’s been a lot of cannabis use in Massachusetts. That’s gone up over the past few years because of legalization, but there’s still only a handful, less than 10, maybe even less than five, I haven’t kept up, dispensaries in the state. So, it’s much more similar to Washington than it is to Colorado. When you get off the plane at the airport in the Colorado, there’s basically a dispensary at every corner, whereas in Massachusetts, although it is legal, it is still not widely available, and so I haven’t seen that much of a change in the patients that are actually presenting to my emergency department. Good question though, Joe.

Joe Elia: Well, I want to thank you very much, Dr. Santaella-Tenorio and Dr. Cerda, for sharing your insights with us today.

Dr. Magdalena Cerda: Thank you. Thank you so much for this…

Dr. Julian Santaella-Tenorio: Thank you. Yeah, thank you for inviting us.

Joe Elia: Okay. Thank you.

That was our 268th episode. They are all available free at Podcasts.Jwatch.org. We come to you from the NEJM group, and our executive producer is Kristin Kelley. I’m Joe Elia.

Dr. Ali Raja: And I’m Ali Raja.

Joe Elia: Thanks for listening. Dr. Ali Raja: Thanks for listening.

Dr. Steven Fishbane (a nephrologist) and his colleagues have just published their findings based on a survey of some 5500 patients with COVID-19 admitted to a metropolitan New York health system. Acute kidney injury developed in about one third of the group, and it was very common (almost 90%) among those requiring mechanical ventilation.

But beyond these clinical features, I wanted to ask Dr. Fishbane about how he and his staff prepared for the viral onslaught, and especially what lessons he takes from the experience.

Running time: 21 minutes

Links:

Kidney International study

Other interviews in this series on COVID-19

1. Dr. Anthony Fauci
2. Dr. Susan Sadoughi
3. Dr. Matthew Young
4. Dr. Julian Flores
5. Dr. Kristi Koenig
6. Dr. Renee Salas
7. Drs. Andre Sofair and William Chavey
8. Dr. Comilla Sasson
9. Dr. John Jernigan
10. Dr. Ivan Hung

Joe Elia:

You’re listening to Clinical Conversations. I’m your host, Joe Elia.

Our first encounters with COVID-19 often focused on the lungs and respirators. Now, that view has widened to take in things like kidney and coagulation disorders.

One large study of kidney complications has recently been published in Kidney International, and we have one of its authors with us. Dr. Steven Fishbane and his colleagues looked at the clinical outcomes in some 5400 COVID-19 patients admitted to roughly a dozen hospitals in the Northwell Health system in metropolitan New York. Their report offers important clinical insights, which we’ll talk about, but it will also be interesting to hear how the group coped with the sudden sharp demand for kidney replacement therapy.

Dr. Fishbane is Chief of Nephrology at Northwell Health. He also serves as Professor of Medicine at Zucker School of Medicine at Hofstra/Northwell.

Welcome to Clinical Conversations, Dr. Fishbane.

Dr. Steven Fishbane:

Thank you. Pleasure to be with you.

Joe Elia:

The Kidney International paper spans roughly one month’s experience — March of this year — with COVID-19. Before we move on to your experience in preparing for it, would you very briefly tell us what you found, clinically, in your…?

Dr. Steven Fishbane:

Right. So, in this study, and to put it in perspective for you, so, COVID-19 moved into New York with such an explosive rate in March, in particular, that you know it greatly overwhelmed the ability of the health systems, which just managed to get their way through, but for us at the time of the writing of this article, it was based on the first 5,449 patients, which now we, as a health system, have treated 15,000 patients, but in the study, the primary findings, I think, which were important to us was first being able to describe the number of patients who have COVID-19 admitted to hospitals. That’s important to describe is that 36.6 percent developed acute kidney injury, and people had been kind of waiting on that number, in that out of China and Italy, the numbers for acute kidney injury look like they were lower, and anecdotally, we, in the US, were experiencing what we thought were higher numbers, and we were just waiting for a rigorous look at it.

So, yeah, and it turned out that we found that a substantially higher number of patients were at least being reported in our study as being higher. That now has come out in some other work out of the United States, and then we had a number of other findings, I think, that were really interesting, as well, but you know, I think the first really important point was to remember, as you pointed out earlier, this is a respiratory illness. It is a remarkably focused, serious respiratory illness, but we are learning that it does affect other organs, as well. So, here, it’s the kidneys that are being demonstrated, as you pointed out, coagulopathic problems. Here, it’s the kidneys that are turning out to be an important secondary problem.

Joe Elia:

So, the number of people with acute kidney injury were found to be roughly the same as yours in a paper being published later today in The Lancet, from New York City, from Columbia. So, same general catchment area and your numbers are very similar.

In reading [your] paper, and I want to focus on the paper a little bit more, 90 percent, roughly 90 percent of patients on mechanical ventilation developed acute kidney injury as opposed to about 20 percent of those not on mechanical ventilation, and so, and the concordance or the concurrence of those things, of people going on mechanical ventilation and requiring or being recognized as having acute kidney injury was pretty close, wasn’t it?

Dr. Steven Fishbane:

Yeah. Right, and so, you know, this is one of those areas in research that I find to be particularly interesting in that, you know, think of it: We are at that point as this research is being conducted, we are so deeply involved with the intense care for these very sick patients. So, you would think that something like that, the concordance of respiratory failure and acute kidney injury would be very self-evident and intuitive and obvious to us, and yet, although I think we might’ve been experiencing that clinically, it wasn’t really until I remember one moment looking at the data where it suddenly occurred to me this is really remarkable.

There’s two things happening. One is that there’s a real concordance in terms of bad kidney injury right about the time that respiratory failure is occurring and that for patients with COVID disease at home, kidney disease is probably not an issue at all. For people with COVID disease who are in the hospital but without respiratory failure, it’s really not a very significant problem, but we found that bad kidney injury, severe kidney injury, kidney injury requiring dialysis was really limited to patients who required mechanical ventilation, and you know that is important in terms of some of the inferences that one can draw based on that. So, a long-winded answer to your question that, yes, very tied together, acute respiratory failure and kidney injury, as well.

Joe Elia:

Well, you know, as I was reading your paper, I was thinking, clinically, when somebody’s evaluating a patient, if that patient is having trouble breathing, you’re not looking at their kidneys. You’re looking at the fact that this patient is apparently drowning, and you’re trying to do something about it, but there were a lot of patients who were admitted to the hospital but who were not part of your study, and the reason for the exclusion was that they had had fewer than two creatinine measurements, I think, during their hospitalization. So, you didn’t feel that it would be fair to evaluate them, and it made me think, “Yeah, the clinicians are focusing on keeping the patient breathing, and those kidney functions are being evaluated in the course of further clinical care.” But I think what you’re saying is clinicians should keep an eye out on kidney function with COVID-19 patients.

Dr. Steven Fishbane:

Right. So, that’s clearly the case that although we need to be laser-focused on the care of the respiratory illness, because ultimately this is such a potent respiratory organism, but it does cause injury to other systems. We’re seeing this unusual syndrome in children right now, but you know to a much greater extent and not in the realm of rare conditions but rather a very common injury that goes along with the respiratory disease is kidney disease. We understand that now. We understand that patients need to be monitored very carefully in terms of the development of kidney disease and then the difficult decisions that go along with management, do you use dialytic support, et cetera.

Joe Elia:

Let’s move away from your findings regarding acute kidney injury and let’s talk about logistics a little bit. When did you realize that this kidney service might be overwhelmed, and how did you prepare for it?

Dr. Steven Fishbane:

So, it was in mid-March that we saw that New York was quickly just having an explosion in infections. New York was essentially becoming what Wuhan was to China in terms of the rate of infection, and you know, at that point, I think people understood the fact that there was a real risk of really overwhelming the health system, and if the virus has another surge in the fall, we’ve got to, again, be very careful with respect to that, but we recognized, I remember the moment when we realized that the rates were increasing so quickly that for the 10 percent of patients that have bad enough disease to require hospitalization and then for the percentage of those that are going to have bad kidney disease with it, we really had to model out what this could look like.

So, as we got into April and May, if it took a relatively benign course, what it might look like, if it took a middle-road course, and if it took a severe road, what it would look like in terms of potential resource needs. So, we modeled it out. It did end up being the most severe possible course that it could have taken, and at that point, we did a lot of purchasing based on our worst scenarios, renting, purchasing, but getting the types of equipment that were going to be very important in terms of being able to provide dialysis services, and the type of dialysis, also, that we do in the most critically ill patients, which is continuous renal replacement therapy, or CRRT therapy, and making sure that our hospitals would have enough of that type of equipment.

And we really strongly went with a mantra from the beginning here that we’ve got to be able to, to the greatest extent possible, try to cure the underlying respiratory infection, the respiratory infection, and we’ll succeed in patients. We won’t succeed in other patients, unfortunately, but that we never want this secondary problem of kidney disease to limit the patient’s outcomes. We want to make sure that we have the resources that we need to be able to treat the kidney part of it, and yet, by the middle of April, I think everybody through New York was running on fumes and came very close to hitting that point of not being able to keep up with the kidney aspects of the disease.

Joe Elia:

Yes, and you had to move clinicians around the system, too, didn’t you, to have enough nephrologists where you needed them?

Dr. Steven Fishbane:

Right. So, you know, I think a lot of health systems experienced this difficult and really painful issue in the New York area. I don’t know if this occurred a lot outside of New York but that there simply were not enough intensivists. There were not enough hospital medicine doctors. So, think of it, you know, this way, our largest hospital out of 23 hospitals is North Shore University Hospital. It’s 865 patients, you know, probably four intensive care units, and before you knew it, the whole hospital was basically an intensive care unit. I mean units that had been classic medical-surgical units were being converted into intensive care units, and there weren’t enough intensivists to be able to care for these patients. So, from specialties that were suddenly less busy, for example, gastroenterologists were not doing a lot of colonoscopies and other procedures, orthopedic surgeons and other surgeons were not doing a lot of elective surgery, and so a lot of people were brought out of necessarily areas of comfort for them.

Tom McGinn, who’s the chairman of medicine and associate chief of staff for the health system, you know, I think in a very touching way, put forth the fact in March that a lot of us were going to have to get out of our comfort zones and get into areas of treating patients, and you know it ended up, I think, for a lot of people that were redeployed into front-line care for intensive care and for hospital medicine care of less sick COVID patients, it ended up, I think, being a really energizing, a very, you know, I think in some ways exciting but very sad, very sad labor that people were involved in. For nephrologists, it was a little bit different. Some of our people got redeployed, but because so much of our work exploded in the hospitals that we were really redeploying our people from office into hospital care.

Joe Elia:

Did you have enough personal protective equipment, PPE, so called, and…?

Dr. Steven Fishbane:

Yes. So, I think that we were fortunate that for all aspects of protective equipment, there was enough. Now, you know, as you probably know, by late March, I think everybody was worried about would there be enough ventilators, would there be enough masks, would there be enough face guards, would there be enough of everything? And you know, I think that New York State was very helpful in this regard. Our health system senior leadership worked very, very hard and long hours to try to make sure that the PPE was there.

So many people, so many doctors, were making a sacrifice, so many nurses making a sacrifice to be at the front lines here and to be able to provide the PPE that was required was so important more in terms of just how people felt about the work and the confidence. So, it’s such an important question, and you know, I think the leadership in New York State, the senior leadership for this health system, and I think for most health systems in New York really did a very good job of keeping us there, but we have to remember, you know, that if you let this pandemic explode out again in too large of a way, there’s always that risk of running short on PPE, and you know I think we saw from some other countries just how bad that can get.

Joe Elia:

If you could advise systems that will be facing a second wave, which we hope will not happen, what lessons did you learn from this wave that you’re going to carry forward with you even into the non-pandemic world?

Dr. Steven Fishbane:

Yeah. So, I think there’s a few lessons here that are important. You know the first is that plan in advance. To the greatest extent possible, don’t try to manage something that is just pulling you along, you know, the proverbial tiger by the tail. Try to stay ahead of it. Use data. I mean we were at the point, at least on the renal side, of every single day, understanding how many nurses did we have available, how many machines, the amount of disposables that are available. At the health system level, that means understanding the number of doctors, nurses that you have to be able to care for critically ill patients.

And you know I would like to add, you know, a third part of it, not just that real-time awareness and management but communication, communication, because it, you know, did come at a time that physician burnout in the United States was already something of an issue, I think it’s fair to say, and having that great physician leadership, which we have a lot of in our health system, to really keep the spirits up of people, and I think, you know, as we’re getting late in the course of this, at least first wave. We had a call last night where we were talking, and there was really a lot of gratitude about the importance of just talking and talking and providing support for not just physicians, of course, but nurses and everybody who’s involved at the front lines of care to be successful. Now, if there should be a second wave, that’s going to be hard, right? That will be you ran on fumes and adrenaline the first time through. The second time through, it’s going to take a tremendous amount of support, but we learned a lot the first time through, I think, to help everybody around the country.

Joe Elia:

If you could say something to the staff that went through these couple of months with you, what would you say?

Dr. Steven Fishbane:

You know I just have learned and have developed such an incredible sense of gratitude for people that have left young children at home, babies at home, that have elderly parents that they’re caring for, that have spouses with medical conditions that have gone willingly to the front lines and very few people that were not willing to do that but just the amazing gratitude for the courage, for the fact that this reenlivens in us the reasons that us as physicians, as nurses, as other healthcare providers, went into healthcare in the first place. It’s terrible that we’ve had to go through this for the patients, most of all, of course, and their families, but you know, I think a real awakening in all of us and you know maybe it takes every once in a while a certain wake-up call about why, why this calling is so important, and I hope young people going into medicine understand that, Joe.

Joe Elia:

I wanted to ask you, Dr. Fishbane, what in your life prepared you for this challenge, do you think?

Dr. Steven Fishbane:

Maybe this is the best answer to your question. You know my training was during the AIDS epidemic, and I think that, at that point in my career, as a trainee, I didn’t really appreciate because this was the normal for me as a trainee, and yet, you know, I think for me and for some of my contemporaries, you know, that was very good preparation, but I think for everybody who has lived through challenges in their lives and they know they can get through it with courage and with, you know, working together, as a team, and feeling that camaraderie and collaboration of working together. It’s so important, right?

Joe Elia:

I want to thank you, so much, Dr. Steven Fishbane, for sharing your experience with us.

Dr. Steven Fishbane:

Great. What a pleasure to speak to you. Thank you.

Joe Elia:

That was our 267th episode. The whole lot is searchable and available free at podcasts.jwatch.org. We come to you from the NEJM group, and our executive producer is Kristin Kelley. I’m Joe Elia. Thanks for listening.

When the triple-drug combo was administered without interferon 7 days or more after the onset of symptoms, the results were no better than with Kaletra alone. Prof. Ivan Hung, the lead author on the report, explains that the researchers were afraid of prompting a cytokine “storm” if interferon was given after 6 days of symptoms — they’re not sure that that reluctance was well founded now. In any case, no patients died in either group.

The study was conducted in Hong Kong and has just been published in The Lancet. (An earlier study by another group published in the New England Journal of Medicine found no special benefit from Kaletra alone — a result seemingly confirmed by this study in The Lancet.)

We were able to interview Prof. Hung over ZOOM from Hong Kong, where he was about to enjoy a Mother’s Day lunch with his mom. It was very generous of him.

Prof. Hung’s article in The Lancet

NEJM study on Kaletra’s ineffectiveness against COVID-19

Running time: 14 minutes

Links to other interviews in this series:

1. Dr. Anthony Fauci
2. Dr. Susan Sadoughi
3. Dr. Matthew Young
4. Dr. Julian Flores
5. Dr. Kristi Koenig
6. Dr. Renee Salas
7. Drs. Andre Sofair and William Chavey
8. Dr. Comilla Sasson
9. Dr. John Jernigan

Transcript __________________

Joe Elia: ________You are listening to Clinical Conversations. I’m your host, Joe Elia.

A study out of Hong Kong, just published in The Lancet, shows that a combination of three antiviral drugs has the effect of shortening the time from the start of COVID-19 treatment to when nasopharyngeal swabs are free of virus. The researchers used a combination of three drugs, all of which have shown activity against coronaviruses related to SARS-CoV-2. Some patients also received interferon.

The regime was compared against a regime using only two of the antivirals and no interferon.

The study’s first author, Professor Ivan Hung, has kindly agreed to talk with us. Professor Hung is with the State Key Laboratory of Emerging Infectious Diseases, Carol Yu Center for Infection, at the University of Hong Kong.

Welcome, Professor Hung, and thank you for agreeing to talk with us.

Professor Ivan Hung: ________Thank you, Joe. Very kind of you.

Joe Elia: ________Previous work on 2003 SARS and 2012 MERS was key here, wasn’t it?

Professor Ivan Hung: ________Absolutely. Yes.

Joe Elia: ________And can you briefly explain the rationale for using the three drugs that you did?

Professor Ivan Hung: ________Yes, the choices of the three drugs are based on our previous research, published in 2003 and also in, subsequently in 2015. The two studies were based on…in 2003, we were using the Kaletra, which is the lopinavir/ritonavir, together with the ribavirin, in patients with SARS in 2003. And we were able to demonstrate that with that combination that patients clinically, they actually performed better with fewer complication of ARDS and also fewer mortalities. Nevertheless, it was a pilot study.

Subsequently, we did another study on marmoset, which is the, you know, the South American monkey, and we did, in that animal model, we were able to demonstrate by using either interferon or with the Kaletra, we were able to suppress the virus and with better survival in the monkey model. And that’s the reason why we choose to use the interferon beta-1b, the Kaletra, and also the ribavirin as our combination for this antiviral.

Joe Elia: ________And you say in the paper, the interferon jumpstarts the immune system. It can, it has that effect. So, you limited the use of interferon to those whose symptoms had emerged less than seven days before starting treatment.

Professor Ivan Hung: ________Yes.

Joe Elia: ________And why did you limit it to early diagnosis?

Professor Ivan Hung: ________We worried about the pro-inflammatory effect of the interferon, and as we know that from, you know, other studies, we know that the viral load actually peaks in the COVID-19 very early, 24 to 48 hours from symptom onset. So, that’s why we chose, we decided to use the interferon within seven days because we worried that if we would give it to patients who presented to us late, beyond seven days, there would be an adverse effect of having activating the inflammatory cytokine storm in these patients, and it might worsen their clinical presentation.

Joe Elia: ________Just because it, as you say, it jumpstarts the immune system, and you don’t want to put it into overdrive, I guess.

Professor Ivan Hung: ________Absolutely. Yes, that’s the reason.

Joe Elia: ________It seems very important to start treatments, at least with the triple regimen of antivirals, within seven days. Is it because the viral load peaks early?

Professor Ivan Hung: ________Yes. From our research in influenza and also other respiratory viruses, we know that if you have treatment very early on, within the seven days from symptom onset, we will be able suppress the viral load, you know, especially for the first few days. By suppressing the viral load, you actually prevent complication from happening in the second week, which is usually complicated with activation of the immune system and you have the cytokine storm, and that is when you get most of your complications, including your severe pneumonia, your respiratory failure, followed by multi-organ failures.

So, it is key, in fact, to treat COVID-19 or influenza within the first few days, or at least within the first week from symptom onset. So, that is very, very important.

Joe Elia: ________And some people who received the triple drug regimen started the drug regimen after the seven days of symptoms. They started…

Professor Ivan Hung: ________No, in this trial, we actually just give two drugs for those who were presented beyond, seven days or beyond. So, in fact, in the treatment arm for those who presented seven days or beyond, we did not give the interferon because of the adverse effects that we worry about from inflammatory effect. So, we only give the Kaletra and the ribavirin for those late presenters.

Joe Elia: ________Let me just be clear. Some of the patients received the Kaletra and ribavirin, but not interferon.

Professor Ivan Hung: ________Yes. Yes.

Joe Elia: ________Okay.

Professor Ivan Hung: ________That is within the combination group, but those patients who presented seven days or beyond, we only give the Kaletra and ribavirin without interferon because of fearing the pro-inflammatory effect of the interferon. In the control group, we only give the Kaletra as a control.

Joe Elia: ________In your table that you describe the results, I think it’s Table 3 or something, the people who received the triple drug regimen, the combo, the combination regimen, and not interferon, did not do significantly better than the people [on the two-drug regimen]…

Professor Ivan Hung: ________Absolutely.

Joe Elia: ________Okay.

Professor Ivan Hung: ________The table is based on subgroup analysis, so we actually split the group back according to when they actually presented with the symptoms, so…which was the fairer comparison, because for those who actually take the triple therapy with interferon, there are 52 of them within the combination group, and we compared these to the control, which is 24 of them who was also presented in the control group within seven days. So, that is the fairer control, a fairer comparison. Whereas, for those who only received the two drugs, that means that they present seven days or beyond, they are compared with the control, with the only-Kaletra group, and there’s no difference between the two groups.

Joe Elia: ________Right. Right. There were no statistically significant [differences]…

Professor Ivan Hung: ________Absolutely. And that actually proved that interferon probably is the big, you know, the backbone of the triple therapy.

Joe Elia: ________Yeah. Well, it’s either interferon or early treatment.

Professor Ivan Hung: ________Yes. As I say, I think it’s both.

Joe Elia: ________Yeah. Yeah. So, it’s…

Professor Ivan Hung: ________If you compared with the control, it would actually show a difference, so…which is also an extra treatment. So, that means interferon is likely to be the key factor.

Joe Elia: ________Yes. Okay. And so, you didn’t use a placebo, and you mentioned in the discussion that there’s a reluctance to use a placebo…

Professor Ivan Hung: ________No. We discussed this in our treatment panel or committee within our hospital authority, and in fact, all the panel members said, you know, placebo is…will not be accepted by the patient, given our painful experience in SARS. So, that’s why we have the Kaletra as the control rather than placebo.

Joe Elia: ________I see. And now, did the results surprise you? Were you expecting that interferon would have the effect that it did have?

Professor Ivan Hung: ________The result was more or less what we expected, although we were a little bit surprised in terms of the difference between the combo and the control in terms of the viral suppression.

Joe Elia: ________Yeah, the shedding was shortened among the combo receivers, recipients from seven days versus twelve days with the controls.

Professor Ivan Hung: ________Yes.

Joe Elia: ________The symptom alleviation, symptoms were alleviated in the combo group in four days versus eight days in the controls.

Professor Ivan Hung: ________Indeed, yes.

Joe Elia: ________And the hospital stay was much shorter. It was nine in the combo group and about fifteen in the controls.

Professor Ivan Hung: ________In the control, yes.

Joe Elia: ________So, yeah. Something was at work, and so…but the two variables seem to be time and interferon.

Professor Ivan Hung: ________Absolutely.

Joe Elia: ________That’s right. So, are you doing more studies on trying to resolve the, trying to get a finer…?

Professor Ivan Hung: ________Yes. Yeah. Yeah, several things we are trying to do in the, you know, in another trial, which we just started, even though we have no patients now in Hong Kong. I think the limitations in our first study is that is all mild cases, mild-to-moderate cases that we have. Most of them come in with the NEWS score of 1 or 2, and the other problem, of course, is that we have very few severe cases, probably because we hospitalize our patients very early on and treat them, most of them, within the first week. So, that’s why we have very few severe cases, including we have, you know, less than 1,000 cases in Hong Kong, confirmed cases. Less than 3% was in the ICU, so…and it’s also, you know, less than 0.4% in terms of mortality. So, it’s very difficult to…you know, we want to recruit severe cases, but we couldn’t.

So, the next step, of course, is to see whether this regimen works in severe cases, if we have more severe cases in the coming winter, or that is that we will be looking at whether we can actually use interferon in patients who presented beyond seven days, which we think that this is not a, you know…a lot of the pro-inflammatory adverse effect is not a problem anymore. We can actually give interferon for patient who present beyond seven days. So, we’ll be looking at that, as well.

Joe Elia: ________But if you were looking for severe cases, then you would need to look no further than Boston. So, are you working with colleagues internationally at all, or…?

Professor Ivan Hung: ________Yes, we have collaborators in Europe, in UK, and also in US, which we’ve communicated with. So, you know, we will be very happy to look for further trials with our collaborators, you know, in the coming winter when more cases evolve.

Joe Elia: ________Have you started using the regimen…you don’t, you say you don’t have any severe cases at the university now. Have you started using the regimen on other patients in other hospitals in Hong Kong?

Professor Ivan Hung: ________Well, in fact, for this trial, we have included six major hospital, public hospital in Hong Kong that actually cover around 75% of the population in Hong Kong. So, in fact, we actually recruited most of the patients in the first, you know, two months up to the 20th of March, of all our confirmed cases. We only have our second wave, you know, in the late March, where we have a surge of cases from about 200 up to, now, 1,000 confirmed cases a day, and so, we have recruited more or less all the patients, a majority of the patients that we have in Hong Kong. So, if we are looking for, you know, more severe cases, then probably we have to look somewhere else with collaborators in other parts of the world.

Joe Elia: ________You mentioned a term I’m not familiar with. You call it NEWS2. It’s a National Early Warning…

Professor Ivan Hung: ________Indeed. National Early Warning Score 2, which was developed in the UK for assessing especially respiratory illnesses affecting with…presented even earlier. And that allows us to compare, you know, the treatment and the control arm in subsequent observations.

Joe Elia: ________So, the severity of the pulmonary…

Professor Ivan Hung: ________Indeed.

Joe Elia: ________Okay. So, pardon my ignorance about that. I want to thank you for speaking with me today, Professor Hung.

Professor Ivan Hung: ________Thank you, Joe. Very kind of you. And Happy Mother’s Day.

Joe Elia: ________Happy Mother’s Day to you. I hope you enjoy it.

That was our 266th episode. All the rest can be found at podcasts.jwatch.org. We come to you from the NEJM group, and our executive producer is Kristin Kelly. I’m Joe Elia. Thank you for listening.

Most intriguingly, over half the patients who tested positive were asymptomatic at the time of their first testing, and a few hadn’t developed any symptoms a week after their positive tests.

The results are instructive to those working in facilities such as this, whose patients are vulnerable to bad outcomes.

Running time: 17 minutes

Links:

New England Journal of Medicine report

MMWR report

Links to other interviews in this series:

1. Dr. Anthony Fauci
2. Dr. Susan Sadoughi
3. Dr. Matthew Young
4. Dr. Julian Flores
5. Dr. Kristi Koenig
6. Dr. Renee Salas
7. Drs. Andre Sofair and William Chavey
8. Dr. Comilla Sasson

Transcript 

TRANSCRIPT

Joe Elia:__________You’re listening to Clinical Conversations. I’m Joe Elia. I’m joined this time by Dr. Danielle Bowen Scheurer, a colleague from earlier podcasts. Dr. Scheurer is a hospitalist and professor of medicine at the Medical University of South Carolina where she serves as chief of quality, safety, experience, and population health. That’s kind of a full plate, Danielle. Welcome back.

Dr. Scheurer:__________Thanks.

Joe Elia:__________We’re talking about COVID-19 again this week. It’s the disease whose effects you can see just by looking out the window: People walking in the streets with masks now seem unremarkable. And speaking of streets, there are hardly any cars out there.

What you can’t easily see, however, is who’s infected and who isn’t, and that’s the point of our interview with Dr. John Jernigan of the Centers for Disease Control and Prevention. He and his team have studied an early focus of the pandemic in the US — a skilled nursing facility in King County of Washington State, which neighbors Snohomish County where another such facility had just recorded the country’s apparent first outbreak. Their recent reports in MMWR and the New England Journal of Medicine show how difficult this disease is to screen for.

Dr. Jernigan is an epidemiologist with the CDC COVID-19 Investigation Team, and he also has a teaching appointment at Emory University School of Medicine, both in Atlanta.

Welcome to Clinical Conversations, Dr. Jernigan.

Dr. Jernigan:__________Thank you so much. Pleasure to be with you today.

Dr. Scheurer:__________Hi, Dr. Jernigan. It’s Danielle Scheurer. I’ve read your study with a lot of enthusiasm. It’s very interesting and impactful, so we just wanted to kind of walk through it and ask a couple of questions. So in summary, your team tested almost 90 residents in this facility with really good technique and of those who tested positive, over half had no symptoms at the time of testing and even a few hadn’t developed symptoms even a week after the testing. So as this was all unfolding and you’re reflecting on what you found, how surprised were you and your team with these results?

Dr. Jernigan:__________Thank you, Danielle, for that question. We were pretty surprised. As a little background, I was part of the CDC team that was deployed to Seattle when the outbreaks were first recognized there, when the first cases in Seattle were being recognized. I was in charge of a team that was over infection control for both acute care and long-term care, but it became apparent pretty quickly that long-term care was the place where we were seeing large and rapid outbreaks. So we began to support the investigation of some of those outbreaks as a way of helping prevent transmission.

One of the early observations: we sort of learned that some of the cases we were finding didn’t seem to have a lot in the way of symptoms. This was a very important issue because most of our infection control strategies rely on symptoms to identify residents or patients who might have infection and where to guide your testing and where to guide your isolation and prevention strategy. So we said we need to find out how widespread this is.

So we started doing these point-prevalence surveys. As you point out, we were quite surprised to learn that over half of the infections that we identified in these populations were asymptomatic at the time of the testing. This is a big problem in infection control. How can you separate those that are infected from those that are not if you can’t really tell based upon your symptoms? So we were quite surprised, to answer your question.

Joe Elia:__________The takeaway from your studies, in my mind, seems to be if I can caricature it: “Listen, clinicians, this disease doesn’t announce itself. You have to assume everyone is positive.” Is that fair?

Dr. Jernigan:__________In this particular population in this particular setting, I think that once you identify a case in your facility, yes, you need to assume that every resident in that facility may be infected. If that’s the case then you have sort of two choices going forward in terms of any transmission. One, you treat everybody in the facility the same way with regard to use of, for example, personal protective equipment, which can be a burdensome thing to do. It requires a lot of personal protective equipment, which is an issue.

As you know, there have been shortages nationwide, and particularly for many long-term care facilities, they have had trouble getting enough personal protective equipment. So that’s one issue. Basically isolate everybody, treat everybody a if they’re infected. Or you test everybody so that you can tell, as you point out, who’s infected, who’s not. Separate those that are infected into a certain cohort so you can put them in the same place in the building, assign certain staff to them, focus a lot of your personal protective equipment use there. Then for residents who are not infected to another place where hopefully you can protect them a little bit better.

Dr. Scheurer:__________And a follow-up on that, in your experience, how prepared do you think most facilities are to do quick and reliable widescale testing?

Dr. Jernigan:__________So this has been a real issue. As you know, there have been testing shortages and in fact when we first made this observation that was a big problem. We felt like testing all residents — and for that matter all healthcare providers — could be very helpful but testing availability really didn’t allow that. Now even at a week since that time testing availability has improved substantially, and so some skilled nursing facilities find themselves in states and other jurisdictions who have testing capacity that will allow taking this approach. Others are still struggling to do that. We hope that testing capacity will continue to improve such that if it turns out that this strategy does prove to be effective that more and more facilities will be able to utilize this strategy.

Dr. Scheurer:__________Even the ability to do the actual test aside, the collection methods are pretty cumbersome as well, right?

Dr. Jernigan:__________It is pretty labor intensive to collect the specimen. Even that is potentially changing a little bit with changes and recommendations of how tests can be performed, whether or not you have to do a nasopharyngeal swab, which is originally that’s what the recommendation was. So it takes a certain skillset and level of training to acquire those. CDC has just amended its recommendation such that swabs to the anterior nares are probably acceptable, which simplifies things a little bit in terms of being able to collect the specimen, but still you have to have the swabs, and you have to have the viral transport media, and you have to have a laboratory who can process these specimens and process them quickly. So there have been challenges in all of those elements. It can be a pretty difficult thing to do. I will say that I believe that capacity is improving pretty rapidly.

Dr. Scheurer:__________Which is great and definitely welcome news for the vulnerable population. Can you expound also a little bit about how you guys define symptoms and how that definition is changing and evolving?

Dr. Jernigan:__________Right. So when we started out this investigation not much was really known about this disease. Originally, the symptoms that were used to guide testing and to identify people who had been exposed and who you thought might be infected were essentially fever, cough, and shortness of breath. So we used essentially that for our definition of kind of typical symptoms.

But part of this investigation (and many others) is showing that there are lots of other less typical symptoms that are a manifestation of this disease. So on the one hand, you have people with sort of kind of the classic, cough, fever, shortness of breath. On the other end of the spectrum you have people who have no symptoms and then in between you have lots of other things.

We think especially in the early phases the illness can present quite subtly with maybe just a headache or myalgias or a little bit of chills, sometimes a little nausea, sore throat. What we’ve learned since then, which wasn’t appreciated when we started the study, the sudden loss of smell or sense of taste may be associated with this. So the sort of menu of symptoms that can be a manifestation of early parts of this illness has expanded pretty substantially.

Dr. Scheurer:__________Do you think there is a logical role for serologic testing in long-term care facilities right now or in the future.

Dr. Jernigan:__________So I’m glad you asked that question. I think there is potential great promise from use of serology to help guide these sorts of strategies, but I don’t think we are there yet. There are a number of different platforms out there. Some perform better than others. There’s also the question of what the presence of antibodies means. Are they neutralizing antibodies or not? Does the presence of these antibodies confer a protection against reinfection? What are the correlates of protection? I think these are all ongoing questions that we need to answer. I think there are many, many people out there working very hard to answer these questions and we hope they will have answers in the relatively near-term. I think at this moment today, our stance — and I guess this is my personal opinion — is that I don’t think we’re ready to use the results of serologic testing to make clinical or infection control or public health decisions. We might be there very soon, but I don’t think we’re there today.

Joe Elia:__________The editorial in the New England Journal of Medicine argues that we must be especially cautious until we can test widely and reliably. Did your team have a reaction to the editorial? Did they share their…

Dr. Jernigan:__________No. We have no interaction with the authors. We saw it when it was published or shortly before. If your question is more broadly about how to relax social distancing measures, et cetera and so forth and the relationship between available testing and that, I’m really not the person to focus on that. My focus is specifically on infection control and long-term care facilities and the relationship of testing and testing availability to that with regard to controlling transmission in long-term care facilities, which, by the way is a really high priority thing, as I think I might have mentioned already.

When SARS COV2 is introduced into these settings it can spread very rapidly and very widely and it can cause great morbidity and mortality in this very vulnerable population. But in addition, more than just protecting these residents and these patients it’s important for the regional healthcare system. What we observed in Seattle is that a large outbreak in even a single skilled nursing facility puts great strain on local hospitals in terms of their ICU bed capacity, et cetera and so forth. What’s more is that when a patient in a long-term care facility gets admitted to a hospital with COVID-19 sometimes it’s difficult to get them discharged, because long-term care facilities may be reticent to accept someone who is positive and may still be shedding virus, et cetera. So not just to protect those residents but it’s also to protect the local healthcare system.

So I think preventing transmission here in these settings should be a high priority. So back to the question of the relationship of that priority and testing. We think that our results suggest that testing can be an important tool to help control spread in these settings, and we agree with the writers of the editorial that the sooner that we can make improved testing capacity to the point that we can use it in these settings in that way the better.

Joe Elia:__________Thank you. I just wanted to ask a final question. What were your team’s reactions to the findings that you made? Were they astonished to see this?

Dr. Jernigan:__________I would say we were very surprised. The potential implications of the findings were immediately obvious to us. It seemed clear that a test-based strategy may be a very important approach and yet we were concerned that testing capacity at that point in time was not sufficient to allow that. We’ve been working since that time to partner with facilities and public health jurisdictions that have been increasing their test capacity and to partner with them in implementing this strategy and learning along with them about the best ways to actually go about implementing it.

For example, if you go out and you test everybody once, is that sufficient? There’s some early clues that that may not be sufficient, because if you test anybody on a given day and they’re negative it could be that they’re actually infected but they’re still in their incubation period and not shedding virus — at least to the extent that can be picked up by the test. That suggests that you may need to go back and do a repeat test and make sure that you haven’t missed any of those patients who are incubating. The findings from our study sort of hinted early on that that in fact was the case. So we were working with these partners to implement the strategy and learn lessons as we go with regard to the best way to implement it, the most efficient way to implement it, what the barriers to implementation are, what the facilitators to successful implementation are, and hopefully we can parlay all that information into better and refined guidance from CDC on how to proceed with this prevention strategy.

Joe Elia:__________My last question was going to be, what do you think your team would like to see as a result of your work? I think you’ve just answered that question.

Dr. Jernigan:__________Yes. I think that’s right. We would like to see testing availability that allows long-term care facilities the option of using a test-based infection control strategy. They have the resources they need to not only do the testing but it’s important to emphasize that they need to have the resources to take the appropriate action based upon the test and be planning about how to cohort patients or cohort residents, and make sure they have appropriate PPE, all these sorts of things. All the testing in the world…you can do all the testing in the world but it won’t help you if you can’t take the appropriate action that should be taken based upon the results.

Joe Elia:__________We want to thank you for your time with us today, Dr. Jernigan.

Dr. Scheurer:__________Thank you so much.

Dr. Jernigan:__________Thank you.

Joe Elia:__________That was our 265th conversation. This and all the others are available free at Podcasts.JWatch.org. We come to you from the NEJM Group. The executive producer is Kristin Kelly. I’m Joe Elia.

Dr. Scheurer:__________And I’m Danielle Scheurer.

Joe Elia:__________Thanks for listening.

We caught up with Dr. Comilla Sasson, the American Heart Association’s VP for science and innovation. She’s an emergency physician who teaches at the University of Colorado. She’d traveled to New York City to “help with the response,” and she talked with us from a field hospital that had been set up on a tennis court in Central Park.

She had lots to say about what’s driving patients away from emergency departments these days and what’s likely to happen in medicine (hello, telemedicine!) once the pandemic abates.

Running time: 15 minutes

Links (courtesy of the American Heart Association):

1. Interim Guidance for Basic and Advanced Life Support in Adults, Children, and Neonates With Suspected or Confirmed COVID-19
2. Oxygenation and Ventilation of COVID-19 Patients
3. New COVID-19 patient data registry will provide insights to care and adverse cardiovascular outcomes
4. COVID-19 Compendium for health care providers
5. Coronavirus (COVID-19) Resources for CPR Training & Resuscitation

Links to other interviews in this series:

1. Dr. Anthony Fauci
2. Dr. Susan Sadoughi
3. Dr. Matthew Young
4. Dr. Julian Flores
5. Dr. Kristi Koenig
6. Dr. Renee Salas
7. Drs. Andre Sofair and William Chavey

Transcript 

Joe Elia:     Welcome to Clinical Conversations. I’m your host, Joe Elia.

There is talk that COVID-19 is apparently scaring myocardial infarctions and other bothersome conditions away from emergency departments. Harlan Krumholz wrote about the phenomenon earlier this month in The New York Times. He pointed to studies suggesting that cardiovascular consultations have dropped by about 50 percent in the days of COVID.

My cohost, Dr. Ali Raja and I have asked Dr. Comilla Sasson to talk about this with us. You know Dr. Raja of the Mass. General and Harvard Medial School already. Dr. Sasson is an emergency physician and associate professor at the University of Colorado School of Medicine. She is also vice president for science and innovation at the American Heart Association.

When we scheduled this interview, she was on her way to New York City to, as she put it, “help with the response.”

Welcome to Clinical Conversations, Dr. Sasson.

Dr. Comilla Sasson:     Thank you for having me.

Joe Elia:     I’d like to ask you what the Heart Association thinks about this phenomenon of evaporating visits for cardiovascular diseases. Have you convened a panel to study it? What are you telling people who inquire about it?

Dr. Comilla Sasson:     You know, I think we’re all a little bit shocked and taken aback by just how quickly and precipitously we’ve seen such a huge drop in our volumes in our emergency department. Specifically, and I think it would be naïve to think that that’s just because we’re not having heart attacks anymore or strokes or other time-sensitive conditions. I think what it really boils down to — and I’ve personally experienced this with my own patients — is that people are afraid.

They are afraid that if they go to the emergency department they will get COVID. Even though we have separate areas for them, different places for them to be taken care of. I think what we’re realizing is that because we’ve done such a good job of getting the word out about make sure you’re appropriately utilizing the emergency department, I think the unintended consequence is maybe we’ve actually scared off some people who actually need to be there.

Dr. Ali Raja:     That’s interesting. Dr. Sasson, let me ask you, I’ve followed your research for years, and it really focuses on resuscitation, especially on educating non-clinicians and bystanders to begin resuscitation. You mentioned that people are scared. Are you concerned at all that that might actually translate to resuscitations and CPR? Do you think that people are going to be reluctant to actually go near and potentially help other in distress?

Dr. Comilla Sasson:     Yes. I think that’s actually something that we’re very, very both fearful of and mindful of, and I think what we’re trying to do, both as an organization as the American Heart Association, is get the word out about just how important it is to still go to the emergency department if you need to, call 911 if you have any kind of signs or symptoms of a heart attack. Then if you do see somebody drop, it’s okay to even do CPR. I think there’s so much fear right now of being even near people, touching people, let alone trying to actually do compressions — maybe even with breaths if it’s a household member. So I think we’re trying to get the word out.

I think we’re trying to also work with our partners in the community because we know there are huge health inequities as well. So can we use our reach as an organization, as the AHA who works in churches and schools and has a really big breadth and depth of work that we do in the community. How do we use our relationships to get that message out? I think we have to work in collaboration with all partners to do that.

Joe Elia:     Are you still in New York, Dr. Sasson? Can you tell us a bit about that experience?

Dr. Comilla Sasson:     It’s amazing. It’s wild. It’s something like I’ve never seen before. So I’m literally sitting right now in one of the field hospitals that have popped up. It was created just less than three weeks ago from scratch from a tennis court, literally.

So I think it’s been fascinating to see how a city responds. How do you coordinate care when you have to build a hospital from scratch; and then how do you bring people in and out of the system in a surge time; and then — even now as we’re plateauing here in New York — when do appropriately transfer folks here so that you can open up more hospital beds? And then how do you think about this in the next wave? So what happens when you hit surge two? What happens when you hit surge three? Is the field hospital the answer that could maybe help with all of those overwhelming videos and stories that we are hearing in New York City when the surge happened? How do you sort of think about this not only for the current COVID crisis but then for all the next waves that we know are going to happen?

Joe Elia:     So how long are you planning to be there to help out, as you put it?

Dr. Comilla Sasson:     For a month.

Dr. Ali Raja:     Wow.

Joe Elia:     So the people listening can’t see what we see. It looks like you’re sitting in kind of a tent-like facility. So do you have patients now in that facility?

Dr. Comilla Sasson:     We do. We’ve been ramping up for the last few days, and we’re continuing to ramp up and increase both our capacity to take care of patients but also to increase our acuity as well. So I think, again, as you’re building a hospital, I mean again from scratch, it’s about thinking about how to ramp up appropriately so that you can also make sure that your lab works, that your x-ray works, that you’ve got oxygen, that you’ve got the things that we take for granted in a real hospital, if you will, that has been there for years. You have to make sure everything works first and then I think that’s when you can start to really increase that acuity.

Dr. Ali Raja:     Dr. Sasson, let me ask you, right now we’re in the response phase. You’re setting up a hospital in a tennis court but we’re also generating a lot of data all over the world and this is happening everywhere at once. It’s not like the Boston Marathon where it happened in one city. This is happening all over the world and there’s a ton of data being generated not just around the world but also in the country. So let me ask you, this is obviously going to prompt a lot of data analysis and research at some point. Is the American Heart Association planning to collect and speak on the lessons learned?  Obviously they are — that’s what they do. But do you have any projects that you can talk about now about what’s going to come out of this from the AHA?

Dr. Comilla Sasson:     So I think our first responses that we had right away to this surge that we started to see in the global pandemic was to really increase our research funding. So we’ve allocated 2.5 million dollars of new research dollars specifically towards COVID research, and that’s generated a huge volume of applications, which just means that there’s a lot of people who have a lot of questions, right. We created a COVID data registry as well so that we can start tracking this and utilizing our expertise as an organization in terms of data collection.

We’ve had Get With The Guidelines for many, many years and so I think now we’ve got the ability to leverage that expertise that we had with Get With The Guidelines, precision medicine platform to build this data registry. So we can look at heart conditions specifically over the course of not just years but actually months and days, which is something different than what we normally do because most data analysis is a year later and then as an organization we are the biggest trainer of ACLS and BLS across the world.

So we just released our new interim CPR guidance for patients who are suspected or known COVID for both BLS and ACLS and PALS as well so that people can understand what are the caveats for resuscitation with those patients. Then we also released, just recently, our oxygenation and ventilation just-in-time training. So when you’ve go your medical student or maybe your ward nurse who’s now reassigned to the ICU, how do I learn how to manage a vent or a vented patient quickly? So really just trying to think about how do we build those educational building blocks that we’re really good at. How do we put those into place now so that people have what they need when the surge comes to their city, which we know it will.

Dr. Ali Raja:     If you don’t mind sending us the links to those, the new ACLS / BLS guidelines and the education that you just talked about we can actually put those in the website. [Done!]

Dr. Comilla Sasson:     And we had a huge, even in less than a week, we had over 38 thousand hits to that oxygenation / ventilation module. I can tell you, being here in the rapid response team for COVID, I’ve had a lot of people who are like I just don’t remember how to do a vent. It’s been a while for most of us, right. I can do 30 minutes of it. I don’t know if I could do six days. I can tell you, I took on a patient yesterday who was taken care of by a dentistry resident. You know, so if you think about what happens in a surge or when you have frontline workers who now have to very quickly increase capacity, that’s a real thing where you’ve got people who are very much outside of their clinical expertise who are just helping manage that surge so that’s what this is really all about.

Joe Elia:     The changes in referrals and ED visits that we’re seeing seem to be part of a larger phenomenon that’s happening in healthcare generally. The question is, would you agree that COVID-19 will be a kind of trigger for serious changes in how health gets taken care of in this country?

Dr. Comilla Sasson:     Yes. I think if we want to think about what are the positive things that have happened because of the COVID pandemic, the number one most important thing that we have done that will absolutely change the way in which we function as a healthcare system is to increase our utilization in telemedicine. It’s so funny because I think for the last 10 years we’ve kind of been struggling trying to get people to get excited about it, getting payers to pay for it, trying to get physicians and advanced care providers to sign on for it to say, yes, this is a valuable tool. I think overnight we kind of flipped the switch, just like they did in Wuhan, China, and moved so much of our care to telemedicine that I don’t think we’re going to go back.

I have a five-year-old son who got strep throat a week-and-a-half ago, even though we were on quarantine, so it happens. But we did two telemedicine visits from my house. I’ll be honest, I don’t think I ever want to go back unless we absolutely have to go see my pediatrician. It was amazing. We had everything that we needed at home. I think that’s one of the biggest innovations that I see both not just for the COVID post era but hopefully into perpetuity.

I did have a personal story of a patient who I took care of on telehealth. It was mind-boggling to me — absolutely mind-boggling. A woman who had multiple comorbid conditions with chest pain, who I was literally chatting with online first, because it started out as just a very normal interaction. It escalated into “Oh, my gosh, I’m really worried about you. You need to go to the emergency department right now.” She said no. I said, “Can I talk to your family member?” So then we had escalated up to her family member and yet her family remember said, “She refuses. She said she would rather die than go to the emergency department right now because she does not want to get COVID.”

I kept telling her there’s different sections. If you’ve got a non-COVID respiratory complaint you’ll be fine. We can keep you separate and she refused, absolutely refused, and said she’d rather die. So those are the people that keep me up at night, because you kind of wonder how many other folks never even bother to call or check in or even say that they have these symptoms. How much EMS volume has gone down for 911 calls because people are just afraid. So I think the more we can do to get the message out that “If you have to call 911, if you have to go to the hospital we can keep you safe.” I think that’s going to be key.

Dr. Ali Raja:     Many of us are starting to plan our health system’s response after we start opening society back up, and one of the things that I and many others — including potentially you — are worried about is that we’ll see a surge in patients with delayed presentations or we’ll see more patients rebounding from non-COVID diseases, the diabetic that hasn’t been well managed for the past few months, the patient whose high blood pressure hasn’t been well taken care of because they didn’t take advantage of the telemedicine that you just talked about. What should we be doing now to prepare for a potential surge in patients with cardiovascular disease presentations coming in when we finally do open things back up?

Dr. Comilla Sasson:     I think that’s a great question. I think you might actually have a better answer than I do, but I think everyone’s vantage point is a little bit different. I think what’s been interesting to me is that we’ve been in a very reactionary mode I think for most…most of medicine has always been about sort of treating the condition. So we wait until you develop heart disease to really plug you into the system and take care of you. So I think hopefully we get back to the idea of prevention and hopefully we go out and actually start being proactive about people’s care. To me, that seems like that’s such an important piece that has always been missing because we’re always just trying to put out the latest fire rather than really thinking about there is a CHF patient right now who’s sitting at home who is probably on the verge of having an exacerbation and may be frightened to come into the hospital. So what are health systems really doing to think about those very vulnerable patients right now to say what can we do while you’re at home, while you’re in the middle of your shutdown? What can we do to make you better so that we don’t have those unintended consequences of the flood gates open on whatever day it is, April 26 in Colorado and all of a sudden all these patients who’ve been waiting to be let out because now all of a sudden they think it’s safe to be let out because we’ve said there’s no shutdown anymore.

We’re going to see all those patients and April 26 for the CHFer may be too late. So I think we have to be much more proactive, and I worry that we’re not as proactive as we could be about reaching out to those folks. We know who they are in our healthcare systems, right.

Joe Elia:     I want to thank you very much, Dr. Sasson, for talking with us today about this.

Dr. Comilla Sasson:     Thank you, guys, for having me. This is really important work, and I’m very fortunate to be part of the Heart Association in that we’ve always looked at the sort of great opportunity both to be within the professional sector but then also with the general public in trying to increase everybody’s knowledge and getting everybody on the same page. So I’m hopeful, again, that through all of this what we’re learning, we can actually work with all of our different partner organizations, especially in the community to get the message out that it’s okay. It’s okay to go to the emergency department. It’s okay to use healthcare. Just because you’re in a shutdown doesn’t mean that you need to ignore your health condition until you’re not in a shutdown, and I think we all need to work together to get that message out.

Joe Elia:     That was our 264th episode. All the previous episodes are searchable and available free at Podcasts.JWatch.org. We come to you from the NEJM Group. The executive producer is Kristin Kelley. I’m Joe Elia.

Dr. Ali Raja:     And I’m Ali Raja. Thanks for listening.

I went back through the recent issues and found this January 10 entry, which began “The CDC is requesting that clinicians ask their patients with severe respiratory disease about any travel to Wuhan City, China. That city has seen at least 59 cases of pneumonia caused by an unknown pathogen since December. Seven of the 59 are critically ill.”

How quaint that all seems now — so three months ago!

Both our guests are being kept busy by that mysterious pathogen, and I thought I’d check in with them.

Running time: 20 minutes

Other interviews in this series:

1. Dr. Anthony Fauci
2. Dr. Susan Sadoughi
3. Dr. Matthew Young
4. Dr. Julian Flores
5. Dr. Kristi Koenig
6. Dr. Renee Salas

TRANSCRIPT:

Joe Elia:     Welcome to Clinical Conversations. I’m your host, Joe Elia. This week’s guests, Andre Sofair and William Chavey are physician-editors on Physician’s First Watch, a daily clinical news alert. They are part of a larger group of clinicians collaborating with First Watch’s writers — people like me.

Dr. Sofair and Chavey have the unique task of looking back over the weeks’ stories and choosing the most important. Their choices and the reasons for them show up first thing in Saturday morning’s email edition. I went back through recent issues and found this January 10 entry, which began “The CDC is requesting that clinicians ask their patients with respiratory disease about any travel to Wuhan City, China. That city has seen at least 59 cases of pneumonia caused by an unknown pathogen since December. Seven of the 59 are critically ill.”

How quaint that all seems now. It’s so three months ago!

Both guests are now being kept quite busy by that mysterious pathogen and I thought I’d check in with them.

Dr. Sofair is a Professor of General Medicine at Yale Medical School where he also holds appointments in the School of Public Health, and Dr. Chavey is an Associate Professor and Service Chief in the Department of Family Medicine at the University of Michigan, Ann Arbor.

Welcome to Clinical Conversations, my friends.

Dr. William Chavey:     Thank you for having us, Joe.

Dr. Andre Sofair:     Thanks for having us.

Joe Elia:     Dr. Sofair, you’re in New Haven, so what are you seeing on the ground there? Connecticut’s cases have more than tripled since the beginning of April and now hover around 13,500. The universities have emptied of students, but what’s the atmosphere on the wards?

Dr. Andre Sofair:     I would say that the atmosphere is quite positive. Our hospital and medical school have done a really good job, I think, in terms of communicating the situation with all of the frontline providers — nurses, clinical techs, the physicians — and I think we have a very good supply of personal protective equipment, which has been critical. And I think that we started our planning process very early on before we started seeing cases, so I think that the frontline staff feels supported and I think that the atmosphere is as good as one would expect. given the circumstances.

Joe Elia:     And Dr. Chavey, you’re just west of Detroit, of all places, in Wayne County, and that’s a hotspot. Ann Arbor must also be pretty quiet with the students gone, but you’re in family medicine there, and that’s an area with lots of closed businesses because of the national quarantine that we’re in. What feels unique about this experience to you?

Dr. William Chavey:     Well. We could probably talk for hours on that, Joe. I think the first most unusual thing for us was the contraction of ambulatory services, so we went from having seven clinic sites to contracting them down to two. Scrubbing schedules and moving everything that was not urgent, either to be deferred for later or to be done by telemedicine, and as this happened everywhere the escalation of telemedicine has been remarkable and dramatic over such a short period of time once the barriers were removed. In juxtaposition with that, we are also active at the University of Michigan Hospital, so we were preparing for what we thought was going to be a surge of historic proportions at the hospital. I was on a planning committee for a field hospital and we were looking at having 1500-bed field hospital. At this point, we’re not planning to have a field hospital at all. We are going to obviously record the efforts that we put in place in case we have to do that at some point, but the social distancing has helped quite a bit.

Our numbers are relatively flat. We are now living in an eerie world where we have a hospital that’s typically about 95 to 98% at capacity, and by cancelling all of the elective surgeries and so forth we now have a hospital that’s at about 65% capacity, and an ER that is seeing patients at a much lower rate than expected. And no one really knows what’s happening with the strokes, and the heart attacks, and the trauma that were coming in before, because they’re not coming in now. And the other interesting phenomenon — because in family medicine we also do obstetrics — a very unexpected phenomenon has evolved there where, when women come in, the thought now is that during part of labor that is an aspect where healthcare professionals might be a particular risk from aerosolizing the virus, and so there have been some studies looking at what percent of pregnant women, when they present to labor and delivery, are positive even if asymptomatic, and those numbers are somewhere between the mid-teens and 30%, so there are some protocols where they were screening every woman who would come in.

Well. The interesting part is a lot of women were declining that, because if they get tested their husband may not be able to come in with them and they don’t want to labor alone. So you now have this odd tension between wanting to protect the healthcare professionals who want to know if a woman is positive and a woman not wanting to be tested because she would then have to labor alone. So from the family medicine perspective we have all of these different areas, all of which have very unique, very unexpected tensions and things that have evolved.

Joe Elia:     So, how are you navigating that, Rusty? How are some of those conflicts resolved?

Dr. William Chavey:     Well. I’ve described a lot of what people are seeing in the literature as “science, thinking out loud,” and I think what we’re also seeing is “medicine responding out loud.” Each of these is unique and idiotypic in its own way and something that we had…I mean, no one ever was anticipating this dynamic in labor and delivery, so the obvious question is how do you handle a woman who refuses to be tested, and how do you protect the healthcare personnel? This is a dynamic we had never considered before.

Joe Elia:     Andre, you’ve spent time in Rwanda setting up medical education facilities and other places, too. Do developing countries have lessons for the first world about how to behave during a pandemic?

Dr. Andre Sofair:     I’m sure that they do. You know, they have different pandemics. For instance, I was recently in Rwanda and they had an outbreak of dengue, the first significant outbreak that they’ve had in years, and so they’re able to mobilize things and do things in the hospital much faster than we’re able to, I think, because the hospitals tend to be smaller and the bureaucracy tends to be not as robust as ours, so I saw them mobilize the units and set up bed nets at the hospital very, very quickly for in-patients to try and prevent nosocomial transmission of dengue, for instance. They also have a lot of experience with the use of personal protective equipment that we don’t have as much, and as especially masking. For instance, they have a lot of tuberculosis and other infectious diseases that we don’t have here, so there are certainly things that they teach us that we can learn from them.

Joe Elia:     Now, in both places, Connecticut and Michigan, are visitors allowed into the hospital? I’m reading reports that for instance at Mass. General everybody’s got to be wearing a mask when they go into the hospital, whether you’re a visitor, or patient, physician. Is that true now, pretty generally?

Dr. Andre Sofair:     At our hospital, everybody is to wear a mask, healthcare providers, when they come into the hospital and wear it throughout the day. Those are typically surgical masks, the N95 masks are reserved really for people that are taking care of COVID-positive patients, or patients that are being evaluated for the possibility of COVID. We have a very strict visitor restriction policy at our hospital where visitors are only allowed to visit if people are dying or on hospice.

Dr. William Chavey:     And we’ve had the same, and we also see this in the ambulatory setting. We’re not allowing people to accompany patients when they are physically seen in the office unless it’s a young child or someone needing assistance in a wheelchair. Something of that sort.

Joe Elia:     Okay.

Dr. Andre Sofair:     I can say, Joe, just to add to that, it has made the stay for the patients very difficult, as you can imagine. They’re communicating with family and loved ones over the telephone. Physicians are doing the same, and it’s also very difficult to the family because of the fact that they don’t have the daily updates in person with their loved ones in the hospital, so it’s made the care of patients very challenging, I would say.

Joe Elia:     So, questions for the both of you. What do you fear will happen as a result of COVID-19.

Dr. William Chavey:     I think right now here is a great deal of uncertainty and health systems, private medical offices and clinicians about what the future holds, and I think one thing that is clear as we emerge is that the post-pandemic world will not resemble the pre-COVID world, and I think…and if it is I think that’s a shame. I think we need…I think one fear or concern I would have is that we pretend all of this is going to go away and things are going to operate the way they used to, and I hope and think that’s probably not going to be the case, but none of us really know, and I think we’ve had to realize that we’re not in control. None of us really know what that post-pandemic world is going to look like. There are health systems that are beginning to lay off staff and faculty and are cutting salaries. There’s concern that we will never have the same volume of patients, or in the same nature that we had before, and I think a lot of people are struggling to figure out what their role is going to be in this post-pandemic world.

Dr. Andre Sofair:     Yeah, I would agree with what Rusty said. I think there are too many unknowns at this point, in terms of how long it will last, what kind of immunity, and what kind of herd immunity, if any, we’ll have. What kind of vaccines, if any, will be available, and whether or not they’re effective in terms of preventing [spread in] the population, so I think there are a lot of unknowns.

But I do think that there will be some changes in the way medicine is practiced. I think that there will probably be more telemedicine than there was before. I think that our rounding procedures will probably be different. I think that our use of personal protective equipment will be different. I think that our attending of medical conferences, whether locally, nationally, or internationally will be different. I think there will be a lot of reliance on communication that is at a distance, as opposed to in-person. I do also share the question and concern about what will happen with out-patient practices because a lot of out-patient practices now have had to close because of lack of patients, and will they be able to reopen in the future because of staff having been laid off and maybe going to other types of work, so I think it’s still very unknown, but those are the changes that, at least, I see in the future.

Dr. William Chavey:     So, Joe, in response to what Andre said there was a…there’s a policy arm of the American Academy of Family Physicians, the Graham Center, and they published data that by June 60,000 family medicine offices would be either closed or would significantly cut back, and this would impact 800,000 employees of these offices, so this could be an existential threat to private practice in that regard, and as Andre said, will they come back online, will they be able to? If they don’t what will happen with the patients who have been going to those practices and can the hospital-based practices, absorb those patients when all of this is said and done.

Joe Elia:     It must be different to prepare yourself for the clinical day in these times. Is there something that…has your routine changed as you get up in the morning and you’re about to go in? Do you recall something that a favorite professor of medicine told you as a young resident, or is there anything different about it?

Dr. Andre Sofair:     I would say for me the major change is how I have led my life at home, so for instance for the past month I’ve been living in the basement and on a different floor from my family, and I’m eating my meals separately. I’m always, or at least try to be, six feet away, and the most notable thing for me is where I have my clothes, how I put them on in the morning, and then when I come back home how I take them off and how I try to make myself as clean as possible so I don’t run the risk of bringing anything home to my family, so that’s been a major change for me.

Dr. William Chavey:     I guess one report from the ambulatory setting yesterday, I think my first four patients were all done in different ways, and we have…we’re doing some drive-by or drive-thru testing so we’re seeing some patients. We walk out to the car…we put our personal protective equipment on and go to the car, and we’ll do sampling there, check blood pressures, do what we need to do with them in the car, and one of my patients was done via that approach. We have divided the clinic into two halves, one clean side, if you will, and one where patients who might have some sort of infectious symptoms come, and so I had to go on one side to see one of the other patients. Another patient was just via phone call and another patient was telemedicine, and so instead of getting into a groove I’m seeing patients in all of these different manners and having to adjust, and take off one coat and put on another coat and go into one office where I have a computer to do the telemedicine, and you don’t…the comfort level that you had, that you developed over the years gets lost because you’re in very unusual situations.

Joe Elia:     Yeah. What advice would you give to a young clinician just starting out in the middle of all of this?

Dr. Andre Sofair:     When I was in medical school, I went to medical school in the Bronx at Albert Einstein, and that was the very beginning of the HIV epidemic, and so people were very unsure about how it was transmitted, what you had to wear to go into the room, and I think that there are a lot of analogies to the way that we responded then and the way that we respond now. And I really think that medicine is still a wonderful profession, whether you’re starting now where there’s a lot of insecurity about where we’ll be in the future, but I think that the calling is still the same. We’re there to collaborate with one another, to do our best together, to take care of suffering patients and families that are afraid, and so I still think it’s a very exciting time to be in medicine, and it’s interesting that some of the house officers that are on our unit said that they’ve spoken with some of their young colleagues who are not in medicine now and wish that they were.

Dr. William Chavey:     I think if you buy someone a gift you can either buy them something you would like or you can buy something they would like, and certainly the latter would be the preferred. Medicine is still, at its core, a vocation of service. And I think the advice I would give is, don’t go into it with your own perspective, your own sense of what it ought to be. If this has taught us anything it’s that we have to be flexible, and if you’re going to be giving the gift of service to a patient it has to be what they need in that environment, and that environment may change, and you may have to put aside your own sense of how you might want to do it in order to be prepared to serve.

Dr. Andre Sofair:     You know, the one thing that has struck me about…at least at our hospital, the way things have gone, and it’s been very comforting to me, is just the preparation on the part of the medical school and also of the hospital. Our hospital had a lot of foresight and started the preparations a couple of weeks before we started seeing our first cases, and we’ve been going at this now for about six weeks, and we have daily calls with our chief of our department of medicine and lots of leaders in the department to brainstorm, to get information out. Nursing has the same thing. The hospital leadership has the same thing, and I think that that planning processes has given people a lot of comfort and has allowed us not only to take care of each other but also to take the best care that we can of our patients. We have teams of physicians and researchers that are working on protocols to make sure that we’re delivering the best medicine that we can, given the lack of evidence.

We have teams that are working on recycling the PPE to make sure that we have adequate PPE that’s safe for us to use, and all of that gets disseminated on a daily basis out to the hospital and to the workers, and so I think that it has been the best situation possible given the circumstances.

The other thing that I just wanted to say — that has really touched me — is the bravery of all of the staff. We have residents that are in pathology, that are in psychiatry, that are in dermatology, that are in neurology that have volunteered to help out on the medical service to take care of patients, and we’ve had attending physicians from all of those levels that have also pitched in to help out. The anesthesiologists have been very helpful, for instance, in our ICUs to helping out the critical care attendings that have been strapped because of all of the patients that have needed care, and there’s been just an extraordinary amount of collaboration between the physician staff, the nursing staff. And the nursing staff have also stepped up. We have nurses that have not worked in an ICU for years that are now working in an intensive care unit, taking care of very sick patients, COVID-positive patients and non-COVID positive patients just to pitch in, so that has been the greatest memory and experience that I’ve had through this whole epidemic.

Joe Elia:     I want to thank you, Dr. William Chavey and Dr. Andre Sofair, for spending time with us today and sharing the wisdom of your experience with COVID-19.

Dr. Andre Sofair:     Thank you, Joe.

Dr. William Chavey:     Thank you, Joe. Thanks, Andre.

Dr. Andre Sofair:     Thanks, Rusty.

Joe Elia:     That was our 263rd episode. All of the previous episodes are searchable and available free at podcasts.jwatch.org. We come to you from the NEJM group. The executive producer is Kristin Kelly. I’m Joe Elia. Thanks for listening.

Back in those halcyon days, COVID-19 was very much a gathering storm, but it had not yet slammed into the United States.

Here we are, over 10,000 U.S. deaths later in early April, not having heard of much else but the disease.

I thought to use this interview now, both to give listeners a small break from “The Virus” — as President Donald Trump refers to it — and to remind us how quickly things can change on the planet.

We make mention during the course of the interview of the need to take the lessons from unanticipated disasters. We can only hope that the lessons the present crisis affords us won’t be lost.

Links:

Dr. Salas’ Perspective article in NEJM

Dr. Salas’ earlier NEJM editorial, written with Drs. Malina and Solomon, on “Prioritizing Health in a Changing Climate”

Harvard’s Global Health Institute

Running time: 18 minutes

TRANSCRIPT OF THE INTERVIEW WITH DR. SALAS

Joe Elia: This is Joe Elia. We’ve just turned the clocks forward here in the US and so summer is looming after a warm winter for Boston. If the past serves as a guide, we’ll have a warm summer, warmer than usual. Sleeping will get tougher, ticks will show up on our ankles, water will beckon us. Clinicians will work in comfortably air-conditioned suites, but their patients will often not be as lucky. Rene Salas reminds you all in a recent NEJM Perspective that hyperthermia is just around the seasonal corner. Our friends in the Southern Hemisphere have just had a horrible summer. Australia’s was unprecedented with an average temperature exceeding 30 Celsius or 86 Fahrenheit. We’ll talk about such things with Dr. Salas, who is a fellow at the Center for Climate Health and the Global Environment at the Harvard School of Public Health. She’s also in the Department of Emergency Medicine at Mass General Hospital and Harvard Medical School.

Welcome to Clinical Conversations, Dr. Salas.

Dr. Salas: Thank you so much for having me. I’m excited to be here.

Joe Elia: It used to be that summer was the time for bug spray and sunscreen. Everything’s changed, hasn’t it?

Dr. Salas: Yes. I think that there has been this growing recognition that climate change is not only happening in the world around us but it’s also impacting us as humans and it’s impacting our health. As this recognition has grown, there has been a goal to increasingly connect it to what we do every day to our clinical practice.

Joe Elia: Your recent perspective article in the New England Journal of Medicine gives a useful table for various healthcare demands, starting with EMTs who are bringing overheated patients to the ER, all the way out to the management types who need to prepare for what they can’t predict yet. Can you talk a bit about that?

Dr. Salas: So we know that there are associations across a broad range of climate exposure. So that ranges from heat to rising pollen levels, wildfire smoke, infectious diseases as you noted in the introduction, changes in water quality, and the intensification of extreme weather, but I think that the recognition is that all of these have very practical implications no matter what your role is in the healthcare system. So there’s a case that I outline about a man who was brought into the hospital because he was confused, but we were in the middle of a record-breaking heatwave, and his wife had called 911 and the EMT said that when they opened the door that it was like they were being hit by the Sahara Desert heat.

They lived on the top floor of lower-income housing and they had no air conditioner. They only had one window that was partially cracked, and so I think that that shows that EMTs are on the front lines, and I think as medicine is increasingly embracing and trying to expand community paramedicine, recognizing that they are my extensions from the emergency department out in the community and so how can we use them to educate patients about the risk of heat, counsel patients on what to do if they lose power, even if they normally have air conditioning.

The National Climate Assessment put out by the federal government has shown that they anticipate that the intensification of extreme weather and extreme heat are going to amplify and intensify the power outages. We actually had one right down the street, in fact, a power outage at Mount Auburn Hospital. That actually caused them to have to bring patients down from the top floor of the hospital because it was getting so warm because the backup generators don’t actually supply cooling to all areas. Even when the power was restored actually a lot of the equipment was so hot that it couldn’t function so they had delayed ability to be able to resume their normal functions because they had to wait for technology to cool down and this was in Greater Boston in 2019.

Joe Elia: Pretty interesting. So, as we were saying before, there were things that administrators must prepare for that they can’t imagine yet. I guess the only way to imagine it is to experience it and say, “Oh, damn, we should have done it this other way!” I mean of course we could be jocular about it now but when it happens — boy, oh, boy. For instance (and I guess you can’t talk about anything including candy bars without mentioning coronavirus these days). What do you think? Do you see any connection at all between global warming, climate change, and this kind of spread of infection? Is that at all on your radar, or is it a strong signal?

Dr. Salas: Yeah. It’s a great question. I mean we know that vector-borne diseases, so diseases transmitted by mosquitoes and ticks, that those have been on the rise. So not only longer seasons but moving to new geographic regions, which makes it hard for clinicians because now suddenly they’re facing patients who come in potentially with infectious diseases that they haven’t been used to seeing. Lyme disease can present in a multitude of areas and one that has really been expanding, here in the Northeast. So every rash to me in the emergency department has to potentially be Lyme, but I think that that shows that we really need to have a dynamic education curriculum and work closely with our public health colleagues in order to ensure that we can stay up to date on emerging infections and also make sure that we can educate our clinicians on those signs and symptoms of diseases that they aren’t used to seeing.

There’s always this issue, right, that we face these situations and research, because of the sound scientific practice it has to go through is delayed. I have to admit, I feel that climate change is truly that meta-problem and that threat-multiplier. So I believe it connects to everything in some way, whether directly, indirectly or even if it’s minimal effects. So my concern is that climate crisis may be fueling coronavirus in some way, but we don’t know yet. It’s too early. I think that it just shows that there’s so much research that needs to be done because we can’t prepare for what we don’t understand.

Joe Elia: Yeah. So back to those poor administrators who are going to be held to account when things go wrong: Is it really possible, do you think, to have drills about power failure? I’ve noted before that the [Boston] Marathon bombings were made a bit less chaotic because Boston hospitals had practiced, and many cities do practice now for mass casualty events. How does an institution practice for a calamity like power failure?

Dr. Salas: Yeah. So this is interesting and I think I really want to promote that that table [in the NEJM Perspective] was more of a thought exercise, where I was hoping to take the reader with me in thinking through different things that we can potentially implement to help prepare us as clinicians for what the climate crisis has brought and will bring. I think we always are better served if we are as prepared as we can be for situations. I think recognizing that power outages create a limited-resource environment in a normally well-resourced hospital. Again, everything from cooling not being in every area and maybe perhaps limited imaging and all of these unintended and unforeseen consequences that if a hospital has already gone through that and knows exactly what to do when a power outage occurs then inevitably I’d like to believe that we would then be better prepared when we actually face that.

You always have to weigh kind of the number of drills versus the benefits and so kind of rely on my disaster preparedness expert colleagues to end up making that decision but it is something to think about.

Joe Elia: Speaking of that, if that happened at Mount Auburn — and it did — how efficiently are the lessons of that disseminated to the other hospitals in the region? Are you aware of any formal way that a hospital having undergone such a calamity is able to share that?

Dr. Salas: Yeah. It’s a great question, and I think one that I know myself and my colleagues and others are thinking about is how can we share these best practices? Even when you think about heat, for example, and the fact that certain areas of the country and even the world have been facing extreme temperatures that are extreme for areas like here in the Northeast but have been facing hotter temperatures and know how to operate in that environment so we can learn from them. But you bring up a good point that when something like this happens like the power failure at Mount Auburn that that isn’t currently disseminated. In fact, when I talk about it even to people in Boston, many people didn’t know that it happened.

Leadership, again, may be aware but again just creating this sense of dissemination of experience is enormously powerful so we can learn from one another. I always come back to my emergency medicine roots and think about when a patient is crashing in front of us and we save them that it’s not saved by one person — it’s a collective team that saves that patient. Everything from environmental services that cleaned the room to the pharmacist to the nurse to the doctor to everyone. I think I recognize that this climate crisis needs to collectively bring the medical community together, across all sectors and disciplines to learn from one another. I think we’re stronger together and that’s part of why we are building this climate crisis in clinical practice initiative where we’re actually going to have symposiums similar to the one that we actually held in Boston on February 13 in different regions around the US at flagship sites and even internationally.

We currently are going to hold one in Australia. The goal of that is to come up with a group of us that have different geographic experiences, are exposed to different climate change exposure pathways, and to build an initiative where we can get some expert consensus and ways to share best practices.

Joe Elia: Here’s a question, what do you say to people who are skeptical about the role of climate change in clinical medicine?

Dr. Salas: It is enormously hard to scroll through your newsfeed, since most of us nowadays digest our news through a phone or some tablet of sorts without seeing that there are new things that people are experiencing in the environment around us. I think personally the science is very clear that the climate change is happening, that it’s human caused, and we have solutions. Nothing is harder for me than having a patient in front of me where I don’t have a treatment. Thankfully, here we have the ultimate treatment and the ultimate prevention, which is a decrease in our production of greenhouse gases. But I think recognizing that if we want to try to minimize the human suffering that is already happening, especially for vulnerable populations, but recognizing that we also have to simultaneously adapt not only our public health infrastructure but our clinical practice. While some of the implications of the climate crisis are clearer than others now, I think there are these insidious changes that we have to recognize. If we want to put the health of patients first in order to deliver the best patient care that we can, we have to add a climate lens to it because historically we’ve always been able to look backwards and try to predict the future based off the past, but that’s no longer possible.

The climate crisis is creating this uncharted future, and we have to prepare and prepare now and work together to do that.

Joe Elia: I wanted to ask you how you got interested in this whole question of the clinical implications of climate change and global warming.

Dr. Salas: I learned about climate change and its impact on health about six-and-a-half years ago, and it was fascinating because I had not heard about it at all during medical school or residency. For me, it was really an epiphany moment where I recognized that I could not imagine focusing my career on anything else because I couldn’t imagine anything else impacting my ability as a doctor to protect the health of my patients and to do my job than climate change. So it really started me on a path that has put me on the course that I’m currently on. For me, you can call it a job hazard of spending all of my time outside of the emergency department focusing on climate change, but I increasingly began to see that it was harming my patients, again sometimes in small ways, sometimes in larger ways, but I quickly saw that there was a need to add a climate lens to what I did in my practice, and I think increasingly as I had more conversations with others recognized that we needed to have a larger conversation to really adapt our clinical practice in the era of climate change, which has led to the initiative that I spoke about.

Joe Elia: As a result of your efforts, Dr. Salas, what do you hope will happen?

Dr. Salas: I think first and foremost we need to recognize that the health sector and the voices of health professionals is the most trusted messenger to connect climate change and health. I think one thing that at least I personally believe is why we haven’t had as much action on climate change and engagement up to this point is that it hasn’t been personal. We have had visions of icebergs and polar bears. Trust me, I love polar bears but it’s really about our children. It’s about our aging parents, who are enormously vulnerable, our less fortunate neighbors, and if that’s not enough to motivate you then it’s about yourself because climate change is harming your health in some way, again, however small, however large.

So the recognition of making these connections and talking about climate change as a public health threat — and I would argue as something that is changing our clinical practice — is first and foremost what we need to do as a medical community. So the ultimate end goal of that, as we engage in this conversation is that we need to talk about the fact that climate action is actually action to improve health. I would say that the Paris Agreement is the world’s greatest public health pact. So recognizing and connecting these things:

That not only are there short-term benefits of reducing particulate matter from the combustion of fossil fuels (which we know will improve health, but also the driver of climate change and thus will decrease, again, the human suffering that we will experience both now and in the future) is really important and encouraging our transfer to renewable energy sources.

Then I think the second half of that is adapting. So ensuring that we can adapt our public health practice and our clinical practice to continue to provide the best care to our patients and our communities when they need it most.

Joe Elia: All right. Well, I want to thank you very much for talking with me today, Dr. Salas.

Dr. Salas: Oh, it was a pleasure. Thank you so much for having me and for lighting this topic.

Joe Elia: That as our 257th episode. The whole collection is searchable and available free at Podcasts.JWatch.org. Clinical Conversations is a production of the NEJM Group and we come to you from NEJM Journal Watch. The executive producer is Kristin Kelly. I’m Joe Elia. Thanks for listening.

Fortunately, we caught her during a one-week vacation (she was supposed to be taking two), and she chatted with us about how she and her colleagues are coping.

We asked her what she thought COVID-19’s larger lessons would be, and she gave an interesting, impassioned answer.

Running time: 12 minutes

Other interviews in this series on COVID-19:

1. Dr. Anthony Fauci
2. Dr. Susan Sadoughi
3. Dr. Matthew Young
4. Dr. Julian Flores
5. Dr. Kristi Koenig

Joe Elia:

You’re listening to Clinical Conversations. I’m your host Joe Elia.

We’ve come to New York City this time, at least electronically, to talk with Colleen Farrell.

Dr. Farrell is a third-year resident in internal medicine at NYU in Bellevue Hospital. This July, she starts a pulmonary and critical care fellowship at New York Presbyterian-Cornell. I became aware of Dr. Farrell when a classmate of hers sent along a posting she’d made on social media. It read, in part, “I feel grateful that I am able to put my training to public service. I don’t do well being cooped up at home. I became a doctor to do this work, but I would be lying if I said I wasn’t scared. I am calm and committed but also deeply, deeply terrified.”

Welcome to Clinical Conversations, Dr. Farrell.

Dr. Farrell:

Thank you. Thank you for having me, Joe.

Joe Elia:

So there you are in New York City. How are you and your colleagues doing? Are you getting enough time away from the clinic to get sleep and get food?

Dr. Farrell:

Yeah. So I would say that the experience varies widely from week to week. So in this situation right now in the midst of the COVID pandemic it seems — like for everyone — you’re either fully on or totally off at home. So you’re catching me in one of those off periods. About two weeks ago, I started taking care of coronavirus patients at Bellevue. When you’re doing that work, the shifts are long and really tiring. Our whole residency schedule has been kind of recreated to meet the staffing needs of this crisis but built into that is some time off.

So right now, I was still due for a two-week vacation towards the end of this year, and so right now I’m getting one week of that. So I’m in this weird place of getting rest right now and knowing that I’m jumping back into it in just a few days.

Joe Elia:

Well you mentioned in that posting that I quoted from, you mentioned a patient. I wonder how that patient fared. Do you know?

Dr. Farrell:

Last I checked he was still in the ICU. He was intubated and requiring dialysis. Yeah. So this is actually the first coronavirus patient I met, and when I met him I was really worried about him. He was still breathing on his own but requiring a lot of oxygen. So it was the middle of the night. I called one of our ICU doctors and he was moved to the ICU where he still is. We’re seeing that with a lot of our patients, that when they get to the ICU it looks like it’s a pretty long course for a lot of them. It’s not needing to be intubated for a few days and quickly extubated, but it’s a long course with a lot of uncertainty. So I keep kind of checking in, hoping that he’ll get better, but it’s going to take time, I think, to see.

Joe Elia:

Yes. Let’s hope that he does get better. How are you keeping up with policy? Have you joined any of the private chat groups like the one described by Dr. Julian Flores during his interview here?

Dr. Farrell:

Yes. Right now, we’re dealing with so much information. So I’m getting information from several places. First of all, I think — especially in my role as a resident physician — decisions I make are about the patients I’m directly caring for, or managing my own team, and so it’s hyperlocal. So first I have to pay attention to the policies from my institution. We get multiple emails a day and like a lot of residents I’m not employed by just one. Well, I’m employed by an academic medical center, but I rotate at NYU Langone, Bellevue Hospital, and the VA. So those are three completely different hospital systems. They’re three different hospitals, for one, but they’re also a private hospital, a public hospital, and a federal hospital.

So just to do your job you have to keep track of those policies. So we have a lot of internal communication with documents: “This is the latest of the PPE standard. This is how long you have to be out of work if you have symptoms. This is when a patient is allowed to move to this place or that place.” Those are the policies I pay the closest attention to. Then I would say while I’ve been home this week on my “vacation” I’ve been tuning into New York Governor Cuomo’s updates and those actually help me understand kind of even what I’m seeing sometimes at the hospital.

He’s been talking about [transferring] patients from some hospitals in New York City to others to even-out the load, and that helps me understand [that] when I’m at work I might be getting transfers from other hospitals and understanding why that is. Then in terms of more informal mechanisms, I’m pretty active on Twitter. I get a lot of updates there from people on the frontlines and then I’ve also been reconnecting with colleagues from medical school that I haven’t been in touch with for years. My Harvard Medical School class Facebook group — I don’t think anyone touched it for three or four years but all of a sudden people are connecting on there, talking about what’s going on in their hospitals and just sending support to each other. We’re all thinking of each other and kind of reading what’s going on in different parts of the country.

Joe Elia:

Tell us a bit about your social media posts. Are you looking at maybe a career as a writer?

Dr. Farrell:

Yeah. I’ve loved writing at least since college and have been writing about social and ethical aspects of medicine since I was an undergrad 10 years ago and I was writing about the early years of the AIDS epidemic in the US. At that time, I was reading Atul Gawande and found his books captivating as so many do. I kind of even realized at that time that I wanted to do the kind of writing in medicine that spoke to audiences beyond the doctors and scientists in a hospital.

So then in medical school I was really closely mentored by Dr. Suzanne Covin, who’s the writer-in-residence at Mass. General Hospital, and she’s been a tremendous role model to me. I use writing as a way of both processing my own experiences and kind of sharing with a broader medical community — and more society at large — some of the social and cultural aspects of medicine. So sometimes that’s through essays that I publish but I actually really like using Twitter and sometimes Facebook as a way to send off little missives. I like that they’re informal. They feel real and authentic. They’re not filtered through an editor or someone else. It can be a really cool way to connect with people and it’s writing. Any time you’re using words you’re learning how to write.

Joe Elia:

Yes. I know those editors do get in the way…

Dr. Farrell:

I’m grateful for editors but sometimes it’s paralyzing knowing that you’re going to be scrutinized.

Joe Elia:

Sometimes they help… So you’re on vacation this week. Are you reading or binge-watching?

Dr. Farrell:

I mean it’s a very weird vacation. I’m just staying inside my apartment. My husband is home. He is a third-year NYU law student and is doing law school remotely this week. We’re watching movies. We take turns who picks the movie each night. So we watched Alien. We watched How to Survive a Plague, a really great documentary about the early years of AIDS and then we watched Indiana Jones. So we’ll see what we pick tonight.

Joe Elia:

Those are all consonant with your current experience…

Dr. Farrell:

And writing. That’s the other thing. Right now, it’s nice to have some time. I’m doing some writing about my experience in the ICU last week and also doing some writing reflecting on…I mentioned I wrote my senior thesis in college on the early years of the AIDS epidemic. I’ve been thinking about what I learned doing that historical research then and what lessons I might be able to take from it now. So it’s nice to have some time to think and marinate a little bit before I jump back in.

Joe Elia:

I want you to project yourself forward in time a bit. When this pandemic ends and you’re training other young clinicians, say 20 years from now, what will you tell them was COVID-19’s most important lesson?

Dr. Farrell:

Well, I think it’s a lesson about health inequities and existing injustices in healthcare. I think that we are seeing right now that the health of one person affects the health of the entire society and that health cannot be treated as a commodity only available to those who can afford it. It needs to be treated as a human right. Right now we’re hearing politicians say no one should be denied a COVID test or COVID treatment because of their ability to pay, well I agree with that, but why shouldn’t that be the case for cancer or diabetes or anything else? I think we’re going to see more that this pandemic doesn’t affect all communities — even within the US — equally. It is ravaging Rikers Island right now, where we have mass incarceration.

When I call families and update them on their sick family member it’s totally different if they have a big apartment where they can separate within the apartment from those who have symptoms and those who don’t. But when you talk to a big family in crowded city housing they don’t have those possibilities. When government support doesn’t include undocumented immigrants you have a huge health justice issue on your hands. So I think that one of the biggest lessons from this time is to say that the social safety net and healthcare for all is not optional. It’s not a luxury. It’s a foundation of a functional society that has any degree of concern for the people within it. I think that we have been existing in a healthcare structure that is grossly unequal and oftentimes prioritizes profits over people, and I think that this pandemic is going to lay that bare for our whole society to see.

I hope that in 20 years I will be able to say maybe this is the last straw that helped our society change and provide healthcare to everyone. I hope that’s the story rather than we continue on or we return to the status quo after this ends.

Joe Elia:

Well, Dr. Farrell, I want to thank you for speaking with me today and I hope you’ll come back in 20 years and we’ll review that together.

Dr. Farrell:

That would be lovely. Thank you so much.

Joe Elia:

That was our 262nd episode. All the others live at Podcasts.JWatch.org. We come to you from Physician’s First Watch and NEJM Journal Watch — members of the NEJM Group. The executive producer here is Kristin Kelley, and I’m Joe Elia. Thank you for listening — and wear your masks and wash your hands.

We’re fortunate to have her as our guest. She’s full of sound advice on organizing a community’s response (for example, setting up “incident command” structures) and evaluating patients as new threats emerge (the well-known “three-I’s” approach — Identify, Isolate, and Inform).

With the number of COVID-19 cases rising quickly there in San Diego, she’s been busy (as have all of you).

Running time: 19 minutes

Links:

Interview from 2016 with Koenig and Schultz on the second edition of their “Disaster Medicine”

Koenig, Bey, and McDonald’s article on applying the 3-i tool to novel coronavirus in Western Journal of Emergency Medicine (Jan 31 online)

Other interviews in this series on COVID-19:

1. Dr. Anthony Fauci
2. Dr. Susan Sadoughi
3. Dr. Matthew Young
4. Dr. Julian Flores

TRANSCRIPT OF THE CONVERSATION WITH DR. KRISTI KOENIG:

Joe Elia:

You’re listening the Clinical Conversations. I’m your host Joe Elia.

Dr. Kristi Koenig is Medical Director for Emergency Medical Services in the county of San Diego, which as of this afternoon, Saturday March 28, had about 420 confirmed COVID-19 cases with six deaths.

The county is lucky to have her, if I may say so, because she’s co-edited a definitive textbook on disaster medicine, and arguably the novel coronavirus epidemic qualifies for entry into that club.

Dr. Koenig is Professor Emeritus of Emergency Medicine and Public Health at the University of California Irvine, School of Medicine, and she was also, I should say, a long-time contributor to NEJM Journal Watch Emergency Medicine.

Welcome to Clinical Conversations, Dr. Koenig.

Dr. Kristi Koenig:

Thank you very much for having me.

Joe Elia:

What are you seeing there in San Diego?

Dr. Kristi Koenig:

Well, we are very concerned in San Diego, as is the rest of the country, and we’re taking a three-pronged approach on the ground in San Diego. Number one is to flatten the epidemic curve. Number two is to increase surge capacity for our healthcare system, and number three is to focus on using an incident command system to coordinate all of our needs and resources, and I can explain each of those in more detail if you’d like.

Joe Elia:

I recognize that, from having looked at your textbook a few years back, so go ahead.

Dr. Kristi Koenig:

In San Diego, we were very early to implement what’s called NPI, non-pharmaceutical interventions, to try to spread out the diseases over time so that we don’t have as a great a chance of hitting a peak number of diseases early on, which could exceed our healthcare capacity.

This so-called flattening of the epi curve, I’m sure people have seen. Even on the news people are getting educated in epidemiology these days.

The idea with that is we won’t necessarily decrease the total number of patients but if we can spread patients out over time we can potentially continue to care for everybody in our healthcare system. This is not only the COVID patients. This is also our regular emergencies.

We know that emergency departments are crowded on a day to day basis. So by using these interventions, which are called things like social distancing (although it’s not really social distancing it’s more physical distancing) we still can keep in contact with people. Other types of interventions to try to prevent the rapid spread of the disease, we can make a huge difference. It’s complicated because we may not see the effects for a week, two weeks, or even more because there are already people in our communities who are incubating the disease that have not had symptoms yet or not. Some people never have symptoms but who have not presented yet to our healthcare system.

The second thing would be for surge capacity, and we’ve developed a concept about 20 years ago along with my colleague, Major General Donna Barbish, for the 3-S concept of surge capacity, which is stuff, staff, and structure. We find it very helpful to organize everything around stuff, staff, and structure, and I can explain that in more detail if you’d like.

Joe Elia:

Yes. I would guess that the “stuff” is going to include things like masks.

Dr. Kristi Koenig:

Absolutely and ventilators and N95 respirators and surgical masks and other types of PPE (personal protective equipment) are very important in an epidemic of this nature. One of the challenges is that the news media and the politicians love to count stuff. You can see it. You can show it on TV. You can touch it. You can count it but one of my famous lines is “Ventilators don’t take care of patients.” Stuff is important but it’s not sufficient. While we do need, certainly, to protect our healthcare workers on the front lines and to have things like ventilators to care for patients in this setting, the stuff component of the 3-S is not enough.

So we also need the staff, which is all of us, the people, and we do know that some people unfortunately will get sick and even die and some people will not be able to come to work because they may be caring for a relative or other reasons. So we have to account for probably maybe perhaps 30 percent of people will not be able to come to work or not be willing to come to work. We also need specialists in the staff. So it’s not just the total number but we need people with specialized expertise. For example, infectious disease specialists, critical care specialists.

Then the third component is the structure and that is the physical location where we care for patients. What we’re seeing now is we’re being very innovative and I think actually this is going to help us after we get through all of this to have better capacity in our healthcare system. We’re seeing alternate care sites develop. We’re seeing field hospitals. We’re seeing the military, for example the Mercy just arrived in Los Angeles today I believe. We’re seeing things like tents being put up outside hospitals to do screening.

In San Diego, we’re also looking at behavioral healthcare centers outside hospitals. We’re seeing telemedicine, telehealth popping up. So lots of things for the structure piece as well where we care for patients. So again, stuff, staff, and structure is very helpful to organize all the components we need to increase the surge capacity of the system.

Joe Elia:

We’ve chatted before when the second edition of your textbook came out. You (or maybe it was Dr. Schultz) mentioned that the third edition should include a chapter on how to prepare oneself to participate in responding. Do you have any advice for clinicians now about to face the challenge of a surge in demand?

Dr. Kristi Koenig:

Yes. We definitely need clinicians. One of the most challenging things about this event is the psychological piece of it. People who are working on the front lines are seeing their colleagues get sick and unfortunately likely even die and it’s very difficult. Or they may have a situation where they don’t have enough resources, and we’re used to taking care of everybody. So keep focused on what we’re doing to take care of patients and take care of your own mental health. There’s lots of resources online for mindfulness and other types of techniques you can use. Make sure that even though we’re physically distancing that we’re still connecting socially with others.

Joe Elia:

When I was going through your textbook again, I noticed the mention of the incident command system. Talk a little bit about that if you would.

Dr. Kristi Koenig:

An incident command system is necessary to coordinate all of the resources that we need. What happens is, people want to help, and they have good ideas, and they try to work outside the established system. And we’re seeing it everywhere. It takes up people’s time to respond to well-meaning requests, spontaneous volunteers, spontaneous donations as opposed to if everything can be funneled into the incident command system it can be coordinated as needed to help manage the disaster.

These are systems that are practiced both in hospitals (we usually use something called the Hospital Incident Command System). In the prehospital setting in all levels of government and there are liaisons between the various incident command systems so that you can coordinate and do something that’s on a regional, statewide, and even national basis that otherwise would be overwhelming to try to manage.

Joe Elia:

At the beginning of an incident like this, what would you do typically with the incident command system, would you put out something immediately saying “We understand you’d like to volunteer” or “If you want to volunteer if you want to bring food, masks, or whatever…”

Dr. Kristi Koenig:

One of the portions of the incident command system would be the logistics section. So the incident commander could refer a volunteer idea to that section who could decide how to best integrate it into the overall response.

Joe Elia:

The US is in mitigation mode right now — as opposed to trying to prevent the entry of the virus into the country…

Dr. Kristi Koenig:

Actually, I wouldn’t agree with that.

Joe Elia:

Tell me how I’m wrong there.

Dr. Kristi Koenig:

The US has different phases right now of the disease. So for example, in New York and some other emerging areas at the time we’re making this recording such as New Orleans and Chicago and Los Angeles, they’re a little bit farther along that epidemiological curve in terms of the rise in cases. But there are some parts of the United States where there are very few cases — or at least few that we know of. So they’re probably earlier on in time. I would say in San Diego, for example, we’re not quite on the same upslope as they are in some other parts of the country like New York.

In places where there’s widespread community transmission, certainly we need to do mitigations and that’s probably most places, to be honest, because we see this disease being spread in asymptomatic or minimally symptomatic people and that’s why this stay-at-home message. This social distancing is so important to flatten that curve, but we also still need to isolate people that are sick. We need to identify them and isolate them so that we can prevent rapid spread by known people who are sick. So we’re doing more than just mitigation.

I’ll just say we’re doing identification and contact tracing to prevent spread of disease from known cases in addition to the mitigation.

Joe Elia:

I mean you started the month with one case in San Diego and now we’re up to many more than that. What have you seen over that time, Dr. Koenig, that has changed your mind?

Dr. Kristi Koenig:

It’s been very interesting in San Diego because we’ve had several disasters within the disaster, if you will. Let me explain what I mean. We have the local military base, Miramar. You may have seen on the news that when we were repatriating people from Wuhan they came into a federal quarantine. So we’ve been closely collaborating and have a strong relationship with the federal entity such as the CDC and what’s called the ASPR, the assistant secretary for preparedness and response, which is located in HHS at the federal level and also the state. Because in the US, the way things are organized it’s local to state to federal in terms of how the resources work.

So we had people coming back from Wuhan that were on quarantine, and we helped support the quarantine on the base. I’ve actually been standing a little bit more than six feet away from a patient who ultimately turned out to be positive from that repatriation. We have systems in place where we have transported patients who became infected or became positive from the base to hospitals and potentially back. Then after we had that mission, which really helped us to get systems in place, we had people coming from the cruise ships. Same thing where we had positive cases in that cohort, and we were able to make sure that those cases did not spread out into the community and that those patients got care and ultimately once their 14-day quarantine was finished they were able to return to where they live.

So that gave us a lot of experience and we’re still actually having more cruise ships coming into San Diego and managing that along with our federal partners. So it’s incredibly complicated, but it’s given us a lot of experience of how to manage this. In addition, you mentioned at the beginning my role in EMS. We put in place screening so that when somebody calls 911, initially several weeks ago when it was more relevant to ask the travel history, we were asking about travel from China and some of the other hotspots, and we were identifying people potentially infected at the level of dispatch so that when our paramedics responded they were already wearing the appropriate personal protective equipment.

When they picked up the patient for transport, they were notifying the hospitals ahead of time, “Hey, we’re coming in with someone who might have COVID” and the hospitals were wearing PPE. Oftentimes, seeing them — if they were stable enough — outside of the emergency department first, to make sure that we weren’t transmitting infection to others.

Joe Elia:

So nothing that you’ve seen so far has changed your mind about the approach that should be taken. Would it be fair to say that it’s reinforced?

Dr. Kristi Koenig:

One of the most challenging things is that the recommendations are changing very frequently. That’s because this is a novel virus. It’s new and we are learning. I’ve actually been following this since December, believe it or not, and I can remember the first report was “It’s not transmitted from person to person,” which I didn’t believe. “Oh, it’s not transmitted to healthcare workers,” which I didn’t believe. But things have been evolving over time in terms of PPE recommendations.

Initially, it was very helpful to identify people traveling from certain international hotspots. Now there’s such widespread disease, that’s less useful at this point. So there is a challenge and there are things that are changing, but one thing that we worked with for all infectious diseases is the concept of the three “I”s. The identify, isolate, and inform. For people working in hospitals, we want to immediately identify patients who are potentially infected, and because this is a disease contagious from person to person we then would immediately isolate them. And the third “I” would be to inform both public health and your hospital infection prevention personnel.

Joe Elia:

Yes. I saw that you had written a paper on the application of the three Is to the epidemic. I’m going to put a link to that on the website.

Dr. Kristi Koenig:

Thank you. And the three-I concept actually developed during the Ebola outbreak in 2014. The idea is that we don’t necessarily think in our day-to-day work about the potential for a patient to be infectious to the point where we could contract the disease or other people in the waiting room to contract the disease, and we have to think about that immediately in something like this epidemic so that we can immediately isolate and protect the patient from exposing both healthcare workers and other patients.

Joe Elia:

As a country, what do you think we could be doing more of or less of at this juncture?

Dr. Kristi Koenig:

It’s important to know that every single person in this country is on the frontlines. For me, this epidemic and every single person’s actions are important to help us stomp out this disease. If you are a non-healthcare person just staying home and washing your hands, as simple as that sounds, can be incredibly helpful, as I talked about earlier, for flattening that epidemiologic curve. So everybody has an essential role in the entire country. As healthcare workers, I would encourage everyone to keep focused. Again, the approach we’re taking in San Diego is this three-pronged approach of the interventions to flatten the curve, coupled with increasing the surge capacity, and making sure we work within an incident command system structure.

Joe Elia:

I know it’s hard to look into the future. How do you think COVID-19 might change clinical practice? Do you see any indication that it might?

Dr. Kristi Koenig:

Absolutely. Once we get through this I think we’re going to have a much better healthcare system. It’s amazing the collaboration and the innovation we’ve had in such a short time. Things are happening you never would have thought could have happened. I mentioned earlier, telehealth as an example, increasing behavioral health resources, increasing resources for the homeless. There are incredible collaborations happening. We’ve had meetings with all the chief medical officers of our 20 hospitals including VA and military in our county. We’ve had meetings with all the CEOs of all our hospitals along with the board of supervisors and the chief medical officer of the county.

This kind of cooperation and collaboration would not have happened if it weren’t in the face of a crisis.

Joe Elia:

Is there one essential lesson that you want clinicians to take as they’re about to face this?

Dr. Kristi Koenig:

Keep focused. We will get through this if we organize our actions and our thinking. We can save lives. You are the heroes. You’re on the frontlines and we thank you for everything you’re doing every day.

Joe Elia:

I want to thank you for your time today, Dr. Koenig. I wish you good luck in the coming days.

Dr. Kristi Koenig:

Thank you very much. Stay safe.

Joe Elia:

Thank you. That was our 261st episode. Its predecessors are all searchable and available free at Podcasts.JWatch.org. We come to you from Physicians First Watch and NEJM Journal Watch — all part of the NEJM Group. My executive producer is Kristin Kelley and I’m Joe Elia. Thanks for listening and stay healthy.

When he was interviewed, the count of Covid-19 cases stood at 412, less than 12 hours later, the new number was 505, as of this posting — on Friday near noon Eastern — it’s at 614. Flores is expecting the wave to hit hard there. Broward is home to Fort Lauderdale (think spring break) and Pompano Beach (think aging retirees). Couple those demographics with a lack of easy testing for the virus, and you’ve got a worrisome situation.

Links of interest:

NEJM Perspective article

NEJM Sounding Board

Running time: 13 minutes

A TRANSCRIPT OF THE INTERVIEW (Please bear in mind that what follows is a conversation and not a polished essay.)

Joe Elia:

You’re listening to Clinical Conversations. I’m your host, Joe Elia, and I’m joined by my cohost, Dr. Ali Raja, Editor-in-Chief of NEJM Journal Watch Emergency Medicine. He’s in the Department of Emergency Medicine at Mass. General and an associate professor at Harvard Medical School.

We continue exploring the COVID-19 pandemic by heading south from our last interview with a first-year OB/GYN resident in Delaware to the State of Florida. Our guest is Julian Flores, an attending physician in the Emergency Department at Westside Regional Medical Center in Plantation, Florida, outside Fort Lauderdale.

Dr. Flores went to college in New York City and then on to Harvard Medical School. He trained in emergency medicine at the University of North Carolina and has been an attending physician at Westside since last July. Welcome to Clinical Conversations, Dr. Flores.

Dr. Julian Flores:

Hi. Good morning. Thanks for having me.

Joe Elia:

As of this morning, Broward County had 412 cases of COVID-19 and three deaths reported. Florida’s governor has mandated self-quarantine for travelers arriving from New York and New Jersey, so what are you seeing there on the ground?

Dr. Julian Flores:

I think the idea is a good start. Social distancing has been shown to work when you do it early. The idea is to prevent community spread. In the 1918 pandemic, it worked to at least stall some of the deaths and the morbidity, but we’re not doing it like that. We’re doing it very fragmentedly, and I understand the United States in and of itself there’s so much population to be able to control under one measure. Some people argue you can’t use the same instrument but the actual application of it, especially when a place is diverse like Florida — like South Florida — I think there’s a lot that goes into the actual implementation of this and for it to actually be realistic and effective. I can personally say that I live in Brickle, the financial district of Miami, and I’m seeing honestly anything but.

I’m seeing people in groups of five, 10, people out everywhere. You know, it’s unfortunate, and I worry honestly that as people start getting antsy-er and start wanting to go outside — more and more sort of unfettered — that’s going to coincidentally be arriving at the same time that we’re expecting our own wave in the next few weeks only leading to further community spread. Our testing hasn’t necessarily gotten that much better, frankly —  the [amount] of testing that we’re doing — and it’s only going to lead, I think, to further undiagnosed cases and leading to potential more critical cases and more resource consumption within our hospitals down here.

Dr. Ali Raja:

Dr. Flores, how has your daily clinical practice changed in the face of this pandemic? Are you changing your practice even for those patients who don’t look like they have any respiratory issues when you first see them?

Dr. Julian Flores:

That’s a great question because as more data comes out, we’re seeing, as you may know, even as up to as high as 10 percent of cases do not come with cardiopulmonary complaints. It’s nausea, it’s vomiting, it’s abdominal pain, it’s fatigue.

Frankly, for my own personal practice, at this point, I am assuming you have it until proven otherwise. To the capacity that I will be able to continue doing so, I will at least wear a surgical mask when I approach your room.

It’s very interesting how people that I would have sent home without any sort of second guessing, at the very least if it doesn’t infiltrate my note it definitely infiltrates what I think of when I send them home with X and Y and Z instructions. How confident do I feel that that mild belly pain wasn’t an undiagnosed COVID-19 case that now is going to exponentially spread into their community. So it’s interesting how it definitely has affected all of us in what we thought were very confident algorithms to go by. Now we’re at least having some thought about it not being the case.

Dr. Ali Raja:

Wow. Aside from the clinical care, let’s talk about you and your team. Does your team have enough personal protective equipment, PPE, right now in the ED?

Dr. Julian Flores:

I could say that for my own particular hospital, thankfully, we are not at the point of having to recycle them. There are some hospitals I can say — some colleagues of mine that are working in nearby hospitals — that are at that point officially, where people are just at the end of the shift all putting their PPE equipment for the day in a collective bin. It’s undergoing some kind of sterilization procedure and they’re being sort of reused the next day. We are being asked to use…as an example, an N95 mask, one mask a shift. There is, from what I’ve heard among my colleagues, there is disparity among to what extent administration is okay with you bringing your own PPE gear.

We know at least from the standpoint of ASA and AAEM — the emergency medicine societies — that this is something that should be allowed but that sort of thought, I could say it hasn’t been a collective thought among the hospitals. That only leads to further sort of frustration, confusion, safety risks, etcetera.

I think I also wanted to make a comment about the fact that a lot of people, my friends, both medical and nonmedical, they like to hang their hat on the percent morality that we’re seeing with this pandemic. Some will argue that it’s much less than we’ve seen with waves of the flu or other related viruses, but I think a comment should also be made on the morbidity that this pandemic is presenting, particularly this COVID-19 virus is presenting.

When you have a virus that takes so long to incubate, I think it’s at least eight to 10 days I think of incubation is what the research suggests, and when you have the average patient that takes 10 to 11 days to wean off, take off the ventilator whether it’s alive or you finally decided to pronounce them as passing, that’s a lot of consumption of resources, of personnel, of equipment, of a bed that will not be available until two weeks from when that decision is made.

One, it falsely reassures you early on of the numbers and it makes it harder to implement thing like social distancing and more stringently a lockdown when you don’t have the numbers from the get-go sort of express what’s projected. Then you’re kind of caught behind the ball when those numbers finally proclaim themselves and you find yourself out of personnel, whether it’s because they’re sick because they didn’t take the appropriate measures or because you don’t have enough equipment anymore or because you never established the infrastructure that can maintain a good practice.

Joe Elia:

So you mentioned other hospitals. Are you sharing information with others on social media? I talked with your classmate, Matt Young, and he mentioned a Facebook group where clinicians are communicating. Can you tell us anything about that? Is it finding it helpful?

Dr. Julian Flores:

Oh, it’s fantastic. I’m part of a private Facebook group called EM Docs. I’m also part of a Facebook group called COVID-19 Physician / APP Alliance or APP Group. I mean the amount of information we’re sharing amongst each other is amazing. Anything from truly understanding what other folks on their own front lines are dealing with — to novel ways of sterilizing equipment to ways to, for example, make a ventilator all of a sudden be able to vent two or three people. So if there’s anything good that’s come out of this it’s the amount of resource sharing that we’re seeing among all kinds of folks ranging from techs to nurses, doctors, et cetera.

Joe Elia:

Your population there runs to age extremes at this time of year, doesn’t it? I mean you’ve got college students at Fort Lauderdale on spring break and aging retirees in Pompano. Can you talk about the age-specific concerns that people have?

Dr. Julian Flores:

I can say that I hope that we are not hit with a strong of a surge as we’re expected to because, as you’re saying, we as a state have much more of a geriatric population than the nearby states, than even New York, I believe. So when you combine the fact that at baseline we have such a large geriatric population with the fact that we’re still allowing flights from harder-hit states to be arriving. You combine that chronologically with just the huge influx of younger folks that we had in Florida that we know on average are asymptomatic or mildly symptomatic along with an ongoing confusion as to truly how to handle this pandemic within the State of Florida. Frankly, it’s the perfect storm. We’re can still consider ourselves within the incubation period for many of these folks that potentially will go on to either have symptoms difficult enough for you to be hospitalized or even further to be put in an ICU.

From what I’m seeing, as an example, NPR yesterday or the other day published an article where you can essentially find how many beds your particular county has. If I’m not mistaken Broward County, as an example, between Miami and Fort Lauderdale has around two thousand, three thousand ICU beds max. I mean at baseline we already use some of those and we’ve already used some more with this growing pandemic. I hope I’m wrong.

There’s this sense of false reassurance. In a way, I can’t fully blame our governor for not acting even more stringently when you don’t really have numbers to work with. You can’t be convincing a population this dense that we’re in crisis when the numbers don’t necessarily yield that. In New York, thankfully, there was enough testing that at least on television you could say to your public, “This is what’s going on. This is why you should support whatever stringent measures I’m applying.” But when you don’t have that. When you have testing that, to this day, I’m still having to go through many loopholes to, at the end of it all, if I get a phone call back to get the confirmation to proceed with testing you can only expect there to be confusion and underreporting.

I can say we’ve all, I think, individually sent home dozens of patients that were not symptomatic [enough] to be hospitalized but definitely with a high suspicion of it — but not with the luxury of being able to swab all of them.

Dr. Ali Raja:

Dr. Flores, you mentioned that you’re expecting to see the surge hit in a couple of weeks and you’re worried about all the folks who have stopped physically distancing themselves. Let me ask, what are you and the hospital doing to prepare for this expected surge and what should the rest of our clinicians who are listening to this be doing with their hospitals?

Dr. Julian Flores:

Well, as an example, we put in place the policy to be mindful with our own PPE gear, as an example. Even though we’re not in crisis, per se, at our own particular hospital, we anticipate that. So being judicious with that, trying to limit the number of personnel that need to go into a given room, as an example as well, because for every time you go in and out, technically you should be changing your gear into a new set, for the most part.

Joe Elia:

Well, we want to thank you, Dr. Julian Flores, for spending time with us today. We wish you good luck and godspeed through the pandemic.

Dr. Julian Flores:

Thank you. I appreciate it. Honestly, I hope we’re wrong about what’s projected, but I know that at least we’re all in this together.

Joe Elia:

That was our 260th episode, all of which are available and searchable at Podcasts.JWatch.org. We come to you from the NEJM Group. We’re a publication of NEJM Journal Watch and Physicians First Watch. Our executive producer is Kristin Kelly. I’m Joe Elia.

Dr. Ali Raja:

And I’m Ali Raja. Thanks for listening.

A ground-level view of an incipient epidemic is what we offer.

Running time: 13 minutes

TRANSCRIPT OF THE CONVERSATION WITH DR. MATT YOUNG

Joe Elia:

You’re listening to Clinical Conversations.

I’m your host, Joe Elia. Like everyone else on the planet, we in the US are obsessing over the morbidity and mortality charts of the COVID-19 pandemic. We’ve done interviews with Dr. Anthony Fauci and Dr. Susanne Sadoughi and I wondered what the newcomers to clinical life are seeing through their fresh eyes.

So I’ve reached out to Dr. Matthew Young, who is completing his first year of an OB/GYN residency in suburban Delaware. I know Matt from working with him on a social media project for the NEJM Group. He was a Harvard medical student back then, finishing up law studies there as well. He’s kept pretty busy (but he admits he hasn’t practiced on his piano for many, many months).

Welcome to Clinical Conversations, Dr. Young.

Dr. Matt Young:

Hey, Joe. Thanks for having me.

Joe Elia:

So you’re finishing up your first year of an OB/GYN residency at Christiana Care in Newark, Delaware. As of this morning, March 24, the state had about 90 cases of COVID-19, so I’d like to ask, what in your experience of obstetrics and gynecology has changed between when you started last July and now?

Dr. Matt Young:

Really the big difference has been work shift and our scheduling. Basically, we’ve adopted a model I think other house staff has — a similar model across the country where we tried to cancel elective procedures and have residents who don’t need to be here, not be here.

So a lot of GYN entails elective surgeries and procedures, and we’ve basically shut those down. Our surgery center is quiet. I’ve never seen it that way. I was there last Monday and there were just no patients there. We’re just complying with CDC and national standards in that regard but it allows sort of this on-and-off model where we have some residents off at certain times. They’re sort of backup or taking home call while other residents who are considered essential and immediate — for example labor and delivery and our obstetrical triage unit — they need to be there because they’re absolutely essential, and certainly that allows patients who need to be delivered or who have obstetrical problems, they need to come in.

Of course, not all elective things are canceled. So elective induction of labor is still considered important and necessarily. So we are allowing all those folks who are scheduled for elective inductions or who want elective inductions to come in.

Joe Elia:

Okay. Labor and delivery, whether elective or not, is not something that you can’t opt out of for more than a reasonable amount of time. So OB/GYN is staying pretty busy I guess you’d say.

Dr. Matt Young:

Absolutely, but we are being very aggressive in terms of trying to curb potential exposure and infection. We are limiting the number of visitors, we’re only allowing one support person to accompany a patient postpartum. We’ve also adopted a new masking policy, and I’d be happy to tell you more about that.

Joe Elia:

Go ahead and tell me about this.

Dr. Matt Young:

So our hospital has been aggressive and followed that directive as well [Matt’s referring to a directive from Boston’s Partners HealthCare that mandates mask-wearing for all employees]. Basically in its initial days and weeks we were told do not consume or use surgical masks or N95 masks unless you’re interacting with a rule-out COVID patient or someone with symptoms or if you yourself have symptoms. Unless you’re dealing with somebody with symptoms you are not to wear or consume PPE (personal protective equipment) like N95 masks or surgical masks. Basically been a 180 degree reversal of that. I mean that policy probably was driven by severe shortages, folks who are calculating out that we’re going to run out in days to weeks, but there’s been a total reversal of that.

Basically, our hospital has adopted a mandatory mask-wearing policy. We basically made masks mandatory for all visitors and for all providers in any patient care areas. Partners Health in Boston is doing this and Christiana Care where I am at we’re doing this now, effective immediately, and we’re all really actually relieved because we got an email saying that we’re kind of lucky we don’t have such an acute shortage like major urban centers do, but even major urban centers like Mass General are adopting this mandatory mask-wearing policy. So I think that providers are getting…every day is a different day with new guidelines evolving, and I think that there’s a lot of provider anxiety.

There are a lot of labor and delivery nurses with families. Some of them are expecting, and that puts them at high risk. There are a lot of residents who are vulnerable or have exposures to vulnerable people. There’s a lot of anxiety among providers about protecting our healthcare workforce. So I’m so glad that major institutions like Mass. General and ours here at Christiana are adopting this.

Now, I have seen other measures being taken as well to sideline certain residents. So we usually have family medicine residents participate in our GYN and OB clinic outpatient ambulatory setting. Those residents are getting pulled and sidelined because there are concerns that because the family medicine residents are interacting with all kinds of populations that we may not necessarily want them interacting and possibly infecting our patients.

Now, all of this is in the setting of a concern about asymptomatic viral shedding or asymptomatic spread and that is what undergirded this new mandatory sort of making-masks-mandatory policy because providers are recognizing that there is serious concern of asymptomatic viral shedding, and we don’t know who has it and there’s so much uncertainty that we need to take universal precautions. It seems like the policy initially was not this way because of the severe shortage concern but we’ve now done a total 180, and I think that’s really important because we are now recognizing there really is asymptomatic viral shedding. So really this is a good policy because some of us — a lot of our attendings, et cetera — were wearing masks against hospital policy because we realized that there is a serious risk of asymptomatic viral shedding and we’re glad that our administrators have realized this and realigned policy.

Joe Elia:

I interviewed Susanne Sadoughi at Brigham and Women’s last week, and she said that they were doing most of their routine visits (now she’s an internist) but they were doing most of their routine visits via telephone and that that was working out well. Are you doing anything like that there?

Dr. Matt Young:

We are calling ambulatory patients and trying to triage and assess if we can just potentially diagnose them and write a script for them, trying to basically assess how urgent their needs are. We just got new policy today, which basically says we’re happy to see people for their follow-up postpartum visits but if they’ve had an uncomplicated vaginal delivery or an uncomplicated C-section, there haven’t been any blood pressure issues or major surgical issues, endometritis or any interventions that may require more aggressive follow-up we are just going to conduct phone postpartum visits instead. And I’ve had patients who…this really requires more advocacy on the part of the provider but I’ve tried to schedule for those more sick patients, routine follow-up with our service or other services, and I’m getting a lot of pushback saying, “We really aren’t scheduling right now until this is over.” And it really requires advocacy on our part to say, “Hold on a second, I really need you to see this patient, we really need your help.”

That has allowed me to sort of get around some of these policies saying we really aren’t going to see folks on an outpatient basis unless it’s urgent or necessary and really it requires advocacy to make that happen, but I think everybody’s trying to do their best. The problem is the situation is constantly evolving. I’m just glad that our healthcare system is adapting day to day and that we have a very responsive healthcare leadership. I will say I was just recently invited to join a Facebook group called SARS COV-2 House Staff Experience and it’s almost a thousand different house staff from across the country coming together in a private group to discuss our anxieties and our worries and our policies across various hospitals.

I’m shocked, frankly, to see that (I won’t mention who or where) but so many other institutions where other house staff and trainees and residents and fellows are, they are coming up with policies that either are misguided or lagging or just wrong-headed and I’m glad that our hospital and other hospitals we talked about are evolving their policies day to day but there’s so many other physicians and clinicians and residents that I’m hearing from that they’re still being told, “No, don’t worry about asymptomatic viral shedding. If you’re asymptomatic and the patient’s asymptomatic, save our PPE. Don’t wear masks.”

I had another resident who just told me that her hospital said to them that they don’t really believe that there is asymptomatic viral shedding, which is in direct contravention to what the national guidelines policies are, and they’re telling them not to wear masks. I just hope and pray that their hospitals are able to see the light and quickly revise and update their lagging policies.

Joe Elia:

I think that the light may be coming pretty quickly. When we had a telephone conversation two nights ago and I was inviting you to do this, Matt, things seems pretty quiet there then, and now I detect the urgency in your voice.

Dr. Matt Young:

Yeah. I’m in touch with a number of my colleagues who are in emergency medicine, and there’s a tremendous amount of anxiety and they’re just saying this is just going to get worse. This is going to get much, much, much worse. I mean the curve will be flattened but it’s still, relatively speaking, exponential. So there’s a lot of anxiety among frontline emergency providers. Most of these conversations are happening in private Facebook groups and in physician-to-physician chat rooms and dialogues, but I will tell you there is a severe discrepancy or asymmetry between the public government narrative and what front-line providers at the healthcare work force is seeing and what we’re bracing ourselves for.

Joe Elia:

Okay. Well, I want to thank you very much, Dr. Matt Young for talking with me today. And best of luck to you.

Dr. Matt Young:

Thank you, Joe. And best wishes and thanks to all the healthcare providers and the entire healthcare workforce that is on the frontlines now.

Joe Elia:

That was our 259th episode, all of them are available free at Podcasts.Jwatch.org. We come to you through the NEJM Group. The executive producer is Kristin Kelly. I’m Joe Elia. Thanks for listening.

Last week, I introduced the Fauci interview by saying that I’d heard a clinician complain that she’d spent half her time answering questions about COVID-19. This week, she’s our guest, and she’s looking back from the vantage point of a completely changed health system. She describes that change as “enormous.”

She’s doing lots of telephone consultations with her patients, talking about sending her kids to be with relatives at the other end of the country, and being wistful about the sound of a cello in her hospital’s corridors.

She’s learning to live with uncertainty, she tells us.

Listen in, clinicians, and see whether these observations resonate with you.

LINKS:

Last week’s interview with Anthony Fauci

Running time: 18 minutes

TRANSCRIPT OF THE CONVERSATION WITH DR. SUSAN SADOUGHI

(Please remember, this is a conversation and not an essay. As such, it can seem incoherent when presented as prose, but perfectly understandable when heard. We present it essentially as spoken in order to get it to you quickly.)

Joe Elia:

You’re listening to Clinical Conversations. I’m your host, Joe Elia.

While many of us work from home, some of us — such as first responders, mail carriers, supermarket clerks, and cooks — continue working during the uncertain course of the COVID-19 epidemic. Clinicians, of course, also continue their services, and we have with us today Susan Sadoughi an internist in the division of General Medicine at Brigham and Women’s Hospital in Boston, where she teaches residents and medical students. Dr. Sadoughi is a deputy editor of the daily Physician’s First Watch and has a been a colleague of mine there for many years.

The other day, during one of her phone calls with the First Watch newsroom she expressed some frustration with the problems the COVID-19 epidemic has created, and I thought it would be useful for other clinicians to hear about those problems or to know at least they were not suffering alone. She’s kindly agreed to talk with us. Welcome to Clinical Conversations, Susan.

Susan Sadoughi:

Thanks for inviting me.

Joe Elia:

It’s my pleasure. Tell us a little bit about your experience these days. Last week, as I said, you said you were spending about half your time answering patients and possibly clinicians’ questions about COVID-19, and I’m guessing you’re probably spending much more time this week.

Susan Sadoughi:

I have to say a week’s span of time has been an enormous difference from last week to this week. A week ago, I would say my clinical experience, in a lot of ways, was similar to the week prior in that I still had scheduled patients. I was seeing patients in the office, and I was seeing 15 patients a day. And last week I was frustrated, I remember, primarily because added to the usual business of seeing patients and filling in regular questions there was all of the discussion around, “Doc, what do you think this is? Can you tell me more about it? How do I protect myself?” It blows my mind how much things are different this week compared to last week.

Suffice it to say, if I were to just highlight the fact that this week I had zero patients that I saw in the office for routine visits. So beginning on Sunday night we actually screened all of our patients for the next two weeks and contacted all of our patients to let them know that almost all patient visits will take place on telephone. So we sort of divided our patients into three categories. If you’re just here to get your physical and you have no complaints or no problems that have to be followed, we will reschedule you for a month from now.

And then there was this category of patients that had problems, that were going to see me for routine follow-up, and we converted it to phone calls. Now, we have been advocating for phone visits forever and we’ve been told about all the barriers of phone visit. Lo and behold, in the middle of crisis, today I had six visits that were phone visits out of the 12 that I was supposed to see in the morning. So six of the visits were completely rescheduled. Six of them were converted to phone visits. And then I had the third category of patients, which are the patients who are symptomatic and need to physically be seen.

We divided those patients into patients with respiratory symptoms, which go to a completely separate wing of our clinic for whom I have to completely use preventive protection. And then symptomatic patients who, say, if they had a headache or other things that are non-respiratory. So our clinic, in the span of one week, has been utterly transformed.

So last week, it was absolutely overwhelming because there was the routine stuff and then the added counseling of the patients around COVID concerns as well as 100 questions on the emails that I was getting via our gateway messages. Ninety percent of those questions are now being triaged by a separate group of clinicians and nurses. There’s a whole hotline that has been developed who basically screen all my messages and if they’re COVID-related questions they’ll triage those questions.

So I think the structure of the clinic is utterly different. The feeling around the hospital is absolutely eerie. You walk around and there are not many people around. All of us are on this standby. The residents have all been pulled off the clinic. No routine visits. Waiting in case they’re needed, and then all the attendings who don’t have urgent care responsibility…so for example, I had urgent care responsibility today so I physically came to the hospital but tomorrow all of my patients are going to be phone visits. So I don’t have to come to the hospital. So they’re not…it’s just absolutely surreal. There’s no other way to describe it.

Joe Elia:

So what do you do to protect yourself? I mean in the absence of readily available testing for the presence of the virus.

Susan Sadoughi:

So essentially, I would say 80 percent of the patient visits have been converted into future visits or phone visits. The people who are being seen are the people who have acute respiratory symptoms. Those people, we pretend as if they do have COVID, and we have universal precautions for them. Other patients who are being seen in urgent care, which are very few…very few patients that are being seen in urgent care are not absolutely necessarily respiratory-type symptoms. Those people we stay away six feet. We wash our hands constantly. We have a ton of Purell and are wiping surfaces constantly. These are completely low-risk to no-risk for possible respiratory process.

And then all the other respiratory symptoms, be it that you have sore throat, be it you have some nasal congestion, be it you have some ear pain, we get dressed as if it could be COVID. So it’s so different this week.

Joe Elia:

So you’re kind of waiting around for the other shoe to drop, aren’t you?

Susan Sadoughi:

Yeah. I have to say, even my residents are like I can’t believe…because I see the same residents from last week to this week, and we were all saying I just can’t believe where we are in one week. Where we all are doing our phone visits and we’re sort of on this standby. Today, as I was going to a different section of the hospital, Brigham has this music-therapist cello player. They only usually come once every week or so. She’s been playing every day, it seems like, all day. And you walk around and I had ran into another colleague who was upstairs. You know, you vacillate between, oh, my God, this is so profoundly sad. Look at what is happening to our hospital.

Then you look around and there will be a message that makes you feel like, okay, I’m a soldier. I’m here. If something happens, I’m going to step up and I have to tell you, at times, I get so teary-eyed listening to that cellist playing because — I don’t know — there’s something incredibly patriotic about it. It’s so crazy because the whole atmosphere has changed.

Joe Elia:

You have a family at home.

Susan Sadoughi:

Yes.

Joe Elia:

And youngish children.

Susan Sadoughi:

Yes.

Joe Elia:

So how are you protecting yourself? Tell me a little bit, if you would, what that’s like.

Susan Sadoughi:

I’m in a little bit of a unique position, knowing that they have three weeks off and I have family in Florida we’re actually contemplating sending the rest of the family to Florida because there is very good chance I will be among the few urgent care doctors who will be assigned to see all the respiratory patients, meaning like every day I will be testing symptomatic people. I think that is high-risk enough that it might mean they’re better off distant from me. If they were home, I would probably, in addition to frequenthandwashing, etcetera, I’m in favor of keeping that six foot distance because what if I am one of those asymptomatic people who will contract it?

Luckily, the data around the young people are pretty encouraging every day, but I probably would be in favor of just keep a safe distance from me and in addition to the usual handwashing, the usual wiping off a surface. I’ve been really good about reminding the residents and also reminding the staff that we should consider ourselves as one of the scarce resources and we don’t want us to be quarantined or furloughed, never mind anything else.

Joe Elia:

The New Yorker has a daily newsletter. Benjamin Wallace Wells, in The New Yorker (who, by the way, lives in Boston) was talking with ethicists about some of the decisions that people might have to make about the use of respirators if things became as bad as they are, say, in Italy. I know that you’ve probably thought about that. Have you had conversations with your residents about that?

Susan Sadoughi:

Yeah. You know, to be honest with you, we’re in a different phase right now in the sense that we are commenting about how we’ve been able to reduce census in the hospital. The hospital feels empty because we really have been so proactive to divert patients who could be managed at home or elsewhere and also I think patients have been really good about trying to avoid the ER and keeping the staff available. So I think at this point, we’re just shocked by, “my God, we’re in this prep mode and we don’t know what to expect.” I think we haven’t prepared ourselves for the other side of the equation where we were totally overwhelmed. I don’t think we’re there yet. So I don’t think we played that scenario as much.

I’ll tell you one thing about my experience with these phone calls, which has been so unique. We’ve been asking to try and have phone visits for years, especially in primary care because so much of it can take place on the phone. Number one, the patients are so incredibly appreciative — Joe, I cannot even tell you — that they don’t have to come in. But also, just how much we can get done on the phone. Literally 90 percent of what we need to get done could get done on the phone for various patients. Then I was struck by every conversation at the end comes to a COVID discussion and the level of the discussion has changed, and it’s really interesting because last week the general public was uninformed. So a lot of the questions were very basic questions. What should I do?

Now, it’s so much different and it’s so unique to their own situation. I spoke to my 75-year-old who has to babysit for the grandchildren and what should he says to his daughter about limiting the little kids’ playdates. Then I had one other patient today, this woman who’s working from home, but she has some mental health struggles and she usually runs outside and exercises, and the gym has closed. And in talking to her about what you could do instead, “You could do this, you could do that, I want you to still do your exercise etcetera, it’s just a completely different discussion from last week. It’s much more advanced around how to protect themselves.

I think people…my own sense of it right now, the mindset is different. I think people have a mindset of what can I do instead? How can I protect myself? What can I do instead? I think there’s basic knowledge and then they’ve come to acceptance. It’s almost this is acceptance. If they’re worried, like I’ve been really trying to emphasize maybe you can do A, B, and C but you can do X, Y, and Z and you should feel good you’re being flexible. You’re being resilient. You’re still trying to find your way to do the things you need to do.

People have been so incredibly appreciative. I think it makes me much stronger and in a much better mindset this week compared to last week.

Joe Elia:

But for the clinicians who haven’t yet seen their first case or their first presumptive case yet, what’s the best advice that you could offer them?

Susan Sadoughi:

You know, I think the very first few times that I was seeing patients and trying to make decisions, should I send this person for COVID testing, should I not test them? It was so unsettling because it seemed like every two hours the guideline was changing. I would reach out to our infectious disease expert and after about the second or the third time where I heard them say, you know what, there is no clear-cut answer right now. Here’s what we need to deal with and there’s no easy answer, I finally realized as physicians we want certainty and in these times you have to understand the guidelines are changing. We don’t have the availability of testing all the people we want, and we have to be comfortable with some uncertainty. I’m better at that now because if the infectious disease person didn’t know the answer and says to me, “This is my best advice I can give you, and these are all hard decisions and we just have to live with that,” I think there’s something calming about that.

Whereas, last week I was terrified that I was making the wrong decision and now I realize this is such a fluid decision that there’s not a black and white answer and there is some comfort in knowing that we have to make decisions with some level of uncertainty, and it just feels different.

Joe Elia:

All right. Well, I want to thank you very much, Susan, for talking with me today about all this.

Susan Sadoughi:

Sure. Sure. There’s a lot to be learned over the next week or so.

Joe Elia:

Or maybe the next several months.

Susan Sadoughi:

Yes.

Joe Elia:

I wish you and your family well.

That was our 258th episode, all of which are searchable and available free at Podcasts.JWatch.org. We come to you from the NEJM Group. Our executive producer is Kristin Kelley, and I’m Joe Elia. Thanks for listening.

We wanted to know, How do you talk with patients about this rapidly spreading infection? How do you keep informed about it?

Listen in.

Link:

The new federal website

Running time: 13 minutes

TRANSCRIPT OF THE INTERVIEW

Joe Elia:

This is Joe Elia.

If you’re like the clinician I heard from last week who said she’s spending half her time counseling patients about COVID-19, you’re probably wondering how best to discuss the problem with your patients.

This time my co-host, Dr Ali Raja, and I are talking with Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases about how clinicians might approach these conversations and about how both parties — clinician and patient — can best inform themselves about the developing details of this widespread illness.

Dr Raja is helping to direct the Mass. General Hospital’s emergency department’s response. He’s Executive Vice Chairman of the Department of Emergency Medicine and he edits the NEJM Journal Watch Emergency Medicine newsletter.

Dr Fauci has directed NIAID for some 25 years, arriving in the early years of the HIV/AIDS epidemic. He has advised six US Presidents on health issues. Most recently we’ve all noticed that he’s become the principal clinical voice in this country’s response to the threat of COVID-19 as a member of the White House Coronavirus Task Force.

Dr Anthony Fauci:

Well, first of all I’ve directed the Institute for 36 years, not 25 years.

Joe Elia:

I’m sorry, Dr Fauci.

Dr Anthony Fauci:

You’re making me younger than I am!

Joe Elia:

Time flies when you’re having fun, right?

Well, so welcome to Clinical Conversations, and we’ll try to get other facts right as we talk to you! We’re going to keep this simple and frontline-clinical to respect your time and preserve your voice. I’ll have Dr Raja ask the first question.

Dr Ali Raja:

Thanks, Joe. Welcome, Dr Fauci.

Dr Anthony Fauci:

Good to be with you.

Dr Ali Raja:

You can imagine that we’ve been getting a lot of patients coming into emergency departments around the country, I’ve seen them here at MGH, with questions and with concerns. Honestly, I’ve struggled with the best way to advise them, so let me ask you. Beyond good hand hygiene and common sense regarding reducing transmission, what can we tell our patients about COVID-19 both to make them aware of the potential risks but also to hopefully calm them and help with the sense of panic that we’re feeling?

Dr Anthony Fauci:

Yeah. I mean, obviously a pivotal and great question that every one of us are facing.

So I think to give them the broad picture without unnecessarily sugar-coating because we’re in a really serious situation here.

But for the individual patient I try to explain that they should not take upon themselves the burden of the broader global health issue. So if you look at the situation of what it means to get infected, in the United States as a country in general the risk of getting infected is clearly very low.

However, the situation is changing, it’s evolving, and the difference of sitting in a place where there are either no cases or two or three easily documented cases. Like a travel case: Someone comes in from Iran to New York, they nail it, they isolate them, it isn’t in the community yet. You have a cluster there.

But for somebody who walks into an ER in an area where there isn’t community spread, the risk of getting infected is low. However, if you do get infected we need to look at the data that we have now and the data predominantly are from China, South Korea, northern Italy, and Japan, and that is about 80 percent of the people who get infected do well. I mean, they’re not asymptomatic, they have a flu-like illness but they recover spontaneously without any specific medical intervention, so to give them a feel.

However if you are an individual who has an underlying condition of which you’re all familiar with — chronic obstructive pulmonary disease, cardiovascular disease, congestive failure, diabetes, anything that could compromise your immune system — if you get infected then you have a much higher chance of having a complication, and then if you look at the serious disease and death it’s totally weighted to that group with the occasional one-off outlier that we even see with flu: A 35-year-old person who’s perfectly well gets the flu and then gets really sick and might die. That can happen, but different from flu, children and young people do really, really well with this.

So you give them the broad picture, that should take like two minutes in the office to tell them that. Then you tell them what do you need to do. Right now in places like Seattle, LA, New York, and Florida there’s clear community spread so what you need to do is start already what we call social distancing which some people don’t understand what that means. It just means separating yourself as best you can. No crowds, don’t get on crowded planes if you’re a senior citizen, particularly with an underlying condition. Don’t get on a cruise ship for sure. Wash your hands as much as you possibly can, and if you have a person in your own home who is immunocompromised or falls into that compromised group, you almost have to act like you yourself are infected.

So if you’re a 35-year-old person who feels healthy and you have someone in your home that’s on cancer chemotherapy, you’ve got to protect them. You’ve got to physically distance yourself from them. Now that’s now in Massachusetts.

If you happen to be in Seattle you’ve got to do more than that. You yourself have to do a lot of social distancing because when you have community spread then you just don’t know the penetration in the community unless you do a massive screening in the community, and that’s where we really need to catch up because what I’d like to see is just flooding the system with testing to see what percentage of people who come into any emergency room actually have COVID-19. If that’s 0.1 percent, okay. If that’s four percent, time out, we really have a problem.

Anyway, I was a little bit more long-winded than my usual answer but…

Dr Ali Raja:

That was exactly what we needed. Thank you.

Joe Elia:

Thank you, and Ali, what’s the situation at Mass General?

Dr Ali Raja:

Well, Joe, as an example let me tell you about the kinds of things that we’ve done in anticipation of a more widespread impact of this virus. As Dr Fauci mentioned we aren’t Seattle yet but we’ve already converted our ambulance bay to a large sealed-off treatment area that allows us to screen and test for patients separate from the rest of the emergency department when they meet the current CDC criteria.

And I want to emphasize that last part because the target seems to constantly be evolving and changing and so in addition we’re having daily meetings with all of our clinicians and our clinical leadership but also our supply chain leaders, our hospital administrators to make sure that the hospital keeps transforming based on the information that seems to be changing every day.

Dr Anthony Fauci:

That’s a really good point. This is not a static situation. It literally changes every day and that’s so difficult to do when you’re trying to put into place the kind of things that Ali just mentioned. You got to, as you say, meet every day and figure, Do we have to turn the knob one way or the other? That’s really important message.

Joe Elia:

I’d like to ask you, Dr Fauci, what do you consider the best sources of information for clinicians and the public who want to keep abreast of that changing information? Is it the CDC site or is it MMWR? What would you recommend?

Dr Anthony Fauci:

You know, the CDC has put up a site, the Federal government, it’s an all-of-government site. It’s called Coronavirus.gov. They just put it up. I mean, we said at the press conference yesterday “Just dial coronavirus.gov,” and I did and it wasn’t where I needed it to be. But it should be there today. The other thing is that what we’re putting up on the website is something that we literally put together yesterday and it is what to do at home, what to do at the workplace, what to do in the hospital, what to do here, and really simple talk that not only physicians can benefit from but the general public.

So I would do CDC.gov and coronavirus.gov.

Dr Ali Raja:

Perfect. I’ll go there today actually. Dr Fauci, what about our listeners? The public isn’t typically going to listen to our podcast but a lot of clinicians do. What do the clinicians themselves do? What should they be doing given the conflicting ongoing need to be able to continue to screen and treat patients who are potentially affected, but also avoiding getting ill themselves? We know the basics of wearing the masks and the gowns, but what else can we be doing or what should we be doing as a system to protect our clinicians?

Dr Anthony Fauci:

Yeah. I mean, obviously that is so critical because if you look at what happened in China, the healthcare providers, I mean, there was like 1700 of them in just in the city of Wuhan who got infected. I would do as strict precautions as you possibly can. I would clearly wear an N95 mask, absolutely. I would wash your hands until it starts getting chaffed. I mean, we do that anyway with universal precautions but I would clearly do that.

The other thing, if you start and you will, guys. You’re going to start seeing cases come in. I mean, it’s inevitable.

Yeah, I would just…when people call in, and I know you’re doing that, you got to tell them and you said you have a system that’s segregated, that if you feel sick don’t just come into the emergency room. Stay at home for now and if you’re going to come in, figure out a way that they don’t come in and essentially infect five other people when they come in. That I think the clinicians need to know.

First instinct is that if this person has it I want to take care of them. You can take care of them but you got to be careful about essentially making the matter worse.

Joe Elia:

Dr Fauci, I wanted to ask you, what is the one thing you hope that people listening to this podcast will do differently in response to COVID-19?

Dr Anthony Fauci:

You know, it’s a binary thing. I want them not to panic because panic gets people to do unreasonable things that are even counterproductive to what you’re trying to do from a public health standpoint. You might overwhelm systems when you don’t need to overwhelm systems. But on the other hand without panicking and without making it dominate your life, pay attention to the fact that you have to act differently like you’ve never acted before. You’ve really got to be socially distant.

You know, it’s very interesting that my deputy was one of the two Americans who went to China as part of the WHO umbrella group that visited and in China now, they got hit badly, they had a few missteps in the beginning but they’re getting it right now. I mean, they’re really being super, super careful. They don’t allow anyone to eat at a common  table. They have these little tables that are separated from each other in the hospital and other places where people don’t mingle. I mean, we’re all social beings but for the next few months, and I hope it does go down, it might not, but I hope it does the way flu does, we just got to hunker down. It’s part of what we need to do, we need to hunker down.

Joe Elia:

All right. I want to thank you, Dr Fauci, for talking with us today.

Dr Anthony Fauci:

It’s my pleasure.

Joe Elia:

Best of luck to you and to you, Ali, in the coming months. Thank you again.

Dr Anthony Fauci:

Thank you both. Thank you, Ali. It’s a pleasure to meet you.

Dr Ali Raja:

You as well. Thank you.

Dr Anthony Fauci:

Take care.

Joe Elia:

That was our 256th episode. The whole collection is searchable and available free at podcasts.jwatch.org. Clinical Conversations is a production of the NEJM Group and we come to you from NEJM Journal Watch. The Executive Producer is Kristin Kelley. I’m Joe Elia.

Dr Ali Raja:

And I’m Ali Raja. Thanks for listening.

She’s coauthor of an article in The BMJ — a meta-analysis — that finds the effect of salt is greater with age, and in non-white populations and those with hypertension.

Links to articles mentioned and apps:

• The BMJ meta-analysis discussed
• Salt reduction in England from 2003 to 2011: its relationship to blood pressure, stroke and ischaemic heart disease mortality https://bmjopen.bmj.com/content/4/4/e004549
• Formulas to Estimate Dietary Sodium Intake From Spot Urine Alter Sodium-Mortality Relationship https://www.ahajournals.org/doi/full/10.1161/HYPERTENSIONAHA.119.13117
• Role of salt intake in prevention of cardiovascular disease: controversies and challenges https://www.researchgate.net/publication/324874931_Role_of_salt_intake_in_prevention_of_cardiovascular_disease_controversies_and_challenges
• Salt Reduction to Prevent Hypertension and Cardiovascular Disease, JACC State-of-the-Art Review http://www.onlinejacc.org/content/75/6/632
• Salt reduction lowers cardiovascular risk: meta-analysis of outcome trials https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)61174-4/fulltext
• Foodswitch app: http://www.foodswitch.co.uk/
• SaltSwitch app: https://www.ncbi.nlm.nih.gov/pubmed/28631933

Running time: 28 minutes

Here is a transcript of the interview:

TRANSCRIPT OF INTERVIEW WITH PROF. FENG HE WHO HAS REVIEWED AND CORRECTED IT

Joe Elia: Salt and sodium intake have challenged medical researchers for generations. What seems indisputable is that too much salt is not good, especially in hypertension. After that things get fuzzier. National advice on restricting salt intake has been challenged by findings that restricting salt too much can increase cardiovascular risk.

Professor Feng He and her colleagues looked at the question of whether existing studies showed a relation between reductions in dietary sodium and changes in blood pressure. They performed a meta analysis of 133 studies comprising some 12 thousand 200 participants. Those studies all randomly allocated participants to either reduced sodium intake or usual (and thus higher) intake. All studies collected 24-hour urine sodium data to estimate those intakes. In short, they found a dose – response relationship between intake and blood pressure change.

Professor He works at the Wolfson Institute of Preventive Medicine at Barts and the London School of Medicine and Dentistry, Queen Mary University of London. Welcome to Clinical Conversations, Dr. He.

Dr Feng He: Thank you. Thank you for having me.

Joe Elia: You have been researching salt for about 25 years. What have you observed about the research over that time? Have you changed your mind about the effect of dietary salt and health and blood pressure?

Dr Feng He: No, I haven’t changed my mind, because when you look at salt reduction as a public health strategy, you need to look at the totality of evidence. You need to look at all different types of studies, including epidemiological studies, population-based intervention studies, randomized trials in humans, animal studies, and also physiological studies.

So all of these different types of studies have consistently shown that a high salt intake is a major cause of raised blood pressure. Salt intake is also an important determinant of the increase in blood pressure with age. I remember when I was in medical school, we were taught that systolic blood pressure increases with age — that this is a normal physiological phenomenon. But later scientific evidence has clearly shown that this is not normal, and that high salt intake is an important contributor for the increase in blood pressure with age.

If you look at the societies now, you know, there are still some societies isolated to tribes. They don’t have added salt in their diet, and that’s like our human ancestors, And their blood pressure, their average blood pressure for the adult population is only 90/60 mm Hg, and their blood pressures do not increase with age and these populations do not have cardiovascular disease at all. You may say, “No, people in isolated tribes die at a much younger age.” However, if you compare those isolated tribes with Western populations of the same age group, in Western societies so many people suffer or die from cardiovascular disease.

Joe Elia: Yeah. The fact that the research is ongoing tells us that not everyone believes that the results are final yet. Would you agree with that?

Dr Feng He: No. Actually you know, you never get a final result because you know what? For any dietary factors, it is extremely difficult to do randomized outcome trials. Remember, for salt reduction you have to randomize many thousand individuals to the high-salt or the low-salt diet and keep these two groups for many, many years to see whether there’s a difference in cardiovascular outcome.

The problem with this is, firstly, there’s overwhelming evidence that shows that a high salt intake is harmful to human health. It’s unethical to put a group of people on a high-salt diet for so many years.

Secondly, you know, on the lower-salt group in the current food environment, it is extremely difficult for individuals to keep to the lower-salt diet for many, many years. That’s almost impossible in the current food environment.

And thirdly, many countries have started salt reduction initiatives — governments and NGOs have programs as do health professionals. Even in the media — in the control group if you want them to be on the high-salt diet, they’ll receive all these messages from the media — from the radio, from television, from newspapers. They [high-salt controls] will lower their salt intake, too. So in the end you wouldn’t see a difference in salt intake between the two groups and then there’s a severe contamination between the two groups.

So it’s difficult to do such outcome trials you know, to keep two groups on the low and the high salt there for many, many years.

Joe Elia: I see. Is it possible to lower salt intake too much?

Dr Feng He: No, if you look at those isolated tribes, they don’t have added salt to their diet. You know, there’s lots of food, and some of the food naturally already has sufficient salt, like meat. Our ancestors, they did not have added salt, but they lived healthily. Now in the isolated tribes, they are still living in the lifestyle of hunter-gatherers. They don’t have added salt. Their salt intake as measured by 24-hour urinary sodium excretion is less than 1 g a day. It’s much lower. You know, they live perfectly well. They don’t have cardiovascular disease.

So, you know, in our current food environment in Western societies there’s no way you could reduce salt intake to such a level. Currently in most countries the average salt intake is about 10 g per day and the WHO recommended level is 5 g per day. And for the US it’s 6 g per day and for the UK it’s also 6 g per day for the general population.

However, for the US, in almost half the population, the target actually is much lower. It’s 4 g per day for individuals with high blood pressure, people of African origin, and people with kidney disease, because they are at increased risk. So their target should be even lower — to 4 g per day.

Joe Elia: Well, what prompted you and your colleagues to undertake this meta-analysis?

Dr Feng He: This actually is an updated meta-analysis. I don’t know whether you know, we have published a meta analysis in 2013 in the same journal, The BMJ. At that time what we looked at was a modest reduction in salt intake and over a longer duration as the current public health accommodation. For example, from 10 g per day to 5 g per day to see whether that had significant effects on blood pressure. What we showed was that a modest reduction in salt intake for a longer term, like for a duration over a month or longer, there’s a significant effect on blood pressure in both hypertensives and normotensives.

So for the new meta-analysis, not only did we update it to include many more trials but also there’s a focus on the dose-response relationship with salt reduction and blood pressure. And we also looked at duration, whether the duration [of reduction] has any effect on the effect of the salt on blood pressure.

So this time the inclusion criteria were different. We basically included almost all of the salt reduction trials with 24-hour urinary sodium measurement. So with these many studies we have shown a clear dose-response relationship; so the greater the reduction in salt intake, the greater the fall in blood pressure.

The current public health recommendation is from the current level of approximately 10 g per day to the WHO-recommended level of 5 g per day. That will have a significant effect on lowering blood pressure. However, if you lower salt intake further, down to 3 to 4 g per day, the effects on blood pressure would be bigger. So there’s a clear dose-response relationship: the greater the reduction in salt intake, the greater the fall in blood pressure.

Joe Elia: So you found that lowering salt intake is good for blood pressure, even among people without hypertension. But you were careful to limit your findings to blood pressure and not cardiovascular disease or other things, and…

Dr Feng He: This is very good question. Because as I mentioned earlier, it’s extremely difficult to do a randomized trial for cardiovascular outcomes. Hardly any trials have looked at the longer-term salt reduction on cardiovascular outcome. And having said that, I don’t know if you have seen our previous meta-analysis published in the Lancet. Basically because there’s an insufficient number of studies looking at long-term salt reduction on cardiovascular outcome, what we looked at in that meta-analysis was the trials whose aim was to look at the blood pressure.

However after the trials completed, the researchers followed this population up for many years after the trial, so even that type of study you know, wasn’t exactly a long-term outcome trial;  but still, that type of study has indicated that a reduction in salt intake has a significant effect on reducing cardiovascular events.

Joe Elia: But the question that you asked was a simpler one and in addition to lowering blood pressure across the board, you found that studies that were of a short duration, for instance two weeks or less, didn’t show the effect as much as those studies that were longer-term. Is that right?

Dr Feng He: That’s right. That’s right. Basically these studies show that the dose-response relationship is much stronger in the longer-term trials compared to short-term trials. So it’s likely that the shorter-term studies have underestimated the impact of salt reduction. The problem with looking at the duration and looking at the effect of duration on the effect of salt reduction is quite difficult, because at the moment not many longer-term salt-reduction trials, only a few trials have had a duration lasting six months or longer.

The problem with this type of trial is, initially, people achieve their reduction of salt intake, but with time you know, with the current food environment it’s impossible for individuals to keep the lower-salt diet for long term. So by the end of, say, a few years their salt level has already gone back to the higher level, so that’s why longer-term studies cannot see a greater effect. Because over the longer term they have not achieved a greater reduction of salt intake.

So if you really want to look at the long-term effect, the duration, the effect of duration on blood pressure, we should have longer-term trials, with the individuals kept on the low-salt diets throughout with multiple measurements of blood pressure throughout. The only study that can show this is the DASH Sodium study. I do not know whether you have heard of the DASH Sodium study. In this DASH-Na study the compliance is perfect because it’s a feeding study. All of the food and the drinks are provided to the participants. So the individual can keep the lower salt diet over the whole study duration. That study has shown that, with a longer duration the effect of salt reduction on blood pressure is bigger, compared to short-term study.

A footnote: Dr. He wanted to add this observation after her comments on DASH: “Countries that have achieved a reduction in salt intake for several years, for example, Finland and the UK, have demonstrated a much greater impact of salt reduction on population blood pressure”.

Joe Elia: The effects seemed especially stronger in older people, non-white populations, and those with higher baseline systolic pressures.

Dr Feng He: That’s right.

Joe Elia: Okay. And so I guess that’s the population it would seem that would have been exposed, especially older people, to this kind of food environment as you describe it, that is going to have loaded their bodies up with salt over many years, isn’t it.

Dr Feng He: That’s one of the reasons but there are other reasons. In our human body we have these hormonal systems like the renin-angiotensin system, and this system is actually maintaining our blood pressure. And because for individuals with older age and people of African origin and also people with high blood pressure, their renin-angiotensin system is suppressed. And so usually, like in young people, if you reduce your salt intake, the renin-angiotensin system would react and then there’s an increase in plasma renin activity and increase in angiotensin II.

This is like a compensatory mechanism to maintain our blood pressure. So for elderly and for people of African origin and also for those with high blood pressure, this system is not as active as in young people or compared to their counterpart in the white population or people with normal blood pressure. That’s one of the mechanisms for those subgroups to have a greater fall in blood pressure for a given reduction in salt intake.

Joe Elia: What do you think these findings mean for people who are skeptical about over-restricting salt intake? There have been some researchers in Europe — I know of one group — that have data saying that over-restriction of sodium leads to greater cardiovascular risk.

Dr Feng He: Yes, I’m fully aware of these publications. We have published several papers and there’s lots of debate about this. The problem with their studies is that there are severe methodological problems. For example, their study measured salt intake using spot urine. Spot urine measured sodium concentration. For example, if I just have two glasses of water now, and two hours later I collect spot urine. If you measure my sodium concentration in that spot urine, it’s much lower because it’s diluted.

And also this spot urine, they converted spot urine sodium concentration to 24-hour urine sodium to estimate individuals’ daily salt intake.

Joe Elia: I see.

Dr Feng He: They used a formula to convert this spot urine sodium to 24-hour urine sodium. This formula included age, gender, sex, height, weight. We all know age is an important determinant of any health outcome and death, and that age is also associated with salt intake. And also the other factors — gender and body weight and a 24-hour urine creatinine — all of these factors are important confounding factors because they both related to salt intake, and also related to health outcome.

So in this study you know, they can’t control such confounding factors.

Joe Elia: I see. Okay.

Dr Feng He: So there’s a lot of methodological [errors]. We call it measurement errors. Using spot urine is one of the contributing factors for the J-shaped findings. We published a paper in the International Journal of Epidemiology and another one in Hypertension, and clearly showed that this formula — the variables like age and gender, height and weight, the creatinine concentration — they all are important contributors to the J-shaped findings.

That’s the only one of the factors. Another factor in lots of cohort studies is that they included people who are not well, who are sick. And this is called “reverse causation,” because we know that if you are not well you can’t eat, and then you have lower salt intake. And then because you’re not well, you have a chronic disease, you’re more likely to die, so the lower salt intake in these individuals is the consequence of their underlying disease and it’s [lower salt intake] not the cause. So there are lots of problems with the J-shaped findings. And so you see our recent paper [which] clearly shows that these different factors have contributed to the J-shaped findings.

If you use accurate measurements of salt consumption like we did, we analyzed the Trials of Hypertension and Prevention [TOHP] follow-up data. Actually that study was done in the US, and we collaborated with Professor Nancy Cook at Harvard University [Brigham and Women’s Hospital]. In the TOHP study, all the participants had multiple nonconsecutive 24-hour urine measurements and measured their salt intake, and so if you look at it, this salt intake, you can see there’s a clear linear association. So the lower the salt intake, the lower the risk of death, down to a salt level of actually 3 g per day. There’s no J-shaped or U-shaped relationship.

Joe Elia: There is none. Okay. What do you hope will happen as a result of your continuing work on this and your current published analysis?

Dr Feng He: I hope definitely there’s a clear message that salt reduction is extremely beneficial to the whole population, not only in those with high blood pressure but also in individuals with blood pressure in the normal range. So firstly, the general public need to be more salt-aware and also reduce their salt intake. And for the clinicians, they need to give their patients appropriate advice on how to reduce their salt intake, because in our clinic, sometimes the patient will say “Oh, my salt intake must be low because I never use salt in my cooking or at the table.”

But when we measure it, you know that salt intake is extremely high. The patients, they did not know that the food they usually eat — bread, breakfast cereal — are really high in salt. So in most of the Western countries like the US, UK, and in many other developed countries, about 80 percent of salt in our diet is added to our food by the food industry.

So for the food industry, they needed to make a gradual and sustained reduction in the amount of salt they add to all of their products. And the UK has been very successful in reducing the population salt intake. In 2000, 2003 we [the UK] started a salt reduction program in collaboration with the Food Standards Agency and also our group Action on Salt. What we did is to set incrementally lower salt targets for over 85 categories of food.

And the principle is a small reduction — a 10 to 20 percent reduction — and then you repeat it at two- to three-year intervals. And if you do it gradually, you know, small reductions, the general public wouldn’t notice any difference in their taste. And they can continue to buy the food that they usually buy and their salt intake will come down. The UK salt-reduction program has been really successful. From 2003 to 2011 salt intake in the population was reduced by 15%, from 9.5 g per day in 2003 to 8.1 g per day in 2011.

So this you know, 15% reduction in population salt intake has led to a significant reduction in population [systolic] blood pressure by 2.7 mm Hg, and this was associated with a significant reduction in population mortality from stroke and ischemic heart disease.

Joe Elia: Oh. I think we should all be reading labels more carefully when we buy food.

Dr Feng He: Definitely. For individuals in developed countries it’s important that when we do shopping, we choose the lower salt option, and actually now there’s an app available. You can use this app and scan the bar code and then it will give you the lower salt option and you know, there is a similar product that tells which ranks high in salt, which ranks low in salt.

Joe Elia: What is the name of that app?

Dr Feng He: It’s [Salt Switch]. Actually there’s a more comprehensive one, it’s called Food Switch.

Joe Elia: Just a footnote here, Dr He contacted me after our interview and wanted to be clear that she had misspoken about the name of one of the apps. They are Salt Switch and Food Switch and I’ve included links to both on the website, podcasts.jwatch.org.

Dr Feng He: And then in the UK, Australia, and in China, and in India, there’s an app, freely available for download and when you go shopping you just scan the bar code and it will give you the “traffic light” labelling. It tells you which one is healthier, and it gives you alternatives to buy.

Joe Elia: Well, I want to thank you very much for talking with me today, Dr He.

Dr Feng He: Thank you. Thank you very much. It’s so good to talk to you.

Joe Elia: That was our 255th episode. All of them are available free at podcasts.jwatch.org. We come to you from NEJM Journal Watch and the NEJM group. The executive producer is Kristin Kelley, and I’m Joe Elia. Thank you for listening. Page 4

An editorial accompanying the paper sketches out a vision of where future efforts should lead, especially given the shift in U.S. medicine from private to institutional practice.

The coauthor of that editorial — surgeon and law professor William Sage — is our guest.

Links:

Malpractice liability and health care quality article in JAMA

Sage and Underhill’s editorial in JAMA

Running time: 17 minutes

A careful study in Cancer by this week’s guest, Ana Rodriguez, and her colleagues adds to the evidence that single-dosing is possible and protective against pre-cancerous cervical lesions.

Cancer article

Cancer editorial 

An earlier (2015) podcast on the question of the number of vaccine doses needed to confer protection

Running time: 16 minutes

Having encountered another of those weeks in which interviewees were either on vacation (richly deserved, we’re certain) or too busy to respond to Joe’s requests (get some sleep!), we’re going to offer that conversation again. We hope you’ll listen and vote — and if you do vote, please leave a comment as well.

URL for November’s original podcast

Running time: 19 minutes

Dr. Ali Raja joins Joe as co-host again this time.

Links:

de Cabo and Mattson’s review in the New England Journal of Medicine

Michael Mosley and Mimi Spencer’s book “The FastDiet”

Running time: 18 minutes

We talk with Dr. Pringl Miller, a Chicago surgeon who’s compiled a collection of instructive stories from women surgeons who’ve had to dodge demeaning questions (and sometimes, flying chairs in the OR). The stories appear in the latest issue of Narrative Inquiry in Bioethics.

“#MeToo in Surgery: Narratives by Women Surgeons” article in Narrative Inquiry in Bioethics

Recent NEJM article on harassment in surgical residency training

Time’s Up Healthcare website

Patricia Dawson’s book: “Forged by the Knife: The experience of surgical residency from the perspective of a woman of color”

Preeti John’s book: “Being a Woman Surgeon: Sixty women share their stories”

Joan Cassell’s book: “The Woman in the Surgeon’s Body”

Running time: 18 minutes

And, what about those requirements for documenting everything?

Listen to a chat with Julia Adler-Milstein, the author of an editorial that comments on a recent Annals of Internal Medicine study detailing the amount of time clinicians typically spend hunched over their EHRs during a patient visit.

Links:

Annals of Internal Medicine editorial

Annals paper on the time clinicians spend

Running time: 17 minutes

Those in the intervention group had a readmission rate within 6 months that was statistically identical to those getting usual care.

True, the Camden patients had particularly complex social and medical problems, so that doesn’t mean that the program can’t work elsewhere.

Listen to our chat with the report’s senior author, Prof. Joseph Doyle, and as well, listen to our interview with Dr. Jeffrey Brenner from 6 years ago — he’s the one who put “hotspotting” on the map. Despite the apparent failure of the trial, the Coalition still has a lot to offer.

Results of the randomized trial in NEJM

Interview with Dr. Jeffrey Brenner from 2013

Camden Coalition’s website

Running time: 15 minutes

Patients, paradoxically, prefer immediate endoscopy to test-and-treat, but unless the patient has “alarm symptoms” (such as dysphagia, weight loss, and anemia), endoscopy is likely to add complications and costs without adding further benefit.

Our guest is Prof. Alexander Ford of Leeds, senior author on the guideline-affirming study in The BMJ.

Links:

Article in The BMJ

Physician’s First Watch summary

NEJM Journal Watch Gastroenterology summary of 2017 joint U.S. – Canadian guideline

This seems to mark a cultural change that will affect both how and where clinical medicine is practiced.

Dr. Haider Warraich’s letter to the editor of the NEJM presents the numbers, and he’s agreed to talk about their implications.

Links:

Cross and Warraich’s New England Journal of Medicine letter (Dec. 12 issue)

Warraich’s 2017 book “Modern Death”

“Near Death,” a Frederick Wiseman 6-hour documentary worth finding

Running time: 16 minutes

We’re posting that interview again for two reasons: first, this week’s planned interviewee remained unreachable, no matter my pleadings; second, listeners reacted strongly (and positively)  the first time around, and I hope newer listeners will find it as interesting.

Links:

URL of the original podcast

Annals of Internal Medicine paper

Running time: 20 minutes

The group reports in the NEJM that daily low-dose colchicine was associated with a lower rate of a composite endpoint than a placebo: death from cadiovascular causes, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization leading to coronary revascularization.

New England Journal of Medicine report

Editorial commentary in NEJM

Harlan Krumholz’s tweet on the report

Running time: 20 minutes

Given that many people have poorly-controlled hypertension, the finding that all antihypertensives are effective in bringing about this result might get your patients to be more adherent.

We talk with Dr. Lenore Launer of the NIH’s Institute on Aging about her recent meta-analysis in The Lancet Neurology.

LINKS:

Launer’s paper in The Lancet Neurology

Lancet comment on the article

Running time: 16 minutes

Ali Raja and Joe Elia host a lively chat with Ian Roberts, the co-chair of the trial’s writing committee, who, in addition to chastising the hosts’ seeming fascination with P-values, recounts a story from early in his training that first stirred his devotion to preventing bleeding-related death after trauma.

NEJM Journal Watch Emergency Medicine summary of CRASH-3

CRASH-3 report in The Lancet

Ian Roberts explains CRASH-3 on YouTube to collaborators in Malaysia

Roberts presents CRASH-3 results at World Congress on Intensive Care on YouTube

Running time: 23 minutes

In California, Garen Wintemute and his group find evidence that people are willing to discuss gun safety with their clinicians, especially when there may be danger of harm present. That willingness extends across gun owners and non-owners. So why aren’t more clinicians doing it?

The findings appear in Health Affairs.

Links to the article & further resources:

Health Affairs article

Wintemute’s essay in Annals of Internal Medicine on gun violence

Another Annals article on preventing gun-related death and injury

Paula Byrne set out to understand what the available data tell us about how many people are taking statins for primary prevention — and how much good is it likely doing them?

Also, how do you discuss their possible harms and benefits with patients?

Links:

Paula Byrne and colleagues’ analysis in The BMJ

Kausik Ray meta analysis in JAMA Internal  Medicine

Kausik Ray 2010 Clinical Conversations interview

NEJM Journal Watch General Medicine comparison of statin guidelines

Veterans Day will be here soon, and this episode introduces you to Patrick Tripp, a writer and radiation oncologist. He’s taken conversations with some of his patients and published thumbnail profiles of several in a remarkable essay in the London Review of Books (that’s right, it’s not a medical journal).

The patients all happened to be veterans of the war in Vietnam. There are no biomedical insights here — or are there? At the very least, you are reminded that the people in the exam room all have stories to tell, and if you have the luxury of listening to them you may just learn more about their true chief complaint.

Patrick Tripp’s London Review of Books essay

A white paper from the Office of the Assistant Secretary for Preparedness and Response (ASPR) advises clinicians, health planners, and emergency responders that the old ways of responding to mass casualty events no longer hold. Wounded people arrive in Ubers and Lyfts at hospitals that are unprepared to be trauma centers. It’s best to practice (sending out an email to the staff doesn’t count) so that everyone in the hospital knows what to do and where to go when chaos strikes.

Ali Raja and Joe Elia talk with Paul Biddinger, one of the contributors to “Mass Casualty Trauma Triage: Paradigms and Pitfalls.”

And by the way, you may think you know how to use a tourniquet, but you probably don’t. Follow the link (below) to Stop the Bleed.

Links:

• ASPR white paper
• Stop the Bleed home page
• Boston Marathon interviews: Ron Walls, Brigham & Women’s Hospital Alasdair Conn, Massachusetts General Hospital Andrew Ulrich, Boston Medical Center Brien Barnewolt, Tufts Medical Center
• NEJM Journal Watch Emergency Medicine summary of the white paper

JAMA has just published an analysis of the latest findings regarding waste in the nation’s $3.5 trillion annual health “co-pay.” And with 25% of that — some eight hundred billion dollars — characterized as wasted, you’d think there would be stacks of competing cost-saving proposals to consider, especially regarding administrative costs. There aren’t.

An editorial comment on all this by our guest, Don Berwick, reminds us that one person’s wasteful spending is another’s lavish income. The question is, with all that money left on the table, what are we foregoing as a country?

Dr. Berwick has thoughts, and he kindly agreed to share them with us.

JAMA article by Shrank et al.

JAMA editorial by Berwick

Recently, Lancet Digital Health ran a meta-analysis concluding — if cautiously — that “deep learning” (more familiarly known as artificial intelligence) can be considered “equivalent to healthcare professionals” in image-based diagnoses.

In an editorial commentary on the analysis, Tessa Cook says, in effect, “not so fast!” And she discusses the reasons behind that caution with us in this episode.

Dr. Cook’s commentary in Lancet Digital Health

The meta-analysis on which she was commenting

Laura Hawks and colleagues undertook a study of forced sexual initiation — that is, a woman’s first episode of vaginal intercourse (and it’s forced when it wasn’t voluntary on her part).

Using government survey data on some 13,000 women of reproductive age, Hawks compared the women whose sexual initiation was voluntary with those whose wasn’t. It turns out that there were longer-term medical consequences apparently associated with the circumstance. Listen in.

Links:

JAMA Internal Medicine article

JAMA Internal Medicine editorial

A national sample of early- to midcareer pediatricians shows that women are lagging behind men in compensation, and another study from the sample shows that they’re not getting much help with the housework, either.

We talk with two of the authors of these studies and get their advice on what to do next — besides emptying the dishwasher and folding some laundry, gentlemen.

Links:

Pediatrics article on earnings

Pediatrics article on housework help

Pediatrics editorial on the two articles

Dr. Marcantonio agrees with the authors of a systematic review who conclude that “current evidence does not support routine use of haloperidol or second-generation antipsychotics to treat delirium in adult inpatients.” In his commentary entitled “Old Habits Die Hard,” he writes “the findings presented are sufficient to stop this clinical practice.”

Links:

Annals of Internal Medicine editorial

Marcantonio’s “Clinical Practice” article in NEJM in 2017

Dr. Joseph Ross and his crew looked at the implications to Medicare spending of all this. They published an interesting letter in the Annals of Internal Medicine detailing how much money the system could save if we stuck with the racemic mixtures. How much? Well, on the order of $15 billion over 5 to 6 years.

Links:

Annals of Internal Medicine letter

NEJM Journal Watch Pediatrics and Adolescent Medicine coverage of albuterol vs. levalbuterol

What are other countries doing to address suicide? It has increased in the U.S. from about 10.4 per 100,000 residents in the year 2000 to about 14.5 in 2017. Do firearm restrictions help? Better household safety? And how does the U.S. rate compare internationally?

Links:

Annals of Internal Medicine editorial

VA guidelines as published in the Annals

OECD stats on international suicide rates

Rishi Wadhera and his co-authors measured readmissions, plus treat-and-discharge ER visits, plus stays in observation units among some 3 million Medicare discharges of a near-4-year span. They found that broadening the definition of readmissions to include not only formal returns to the hospital for a standard stay but also those ER and observation-unit encounters tells a different story. It’s a story that should make HRRP’s administrators rethink what should be measured and how expanding the definition of readmissions could benefit patients by truly promoting better quality-of-care.

Links:

Article in The BMJ on readmissions

Earlier article in JAMA on readmissions for heart failure

Dr. James Douketis and international colleagues have a simpler approach in their PAUSE study. On the basis of the known pharmacokinetics of DOACs, they dispense with coagulation testing and heparin bridging. Their approach involves assessing the likelihood of the procedure to cause bleeding. For low-risk procedures, DOACs are suspended a day before and resumed a day after; for riskier procedures, like resections, it’s two days before and two after.

The drugs under study were apixaban, dabigatran, and rivaroxaban.

We discuss the PAUSE results with Dr. Douketis.

LINKS:

JAMA Internal Medicine paper on PAUSE study

Physician’s First Watch summary (with links to other resources)

Using a 100,000-patient simulated cohort, Nielsen’s group found that more intensive imaging found more cancers than the other approaches. However, radiation-induced cancers from CT wiped out that advantage.

Join us as Dr. Nielsen walks through his findings and their clinical implications. The work appeared in JAMA Internal Medicine.

Links:

JAMA Internal Medicine article

NEJM Journal Watch General Medicine summary of ACP guidance on evaluating hematuria (from 2016)

American Urological Association guideline (from 2012)

We talk with Dr. Sunil Badve, senior author of a meta-analysis in a recent Annals of Internal Medicine. His findings? Non-vitamin K oral anticoagulants (or “NOACs”) seem better suited for those with early-stage disease than vitamin K antagonists like warfarin. In later-stage CKD, there just isn’t enough data available yet, and so the choice of therapy — if any — must weigh benefits against harms carefully.

Links:

Annals of Internal Medicine meta-analysis

Physician’s First Watch coverage

Sandro Galea, dean of Boston University’s School of Public Health, has written a new book. It’s called “Well: What we need to talk about when we talk about health,” and it’s the centerpiece of our discussion.

Dr. Galea, who trained as an emergency physician, believes that health is a public good and thus worthy of public investment in the things that will promote health in the future, like public education, breathable air, drinkable water, and the like.

Listen in.

The book is available through Amazon or your local bookseller. It’s published by Oxford University Press.

The principal and senior authors of that analysis are our guests this time.

Links:

• Annals of Internal Medicine study (free abstract)
• Annals editorial (Annals subscription required)

Khera’s research article, it should be noted, originally appeared months earlier in draft form on BioRxiv, a biomedical preprint server.

Khera argues that the “official” journals are too slow. He fears their slowness. for instance, can prevent important data from reaching policymakers when it’s most needed — while they are making decisions based on new research languishing in the standard publication process.

Khera’s BMJ commentary

Khera et al.’s preprint on BioRxiv

Khera et al.’s resarch article as published in The BMJ

Conversation with Harlan Krumholz (from 2016): “Rethinking what medical journals do”

What are the implications of this for clinicians?

Harlan Krumholz, senior author of an analysis in The BMJ, talks about the problems and the opportunities for collaboration with patients.

BMJ article (free)

I thought listeners might want to know more about the dramatic change in the way primary care is acquiring, in Barnes’s words, an “increasing interdisciplinary character.”

Health Affairs abstract

He and his colleagues conclude that, as with mumps, slowly waning vaccine protection is at play. However, they identify the “core transmission group” as schoolchildren, who have a greater frequency of contacts. Adults, they find, have “at most a minor role.”

LINKS:

• Science Translational Medicine abstract
• Proc Royal Society B review on “the pertussis enigma”
• Podcast 220 on mumps resurgence

Our guest, Joseph Lewnard, and his coauthor, Yonstan Grad, probed studies of mumps vaccine efficacy carried out over five decades. They show that the fault, dear clinician, is not in our vaccines or new viral strains, but in ourselves. Our bodies slowly lose their immune response after vaccination, and about 25 years after the last vaccine dose, it’s gone.

Listen in.

Links:

Science Translational Medicine study

CDC recommends a third dose of MMR vaccine in an outbreak

Links:

Annals of Family Medicine abstract

Physician’s First Watch coverage

We discuss this with Dr. Saraswathi Vedam, the study’s first author.

Links:

University of British Columbia’s Birth Place Lab

PLoS One article

First Watch coverage of the Lancet series on midwifery

A note to listeners: Dr. Anderson and I conducted the interview over several sessions, so the first-half audio sounds a bit rougher than the second. Your speakers don’t suddenly get better — my equipment does!

Links:

NEJM report

NEJM editorial

Journal Watch General Medicine summary

Dr. Diana Buist, the study’s principal author, helps sort out the implications of this study, done on some 2 million screenings.

Running time: 18 minutes

JAMA Internal Medicine paper

USPSTF guidelines on breast cancer screening for normal-risk women

American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline

American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography

National Comprehensive Cancer Network clinical practice guidelines on breast cancer