two top FDA vaccine leaders stepping down over agency practice

they cite frustration, meddling from white house and CDC/ACIP, and inability to do their jobs

well, this is a nasty turn of events. it turns out that the hyper politicization of the FDA under acting head janet woodcock is increasingly leading to those of good conscience being unable to continue to support the agency.

the top people in the vaccine division are leaving because they do not want to be associated with the current regulatory environment and the encroachment of politics into medicine.

news from biopharma industry publication ENDPOINTS.

and these two were the key folks in the FDA vaccine effort.

“These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Former BARDA director Rick Bright wrote, weighing in on the news.”

endpoints is not a publication known for histrionics or partisan politics.

this level of statement from them is exceptional and starts to evidence the rage and disgust i’ve been hearing so much of out of all but the biggest in pharma and biotech. no one can believe what has happened to the FDA in the last 2ish years since gottlieb (who had, frankly, been doing a great job, one of the best in decades, possibly ever) abruptly resigned mid-term to “spend more time with his family.” he’s was 46, hardly “gold watch and hearty thanks” territory.

he was replaced by acting head woodcock. she has, after 2 years, still not been confirmed. this means she’s 100% politically vulnerable and can be yanked any time. so when political bosses say “jump",” she must say “how high?” or hit the bricks.

this is where the politics enters. i’ve been getting earfuls on it for 18 months from industry, but don’t take my word for it, let’s ask those who just resigned:

“A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA. The former FDAer also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA.

What finally did it for them was the White House getting ahead of FDA on booster shots.

endpoints continues:

“The bombshell announcement comes at a particularly crucial moment, as boosters and children’s shots are being weighed by the regulator. The departures also come as the administration has recently jumped ahead of the FDA’s reviews of booster shots, announcing that they might be available by the week of Sept. 20.

are you getting this? this is not “the side of science” it’s “get me some sciencyness to support my politics and help me cover my heinie on rapid collapse in vaccine efficacy right after i just hectored america endlessly on their need and effectiveness.”

that’s not medicine, that’s a propagandistic whitewash.

you do not get to claim to be on the side of science and then push programs and mandates for which the data is not even collected, much less analyzed thereby completely sidestepping the regulators you claim everyone needs to listen to.

that’s medical malpractice. it’s an absurdity.

and it’s becoming the norm, not the exception.

getting the public accustomed this this level of mendacious doublespeak is a descent into 1930’s level propaganda right down to “always accuse your enemy of that which you are doing.” call them anti-science and accuse them of politicizing it because that is your primary practice.

covid has really brought this to the fore, but it’s now endemic to the FDA.

3 panel members for alzheimer’s quit in disgust after the FDA approved aduhelm despite a clear ADCOM panel recommendation against such approval.

those of good conscience simply do not want to be a part of an organization this captured, corrupt, and politicized.

and that makes this all the more worrying:

peter is the career chasing bureaucrat who has been at the fore of this unwelcome transition. he’s playing ball to get ahead, perhaps aspiring to a fauci fiefdom of his own. and now he’s going to replace some principled people in key positions with his own lackeys.

anyone want to bet that “principles and science over politics” are going to be key resume features in this search? because i’ll take the other side of that action.

bigly.

this is how agencies rot like fish: from the head down. leaders get ambitious and politicized and they force this downstream. those seeking to do otherwise get frustrated, disgusted, and then forced out. their replacements are hand picked by the grifters and politicos. and thus, science dies.

when you politicize science, it’s not science anymore.

when you push policy before you gather data, you’re not engaging in evidence based medicine.

when you’re forcing your best people out over and over, you’re not a healthy health regulator.

and the politicians doing this are playing the public for a chump.

so, seriously…

the FDA is and US health agencies are going to need a nose to tail rework when this is all over.

they are run by politicians, grifters, and fief builders. liars like fauci who push gain of function research (perhaps because his wife is the head of bioethics that should have reigned this in?) and then lie about it are just a symptom. this is a fully metastasized institutional cancer and it’s only going to get worse until we address it.

if you think this public health response got out of control, wait until you see what it looks like with all the good, principled scientists gone.

better still, let’s not wait. let’s make this a priority and let’s get this fixed. absolutely no one should need to see how much worse this can get.