{"id":16051,"date":"2025-04-04T23:31:04","date_gmt":"2025-04-04T23:31:04","guid":{"rendered":"https:\/\/wifamily.news\/?p=16051"},"modified":"2025-04-06T16:03:34","modified_gmt":"2025-04-06T16:03:34","slug":"big-pharma-gravy-train-hits-the-skids-under-trump-panicking-revolving-door-regulators-investors","status":"publish","type":"post","link":"https:\/\/wifamily.news\/?p=16051","title":{"rendered":"Big Pharma Gravy Train Hits the Skids Under Trump, Panicking Revolving-Door Regulators, Investors"},"content":{"rendered":"

This post originally appeared at https:\/\/thestarnewsnetwork.com\/2025\/04\/04\/big-pharma-gravy-train-hits-the-skids-under-trump-panicking-revolving-door-regulators-investors\/<\/a><\/p>\n

<\/div>\n
by Greg Piper<\/h5>\n

\u00a0<\/p>\n

The Food and Drug Administration is \u201cfinished.\u201d One of its leading boosters for accelerated approval of mediocre drugs left in a huff. Drug stocks are dropping.<\/p>\n

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\u2019s extreme makeover of the federal public health workforce and leadership.<\/p>\n

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.<\/p>\n

Days after Health and Human Services Secretary\u00a0Robert F. Kennedy Jr. announced HHS would cut<\/a>\u00a0another 10,000 jobs for a total reduction of 20,000 \u2013 24% of its workforce \u2013 its National Institutes of Health reportedly put five chiefs on administrative leave late Monday.<\/p>\n

Two of them lead the National Institute of Allergy and Infectious Diseases, which\u00a0funded Chinese research that may have unleashed SARS-CoV-2<\/a>, and the National Institute of Child Health and Human Development, which\u00a0funded gruesome transgender mice research<\/a>\u00a0and whose\u00a0clinical director crusades for puberty blockers<\/a>\u00a0for gender-confused kids.<\/p>\n

NIH Director Jay Bhattacharya told staff Tuesday, when\u00a0he was sworn in<\/a>, that the reductions would require \u201can entirely new approach\u201d to \u201ccommunications, legislative affairs, procurement, and human resources\u201d at NIH, which he\u2019ll focus on reproducibility, rigor, transparency and academic freedom, according to his email obtained by\u00a0Nature<\/em><\/a>.<\/p>\n

NIH Deputy Director of Public Affairs Amanda Fine told\u00a0Just the News on\u00a0<\/em>Thursday to file a Freedom of Information Act request for the email because \u201cit\u2019s considered an official record.\u201d<\/p>\n

\n

\u201cI don\u2019t want retribution. What I want is for gold standard science to happen, and that means even people who disagree with me should have their say. We will never use this agency to censor scientists who disagree.\u201d@DrJBhattacharya<\/a> pic.twitter.com\/oKkcz8wywG<\/a><\/p>\n

\u2014 Daniel Kotzin (@DanielKotzin) April 2, 2025<\/a><\/p>\n<\/blockquote>\n

Some agency leaders were offered far-away transfers to the Indian Health Service, according to\u00a0Nature<\/em>, 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,\u00a0NOTUS<\/em><\/a>\u00a0reported.<\/p>\n

\u201cThe FDA as we\u2019ve known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed,\u201d former FDA Commissioner\u00a0Robert Califf<\/a>, known for\u00a0hiding vaccine safety and efficacy data<\/a>\u00a0and\u00a0promoting low-quality studies<\/a>\u00a0to justify federal recommendations,\u00a0wrote on LinkedIn<\/a>.<\/p>\n

Califf worked as a part-time adviser<\/a>, then\u00a0full-time head of medical strategy and policy<\/a>\u00a0for Google parent Alphabet between serving as FDA commissioner in the Obama and Biden administrations.\u00a0FDA ethics officers blessed<\/a>\u00a0departing COVID vaccine reviewers to influence the agency \u201cbehind the scenes\u201d for their new employer, Moderna.<\/p>\n

Pfizer board member Scott Gottlieb<\/a>, the first Trump administration\u2019s commissioner, warned this \u201ccumulative barrage\u201d on drug discovery \u201cthreatens to swiftly bring back those frustrating delays for American consumers\u201d before the U.S. overtook Europe in drug innovation, \u201cparticularly affecting rare diseases and areas of significant unmet medical need.\u201d<\/p>\n

Earlier wailing portrayed the\u00a0slashing of indirect-cost payments on top of federal grants<\/a>\u00a0\u2013 which are far more generous than what private foundations pay and allegedly enrich administrators at the expense of researchers \u2013 as a mortal threat to scientific and medical progress.<\/p>\n

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\u00a02022 peer-reviewed study<\/a>\u00a0by University of Michigan and Bristol Myers Squibb researchers.<\/p>\n

University of California San Francisco epidemiologist\u00a0Vinay Prasad showed little sympathy for the cuts to \u201cbad science<\/a>,\u201d such as erroneous practices by Centers for Medicare & Medicaid Services that he estimates cost taxpayers \u201chundreds of billions\u201d a year.<\/p>\n

\u201cIf any company wants to make an oral COVID vaccine\u201d \u2013\u00a0Vaxart\u2019s trial now seems doomed<\/a>\u00a0\u2013 they should not receive federal money and the FDA should force them to \u201cpower their trial for hard endpoints,\u201d which would likely scare off investors, he said.<\/p>\n

False impression he quit out of principle?<\/strong><\/p>\n

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.<\/p>\n

FDA Commissioner Marty Makary \u201csigned off\u201d on pushing out Center for Biologics Evaluation and Research Director\u00a0Peter Marks \u2013 who himself sidelined Gruber and Krause<\/a>\u00a0to authorize boosters, which\u00a0Krause later shunned for himself<\/a>\u00a0\u2013\u00a0Politico<\/em><\/a>\u00a0reported Monday.<\/p>\n

It cited \u201cfour people familiar with the matter\u201d who claimed Kennedy acted with Makary\u2019s approval after he was sworn in \u201clate last week.\u201d A \u201cformer FDA official familiar with the discussions\u201d told the\u00a0Associated Press<\/a>\u00a0that Marks was given the option to resign or be fired by Kennedy.<\/p>\n

Makary quickly hired Danish-American MIT vaccine-safety researcher Tracy Beth Hoeg, a\u00a0vocal critic of the quality of federal COVID research<\/a>\u00a0and the\u00a0bloated U.S. childhood vaccine schedule<\/a>, as a special assistant, she confirmed to\u00a0Just the News<\/em>\u00a0on Wednesday after\u00a0Reuters<\/a>\u00a0and\u00a0Endpoints News<\/em><\/a>\u00a0reported he announced her hire at his inaugural speech earlier that day.<\/p>\n

Unlike\u00a0HHS\u2019s announcement for Kennedy\u2019s swearing-in<\/a>\u00a0and NIH\u2019s for Bhattacharya\u2019s, which both stated they happened \u201ctoday,\u201d the FDA\u2019s\u00a0April 1 press release<\/a>\u00a0on Makary\u2019s doesn\u2019t say when it happened. HHS didn\u2019t answer\u00a0Just the News<\/em>\u00a0queries for the date.<\/p>\n

When exactly Makary became official could shed light on whether Marks created a false impression in his\u00a0March 28 resignation letter<\/a>, addressed to acting Commissioner Sara Brenner but written for public consumption, that he quit out of principle rather than to avoid firing.<\/p>\n

\n
<\/div>\n<\/div>\n

Marks invoked George Washington as a pioneer of vaccine mandates, shared a widely repeated CDC claim that\u00a0MMR vaccines are 97% effective<\/a>\u00a0against measles infection \u2013\u00a0the source for which<\/a>\u00a0appears to be a\u00a0textbook behind a paywall<\/a>\u00a0\u2013 and flatly rejected it having any connection to autism,\u00a0contradicting a CDC whistleblower<\/a>.<\/p>\n

The letter\u2019s real purpose seems to be disparaging Kennedy as seeking \u201csubservient confirmation of his misinformation and lies\u201d rather than the \u201ctruth and transparency\u201d Kennedy claims in his concerns about vaccine safety.<\/p>\n

\u201cIf 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,\u201d an HHS spokesperson told\u00a0NBC News<\/a>.<\/p>\n

Biotech investors weren\u2019t fazed last month when Center for Drug Evaluation and Research Director\u00a0Patrizia Cavazzoni left the FDA for Pfizer<\/a>\u00a0and Deputy Commissioner for Human Foods\u00a0Jim Jones resigned in protest of federal job cuts, but evidently considered Marks indispensable.<\/p>\n

Firms that specialize in \u201cmore innovative treatments like gene therapies and mRNA vaccines,\u201d including Moderna, Beam and Sarepta, saw their worst single-day plunges in months on April 1 when Marks\u2019 departure became public,\u00a0The Wall Street Journal<\/em><\/a>\u00a0reported.<\/p>\n

\u201cPeter Marks was a mediocre academic hematologist\u201d<\/a>\u00a0who inexplicably \u201cobtained an important job in government\u201d and became \u201cone of the most dangerous, pro-pharma regulators of the 21st century,\u201d\u00a0UCSF\u2019s Prasad wrote when Marks departed<\/a>.<\/p>\n

He repeatedly approved COVID boosters for infants without \u201crandomized data regarding clinical outcomes,\u201d helped President Biden \u201cadvance the single greatest anti-vax action in the 21st century\u201d \u2013 rushing full vaccine approval to legally enable mandates \u2013 and twice overruled his scientists on Sarepta\u2019s gene therapy with \u201cno evidence it helps boys,\u201d\u00a0one of whom died<\/a>.<\/p>\n

\u201cDr. Marks has repeatedly disregarded long-held FDA policies to side with industry over patient safety\u201d and has \u201chis own history of misinformation and lies,\u201d Stanford pediatrics professor and biotech drug veteran\u00a0George Tidmarsh wrote in a guest essay<\/a>\u00a0for former Senate pharma corruption investigator Paul Thacker\u2019s newsletter.<\/p>\n

\n

Stanford\u2019s George Tidmarsh says FDA\u2019s Peter Marks was a hero to biotech investors, not the public.<\/p>\n

Several poor decisions that ignored FDA staff and outside experts marked Dr. Marks for government termination. pic.twitter.com\/Fc4xh3ZnaL<\/a><\/p>\n

\u2014 Paul D. Thacker (@thackerpd) April 2, 2025<\/a><\/p>\n<\/blockquote>\n

Tidmarsh cited reports that Marks overruled FDA career scientists to approve the since-withdrawn Alzheimer\u2019s drug\u00a0aducanumab, which was greenlit<\/a>\u00a0based on the feds\u2019 preferred but controversial\u00a0\u201camyloid hypothesis<\/a>.\u201d Bhattacharya denounced the NIH\u2019s tunnel vision on Alzheimer\u2019s research in his\u00a0confirmation hearing<\/a>.<\/p>\n

It\u2019s part of a pattern of support by Marks for \u201cineffective 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,\u201d Tidmarsh said.<\/p>\n

\u00a0\u2013 \u2013 \u2013<\/p>\n

Greg Piper is a reporter for Just the News.
\nPhoto \u201cRobert F. Kennedy Jr.\u201d by Secretary Kennedy.<\/a><\/em><\/p>\n<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\n
Reprinted with permission from Just the News<\/a><\/span><\/div>\n
\n

The post Big Pharma Gravy Train Hits the Skids Under Trump, Panicking Revolving-Door Regulators, Investors<\/a> first appeared on The Star News Network<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

This post originally appeared at https:\/\/thestarnewsnetwork.com\/2025\/04\/04\/big-pharma-gravy-train-hits-the-skids-under-trump-panicking-revolving-door-regulators-investors\/ by Greg Piper \u00a0 The Food and Drug Administration…<\/p>\n","protected":false},"author":79,"featured_media":16046,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[23],"tags":[],"class_list":["post-16051","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-wi-daily-star"],"_links":{"self":[{"href":"https:\/\/wifamily.news\/index.php?rest_route=\/wp\/v2\/posts\/16051","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wifamily.news\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/wifamily.news\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/wifamily.news\/index.php?rest_route=\/wp\/v2\/users\/79"}],"replies":[{"embeddable":true,"href":"https:\/\/wifamily.news\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=16051"}],"version-history":[{"count":1,"href":"https:\/\/wifamily.news\/index.php?rest_route=\/wp\/v2\/posts\/16051\/revisions"}],"predecessor-version":[{"id":16052,"href":"https:\/\/wifamily.news\/index.php?rest_route=\/wp\/v2\/posts\/16051\/revisions\/16052"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/wifamily.news\/index.php?rest_route=\/wp\/v2\/media\/16046"}],"wp:attachment":[{"href":"https:\/\/wifamily.news\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=16051"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/wifamily.news\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16051"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/wifamily.news\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16051"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}