Peter Marks' FDA is Playing Games with Young Men's Health & Maximizing Pfizer's Profits
3 pieces of data from this week.
I want to present 3 pieces of data which continue to build the case that this FDA, under Peter Marks, is acting recklessly with its push to boost, in perpetuity, 18 year old men who had COVID19.
This week, internal emails show Marion Gruber, former head of FDA vaccine science frustrated with Marks. She specifically highlighted the myocarditis issue. Myocarditis appears to occur at least 1/10k with boosters, and subclinical troponin elevation is likely 100 times as high (based on 2 studies). This concern was ignored.
FDA under Marks has changed the date Pfizer is required to turn in postmarket safety data. From Dec to June. This is the study to look for troponin in young men. These data were needed in 2021— their continued delay is catastrophic.It appears FDA has extended the due date for Pfizer's subclinical substudy that was a condition of approval to Jun 2023 from Dec 2022, a change made since I last checked the website on Jan 23. H/T ! accessdata.fda.gov/scripts/cder/p… fda.gov/media/151710/d…@rfsquared @US_FDA @pfizer @DrPaulOffit On #9 the question is simple: What was the incidence of subclinical myocarditis following administration of a third dose in a subset of participants 16 to 30 years of age? TY @IamBrookJackson for sharing this nifty website: https://t.co/V5mncKgLEs https://t.co/8cS0TFOtbsJessica Adams @RxRegA
It is now clear that bivalent boosters also have myocarditis; from today’s VRBAC
If the rate of myocarditis is 1/10k hospitalized (consistent with Sharff’s estimate for the last booster), how can the benefit outweigh this in a 16 year old man who had COVID? He does not have even an absolute risk of 1 in 10k hospitalization from reinfection. This is now a harmful intervention until proven otherwise.
Peter Marks has eliminated all dissenting voices at FDA and is hellbent on sacrificing evidence based medicine in an effort to give Pfizer a perpetual market share in young people. If he were at FDA instead of Frances Kelsey, thalidomide would still be a treatment for morning sickness.