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Economy
Big Pharma gravy train hits the skids under Trump, panicking revolving-door regulators, investors
2025-04-04
[JustTheNews] The Food and Drug Administration is "finished." One of its leading boosters for accelerated approval of mediocre drugs left in a huff. Drug stocks are dropping.

The shared interests of regulators and the industry they often join after or between federal service became unmistakable in the past week amid the Trump administration's extreme makeover of the federal public health workforce and leadership.

It suggests the Big Pharma gravy train is derailing, and its passengers in and out of government are panicking, prophesying and pulling out in a flurry of sky-is-falling predictions, ad hominem attacks and investors fleeing companies whose novel therapeutics seem unlikely to keep zipping through emergency and full approvals.

Days after Health and Human Services Secretary Robert F. Kennedy Jr. announced HHS would cut another 10,000 jobs for a total reduction of 20,000 – 24% of its workforce – its National Institutes of Health reportedly put five chiefs on administrative leave late Monday.

Two of them lead the National Institute of Allergy and Infectious Diseases, which funded Chinese research that may have unleashed SARS-CoV-2, and the National Institute of Child Health and Human Development, which funded gruesome transgender mice research and whose clinical director crusades for puberty blockers for gender-confused kids.

NIH Director Jay Bhattacharya told staff Tuesday, when he was sworn in, that the reductions would require "an entirely new approach" to "communications, legislative affairs, procurement, and human resources" at NIH, which he'll focus on reproducibility, rigor, transparency and academic freedom, according to his email obtained by Nature.

NIH Deputy Director of Public Affairs Amanda Fine told Just the News on Thursday to file a Freedom of Information Act request for the email because "it’s considered an official record."

Some agency leaders were offered far-away transfers to the Indian Health Service, according to Nature, which said mass layoffs primarily targeted administrative staff. Centers for Disease Control and Prevention top officials were given the same IHS offer to relocate far from its Atlanta base, NOTUS reported.

"The FDA as we've known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed," former FDA Commissioner Robert Califf, known for hiding vaccine safety and efficacy data and promoting low-quality studies to justify federal recommendations, wrote on LinkedIn.

Califf worked as a part-time adviser, then full-time head of medical strategy and policy for Google parent Alphabet between serving as FDA commissioner in the Obama and Biden administrations. FDA ethics officers blessed departing COVID vaccine reviewers to influence the agency "behind the scenes" for their new employer, Moderna.

Pfizer board member Scott Gottlieb, the first Trump administration's commissioner, warned this "cumulative barrage" on drug discovery "threatens to swiftly bring back those frustrating delays for American consumers" before the U.S. overtook Europe in drug innovation, "particularly affecting rare diseases and areas of significant unmet medical need."

Earlier wailing portrayed the slashing of indirect-cost payments on top of federal grants – which are far more generous than what private foundations pay and allegedly enrich administrators at the expense of researchers – as a mortal threat to scientific and medical progress.

Modern drug development has a poor track record for the time and money required, with 90% of drug candidates that make it to phase 1 clinical trials failing, not including failures in preclinical stages, and a 10-15 year process that costs $1-2 billion per approved drug, according to a 2022 peer-reviewed study by University of Michigan and Bristol Myers Squibb researchers.

University of California San Francisco epidemiologist Vinay Prasad showed little sympathy for the cuts to "bad science," such as erroneous practices by Centers for Medicare & Medicaid Services that he estimates cost taxpayers "hundreds of billions" a year.

"If any company wants to make an oral COVID vaccine" – Vaxart's trial now seems doomed – they should not receive federal money and the FDA should force them to "power their trial for hard endpoints," which would likely scare off investors, he said.
Posted by:Skidmark

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