Antivaccine nonsense Medicine Quackery

Peter Götzsche is now officially antivaccine

Peter Gøtzsche, formerly leader of the Nordic Cochrane Center, has teamed with Maryanne Demasi to write a systematic review of the “harms” of COVID-19 vaccination. Besides accepting the highly dubious methodology behind one study, their preprint is yet another example of how EBM can be corrupted to promote antivax ideas.

When last I wrote about Peter Gøtzsche, he was complaining bitterly that antivaxxers were quoting him in support of their attacks on COVID-19 vaccines. A couple of years before that (and a year before the pandemic hit), I had also written about how Gøtzsche had agreed to speak about vaccine mandates as unethical alongside antivaccine “luminaries” like Robert F. Kennedy, Jr., Toni Bark, and Mary Holland at a conference organized by Physicians for Informed Consent, a prominent antivaccine physicians group. It didn’t take long before Gøtzsche was sufficiently embarrassed by the criticism directed his way to back out, claiming that he had been unaware that PIC was rabidly antivaccine. In the wake of the incident, he also later also complained bitterly that he wasn’t antivaccine—because of course he did!—and that he had hoped to persuade some of the attendees of the safety of the MMR vaccine. Portraying himself as misunderstood and unfairly attacked, Prof. Gøtzsche actually claimed that he had wanted to educate and persuade the attendees of the conference, leading me to wonder why he had so little self-awareness that it apparently had never occurred to him (and still doesn’t occur to him) why antivaxxers like him so much.

I concluded at the time that he was either hopelessly ignorant and naïve or disingenuous, because his opposition to vaccine mandates not only aligned very closely with standard antivax opposition to vaccine mandates but used the same sort of language. The charitable interpretation at the time was that Prof. Gøtzsche didn’t understand that groups like PIC don’t mean the same thing that physicians and bioethicists do when they use the term “informed consent” in the context of vaccines (or any other medical intervention, for that matter). Let’s just say that there’s a reason why I call what they promote what I used to call “misinformed consent” but now refer to, more appropriately, as “misinformed refusal.”

I bring this part of Prof. Gøtzsche’s history up because a little over a week ago I noticed an article on the Brownstone Institute website by Maryanne Demasi touting a systematic review article by him entitled Serious Harms of the Covid-19 Vaccine: A Systematic Review. Apparently this is the second version of this systematic review posted to the MedRxiv preprint server, the first version having been posted in December and apparently unnoticed by me. I also mention that Maryanne Demasi is not a physician, although she apparently does have a PhD in rheumatology and did work for a decade at the Royal Adelaide Hospital in Australia as a research scientist. After that, she was a TV presenter for a number of years, during which she became known as a statin denier, who falsely claimed that cholesterol and saturated fats do not contribute to heart disease and that therefore statins are ineffective in lowering the risk of cardiovascular disease—and dangerous, to boot. More recently Demasi has aligned herself firmly with the antivaccine movement. She now contributes regularly to the Brownstone Institute and is frequently cited by Robert F. Kennedy, Jr.’s minions at Children’s Health Defense. Her Substack is full of antivax content, including the usual antivax tropes about COVID-19 and masks, and she is a big fan of Dr. Asseem Malhotra.

Seeing this new systematic review as a preprint and noting that Prof. Gøtzsche had teamed up with an antivaccine and anti-statin activist, whose most recent shtick has been to claim that the original clinical trials of the Pfizer and Moderna mRNA-based COVID-19 vaccines did not account for serious harms, to write it, I had to wonder yet again: What is it about being a guru of evidence-based medicine (EBM) that predisposes to contrarian takes? Part of the reason I wondered this again is because, unlike some of the other EBM “gurus” (e.g., Drs. John Ioannidis and Vinay Prasad) who took a heel turn into COVID-19 contrarianism and antivax-adjacent positions, Prof. Gøtzsche has been on this path for a long time, dating back to years before the pandemic. If there were any EBM guru who could have been most easily predicted at the outset of the pandemic to go COVID-19 contrarian, it has to be Peter Gøtzsche, and his teaming up with Maryanne Demasi is just the latest indicator of that.

First, though, let’s take a look at the review itself, which is, again, only a preprint and remains as yet unpublished in a peer-reviewed journal.

The return of the revenge of “SAEs of special interest”

Reading the review article, I was immediately struck by this statement in the abstract:

We included 18 systematic reviews, 14 randomised trials, and 34 other studies with a control group. Most studies were of poor quality. A systematic review of regulatory data on the two pivotal trials of the mRNA vaccines found significantly more SAEs of special interest with the vaccines compared to placebo, and the excess risk was considerably larger than the benefit, the risk of hospitalisation.

Does that last part sound familiar? It should. It’s the claimed finding that was making the rounds on antivax social media last fall about “serious adverse events of special interest” from a “reanalysis” of the Pfizer and Moderna clinical trial data by Joseph Fraiman and Peter Doshi—yes, that Peter Doshi, the same one who originated what I like to call an antivax “slasher stat” claiming that the vaccines weren’t really 95% effective but only 19% effective—plus other coauthors submitted to the FDA to gain emergency use approval (EUA) for their mRNA-based vaccines. What were these “SAEs of special interest”? I’ll refer you to my original long discussion of what was wrong with the paper and how Fraiman, Doshi, et al had used “SAEs of special interest” to compare apples to oranges and falsely conclude that the risk of hospitalization from the vaccine was higher than it was from COVID-19. I’ll also refer you to Dr. Susan Oliver’s discussion of the study and its data dredging when it was still a preprint last summer:

And David Grimes’ Twitter thread:

Again, you can explore the previous links if you want the details, but the TL;DR version is simple. The study was deeply misleading based on its data dredging combined with misleading comparisons that included counting multiple adverse events in the same patient multiple times, further combined with a low enough risk of COVID-19 in the two populations at the time of the randomized controlled trials to allow for a low rate of hospitalization when normalized to the entire population in the control group. At the time, I also characterized it as nothing less than antivax misinformation disguised as a “reanalysis” of the original Pfizer and Moderna trials that didn’t even show what it claimed to have shown, namely that the trials were somehow designed and written in such a way as to hide lots of adverse events.

Now let’s see how Gøtzsche and Demasi incorporate this trial, which is obviously what they were talking about in the abstract, into their systematic review:

The most methodologically rigorous, reliable, and relevant research paper we retrieved was a systematic review conducted by researchers from USA, Spain, and Australia of regulatory data on the two pivotal randomised trials of the mRNA vaccines, one from Pfizer and one from Moderna.17 The review analysed SAEs in general and SAEs of special interest (AESI) according to two lists for the Brighton Collaboration criteria adopted by the WHO. The trials were expected to follow participants for two years. However, within weeks of the FDA emergency use authorisation, the sponsors began to unblind the participants and offered the vaccine to those in the placebo group.17 Therefore, the authors used the interim datasets that were the basis for the emergency authorisation, covering about four months after the trials commenced. The authors included SAEs results tables from the websites of the FDA and Health Canada. Based on blinded tables, two clinicians judged independently whether an SAE was also an AESI. To account for multiple SAEs occurring in the same patient, a standard adjustment was used to widen the confidence intervals.

The “most methodologically rigorous, reliable, and relevant research paper”? You keep using that long term. I do not think it means what you think it means.

Casedemic and The Princess Bride
“The “most methodologically rigorous, reliable, and relevant research paper”? Lots of words to apply this meme to!

In the discussion, Gøtzsche and Demasi even doubled down on this characterization of the Fraiman/Doshi reanalysis:

By far the most reliable study we identified was the systematic review that used regulatory data from the two pivotal randomised trials of the mRNA vaccines and restricted the observation period to reduce the contamination caused by offering the vaccine to patients in the placebo group.17 The researchers put their findings into perspective by comparing them with hospitalisations. The excess risk of SAEs of special interest was considerably larger than the reduced risk of hospitalisation, 10.1 vs 2.3 per 10,000 vaccinated people for Pfizer’s vaccine, and 15.1 vs 6.4 for Moderna’s vaccine. Even after the researchers adjusted for multiple events in the same patient in a sensitivity analysis, the risk was larger.

Yes, once again, I emphasize that Gøtzsche and Demasi are referring to the awful Fraiman/Doshi antivax propaganda paper full of misleading comparisons and data dredging that was so bad that it should never have been published but somehow managed to fool the editors and peer reviewers of Vaccine and representing it as the best evidence available. While it doesn’t surprise me in the least that Demasi would mischaracterize this study as the best evidence available, Gøtzsche should know better but apparently no longer does. In fact, I would argue that the very fact that they characterized this study as so high quality and emphasized it so much in their review is almost enough reason to reject their entire systematic review as hopelessly biased, but there are other indicators of how biased and misleading their review is as well.

From obvious antivax propaganda to more subtle antivax propaganda

Another indicator that this systematic review is antivax propaganda besides its emphasis of a misleading review article as, apparently, the best current synthesis of evidence available, is to compare the first version of the review to the second version and look for changes. The reason is that the second version is likely what Demasi and Gøtzsche came up with in response to peer review of the first version. An example comes up right in the abstract. Compare the conclusion in the abstract version 1 to the conclusion in version 2.

Here’s the conclusion from the abstract of version 1:

Serious and severe harms of the COVID-19 vaccines have been ignored or downplayed, and sometimes been deliberately excluded by the study sponsors in high impact medical journals. This area needs further study. Authorities have recommended virtually everyone get vaccinated and receive booster doses. They fail to consider that the balance between benefits and harms becomes negative in low-risk groups such as children and people who have already acquired natural immunity.

However, this is the conclusion from the abstract of version 2:

Further randomised trials are needed. Authorities have recommended populationwide COVID-19 vaccination and booster doses. They do not consider that the balance between benefits and harms becomes negative in low-risk groups such as children and people who have already recovered from COVID-19 infection.

That conclusion in the abstract of version 1 is a pretty inflammatory conclusion, wouldn’t you say? (I wonder why it was changed for version 2.) In the first version, Gøtzsche and Demasi are basically stating as a conclusion that “they”—the pharmaceutical companies, regulatory agencies, etc., I guess—have been “ignoring,” “downplaying,” and even outright hiding “serious and severe harms” due to COVID-19 vaccines. It’s basically a conspiracy theory that is unproven. Why do I say that? For one thing, they reference a blog post by Maryanne Demasi to argue that adverse events in COVID-19 vaccine trials were “underreported” based on a 2016 review suggesting that adverse events were underreported in RCTs, without actually showing that the COVID-19 RCTs used to gain regulatory approval actually did underreport adverse events. In her blog post, she also relied on anecdotes and the usual antivax misinterpretation of reports to the Vaccine Adverse Events Reporting System (VAERS) database, where she also noted:

SAEs have been systematically eliminated from the pivotal trials.8 In the Pfizer and AstraZeneca vaccine trials, participants were given digital apps to record adverse events remotely, but the apps only allowed the participants to record what the company deemed as “expected” events. If they developed thrombosis, myocarditis, Guillain-Barré Syndrome, transverse myelitis, or other serious neurological events, there was no option for them to record it on the app. Brianne Dressen, a participant in an AstraZeneca trial, became disabled after her first injection.8 She is still disabled today, but there is no mention of this in the trial report in New England Journal of Medicine.36 As Dressen was concerned about the lack of reporting of her serious adverse event (and others) in the trial’s publication, she wrote to Dr Eric Rubin, editor in chief of the journal, and asked for the inaccuracies to be corrected and demanded complete reporting of the results. Rubin refused to correct the inaccurate data in his journal. The full email exchange has been made public.8

Of course, at the time of the original RCTs, it had not yet emerged that myocarditis might be a risk from COVID-19 vaccines, making it therefore unsurprising that those events would not be included on the app, and, of course, the app was not the only method used to catalog adverse events. Another interesting thing that became apparent to me is that Ms. Dressen is reported to have been hospitalized, but in neither Demasi’s blog post nor the email exchange referenced in her post could I find what her disabling SAE claimed to have been due to the AstraZeneca vaccine actually was, beyond a “cascade of neurological symptoms” only vaguely described the videos referenced.

While I have little doubt that Ms. Dressen suffered, there is really no good evidence other than her belief that something nefarious happened or that she had been incorrectly excluded from from the reported results ultimately published or that AstraZeneca and the New England Journal of Medicine had somehow conspired to cover up SAEs from the vaccine. Even if you take her personal story at face value, it is one case and Demasi and Gøtzsche do not present any good evidence to suggest that her story is generalizable or common. Moreover, the passage from version 1 cited above about Brianne Dressen remains in version 2 word-for-word.

So, too, does this anecdote remain the same between versions:

When Pfizer had recruited 12-15 year olds for its mRNA vaccine trial, the published data in New England Journal of Medicine stated that there were “no serious vaccine-related adverse events.”46 One of the participants, however, was 13 year old Maddie De Garay who suffered a serious adverse reaction following her second injection, which left her in a wheelchair and fed by a nasogastric tube.10 She was referred to hospital for a full assessment and a doctor diagnosed her with a “functional disorder.” This doctor decided she had a pre-disposition to hysteria, and she was referred to a mental health facility. Professor and psychiatrist David Healy subsequently conducted a thorough review of her medical records, including an interview with her family, and found no such history of pre-existing conditions or mental illness.

Notice any commonalities, besides the narrative that the pharmaceutical companies somehow covered up SAEs? Both stories are anecdotes told from only one side. In the case of Maddie De Garay, the family has never presented any evidence that Maddie was diagnosed as harmed by a Covid-19 vaccine, and her story has been widely used in advertising by an antivaccine group run by Steve Kirsch. As is often the case, reading what advocates write about Maddie’s case does not allow even a good guess as to whether a claim of causation from the vaccine is plausible, and the information available is consistent with a diagnosis of functional disorder, not vaccine injury. In Dressen’s case, the story is not nearly as clearcut as it is being portrayed, although there are some scientists who speculate that her symptoms could be a rare case of long COVID being caused by vaccines rather than COVID-19. Both stories are being promoted by David Healy, a psychiatrist who, even a brief perusal of his blog and publication list reveals, is at least as anti-pharma as Peter Gøtzsche is, and, remember, Gøtzsche likes to compare pharmaceutical companies unfavorably to the mafia. Is this a reason to doubt his accounts regarding De Garay and Dressen? No, but it is a good reason to have a healthy dose of skepticism, particularly given the comparison he makes in this blog post:

So relentless was the focus on Scientologists that it became close to impossible for anyone to liaise with anyone who had any Scientology connections or even to think Prozac might cause problems without being branded as a Scientologist. Anti-Vaxxers are the new Scientologists, liaison with whom will cause an instant loss of credibility. Locating all our problems in 1990 in a fringe cult, leaving the rest of society to proceed with business as normal, did not seem such a hazardous thing to do. Now however we are extraordinarily polarized. The seeds of this polarization can be seen in the Prozac story. The most extreme polarization now centres on health issues, with people dividing into bioliberals and bioconservatives. The middle ground has vanished. It is not possible to establish a middle ground even for those who are pro-vaccine but who have been injured by the vaccine.

How many times have we heard antivaxxers say things like this? Also, it’s not a good look for someone who claims to be pro-vaccine to be making such comparisons.

As for the rest, the key “findings” of this review include:

  • “Many of the studies we reviewed were of very poor quality and published in journals that failed to identify fundamental errors.” [Like Vaccine, which failed to identify the fundamental errors in the Fraiman/Doshi review? Sorry, couldn’t resist.]
  • “To date, the most methodologically rigorous systematic review of SAEs was conducted by Fraiman et al, which re-analysed trial data from two pivotal randomised trials of the mRNA vaccines (Pfizer & Moderna), including SAEs from the websites of the FDA and Health Canada. The risk of an SAE following vaccination exceeded the risk of hospitalisation from covid-19.”” [See the discussion above.]
  • “The adenovirus vector vaccines increased the risk of venous thrombosis and thrombocytopenia. (Authorities have responded by suspending the use of AstraZeneca’s vaccine across many European countries, and in the US, regulators have advised restricted use of Janssen’s vaccine).” [This is one of the few accurate findings, and we were writing about how the adenovirus-based vaccines appear to predispose to a rare clotting disorder—in 2021.]
  • “The mRNA-based vaccines increased the risk of myocarditis, with a mortality of about 1-2 per 200 cases. It was more common in younger males. [This leaves out the important context that myocarditis is uncommon from the mRNA vaccines, with an incidence of 0.0035%, and that the risk of death from COVID-19 induced myocarditis, which is much more common after the disease than the vaccine, is much higher.]
  • “We found evidence of serious neurological harms, including Bell’s palsy, Guillain-Barré syndrome, myasthenic disorder and stroke, which are likely due to an autoimmune reaction from mRNA and adenoviral vector vaccines.”” [I was personally puzzled by this one, because many of the studies cited in the review found no association with COVID-19 vaccines or even lower risk of neurologic sequelae after vaccination. Just read the relevant section if you don’t believe me.]
  • Drug regulators and other authorities have been very slow in following up signals of serious harms. [No, the COVID-19 vaccines have been arguably the most intensively monitored and studied vaccines in history.]
  • Severe harms, i.e. those that prevent daily activities, were underreported in the randomised trials. [This was not proven anywhere in the review other than anecdotally.]
  • Severe harms were very common in studies of fully vaccinated people receiving boosters (3rd dose), and in a study of vaccination of previously infected people (i.e. those with naturally acquired immunity).

That last one is worth discussing as well. The authors rely on one study to conclude that fully vaccinated people suffered severe harms after COVID-19 vaccination:

In an Israeli study, Pfizer’s vaccine was given to 78 people with a previous COVID-19 infection and to 177 matched controls.74 Some numbers and percentages are erroneous. Emergency department visit or hospitalisation was required for 5 (6%) vs 1 patients (0.6%). Even though the authors showed in a table that this difference was statistically significant (P = 0.01), they concluded that the vaccine was safe in people with previous infection. This is not correct. Hospitalisation is a serious harm, and harms occurred ten times as often if the patients had been infected earlier, suggesting that those with acquired immunity are at higher risk of experiencing SAEs post vaccination.

A much more recent review found much lower numbers:

Within 1 week of receipt of the first vaccine dose, a higher percentage of previously infected individual experienced AEs capable of interfering with daily activities compared with those with no history of COVID-19 infection (range, 12%-16% vs 3%-12%, respectively). The percentage of individuals who experienced severe AEs requiring emergency department admission or hospitalization following vaccination also was increased among those who were vs were not previously infected with COVID-19 (range, 0.6%-0.7% vs 0.2%-0.5%).

May I suggest that Demasi and Gøtzsche update these figures to include this March 2023 review in the third version of their preprint?

Similarly, the claim that boosters (third dose) are so much more likely to cause SAEs is not well supported by the literature cited, and the authors dismiss studies that contradict their predetermined finding thusly:

In a US study of Pfizer’s vaccine, conducted by Pfizer, patients were randomised to receive a third dose or placebo.43 After a third dose, 16 of 5,055 patients had an SAE on the vaccine and 24 of 5,020 on placebo. The study was published in New England Journal of Medicine, and 24 of the 32 authors were from Pfizer or hired by Pfizer.

In other words, don’t believe a safety study because it was done by the pharmaceutical company. While I very much view studies done by pharmaceutical companies with more skepticism than those done by others investigators, I don’t use the fact that they were done by pharmaceutical companies as a reason to dismiss them out of hand, which is what is clearly implied here by Demasi and Gøtzsche. Similarly, when Demasi and Gøtzsche claim that “systematic reviews of randomised trials should be the most reliable source of evidence, but serious harms are vastly underreported, if reported at all, in published drug trials,” leading them to assert that, “underreporting seems to be particularly pronounced in vaccine trials.10,11,84 For the COVID-19 vaccines,” the only evidence that they reference are Gøtzsche’s books Deadly medicines and organised crime: How big pharma has corrupted health care and Vaccines: truth, lies, and controversy (and not even a specific chapter in either book!), Demasi’s blog post, and an article by Gøtzsche for his Institute for Scientific Freedom entitled The Chinese virus: Killed millions and scientific freedom. None of these are peer-reviewed scientific publications. Also, while it is true that the pharmaceutical industry has engaged in some unethical practices and covered up adverse event data, it is not enough to point to that history and say that it did happen with COVID-19 vaccines. You need to actually show that it did, something not done in this review.

Peter Gøtzsche: Medical maverick gone antivaccine (at least anti-COVID vaccine)

At this point, I’m not surprised that Prof. Gøtzsche would have teamed up with an antivaccine “journalist” with a history of statin denial to publish a “review” article claiming that SAEs from COVID-19 vaccines have been systematically “covered up” by, apparently, a cabal consisting of pharmaceutical companies manufacturing the vaccines and regulatory agencies tasked with approving the vaccines. As I noted in 2019, he was already well down that path, his opposition to vaccine mandates being, as it is for so many physicians and scientists who go antivax (heck, for anyone previously not antivax who goes antivax), a major factor that leads to susceptibility to believing and then spreading antivaccine misinformation. As I like to say, “Come for the parental rights and freedom from mandates, stay for the antivax conspiracy theories.” It’s an old story that long predates COVID-19.

Moreover, Prof. Gøtzsche had been continuing down that pathway before the pandemic. It wasn’t just his agreeing to speak at a conference organized by antivaxxers and then being shamed into backing out, as he did in early 2019. Before that, he had been fired as director of Nordic Cochrane Center after having published an unjustified and badly reasoned attack on the Cochrane Collaboration’s meta-analysis of the safety and efficacy of the human papilloma virus (HPV) vaccines, an attack that has been referred to (correctly, in my opinion) as a “hatchet job” that basically included a favorite anti-HPV trope about the use of saline placebo controls instead of adjuvant-containing placebo and another common antivaccine trope about the use of “surrogates” for cervical cancer, called cervical intraepithelial neoplasms (CIN).

It was also around the time that Prof. Gøtzsche was embarrassing himself by accepting and then backing out of an invitation to speak at an antivaccine conference alongside RFK Jr. that he formed his Institute for Scientific Freedom, where you can find interspersed with reasonable criticisms of the science used to develop and approve pharmaceuticals, a lot of antipsychiatry rhetoric and, yes, the promotion of COVID-19 minimization and “lab leak” conspiracy theories, and antivax misinformation like the review that he wrote with Demasi. There’s even an article entitled Should I get chemotherapy for cancer? Probably not, in which he concludes that, “from testicular cancer and lymphomas, I cannot imagine any cancer that would make me accept chemotherapy should I get cancer.” I’d suggest that if Prof. Gøtzsche ever gets colon cancer that is node-positive and successfully resected, he should take chemotherapy. Ditto for rectal cancer. Indeed, the last article is so appallingly awful that I’m keeping it in my back pocket as a topic if I ever need one, as it ignores the difference between primary and adjuvant chemotherapy, as well as a number of cancers for which chemotherapy has definitively been demonstrated to have survival benefits, such as in breast and colorectal cancer.

Earlier this year, I asked why the EBM paradigm seems to predispose to COVID-19 contrarianism. At the time, I speculated that, at least in part, it likely has something to do with how EBM values randomized controlled clinical trials above all other forms of evidence, even when RCTs are not the most appropriate methodology to examine a scientific question. In conclusion, revisiting the case of Peter Gøtzsche, I have to wonder if there is another reason that is indirectly related to the EBM paradigm, specifically experience with how much chicanery goes on in pharmaceutical company sponsored RCTs leading some EBM gurus, like Peter Gøtzsche, to go beyond a healthy skepticism of pharmaceutical companies and their RCTs into complete nihilism and cynicism that lead them to reject almost out of hand any pharmaceutical company-funded study. After all, if you genuinely think that pharmaceutical companies are worse than the mafia, as Prof. Gøtzsche has repeatedly stated and compare them to the mob, as he did in the title of one of his books, then how can you ever believe anything reported by pharmaceutical companies? This is the vibe that I get from Prof. Gøtzsche, along with an attitude that I frequently find in Cochrane and EBM gurus who don’t actually do clinical trials themselves, namely a lack of understanding of how RCTs have to be balanced with what is practical and ethical, how there must be clinical equipoise before an RCT can be considered ethical, and how, if an RCT is not practical or ethical, you simply have to accept other forms of evidence. Unfortunately, EBM considers anything below RCT evidence to be “weak.”

On the other hand, what does it mean if you say something like this:

Rather than relying solely on randomized controlled trials, he says, “observational studies and case reports can be very important for finding harms.”

In other words: RCTs above all for efficacy, but case reports and observational studies, the “lesser forms” of evidence are fine for finding “vaccine injury.” And antivaxxers pick up on this double standard, as they did at the first meeting of the Institute for Scientific Freedom four years ago:

The fact that Gøtzsche had inadvertently organized a kind of impromptu anti-vaccination convention became clear during the first Q&A, after the fourth or fifth successive question about vaccines. One questioner asked Peter Aaby — who conducts vaccine research in Africa — why, given the apparent abundance of studies showing that measles is actually good for you, we don’t try and study what happens when you give certain African children large doses of Vitamin C instead of “injecting them full of toxins” (i.e., giving them the measles vaccine). “Could I perhaps ask also for questions about … not vaccines?” Gøtzsche asked eventually. The next questioner promptly took the mic and said they had a question about vaccines. “Please, please, please talk about something else now!” said Gøtzsche. “I just want to say that the BCG part of tuberculosis, which is in the BCG vaccine, was never on the schedule in the U.S., and tuberculosis was the number two killer in — ” “But please, excuse me, this is still — ” The woman talked over him, so Gøtzsche raised his voice to match: “I ask you very kindly to not ask a question about vaccines at this point in time.”

I still chuckle when I read that account.

I like to contrast the sort of attitude shown by Prof. Gøtzsche to that of someone like, for instance, Ben Goldacre, who is very skeptical and suspicious of pharmaceutical companies but does not devolve into nihilism and such cynicism that he rejects everything they do. One can argue where the line should fall that divides healthy skepticism from cynicism and nihilism with respect to pharmaceutical companies and RCTs, but, wherever that line is drawn, I am now certain that Prof. Gøtzsche is now very much on the wrong side of it. After all, if you’re willing to team up with an antivaxxer like Maryanne Demasi, who brags that her blog post questioning if SAEs were being “downplayed or excluded” was the “impetus” for the review article you do with her, you have abandoned any right to complain when I—or others—start to wonder if you are antivaccine.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

41 replies on “Peter Götzsche is now officially antivaccine”

Gøtzsche should know better but apparently no longer does.

It sounds like that should end with no longer cares.

I agree with your comments about the reasons for the change in language from the first abstract to the second: it’s one thing to point out perceived issues with someone else’s work, quite another to make a blatant accusation of deliberate fraud. They clearly realize [or were advised on this] that a seemingly subtle change in wording will completely alter the tone: they’ve shifted themselves from being perceived as making an empty accusation to being more insightful than the study’s authors.

But this

Rather than relying solely on randomized controlled trials, he says, “observational studies and case reports can be very important for finding harms.”

is astounding. Just what we need: basing conclusions about harm on stories that come from people playing “telephone” with an anecdote about a niece’s bestie’s brother’s girlfriend.

I cannot help but notice two things:

1) Honest scientists and authors with long impeccable careers and well developed critical thinking are becoming anti-Covid-vax

2) Orac is also a highly intelligent and published author and a well-informed scientist with highly developed critical thinking, who does strike me as opinionated, combative and biased, but does not strike me as dishonest

My prediction is that some day, Orac will see the light, will also become anti-Covid-vax, and will find strength to overcome cognitive dissonance. Cognitive dissonance is nothing to be ashamed of as we are humans and changing long held beliefs is difficult for all of us.

When that happens, we, science-minded anti-Covid-vaxxers, will accept Orac with open arms and warm hearts. If that happens, Orac will become a world-famous hero and a shining star of anti-Covid-vax movement.

Now… something of interest vaccinology related…

Take a look at the latest VA study titled “Risk of Death in patients hospitalized for COVID-19 vs Seasonal Influenza in Fall-Winter 2022-2023”.

Take a look at Table: “baseline characteristics”. You will see that after propensity score weighting, 63.43% of veterans with influenza were vaccinated for influenza. Also, 63.84% of veterans with Covid-19 (against which the influenza vaccine does NOT protect) were also vaccinated for influenza. This allows us to apply the “test-negative design” method of vaccine effectiveness estimation and notice that the flu vaccine does NOT prevent flu hospitalization.

Similarly, 54.54% of veterans hospitalized for Covid were boosted with Covid vaccine. Whereas, 55.43% of veterans hospitalized with influenza were boosted with Covid boosters. This allows us to apply the same “test-negative design” and see that Covid boosters offer no protection against hospitalization.

Had Covid boosters been 100% effective against Covid, zero boosted veterans would be hospitalized for Covid. Similarly, had the flu vaccine protected against flu, zero veterans who are vaccinated against flu would be hospitalized for flu. Instead, proportion of vaccinated people is the same in the test-positive and test-negative group.

How could this be? I thought “hospitals are full of unvaccinated people”?

P.S all VA studies comparing vaxed against unvaxed people are gold mines for truth-based antivax findings

My prediction is that some day, Orac will see the light, will also become anti-Covid-vax, and will find strength to overcome cognitive dissonance. Cognitive dissonance is nothing to be ashamed of as we are humans and changing long held beliefs is difficult for all of us.


Nope. Not gonna happen, because the evidence doesn’t support it.

I was there when you expressed concerns about COVID-19 vaccines before they were authorized. You were worried about political interference.

You changed your mind and started supporting them because of the evidence that came out.

You follow the evidence, and imagining that you will suddenly go anti-vaccine on the current evidence is unrealistic.

As Stalin did not say number SAEs is not important, important is who counts them and how. You did not notice the trick, of course. Read and comment Orac’s analysis.
You link says this:
“This study uses data from the US Department of Veterans Affairs to assess whether SARS-CoV-2 remains associated with higher risk of death compared with seasonal influenza in fall-winter 2022-2023.”
It was not about efficiency of at all.

Aarno, you are absolutely right – the VA study’s objective was something else other than estimating Covid and flu vaccine effectiveness.

However, the data that the study provides – the percentages of vaccinated people who have flu and Covid respectively – allows us to see that neither flu nor Covid vaccine had any effectiveness this season. The method is called “test-negative design”, and it looks at percentage of hospitalized people who have disease X and are vaccinated against X, vs people who are hospitalized for “something else” but are also vaccinated against X. Test-negative design avoids confounders such as health-care seeking behavior.

If the vaccine is effective, the first percentage above would be lower than the second. In our case, the percentages are the same, so there is no effectiveness.

This is an unintended finding that the authors did not highlight but that follows from the data.

Snake oil would have been a much safer (and just as ineffective) alternative to both flu and Covid vaccines during the last winter season.

The same exact finding is in the CDC VISION network study that I mentioned in one of the recent replies to another post.

Actually you need to know number of vaccinated among veterans. There are vaccine mandates in military.

science-minded anti-Covid-vaxxers,

Igor, you’ve demonstrated that you can spell science [maybe you have it written on a note so you can look at the word when you type] but you are not, in any honest sense of the phrase, science-minded. You’re devoted to lies, conspiracies, and just pure bullshit.

Whether dishonesty and ignorance come naturally to you, or you’ve simply worked hard to wipe away any sense of decency you once had isn’t clear. What is clear is that you have zero credibility.

Igor Chudov writes,

Orac is…, but does not strike me as dishonest.

MJD says,

Agreed, although, Orac rarely writes within his area of expertise i.e., cancer.

@ Orac,

MJD recently published a review paper titled, Cancer immunotherapy – Allergies and Degranulation:

Q. Are you burned out when it comes to discussing cancer research.

1) Stop pestering Orac to allow you a guest post.
2) Set up your own blog and you can post to your heart’s content. I use WordPress, but there are other purpose designed platforms you can use to create a blog.

@ Michael J. Dochniak (MJD)

You write: “Orac rarely writes within his area of expertise i.e., cancer.”

First, some cancers are caused by infectious microbes; e.g., liver cancer, hepatitis b and vaccines have been shown to prevent. So, knowledge of infectious diseases is not outside of “cancer.”

Second, Orac has a PhD in cell physiology, which, of course, among other things includes mRNA, viruses, and other things that enter cells, etc.

And if you actually carefully read his articles, he does an incredible job of keeping up on many areas in medicine.

@ Michael J. Dochniak (MJD)

You write: “MJD recently published a review paper titled, Cancer immunotherapy – Allergies and Degranulation” in International Journal of Cancer Medicine.

I checked PubMed, journal not even listed. Went to several other websites that list cancer journals, not listed. Wow, you got a publication in a basically unknown journal which charged for publishing and your only other publication that I’ve found was in Medical Hypotheses, years ago, a journal that only a very few libraries even subscribe to: Medical Hypotheses’ (2007) paper entitled ‘Autism spectrum disorders – Exogenous protein insult.

And you are a graduate of the University of Wisconsin RiverFalls (Psychology/Chemistry). I assume a BA or BS. Whereas David Gorski went through medical school which includes comprehensive courses in various areas of medicine, including, of course, infectious diseases, immunology, etc.

“Cognitive dissonance is nothing to be ashamed of as we are humans and changing long held beliefs is difficult for all of us.”

[email protected]#k me!

Instead of ‘Remember you are mortal’, Igor’s internal voice sings the theme from The Spy Who Loved Me.

As well as a reading comprehension problem, you also evidence a rich fantasy life. These things may be related or and indication of something else.

“1) Honest scientists and authors with long impeccable careers and well developed critical thinking are becoming anti-Covid-vax”

Gee, none of the scientists I work with have become anti-COVID-vax. Nor have any of the scientists I went to school with. Nor the scientists I used to work with who’ve moved on to other companies.

Maybe you don’t actually know very many scientists, and are only aware of the ones who are prolific communicators?

An example of where you should take care of the company you keep, lest you become contaminated by their conspiracy theories. Writing a paper with an anti-vaccine adjacent journalist makes you look anti-vaccine.

Steve Kirsch? ROTLMAO!

He’s such a loon that he embarrasses even other antivax loons. Dude clearly doesn’t understand statistics if he’s flogging that old gem about the Pfizer trial.

Actually FDA analyses deaths during trial. not sponsoring company (for obvious reasons). Read this part of Pfizer trisl report.

It’s good to see Dr. Gorski/Orac get cited more and more often in the press. For a long time he, the other SBM contributors, and a few others were at the forefront of proactively combatting the anti-vaccine, anti-science onslaught from the alt-med crackpots.
It has taken the deadly COVID pandemic to bring out more and more doctors and scientists resolved to combat the dangerous and insane kookery from the alt-med grifters and True Believers®. This is encouraging as it indicates rationalists are no longer going to remain “shruggies” in their ivory towers, but get down in the trenches with Orac, et al., and oppose the forces that want to take us back to the Dark Ages.
Let us hope this lesson on how easy it is to lose human advancement to the forces of fear, superstition, and ignorance isn’t soon forgotten.

Replace “United States” with “world”:
“There is a cult of ignorance in the United States, and there always has been. The strain of anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means that ‘my ignorance is just as good as your knowledge.'” —Isaac Asimov

BMC Infectious Diseases’ retraction notice says in part that Skidmore didn’t sufficiently disclose the funding role of antivaxer Catherine Fitts, a former assistant HUD secretary under George H.W. Bush. Fitts has since appeared in “Planet Lockdown” helping spread weird conspiracy theories, according to Forbes:

“In the video, Fitts alluded to a “committee that runs the world” that she called “Mr. Global.” This is a bit different from the “Mr. Vain” that the Culture Beat referred to in its 1993 dance song. According to Fitts, “Mr. Global” is utilizing the Covid-19 coronavirus pandemic to grab further control of you and others around everyone, possibly by injecting microchips via the Covid-19 vaccines. Those Covid-19 vaccines will “modify your DNA and for all we know make you infertile,” as well, without really offering any evidence supporting these claims. Yep, that’s what she said. Oh, and, by the way, Fitts claimed that “massive voter fraud” occurred during the 2020 Presidential Election.”

Sounds like another labarge go-to source.

@ Igor Chudov

You write: “Had Covid boosters been 100% effective against Covid, zero boosted veterans would be hospitalized for Covid. Similarly, had the flu vaccine protected against flu, zero veterans who are vaccinated against flu would be hospitalized for flu. Instead, proportion of vaccinated people is the same in the test-positive and test-negative group.”

Over and over I, Orac, and others have explained that Covid and flu vaccines do NOT confer 100% protection; however, they do reduce number severely ill, number hospitalized AND number dying, so what does the article actually say:

“The risk of death decreased with the number of COVID-19 vaccinations (P = .009 for interaction between unvaccinated and vaccinated; P < .001 for interaction between unvaccinated and boosted). . . The increased risk of death was greater among unvaccinated individuals compared with those vaccinated or boosted—
findings that highlight the importance of vaccination in reducing risk of COVID-19 death.”

And numerous studies have supported these findings. However, flu vaccines depend on how close they match the current circulating flus, some years much better than others; but even best of years less effective than COVID vaccines, though still significantly reduce hospitalizations and deaths. But flu already has much lower risk of hospitalizations and deaths compared with COVID.

Just how STUPID and/or DISHONEST are you, literally focusing on hospitalizations and ignoring that the article actually said COVID vaccination reduced risk of death??? Though I would love for a vaccine to completely prevent any discomfort and, of course, hospitalization; but if all it did was prevent death, that too would be acceptable.

It’s AND, definitely AND.

To be fair, it’s probably used to talking to its fellow plague-rats, who never check any talking point that agrees with their goal of killing as many people as possible.

I would put it as
“Had Covid boosters been 100% effective against Covid”, doctors, researchers and public health officials would have been ecstatic!!!

But of course such a result was highly unlikely given that the initial trials only showed about 90-95% protection against symptomatic disease. And no serious scientist expected them to be 100% effective for any measure, even when for instance the trials with 5-17 age youths found no deaths.

But that’s not really what this study is about anyway.
They say at the outset

In the first year of the COVID-19 pandemic, 2 US studies suggested that people hospitalized for COVID-19 had nearly 5 times the risk of 30-day mortality compared with those hospitalized for seasonal influenza.Since then, much has changed, including SARS-CoV-2 itself, clinical care, and population-level immunity; mortality from influenza may have also changed. This study assessed whether COVID-19 remains associated with higher risk of death compared with seasonal influenza in fall-winter 2022-2023.

So the new SARS-Cov-2 virus was much more dangerous than the influenza virus, which most of the population already had immunity from infection or vaccination or both.
They wanted to see how much vaccinating against both diseases changed that ratio.

There were 8996 hospitalizations (538 deaths [5.98%] within 30 days) for COVID-19 and 2403 hospitalizations (76 deaths [3.16%]) for seasonal influenza (Table). After propensity score weighting, the 2 groups were well balanced (mean age, 73 years; 95% male).

The death rate at 30 days was 5.97% for COVID-19 and 3.75% for influenza, with an excess death rate of 2.23% (95% CI, 1.32%-3.13%) (Figure). Compared with hospitalization for influenza, hospitalization for COVID-19 was associated with a higher risk of death (hazard ratio, 1.61 [95% CI, 1.29-2.02]).

So the hazard ratio had dropped from almost 5:1 down to a bit under 2:1.

Covid-19 is still more dangerous, but maybe the Covid-19 vaccines do a better job of protecting against it than the flu vaccines do for influenza?

They are studying a population that has already gotten seriously ill and been hospitalized. So there is no way to use this study to calculate an absolute risk for mortality, much less hospitalization or infection.

Also note that out of a broad group of people in the VA health system (they were studying all patients hospitalized over a 4 month period), there were over 3 times as many Covid-19 hospitalizations as for flu!

==> Covid-19 is still more dangerous, but maybe the Covid-19 vaccines do a better job of protecting against it than the flu vaccines do for influenza?

Both Covid and flu vaccines are snake oil.

Covid vaccine is more dangerous than the flu vaccine, which is also dangerous. Both are equally useless.

Not all diseases can be vaccinated against, sadly.

Covid vaccine is more dangerous than the flu vaccine, which is also dangerous.

I understand now why you are always late to post references: when you make a blatant lie like this one there is no actual data to support it so you can’t post anything in its support.

You serial liars are pathetic.

Hi Joel, thanks for responding. Also thanks for acknowledging that Covid vaccines do not protect against hospitalization.

I am not blind and I did read the article’s conclusion. Instead of mindlessly repeating the conclusion, I analyzed the data that the study provided but did not analyze. This is my contribution to the science of vaccinology.

The conclusion of the study needs to be properly stated as “Covid booster provides about 40% death protection” — but only AMONG PEOPLE WHO ARE HOSPITALIZED. But what about people who die without being hospitalized, the so called “died suddenly”? Covid is known to increase such a risk.

So, the VA hospitalization study cannot answer whether Covid vaccines provide protection about overall Covid deaths or reduce overall mortality.

The UK’s “excess mortality presentation” has data on excess mortality by “place of death”. Deaths at home are up about 30%. Hospital deaths are barely up. So focusing on hospital deaths leads to incorrect conclusions.

I analyzed the data that the study provided but did not analyze. This is my contribution to the science of vaccinology.

Analyzed? Good lord, you are as fundamentally ignorant as you are dishonest.

To my layperson’s eye, the EBM paradigm doesn’t so much predispose to COVID contrarianism or alt-med-woo as just allow for such things, due to certain methodological weakness that can be exploited. Aarno seems to have zeroed in on how Gøtzsche re-produces the misleading tabulations of “SAEs” from Fraiman et. al.: “number SAEs is not important, important is who counts them and how.” It’s not just a counting issue, though, but first and foremost a language issue: how the term embracing the things being counted is defined. The I say science has a language problem is the frequency with which researchers get away with questionable category construction. Science folk just seem to be in the habit of accepting that a word or phrase has some concrete, coherent referent in the real world for which there is a valid quantitative gauge. It’s a habit, I suppose, since so much of the natural sciences is about counting things that are fairly objective and specific. Whatever, if a study’s results seem suspect, science folks tend to go right to the stats to look for skullduggery or error. Conversely, if something seems off to me, being rooted in the humanities and generally mystified by statistics, go right to looking for gaming in language. I suspect EBM is more conducive to getting away with funny-business just out of a history of using things like patient surveys as ‘hard data’, including in cases where it might mostly ‘work’, that it’s just kinda baked-in. (???)

As for Gøtzsche, I can’t help but speculate a bit about what could be afoot psychologically.. Orac suspects he has a long history of “experience with how much chicanery goes on in pharmaceutical company sponsored RCTs,” leading him to the cynical, nihilistic stance that the pharmas are “worse than the mafia”. I can imagine that someone devoted to using RCTs for ‘good’ takes any abuse very personally, to the point of urgency in raising alarm, and great frustration that little or nothing comes out of that. It strikes me that there are a lot more appropriate targets than vaccines for a rational critique of the pharmas. Gøtzsche could be cozying up to antivaxers simply because they listen to him, and share his sense of alarm. The facts Orac relate above — pairing with Demasi on one hand, but upset by the monomania of antivaxers at that meeting of the Institute for Scientific Freedom on the other — suggest he’s no true believer, but off on a more personal agenda. IOW, I get similar vibes here as with poor Bill Thompson, who tried to use Brian Hooker to score points against his disrespectful CDC colleagues, not caring enough about how Hooker and Wakefield were using him.

@ Michael J. Dochniak (MJD)

You write: “MJD recently published a review paper titled, Cancer immunotherapy – Allergies and Degranulation:

The article is in the journal “International Journal of Cancer Medicine.”
Not listed in the National Library of Medicine’s online database PubMed. Not included in other cancer journal rankings; e.g., Scimago Journal and Country Rank, Journal Rankings, etc.

So, you paid to have your article published in a journal with no recognition. And as far as I can find, you have only published one other article in 2007: “Autism spectrum disorders – Exogenous protein insult” in journal Medical Hypotheses, a journal subscribed to by an extremely few libraries in the United States and at the time, not peer-reviewed.

You have a B.Sc. degree in Psychology and Chemistry from University of Wisconsin River Falls campus. While having ONLY a B.Sc. doesn’t mean one can’t come up with valuable insights, so far you have shown NONE.

And so far your numerous comments on Respectful Insolence have contributed NOTHING of scientific validity to the ongoing discussions.

@ Igor Chudov

You write: “Hi Joel, thanks for responding. Also thanks for acknowledging that Covid vaccines do not protect against hospitalization.”

I did NOT acknowledge that Covid vaccines do not protect against hospitalization, simply that the article did NOT deal with this. There are other articles that clearly show that the vaccines significantly reduced risk of severity and hospitalization; but not in your sick mind by 100%. Just one more example of how you either stupidly and/or dishonestly twist what someone writes.

You write: “The conclusion of the study needs to be properly stated as “Covid booster provides about 40% death protection” — but only AMONG PEOPLE WHO ARE HOSPITALIZED. But what about people who die without being hospitalized, the so called “died suddenly”? Covid is known to increase such a risk.”

There are studies including deaths at home; but it would be a waste of time listing them as you will ignore as usual.

You write: “So, the VA hospitalization study cannot answer whether Covid vaccines provide protection about overall Covid deaths or reduce overall mortality.”

So what? It wasn’t the focus of the one study; but for you, ignore other studies and single out one to confirm your ignorant unscientific bias.

You write: “The UK’s “excess mortality presentation” has data on excess mortality by “place of death”. Deaths at home are up about 30%. Hospital deaths are barely up. So focusing on hospital deaths leads to incorrect conclusions.”

Not deaths from COVID; but from other diseases because couldn’t get treated during pandemic and/or increased violence during pandemic and alcohol drug use, traffic accidents, etc. Both UK and US not prepared for an inevitable pandemic, so, among other things, hospitals not even close to needed capacity and staff, people frustrated at home, etc. Read Michael T Osterholm’s book: Deadliest Enemy: Our War Against Killer Germs. He makes absolutely clear that we are ill-prepared for inevitable pandemics, resulting in, among other things, more deaths, more economic disruptions that necessary, etc. And both US and UK had much higher per capita death rates than other nations who reacted appropriately.

So, you thank me based on reading your unscientific bias into what I wrote.


It really is a waste of time responding to you as you either refuse to understand or intentionally ignore and just continue with your ignorant bias. Why not read the two books I recommended and try to actually learn something rather than living in your sick fantasy world???

@ Igor Chudov

I forgot to mention that VA hospital patients are among the least healthy in our nation and older, so risk of severe illness, hospitalization, and deaths higher than average population. Though in my late 70s, having never smoked, barely tasted alcohol many years ago, never used ever any recreational drug except caffeine, started becoming a vegetarian in my late teens and, though a lousy athlete, jog, swam, bicycled, used stairs, and have been blood donor for 45 years, since pandemic every two to four weeks. Blood tests of antibodies to COVID vaccine show quite good, so my overall health with vaccine and always wearing N95 mask when out shopping reduces my risk exponentially; but not to zero.

I repeat, VA hospital patients among least healthy, so the level of protection by vaccine still remarkable.

@ Igor Chudov

“During Omicron, COVID-19-associated hospitalization rates increased for all adults, regardless of vaccination status, but rates were 12 times higher among adults who were unvaccinated compared to adults who received a booster or additional doses.” CDC (2022 Mar 18). COVID-19 vaccines continue to protect against hospitalization and death among adults.”

12 times!!!

And I could list more.

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