The Circular Credibility Problem in Medicine

The Circular Credibility Problem in Medicine

THE CDC’S PROPENSITY TOWARDS DATA FRAUD PERPETUATES THE CREDIBILITY PROBLEM

“The Circular Credibility Problem in Medicine”, and to begin with, it is worth highlighting that there are numerous examples that the US Centers for Disease Control and Prevention (CDC) cannot be trusted in relation to vaccines and infections. The CDC has claimed, for example, that influenza vaccines reduce hospitalisations and mortality even though the randomised trials did not find this. But, the CDC did not also provide a single comment that its claims were based on deeply flawed case-control studies. Similarly, on the 17th of August, Maryanne Demasi published a very disturbing article showing that corruption and scientific misconduct at the CDC are not things of the past.

This was further evidenced by the fact that, in June, the CDC’s vaccine advisory panel met for the first time since being overhauled by Health Secretary Robert F. Kennedy Jr, in order to get rid of the financial conflicts of interest. Kennedy had promised that his new appointees would demand full transparency and scrutinise the evidence before making recommendations.

HOWEVER, if the documentation provided by the CDC to its advisory panel is flawed, it is difficult for the panel to make rational, evidence-based recommendations. And this is exactly what happened when the panel voted about whether to endorse Merck’s monoclonal antibody for babies against the Respiratory Syncytial Virus (RSV), nearly identical to Sanofi’s version, which was approved in 2023. What essentially happened is that the CDC assured the advisory panel committee there were “no safety concerns,” but (of course) there surely were. Professor Retsef Levi, who cast one of the two dissenting votes, noticed a troubling pattern across four major clinical trials conducted by Sanofi. In each, there was a consistent imbalance in “nervous system” serious adverse events, most often including seizures, in the treatment groups compared to controls – which (as a side note), is why control studies are so crucial, and often so ignored by vaccine developers.

In any case, Merck’s Dr Anushua Sinha downplayed the concerns, saying there had been “extensive analysis of the events” and that Merck’s investigators had deemed that none of the nervous system harms were related to its product. Now, this is not reassuring, because if a product developer tells me that its own investigations proved its product safe, I do not have good reason to trust them because they profit from the sale of that product, and thus have a vested interest in ensuring that the product hits the market soon than later, even at the expense of the safety of patients – as has been the modus operandi of the pharmaceutical industry. But, before we proceed, here’s more about the CDC’s credibility problem, which was compounded during the COVID era.

WHAT THE ACIP WAS NOT SHOWN: ADDRESSING A KEY ISSUE FROM THE JUNE 2025 MEETING

Let’s proceed to zoom in on the previously alluded to ACIP meeting, which was their first meeting in June 2025, after Secretary Kennedy disbanded the previous pro-vaccine and financially conflicted ACIP panel. Now, the public expectation concerning this meeting and ACIP panel (as a whole) was clear: and it was that this newly appointed committee would restore rigor, independence, and critical examination of evidence before recommending routine use of new pharmaceutical products. Well, one of the most significant items on the agenda (as we alluded to earlier) was whether to recommend Merck’s new RSV monoclonal antibody, called Cles-rovimab, for routine use in healthy newborns. Though marketed as a new product, it is nearly identical in structure and function to Sanofi–AstraZeneca’s nirse-vimab, which was approved in 2023.

The committee then ultimately voted 5 to 2 in favour of the recommendation. That vote followed a CDC presentation, which framed the safety data as reassuring, leading most members to conclude there were no outstanding safety concerns. But the question then becomes: Was that reassurance justified? And on what exactly was it based?

Well, in answering these questions, deliberate data misrepresentation techniques become exposed. First is that during its June 2025 meeting, ACIP members were shown a safety slide from the CDC’s Vaccine Safety Datalink (VSD), focusing on seizures after administration of nirsevimab. The data were split into two age groups: infants aged 0 to 37 days and those aged 38 days to under 8 months. Each group showed elevated risk ratios for seizures (3.50 and 4.38, respectively), but both were labeled “not significant”; while NO pooled analysis was displayed – meaning the CDC slides did not combine the  multiple studies to create a single, larger dataset for analysis.

However, as Dr Maryanne Demasi later reported, combining the two groups into a single cohort yields a very different picture: in that it reveals a nearly four-fold increase in seizure risk, a result that is statistically significant; and yet that consolidated signal was never presented to the ACIP committee. Not only this, but the decision to stratify at 38 days – which is precisely the point in US schedules when routine infant vaccinations begin – this decision had no clear biological justification, and by dispersing the signal across two smaller groups, it effectively then erased the statistical significance. This then tells us that the CDC knew that if they presented these findings as one larger data, as opposed to splitting into two age groups, it would have revealed a statistically significant elevated risk ratio for seizures in infants, and so, they opted for a representation of the data that concealed the issue. This is what happens when regulatory and policy making authorities (like the CDC) are corrupt, and care more about vaccine manufacturers than the public – they will go as far as to misrepresent data just to get a vaccine approved. But that was just problem number 1.

A second design choice further compounded the problem. In essence, the CDC’s analysis applied a self-controlled risk interval with only the first 7 days designated as “risk” and days 8-21 treated as the “control” period. This simply means that any seizure occurring on day 8 or later in an infant was thus counted by the CDC against the background rate, even though such timing could plausibly reflect a product-related effect. Not to mention, standard pharma-covigilance practice calls for testing multiple windows, not a single narrow cutoff. In any case, these analytical decisions mattered. The vote to recommend cles-rovi-mab passed 5-2. BUT… had the ACIP members been shown the pooled seizure risk alongside the consistent trial-level imbalances in nervous system events, shifting just two votes would have changed the outcome.

Then, finally, as Dr Demasi emphasised, the concern is not confined to just one brand of the RSV vaccine. Given the structural similarity between nir-sevi-mab and cles-rovi-mab, the seizure risk is likely a class effect. This means the omission of the pooled analysis did not just obscure a statistical detail. Rather, it withheld information with direct implications for every RSV monoclonal antibody now in use. AND YET, these findings emerged only through independent reanalysis. Without Dr Demasi’s work, they may have remained unknown – not only to the public, but even to ACIP members casting their votes. And so, I hope you are beginning to appreciate what I stated at the beginning of our discussion, which is that: with all the structural and personnel changes that are being implemented by the Trump administration, if we do not fix how medical literature and data from studies are collected and represented, we risk perpetuating the same problems only with new structures and personnel at the helm.

LIVES ARE DESTROYED WHEN THE CDC SPEWS MISLEADING DATA

But, as you would imagine, there is more than information integrity at risk when the CDC churns out misleading data about vaccines. To be more blunt, this practice of misleading data actually makes the CDC culpable for the deaths of many. And this is considering that as the ACIP deliberated without access to full trial data, an even more alarming pattern was already unfolding in the real world. In particular, a warning sign was already visible in the clinical trials: in that infant deaths in the treatment groups were twice as frequent as in the control arms – which is a signal that should have triggered immediate scrutiny.

Meanwhile, it emerges that this was not even the only red flag kept from the ACIP committee, because an analysis of real-world data from the FDA’s adverse event reporting system (FAERS) reveals an even starker reality: since Sanofi’s Beyfortus (nirsevimab), which was approved and added to the US infant immunization schedule in 2023, there have been 1,012 adverse event reports – including 37 infant deaths, which (by the way) is a concentration rarely seen in paediatric vaccine safety profiles. And yet, all of this is happening because the CDC is a highly politicised organisation, that has been corrupted by pharmaceutical corporations – even to the extent that it is willing to cover up the deaths on infants, all so it can continue to parade vaccines as a safe necessity. The CDC has really earned its reputation for notoriety.

THE FOUNDATIONAL FLAW IN VACCINE SAFETY SCIENCE

But, let’s dig deeper into the faulty nature of how medical literature and safety studies are conducted and presented. A bombshell admission from within the ACIP committee has exposed a foundational flaw in vaccine safety science. During a discussion on MMRV and Hepatitis B vaccines, committee member Dr Retsef Levi pointedly questioned the confident “safe and effective” declarations made in the absence of gold-standard evidence.

Now, Dr Retsef Levi’s statement cuts to the core of a decade-long demand from transparency advocates: which is a demand for an answer to the question on why none of the vaccines on the CDC’s routine schedule have been licensed based on placebo-controlled trials using an inert saline placebo. This revelation is now forcing a public defense of this practice. A recent PBS article quotes experts arguing that placebo trials are apparently “unethical” once a vaccine exists, as the so-called “standard of care” is the older vaccine. Let’s directly respond to this. Simply, the problem with this is that this logic creates an unsolvable circular problem, where new vaccines are only tested against older vaccines, and NOT a true placebo, which then means that the original safety benchmark for the first vaccine in a class of vaccines is never established against a neutral control. As a result, the entire schedule rests on a pyramid of relative comparisons, with no absolute baseline for safety. And yet, this is what they are propping up as the gold standard of vaccine safety science – just relative comparisons to previous vaccines, which probably also had inherent flaws, as taught to us by the history of the smallpox vaccine. In any case, that is the response to the claim made in the PBS article, arguing that placebo trials are apparently “unethical” once a vaccine exists.

VACCINE DEVELOPERS ALSO DETEST PLACEBO-CONTROLLED TRIALS

Then the second argument in the PBS article trying to defend why NONE of the vaccines on the CDC’s routine schedule have been licensed based on placebo-controlled trials using an inert saline placebo, tries to dismiss using unvaccinated populations (like the Amish) as controls, claiming that their lifestyles are too different. The simple response to this is that this obviously leaves a critical question unanswered: which is that if we cannot ethically conduct a gold-standard trial and cannot use existing unvaccinated groups, how can we ever truly know the long-term health impacts of the entire vaccination schedule? And again, this brings me to something I alluded to earlier, which is that vaccine manufacturers detest control studies. They fight hard against comparing vaccinated groups against those who are not vaccinated: this is why they have fought hard to cover one of the biggest control studies conducted in light of the childhood vaccine schedule – being the study from the Henry Ford Health System in Detroit.

More specifically, you’d recall that on the 9th of September, attorney Aaron Siri testified before the US Senate’s Permanent Subcommittee on Investigations during the hearing titled: “How the Corruption of Science has Impacted Public Perception and Policies Regarding Vaccines.” In his sworn testimony, Siri revealed the results of a long-hidden study from the Henry Ford Health System in Detroit, MI. This is the largest vaccinated vs unvaccinated birth cohort study ever conducted in the United States (looking at 18,468 participants). Children were tracked from birth over a 10-year period. The data were drawn directly from electronic medical records — the gold standard for real-world health outcomes.

The study’s official title is (quote): “Impact of Childhood Vaccination on Short- and Long-Term Chronic Health Outcomes in Children: A Birth Cohort Study.” The measures and outcomes of this study come directly from the testimony of Aaron Siri, who presented these findings under oath in the US Senate, as unfortunately, the study is not yet publicly available (again, considering that it was largely hidden for the longest time).

The key findings from the Henry Ford Health System study found that, compared to unvaccinated children, those who received one or more vaccines had dramatically higher rates of chronic illness; specifically 329% more asthma, 203% more atopic disease, 496% more autoimmune disease, 453% more neurodevelopmental disorders, 228% more developmental delays, and 347% more speech disorders. In light of these findings, Aaron Siri testified that all of these findings were statistically significant. And even more striking is that, in conditions where unvaccinated children had zero cases (and this is looking at conditions like brain dysfunction, ADHD, learning disabilities, intellectual disabilities, and tics), there were hundreds of cases among the vaccinated group!

RELATIVE COMPARISON IS A DANGEROUS STANDARD IN MEDICINE

Finally, and to expand further on why the defence of relative comparison to a previous product cannot stand, we ought to address this standard of relative comparison in light of the issues with medical devices. The FDA often prioritises having a faster pathway for what are said to be low-to-moderate risk medical devices through what is called the 510(k) process. How this works is that for many Class II (or moderate risk) devices, approval is based on demonstrating “substantial equivalence” to a legally marketed “predicate device”, and a predicate device is a legally marketed medical device used as a benchmark – in other words, the 510(k) process is a relative comparison standard.

Well, they claim that this is good to fast track medical devices, especially those that are said to be moderate risk. But did you know that based on this standard or relative comparison, people have received joint replacement devices made of metal that poisoned their blood stream from the tiny metal pieces that would be released through friction? Did you know that pacemakers, implantable cardioverter defibrillators are injuring hundreds and killing others? In fact, in April 2024 (alone) the FDA recalled medical devices that mechanically pump blood to the heart because they caused hundreds of injuries and more than a dozen deaths. And so, the medical device industry is proof that relative comparison is a ridiculous standard to enforce in medicine.

Written By Lindokuhle Mabaso

Leave a comment

Your email address will not be published. Required fields are marked *