Why is Peter Doshi still an associate editor for The BMJ? I keep asking that question, but no one seems able to answer it.
I first encountered Peter Doshi in 2009, when I noted that, as the H1N1 pandemic of 2009-2010 was bearing down on us, he was scheduled to speak at an antivaccine conference hosted by the National Vaccine Information Center (NVIC). Indeed, he had even been contacted about the nature of the conference and replied with a lame, “my speaking there does not imply endorsement” gambit. Since then, he’s been nothing if not consistent. While all the while claiming he’s “not antivaccine, he’s parroted more than a few antivaccine talking points himself while trying to portray himself as an authority on influenza and the flu vaccine. Through it all, he’s played the “victim” card that people who are borderline antivaccine or antivaccine love to play, claiming that they are “just asking questions” and that anyone who “questions” vaccines is labeled, in a knee-jerk fashion, “antivaccine.” In fact, Doshi’s borderline antivaccine stylings go back further than 2009, when senior pseudonymous epidemiologist whose blog I used to read religiously back then chastised him for an “unhelpful” commentary in which Doshi had claimed that estimates for yearly influenza deaths were “grossly inflated.” That was 2006.
Since then, Peter Doshi has somehow managed to become an associate editor of The BMJ, one of the premiere medical journals in the world. How this happened, I have no idea, but periodically he publishes posts for The BMJ that are—to put it kindly—far below the standards that a medical journal with the history of The BMJ should ever associate itself with. Most recently, he published one more such blog post entitled, Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data.
How “reasonable” sounding. After all, who could argue against more transparency, right? But notice the scare quotes around “95% effective.” They give the game away right there. So does the beginning of the post, which seeks to cast doubt on the conclusion that the two mRNA vaccines are roughly 95% effective at preventing COVID-19:
All attention has focused on the dramatic efficacy results: Pfizer reported 170 PCR confirmed covid-19 cases, split 8 to 162 between vaccine and placebo groups. But these numbers were dwarfed by a category of disease called “suspected covid-19”—those with symptomatic covid-19 that were not PCR confirmed. According to FDA’s report on Pfizer’s vaccine, there were “3410 total cases of suspected, but unconfirmed covid-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”
With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% (see footnote)—far below the 50% effectiveness threshold for authorization set by regulators. Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29% (see footnote).
If many or most of these suspected cases were in people who had a false negative PCR test result, this would dramatically decrease vaccine efficacy. But considering that influenza-like illnesses have always had myriad causes—rhinoviruses, influenza viruses, other coronaviruses, adenoviruses, respiratory syncytial virus, etc.—some or many of the suspected covid-19 cases may be due to a different causative agent.
But why should etiology matter? If those experiencing “suspected covid-19” had essentially the same clinical course as confirmed covid-19, then “suspected plus confirmed covid-19” may be a more clinically meaningful endpoint than just confirmed covid-19.
First of all, I can’t help but note that the whole “adding different hyperlinks to several words in a sentence in a row” thing is highly annoying, the sort of thing that bloggers should do very sparingly, if at all. Second, let’s look at Doshi’s arguments, which, at its core is that the clinical trials for the Moderna and Pfizer vaccines had a critical flaw that led them to miss a whole lot of cases of COVID-19, which, if included in the analysis, would lead to an analysis that would have shown much less efficacy of the vaccine. At its core, this is an argument so profoundly ridiculous and unscientific that it’s a wonder that The BMJ would allow it to be made on its blog. Think about it. After having made the observation that many different viruses cause the common cold and influenza-like illnesses (true), Doshi is arguing that Pfizer and Moderna should have included influenza-like diseases not confirmed as COVID-19 in its analysis, even though the vast majority of them were almost certainly not COVID-19.
Before you read that, I want to emphasize that Dr. Doshi is just wrong. He claims that the clinical trials for the vaccines contained a design flaw that has made them miss a large number of cases of COVID-19. Specifically, he believes it is inappropriate that they measured only confirmed cases of COVID-19 rather than looking at suspected cases of COVID-19. His argument is that if you look at suspected cases, you see a vaccine efficacy of only about 19%, where looking at confirmed cases gives an efficacy of 95%.
The thing is, this analysis is wildly flawed. Dr. Doshi conveniently ignores the fact that many of the suspected cases turned out to be negative for SARS-CoV-2 infection. So many, in fact, that it would suggest that PCR tests only correctly detect 5% of tested cases. We know this isn’t the case.
While it is probable that some positive cases were missed, it is unlikely that this is a very substantial number.
Exactly. Respiratory infections are very common, and at the time that the studies were being done most of them would not have been expected to be due to COVID-19. Doshi seems oblivious to the observation that the number of cases of “suspected” COVID-19 were roughly similar in both trials. As our feathery reptilian friend Skeptical Raptor notes, removing these cases doesn’t have a material impact on the analysis, and as Skylar further notes:
Additionally, it is not reasonable to just assume that all cases of respiratory illness in a sample of 30,000 people are due to COVID-19. This disease does not have a lot of characteristic symptoms. It is easily confused with other illnesses. Bacterial infections can cause many of the symptoms that COVID-19 causes, and there is no virus involved there even! Not to mention other viruses that can cause COVID-19-like illness. To presume without confirmation that all of these cases—even after we rule out the very many of them with negative PCR tests—are COVID-19 is, frankly, just bad science.
“Bad science” is Peter Doshi’s middle name, actually, going back at least to 2006, accelerating in 2009 as the H1N1 influenza pandemic hit, and continuing all the way to 2021. It’s his schtick. It’s what he’s known for.
Particularly silly is this complaint by Doshi:
Another reason we need more data is to analyse an unexplained detail found in a table of FDA’s review of Pfizer’s vaccine: 371 individuals excluded from the efficacy analysis for “important protocol deviations on or prior to 7 days after Dose 2.” What is concerning is the imbalance between randomized groups in the number of these excluded individuals: 311 from the vaccine group vs 60 on placebo. (In contrast, in Moderna’s trial, there were just 36 participants excluded from the efficacy analysis for “major protocol deviation”—12 vaccine group vs 24 placebo group.)
What were these protocol deviations in Pfizer’s study, and why were there five times more participants excluded in the vaccine group? The FDA report doesn’t say, and these exclusions are difficult to even spot in Pfizer’s report and journal publication.
Again, Peter Doshi is not a scientist, nor is he a clinical trials expert. Protocol deviations are routinely excluded from analysis in clinical trials, not just of vaccines, depending on the severity. Basically, a protocol violation/deviation is defined as an “unplanned excursion from the protocol that is not implemented or intended as a systematic change.” There are generally two main types of protocol deviations that occur in a clinical trial:
- Deviations that have the potential to be significant, meaning they could potentially affect subjects’ safety and/or the data’s integrity
- Deviations that are insignificant, meaning they could not.
Most commonly, “insignificant” deviations or violations are unplanned minor or administrative instances of noncompliance on the part of the subject, investigator, or study staff, such as minor paperwork oversights or “out of window” visits for medical followup, which occur when a subject misses a time frame (or has a medical visit outside of the timeframe) during which a followup evaluation is required in the protocol. As for the Pfizer and Moderna trials, they had a combined total of well over 70,000 subjects. The numbers Doshi is harping on are tiny compared to the size of the clinical trials used to gain an emergency use authorization (EUA) from the FDA for these vaccines. As our feathery friend notes, this is less than 0.5% of the total number of subjects, which is actually pretty damned good for such large clinical trials. Basically, as a “gotcha” observation, this is really nitpicking. Most clinical trialists would be thrilled to have only 0.5% of the subjects in one of their trials need to be excluded from the final analysis for protocol deviations, and even given the imbalance in deviations between the placebo and vaccine groups this is a number too small to have significantly affected the final analysis.
Doshi pulls the same schtick with the number of “confirmed” cases of COVID-19 at baseline, where he complains about a small percentage of COVID-19 positivity noted at baseline. Indeed, what Doshi did for his “analysis” reminds me very much of what antivaxxers do with vaccine clinical trials. He went through the data tables published by the FDA line-by-line, looking for any anomaly he can spin to cast doubt on the trial, whether significant or not.
Another strange complaint that Doshi raises is this:
Last month I expressed concern about the potential confounding role of pain and fever medications to treat symptoms. I posited that such drugs could mask symptoms, leading to underdetection of covid-19 cases, possibly in greater numbers in people who received the vaccine in an effort to prevent or treat adverse events. However, it seems their potential to confound results was fairly limited: although the results indicate that these medicines were taken around 3–4 times more often in vaccine versus placebo recipients (at least for Pfizer’s vaccine—Moderna did not report as clearly), their use was presumably concentrated in the first week after vaccine use, taken to relieve post-injection local and systemic adverse events. But the cumulative incidencecurves suggest a fairly constant rate of confirmed covid-19 cases over time, with symptom onset dates extending well beyond a week after dosing.
That said, the higher rate of medication use in the vaccine arm provides further reason to worry about unofficial unblinding. Given the vaccines’ reactogenicity, it’s hard to imagine participants and investigators could not make educated guesses about which group they were in. The primary endpoint in the trials is relatively subjective making unblinding an important concern. Yet neither FDA nor the companies seem to have formally probed the reliability of the blinding procedure, and its effects on the reported outcomes.
While this starts with a somewhat reasonable concern (certainly NSAIDs can mask fever and muscle aches), the likelihood that NSAIDs would so totally mask symptoms as to make a diagnosis of COVID-19 so much less likely as to decrease the apparent numbers of COVID-19 cases in the vaccine group is incredibly unlikely given that COVID-19 is a respiratory illness and NSAIDS would not mask respiratory symptoms. Nor would NSAIDs mask other common COVID-19 symptoms, such as loss of sense of taste and smell, GI symptoms, and others. Certainly, in a population as closely monitored as the participants in these clinical trials, it’s highly unlikely that this would make a difference, particularly given that the trials were double-blinded.
Not that any of this stops Doshi from implying nefariousness by pointing out that the event adjudication committee for the Pfizer trial consisted of three Pfizer employees. Of course, he also mentions that the Moderna event adjudication committee consisted of university-affiliated physicians. So does that mean that Doshi accepts the rulings of the Moderna event adjudication committee with respect to COVID-19 cases? Or is he “just asking questions,” a.k.a. JAQing off?
Doshi concludes with a plea that we “need the raw data”:
Addressing the many open questions about these trials requires access to the raw trial data. But no company seems to have shared data with any third party at this point.
Pfizer says it is making data available “upon request, and subject to review.” This stops far short of making data publicly available, but at least leaves the door open. How open is unclear, since the study protocol says Pfizer will only start making data available 24 months after study completion.
Moderna’s data sharing statement states data “may be available upon request once the trial is complete.” This translates to sometime in mid-to-late 2022, as follow-up is planned for 2 years.
To be honest, I’m a bit torn here. Yes, access to raw data is desirable. Transparency is generally a good thing in science. However, in the case of any clinical trial, be it for a COVID-19 vaccine or any other drug, the question is: “When?” In general, clinical trial raw data are not made public at least until after the clinical trial is completed, often not at all, our trust being placed in government regulatory agencies to evaluate the trial data. Maybe that should change as a result of the pandemic. However, Peter Doshi’s demands for “transparency” strike me as very self-serving in that there is a huge contingent of people like him out there, waiting to go through the clinical trial raw data with a fine tooth comb looking for even the smallest anomalies (of which there will always be at least a few in any large clinical trial, given that human beings are not perfect and no clinical trial is perfect) that they can use to sow fear, uncertainty, and doubt about the vaccines, whether justified or not.
Going back to our feathery reptilian friend, too, I can’t help but note that Doshi seems to think that he knows more than the committee charged with evaluating the clinical trial data for the Moderna and Pfizer vaccines:
Here’s my largest problem with Peter Doshi and his anti-vaccine opinions – he arrogantly believes that he has some “gotcha” moment that wasn’t discovered during an all-day review of actual vaccine scientists at the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA).
VRBPAC is the expert committee that reviews all vaccines before making a recommendation to the FDA for approval or non-approval. It is made up of experts in vaccines, public health, and statistics. There are around 30 individuals on the committee including one vaccine industry expert (a clinical physician-scientist, not some highly-paid executive) and one consumer representative, in this case, a respected attorney who concentrates on healthcare issues.
Could it be, perhaps, that the reason VRBPAC did not find these anomalies that Doshi is harping on to be sufficient reason not to issue an EUA for the Pfizer/BioNTech and Moderna vaccines is because, scientifically, they were big nothingburgers as far as problems with the clinical trials go? Could it be that Doshi, who has no relevant expertise in clinical trial design or implementation, virology, epidemiology, or infectious disease, thinks he knows more than, for instance, John Skylar? Skylar, after all, saw the same datasets that Doshi did and concluded:
Unfortunately, now that the datasets have been released, it’s quite clear that the vaccines are efficacious. The testing protocols were accurate. Yes, the trials could have been designed to tell us more about severe cases, or more about how the vaccines impact the spread of the virus, but these are studies that remain planned. The raw efficacy, as measured, is convincing. It is my feeling that Dr. Doshi has become entrenched in a position due to his past communications, and is having trouble admitting that the vaccines worked despite the criticism. Unfortunately, I think this is leading him to communicate things that fall into the realm of misinformation, which is why I chose to speak out.
It’s important to think critically and read many sources. While an article like this may appear to be convincing, it is not always clear what the author might not be telling you. It is easy for an expert to be misleading, even unintentionally. I hope to combat that, every time I sit down to write this newsletter.
John Skylar is far too kind in his assessment of Peter Doshi, whose training is in anthropology, East Asian studies, history, and “science, technology and society.” True, he apparently did finish a fellowship in comparative effectiveness research, but without Doshi having a background in the relevant sciences, I have a hard time accepting him as any sort of clinical trial, infectious disease, or vaccine expert. Indeed, after nearly 15 years of observing Doshi, I’ve come to two conclusions. First, I can’t believe that I’ve never done a post primarily about him in all the years and view this post as an opportunity to rectify that deficiency in my blog. Second, I’m no longer willing to give him the benefit of the doubt, as Skylar is. After all, Doshi now has a long history of parroting the more “reasonable”-seeming antivaccine talking points in the guise of “transparency.” Indeed, he even once bought into a truly risible conspiracy theory about the Vaccine Adverse Event Reporting System (VAERS), which is hardly the sign of someone who knows how vaccine adverse events are reported or even understands the basics of how websites work.
The bottom line is that Peter Doshi is a false authority on vaccines and clinical trials. He does not possess the requisite expertise, his apparent completion of a fellowship in comparative effectiveness research not withstanding. If you don’t accept my assessment, just look at his history of playing footsie with the antivaccine movement, amplifying antivaccine conspiracy theories, downplaying the severity of influenza and thus feeding antivaccine narratives, using sleight-of-hand to downplay the effectiveness of flu vaccines, and generally playing the role of a false skeptic with respect to vaccines. At this point, I can’t help but note that Doshi also once signed a petition “questioning” whether HIV causes AIDS. When called out on it by Steve Salzberg, he responded disingenuously:
On the question of signing the HIV/AIDS petition, Doshi responded that “Seeing how my name was published and people have misconstrued this as some kind of endorsement, I have written the list owner and asked for my name to be removed.” He declined to state directly that he agrees that the HIV virus causes AIDS—though I gave him ample opportunity.
Let me remind you of what Peter Doshi signed and then only asked for his signature to be removed after being publicly called out. It’s a petition “questioning” the hypothesis that HIV causers AIDS. The Wayback Machine shows his name in the list of signatories. It even includes this gem when you scroll over certain text:
You get the idea. Think of it this way: What is one doing when one signs a petition other than endorsing the statements on that petition? No, seriously. I want to know. Why on earth would Doshi have signed that HIV/AIDS denial petition if he didn’t endorse at least some, if not all, of the statements included the petition at the time he signed it? Does Doshi really think that Steve Salzberg (or anyone else) would be so clueless as to believe that he would have signed a petition that he didn’t believe in? I could have believed and perhaps forgiven Doshi if he had explained his removal of his signature as coming from the sort of shame that results from a realization that he had made a huge mistake and been totally wrong to have questioned the science showing that HIV causes AIDS and apologized for his mistake, but he did not. Instead tried to dismiss the “reaction” to his having signed the petition as a “misconstrual” of his intent and removed his signature in a fit of pique at that “misconstrual.”
No, there was no “misconstrual” of Peter Doshi’s intent in signing that petition. He was just angry and embarrassed that someone as high profile as Steve Salzberg had noticed and asked him about it while doing research for a Forbes post.
The bottom line is that Peter Doshi is a false expert on vaccines and vaccine clinical trials. Historically, his big bugaboo has been the influenza vaccine, his demonization of which has long included classic antivaccine tropes that the “disease isn’t that bad” and that the “vaccine doesn’t work.” It’s not surprising (to me, at least), that he’s pivoted to amplifying similar antivaccine tropes about the COVID-19 vaccines, which is a far easier task given the newness of the vaccines. I therefore end this article as I began it by asking: Why the hell is Peter Doshi still an associate editor of The BMJ?
I totally forgot about it while writing this, but Doshi also served as an expert witness in a bogus lawsuit by Robert F. Kennedy, Jr.’s antivaccine group Children’s Health Defense. Dorit Reiss reminded me in a comment below:
He was also one of the expert witnesses for the anti-vaccine organization Children’s Health Defense lawsuit against the University of California’s influenza vaccine mandate. A judge has rejected their request for preliminary injunction in a decision that strongly suggested the case was dead on arrival, but participation in a case by an organization that is clearly anti-vaccine raises questions.
The question Doshi’s involvement primarily raises is: Is he antivaccine? Can someone with so much education be so utterly clueless as not to realize that Children’s Health Defense is an organization that is antivaccine to the core? That’s the only alternative to Doshi’s being antivaccine that I can think of right now.