I also host the This Week in Cardiology podcast (#TWICPodcast). I review the top studies in cardiology each week.
And of course I still love my work with TheHeart.org | Medscape Cardiology. My column is called Musings from Mandrola
Another place to find my work is a new venture called Sensible Medicine. Along with colleagues, we aim to present diverse opinions on medical topics.
Finally, I’ve been active in academic writing. You can read my 67 papers from the peer-reviewed literature here.
The blog had a bit of a crash and this is my best attempt to revise it.
JMM
I’ve recently started a newsletter on Substack. It’s called Stop and Think. In the latest post, I have included a Watchman lecture I gave at the Heart Rhythm Society meeting in Boston.
I hope you subscribe to the newsletter. It’s about science and medicine.
Here is the link for the Case Against Watchman
JMM
]]>When they saw the pandemic unfolding in China and Lombardy, their first thought was to design a proper clinical trial to determine what works for COVID19.
Normally, it takes a year or more to design a medical trial, but they got it done in weeks. This process is super important. You have to write a design first and decide what you will measure. Here is the protocol.
There were two keys to success: one was that the trial had to be simple and the other was that it needed buy-in from hospitals and doctors. Buy-in comes easier in the UK because they have the NHS–a nationalized healthcare system.
The idea behind the RECOVERY trial is that COVID19 is a novel disease, and doctors don’t know what works. The fancy term for this is equipoise.
In the US and other countries, doctors often “throw the kitchen sink” at patients. The problem there is that you can’t figure out what works.
In the UK doctors enrolled patients in the RECOVERY trial. This meant the choice to use a drug like dexamethasone was not up to the doctor but was random.
Some patients got placebo, some got the steroid. Randomization is crucial as it usually balances the groups of patients and allows us to infer causation.
It turns out that the inexpensive and commonly-used drug was beneficial. In a NEJM paper, the authors reported a 17% lower rate of death in the group that got the drug.
In absolute terms the reduction was 2.8%. A rough way to think about that is for every 35 patients treated, one life is saved. Or this: for every one million patients with COVID19 treated with this simple drug, 28,000 lives are saved.
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Readers of this blog and my podcast This Week in Cardiology know how much I believe in the randomized clinical trial. I’ve even said that the the RCT may be the most important medical development of our lifetime.
One hope I have is that COVID19 will help develop the infrastructure needed to do more clinical trials here in the US.
RCTs are not perfect, but they are the best way to know what works and what does not work.
]]>Two outlets have declined to publish our piece. This is not surprising given that we critique a research letter written by prominent academic leaders. As you read our take, please keep in mind that we oppose only the ideas expressed in the interpretation of data.
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The Journal of the American Medical Association recently published a research letter that reported an excess of nearly 12,000 deaths among younger adults this year. Of these deaths, slightly more than one in three were due to COVID19.
Three of the authors then explained their findings in an OpEd in the New York Times that ran with the title “People Thought Covid-19 Was Relatively Harmless for Younger Adults. They Were Wrong.†The subtitle doubled down on the fearsome messaging: “New research shows that July may have been the deadliest month for young adults in modern American history.â€
We do not deny the seriousness of COVID19, but we are concerned that prominent medical leaders have potentially misinterpreted their findings. This is remarkable because one of the co-authors is Rochelle P. Walensky, MD the newly appointed head of the CDC.
We offer four reasons why this study and OpEd do not support the claim that young adults should live in fear from the virus. The point of our critique is not to tell young people to avoid basic measures such as mask wearing and social distancing, but instead to counter the exaggeration of scientific findings—even if the intent is well-meaning.
The first problem relates to the authors†choice to assess excess mortality rather than death due directly to COVID19. They state that this was a better way to assess the full burden of the pandemic, as “mortality in young adults may go uncaptured due to uncoded COVID19 and other pandemic-related mortality.â€
As doctors who care for patients in the hospital and ICU, we disagree with the premise that undercounting of COVID19 deaths in young adults is common. In an older person with numerous advanced organ diseases, it is sometimes difficult to sort out the true cause of death—especially when death occurs at home. But in a young person, without these chronic diseases, death due to COVID19 pneumonia is much more straightforward to diagnose.
If under-reporting of COVID19 death is not a major problem in young adults, then one could assess the burden of viral infection by simply counting the number of deaths from the virus. That has been done. A systematic review of more than a hundred studies has shown that the infection fatality rate for young adults is quite low. The authors even cite a study documenting the low case-fatality rate in this age group.
The second issue relates to the choice to compare excess deaths this year to accidental opioid overdoses from 2018. When we looked at the data presented in the paper and its supplement, we found that with exception of a few scattered months, in a couple of regions, COVID19 deaths were lower than opioid overdose deaths in 2018. An alternative conclusion therefore could be that COVID19 deaths in this age group are much less common than opioid overdose deaths. The authors acknowledge this point in their discussion of the studyâ€s limitations.
The third issue is the tiny absolute increase in risk. An excess of 12,000 deaths sounds bad, but Professor Don Boudreaux, from George Mason University, has noted that there are nearly 88 million people in this age group. Thus, the individual risk for a person this age is found by dividing 4,560 (the number dead from COVID19 in this study) by 88 million. This equates to a 0.0052% risk of dying from COVID19.
While people have different risk thresholds, we struggle squaring a 1 in 20,000 chance of death from the virus with the following statement in the NYT OpED: “Young adults are dying at historic rates.â€
The fourth issue relates to the ratio of virus-related and non-virus-related death. The authors report that 38% were related to COVID19. We ask: what were the causes of the other 62% of excess deaths?
All practicing doctors understand that harm can come from both a disease and its therapies. In this case, the disease is the viral infection; the main therapy is societal interventions. Based on the finding that a higher proportion of deaths occurred from non-viral causes, why wouldnâ€t an impartial scientist consider the possibility that pandemic interventions have dealt more harm to young adults than the infection itself?
To prove this thesis would require a deeper look into the data, but we propose that it is reasonable to speculate that economic damage brought by the pandemic could have increased “diseases of despair,†such as depression, suicide and drug overdoses. Another plausible reason for an increase non-COVID19 deaths is avoidance of routine medical care and the postponement of non-emergent procedures.
In sum, the data in this research letter is inconclusive for drawing conclusions about the risk of dying from COVID19 infection in young adults. The authors noted some of these limitations in the manuscript, but then amplified a fearsome message in the New York Times.
We understand that the authors†intention to nudge young adults to adhere to social distancing is benevolent. Our aim in submitting this critical appraisal is not to minimize COVID19 nor to attack the authors, but to uphold the impartial judging of science. Because without impartiality, public trust is lost. And trust will prove crucial for maximizing the benefits of the newly developed vaccines.
The young have many reasons—ethical and moral–to adhere to social distancing during the pandemic. Fear of death is not one of them. In our view, promoting flawed evidence is counterproductive.
]]>Two emergency medicine specialists felt that I was both wrong and insulting in saying that hospitals were not overwhelmed.
What I meant in the word ‘overwhelmed’ is the notion of not being able to support a sick patient in the ICU or on a vent. That didn’t happen, but both doctors make important points.
First I mean no insult to my frontline colleagues. It’s the opposite really. As a specialist who deals mostly on the treatment side of things, I’ve held those who must make diagnoses in the highest regard. Their work in the pandemic has only increased that respect.
Second, the point that there were consequences to the “massive and costly” efforts to shift resources is valid. Data in our (cardiology) journals hint at the fact that heart attacks and stroke admissions were way down during the height of the pandemic.
But it’s hard to believe that heart attacks and strokes stopped happening during this stressful period. Post-pandemic reviews will likely show that the efforts to care for patients with COVID19 will have increased unnecessary non-viral deaths due to lack of care. (The counter is that the pandemic also stopped a lot of low-value, potentially harmful care.)
Nonetheless, “overwhelmed,” was a poor word choice. Sorry.
2. My Twitter friend, Dr. Mike Johansen (who is a super-sleuth when it comes to critical appraisal) pointed out that my comparison to NZ and Australia is problematic.
Dr. Johansen’s first point about not using the dichotomy between NZ and the US is well-taken–especially given the surprise of vaccine development.
Response to the pandemic has clearly been on a continuum. As he wrote, countries such as Canada, Germany, Denmark, Finland have done better than the US. And now that we have vaccines, countries that did better with pandemic control will end up with less death due to COVID19.
It’s interesting, too, that the countries mentioned above all have better safety nets than the US. Though, there are many other factors in a country’s response to the pandemic.
This country has to figure out a way to improve our safety net. I realize that people differ on how to get there. But no one can disagree that it is an existential problem.
3. An anonymous commenter pushed back on my assertion #6.
What evidence is there that reductions in IFR are due to masks and distancing?
My thinking is not that masks or distancing affect the IFR directly, but that delaying getting the infection will reduce one’s chance of dying. For two reasons:
It was a novel virus; it took time to learn stuff. So it is clearly better to get the virus in December than in April.
And now there are vaccines.
For a person with risk factors, therefore, it makes sense, now, to stay hunkered down for a few more months. There is an end in sight.
If you have the means, you use online shopping, you avoid weddings and large gatherings, get an N95 mask, do Zoom Christmas and take the vaccine.
But my commenter is right: Social distancing and masks do not affect the severity of illness–though there is a theory that a mask might lower the severity of illness by reducing the amount of virus that gets in your body.
The pandemic forces everyone to think. This is a good thing.
JMM
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