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Monday, March 31, 2025

The same media that lied about all things COVID is lying about Peter Marks' departure from FDA

 by Vinay Prasad

Peter Marks was a mediocre academic hematologist prior to joining the FDA now 13 years ago. A review of his publication record in those years would likely find him to be entirely average and unimpressive. Take a look, and read the papers. Nevertheless, he obtained an important job in government and rose within the FDA through the civil hiring service.

At FDA, Peter eventually became director of the Center for Biologics— overseeing vaccines and gene therapies. In this role, he made some of tbe biggest regulatory errors in the 21st century.

Without randomized data regarding clinical outcomes, he repeatedly approved COVID boosters for kids as young as 6 months

Without randomized data he approved these boosters for individuals who recently had COVID

When Biden wanted to mandate the COVID 19 vaccine via OSHA and to military members and to pressure companies to do the same, he faced a challenge. The vaccine was authorized only under Emergency use authorization and not full biologic licensing agreement. Legal experts disagreed if a vaccine could be mandated without BLA.

Peter Marks then pressured Gruber and Krause at FDA to grant full BLA. When they did not play ball, Marks pressured them to resign (This was also documented in Krause’ testimony to Congress.

Then, with the BLA in hand, Biden was allowed to advance the single greatest anti-vax action in the 21st century. Mandating a vaccine that did not halt transmission and has no third party benefit.

This has resulted in massive vaccine hesitancy.

Then to top it all off, Peter was a long time proponent of lowering the bar for gene therapy. Against the advice of 3 FDA scientists on 2 occasions he granted both accelerated and regular approval to Sarepta’s Duchenne’s MD gene therapy. A therapy that has no evidence it helps boys. Sadly, now, at least 1 is dead

Peter Marks, single handedly has indirectly killed more boys with DMD than he has saved with this regulatory action. The drug does not actually improve motor outcomes in randomized trials.

Meanwhile the media is lying about Peter Marks. They state that Marks was pressured to be anti-vax by RFK Jr. Yet, no single specific action is cited. What precisely did RFK Jr ask Marks to do? Some articles even call Marks a hero, and he is praised by past FDA officials who now consult for drug companies or serve on their board.

In short, Peter Marks was one of the most dangerous, pro-pharma regulators of the 21st century. He is leaving and crafting an narrative that portrays him as a saint. That’s natural. But what is shocking is that the media is so uncritical, and not honest about his actions. The same media that lied about lab leak, masks, and all things covid is lying about Peter Marks.

Overall, he is what happens when a mediocre academic becomes a pro-Pharma FDA regulator, and makes a series of the most calamitous mistakes in 21st century drug regulation. Because of him, the American people are poorer and worse off. Companies meanwhile profited from his actions. My only question is whether he starts working at Pfizer, Moderna, Sarepta or a consultant for all three.

https://www.drvinayprasad.com/p/the-same-media-that-lied-about-all

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