departing heads of FDA vaccines division say there is no compelling evidence for booster shots

now able to speak freely, they caution that the data is poor, the conclusions premature, the process politicized. we should listen.

two weeks ago, marion grueber and philip krause (director and deputy director respectively of the office of vaccines research and review) resigned from the FDA in disgust over the politicization of their agency around vaccines and the relentless drive to push boosters without sufficient evidence.

i spoke to this and their unusually blunt comments as they left HERE.

these 2 were the backbone of the science team at FDA for vaccines.

today (9/13/21), they are back signing on with 16 other health experts in a piece published in “the lancet” HERE.

in it, they reiterate and amplify their concerns about boosters

• lacking any solid foundation in science at this time,

• questioning the concept altogether,

• and laying out their concerns on the data, the process, and the politics.

this lays plain their reasons for leaving the FDA and, freed from the organizational censors and political pressures, lets them speak their minds freely for the first time.

in an ecosystem this cozy where “playing the game” and “adhering to the party line” gets you board seats, sinecures, grants, and honorariums for life they could have stayed silent and just reaped rewards. this is the time honored practice of nest feathering.

instead they have chosen to speak.

this is a brave and selfless act and it WILL cost them dearly as the vaccine companies and politicians alike are going to take a very dim view of what they are saying.

personally, i’d like to thank them and to suggest that we listen to them. what they are saying is important.

they suggest evidence based medicine and risk reward calculations. this is real medicine and real health being discussed, not shilling and marketing for political purpose.

“Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.”

they describe the full picture and want to do real science. this is a principled stand and what real doctors and researchers are supposed to sound like.

why, if i didn’t know better, i’d start to wonder if perhaps these people were actually internet felines.

let’s hear some more:

and watch as actual adults and actual experts speak freely.

warning: may contain concepts like “risk/reward” that many faux practitioners of medicine and drug company barkers may find objectionable.

“there could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines,3 or ,3 Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines4).

If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”

that is what public health sounds like when it’s discussed by actual public heath experts. after 2020-1, it’s kind of jarring, isn’t it?

this is what the real experts were really thinking all along.

how odd they were never allowed to speak and had to literally quit their jobs to be able to do so.

and how grossly disappointing that our health agencies have become the sorts of places where the experts are silenced so the politicians can stay “on message.”

let’s hear some more.

like them, i agree that vaccines seem to show efficacy in mitigating severe disease (on the order of 50% when i assesses the UK data HERE) but it’s also worth pointing out that they show no efficacy to stop spread and may well be accentuating it and selecting for hotter, more dangerous future variants because that’s what leaky vaccines do. i think their data on vaccine efficacy looks a bit rigged (because the studies that established it were salted and dis-included most high risk patients and therefore could never really demonstrate real world effects in weaker and higher risk populations).

vaccines (just like boosters) look like a strong idea for some, and a poor idea for others.

as i so often repeat: “medicine is everywhere and always a cost benefit decision”

it is only because this issue has been so politicized in the hands of a reckless few monopolizing message and mandate that this idea has not been front and center all along.

it’s not at all that the FDA did not know this.

of course they did.

they were just not allowed to say it. but now the experts may speak their minds and they are doing so with great clarity:

and i really think we ought to listen.

these are the actual experts. not fauci, not brix, not walensky, not murthy, and certainly not the angry grandpa “losing his patience” we had to endure the other evening.

this is what sense sounds like and what real public health evaluation is supposed to look like.

we’ve been throwing all the things we knew how to do out the window for 18 months and going on an truly unprecedented epidemiological joy ride with the lives and livelihoods of billions. we’ve ignored 100 years of evidence based pandemic guidelines and drug development knowledge and process.

we did it by silencing those that actually knew anything and subjugating them to grifters, hucksters, political fief builders, politicians, and demagogues.

this is not the road to good science or to good policy.

it’s clear these agencies are no longer about public health and it’s reprehensible that we’re created a situation where the top people have to quit to be allowed to speak the truth about medical interventions being marketed to and increasingly forced upon the american people.

but we have, and they did.

and we really ought to listen.

enough damage has been done.

we should follow the experts, not the agency nameplates.

they are only as good as the people who work there and when elvis leaves the building and holds a concert in the parking lot, where do you want to hear the music?