I must admit that, as the weekend rolled around and I realized that I had to come up with a post for Monday, there were so many things going on last week that it was truly difficult for me to decide what to write about, ranging from COVID-19-related misinformation to topics that I haven’t much written about since the pandemic hit, such as run-of-the-mill cancer quackery. However, as I sat down to write yesterday, one article continued to stand out, even though it was published nearly a week ago. It’s an article by Dr. Asseem Malhotra, which was spread widely on social media as some sort of “slam dunk” evidence that COVID-19 vaccines are awful. I think that what kept drawing me to it is his obvious attempt to reverse the narrative, as evidenced by the title of the article, “Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based medicine – Part 2“. (I apparently missed part one in June, which is here. I can only speculate that either I was distracted or the first part didn’t make as big a splash as the second.)

So let’s look at these papers, how they are being used as antivax disinformation, and the numerous errors of fact, omission, and interpretation in them.

Dr. Malhotra “repents”

Last week on Twitter, Dr. Malhotra portrayed his most recent paper as “the most important announcement of my life and career thus far”:

I suppose that one could make an argument that writing something that completely destroys what’s left of one’s professional reputation could arguably called “the most important announcement of my life and career thus far”, but I’d add that this importance is actually not a change that is good.

This brings me to another reason that led me to stick with this topic, which was how Dr. Malhotra’s article, based on the video above—which was full of Dr. Malhotra posturing as being so very, very “regretful” in having come to the conclusion that COVID-19 vaccines are “not completely safe”, have “unprecedented harms”, and “need to be suspended until all the raw data has been released for independent analysis” (whatever “independent” means to him)—was being spun by the usual suspects, in particular the “spiritual child of the Great Barrington Declaration” known as the Brownstone Institute, which didn’t take long after its founding to pivot from promoting a “let ‘er rip” approach to the pandemic in a futile bid to reach “natural herd immunity” and thus get business up and running faster, to spreading the vilest kind of antivax disinformation about COVID-19 vaccines, complete with Holocaust references and calls for “justice” disguised as retribution that echo the “Nuremberg 2.0” trope embraced by COVID-19 minimizers and antivaxxers, an antivax trope that long predates the pandemic. Just this weekend, Daniel Klein posted an article there titled “The Regret, Repentance, and Redemption of Dr. Aseem Malhotra“. Of course, everybody (including science communicators, truth be told) loves a “conversion” story, in which someone who advocated for the position they oppose radically changes his position to agree with them, such as a pro-vaccine advocate becoming an antivaxxer (like Dr. Malhotra) and, admittedly, an antivaxxer who becomes pro-vaccine. It’s therefore no surprise that a Brownstone Institute flack would spin Dr. Malhotra’s papers this way:

Back when the vaccines were being rolled out, the eminent UK cardiologist, Dr. Aseem Malhotra encouraged people to accept them. He was trying to overcome “vaccine hesitancy”—see for example here in November 2020 and here in February 2021.

Personal loss led to a change. Sadly, his father suffered cardiac arrest and died in July 2021. As told here, here, and here, though a cardiologist with an enormous Twitter following, Dr. Malhorta could not explain the post-mortem findings and started down medical-research rabbit holes he’d not gone down before.

Now, Malhotra says the Covid vaxes (or, at least, the mRNA vaxes) are not known to be safe and calls vax mandates and passports “unethical, coercive, and misinformed”—see the video here and here. Vax rollouts, he says, “must stop immediately.”

I note that the citations regarding Dr. Malhotra’s conversion link to known COVID-19 contrarian, minimizer, and antivax sources, such as Ivor Cummins (a.k.a. “The Fat Emperor,” who first came to my attention for promoting the “casedemic” conspiracy theory about COVID-19 PCR testing), Steve Kirsch, and (!) The Epoch Times. This is not a good sign. Nor is it a good sign that his video is being shared widely by people like Dr. Robert “inventor of mRNA vaccines” Malone, a man who has become one of the foremost promoters of COVID-19 and antivaccine misinformation since the pandemic began and now resembles “old-school” antivaxxers. Even worse is that Dr. Malhotra’s “scientific review” is now being amplified by the quack tycoon who before the pandemic had already built a net worth north of $100 million selling quackery and antivax propaganda, Joe Mercola, on his Substack, where he repeats the antivaccine tropes in Dr. Malhotra’s papers quite fluidly, given that they’ve all been parroted before on his website and he knows them well.

This should tell you nearly all of what you need to know about Dr. Malhotra’s “two-part scientific review,” not that that will stop me from explaining in detail why this “review” is a fake scientific review weaponized as disinformation.

To Dr. Malhotra’s credit, it is true that back in 2020 he was, in fact, strongly advocating for COVID-19 vaccines, for example, in November 2020, just as the Pfizer vaccine was coming up for consideration by the FDA for an emergency use authorization (EUA) and by the regulatory authorities in the UK for use there:

Which was definitely correct, as was this, in February 2021:

Now he’s concluding in his papers that the vaccine is more dangerous than the disease, first in a less concrete statement made in June, in which he echoes a common antivax fallacy known as the “appeal to informed consent“, which I now like to refer to as the appeal to “misinformed refusal“, a tactic used by antivaxxers going back to before I even started paying attention to the antivaccine movement:

It cannot be said that the consent to receive these agents was fully informed, as is required ethically and legally. A pause and reappraisal of global vaccination policies for COVID-19 is long overdue.

Sound familiar? To reiterate, it’s an obvious appeal to what I used to call “misinformed consent” but now refer to it by what I consider to be a more accurate term, “misinformed refusal.”

Then, last week, Dr. Malhotra wrote:

There is a strong scientific, ethical and moral case to be made that the current COVID vaccine administration must stop until all the raw data has been subjected to fully independent scrutiny. Looking to the future the medical and public health professions must recognise these failings and eschew the tainted dollar of the medical-industrial complex. It will take a lot of time and effort to rebuild trust in these institutions, but the health – of both humanity and the medical profession – depends on it.

This is a similar tact to the one taken by Peter Doshi, who has since February 2021 (when he originated the myth that the clinical trials really only showed the mRNA vaccines to have been 19% effective, which has since evolved into myth that they were only 12% effective) has been demanding to see the “original data” for the Pfizer and Moderna vaccine trials, up to the point last month in which he published an antivax “reanalysis” of the available data from the trials to try to paint an extremely misleading picture of the vaccine being more harmful than COVID-19.

Then there’s the issue of the journal in which these two articles were published, The Journal of Insulin Resistance, which is described as:

The Journal of Insulin Resistance is a peer-reviewed, clinically oriented open access journal covering advances in disorders related to insulin resistance. Articles will focus on pathophysiology, prevention, management and advancing therapy for different patient populations with insulin resistance and related disorders, including obesity, metabolic syndrome, type 2 diabetes, cardiovascular disease, non-alcoholic steato-hepatitis, Alzheimer’s dementia, sexual dysfunction, amongst others.

The journal will feature original research with a broad biomedical approach from bench to bedside, including basic research and clinical case studies, as well as review articles and editorials. Content will be of interest to an academic and clinician-based audience i.e., medical practitioners, clinical educators, dietitians, nutritionists, nurse practitioners, pharmacists, and other health care professionals. Submissions in English (full article) will be considered for publication.

Was there anything about immunology, infectious disease, coronaviruses, public health, or anything similar? Funny, but I must have missed it. In fact, as Gideon Meyerowitz-Katz has pointed out, very little has been published in this “journal” since 2016, and at least half of it was published by members of the editorial board, all of which raises red flags for this being an ideology journal disguised as a medical journal:

Finally, there’s Dr. Asseem Malhotra himself. Although he didn’t go full antivax until relatively recently, Dr. Malhotra was never what one could reasonably describe as a defender of science-based medicine. He has long promoted dietary advice that was…debatable…having published The Pioppi Diet, a book that “earned” the “honor” of being named one of “Top 5 worst celeb diets to avoid in 2018” by the British Dietetic Association, which noted how the diet was patterned after the Mediterranean diet but with a low carb agenda. In essence, the Pioppi diet was a tarted-up version of the Mediterranean diet that “recommends a higher fat diet than the traditional Mediterranean one” and notes that “adherents are encouraged to eat lots of vegetables, nuts, legumes, and fish and discouraged from eating red meat, starchy carbs, and sweetened treats.” It also encourages 24-hour fasting. Dr. Malhotra has also very much been in the anti-processed sugar camp, having characterized sugar as “enemy number one in the Western diet“. He has also channeled Peter Gøtzsche in arguing that modern medicine does more harm than good treating chronic conditions with medications and claiming that “too much medicine can kill you“. Of course, as I’ve said before, it is not in itself unreasonable to criticize too much medical intervention, particularly medical intervention of questionable value, but to me a brief perusal of Dr. Malhotra’s oeuvre gave off a seriously disturbing vibe that medicine doesn’t do any good for chronic illnesses. Unsurprisingly, he is also a statin denialist, even having gone so far as to suggest that stopping statins might save more lives and that statins probably don’t benefit anyone.

Consistent with this bent, Dr. Malhotra made the news early in the pandemic when he attacked Royal Free London NHS Foundation Trust for accepting a gift of 1,500 Krispy Kreme doughnuts sent to the staff as a gift for their work in dealing with the COVID-19 pandemic in the UK. Also consistent with his tendency to ascribe super immune-producing effects to diet alone, later in 2020 Dr. Malhotra published a book titled The 21-Day Immunity Plan: How to Rapidly Improve Your Metabolic Health and Resilience to Fight Infection, in which he “excoriated the mainstream media for their failure to notice the role nutrition has in the outcome of Covid-19 cases. Obesity, diabetes, and other metabolic diseases led to increased hospitalization rates, overwhelming the NHS.” Basically, his claim was that it is possible to rapidly—in 21 days!—reverse the sorts of metabolic disorders (e.g., type II diabetes and obesity) that render large swaths of the population particularly vulnerable to severe disease and death from COVID-19. At the time, I was…skeptical. Given that background, it really shouldn’t be that big surprise that Dr. Malhotra’s gone antivax, particularly given statements like this:

I will cut Dr. Malhotra a little slack given that when his book was published there were as yet no COVID-19 vaccines available. But just a little. Also, I’ve observed over the years that there’s a strong attraction to antivax pseudoscience among people who promote overblown claims for what diet can do for your health.

“I know you are, but what am I?” (Round One)

As I said at the beginning, one of the favorite tactics of quacks, cranks, and antivaxxers is projection: To accuse their critics of what they themselves are guilty of, and both of Dr. Malhotra’s articles are prime examples of this tactic, starting right from the title, in which he claims the mantle of evidence-based medicine for himself against what he characterizes as “misinformation” coming from health authorities and the conventional press. Interestingly, Dr. Malhotra barely uses the word “misinformation” in his first article, but uses it much more frequently in his second article, as though he were doubling down on his first assertion. I was going to leave the first article mostly alone, except that it contains an explanation of what might have pushed Dr. Malhotra over from just questionable on COVID-19 and vaccines to full antivax.

The articles are both odd ducks, too, not being written in a true “scientific review article” format. The first review is billed as a “narrative review of the evidence from randomised trials and real world data of the COVID mRNA products with special emphasis on BionTech/Pfizer vaccine”, while the second review is claimed to be a “narrative review of both current and historical driving factors that underpin the pandemic of medical misinformation”. Of course, given that Dr. Malhotra is on the editorial board of this faux journal, it’s unlikely that either of his “review articles” underwent anything resembling actual peer review. In reality, these articles are no more than opinion pieces representing Dr. Malhotra’s views, backed up by cherry-picked low-quality evidence.

It is interesting to note that in the first article, Dr. Malhotra describes why he changed his mind about COVID-19 vaccines. First, he burnishes his seeming pro-vaccine credentials by noting that he was one of the first to get the Pfizer vaccine at the end of January 2021. (By comparison, I leapt at the chance to get the Pfizer vaccine and actually got my first dose in mid-December 2020), going on to write:

Although I knew my individual risk was small from COVID-19 at age 43 with optimal metabolic health, the main reason I took the jab was to prevent transmission of the virus to my vulnerable patients. During early 2021, I was both surprised and concerned by a number of my vaccine-hesitant patients and people in my social network who were asking me to comment on what I regarded at the time as merely ‘anti-vax’ propaganda.

I was asked to appear on Good Morning Britain after a previously vaccine-hesitant film director Gurinder Chadha, Order of the British Empire (OBE), who was also interviewed, explained that I convinced her to take the jab.

This was all well and good, but then:

But a very unexpected and extremely harrowing personal tragedy was to happen a few months later that would be the start of my own journey into what would ultimately prove to be a revelatory and eye-opening experience so profound that after six months of critically appraising the data myself, speaking to eminent scientists involved in COVID-19 research, vaccine safety and development, and two investigative medical journalists, I have slowly and reluctantly concluded that contrary to my own initial dogmatic beliefs, Pfizer’s mRNA vaccine is far from being as safe and effective as we first thought. This critical appraisal is based upon the analytical framework for practicing and teaching evidence-based medicine, specifically utilising individual clinical expertise and/or experience with use of the best available evidence and taking into consideration patient preferences and values.

Unfortunately, personal tragedy appears to have been the impetus that led Dr. Malhotra (farther) astray:

On 26 July 2021, my father, Dr Kailash Chand OBE, former deputy chair of the British Medical Association (BMA) and its honorary vice president (who had also taken both doses of the Pfizer mRNA vaccine six months earlier) suffered a cardiac arrest at home after experiencing chest pain. A subsequent inquiry revealed that a significant ambulance delay likely contributed to his death.3 But his post-mortem findings are what I found particularly shocking and inexplicable. Two of his three major arteries had severe blockages: 90% blockage in his left anterior descending artery and a 75% blockage in his right coronary. Given that he was an extremely fit and active 73-year-old man, having walked an average of 10–15 000 steps/day during the whole of lockdown, this was a shock to everyone who knew him, but most of all to me. I knew his medical history and lifestyle habits in great detail. My father who had been a keen sportsman all his life, was fitter than the overwhelming majority of men his age. Since the previous heart scans (a few years earlier, which had revealed no significant problems with perfect blood flow throughout his arteries and only mild furring), he had quit sugar, lost belly fat, reduced the dose of his blood pressure pills, started regular meditation, reversed his prediabetes and even massively dropped his blood triglycerides, significantly improving his cholesterol profile.

Dr. Malhotra has my sympathy for losing a parent, but not so much that I won’t push back against his story as related. I note that it is indeed nearly always a major blow when a parent dies, even more so when that parent is relatively young (and early 70s these days is relatively young) and was thought to be in “perfect” health. The natural reaction is to look for reasons why he died so suddenly. Given Dr. Malhotra’s leaning in terms of medicine, it’s not surprising that he soon landed on vaccines as a potential cause, just as parents who lose a child to sudden infant death syndrome all too frequently do:

I couldn’t explain his post-mortem findings, especially as there was no evidence of an actual heart attack but with severe blockages. This was precisely my own special area of research. That is, how to delay progression of heart disease and even potentially reverse it. In fact, in my own clinic, I successfully prescribe a lifestyle protocol to my patients on the best available evidence on how to achieve this. I’ve even co-authored a high-impact peer-reviewed paper with two internationally reputed cardiologists (both editors of medical journals) on shifting the paradigm on how to most effectively prevent heart disease through lifestyle changes.4 We emphasised the fact that coronary artery disease is a chronic inflammatory condition that is exacerbated by insulin resistance. Then, in November 2021, I was made aware of a peer-reviewed abstract published in Circulation, with concerning findings. In over 500 middle-aged patients under regular follow up, using a predictive score model based on inflammatory markers that are strongly correlated with risk of heart attack, the mRNA vaccine was associated with significantly increasing the risk of a coronary event within five years from 11% pre-mRNA vaccine to 25% 2–10 weeks post mRNA vaccine. An early and relevant criticism of the validity of the findings was that there was no control group, but nevertheless, even if partially correct, that would mean that there would be a large acceleration in progression of coronary artery disease, and more importantly heart attack risk, within months of taking the jab.5 I wondered whether my father’s Pfizer vaccination, which he received six months earlier, could have contributed to his unexplained premature death and so I began to critically appraise the data.

One can’t help but note that Dr. Chand died six months after he had received the Pfizer COVID-19 vaccine. Similarly, one also can’t help but note that one can have significant underlying heart disease and still appear to be just fine—fit, even!—until the heart disease progresses to a level where compensatory mechanisms can no longer prevent complications. I can see how such a death so close to home could shake Dr. Malhotra’s belief system of diet and lifestyle über alles as panaceas for good health. After all, if his father, who led the “right lifestyle” and walked 10,000-15,000 steps a day could succumb to coronary artery disease, then perhaps Dr. Malhotra’s faith in diet and exercise alone as panaceas against heart disease were misplaced or, at the very least, excessive.

As often is the case with those who believe in something very strongly, rather than question his existing belief systems, Dr. Malhotra appears to have started looking for “other” causes for his father’s sudden death. I can only speculate, but, given his apparent belief in diet as the be-all and end-all of cardiovascular (and general) health, my guess is that in his grief he was even more susceptible than he might have been to the blandishments of the antivaccine movement and that susceptibility ultimately led to his going down the rabbit hole of antivaccine misinformation and conspiracy theories bolstered by bad science. I will note that the reference to which he refers was an abstract of a particularly useless study by a physician associated with Goop, who used an unvalidated test for “inflammatory markers” after vaccination that showed nothing, as described by pediatric cardiologist Dr. Frank Han here and myself elsewhere. Citing very weak science is not a good look for a someone proclaiming himself as pushing back against “misinformation” promoted by the medical profession and claiming the mantle of evidence-based medicine. Also, as Dr. Han has pointed out, atherosclerosis takes years, not months, to develop. As someone who early in his career, before becoming interested in cancer, studied vascular smooth muscle cells and their role in atherosclerosis and restenosis after coronary angioplasty, I will reemphasize that point.

Later in the same article, Dr. Malhotra cites four cardiac arrests observed in the Pfizer trial. After admitting that these “figures were small in absolute terms and did not reach statistical significance in the trial, suggesting that it may just be coincidence”, he nonetheless claims that “without further studies it was not possible to rule out this being a genuinely causal relationship (especially without access to the raw data), in which case it could have the effect of causing a surge in cardiac arrests once the vaccine was rolled out to tens of millions of people across the globe”. While that is true enough, to conclude that some obvious adverse event due to the vaccines has been missed for nearly two years one has to ignore all the safety studies carried out since first millions, then tens of millions, then hundreds of millions, and then billions of doses of the Pfizer and Moderna vaccines were administered throughout the world.

As just a taste of these data, it’s noted that the UK has not noted an increase in mortality from ischemic heart disease since the vaccines rolled out:

Dr. Malhotra then goes on to cite a number of low quality sources. Consistent with this, Dr. Malhotra uses a number of common antivax techniques to make COVID-19 vaccines look as ineffective and risky as possible. For example, echoing the “number needed to treat” (NNT), a frequent measure of how many people need to be treated to prevent a single adverse event or death, Dr. Malhotra cites the “number needed to vaccinate” to prevent one death due to COVID-19 in various age groups, which he estimates to be 10,000 for people in their 40s. However, the source he cites is not even a scientific article but a blog post, as Meyerowitz-Katz notes:

One also notes that vaccines by their very nature necessitate vaccinating a relatively large number of people in order to avoid one death from the disease vaccinated against:

That is, of course, why the safety bar is so much higher for vaccines than other medications. They are administered to a presumably healthy population in order to prevent an infectious disease, not to a population ill with a disease in order to treat that disease.

Similarly, emphasizing absolute versus relative risk is another favorite tactic of those seeking to downplay the benefits of vaccinating. Come to think of it, emphasizing death as the only endpoint worth looking at, rather than considering severe non-death adverse outcomes, is another favorite tactic of antivaxxers. We do, after all, vaccinate to prevent not just death, but disease and serious complications. Another claim that he makes is that we should look at all-cause mortality after vaccination but are not doing that. Of course, we actually are, and the UK (where Dr. Malhotra is based) has those data, as noted by Vicki Male:

Dr. Malhotra also cites Maryanne Demasi, claiming that she had shown that the original mRNA vaccine trials had failed to account for serious harms. (Unsurprisingly, Demasi now writes for the Brownstone Institute, which is how I remembered who she was, even though I don’t recall having written about her before.) He exaggerates the risk of myocarditis relative to the potential benefit of the vaccine in young adults and children, a topic that we’ve covered a number of times here, and cites reports to the Vaccine Adverse Events Reporting System (VAERS), exhibiting a lack of understanding of how VAERS works and acting as though all the reports were caused by the vaccines. Hilariously, he tries to make his spin seem more credible by noting that “knowingly filing a false VAERS report is a violation of Federal law punishable by fine and imprisonment”. (So what?) He then misrepresents a paper in Scientific Reports as having been published in NatureScientific Reports is Nature Publishing Group’s open access journal and nowhere near as prestigious as Nature itself—claiming an increase in cardiac deaths due to the rollout of the vaccines. If I give him the benefit of the doubt, this was poor scholarship. If I don’t, this is using an antivaccine technique in which any article published in a Nature Publishing Group journal, no matter how lowly, is misrepresented as having been published in Nature.

The misrepresentation of the journal aside, this was a flawed and highly problematic study, as described here. Based on a cherry picked citing of low-quality data, Dr. Malhotra concludes that “it remains a real possibility that my father’s sudden cardiac death was related to the vaccine” and a “pause and reappraisal of vaccination Policies for COVID-19 is long overdue”.

“I know you are, but what am I?” (Round Two)

Dr. Malhotra’s second article is of more interest to me, because in it he tries to flip the script and accuse those fighting misinformation of actually spreading it. Indeed, that’s the message he starts his article with, accusing health authorities of horrific missteps:

What has become clear with regard to the coronavirus disease 2019 (COVID-19) vaccines is that we have a pandemic of misinformed doctors and a misinformed and unwittingly harmed public. Coercively mandating these COVID-19 vaccinations (most certainly not an evidence-based policy) has been a particularly egregious mis-step, especially in the light of clear indicators suggesting that the use of these pharmaceutical interventions – especially in younger age groups – should have been suspended. Such policies continue to undermine the principles of ethical evidence-based medical practice and informed consent, to the detriment of optimising patient outcomes.

He cites a 2017 Perspective paper by John Ioannidis that, in retrospect after Prof. Ioannidis’ plunge from grace with respect to evidence-based medicine and his abuse of his position to get very low quality ideology-driven papers published since the pandemic hit, seems less impressive now than I might have considered it five years ago.

Ironically, the drivers and “sins” that lead to misinformation spreading as described by Prof. Ioannidis and cited by Dr. Malhotra now are not inaccurate.

First the drivers:

  • Much published medical research is not reliable or is of uncertain reliability, offers no benefit to patients or is not useful for decision makers;
  • Most healthcare professionals are not aware of this problem;
  • Even if they are aware of this problem, most healthcare professionals lack the skills necessary to evaluate the reliability and usefulness of medical evidence; and
  • Patients and families frequently lack relevant, accurate medical evidence and skilled guidance at the time of medical decision making.

And the “sins,” from a book Better Doctors, Better Patients, Better Decisions, edited by Gerd Gigerenzer and J.A. Muir Gray:

  • Biased funding of research (that’s research that’s funded because it’s likely to be profitable, not beneficial for patients)
  • Biased reporting in medical journals
  • Biased reporting in the media
  • Biased patient pamphlets
  • Commercial conflicts of interest
  • Defensive medicine
  • An inability of doctors to understand and communicate health statistics

Unfortunately, in the age of the pandemic, most of these problems just don’t apply in the way that Dr. Malhotra thinks that they do. For instance, COVID-19 cranks (like Dr. Malhotra) take advantage of the low quality and reliability of a lot of medical research to contribute even more to that low reliability by publishing propaganda in journals like The Journal of Insulin Resistance. Indeed, I once called this phenomenon scientific review articles weaponized as disinformation, a label that describes Dr. Malhotra’s two part “narrative review” quite well.

Looking back at both articles, it’s clear to me that the first article was intended to sow doubt about COVID-19 vaccines through the use of a compelling anecdote about his father followed by cherry-picked data. As much as I might feel sorry for Dr. Malhotra because of his loss, I cannot allow that feeling to prevent my directly addressing his misuse of the anecdote of his father’s death to spread fear, uncertainty, and doubt about vaccines. The second article is more of a generalized antivaccine rant that uses tried and untrue techniques that try to paint big pharma and government regulatory entities as so completely corrupt (as well as ideology- and profit-driven) that they ignore evidence of harm.

He even cites common antivax tropes, such as the claim that the FDA wanted 55 years to release the data on the Pfizer clinical trial of its vaccines:

It is against this backdrop that transparency advocates sued the Food and Drug Administration (FDA) to gain access to the data upon which the Pfizer (BNT162b2) vaccine was granted emergency use authorisation.31 The FDA wanted a US Federal court judge to allow the agency 55 years to release this data. 32 Why would the FDA – ‘which is responsible for the oversight of more than $2.7 trillion in consumption of food, medical products, and tobacco’33 – do this? Secrecy should never surround any public health intervention.

In fact, the reason why the FDA estimated that it would take from 55-75 years to release all the requested documents is not due to nefarious intent, but rather because of the sheer mass of documents requested (which require redaction of patient-identifiable information, as well as business and trade secrets) and the resources that it has available for FOIA requests. Here’s a hint: When you’re recycling antivax talking points promoted by, for example, Robert F. Kennedy, Jr., you might want to rethink what has led you to this point.

Dr. Malhotra then goes on to rail against what he sees as the causes of this supposed debacle of COVID-19 vaccines: financial interests of big pharma, “biased” reporting, and, of course, “censorship” of debate. He even approvingly cites Dr. Robert Malone. I kid you not:

The BBC, though seemingly not directly influenced by industry interests, has traditionally been seen by some as the UK’s most trusted media source. Its coverage of issues surrounding COVID-19 has in my view (possibly through additional government pressure) been extremely poor and – specifically on issues surrounding the vaccine – grossly negligent. During a recent report on tennis player Novak Djokovic explaining his decision to not take the vaccine until he has more information on its benefits and harms, a reporter asked the question ‘how much more information does he need?’. The reporter failed to mention the fact that Djokovic has had COVID-19 and that evidence suggests that natural immunity offers significant protection against reinfection and severe disease, and that systemic side effects are almost threefold more likely in those with natural immunity who subsequently get vaccinated. Furthermore, the BBC falsely framed a guest on popular podcast host Joe Rogan, Dr Robert Malone, as a ‘known anti-vaxxer, who is against vaccinating kids’, failing to mention that Dr Malone is a co-inventor of the very technology that led to the vaccine, has spent 20 years in vaccine development at US government level and was one the first to actually receive two shots of the Moderna jab. The BBC also strangely failed to cover perhaps one of the most significant stories of the pandemic published in one of the most respected and influential medical journals in the world: An investigation by the BMJ revealed evidence of poor practices at a contract research company involved in Pfizer’s pivotal COVID-19 vaccine trial. A regional director employed at one of the trial sites in Texas, US, documented evidence that Pfizer falsified data, unblinded patients, employed inadequately controlled vaccinators and was slow to follow up on adverse events. The very same day that she emailed her complaint to the FDA she was fired from her position. 51 She subsequently commenced litigation under whistle-blower legislation for fraud against Pfizer on behalf of the American Government (and the people of the US). Pfizer’s motion to dismiss the case (which apparently did not sway the judge) was based on the fact that the FDA had not acted on her (or any other) complaints, hence the allegations were not material to the Government.

I would respond that “natural immunity” isn’t nearly the magical mystical force that Dr. Malhotra represents it to be. After all, if it were, there wouldn’t be claims that you could be reinfected within three weeks, and the Delta wave wouldn’t have resulted in so many reinfections of people who had had the original strain, nor would the Omicron wave have resulted in so many reinfections of people who had had Delta or the original strain. Second, Dr. Malone is antivax, period. He’s even starting to embrace more “traditional” pre-pandemic antivax views. The BBC’s characterization of him was accurate. Finally, that story cited by Dr. Malhotra was a shoddy piece of “investigative journalism” by conspiracy theorist Paul Thacker, whose many shortcomings I have discussed in depth more than once.

And, of course, Dr. Malhotra blames social media platforms for spreading “misinformation”:

Social media platforms continue to be guilty of spreading misinformation. Their business model that focusses on increasing engagement at any cost makes society increasingly lose access to the truth and worsens our capacity for empathy as individuals, sowing even greater division and hostility. The so-called ‘fact checkers’ have censored anything that challenges the prevailing mainstream narrative (the establishment is trustworthy, and the vaccines are completely safe). They even labelled the BMJ‘s investigation into potential fraud in Pfizer’s pivotal trial as misinformation and stopped users sharing the story on their platform. A letter from the journal’s current and former editor in chief to Mark Zuckerberg calls into question the integrity of Facebook’s fact checkers:

[R]ather than investing a proportion of Meta’s substantial profits to help ensure the accuracy of medical information shared through social media, you apparently delegated responsibility to people incompetent in carrying out this crucial task.53 (p. 1)

Again, Paul Thacker’s “investigation” was trash, as I discussed on SBM. Moreover, as I wrote elsewhere, the editors of The BMJ did not exactly cover themselves in glory when they wrote that open letter, given that they basically did not refute any of the fact checking that showed quite clearly how shoddily-reported Thacker’s “bombshell” was.

Dr. Malhotra also can’t help but ride his favorite hobby horse, his claim that you can optimize your “metabolic health” in 21 days to make yourself magically immune to severe complications from COVID-19:

The government and medical authorities should have made it a priority to emphasise the importance of eliminating ultra-processed foods and low-quality carbohydrates to reduce risk. They could have made the public aware that reversal of metabolic syndrome has been shown to occur in up to 50% of patients – independent of weight loss – within four weeks of dietary changes alone.61

Of course, Dr. Malhotra has never been able to show anything resembling robust data that this reversal decreases these patients’ risk of severe disease and death from COVID-19. Don’t get me wrong; no one is arguing that weight loss and diet changes don’t improve health or decrease the risk of chronic diseases. What I question is Dr. Malhotra’s claims that “metabolic optimization” is some sort of magic bullet against COVID-19, to the point where, in the middle of a pandemic, the government should have made it a priority over measures designed to slow the spread of the disease and, after vaccines were made available, to get as many people vaccinated as possible.

Certainly, nothing Dr. Malhotra has written justifies this hyperbole:

The profession must explain that optimising metabolic health will give patients the best chance for ensuring they are not just resilient to infection but reducing their risk of chronic disease including heart disease, cancer and dementia.

The time has come to stop misleading evidence flowing downstream into media reporting and clinical decision making and resulting in unethical and unscientific policy decisions. It’s time for real evidence-based medicine (Box 464).

The irony is, of course, that Dr. Malhotra claims the mantle of “real evidence-based medicine”, even as he cites low quality studies and invokes conspiracy theories to imply that COVID-19 vaccines likely do more harm than good and demand access to the full raw data from the Pfizer and Moderna clinical trials, while ignoring all the real-world evidence evaluating safety and efficacy since. I’ll repeat a simple observation and conclusion that I made four weeks ago. It’s been nearly two years since the randomized clinical trial (RCT) results for the Pfizer and Moderna vaccines were first reported. Both of these trials involved only ~43K and ~30K participants, respectively. Even large randomized clinical trials used to approve drugs and vaccines miss less common adverse events (AEs), including serious AEs (SAEs). That’s why we do post-marketing surveillance studies, particularly for vaccines. Less common AEs sometimes don’t show up until after a vaccine is rolled out and distribution goes from a population of tens of thousands to administration to millions, tens of millions, hundreds of millions, and even billions, as has happened with the Pfizer and Moderna COVID-19 mRNA vaccines over the last many months.

In other words, if you are truly interested in the actual real-world safety and efficacy of COVID-19 vaccines right here, right now, in October 2022, then the original RCT data are not the best data to use to estimate rates of adverse events. After all, nearly 13 billion doses of all the COVID-19 vaccines have been administered since then, and numerous countries have safety and efficacy data. That’s why I consider Dr. Malhotra’s call for the raw data at the end to be arrogant and performative:

We must use this as an opportunity to transform the system to produce better doctors, better decision making, healthier patients and restore trust in medicine and public health. Until all the raw data on the mRNA COVID-19 vaccines have been independently analysed, any claims purporting that they confer a net benefit to humankind cannot be considered to be evidence-based.

First off, what does Dr. Malhotra mean by an “independent” analysis? Who would qualify? Which investigators or organizations would he trust as sufficiently “independent” that they would not be unduly influenced by the nefarious machinations of big pharma? More importantly, though, as I’ve said before, there’s one reason, and one reason only, that scientists might want a “reanalysis” of data from a completed and long ago published clinical trial, and that’s if they suspect some sort of serious flaw in the RCT design or how the RCT was carried out. They might even suspect outright fraud. Clearly, that’s what Dr. Malhotra is implying, joining Peter Doshi in his conspiracy mongering. Let’s just put it this way. Even if there were serious problems with the original clinical trials that would call their results into question (not likely, but not impossible), they are almost irrelevant now for the determination of whether the vaccines are safe and effective in October 2022, particularly given the rise of the Delta and now Omicron variants, which did not exist in the summer and fall of 2020, when the clinical trials of the Pfizer and Moderna vaccines were being carried out.

Dr. Malhotra’s article is projection, pure and simple, or, as I put it: “I know you are, but what am I?” He’s accusing conventional medical authorities, big pharma, and social media companies of spreading medical misinformation about COVID-19 vaccines by using the very techniques of misinformation that he claims to decry, such as cherry-picked studies and conspiracy theories, to do it. I know you are, but what am I, indeed.

Author

Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.