(David Gortler) Before parents consent to vaccinate their children against COVID, basic medical ethics requires that they be informed of how safe the vaccine is. Yet in a shocking on-video admission, Dr. Eric Ruben, an advisory committee member to the FDA, said this about the COVID vaccine in children five to eleven during an official FDA hearing: “We’re never going to learn about how safe the vaccine is until we start giving it. That’s just the way it goes.”
Related The Scandal Behind the FDA Fake Approval of Pfizer’s Jab
by David Gortler, November 1st, 2021
No, Dr. Ruben, that isn’t “the way it goes.” American children are not experimental subjects. You could and should have demanded more safety studies.
Despite the admitted lack of safety data, the FDA “expert” advisory committee went on to vote 17–0 for emergency-use authorization of the Pfizer-BioNTech COVID-19 vaccine. The FDA itself codified their recommendation on Friday. This is a scandal.
The FDA’s fundamental medical mission is a simple one. Its job is to make sure that our drugs, biologics, and medical devices are free of impurities; that they are safe; and that they have a positive clinical benefit. Given that the FDA is a public- health agency, and especially given the White House’s appetite for vaccine mandates, we depend more than ever on the FDA remaining independent and scientifically objective and on its advisory committee strictly adhering to its clinical and scientific responsibilities. Under the still commissioner-less Biden FDA, they aren’t, and this isn’t the only example.
One of the problems is how the FDA advisory panels are composed. To serve as an outside expert at the FDA, the person selected cannot have even the appearance of an outside conflict of interest. Those conflicts obviously include having been employed by a pharmaceutical company whose drugs are under review.
Also excluded are scientists who have ever received funding from any pharmaceutical company in the form of research grants or speaking fees. Since “publish or perish” research is a core component of academic tenure, and research is very expensive, scientists may find themselves in a position of needing funding from private sources at some point, including “Big Pharma.”
Moreover, prohibitions on speaking fees preclude most top experts from FDA advisory committees because they are precisely the ones most in demand for talks at conferences. Consequently, the people serving on FDA committees are sometimes not the most well-informed individuals when it comes to knowing or even understanding the complex fundamentals of FDA regulatory affairs or the FDA’s mission.
As a former FDA medical officer/senior medical analyst on the FDA’s Division of Metabolism and Endocrinology, I recall that my FDA colleagues and I were more than a little puzzled to hear FDA advisory members asking elementary questions already answered at length during advisory committee meetings. It made us realize that they didn’t fully understand the material placed before them.
Dr. Rubin’s comment during Tuesday’s official FDA panel makes me realize that, despite his Harvard and New England Journal of Medicine chief-editor pedigree and acumen, he does not understand the FDA’s fundamental safety mission. Neither does the rest of the advisory committee, which may have just followed Dr. Rubin’s lead because of his auspicious titles.
The fact remains that America’s young children are not drug-safety research volunteers, and the panel’s failure to address comprehensively safety concerns will only undermine its goal of mass vaccination of kids and getting their anti-vaccine or vaccine-hesitant parents vaccinated too. Because the Biden administration is fond of using the FDA as cover for its medical mandates, it is all the more important that the FDA produce comprehensive and conclusive safety data for public review before approving the vaccines—even if it’s for emergency-use authorization (EUA).
The FDA’s mandated drug-safety testing requirements have been around since 1938. Before that, the only requirement as of 1899 was that the list of ingredients on a medical container accurately reflects the container’s contents. It wasn’t until 1962 that the FDA added its mandate requiring a beneficial effect or efficacy.
A central question that the FDA seems to have ignored is whether giving emergency vaccinations to children five to eleven years old is needed at all, given that it is well-established that children are at low risk for serious COVID complications, especially with the dominant variant. What must also be considered is the availability of therapeutics with known safety records, along with mask-wearing and social distancing as alternate protective measures.
As is already known, the FDA still hasn’t gotten around to releasing its medical-officer report detailing the FDA’s comprehensive findings on safety from its August 23 2021 approval of the Pfizer vaccine. Despite that, this FDA advisory committee is comfortable recommending that parents administer that same biotechnological to America’s children without transparency on its safety. It breaks all FDA norms and practices to leap into this so blindly, especially when we are talking about children.
Emergency approval for young children is identical to the emergency approval of COVID vaccines for adults in 2020. We are no longer deeply embedded in the throes of the pandemic. It’s unclear why we now need emergency measures in the form of FDA EUAs for such young children, with the exception, conceivably, of the most vulnerable children.
Leaving aside the bioethics argument and question of using our children as test subjects, whatever happened to “following the science”? What about the physician’s centuries-old sacrosanct vow of doing no harm? What about the safety findings in adults the FDA seems intent on keeping under wraps?
As someone who has committed the past two decades of his life to drug epidemiology and drug safety, and who served as an advisor to the former FDA commissioner on the same topics, I rely on the FDA’s objective historical standard requiring that drugs must be comprehensively tested for safety before it will recommend them.
The FDA’s lack of drug-safety transparency is disappointing, as is the FDA panel’s abandonment of basic safety standards that have served us well for nearly a century.
With Biden’s FDA and its “experts” like these, it sounds as if drug safety simply isn’t a priority.
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About The Author
Dr. David Gortler is a pharmacologist, a pharmacist, and an FDA and healthcare policy scholar at the Ethics and Public Policy Center in Washington, D.C. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served as a faculty member at the Yale Center for Bioethics. He was an FDA medical officer who was later appointed by the White House to serve on the FDA’s Senior Executive Leadership Team as senior advisor to the FDA Commissioner for drug safety, drug epidemiology, FDA science policy, and FDA regulatory affairs.
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