{"id":20292,"date":"2022-03-04T11:04:42","date_gmt":"2022-03-04T09:04:42","guid":{"rendered":"https:\/\/antidote-europe.eu\/?p=20292\/"},"modified":"2022-03-04T18:04:34","modified_gmt":"2022-03-04T16:04:34","slug":"the-food-and-drug-administration-has-failed-in-its-public-health-mission","status":"publish","type":"post","link":"https:\/\/antidote-europe.eu\/en\/the-food-and-drug-administration-has-failed-in-its-public-health-mission\/","title":{"rendered":"The Food and Drug Administration has failed in its public health mission"},"content":{"rendered":"\n

DAVID GORTLER INTERVIEW<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

Dr. Gortler is no ordinary scientist. He is a pharmacologist, pharmacist and an FDA and health care policy fellow at the\u00a0Ethics and Public Policy Center<\/a>\u00a0Think 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\u2019s Bioethics Center, and was an\u00a0FDA Medical Officer\u00a0who was later appointed by the White House to serve on the FDA\u2019s Senior Executive Leadership\u00a0Team as\u00a0senior advisor to the FDA Commissioner<\/a>\u00a0for\u00a0drug safety, FDA science policy, and FDA regulatory affairs.\u00a0 As a drug safety expert, he had been closely monitoring adverse events associated with novel mRNA administration. Even worse\u00a0; his drug safety position at the FDA still hasn’t been replaced by anyone, let alone someone with Gortler\u2019s specialized background and knowledge.<\/p>\n\n\n\n

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multiple key areas at the FDA including his investigation into eliminating the FDA\u2019s requirements for cruel, outdated and poorly predictive animal testing by proposing the validation of state-of-the-art human organ-on-a-chip technology (OOC): \u00ab In addition to reducing the cruel experimentation, this technology also stands to greatly speed up drug development and approval. It\u2019s a win for everyone ; patients, scientists, and especially for America\u2019s dogs and other animals. \u00bb<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

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 \u201cproof of concept\u201d 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\u201d.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

This sounds very much like an example of \u00ab regulatory capture \u00bb 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. <\/p>\n\n\n\n

Equally puzzling is the FDA\u2019s own admission in 2004 that 92 percent of drugs that pass preclinical tests, including \u201cpivotal\u201d 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<\/em>. The main causes of failure are lack of effectiveness and safety problems that were not predicted by animal tests.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

Gortler is far more progressive : \u00ab It wouldn\u2019t 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 \u00ab set the standard \u00bb to potentially eliminate animal testing. If the FDA did, the policy would cascade down to the entire pharmaceutical industry and all university academic research. \u00bb<\/p>\n\n\n\n

Gortler concludes : \u00ab 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 \u00ab us against them \u00bb 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\u2019t stop Patrizia Cavazzoni<\/a>, 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\u2019t even merit discussion, much less consideration. That sort of partisan treatment of fellow FDA scientists has no place anywhere, let alone in America.\u201d<\/p>\n\n\n\n

\n <\/div>\n\n","protected":false},"excerpt":{"rendered":"

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… Read more<\/i><\/a><\/p>\n","protected":false},"author":2,"featured_media":20290,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[153,25],"tags":[],"class_list":["post-20292","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-hom","category-interviews-caten","has-post-title","has-post-date","has-post-category","has-post-tag","has-post-comment","has-post-author",""],"yoast_head":"\nThe Food and Drug Administration has failed in its public health mission - Antidote Europe<\/title>\n<meta name=\"description\" content=\"DAVID GORTLER INTERVIEW When a former Yale University professor and former Food and Drug Administration (FDA) Medical Officer appointed by the White House\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/antidote-europe.eu\/en\/the-food-and-drug-administration-has-failed-in-its-public-health-mission\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Food and Drug Administration has failed in its public health mission - 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