Despite Progress In Data Transparency, The FDA Still Keeps Its Data Secret

despite-progress-in-data-transparency,-the-fda-still-keeps-its-data-secret

History shows that hiding clinical trial data can be deadly.

Vioxx is a well-known example of how the US drug regulator withheld important information about the harms of the drug for over three years, before it was withdrawn from the market and tens of thousands of people died as a consequence.

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Numerous initiatives have been launched over the past two decades to improve access to trial data after it became evident that what was reported in peer-reviewed journals was often cherry-picked and misleading.

Eminent scientists have succeeded in gaining access to trial data from the European and Canadian drug regulators, but a recent analysis published in the Journal of Law, Medicine, & Ethics, found that the US FDA still lags behind others when it comes to data transparency.

Europe ahead of the pack

Drug regulators have traditionally been the guardians of a treasure trove of trial data which they kept hidden from the public. But, over a decade ago, the efforts of Danish professor Peter Gøtzsche turned that on its head. 

Gøtzsche and his PhD student were studying the effects of an anti-obesity drug and requested the trial data held by the European Medicines Agency (EMA).

“We already had good evidence that the efficacy and harms of drugs were incompletely reported in the medical journals, so by asking for the regulatory data for the anti-obesity pills, we were convinced it would get us closer to the truth”, said Gøtzsche.

At first, EMA denied their request, saying that it needed to protect commercially confidential information, but Gøtzsche was undeterred. He made a formal complaint to the European Ombudsman.

After an arduous 3-year process, the Ombudsman accused EMA of “maladministration” for refusing to share its data – it was a serious and embarrassing charge, so EMA had no choice but to capitulate.

In 2013, EMA announced that it would provide public access to regulatory data – which included study reports, protocols and the raw anonymised patient data in statistical programmes enabling anyone to independently scrutinise the data for all new drugs that it approved.

It was a bitter-sweet moment for Gøtzsche. 

“I was satisfied with the outcome, but I also felt a bit betrayed. When EMA praised itself for being transparent, it conveniently omitted telling the public that it was basically forced to make the decision because of my efforts and that of the Ombudsman,” said Gøtzsche.

“I’ve been around a while to know that this is exactly how the drug industry operates. They cover up their failures while praising themselves for what others force them to do,” he added.

Millions of pages containing trial data have since been released. Interestingly though, this remarkable feat has gone largely unrecognised and the response from the research community has been rather tepid.

Gøtzsche suspects it’s because analysing regulatory documents is complex and requires experience to decipher regulatory data – skills that few researchers have. 

“It is a huge job to do systematic reviews of clinical study reports held by drug regulators, but it is the difference between producing reliable reviews or merely “garbage-in, garbage-out” reviews,” said Gøtzsche.

Since then, Gøtzsche’s group showed this was the case for reviews of antidepressant drug trials. 

When they compared data from medical journals to that from regulatory documents, they found major discrepancies such as underreporting of harms, including suicide attempts and aggressive behaviour.

Canadian regulator in the cross hairs

Following the landmark policy change in Europe, researchers believed it would help unlock regulatory documents elsewhere that were historically kept hidden from the public.

In 2016, Peter Doshi, professor at the University of Maryland and senior editor of The BMJ requested the release of unpublished clinical trial data relating to antivirals for the treatment of influenza (Tamiflu, Relenza) and three human papillomavirus vaccines from the Canadian drug regulator, Health Canada.

After some resistance, Health Canada agreed to allow Doshi access to the documents but imposed a confidentiality agreement that would prevent him from making his findings public.

When Doshi refused to sign the confidentially agreement, his request for access to the trial data was denied, so he filed a lawsuit in a federal court seeking a judicial review of the regulator’s decision.

Remarkably, in 2018, in the case of Peter Doshi v. Attorney General of Canada, a federal court judge ruled in favour of Doshi and in the public’s interest, ordering Health Canada to hand over the trial data for independent scrutiny.

It was hailed a “major victory” for transparency and after the win, Doshi told The BMJ, “For me this case has always been about something larger than my specific request. It is about the principle of transparency. If my case sets a precedent and Health Canada begins making clinical trial data available to others—promptly, and without imposing confidentiality agreements—that will be the real victory.”

Notably, the Canadian drug regulator has gone one step further than EMA by proactively releasing data for not only approved drug submissions, but also“unapproved, and withdrawn drug and biologic submissions…Class III and IV medical device applications.”

What about the US FDA?

The US FDA houses the largest known repository of clinical trial data in the world, but it doesn’t proactively share it.

In 2018, the FDA launched a new pilot program to proactively publish clinical study reports from the pivotal studies of nine recently approved drugs – but the agency put an end to that program in March 2020.

“It is just so typical of the FDA, which is very beholden to industry, and which some have dubbed the Foot Dragging Agency when it comes to the public interest,” said Gøtzsche.

Now, the only mechanism to ascertain regulatory data for FDA-approved drugs is to submit Freedom of Information Act (FOIA) requests, a lengthy process which often results in heavily redacted documents of limited value.

study by US researchers, analysed the FDA’s willingness to release data, compared to other regulators, EMA and Health Canada.

They found that between 2016 and April 2021, EMA released data for 123 unique medical products, while Health Canada released data for 73 unique medical products between 2019 and April 2021.

In stark contrast, the FDA only proactively disclosed data supporting one single drug that was approved in 2018, clearly demonstrating that the agency has failed to keep pace with the European and Canadian regulatory bodies.

The problem of data secrecy within the FDA has been especially evident during the pandemic. Recently, I reported in The BMJ that the agency had failed to disclose covid-19 vaccine ‘safety signals’ derived from post-marketing data.

Also, the non-profit group, Public Health and Medical Professionals for Transparency had to sue the FDA for access to trial documents used as the basis for licensing Pfizer’s covid-19 mRNA vaccine. Initially, the agency wanted 75 years to release all the data but a Federal Court Judge rejected its request, ordering the release of the documents at a rate of 55,000 pages per month, taking approximately 8 months.

Given the widespread use of this important public health intervention, and the billions of dollars in public funds used to conduct vaccine research and development, these data should have been made publicly available immediately.

Data secrecy has undermined the health care system by subverting the allocation of scare resources and eroding public trust. The damage done to people’s confidence in vaccines, and medicines more broadly, will be felt for generations and likely to harm public health.

FDA Silent On Covid-19 Vaccine Safety Signals

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My latest investigation for The BMJ reveals that, in July 2021, the US Food and Drug Administration (FDA) quietly disclosed findings of a potential increase in four types of serious adverse events in elderly people who had had Pfizer’s covid-19 vaccine:

  • acute myocardial infarction, 
  • disseminated intravascular coagulation, 
  • immune thrombocytopenia, and 
  • pulmonary embolism.

More than one year later, however, the agency has not issued a press release, or notified doctors, or published the findings via preprint or the scientific literature or updated the vaccines’ product label.

I spoke with leading doctors about the FDA’s failure to inform the public of these vaccine safety signals, and the consequences of keeping such information secret.

Here is a FREE LINK to the article and a link to the PDF

Republished via the author’s Substack.

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New Law Seeks To ‘Gag’ Doctors Contradicting Consensus On Covid-19

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This week, California Governor Gavin Newsom signed Assembly Bill 2098 into law, which allows the state’s medical board to punish doctors for disseminating “misinformation” or “disinformation” regarding covid-19.

The new law states that doctors should not contradict “scientific consensus” on covid-19, or they could be charged with “unprofessional conduct,” and possibly have their medical license suspended or revoked. 

Criticism of the law has been swift and fierce. Doctors object to being told they need to “stick to the script”, saying it violates their right to speak freely and openly with their patients. 

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Jay Bhattacharya, professor at Stanford School of Medicine says the new law will have a “chilling” effect on free speech.  He tweeted, “The attempt to regulate medical speech violates civil liberties, harms science, and will ultimately harm patients. California doctors now serve public health more than patients.”

Aaron Kheriaty, a fellow at the Ethics and Public Policy Centre said, “It’s a way to force scientific consensus where none exists by threatening physicians who challenge the government’s preferred COVID policies, threatening them with the most severe form of professional punishment that a doctor could receive, which is discipline against the doctor’s medical license.”

What is misinformation?

The California law states; 

“Misinformation” means false information that is contradicted by contemporary scientific consensus contrary to the standard of care.

Laura Powell, a civil rights attorney, and founder of Californians for Good Governance said, “No clear scientific consensus exists with respect to this novel virus, and even if it did, it may be proven incorrect later.”

“Without clear guidance regarding what would constitute “misinformation,” physicians can only guess if they risk losing their licenses for expressing their good-faith disagreements with positions of public health officials,” added Powell.

The law also states that “physicians have a duty to provide their patients with accurate, science-based information,” and cites the US Centres of Disease Control (CDC) as one such reliable source. 

But as Tracey Beth Høeg, a California-based physician and public health expert, points out, “Ironically, the new law already contains misinformation. It says that unvaccinated individuals are at 11 times greater risk of dying from covid than fully vaccinated individuals, but this contradicts the CDC website, which says its only 5 times the risk.”

The CDC website also states that “masks are recommended in indoor public transportation settings,” and that “children aged 2 years and older can wear masks or respirators to protect themselves and others from covid-19”. 

But wearing masks during the pandemic has been a hotly contested issue with wildly different interpretations of the evidence. 

“There’s certainly no clear scientific evidence for the use of cloth masks in community settings. If anything, the consensus of the research literature would suggest that masks outside of strictly controlled settings are not useful for respiratory viruses,” said Kheriaty.

Dr Eric Widera, professor of Medicine, University of California San Francisco agreed, “When I tell my patient that cloth masks don’t work, who decides if that is misinformation or [the] current state of the science?”

Kheriaty says trying to codify a particular scientific consensus into law makes no sense and is “totally incompatible” with science. 

“Anyone who attempts to do that does not really understand how science advances. It’s not through consensus, but through conjecture, and refutation, and debate and argumentation,” said Kheriaty.

An ethical breach

As an expert in ethics and public policy, Kheriaty says he struggles to think of a bill that would more radically undermine the trust between a patient and a doctor.

“Patients who ask their physician a question about COVID, want to hear what their physician actually thinks, not some predetermined script prepared by public health bureaucrats,” said Kheriaty, “A physician with a gag order, is clearly not a physician that you can trust.”

He said the politicisation of covid-19 presents some serious ethical dilemmas. “The medical board [assessing the cases] is ultimately appointed by the state governor so, it’s not very difficult for the governor or the executive to use the medical board as a long arm of enforcement for those preferred policies,” said Kheriaty.

“They can strong arm physicians to fall into line with their policies – policies which may have been influenced by financial inducements by pharmaceutical corporations. Politicians are now making our health recommendations, not the physicians,” he added. 

recent analysis of lobbying and campaign contribution data from OpenSecretsshowed that the pharmaceutical industry spent at least US$142.6 million on lobbying Congress and federal agencies in the first half of 2022, more than any other industry.

Kheriaty said, “Senator Richard Pan, who introduced and co-wrote this legislation has been in the back pocket of Big Pharma for his entire political career, as evidenced by his campaign contributions.”

Senator Pan’s office was contacted for comment but did not respond by the deadline.

Australia set to follow California’s footsteps

Amendments to a bill (Health Practitioner Regulation National Law Act 2009) have been put before the Queensland Parliament, due to be debated and voted into law on 11 Oct 2022.

The proposed amendments, which appear to have broader implications beyond advice about covid-19, has angered medical groups like the Australian Medical Network (AMN), representing over 10,000 health professionals and private citizens. 

In a media release, the AMN stated:

Doctors will no longer be able to express their opinion or use their experience, training, and education, if their opinion goes against what the health bureaucrats say is in the interests of “public confidence in safety”. Doctors will be bound to follow government policy, which means that government health bureaucrats will determine how doctors should approach treatment recommendations for their patients.

If passed in Queensland, it will also apply to all the other States and Territories, (except for Western Australia and South Australia) because the health professions are regulated through a co-operative national scheme.

Writing under a pseudonym for fear of reprisal, *Dr Frank Mercy* who is currently employed at an Australian university said, “Healthcare is nuanced, almost every day I ‘violate’ textbook recommendations because patients do not conform to idealised representations, each has unique features. Those deviations come down to experience, which is the patient’s and doctor’s most powerful asset.”

Tony Nikolic, civil rights lawyer at AFL solicitors, says it’s critical that doctors have the capacity to question, and challenge matters relating to public health.

“Doctors go through rigorous education and training and should be allowed to voice their medical and professional opinions freely. Disciplining doctors who use their skill, care and diligence to inform patients about matters relating to safety and efficacy is open to abuse and capture,” said Nikolic.

“The doctor-patient relationship is sacred. It should remain confidential and independent of bureaucratic or political interference,” he added.

Reposted via the Author’s Substack

I’ve Just Been Released From LinkedIn Jail…I'm Out On Parole

i’ve-just-been-released-from-linkedin-jail…i'm-out-on-parole

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Recently, LinkedIn suspended my account, a platform claiming to be “the world’s largest professional network on the internet.”  Over the years, I accrued thousands of “network connections,” and in the blink of an eye, it all disappeared.

I’m not the first, and I won’t be the last.  I join a long list of dissidents — professors with unimpeachable reputations, such as Harvard University‘s Martin Kulldorff and Flinders University’s Nikolai Petrovsky, who were abruptly cancelled after expressing their objections to covid-19 vaccine mandates.

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As many of you know, this heavy-handed approach is not unique to LinkedIn – YouTube, Twitter and Facebook are among the social media platforms censoring information purported to violate their “covid-19 professional community policies.”

LinkedIn gave me a warning. My first offence was posting an article titled “FDA authorised new mRNA formula for kids without a clinical trial.”

I interviewed eminent experts such as Tom Jefferson, epidemiologist at the University of Oxford, about the lack of regulatory oversight after Pfizer changed the formulation of its mRNA vaccine and rolled it out to millions of children without clinical trials.

LinkedIn notified me that the post had been blocked from public view. I had an opportunity to appeal the decision, and I did, but heard nothing in return. 

Two weeks later, I posted an article titled, “A 5th jab – implications for the immune system.”

I interviewed Cody Meissner, professor at Tufts University School of Medicine, who spoke candidly about his concerns over the potential adverse impacts on a person’s immune response after repeated covid-19 boosters.

LinkedIn explained that my articles violated their “Professional Community Policies.”  I asked for details on which specific claims were alleged to be “false” or “misleading” and any corresponding references.

They would not play ball. 

Instead, LinkedIn stated it “wouldn’t be able to interpret our User Agreement and professional community guidelines any further,” and pointed me to its website: 

“Do not share content that directly contradicts guidance from leading global health organizations and public health authorities; including false information about the safety or efficacy of COVID-19 vaccines.”

The policy defies logic. 

Not only does it fail to define what it considers to be “false information,” the guidance from different “leading global health organisations and public health authorities” varies significantly. 

The US, for example, recommends boosters for everyone over the age of 12, whereas Denmark no longer recommends boosters for healthy people under 50.

Also, the decisions on who will be censored are inconsistent. For example, Thomas Wilckens, a medical doctor and entrepreneur, posted information that was ultimately removed from LinkedIn, but the same data posted by someone else, remained public.

I was interested to know how my articles came to the attention of LinkedIn censors. Did certain words in my article trigger an algorithm or did someone submit a vexatious complaint?  Again, LinkedIn refused to explain:

“We are not in a liberty to share the details about the reason that led to an account restriction or our internal findings.”

So, it’s a black box – no transparency, no insight into the fact-checking process and no procedural fairness.

In order to have my account reinstated, I had to agree to comply with the platform’s User Agreement and Professional Community Policies. I was also warned that any further violation would result in my permanent cancellation from the platform.

I superficially agreed to avoid further breaches, and in return, my account was reinstated.  I have just been released from LinkedIn jail and I am now on parole.

Over the last few days, many readers have asked for details on why I was suspended from the platform and how I managed to get reinstated – so here it is.

While I’m none the wiser about what specifically triggered the censorship, it has been an effective deterrent. I doubt that I will post covid-19 vaccine articles on the platform in the future.

Reposted from the Author’s Substack

A 5th Jab? Implications For The Immune System

a-5th-jab?-implications-for-the-immune-system

Following the recent authorisation of the new omicron boosters, the former US Surgeon General encouraged Americans to receive two to four mRNA jabs annually. 

Residents in northeast Australia have been told they might need a fifth dose by the end of the year.

In fact, it wasn’t that long ago that New South Wales’ top doctor said that people should expect to receive covid-19 booster shots “indefinitely.”

But could repeated boosters at close intervals be causing more harm than good?  I speak with experts concerned that policymakers are not following the science.

Europe Sounded the Alarm

Earlier this year, the European drug regulator sent a dire warning to the world.  The agency was concerned that repeated boosters every four months could weaken a person’s immune response to the coronavirus.Marco Cavaleri, the agency’s head of vaccines strategy, said that regular boosters might be “overloading people’s immune systems and leading to fatigue.” I spoke with Cody Meissner, an FDA advisory member, ahead of the agency’s April 6 meeting, during which experts were to discuss the evidence for a fourth dose.  He told me that he was not convinced by the data at the time. 

Prof Cody Meissner, FDA advisory member

“I personally don’t think that we have sufficient basis on which to recommend a fourth dose, and we don’t know what the harm will be,” said Meissner.

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“The reason we’re giving the vaccine is to keep people out of the intensive care unit and to keep people from dying, or even going into the hospital. So, before we vigorously endorse a fourth dose of this vaccine, I think we have to understand not only more about the immune response, but also about how much severe disease is occurring after three doses,” he added.

Meissner blamed socio-political interference for many of the questionable covid-19 strategies. “I think that the politicians and certain groups within society, such as the teacher’s union here in the United States, have driven a political agenda that is certainly not based on science. People like to say it’s based on science. It’s not. It’s based on emotion and generating great fear,” said Meissner.

Despite the concerns, most policymakers have forged ahead with recommending third, fourth and fifth doses for large swathes of the populations.

But over the past year, observational data have emerged from countries like the UK, Scotland and Australia showing that the most highly vaccinated people are acquiring the highest rates of covid-19 infections, suggesting that the vaccines have lost their effectiveness or something unexplained is happening.

Multiple jabs, multiple infections

Meissner hinted at a possible explanation for why someone’s immune response could be suppressed after multiple covid-19 shots. “It gets into this issue of ‘original antigenic sin’, which is still a theoretical issue, but may have some validity it seems to me,” said Meissner earlier this year.

Original antigenic sin – scientifically referred to as immune imprinting – is a phenomenon whereby prior exposure to one virus strain (e.g. wuhan stain) limits the development of immunity against new variants (omicron strain), because the immune system has been “imprinted” to favour the original strain.

This leaves the immune system trapped because the antibodies it prefers to produce against the original strain are ‘mismatched’ for the new strain. 

Meissner said, “To keep vaccinating with very similar [wuhan] antigens, may or may not be beneficial — or the benefit may not outweigh the harm. I think we need to look at that.”

Since then, the data suggesting that immune imprinting is occurring, has only strengthened says Nikolai Petrovsky, Professor at Flinders University and developer of a protein-based covid-19 vaccine called SpikoGen® in use in Iran.

Prof Nikolai Petrovsky, Flinders University

“I feel the evidence for immune imprinting is increasingly compelling. It’s a known phenomenon with flu where it was first described, and the data now suggests it’s happening with covid-19,” said Petrovsky.

“The omicron vaccines may struggle to switch the immune system of a heavily vaccinated person to making omicron-specific antibodies, as their immune system is so heavily biased toward the Wuhan spike protein in the original vaccines. In the end, this could be harder to achieve in a vaccinated person than someone who has not yet been exposed to any spike protein, for example, someone unvaccinated,” he added.

Petrovsky says not only do too many shots of the mRNA vaccines increase the risk of immune imprinting, but they also seem to be uniquely pushing the immune system into “tolerance” against the virus.

“Immune tolerance” occurs when the immune system becomes unresponsive to a particular antigen after repeated exposure. This is the principle for desensitising people to allergy, i.e. by repeatedly injecting them with small doses of the offending allergen over time.

Petrovsky points to a recent pre-print study out of Germany.  “People who’ve had three or more doses of mRNA showed a change in their antibodies to IgG4 which is typically an antibody associated with allergy desensitisation but not a normal antibody seen produced after infectious disease vaccines,” said Petrovsky.

Petrovsky said, “What this means, we simply don’t know as this has never been seen before.  That in itself is concerning as it indicates just how little we understand about what these new mRNA vaccines are doing and how they work. But to me, it raises a red flag that repeated doses of the mRNA vaccines might be driving immune tolerance against the virus. Maybe this could explain why the more doses of these vaccines, the less they seem to work, and more and more people are getting breakthrough infections?” Interestingly, the study did not find a similar shift in antibody patterns after AstraZeneca’s covid-19 vaccine.

Now, that the FDA has authorised the new bivalent boosters – which code for the original wuhan strain plus BA4/BA5 omicron lineages – without first requiring any human data to be collected, it has left many doubting that our public health authorities are even paying attention to the science.

Reposted from the author’s Substack

The Serious Adverse Events of mRNA Covid-19 Vaccine Trials

the-serious-adverse-events-of-mrna-covid-19-vaccine-trials

In December 2020, the US FDA authorised the Moderna and Pfizer mRNA covid-19 vaccines, claiming “the benefits outweighed the harms.”

Now, a group of international researchers has gone back to re-analyse the original trial data upon which that claim was made. 

A Valid Claim?

A pre-print study (not yet peer-reviewed by Fraiman and colleagues contradicts the FDA’s claim that the benefits outweigh the harms of the mRNA vaccines. In fact, the authors conclude that the vaccines are associated with an “increased risk of serious adverse events” that surpass the “risk reduction for covid-19 hospitalization” relative to the placebo group.

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The conclusion is provocative. While some have criticized the study for fuelling ‘anti-vax’ sentiment, many have welcomed the independent scrutiny of the trial data.

The researchers focused on analyzing serious adverse events – specifically, they narrowed it to serious adverse events of “special interest” which were derived from a predefined list by the Brighton Collaboration, an established framework for vaccine safety used for over two decades.

The advantage of this method is that it removes adverse events that are unlikely to be vaccine-related such as gunshot wounds and car accidents, thereby removing ‘noise’ from the analysis.

They also pooled the trial data for the two mRNA vaccines which increased the sample size and achieved higher confidence in the results (more precision). 

The upshot of the analysis was that mRNA vaccines were associated with an absolute risk increase of serious adverse events of 12.5 per 10,000 vaccinated people (95% CI 2.1 to 22.9) over placebo.

Put another way, 1 in 800 people experienced a serious adverse event following either one of the mRNA vaccines (95% CI: 437 to 4762).That is very high for a vaccine.

“No other vaccine on the market comes close,” says Martin Kulldorff, professor of medicine at Harvard (on leave) and former CDC vaccine safety committee member who was not involved in the study. 

Kulldorff says the closest any other vaccine on the US market comes to this is the MMRV vaccine which is no longer recommended for 1-yr-olds because they found the excess risk of febrile seizures was 1 in 2300 compared to separate MMR and Varicella vaccines (no excess risk in 5-yr olds).

The Fraiman study found that coagulation disorders and cardiovascular problems were driving most of the serious adverse event in the trials, which seems to corroborate reports in the pharmacovigilance databases.

Kulldorff says that while randomized trials offer high level evidence for a causal association between the vaccine and harms, we can acquire valuable information from pharmacovigilance data which are based on millions of vaccinations.

The superior databases for recording adverse events comes from the CDCs Vaccine Safety Datalink (VSD) and the FDA’s Biologics and Effectiveness Safety System (BEST). But there’s a problem – the agencies do not analyze the data and present them to the public.

“It’s a scandal” says Kulldorff. “In July 20221, the FDA came out with a  press release saying that it had found a signal with cardiovascular problems but there’s been no published follow up. A signal may be real or an artifact, but it’s the FDA and CDC’s obligation to be open and transparent with the public, showing that vaccines are safe when they are safe and to be honest when there are adverse reactions” he adds. 

Kulldorff says these agencies have been derelict in their duty and the result has been vaccine hesitancy.

“That’s why we do this vaccine safety work, to build trust for the vaccines – measles, polio, rotavirus vaccines, the list is long.”

The way that the FDA and CDC have fumbled with the covid-19 vaccine, I think has had extremely bad consequences on the trust in other vaccines as well as in public health generally,” says Kulldorff.

Do the harms outweigh the benefits?

Jay Bhattacharya, professor of Medicine at Stanford University says that determining whether the benefits outweigh the harms is not black and white. It depends on a person’s age since there’s a 1000-fold difference in the infection fatality rate between young and old.

Looking back at the pivotal mRNA trials, Bhattacharya says,

“There’s no firm age cut-off, but for an immune naïve patient facing the alpha or delta variant, I’d say the balance of risks and benefits favoured vaccinating everyone over 65 and not recommending it for most people below 30.”

Jay Bhattacharya

What about those aged between 30 and 65 years? 

Bhattacharya says,

“For the ages in between, it was a grey area where vaccination made sense for some and not others, depending on risk factors like diabetes and morbid obesity and, of course, prior infection. As a population wide recommendation for young people, I think it was a mistake.”

Jay Bhattacharya

Kulldorf agrees.

“The right thing to have done at the time was to authorise the vaccines for older people who are at higher risk of dying from covid-19, people in their 70s, 80s and 90s – not for younger people. But we still don’t know where the cut-off should have been.”

Martin Kulldorf

It’s one reason why Kulldorff has argued against mandating the vaccines. “If you don’t know the risks, you should let people make their own decision, give all the information you have and not force people to take it,” says Kulldorff.

“Also, the FDA should have demanded that the original trials be designed for important outcomes, like hospitalizations, and deaths, and they should have done the trial with older people because they were poorly represented in the original trials,” adds Kulldorff.

In 2020, only a small proportion of subjects in the original clinical trials had prior exposure to the virus, but today the situation has changed — a large proportion of people in the west have natural immunity.

“If people have been previously exposed to the virus and recovered, they have better immunity than the vaccine itself can provide, and I think now it’s going to be of limited use, population wise, compared to 2021,” says Bhattacharya.

Upon reflection

The Fraiman analysis has revealed that the FDA and the CDC underplayed the harms of the mRNA vaccines in Dec 2020. By authorising and recommending a population-wide vaccination campaign, authorities neglected to focus on protecting the elderly, and exposed many younger people to unnecessary harm. As the pandemic progresses, and new variants emerge, the benefits of the mRNA vaccines will continue to diminish, while the harms are likely to compound.

For more on making sense of COVID vaccines, please see our presentation below.

Republished from the Author’s Substack.