11 pharma execs and a criminal slam demands for clinical data
'FDA Commissioner' does not mean 'Selfless public Servant'
Vinay Prasad is now the chief medical and scientific officer at the FDA. He’s a practicing hematologist-oncologist, a professor, and now serves as Director of the FDA’s Center for Biologics Evaluation and Research since 2025. But to the biomedical and pharmaceutical complex, he’s an antivax shill because he once suggested the mRNA vaccines shouldn’t have been recommended to kids. He’s now in the centre of a very interesting storm: acting as chief medical and scientific Officer, he recently wrote an internal email to FDA staff which makes for very interesting reading and has….put the cat amongst the pigeons shall we say.
In short, Prasad told staff that currently immunobridging studies will no longer be enough to get vaccines onto the market. These are studies where pharmaceutical companies don’t measure how well their product reduced disease, like reducing your risk of pneumonia or something. Instead the industry use weird ‘surrogate’ endpoints like ‘antibody titers’; did our drug move antibodies in the right direction? Because if so, the rest is a proven perfect science! You will get less sick or you won’t get sick at all!
What Prasad has now demanded means the FDA “will not be granting marketing authorization to vaccines in pregnant women based on unproven surrogate endpoints, and we will demand pre-market randomized trials assessing clinical endpoints for most new products. Pneumonia vaccine makers will have to show their products reduce pneumonia and not merely generate antibody titers.”
Demanding actual randomised control trials with a placebo got the industry all riled up. But there was one other thing I should probably mention. Prasad, and therefore the FDA, also said that the mRNA vaccines had killed at least 10 kids. “This is a profound revelation. For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children. Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death.”
As you might expect, that caused a bit of a stir...
The pharmaceutical complex clearly needed a swift response to this letter. Not only had Prasad (and therefore the FDA) said the unsayable, that their darling mRNA technology had killed children, even worse, they were now demanding clinical data before products could hit the market! Whipping their legacy institutionalists into action, a letter was soon published in their favourite legacy publication the New England Journal of Medicine. With incredibly grand and pompous language, the letter is a crystal clear demonstration of exactly what is still wrong in the old industrial view: surface level arguments from the experts remain top trump.
The ‘spin’ was simple: twelve former FDA chiefs stand united against this ‘threat to evidence based vaccine policy’. That sounds pretty damning doesn’t it? If twelve former FDA chiefs disagree with you, you’re miles off the truth!
As predictable as the sun setting over the hills, the medical and scientific ‘voices of reason’ flooded x.com with this damning new letter. “As former commissioners of the US Food and Drug Administration…” the letter roared, “we are committed to medical product safety”. The new guidelines, the letter argued, “breaks sharply with the norms that have anchored the FDA’s globally respected integrity.” Is demanding clinical data breaking a norm?!
Details don’t really matter though. To the lay audience this was aimed at, all that’s needed is the headline. So the media minions went to work retweeting, tutting, and shrugging their way to an incandescent rage over Prasad’s quite reasonable demands. What was important was getting the headline under your nose. Did they they think to check the backgrounds of these 12 ‘former FDA commissioners’ before they forced this letter into your timeline? I doubt it, and even if they did, I’m not sure they’d even care about what they’d find. They got their headline, and it works perfectly for its intended target, but it’s a headline that’s incredibly economical with the truth. More accurately, you could say “11 Pharma execs and a criminal slam Prasad’s plan for clinical data”.
Such is the depravity of the FDA’s revolving door that a headline can actually say “former FDA commissioners” to obscure the more important truth that these people are actually representatives of pharmaceutical industry with a legal duty to maximise profits to their shareholders. Prasad’s new higher standard of evidence would absolutely eat into those profits, and so these ‘former FDA officials’ (pharma execs) need to earn their keep and demand the rules are dropped. To the public, former FDA commissioner means selfless public servant, but this couldn’t be further from the truth.
Without further ado, here are the declared and undeclared conflicts of interest of this majestic 12, in which every single one of them have disqualifying ties to industry, and in one case, a federal criminal conviction for misleading the public about drug safety. It’s so absurd that it’s hard to believe… but here we are.
Scott Gottlieb, M.D. (FDA Commissioner 2017–2019)
Perhaps the most visible example of the revolving door in modern history, Dr. Gottlieb’s transition from the FDA to the boardroom of a vaccine manufacturer was rapid and controversial.
Pfizer (Board Member): Dr. Gottlieb joined the board of Pfizer shortly after leaving the FDA. During the COVID-19 pandemic, while frequently appearing on television as a neutral “public health expert,” he was a director of the company manufacturing the primary mRNA vaccine. He had a direct financial stake in the regulatory decisions regarding boosters, mandates, and pediatric approvals—topics on which he commented publicly, often criticising those who urged caution. His compensation for this role involves significant equity, aligning his personal wealth with the company’s stock performance.
UnitedHealth Group (Board Member): Gottlieb serves on the board of one of the largest healthcare and insurance conglomerates in the world, integrating his influence across both the payer and provider sides of the market. This position gives him insight into reimbursement strategies that are directly affected by FDA approval classifications.
New Enterprise Associates (NEA): As a partner at this massive venture capital firm, Gottlieb directs investment into biotech startups. His ability to predict (or influence) the FDA’s regulatory posture toward new technologies directly impacts the valuation of NEA’s portfolio. He essentially acts as a guide for capital to navigate the regulatory maze he helped construct.
Other Boards: Illumina (genomics), Tempus, Aetion.
Mark B. McClellan, M.D., Ph.D. (FDA Commissioner 2002–2004)
Dr. McClellan represents the establishment wing of the revolving door, with deep, long-standing ties to legacy pharmaceutical giants.
Johnson & Johnson (Board Member): McClellan has served for many years on the board of J&J. This role places him at the fiduciary helm of a company responsible for the Janssen COVID-19 vaccine, as well as a history of litigation regarding opioids and talc products. As a director, he is responsible for the strategic direction of a company that is frequently under FDA scrutiny for product safety and marketing practices.
Cigna (Board Member): His role at this major health insurer aligns his interests with the reimbursement side of the pharmaceutical equation. Insurance companies rely on FDA designations to determine coverage policies; McClellan’s dual insight into regulation and insurance is a highly valuable asset for Cigna.
Alignment Healthcare (Board Member): Further entrenchment in the corporate healthcare delivery system.
Jane E. Henney, M.D. (FDA Commissioner 1999–2001)
Dr. Henney’s post-FDA career illustrates the breadth of industry entanglement, spanning manufacturing, distribution, and insurance.
AstraZeneca (Former Board Member): Henney served on the board of this global vaccine and drug manufacturer. AstraZeneca’s COVID-19 vaccine faced significant regulatory hurdles and safety questions in Europe and the US; her previous leadership there indicates a deep alignment with industry operations and a history of overseeing corporate strategy for a major vaccine producer.
AmerisourceBergen (Board Member): As a director of one of the three largest drug distributors in the US, Henney’s interests are tied to the volume of pharmaceutical product moving through the supply chain. Tighter regulation generally means lower volume and slower approvals, which negatively impacts distributor revenue.
Cigna & Cubist Pharmaceuticals: Additional board roles solidifying her status within the corporate elite. Her tenure at Cigna overlaps with other commissioners, creating a network of influence.
Michael A. Friedman, M.D. (Acting FDA Commissioner 1997–1998)
This is the most damning entry in the dossier. The inclusion of Michael Friedman in a letter lecturing the public on “integrity” and “trust” is, given his legal history, a profound irony that undermines the entire document.
Criminal Conviction (Purdue Pharma): After leaving the FDA, Friedman became a top executive at Purdue Pharma, the maker of OxyContin. In 2007, he—along with the company and two other executives—pleaded guilty to federal criminal charges related to the “misbranding” of OxyContin. The charges centered on the company’s deceitful marketing regarding the drug’s potential for abuse and addiction. Friedman was sentenced to community service, fined, and notably, excluded from participation in federal health programs for 12 years. This exclusion is a severe penalty reserved for individuals deemed a risk to the integrity of the healthcare system.
Industry Ties: Despite this conviction, he has served on boards for Celgene, Smith & Nephew, Intuitive Surgical, and MannKind Corporation. This demonstrates the industry’s willingness to rehabilitate and employ individuals with regulatory expertise, even those with criminal records related to their work.
That a criminally convicted executive, whose crimes contributed to the opioid crisis, feels emboldened to sign a letter chastising Vinay Prasad for questioning safety data standards is a testament to the lack of shame within the regulatory class.
Robert M. Califf, M.D. (FDA Commissioner 2016–2017; 2022–Present)
Dr. Califf is unique in that he has spun through the revolving door multiple times, moving from academia/industry to the FDA, back to industry, and back to the FDA.
Verily (Alphabet/Google): Between his stints as Commissioner, Califf was the Head of Clinical Policy and Strategy at Verily. This role involved developing data platforms and clinical trial technologies that the FDA regulates. His work there focused on using “Big Data” to streamline clinical trials—a methodology that often competes with the traditional RCTs Prasad advocates.
Consulting Fees: Califf has a history of receiving consulting fees from a “who’s who” of big pharma, including Merck, Biogen, Eli Lilly, and Novartis. These fees establish a financial dependency on the industry’s goodwill.
Board Memberships: Prior to his 2022 confirmation, he sat on the boards of Cytokinetics and Centessa Pharmaceuticals. His return to the FDA required him to divest, but the relationships and ideological alignment remain.
Andrew C. von Eschenbach, M.D. (FDA Commissioner 2006–2009)
Bausch Health (formerly Valeant): He serves on the board of Bausch Health. The company, under its previous name Valeant, was notorious for price-gouging scandals and aggressive acquisition strategies rather than R&D. Serving on the board of a company with such a reputation suggests a high tolerance for corporate practices that prioritize profit over patient access.
Lineage Cell Therapeutics & Viamet: Board roles in smaller biotech and developmental pharma, indicating continued involvement in the speculative side of drug development.
Samaritan Health Services: President.
Margaret A. Hamburg, M.D. (FDA Commissioner 2009–2015)
Alnylam Pharmaceuticals (Board Member): Joined in 2018. Alnylam is a leader in RNAi therapeutics, a cutting-edge field heavily dependent on FDA flexibility regarding novel mechanisms of action. Her presence on the board provides the company with invaluable insight into how to navigate the regulatory landscape for these new modalities.
Henry Schein (Former Board Member): A massive distributor of healthcare products, linking her to the supply chain infrastructure.
National Academy of Medicine: While a non-profit role, her position as Foreign Secretary keeps her influential in global policy, often harmonizing standards in ways that benefit multinational pharmaceutical corporations by streamlining international approvals.
Norman E. Sharpless, M.D. (Acting FDA Commissioner 2019).
Jupiter BioVentures (Partner): An investment role where he picks winners and losers in the biotech space, banking on his regulatory insight to guide capital. As a VC partner, his primary metric of success is the return on investment (ROI) of the portfolio companies, which is contingent on FDA approval.
G1 Therapeutics (Founder/Board): Having founded the company, his wealth is directly tied to the regulatory success of its assets. This is the definition of a vested interest in the regulatory ecosystem.
Nucleus Radiopharma & Karius: Board memberships in specialized biotech sectors.
Brett P. Giroir, M.D. (Acting FDA Commissioner 2019)
Altesa BioSciences (CEO): Giroir is not just a board member but the CEO of a drug development company. He is an active player in the industry seeking FDA approvals. His daily professional existence is defined by the need to get products past the agency he once led.
MindMed (Board Member): Involvement in the psychedelic medicine space, a sector currently lobbying the FDA intensely for new regulatory pathways. His role here is likely strategic, helping the company navigate a complex and evolving regulatory environment.
David A. Kessler, M.D. (FDA Commissioner 1990–1997)
The Conflict Profile: Often remembered as the “anti-tobacco” commissioner, Kessler’s post-FDA career has nonetheless embraced pharmaceutical industry compensation.
Ellodi Pharmaceuticals (Board Member): Current directorship. This role places him in the governance structure of a pharmaceutical company, with all the attendant fiduciary duties.
ImmunoGen (Former Board Member): Past directorship in the oncology space.
Janet Woodcock, M.D. (Acting FDA Commissioner 2021–2022)
Rapid Board Appointments: Shortly after retiring in early 2024, she joined the boards of Quantum Leap Healthcare Collaborative, Friends of Cancer Research, and Every Cure. While these are technically non-profits, they are heavily intertwined with pharmaceutical industry funding. These organizations lobby for “accelerated approval” pathways and the use of “real-world evidence” (RWE) in lieu of RCTs—precisely the mechanisms Prasad critiques. Her role in these organizations perpetuates the policy preferences of her tenure.
Legacy: Woodcock was the architect of the modern FDA approval pipeline. Her defense of the agency is a defense of her own life’s work, which prioritized speed and industry collaboration over the slow, rigorous trials Prasad advocates.
Stephen M. Ostroff, M.D. (Acting FDA Commissioner 2015–2016; 2017)
The Conflict Profile:
Consulting (Complete Response Solutions): Ostroff works as a consultant to the food and medical product industries. His firm, Complete Response Solutions, explicitly helps companies navigate regulatory hurdles. His value proposition to clients is his insider knowledge of the FDA. By signing the NEJM letter, he reinforces the authority of the agency, thereby maintaining the value of his consultancy as a bridge to that authority.