Big Pharma gravy train hits the skids under Trump, panicking revolving-door regulators, investors

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. 

False impression he quit out of principle?

Critics of one FDA scalp scolded the media for sanctifying a man who allegedly served Mammon over good science and marginalized voices of caution such as then-Office of Vaccines Research and Review Director Marion Gruber and Deputy Director Philip Krause.

FDA Commissioner Marty Makary "signed off" on pushing out Center for Biologics Evaluation and Research Director Peter Marks – who himself sidelined Gruber and Krause to authorize boosters, which Krause later shunned for himself – Politico reported Monday.

It cited "four people familiar with the matter" who claimed Kennedy acted with Makary's approval after he was sworn in "late last week." A "former FDA official familiar with the discussions" told the Associated Press that Marks was given the option to resign or be fired by Kennedy.

Makary quickly hired Danish-American MIT vaccine-safety researcher Tracy Beth Hoeg, a vocal critic of the quality of federal COVID research and the bloated U.S. childhood vaccine schedule, as a special assistant, she confirmed to Just the News on Wednesday after Reuters and Endpoints News reported he announced her hire at his inaugural speech earlier that day.

Unlike HHS's announcement for Kennedy's swearing-in and NIH's for Bhattacharya's, which both stated they happened "today," the FDA's April 1 press release on Makary's doesn't say when it happened. HHS didn't answer Just the News queries for the date.

When exactly Makary became official could shed light on whether Marks created a false impression in his March 28 resignation letter, addressed to acting Commissioner Sara Brenner but written for public consumption, that he quit out of principle rather than to avoid firing.

Marks invoked George Washington as a pioneer of vaccine mandates, shared a widely repeated CDC claim that MMR vaccines are 97% effective against measles infection – the source for which appears to be a textbook behind a paywall – and flatly rejected it having any connection to autism, contradicting a CDC whistleblower.

The letter's real purpose seems to be disparaging Kennedy as seeking "subservient confirmation of his misinformation and lies" rather than the "truth and transparency" Kennedy claims in his concerns about vaccine safety.

"If Peter Marks does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy,” an HHS spokesperson told NBC News.

Biotech investors weren't fazed last month when Center for Drug Evaluation and Research Director Patrizia Cavazzoni left the FDA for Pfizer and Deputy Commissioner for Human Foods Jim Jones resigned in protest of federal job cuts, but evidently considered Marks indispensable.

Firms that specialize in "more innovative treatments like gene therapies and mRNA vaccines," including Moderna, Beam and Sarepta, saw their worst single-day plunges in months on April 1 when Marks' departure became public, The Wall Street Journal reported.

"Peter Marks was a mediocre academic hematologist" who inexplicably "obtained an important job in government" and became "one of the most dangerous, pro-pharma regulators of the 21st century," UCSF's Prasad wrote when Marks departed.

He repeatedly approved COVID boosters for infants without "randomized data regarding clinical outcomes," helped President Biden "advance the single greatest anti-vax action in the 21st century" – rushing full vaccine approval to legally enable mandates – and twice overruled his scientists on Sarepta's gene therapy with "no evidence it helps boys," one of whom died.

"Dr. Marks has repeatedly disregarded long-held FDA policies to side with industry over patient safety" and has "his own history of misinformation and lies," Stanford pediatrics professor and biotech drug veteran George Tidmarsh wrote in a guest essay for former Senate pharma corruption investigator Paul Thacker's newsletter.

Tidmarsh cited reports that Marks overruled FDA career scientists to approve the since-withdrawn Alzheimer's drug aducanumab, which was greenlit based on the feds' preferred but controversial "amyloid hypothesis." Bhattacharya denounced the NIH's tunnel vision on Alzheimer's research in his confirmation hearing.

It's part of a pattern of support by Marks for "ineffective therapy that gave patients false hope, eroded trust in the regulatory process for bringing new medicines to market, and provided nothing but risk and cost to Americans," Tidmarsh said.