Do groupthink and politics drive federal healthcare policy, including U.S. Food and Drug Administration (FDA) regulatory decisions? TrialSite has suggested for nearly a couple of years now that a growing gap exists between actual science and COVID-19 federal decisions, from industry bias to an irrational mass vaccination to eradicate the SARS-CoV-2 pathogen to even discussions about the origin of the virus. Now Johns Hopkins University MD and professor Martin Makary addresses this important topic in what some might consider a controversial Wall Street Journal (WSJ) opinion piece titled “FDA Shuts Out its Own Experts in Authorizing Another Vaccine Booster.”
Trouble mounts at what has traditionally been the world’s best regulatory agency. Yet the perspective of regulatory capture, politics, and groupthink put the FDA in trouble. Philip Krause and Marion Gruber, two former high-profile FDA officials who knew there was trouble, quit in September due to the politicization of the vaccination authorization process. While there were pressures to authorize the booster, Krause went on the record that there just wasn’t enough data to support that move.
While the FDA recently authorized yet another boost (second booster and fourth dose) of the COVID-19 vaccine in less than 1.5 years, the traditional Gold Standard agency will convene its advisory committee meeting this week to open up about further vaccine needs. Yet Makary says, “That’s like having lawyers present arguments to a judge who’s already issued a verdict.”
Why? Because the agency’s own experts disagree with this decision! For example, the editor-in-chief of the New England Journal of Medicine, Eric Rubin, who is part of the advisory committee, already told CNN that he hadn’t seen enough data to make an informed decision about the need for a fourth dose.Subscribe to the Trialsitenews “COVID-19” ChannelNo spam – we promise
How about Cody Meissner? The chief of pediatric infectious diseases at Tufts Children’s Hospital shared with Makary that the fourth dose is “an unanswered scientific question for people with a normal immune system.”
While Paul Offit, a notable employee of the academic medical center Children’s Hospital of Philadelphia (CHOPs), shared with the Atlantic that he is personally advising his own son (in his 20s) to not opt for the third jab even though the FDA recommends for all over the age of 12.
Why are They Ignoring B-and T-cells?
While public health officials obsess on vaccine-induced antibodies, which wane over time in effectiveness, they talk little of B-and T-cells, declares Professor Makary. Yet B-and T-cells, when activated either via vaccine or infection and then augmented with a booster in the elderly, represent a superior class of prevention against COVID-19. Finally, Makary suggests that like a drug addict chasing the “fleeting high in antibody levels,” the additional jab probably provides only “mild and short-lived protection” against COVID-19.
Are the Additional Doses Safe?
As TrialSite has repeatedly mentioned, while the data from various public health agencies show a general correlation between more protection against death or serious disease associated with COVID-19, that protection seems to wane in effectiveness. Additionally, the vaccine does little to stop community transmission with the Omicron or BA.2 mutants.
Yet the FDA hasn’t requested any formal randomized controlled trials to identify the safety and efficacy implications of three or four doses. While both Krause and Gruber resigned in protest during the third booster authorization, Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC), went on the record that “the additional doses are safe,” writes Professor Makary. Yet Walensky cannot know this to be true as these regimens haven’t been studied in this way. Instead, she simply made a convenient statement while ignoring the topic of adverse events, which seemingly become more relevant by the month. Thirteen thousand six hundred thirty-seven deaths have been reported to the CDC’s VAERS database in association with the COVID-19 vaccines. Of course, just because these deaths are reported doesn’t mean they are associated with the vaccine, but the whole point of having the VAERS system is to have one way of identifying safety signals. The fact that all of these deaths have been reported since the launch of the mass vaccination program definitely raises questions. TrialSite has chronicled numerous deaths associated with the COVID-19 vaccines authorized in America, including a recent analysis.
Makary also has questions, noting that despite growing reports of vaccine complications, “…neither the CDC nor the National Institutes of Health has made a priority of studying vaccine complications. The CDC isn’t even transparent about its investigations into young people who have died after COVID-19 vaccination.”
Moreover, he points to a recent study revealing that 69% of children who experienced myocarditis after receiving a COVID-19 vaccine also experienced a related abnormality called gadolinium enhancement.
What about Competition & Consumer Choice?
Yesterday, TrialSite raised important questions: FDA: Where is Novavax? Why haven’t you authorized it? Who are you protecting? Makary, aligned with this set of questions, notes in his WSJ editorial that while the FDA “has approved fourth doses quickly and with little supporting data, it’s also been sitting for months on amble data supporting two new COVID vaccines including Novavax.”
Makary and other smart physicians, academic researchers, health policy experts, attorneys, and the lay public know something is terribly off. It’s time to take on the bias in the U.S. medical system.
Call to Action: Follow the link to read this important WSJ Op-ed.