The British Medical Journal (now The BMJ) is one of the oldest and most respected medical journals in the world that also has a history of publishing some excellent investigative journalism. For instance, over a decade ago, it was The BMJ that published investigative journalist Brian Deer’s articles recounting the strong evidence indicating that Wakefield’s case series published in The Lancet that linked the measles-mumps-rubella (MMR) vaccine to autism was based on fraud. That study launched the modern iteration of the antivaccine movement and is, as I like to say, the study that launched a thousand quackeries directed at autistic children to “cure” them of their “vaccine-induced autism.” The headline of Deer’s accompanying commentary after his account of how the “case against the MMR was fixed” even referred to Wakefield’s study as “Piltdown medicine“, after the infamous Piltdown Man fraud.
Unfortunately, more recently the investigative journalism coming from The BMJ has left a lot to be desired, and I say this even though The BMJ recently published a commentary co-authored by Gavin Yamey and me about the Great Barrington Declaration and the new “merchants of doubt“. Indeed, I almost felt a reluctance to write this post, as it felt a bit like biting the hand that feeds, but after seeing an article published by The BMJ last week I felt that I had no choice. The article was by investigative journalist turned anti-GMO muckraking crank Paul Thacker and was titled “Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial“. It’s an article that, since its publication last Tuesday, has been widely cited and shared by a wide variety of antivaxxers in order to portray the clinical trial of the Pfizer vaccine that led to its emergency use authorization (EUA) in the US as hopelessly corrupt. Here are a few examples from Twitter:
Wait till everybody finds out about the vaxxes Pfizer are alleged to have given to a placebo group in the tests, to make it look like the adverse events were normal when they were suffered by both groups in the #RiggedTrials.https://t.co/Z2sVflFINY
— Michael O'Bernicia (@TheBernician) November 2, 2021
More whistleblowers in the medical world are starting to speak up and expose shenanigans.
— ZUBY: (@ZubyMusic) November 5, 2021
"Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial"
Published today in the BMJ, one of the top 5 medical journals in the world.
— Dr. Eli David (@DrEliDavid) November 2, 2021
Whistleblower report on Pfizer’s pivotal phase III trial:
– data falsified
– unblinding of patients
– untrained vaccinators
– slow to follow up on adverse events
– quality control staff overwhelmed by problems
– whistleblower fired after warning the FDAhttps://t.co/95y4nHYXpu
— Klaus K (@KlausKblog) November 6, 2021
COVID-19 vaccines are effective at reducing the risk of severe illness, hospitalization & death. There are also concerns about uncommon but underreported adverse events, some data quality, & suppression of politically unpopular perspectives. https://t.co/Noq6I2n2ZC
— Joseph A. Ladapo, MD, PhD (@FLSurgeonGen) November 4, 2021
That last Tweet comes from Dr. Joseph Ladapo, Gov. Ron DeSantis’ selection to head up the Florida Department of Health, whom Jann Bellamy discussed in September. He’s a member of “America’s Frontline Doctors” who, in addition to supporting a “natural herd immunity” approach to the pandemic, has openly opposed mask and vaccine mandates, while echoing antivax talking points.
If you don’t believe me about how much antivaxxers have embraced Thacker’s work, take a look at Robert F. Kennedy, Jr.’s antivax Children’s Health Defense website, which republished Thacker’s report verbatim under the terms of the under the terms of the Creative Commons BY NC license used by The BMJ. Interestingly, Children’s Health Defense even features an “author page” for Thacker that, if you don’t look closely enough, could give the false impression that he had written the article for Children’s Health Defense. From this author’s page, one can see that Thacker wrote two other articles for The BMJ that were republished, both demonstrating that he clearly buys into the conspiracy theories surrounding the “lab leak” hypothesis for the origins of COVID-19. Perusing The BMJ‘s site itself, one can see that Thacker is a regular contributor and there are more articles about the “lab leak” hypothesis that Children’s Health Defense didn’t republish.
For this post, I’m going to focus primarily on the article about the Pfizer clinical trial because it is the one that most resembles actual journalism, albeit just barely given that its sourcing is a bit sketchy and its framing is relentlessly one-sided and clearly designed to leave the reader with exactly the sort of message that antivaxxers are taking from it, namely that Pfizer is corrupt and was careless about oversight of the massive clinical trial of its COVID-19 vaccine in 2020. Thacker’s articles about the “lab leak” hypothesis published in The BMJ in general don’t even try to resemble investigative journalism (not that I won’t briefly cover them). Basically, it’s hard not to wonder what the heck has happened to The BMJ, in much the same way I recently wondered what the heck happened to John Ioannidis, a scientist whom I used to admire greatly until his turn into COVID-19 contrarianism and minimization.
I will also preface the remainder of the post by emphasizing that, if Thacker’s report is accurate, there did appear to be some significant problems with the three sites in Texas managed by Ventavia, the company that ran the clinical trials. However, the overall impression given by the article is that the entire enterprise should now be questioned, Thacker’s Competing Interests statement that he “has been doubly vaccinated with Pfizer’s vaccine” notwithstanding. In other words, narrative matters. Context matters. Framing matters. Everything about Thacker’s article frames the clinical trial and Pfizer in the worst possible light. It’s almost as though the report is custom-made to provide grist for antivax conspiracy theories, and it definitely succeeds at doing just that. Whatever good some of the report might do, that The BMJ commissioned this report and failed in its “fact checking” to realize that every good propagandist knows how to spin verified facts into deceptive narrative does not speak well of what has happened to the journal, particularly in light of other articles it has published.
Thacker’s whistleblower report on Ventavia and Pfizer
I will begin by discussing what Thacker reports in his article, starting with this framing right at the beginning of the report, and I will quote liberally citing the same Creative Commons license that Children’s Health Defense cited when it republished the article in its entirety:
In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.
But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.
Notice the framing. Contrary to Bourla’s statement, the narrative goes, “several” (three, actually, as it turns out) sites in Texas run by Ventavia were supposedly flouting clinical trial safety and unblinding patients, but an intrepid whistleblower reported them. Whistleblower narratives can be valuable, but they can also be potentially misleading, particularly when used as grist for a report by someone like Thacker. After all, whistleblowers often have their own axes to grind. That characteristic in and of itself is not a reason to dismiss (or not to protect) whistleblowers, but it is a reason to be cautious about basing conclusions on their claims alone, particularly a whistleblower who was employed by the company for just two weeks, as was the case with Jackson.
Similarly, when evaluating reports of problems with the conduct of a clinical trial, it is important to consider the actual details and context of the reported violations. In this case, Thacker mixes reports from Jackson that might have impacted trial data and safety with reports that could not possibly have. More than that, Thacker gleefully mixes the two, starting thusly in the more detailed discussion of his findings:
Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box.
So apparently Ventavia was careless about disposing of sharps. That’s definitely sloppy lab practice, if it happened, although I feel obligated to point out that we don’t know if this was one screwup or a common problem. Either way, Ventavia’s handling of sharps couldn’t possibly have affected the results of the clinical trial and is more a concern of OSHA violation than any concern that the FDA should look into that could have resulted in data compromise or compromise of the safety of patients. It’s interesting to me that Thacker chose to lead with this tidbit in the section after his introduction, when he started to go into more detail about his more general charges listed in the introduction, given that it has nothing to do with data integrity. I understand that he’s trying to frame the story as one of poor laboratory management, but, really, this accusation seems to have been inserted at the beginning in order to provide what I like to call a “Yuck!” factor, to get the reader to feel disgust on a visceral level towards the company, before going into the more mundane and difficult-to-explain issues of clinical trial management. It’s a very transparently manipulative framing tactic akin to how Thacker likes to paint genetically modified organisms (GMOs) as “unnatural” and “Frankenfood”.
The “yuck” factor having been established, Thacker then continues:
Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.
Notice the contrast between what Thacker writes in the introduction, in which he claims that Ventavia unblinded patients, not that “inadvertent unblinding may have occurred”. There’s a huge difference between the two. Think about it. Leaving the printouts in patient’s charts might have compromised blinding in some cases and was definitely a sloppy practice (and was corrected), but Thacker quite noticeably presents zero evidence that unblinding ever actually occurred, despite stating unequivocally right at the beginning of the article that patients were “unblinded”. Which message do you think that readers will come away with, the one saying that Ventavia definitely unblinded patients or the one saying that unblinding “may have” happened?
I find it even more telling that the scope of problem is not mentioned until more than halfway into the report, where it’s revealed that Ventavia ran three sites in Texas out of the 153 total clinical sites participating in the Pfizer trial and signed up a small fraction (~1,000 by the time the whistleblower was fired) of the trial’s over ~44,000 subjects. Note again the framing, “Early and inadvertent blinding may have occurred on a far larger scale”. This is clearly meant to imply more than just the Ventavia sites, given the context. Of course, Thacker reports almost as an afterthought that appropriate corrective measures were eventually instituted at this one site. One could certainly argue that Ventavia took longer to institute these corrective policies than it should have, but, even so, when I looked at the details of the actual claims made they do not support the insinuation that wide-scale inadvertent unblinding had occurred in the Pfizer trial.
Thacker does something even more deceptive as well. According to an anonymous source:
After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)
“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”
Again, note the juxtaposition. These 477 patients who reported COVID-19 symptoms but never received nasal swabs were across the entire trial of well over 40,000 subjects, but the way it’s phrased, not put into context of the size of the entire trial, makes this sound like a huge number. As has been pointed out, though, this is deceptive framing that leaves out some very important information:
What @thackerpd didn't mention: The share of non-tested trial participants was very similar in the treatment and the placebo groups (9.2% vs 10.1%), and a sensitivity check was done on this issue. https://t.co/7g4B3AUqyG pic.twitter.com/q3DDySb2KG
— Andreas Backhaus (@AndreasShrugged) November 3, 2021
In other words, the FDA and Pfizer did the appropriate analysis and demonstrated that the missing PCR test results for SARS-CoV-2 were similar in both the control and experimental groups and that excluding them had minimal effect on the estimated vaccine efficiency found by the trial. One would think that this would be an incredibly important thing to mention in order to put the figure of 477 people with COVID-19 symptoms within seven days of a dose who were not tested into proper context. Thacker’s implication that these 477 cases had an impact on the results of the trial is a big nothingburger that Thacker tries to turn into a gourmet double-decker burger of doubt.
Let’s look at some of the other charges from the whistleblower, listed in Thacker’s report in addition to the two main charges of “unblinding” (which might have happened, but Thacker never establishes to have actually happened and, if it ever did, what the frequency was) and failure to swab every subject who reported COVID-19 symptoms:
- Participants placed in a hallway after injection and not being monitored by clinical staff
- Lack of timely follow-up of patients who experienced adverse events
- Protocol deviations not being reported
- Vaccines not being stored at proper temperatures
- Mislabelled laboratory specimens, and
- Targeting of Ventavia staff for reporting these types of problems.
I’ll deal with the mislabeling of specimens first because it’s the easiest. This is the only place where Thacker makes this claim. A common theme you’ll be hearing from me is that details matter, and Thacker’s piece is notably lacking in details. How many specimens? What was the specific mislabeling? Without knowing these details, there is no way to determine how serious the problem was or if it could possibly have affected the clinical trial data significantly. Think of it this way. There’s a huge difference between one or two (or a handful of) specimens being mislabeled and the error caught and corrected and large numbers of specimens mislabeled so that they became useless because there was insufficient information to allow the investigators to correct the mislabeling. Which happened? We don’t know. Thacker doesn’t tell us. He just tells us it was awful.
Now, let’s move on to the first claim on the list (participants in the hallway). That is obviously less than ideal, even if it happened only once, but, again, details matter. Thacker never reports how often this happened or how many subjects were treated this way. He seems to imply that subjects were left standing in the hallway (or maybe I’m reading too much into this). Were there chairs? Again, this would have been less than ideal, particularly if monitoring was lax, but Thacker gives no details to let me as someone who’s dealt with clinical trials over his career come to a judgment. Moreover, even if this did happen, it would have been incredibly unlikely that it affected the results of the trial from these sites.
The next example is also curious. Thacker states that his whistleblower reported that Ventavia staff were “slow to follow up on adverse events”, but these are the only two examples that he could apparently find:
Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”
Again, coming back to my theme, details matter, and I bet that Thacker knows that a Grade 3 local reaction sounds horrible to the average reader, who won’t know what it is. In fact, a grade 3 local reaction is just that, local. Vaccine reaction grades, both local and systemic, are defined in this document, with a Grade 3 local reaction to the injection being a one that meets certain criteria; e.g., requiring the use of narcotics for pain, being greater than 10 cm in diameter, causing significant discomfort at rest that interferes with daily activities, association with a high fever or heart rate, and the like. These are not potentially life-threatening reactions and do not require hospitalization. (If they did require hospitalization or were life-threatening, that would automatically upgrade them to Grade 4.) While it’s obviously less than ideal that it took more than 24 hours to contact these patients, failure to do so for two patients is not such an incredible lapse that it invalidates the trial or is consistent with patients being endangered by the trial.
Regarding Thacker’s report of protocol deviations not being reported, I’m a bit confused, given this passage:
Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.
At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.
It sounds as though protocol violations were reported to the company, which took corrective action. You can argue if it acted fast enough or was tough enough on the staff involved, but I’m getting mixed messages here.
I also note that, although Thacker claims that Ventavia “falsified data” in the very introduction of his report, this is the only mention of “falsifying data” that occurs anywhere else. There is no description of any specific incidents of “falsifying data” listed, only a memo mentioning three staff members, one of whom was apparently counseled about “changing data and not noting late entry.” One also notes that this memo comes from early August 2020, shortly after the trial began, which means that Ventavia intervened before that many patients could have been signed up. This is truly thin gruel to make sensationalistic claims about “falsifying data” in the introduction in such a way as to make it sound as though the practice was widespread. Basically, we don’t know if falsification occurred, if it occurred how often it occurred, or what the specific “falsifications” were. Indeed, the phrasing of the memo could have indicated that the changing of data, which could have been the correction of errors for all we know, and not noting a late entry could have been discussed in the context of how even minor violations like that could be interpreted as falsifying data. Again, we just don’t know, and Thacker doesn’t tell because he doesn’t have evidence. (If he did, you know he would have cited more than just a cherry picked quote from a memo, which is very thin gruel indeed to base a charge of “data falsification” on.)
As for vaccines not being stored at the appropriate temperature, the Pfizer vaccine needed to be stored at -70°C (and was known at the time to be good for at least six months at that temperature), thus requiring either a -80°C freezer or dry ice. Once it’s thawed, the vaccine was reportedly at the time good for five days in a refrigerator. Knowing these parameters, details (of which Thacker provides none) matter. How far off were the temperatures? For how long? How many doses of vaccine were involved? If, for example, a single vial of vaccine were left out on the bench at room temperature for several hours, that would be a rather trivial violation compared to the situation where a whole shipment was stored in, for instance, a standard -20°C freezer rather than a -80°C freezer. We have no way of knowing how serious or prevalent this problem was. More importantly, Thacker doesn’t report whether the vaccines stored at an incorrect temperature were ever administered to clinical trial subjects or whether they were discarded, which matters a whole heck of a lot when it comes to vaccine trial safety and efficacy, particularly given that administering such vaccines would actually result in a lower vaccine efficacy because presumably they would lose potency the longer they were stored at too warm a temperature. Leave it to Thacker, though, to make it seem as though huge numbers of vaccine doses were messed up by being improperly stored.
The last item in Thacker’s list, if true, is the most damning charge, that Ventavia targeted employees for speaking out. It’s hard to tell if this were truly the case with Brook Jackson, but I will concede that the optics aren’t great. On the other hand, Thacker reports that Ventavia fired her the same day that she sent a complaint to the FDA detailing her concerns. It’s unlikely that the FDA contacted the company the same day of a complaint. (The FDA generally doesn’t move that fast.) Yet, Thacker goes out of his way to imply that the reason she was fired is that she ratted out Ventavia to the FDA. Similarly, it’s a bit disturbing that none of the Ventavia sites were among the sites audited by the FDA. On the other hand, there are always minor errors in trials of this size, particularly when they’re undertaken in haste, as the vaccine trials were in the middle of a pandemic. It’s impossible to know if the problems at Ventavia sites reported by Thacker rise to the level that they could have impacted the results from that site to a significant degree.
In the end, we’re left with a lot of smoke, but no clear fire. There clearly were some problems with Ventavia, which ran three clinical trial sites and signed up a small fraction of the total clinical trial subjects for the entire trial. Again, that’s not good. We have Brook Jackson and an anonymous source claiming that the environment at Ventavia was beyond the pale compared to previous places where they’d worked, coupled vaguely described incidents and allegations without even good examples or estimates of how prevalent the problem was. It’s also reported that Pfizer did audit the company and was apparently sufficiently satisfied to use it again. Of course, to Thacker, Pfizer (or any other large pharmaceutical company) is pure evil; so you can’t trust that. I would counter that, if one site’s data were so unreliable due to problems of the sort that Thacker reported, then pure profit motive would provide a strong reason for a pharmaceutical company to cut that company loose, rather than risk the FDA ever finding out.
None of this is to say that nothing should be done. Assuming that Thacker’s allegations are not a huge exaggeration, at the very least an FDA audit would be a good idea. At the very worst, even though it’s standard practice to do sensitivity analyses to look for variation in results, protocol deviations, failure to do follow-up testing, etc., between sites in a large clinical trial like this, in the worst case scenario, the data from the subjects enrolled at Ventavia sites could be excluded and the rest of the subjects reanalyzed. My guess is that, even if this most extreme step were to be undertaken, it would make minimal difference in the results of the trial.
Basically, Thacker takes fairly uncontroversial observations (e.g., that the FDA is underfunded and doesn’t audit sites as often as it should, something I’ve noted multiple times in my posts for SBM about cancer quack Stanislaw Burzynski and his bogus clinical trials, for instance) and combines them with vague reports of what are probably mostly minor violations played up as huge, impactful violations:
addressed within 24 hours? That’s a good one. I’m not going to mention what my average used to be 😂
The one good point it raises is that FDA is severely underresourced. There’s no doubt there. 2/
— Jason Gallagher (@JGPharmD) November 2, 2021
Again, the most disturbing thing about the report is the question of whether Ventavia did, in fact, retaliate against Jackson for her having agitated about problems at the site, even if the timeline suggests that it’s probably impossible for her having reported her concerns to the FDA to have been the reason she was fired. If that’s the case, then there should be an investigation and harsh penalties applied to Ventavia. The rest of the report is just Thacker being Thacker, trying to turn a molehill into the proverbial mountain, as long as it fulfills his purpose of demonizing big pharma.
What the heck happened to The BMJ?
If Thacker’s muckraking (and not in a good way) report on Ventavia were the only example of The BMJ going wrong, it wouldn’t be such a big deal. Every publication makes missteps from time to time, and no editor’s judgment is perfect. Sometimes otherwise solid publications screw up. It happens. Unfortunately, this is part of a pattern.
I first noted inklings of unease with The BMJ in 2017, when it published a couple of rather credulous “state of the art” reviews on “integrative medicine,” specifically, about using such “integration” of quackery with real medicine to treat chronic pain and headache. Again, these could have been missteps. It’s not as though The BMJ is the only respected medical journal to have published nonsense about “integrative medicine”. It is, sadly, a thing these days. Unfortunately, though, there is the case of Peter Doshi.
The first time I can recall ever having mentioned Peter Doshi was in 2009, when he spoke at an antivaccine conference hosted by Barbara Loe Fisher’s National Vaccine Information Center (NVIC) and, when contacted about it, responded with a transparent, “my speaking there does not imply endorsement”. (Remember that 2009 was the year when the H1N1 influenza pandemic was bearing down on us and that at the time Doshi had been fear mongering about the flu vaccine and questioning its efficacy.) 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 somehow managed to become an associate editor of The BMJ. 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. Early this year, for instance, he published one more such blog post entitled, Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data. It was a post custom designed to try to claim that Pfizer and Moderna had exaggerated the efficacy of their vaccines through some statistical prestidigitation. He also called for the “raw data,” echoing a Thacker technique of cloaking dubious claims in issues that almost everyone can agree on, such as transparency in clinical trials. (John Skylar and Skeptical Raptor also discussed the deception behind his articles.) Doshi once also bought into a truly risible conspiracy theory about the Vaccine Adverse Events Reporting System (VAERS) that I hadn’t even seen from antivaxxers. There was much mockery. More recently, Doshi published more misinformation in The BMJ about COVID-19 vaccines, claiming that there was “no biodistribution data” (even though there was and biodistribution data aren’t required for vaccines anyway) and insinuating that the trials had been unblinded earlier this year not out of ethical concerns about leaving the subjects in the placebo group susceptible to a potentially deadly pandemic disease, but rather to hide differences in adverse events between the groups and to facilitate the ability of businesses and local governments to mandate COVID-19 vaccines not yet approved by the FDA but only available under an EUA. (I wrote about the issue of unblinding the Pfizer and Moderna clinical trials in April. Suffice to say that it’s a complex issue of clinical trial ethics and science, far more so than what Doshi implies.)
Indeed, Doshi has 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.
Here’s what Peter Doshi signed and then only asked for his signature to be removed from the document after being publicly called out. It’s a petition “questioning” the hypothesis that HIV causes AIDS, and the Wayback Machine shows his name in the list of signatories.
No surprise, Peter Doshi has his own author page over at RFK Jr.’s Children’s Health Defense of articles republished from The BMJ under a Creative Commons license, his most recent “contribution” being an op-ed in which he laments calls for state medical boards and medical specialty boards to take action against the medical licenses and board certifications, respectively, of physicians spreading COVID-19 misinformation. Let’s just say that we at SBM disagree strongly and, if anything, think that state medical boards have not gone nearly far enough to protect the public.
It goes beyond that, though. Peter Doshi actively has actively allied himself with Robert F. Kennedy, Jr. For instance, he served as one of the expert witnesses last year for the plaintiffs in Children’s Health Defense’s lawsuit against the University of California opposing its flu vaccine mandate:
— Rosewind (@Rosewind2007) January 20, 2021
More recently, there’s been this:
Here is is as well:
For those of you not familiar with him, Ivor Cummins, a.k.a. “The Fat Emperor,” is one of the more famous COVID-19 contrarians, and his approval should be a red flag right there. That’s right. Peter Doshi testified before Senator Ron Johnson’s panel on COVID-19 a week ago, ostensibly about “COVID-19 vaccine injuries and mandates“. We’ve met Sen. Johnson before in the context of his promotion of dangerous “right-to-try” legislation. Since the pandemic, he has, predictably and like so much of the rest of the Republican Party, pivoted to become a COVID-19 pandemic minimizer and an opponent of COVID-19 vaccine mandates to the point of parroting antivaccine talking points. In his testimony, Doshi denies that this is a “pandemic of the unvaccinated,” citing a report from July from the UK that most hospitalizations are among the fully vaccinated. It turns out that this report was in error, substituting “vaccinated” for “unvaccinated” and the majority of hospitalizations were among the unvaccinated, even though they made up only 31% of the population at the time. He even cites cherry-picked tables to claim that the vaccine doesn’t save lives in what is basically an updated rehash of the nonsense he peddled in May (also deconstructed by Dr. Hilda Bastian). In a truly risible moment, he even cites the Merriam-Webster definition of “antivaxxer” as opposed to those supposedly opposed to mandates to argue that he and his fellow COVID-19 contrarians are “not antivaccine” and that large numbers of people would qualify as “antivaccine”. He even parrots the antivaccine talking point that mRNA vaccines are not really vaccines and therefore shouldn’t be mandated like vaccines. I kid you not.
I was flabbergasted. I knew Doshi was bad. I’ve known it since 2009. However, until I saw this video clip even I never realized he was this bad. I used to say that Doshi was not antivaccine. I’m no longer so sure and am leaning towards believing that he is antivaccine, based on his long history on the H1N1 vaccine, other vaccines, and finally the COVID-19 vaccines. Indeed, at the very least I have to agree with Dr. Zoë McLaren:
— Zoë McLaren, PhD (@ZoeMcLaren) November 5, 2021
In the meantime, Paul Thacker has published some doozies of conspiracy mongering articles about the “lab leak” hypothesis of SARS-CoV-2 origins.(He even bought into a narrative beloved of cranks that discussion of the origins of the pandemic has been “suppressed” by labeling any discussion of lab leak hypotheses as a “conspiracy theory”, referring to it as a “conspiracy to label critics as conspiracy theorists.” (Meanwhile, on his own Substack, he explicitly buys into the “Fauci lied” narrative spread by US Sen. Rand Paul and right wing media.) I don’t want to go into detail about these conspiracy theories, given that I’ve discussed them before, other than to say that, recent news reports of “gain of function” notwithstanding, it is still incredibly unlikely—arguably impossible, even—that SARS-CoV-2 was engineered in a laboratory, be it in Wuhan, China, where the pandemic appears to have originated or anywhere else. It is only slightly more likely than that that COVID-19 could have arisen due to the escape of a natural coronavirus being studied in a laboratory, but a natural origin due to a “spillover event” from an animal reservoir (most likely bats) remains far, far more likely than the incredibly unlikely possibility of a lab leak of a “gain-of-function” engineered coronavirus or a natural bat coronavirus being studied causing the pandemic.
Finally, before I conclude it is necessary to recount a bit of Paul Thacker’s history. Besides being known for promulgating anti-GMO conspiracy theories, this is a “journalist” who is known for using abusive Freedom of Information Act (FOIA) requests in order to harass scientists, in particular Kevin Folta. More recently, Steve Novella discussed how Thacker attacked him (and me) as “vaccine cheerleaders” based on our supposed denial and downplaying of potential complications due to the Johnson & Johnson COVID-19 vaccines. Thacker was, as usual, peddling nonsense, of course, because neither Steve nor I (nor other science bloggers targeted by him) had actually denied or tried to “sweep under the rug” the clotting complications being reported for that vaccine last spring. Rather, we had adopted a “wait and see” approach given the relative rarity of the complication reported. It didn’t take us long to acknowledge that the specific clotting problem attributed to the vaccine was very likely in rare cases caused by the vaccine. Thacker, as usual, misrepresented caution for “vaccine cheerleading” and denial that vaccines could ever cause harm. It’s what he does and why I expect that I will soon be subjected to yet another article by Thacker smearing me. It’s coming. I’m willing to endure it, though, if this post forces Thacker to publish more of the evidence behind his article and provide at least some of the details enumerated above that were missing, so that I can at least have a shot at judging the actual severity of the allegations made by his whistleblower. Right now, I just can’t, and certainly I know not to take Thacker’s word for anything.
Too bad that The BMJ doesn’t know that.
Sadly, I can now see a bit more why The BMJ has fallen so far, at least in its reporting, if not the science it publishes. Its editor-in-chief, Fiona Godlee, recently echoed Thacker’s conspiracy mongering in an official editorial for The BMJ, calling for a “full and open independent investigation” into the origins of SARs-CoV-2:
But, as Paul Thacker explains (doi:10.1136/bmj.n1656), suppression of the lab leak theory was not based on any clear evaluation of the science. Indeed, it happened despite no good counter-evidence for the alternative: natural spillover from animals to humans. Instead the lab leak theory sank under the weight of a concerted campaign by heavily conflicted scientists, leading to a “year of biased, failed reporting” by science journalists and journals. Now, thanks to the seismic shift in US politics and some dogged and fearless journalism, the theory is emerging from the shadows into mainstream public debate. We don’t know which theory is right, but a lab leak is plausible and worthy of serious inquiry.
This paragraph could have been published verbatim by Fox News or on any number of websites run by COVID-19 contrarians, and the part about there being “no good counter-evidence” for natural spillover as an origin is just plain wrong, given everything that we know about previous pandemics and the nucleotide sequence of SARS-CoV-2. Indeed, it is irresponsible in the extreme to have written “we don’t know which theory is right” without providing the context of which one is more likely to be correct. (Also, it’s a hypothesis, not a “theory”. In science, the word “theory” implies a much higher level of confidence than is justifiable in this context.) I outright cringed as I read Godlee’s article, having discovered it when I wondered what else The BMJ had published by Thacker besides his most recent “exposé”. It was incredibly disappointing to me to see the editor of The BMJ write something like this op-ed.
Unfortunately, Thacker’s most recent “bombshell” is yet another example of how The BMJ has gone astray, at least in terms of its news reporting and commentary, over the last several years. Peter Doshi, for instance, has now been with the journal for several years, despite many of us asking why the heck he’s still an editor, and Thacker is just the most recent symptom of the rot. I note that Doshi, for instance, has defended Thacker’s story as having been “rigorously fact-checked“. Unfortunately, it’s not the individual “facts” that he uses to weave a deceptive narrative; rather, it’s how he weaves those “facts” together to tell a story while leaving out important context, something all skilled propagandists know. Reluctantly, as I’ve observed the descent of The BMJ‘s news reporting and commentary to the level of conspiracy theory and supporting antivaccine narratives, I must conclude that the rot must start at the top. It’s not as though the problems with The BMJ‘s reporting and having an editor like Peter Doshi haven’t been pointed out for a long time now.
Think about it this way. If one of your editors and one of the freelance reporters that you’ve been publishing have their own pages at an antivaccine website, which republishes their work enthusiastically to spread fear, uncertainty, and doubt about vaccines and COVID-19 public health interventions, you really are doing things very, very wrong and contributing to pandemic misinformation in a huge way, given The BMJ‘s status.