I’ll start this post by noting, as I did the last time I wrote about this topic in a major way, that 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, well over a decade ago, it was The BMJ that published investigative journalist Brian Deer’s reports recounting the strong evidence indicating that Andrew Wakefield’s case series published in The Lancet in 1998 that linked the measles-mumps-rubella (MMR) vaccine to autism had been based on fraud. As most of our readers know, Wakefield’s 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, in more recent years, the “investigative journalism” published by The BMJ has left much to be desired. Let’s just say that The BMJ‘s reporting has taken on a distinctly credulous bent when it comes to antivaccine narratives. The prominent example that I wrote about two years ago was conspiracy-mongering free lance “journalist” Paul Thacker‘s report, “Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial,“ At the time, I (and others) dissected all the ways in which this report was misleading, asking (the first time) What the heck happened to The BMJ? Unfortunately, the editors of The BMJ not only extrapolated from a story about supposed lapses at one study site for the Pfizer COVID-19 phase 3 clinical trial to generalize them to the whole clinical trial, but to all industry-supported clinical trials as well, and, when called out on it, doubled down. Tellingly, when Lead Stories published a fact check used by Facebook regarding how misleading the story was, instead of addressing the criticisms, the editors of The BMJ instead wrote an open letter to Mark Zuckerberg, CEO of Meta (Facebook’s parent company) complaining without actually refuting any of the criticisms made by Lead Stories, all while ignoring another story published by MedPage Today recounting many of the same obvious problems with Thacker’s report that Lead Stories had.
Well, here we go again, as last week The BMJ published a misleading report about the Vaccine Adverse Events Reporting System (VAERS) that relies on anecdotes and leaves out critical context in order to produce a picture of a “totally broken” system that is hiding data and intentionally covering up reports of injuries due to COVID-19 vaccines.
Jennifer Block in The BMJ: VAERS is “broken” (and—nudge nudge, wink, wink—therefore COVID-19 vaccines are dangerous)
Last week, The BMJ published a report by “investigative journalist” Jennifer Block about VAERS:
A US reporting system designed to detect potential safety issues with vaccines is supposed to be user friendly, responsive, and transparent. But an investigation published by The BMJ finds it’s not meeting its own standardshttps://t.co/qxH5OzC5YJ
— The BMJ (@bmj_latest) November 10, 2023
Predictably, antivaxxers are amplifying the story and claiming that it’s evidence that they were “right all along” about VAERS:
— Old School Tin-Foil-Hat Rock Chick (@KathleenDoty) November 17, 2023
Three years too late and barely scratching the surface. https://t.co/ca7eRQMhkT
— Anne Rose (@MetriMommy) November 17, 2023
OpenVAERS raise concerns about this deceptive bookkeeping system by the CDC.
— GQ4U (@GQ4U52) November 18, 2023
Notice that last one, with the meme. Basically, it’s an antivaxxer using Block’s report to argue that OpenVAERS, the fake VAERS database created in 2021 by an antivaxxer named Liz Willner, who scrapes and misrepresents data VAERS data regarding harms produced by COVID-19 vaccines in order to spin a false narrative that vaccine injuries are being “covered up,” was “right all along.” How does her report accomplish this? Let’s dig in.
Here’s anecdote number one:
Three weeks after receiving a second dose of a covid vaccine, Robert Sullivan collapsed at home on his treadmill. An anaesthesiologist in Maryland, USA, he was a particularly fit 49 year old: the week before falling ill, he’d been happily skiing at altitude in Colorado.
Sullivan was given a diagnosis of sudden onset pulmonary hypertension, which is generally progressive, can be fatal, and in most cases can’t be cured. The condition is rare, especially in middle aged men. Sullivan decided to file a report in the Vaccine Adverse Event Reporting System (VAERS), which collects reports of symptoms, diagnoses, hospital admissions, and deaths after vaccination for the purpose of capturing post-market safety signals.
But the submission process was a glitchy race against the clock. “The format is cumbersome and it times you out,” he tells The BMJ. For his troubles, Sullivan received a confirmation by email and a temporary “e-report” number. He learnt from his doctor’s office that a VAERS representative had requested medical records. Then he didn’t hear back for a year.
This is what Block leads with? After all, one would think that a journalist would lead with her strongest anecdote supporting the findings of her report. This is some seriously thin gruel so far. Think about it. What do we have so far? It sounds as though the server was overloaded, but that Dr. Sullivan did manage to make his report. Then, the system appears, thus far, to have worked as intended, even if glitchy, with a VAERS representative contacting his physician for medical records, before no updates for a year. What does this mean? If you believe Block and The BMJ it means:
VAERS is supposed to be user friendly, responsive, and transparent. However, investigations by The BMJ have uncovered that it’s not meeting its own standards. Not only have staffing levels failed to keep pace with the unprecedented number of reports since the rollout of covid vaccines but there are signs that the system is overwhelmed, reports aren’t being followed up, and signals are being missed.
I doubt that anyone would deny that, early after the rollout of COVID-19 vaccines, the system was overwhelmed. After all, this was the largest and fasted rollout of a vaccine since VAERS was created over three decades ago. It was also the first time that the government had so heavily advertised VAERS with each dose of COVID-19 vaccine and encouraged people to report any adverse events (AEs) that they thought to be due to the vaccine. The CDC even created another system (V-Safe) that, unlike VAERS, a passive reporting system, send periodic text messages to vaccinees who signed up to ask them how they were doing. This provided more cues to report to VAERS than had ever been provided before. Now, don’t get me wrong. If the system was overwhelmed and understaffed to the point where its servers would time out and its staff couldn’t follow up in a timely fashion on AE reports, then that should have been fixed.
However, were safety signals being missed? Given how fast safety signals for unusual blood clots, myocarditis, and other issues were identified, studied, and reported, I would argue that VAERS, for all its struggles and shortcomings, did a surprisingly good job serving its intended purpose: To serve as the “canary in the coal mine” to identify possible problems with vaccines meriting further study to determine if they were related to the vaccine. Remember, VAERS cannot demonstrate causation, nor can it accurately estimate prevalence of specific AEs, as I have written many times before dating back to 2006 at my not-so-super secret other blog, where I discussed how antivax lawyers had encouraged reports to VAERS in order to game the database in favor of supporting a causal link between vaccines and autism. Unsurprisingly, with the massive rollout of COVID-19 vaccines, it took very little time at all before antivaxxers were misleadingly claiming that VAERS supported all sorts of AEs due to the vaccines and even massive numbers of deaths, all starting less than two months after emergency use authorization (EUA) for the vaccines.
Let’s see what Block and The BMJ base their conclusions on:
The BMJ has spoken to more than a dozen people, including physicians and a state medical examiner, who have filed VAERS reports of a serious nature on behalf of themselves or patients and were never contacted by clinical reviewers or were contacted months later.
Our investigation has also found that, in stark contrast to the US government’s handling of adverse reaction reports on drugs and devices, the publicly accessible VAERS database on vaccines includes only initial reports, while case updates and corrections are kept on a separate, back end system. Officials told The BMJ that this was to protect patient confidentiality—but this means that patients, doctors, and other public users of the database have access only to an incomplete and uncorrected version.
Sounds pretty damning, doesn’t it? But does the report really support such conclusions? Spoiler alert: This investigation does suggest areas where VAERS has fallen short and could be improved, but not the claim that the CDC and FDA (which run the database) has been intentionally hiding or “covering up” AEs or that it’s missing huge safety signals.
First, though, let’s start with this:
Co-managed by the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration, the VAERS reporting system relies on a mixture of voluntary adverse event reports from doctors and patients and mandatory reporting from vaccine manufacturers, which are required by law to report all adverse events they become aware of.
This is an interesting bit of misdirection. It is true that manufacturers are required to report all serious AEs and deaths that they become aware of to VAERS. It is also true, but not mentioned, that drug and device manufacturers are also required to report serious AEs and deaths to the FDA under postmarketing reporting requirements for drugs and medical devices. In other words, VAERS is not the be-all and end-all for reporting AEs, at least not for manufacturers. There are various other pharmacovigilance systems in place to monitor potential AEs. It turns out that the same is actually true for vaccines as well in that there are multiple active surveillance systems, such as the Vaccine Safety Datalink (VSD), the Clinical Immunization Safety Assessment (CISA) project, or FDA’s Post-licensure Rapid Immunization Safety Monitoring System (PRISM). Systems like these actively search for AEs in massive medical record databases that might be linked to vaccination. VAERS, as I often point out, is intended as a hypothesis-generating reporting system, given that reports to it are voluntary (e.g., passive in that it waits for reports instead of, like for instance the VSD, going out an looking for AEs and trying to correlate them to vaccinations), not a system that can prove causality.
In fairness, before I get to the misdirections and malinformation, let’s look at what Block reports that suggests a real problem:
VAERS’s standard operating procedure for covid-19 states that reports must be processed quickly, within days of receipt.12 “Serious reports” trigger the requisition of medical records and at minimum a “manual review,” while deaths and other “adverse events of special interest” may undergo a more “in-depth” clinical review by CDC staff.
However, The BMJ has learnt that in the face of an unprecedented 1.7 million reports since the rollout of covid vaccines, VAERS’s staffing was likely not commensurate with the demands of reviewing the serious reports submitted, including reports of death. While other countries have acknowledged deaths that were “likely” or “probably” related to mRNA vaccination, the CDC—which says that it has reviewed nearly 20 000 preliminary reports of death using VAERS (far more than other countries)—has not acknowledged a single death linked to mRNA vaccines.
Before the pandemic VAERS was receiving nearly 60 000 adverse event reports each year. A 2015 CDC article suggests that the agency had the capacity to request records for just a few thousand serious reports each year.3 But in 2021 the total number of reports shot up to a million, and another 660 000 have been filed since. Nearly one in five meet the criteria of serious. This surge reflects the unprecedented campaign to vaccinate against covid-19—in the US alone some 675 million doses have been administered—and the vast majority of recent reports are related to covid vaccines. The CDC states that, “in the event of a significant increase” in VAERS reports warranting clinical review, the standard operating procedure requires additional CDC Immunization Safety Office staff to process cases.
It is, of course, unsurprising that a system might buckle when it suddenly receives nearly 20-fold more reports than it is used to processing. Moreover, it is now clear that, in retrospect, prior to the pandemic the CDC and FDA were seriously underfunded compared to what their mandate according to law was. The report mentions a Pfizer report from February 2021 that described how the company had onboarded 600 additional full time employees to handle the volume of AE reports and at the time planned to employ a total of 1,800 for this purpose, although the number now is unknown. Block cites:
Freedom of Information Act documents seen by The BMJ suggest that Pfizer has around 1000 more full time employees working on vaccine surveillance than the CDC, despite the latter’s responsibility for handling adverse event reports on all products. The CDC didn’t provide The BMJ with specific numbers, instead stating that its staffing “reflects the needs of the office” at any given time and can range from “several dozen to hundreds,” including contractors and individuals reassigned “from across the agency.” The latest confirmed number of staff, as of November 2022—at the Immunization Safety Office, which houses VAERS—is 70-80 full time equivalent workers.
The wag in me can’t help but point out that this observation suggests that, far from the antivax narrative that portrays big pharmaceutical as being relatively unconcerned about pharmacovigilance and AE monitoring, pharmaceutical companies, for all their flaws and greed, actually do care if their products are hurting people enough to devote considerable resources to the task of postmarketing surveillance for AEs due to their products. Let’s look into more of the specifics, though. On what evidence does Block base her claim that VAERS is “broken”?
A dozen anecdotes, or: Where’s the beef?
So how does Block come to the conclusion that VAERS is “broken”? The first piece of evidence that she cites comes from “more than a dozen” VAERS users who had difficulty filing reports. I kid you not. “More than a dozen.” Whenever I see someone cite more than a dozen, I suspect that what they really mean is thirteen, which is the lowest number that is “more than a dozen,” but, then, I’ve seen this sort of reporting before, where a small number of anecdotes are generalized to be representative of a much larger problem. In fairness, maybe these “more than a dozen” anecdotes are representative of larger problems, but if you’re going to make that argument you’d better have the goods to back it up. I also note that, of the “more than a dozen” anecdotes only a handful are discussed, starting with Dr. Sullivan’s anecdote above (which, tellingly, is never mentioned again after the introduction) and continuing to:
Those people include Patrick Whelan, a rheumatologist and researcher at the University of California Los Angeles, who in 2022 reported how one of his patients, a 7 year old boy, had a cardiac arrest after covid vaccination. The patient was intubated when Whelan filed a VAERS report, and he expected a prompt follow-up call from a CDC investigator.
“I assumed that, since it was a catastrophic event, the safety committee would want to hear about it right away,” he says. But, to his knowledge, nobody called or requested medical records. In an email sent to Whelan months later the FDA said that it had followed up “soon after” receiving his report and had made “several requests” for medical records. The agency added, “Generally speaking, staff might not reach out to providers unless they have specific questions about a case or a VAERS report.”
Wait a minute. So VAERS personnel did follow up and make requests for medical records “soon after” the report? The implication in Block’s reporting is that because Dr. Whelan didn’t receive the request that no request was made, but in reality it would be the hospital records that VAERS would most likely have requested. Moreover, Dr. Whelan’s name sounded familiar, and all I had to do to remember who he was was to search this very blog, where I found that he had been one of the co-authors on Joseph Fraiman’s p-hacking masterpiece of a crap study—which started making the antivax rounds first as a preprint—looking at COVID-19 “serious adverse events of special interest” (SAESIs). The study claimed to be a “reanalysis” of the Pfizer and Moderna phase 3 trials finding that there were far more SAESIs than reported. It didn’t.
It turns out that just searching my blogs for names mentioned here shows that many of the “experts” interviewed by Block have a definite point of view that is biased against COVID-19 vaccines. Indeed, as early as December 8, 2020 (the meeting after which the FDA issued the EUA for the Pfizer vaccine—Dr. Whelan expressed extreme concern about using the vaccine in children because of systemic inflammation and toxicity due to spike protein. This was before the vaccine was even being considered for use in children, and he has been quoted saying things like, “It is a lot easier to put shot in arms than test people, than await results and then give people a choice.”
Later in the story, this case is used to build the conspiracy theory that the CDC is “covering up” COVID-19 vaccine injury and deaths, although before we get to that, there is another familiar story:
James Gill has been a medical examiner and forensic pathologist for 25 years and is currently chief medical examiner for the state of Connecticut. In June 2021 he made the first VAERS report of his career. It was for a 15 year old boy who died suddenly days after getting a second jab—what Gill concluded on autopsy was “stress cardiomyopathy following second dose of the Pfizer-BioNTech covid-19 vaccine.”567
Gill, who has appointments at Yale University and the University of Connecticut, can’t recall getting any calls from VAERS after he filled out the online form, and he still has only a temporary “e-report” number. After he published the case reports in the Archives of Pathology & Laboratory Medicine in February 2022, however, the CDC did respond—in the form of a letter to the editor contesting Gill’s findings.567
I link to that letter regarding his report cited above and cite part of it, because the CDC did more than contest Dr. Gill’s findings. It brought home the evidence:
The conclusion of IDPB, based on the composite histologic, immunohistochemical, and molecular findings, was death attributable directly to C septicum sepsis. This conclusion is supported further by several salient and well-recognized clinicopathologic characteristics of this disease. Clostridium septicum sepsis is characteristically a fatal and fulminating infection that often presents with nonspecific signs and symptoms. The infection is lethal in approximately 60% to 70% of cases, and death typically occurs within 12 to 48 hours of symptom onset.7–9 In contrast to the report by Gill et al,1 information reported to the Vaccine Adverse Event Reporting System10 noted that the patient described “flu-like symptoms” for 2 days before death. Clostridium septicum produces multiple toxins that cause necrosis of striated muscle cells9,11 and inhibit influx of neutrophils to infected tissues; indeed, paucity of neutrophilic infiltrates in tissues infected with C septicum is considered a hallmark of this disease.9,12 Clostridium septicum is not considered normal flora of the human intestinal tract,13,14 but rather an opportunistic invader of immunologically compromised hosts, particularly persons with colonic adenocarcinoma, leukemia, diabetes, bowel ischemia, or cyclic, congenital, or acquired neutropenia.7,8 Spontaneous infections have been described for a few pediatric patients with no recognized risk factor and for whom microscopic breaches in the mucosa of the large intestine were considered the likely portal of entry.8,15 No representative samples of the small or large intestine were provided to the IDPB for evaluation; however, histologic evidence of bacterial invasion of the external surfaces of the adrenals, kidneys, liver, and spleen support an intraabdominal source of infection. The IDPB’s initial results were reported to the submitters on August 19, 2021, and an addendum report was issued on October 22, 2021. Of these findings, only the negative SARS-CoV-2 RT-PCR result is included in the paper.
The report by Gill et al1 unfortunately omitted many important findings provided by pathologic evaluations at the CDC that suggested an alternate cause of death for patient A and identified a specific infectious cause of death for patient B. These omissions could lead incorrectly to the assumption that COVID-19 vaccines were directly responsible for the deaths of these 2 patients. We believe that providing these important pathologic findings will allow readers a fuller perspective of the causes of death in these cases.
Again, this is more than just “contesting” Dr. Gill’s findings. It’s investigating the VAERS report in depth and the cause of death. It is the CDC doing its job. You can argue that it should have done this before Dr. Gill published his report. That could indeed be viewed as a failure. However, this investigation certainly does not support Block’s conclusion that the CDC fails to follow up. Moreover, the real burn comes where the CDC mentions that it had reported all this to Dr. Gill before he had published his report but that Dr. Gill had left out this critical information. No wonder Block just breezed over this as the CDC merely “contesting” Dr. Gill’s conclusions.
Then, of course, there’s the group of “physicians and advocates” that met with FDA officials in 2021 and 2022 about VAERS:
A group of physicians and advocates have met multiple times with FDA representatives from 2021 to 2022, including Peter Marks, director of the Center for Biologics Evaluation and Research, and Narayan Nair, the FDA division director who oversees VAERS, to express their concerns that the system isn’t operating as intended and that signals are being missed.
One participant in the group—Helen, an intensive care and emergency physician who asked to use a pseudonym to protect her employment—had filed reports on behalf of several patients, including six who died, among them a 40 year old man. She tells The BMJ that she received a request for medical records for just one of the deaths and for two of her patients admitted to hospital. “You’re not meeting your defined definition of follow-up,” she told Nair and Marks during an online meeting on 22 March last year. “There’s a breakdown in your system.”
The BMJ obtained audio of these meetings, totalling seven. In March 2022, in response to the physician, Nair responded that if a report meets the definition of serious, “there really should be a request for records.” In the case of a reported death, “we prioritise getting the records for those extremely quickly.” He added, “You know, we’ve received a large volume [of serious reports]. And I don’t know what the back-up is.”
I like how Block makes it sound as though getting the audio for these meetings was some sort of coup, as the audio files are all over antivax social media. For example, in September Dr. Drew Pinsky posted one of his shows to X that included the recordings, specifically citing one of the meetings as the March 2022 meeting:
The call – recorded by Dr. Joseph Fraiman in March 2022 – included FDA Director Dr. Peter Marks, Dr. Peter Doshi, Dr. Celia Witten, Dr. Sarah Walinsky, Dr. Lorrie McNeill & many others.
"This was a top level meeting," says Dr. Fraiman. It "terrified my entire work group."
— Dr. Drew (@drdrew) September 11, 2023
This call was recorded by Dr. @JosephFraiman in March 2022. He played part of the call on the 9/6/23 episode of @AskDrDrew w/ @DrKellyVictory & Dr. @JesslovesMJK. The audio has been enhanced for clarity but is unaltered.
Watch the full episode for more: https://t.co/ege2BHiRoj
— Dr. Drew (@drdrew) September 11, 2023
I note that this episode of Dr. Drew’s podcast features Jessica Rose, who is antivax to the core and known for dumpster diving into VAERS, and Dr. Kelly Victory, a COVID-19 crank since 2020 who tried to portray the virus as basically harmless (unless you’re old) but is now fully antivax. Listening to Dr. Fraiman defend his execrable study on SAESIs, I can only picture FDA officials facepalming and eyerolling at these claims, because, fortunately for them, this was a telephone call and not a Zoom meeting. It’s also a straw man to claim, as Dr. Fraiman does, that the FDA is not doing statistical testing on these adverse events. If you listen to the response, what the FDA said is that it doesn’t compare apples and oranges; i.e., rates of different AEs that are unlikely to be due to the same mechanism. In any event, there’s nothing special about this phone call. No doubt Dr. Whelan just gave Block the audio, and the FDA said at one of the meetings:
At the following meeting in May 2022 an FDA spokesperson, Lorrie McNeill, said that “for all of the reports categorised as serious, the VAERS contractor either obtained records, or made several attempts to do so and closed out a report if they didn’t get a response.”
The closest Block comes to citing actual evidence is to point to a “study” by React19, described as an “advocacy group advocacy group of some 30 000 people who have experienced prolonged illness after covid vaccination.” React19 claims that a large percentage of the 126 reports from its members either never got a permanent VAERS number (22%) or had “had disappeared from the system entirely—in other words, one in three of the reports they looked for didn’t show up in the publicly searchable database.” Of course, this likely suggests that the cases were investigated.
I take whatever React19 reports with a grain of salt, however. If you visit the React19 website, it becomes clear that this is an antivaccine advocacy group. It’s full of “testimonials” blaming vaccines for serious injury and a board with a notable paucity of actual scientists and practicing physicians, which makes me wonder who will peer review applications for their “research grants,” plus a “research database” that just lists URLs to every paper under the sun about COVID-19 adverse reactions, regardless of quality. Its website also features a lot of testimony from lawyers, patients, and people denying that they are antivax. React19 does, however, have its own physician provider network where it recruits doctors to treat “vaccine injury,” something that reminds me very much of the old Defeat Autism Now! (DAN!) antivax doctors back in the day, particularly given the number of acupuncturists, “integrative” and “functional” medicine” doctors, and the like. (Antivax quack Lee Vliet is one.) There’s also a sentence near the end of the list stating, “Many of our networked doctors do not wish to be listed. We can connect you!” (I wonder why they don’t wish to be listed.) Also, I just saw this week that one of the fathers of the children featured in an antivax propaganda movie Shot Dead wears a React19 hat the entire time he’s on camera.
Enter the conspiracy theory.
“Separate systems” or following HIPAA?
Up until this part, Block’s report is mainly anecdotes, quotes, and trying to link the anecdotes to a more general failure of VAERS, the CDC, and the FDA based on insinuation and rather thin gruel. It is when Block states that there are two systems, one public, and one private, and that the private system has all the “real dirt” that is being hidden from the public that we get to a new iteration of what I like to call the central conspiracy theory of the antivax movement: That “They” (the FDA, CDC, medical profession, pharma, etc.) “know” that vaccines are deadly but are covering it up.
Here’s what I mean. She comes back to Dr. Whelan and uses his claimed experience to spin a conspiracy narrative:
A week after Whelan filed the VAERS report for his young patient in Los Angeles, he had cause to update it. The boy’s condition didn’t improve, and the decision was made to terminate life support. But “there was no mechanism for [updating] it,” he tells The BMJ. “The only option I had was to make a new VAERS report.”
Three weeks later he met with the FDA in his capacity as a researcher to discuss a forthcoming paper, and without having planned to he mentioned the case and the lack of follow-up. Nair reached out by email the next day, and six weeks later Whelan discussed the case with Nair and a press officer for around 35 minutes.
Today, however, that VAERS report still shows the child as having been admitted to hospital. “I made the false assumption that that conversation would result in an adjustment in the publicly reported case,” says Whelan. “Think of all the people who are using VAERS data as a means to assess what’s happening with the vaccines—except in this case you’d be left with the false impression that the child had had a serious adverse event,” rather than seeing that he’d died.
The BMJ has found that the FDA and CDC essentially maintain two separate VAERS databases: a public facing database, containing only initial reports; and a private, back end system containing all updates and corrections—such as a formal diagnosis, recovery, or death.
Unfortunately, she is forced to cite an FDA spokesperson as to the reason for the two systems:
In December last year Nair explained the situation at a meeting with advocates. He said, “There’s two parts to VAERS, the front end system and the back end . . . Anything derived from medical records by law” can’t be posted on the public facing system. The CDC has told The BMJ that “protecting patient confidentiality is a priority.”
Damn that pesky HIPAA! It’s also not as though there isn’t a history of antivaxxers trying to use a vaccine safety database to suss out personally identifiable information. Mark and David Geier were busted for doing just that when merging datasets to do one of their antivax studies using the VSD and had their institutional review board (IRB) approval yanked as a result. I would also point out that this “backend VAERS” with investigated and adjudicated reports is what is used when the FDA and CDC present to the Advisory Committee on Immunization Practices (ACIP) periodically.
In fairness, Block notes that the FDA Adverse Event Reporting System (FAERS), which collects reports on drugs, does maintain a publicly accessible database that gets updated, as does the agency’s Medical Device Reporting system, which leads to the question of why VAERS can’t do the same. Perhaps VAERS should, but it would take funding and will to updated VAERS and scrub reports of any patient-identifiable information in order to produce a publicly accessible database with more than just the raw VAERS reports. In addition, in order to test these databases, I did a few searches for various drugs and devices, and I was unsure whether to be relieved or disappointed in the small number of reports. In other words, I’m not sure whether FAERS is so much superior.
That being said, let’s review the structure of this report. First, it lists a handful of anecdotes about people and healthcare professionals who had difficulty entering reports into VAERS, getting followup from VAERS, and/or seeing whether VAERS ever followed up with medical record requests, which could suggest legitimate shortcomings in the system as the grain of truth that all good conspiracy theories need at their core, asking one legitimate question: Why isn’t VAERS maintained and updated better for the public? If that’s all it had done, I would likely have had no problem with it. Vaccine advocates have long complained about VAERS, in particular how easily it is gamed and whether reports are adequately vetted. Everyone remembers the classic example from two decades ago when a vaccine advocate entered a fake report saying that the influenza vaccine had turned him into a creature resembling The Incredible Hulk, a report that was accepted. (In fairness again, VAERS personnel did eventually contact the advocate to inquire about it.)
But Block didn’t confine herself to that, because the narrative is that the shortcomings in VAERS exist in order to downplay or cover up vaccine injuries. So she intersperses these anecdotes with quotes from sources who are at least suspicious of COVID-19 vaccines or have co-authored bad studies that seek to make the vaccines look dangerous, at every step portraying the FDA and CDC as stonewalling her for answers, while cleverly adding a throwaway observation that “if a reporter successfully treated a diagnosis and the patient improved, or if they confirmed that the cause of the illness was unrelated to a vaccine, this wouldn’t be reflected in the public database.” Of course, the publicly facing database doesn’t include the adjudication of each case as being caused by or not caused by a vaccine, just the report that was made, which is why antivaxxers have loved dumpster-diving into VAERS for decades.
Block’s narrative isn’t even fully cohesive, either. There are internal contradictions, given how at one point she notes that “it took just six VAERS reports of thrombosis with thrombocytopenia syndrome after administration of the Janssen covid vaccine for regulators to issue a ‘pause’ in April 2021,” which to me sounds as though the FDA was doing its job. I would also argue that the FDA detected the increased risk of myocarditis in young males in a pretty timely fashion as well. None of that stops her from going into “just asking questions” (JAQing off) mode:
Ralph Edwards, former director of the Uppsala Monitoring Centre and until recently editor in chief of the International Journal of Risk & Safety in Medicine, explains that monitoring systems such as VAERS excel at detecting adverse reactions that occur very soon after vaccination or are known from other vaccines, such as anaphylaxis or Guillain-Barré syndrome. But detecting new and unusual reactions, especially those with latent effects, has been an ongoing challenge in the world of pharmacovigilance.
Edwards tells The BMJ, “If something hasn’t been heard of before, it tends to be ignored.” He explains that regulators may be relying too heavily on epidemiological evidence to acknowledge a signal. VAERS alone is unlikely to capture such long term adverse outcomes unless reports are regularly updated and reviewers are closely following such cases—“a real catch 22,” he says. “You’ll never get the evidence unless you have the idea to look for it in the first place.”
While Edwards is not to my knowledge an antivaxxer, the reason he is being quoted here is because what he is saying, although not unreasonable in and of itself, in the context of the story supports a favorite narrative of antivaxxers, namely that vaccines cause horrific effects that are not seen immediately. In other words, it supports the antivax narrative about virtually every vaccine that it hasn’t been studied long enough to rule out horrible “long term” effects. Never mind that there are no known AEs from vaccines that take longer than six months to manifest themselves and that all known AEs from vaccines (even “delayed” reactions) occur relatively soon after vaccination (as in hours to days to weeks), not many months to years.
Block also cites Svetlana Blitshtey, a neurologist and researcher at the University at Buffalo who believes that vaccines postural orthostatic tachycardia syndrome (POTS). I note that she has served as expert witness in at least one case before the Vaccine Court trying for a case of POTS after HPV vaccination. (POTS is a “vaccine injury” that is most often attributed to HPV vaccines.) I’ve touched on POTS before, noting that large studies have not found good evidence of a link to HPV vaccination, including in VAERS. (Dr. Vincent Iannelli has a more detailed discussion of the evidence showing that vaccines are unlikely to cause POTS, while I note that antivax “researcher” Yehuda Shoenfeld basically made POTS up as a new syndrome out of whole cloth.) In other words, Block’s choice of experts is quite strategic, designed either to portray VAERS staff as unresponsive, VAERS as secretive, or to JAQ off about “long term side effects” that VAERS won’t catch because of the problems a small number of reporting patients and doctors have experienced, adding:
Helen is calling for an end to the “negative feedback loop . . . the FDA is not naming additional adverse reactions to the vaccines because the passive surveillance systems aren’t displaying it. But the passive surveillance systems aren’t displaying it because physicians are blinded to the adverse reactions in their patients, and thus aren’t reporting them.”
I’m really wondering which emergency medicine and critical care physician “Helen” is. I doubt that it’s Kelly Victory, given that Dr. Victory has a lucrative social media grift going with Dr. Drew pushing her antivax message. (It wouldn’t surprise me if it’s a member of the Frontline COVID-19 Critical Care Alliance or some such group.)
Overall, the entire narrative of this story is one of conspiracy theory, in which the FDA and CDC are gaming VAERS to cover up the death and destruction wrought by COVID-19 vaccines and brave heroic truth tellers like these “over a dozen” doctors with anecdotes, an antivaccine advocacy group and antivax investigators, along with some investigators JAQing off are fighting to uncover The Real Story.
The BMJ sinks lower and lower
When I first wrote about how low The BMJ has been descending, it was in the context of its story about the Pfizer vaccine clinical trial written by Paul Thacker. Besides being known for promulgating anti-GMO conspiracy theories, Thacker is a “journalist” who is known for using abusive Freedom of Information Act (FOIA) requests in order to harass scientists, in particular Kevin Folta. A while back, 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. Before that and continuing to this day, for some inexplicable reason The BMJ has kept Peter Doshi on as a senior editor, despite his long history of playing footsie with the antivax movement. Doshi, of course, has 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. During the pandemic, he has published in The BMJ articles that falsely claim that the actual efficacy of COVID-19 vaccines in the randomized clinical trials was 19%, rather than over 90%, a claim that antivaxxers ran with to produce misleading claim that the vaccine was only 19% effective, misinformation that I discussed elsewhere, as did others, such as Skeptical Raptor and John Skylar.
But what about Jennifer Block? The name sounded familiar, which led me to do a few searches, where I found that, just as COVID-19 was starting to make the news in early 2020, she had co-authored a screed defending Goop’s Gwyneth Paltrow and her promotion of quackery in the name of “wellness,” characterizing such attacks as due to “patriarchy” and “misogyny.” A bit earlier, she had published the same message in Scientific American, just without Goop:
Embarassing. "But in every edition [the book @DrJenGunter criticizes] cautiously reported some version of 'some of us have had success.' There’s nothing scandalous or unscientific or pseudoscientific about that statement."
THAT IS THE VERY DEFINITION. @tylerblack32 I can't even.
— Ryan Black ⚖🎮🏀🍁 (checkmark) (@RyanJBlack) November 28, 2019
That’s not a great look. A quick search of her X/Twitter feed for the word “vaccine” reveals that she promotes a lot of antivaccine narratives, including false claims that COVID-19 vaccines don’t prevent transmission at all, that “natural immunity” is superior, and that we should embrace “urgency of normal.” Meanwhile, her Twitter feed is a cesspit of transphobia about “gender affirming care.” (Just peruse it for yourself if you don’t believe me.) As for the resemblance of her report to Paul Thacker’s “investigation,” I discovered that she had been Opinions Editor at Grist when Paul Thacker published an article there, but there’s no way to know if they worked together.
What I do know is that The BMJ has become a source of what is known as malinformation. Malinformation differs from misinformation and disinformation in that it is “nominally true information, misleadingly presented or curated with the intention to deceive or mislead.” In my opinion, Thacker’s report from 2021 qualifies in that it found some problems at one site for the Pfizer clinical trial but then exaggerated them and tried to generalize them to the whole trial, all to cast doubt on the safety of the COVID-19 vaccine. Block’s report does the same thing, finding problems with VAERS and implying—never outright arguing directly—without proving that these problems mean that VAERS is completely unreliable and that COVID-19 vaccine safety is in doubt. (And don’t even get me started on how many times Peter Doshi has published dubious antivax-adjacent “analyses” and “investigations.”)
There was a time when The BMJ was not just a great biomedical journal but also did some really good investigative journalism related to science and health, as it did back when Brian Deer blew the lid off of Andrew Wakefield’s MMR fraud in its pages. These days, it’s difficult to trust anything that The BMJ publishes, particularly when it employs muckraking conspiracy mongering hacks like Paul Thacker and Jennifer Block and then champions their work as anything more than muckraking conspiracy mongering malinformation. In fact, I’m now starting to doubt the quality of the scientific studies that it publishes, given how low the quality control bar has fallen for “investigative journalism” and analysis, particularly with respect to COVID-19 and vaccines.