The Food and Drug Administration has failed in its public health mission
DAVID GORTLER INTERVIEW
When a former Yale University professor and former Food and Drug Administration (FDA) Medical Officer appointed by the White House is dismissed by an incoming president, and all of his non-partisan, ongoing public health projects are abruptly terminated, alarm bells should start to ring. Dr David Gortler was forced to resign his senior executive leadership position at the FDA in 2019after serving Americans for a little over one year.
Dr. Gortler is no ordinary scientist. He is a pharmacologist, pharmacist and an FDA and health care policy fellow at the Ethics and Public Policy Center Think Tank in Washington, D.C. He was a professor of pharmacology, biotechnology and FDA regulatory affairs at the Yale University School of Medicine, where he also served as a faculty member at Yale’s Bioethics Center, and 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, FDA science policy, and FDA regulatory affairs. As a drug safety expert, he had been closely monitoring adverse events associated with novel mRNA administration. Even worse ; his drug safety position at the FDA still hasn’t been replaced by anyone, let alone someone with Gortler’s specialized background and knowledge.
He additionally worked in a multitude of other ways to reform and modernaize multiple key areas at the FDA including his investigation into eliminating the FDA’s requirements for cruel, outdated and poorly predictive animal testing by proposing the validation of state-of-the-art human organ-on-a-chip technology (OOC): « In addition to reducing the cruel experimentation, this technology also stands to greatly speed up drug development and approval. It’s a win for everyone ; patients, scientists, and especially for America’s dogs and other animals. »
The FDA has recomended animal testing for almost 100 years. The Kefauver-Harris Act animal testing requirement was last updated in 1962. A lot of technological advancement and an abundance of published data has accumulated about the poor predictiveness of animal testing in humans since then, but the FDA has not kept up with modern times.
To Gortler, this initially appeared to be an oversight by the FDA, and he saw a solution to the problem in the form of seed funding to encourage the implementation of OOC technology in tandem with traditional animal testing to test the “proof of concept” and predictability in order to fully validate OOC and potentially replace animal testing. After researching the technology for months, it became clear that it was worthy of further exploration. However, even though costs for this project were minimal, there was no dollar value which could be placed on the potential ethical and humane advances of such a project. On top of that, it appeared from early studies that OOC technology ended up being faster, less costly and potentially more predictive than animal testing, since organ-on-a-chip technology uses human cellular lines rather than that of animals”.
When Gortler tried to bring this to the attention of the FDA, he was fought every step of the way by entrenched bureaucrats who refused to place aside their political dogmas, even in the name of science and preventing animal suffering.
This sounds very much like an example of « regulatory capture » which is a form of corruption of authority that occurs when a special interest is prioritized over the general interests of the public, leading to a net loss for society.
Equally puzzling is the FDA’s own admission in 2004 that 92 percent of drugs that pass preclinical tests, including “pivotal” animal tests, fail to proceed to the market. More recent analysis suggests that the failure rate has actually increased and is now closer to 96 percent. The main causes of failure are lack of effectiveness and safety problems that were not predicted by animal tests.
This surely has to be one of the most grotesque chapters in the history of science and medicine. The general public would not tolerate this situation if it was aware of these facts and figures, which is perhaps why countries like the Netherlands would like to phase out these kinds of animal tests by 2025.
Gortler is far more progressive : « It wouldn’t take me until 2025 to implement studies confirming the proof of concept. I would have immediately secured funding and/or waived FDA application fees or pursued another avenue to test to see if organ-on-a-chip testing can be validated in real time, if I had any authority to do so. The FDA has the ability to « set the standard » to potentially eliminate animal testing. If the FDA did, the policy would cascade down to the entire pharmaceutical industry and all university academic research. »
Gortler concludes : « Unnecessary animal cruelty requirements are a non-partisan topic if there ever was one. Everybody loves their pets regardless of their political opinion. This partisan « us against them » has no place when it comes to drug development, ethics, public health or animal cruelty. Despite that, when I was at the FDA it didn’t stop Patrizia Cavazzoni, a psychiatrist and former executive at Pfizer (i.e. an executive non-scientist in her previous role) who has been promoted to the most powerful scientific position at the FDA under Biden, from refusing to even permit discussing this matter with me, and likewise to even consider the lengthy research paper I had written on the overwhelming benefits of organ-on-a-chip. Cavazzoni – and Cavazzoni alone – has the power to implement validation testing. Unfortunately, she apparently believed my proposed animal testing alternatives didn’t even merit discussion, much less consideration. That sort of partisan treatment of fellow FDA scientists has no place anywhere, let alone in America.”