FDA head asks for investigation into Aduhelm drug approval
businessinsider.com
businessinsider.com
Is this sort of thing common? Seems like an investigation is definitely warranted if this type of resignation is a rare as I would imagine it be.
[0] https://blogs.sciencemag.org/pipeline/archives/2021/06/08/th...
[1] https://blogs.sciencemag.org/pipeline/archives/2021/06/24/op...
From January 2020 (17 months before aduhelm approved):
https://www.npr.org/sections/health-shots/2020/01/14/7962270...
FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find
> Almost half of recent new drug approvals were based on only one pivotal clinical trial instead of the two or more that used to be the norm, according to the study published Tuesday in JAMA, the journal of the American Medical Association. And the reliance on surrogate measures — stand-ins for presumed patient benefits — has increased. In the case of cancer drugs, a surrogate measure could be shrinkage of tumors instead of improvements in survival after treatment.
> …Drugmakers also began paying the FDA fees to fund the review process after AIDS activists protested the agency's sluggishness in the 1980s… "There is some concern about the incentives that this is created within the FDA," Darrow says. "And whether it has created a culture in the FDA where the primary client is no longer viewed as the patient, but as the industry."
["surrogate measures" is a complaint with aduhelm approval, when they say there was no "evidence showing the drug slowed the disease", they mean the approval was based only on surrogate measures.]
Surrogate measures are a trade off that we as a society have decided to make to reduce regulatory burden and accelerate brining new therapies to market. Maybe you disagree with it, but someone with a terrible disease waiting on a new life saving treatment might see the issue differently. In some cases it is clear that the surrogate is a good endpoint. In others maybe less so. Regulators have the tough job of balancing the risks, benefits, and science when making the call on whether to accept one.
Generally FDA is doing many things to streamline and accelerate the regulatory process. This is good. We want them to innovate and take advantage of new scientific knowledge and technological breakthroughs.
Finally I would say that the real precedent for this was the decision for the Duchenne Muscular Dystrophy drug (also happened on Woodcock’s watch). I kind of had this sinking feeling this was about to happen when I saw that she was acting commissioner. Say what you will about Trump, but Gottleib was a damn good appointment - at least until he got fired for going after vaping. Azar was a pussy and basically an empty suit.
I am curious. How much of the society was involved in making this decision. We can all agree that there is enormous financial pressure from the industry to make such decisions go in its favour, and virtually none to go in favor of the public.
So isn't there a chance that eventually such trade offs will go in a direction that is harmful to the public?
>Maybe you disagree with it, but someone with a terrible disease waiting on a new life saving treatment might see the issue differently.
Sure, but we don't do things this way. You can always find someone who benefits from a community wide applied bad idea. Does not justify the bad idea sadly.
This kind of short term, localised thinking might allow the regulatory process to bend heavily under the aforementioned financial pressures, in favour of the industry, and result in great public harm that might go unnoticed for a very long time..
As far as patient advocates, as many pieces point out, one of the historical things was AIDS activism for availability of drugs. I was struck by this from a recent piece about ACT UP, from one of the activists at that time:
«Today, Franke-Ruta is a journalist, and she spoke to Schulman about the wider implications of some of act up’s success. “I don’t think that we realized at the time that this was part of the broader gutting of the FDA that we’ve seen since; that there was a lot of political agendas that we just happened to be in sync,” she said. After President Donald Trump touted the promise of hydroxychloroquine as a treatment for covid-19, the F.D.A. issued an emergency-use authorization for the drug, which was shown to be useless for the purpose. (The agency withdrew the authorization three months later.) “Sometimes it seems like it’s gone too far in the other direction,” Franke-Ruta went on. “But there’s a really strong pharmaceutical lobby against the FDA as well that I don’t think we were aware of.”»
And from the article's author, editorializing a bit:
«In retrospect, one can ask whether act up’s victories on the research front pushed the F.D.A. too far. The drugs-into-bodies approach to fast-tracking—the use of “surrogate endpoints” (like T-cell counts or viral load), for example, rather than clinical benefits in actual people—can be valuable, especially for patients who are facing death and have no good alternatives. This approach at least offers desperate patients a chance, while allowing scientists to gather meaningful data. But, today, a number of drugs, for everything from asthma to periodontitis, have won approval before benefits in human patients were established, and critics argue that drug approval is too often based solely on benefits shown in biomarkers rather than in bodies. “Right to try” legislation, meanwhile, enables the sale of drug candidates without even involving the F.D.A. When restrictions are weakened, experimental drugs—many of which end up proving useless or worse—become harder to distinguish from effective medicine.»
https://www.newyorker.com/magazine/2021/06/14/how-act-up-cha...
I disagree. If you have media in your team, this is easy, given some time. Particularly in current times when you have a treasure trove of possible distractions that you can make the media throw at a gullible public.
If one looks closely, then I think CDC/FDA etc have lost credibility a long time back. The real events portrayed in documentaries like "What lies upstream" and movies like "Dark Waters" should be enough to reject these agencies outright.
What is enormously surprising to me is that, not only we consider them very credible, but are also willing to consider their word as unfailable and final in many cases.
Even more sad thing is that the power of CDC/FDA extends even to many developing countries, so this affects much more than their home country.
It's just a column.
But that's not to say the reactions from journalists weren't critical. Adam from Stat had some choice words about the decision.
If the other drug researchers are sticking necks out to say this is bullshit, it's pretty like that ... this is bullshit. The situation he describes that all the other companies had already failed to their useless drugs approved. Now that one useless drug slips through, all the others are going try and do that.
The point is, it doesn't seem like a useful distinction.
Sometimes, the agency is confident that it handled things correctly, so they want an auditor to come in to prove it to the public and reassure everyone that nothing untold happened. Other times, the agency suspects internal wrongdoing but lack the resources to investigate it without disrupting their day-to-day operations. It can also be a political move from a presidential appointee when they suspect that the investigation will uncover that it was their predecessors fault.
At the end of the day, though, inspectors general have wide latitude to investigate what they choose. HHSOIG would probably have investigated this anyway, so it’s just a good PR move for the agency to invite the scrutiny.
> In his resignation letter, Kesselheim said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history.”
The drug Humira for example is a drug with a similar cost and schedule that is used to treat chronic auto-immune diseases. Humira was similarly a first of its kind drug that for the disorders it is used to treat. It became perhaps the most lucrative drug in U.S. history eventually leading to the company that made it spinning it off into its own company. It has sent pharmas across the world scrambling to enter the market, with many of them doing quite well too. And dementia is an even bigger market than autoimmune disease.
It’s not full approval, it’s conditional approval based on the possibility of clinical benefit.
ref: https://www.forbes.com/sites/matthewherper/2016/09/20/approv...
What is the normal baseline?
So if you want to do “science” then a government job is likely one of the highest paid jobs you can get.
[0] https://www.opm.gov/policy-data-oversight/pay-leave/salaries...
[1] https://www.opm.gov/policy-data-oversight/pay-leave/salaries...
[2] https://www.opm.gov/policy-data-oversight/pay-leave/salaries...
[1] https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-dr...
How long is it going to take for the scientists who have built their career on the amyloid hypothesis to die out so new ideas can be investigated?
[0] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3titl...
Diabetes and obesity are still rampant, so I'd say something is certainly wrong.
And this is where the issue gets complicated. Why do people eat more than 2000 calories / day and exercise less. Are they lazy and stupid, or is there something deeper.
Personally, I think the most compelling argument appears to be that high insulin levels hijack the hypothalamus through hormonal disregulation. The hypothalamus of these insulin resistant people drives them to over eat and expend less energy because it thinks they are underfed.
This model suggests severely restricting carbohydrate in order to drive down insulin levels.
Low-carb certainly isn’t the solution. For some it is, but not for most.
The government will pay for medication “that works”.
It determines that medication is one “that works” by seeing if the FDA approves it.
The FDA doesn’t want to always be too slow to approve medication so sometimes it wants to approve medication as “doesn’t hurt”.
Ultimately, the problem is that American policy relies on categories rather than spectra. My personal belief is that this is because the bureaucrats and policy makers are taking advantage of common American knowledge of categories vs spectra. So it needs some categorization mechanism and since one exists, they use that one. Presumably, out there is a bureaucrat with the same impulse as the engineer reading your PR who says “We already have a function to calculate radians to degrees. Why don’t we use that?”
In comparison, the NHS will measure how much to spend on a treatment based on an adjusted QALY measure (that boosts the value of the last few months). X QALYs are worth Y pounds.
Almost all American policy, by comparison, is category-based.
Other examples:
- immigration: America does categories (so either family or employment or refugee) while other nations use scores (if you both have family and employment you get some boost from both rather than the US max(categories)) system
- social security: Thresholds on disability and poverty are cliffs resulting in marginal income improvement resulting in marginal post-support income decrease. These should scale down, not drop off based on in-category/out-category
And odd you’d call the US out when QALYs can be very subjective and the QALY thresholds in the UK create hard limits to price that don’t always make sense (as QALY doesn’t capture all benefits).
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/76...
> The head of the FDA is calling for an investigation into her agency's controversial decision to approve a new Alzheimer's drug
I'm suspect that a lot of lesser, bad behavior had to go unchallenged, for us to wind up with a decision that was this blatantly corrupt.
How can you be pro-Marijuana and then not trust doctors to have another tool in their arsenal? The FDA should exist to prevent fraud and monitor quality, and nothing else. In this case, it would be highly reasonable to restrict the claims of the drug based on the study. But to ban it? What gives you or them the right to protect people from themselves?
The FDA acknowledged as such in their conditional approval, weakly suggesting expanded access might allow BioGen to demonstrate this in a larger population. This would lead Medicare to pay for an extensive, unethical study fueled by nothing more than the hopes of desperate patients and their caregivers.
That correlation has actually been turning out to be very weak. The very studies conducted to test this drug are some of the proof (reducing amyloid buildup doesn't affect disease progression), And there is also mounting proof from brain imaging that Amyloid buildup exists in the brains of many people with no mental problems.
And in general, if we know the drug does nothing at all, why allow the company to force doctors to prescribe it (by marketing to desperate patients)?
The drug can still be used in new research. But unless and until research shows that it has an effect on some disease, it should be illegal to market it as medication. At best it could be sold as a supplement, for those gullible enough to try it.
That's exactly what I stated. But banning substances outright is anti-science and anti-freedom. Just prevent fraud, and make sure it isn't poison.
It hasn't been, and probably doesn't, but now they can get billions from Medicare for it.
And no, it won’t cost billions. That’s a scare tactic. Medicare can choose not to reimburse.
It doesn’t cost $55,000 a year to smoke weed, and if nothing else weed will get you high. Most people have a problem with Medicare paying for this drug, not people taking the drug itself.
"There's no evidence that it cures one of the worst diseases around...The FDA should exist to prevent fraud and monitor quality..."
Then the FDA is doing exactly it's job. If there's no evidence that it works, then selling it would be fraud, right?
If I was a gambling man, which I am, I would add this to my paid newsletter and call it investing (with contradictory and nullifying disclaimers of course)
That being said, informal interactions where FDA talks you through regulatory options do happen for high priority / unmet need diseases, but there the “friendlies” are compartmentalized away from the those who review the applications.
My guess is that the review will show that someone from FDA met with the company to facilitate the application because Alzheimer’s is a priority disease, but strict compartmentalization from the review process was maintained. If not, then someone is getting fired.
I'll put my hand up to perform ethically at my job and not allow regulatory capture.
We'll see. What's playing out now is exactly how robust institutions work. Individual components can be corrupted, but the institution has a whole holds because of checks and balances.
Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear (namely, inclusion of Scientific Advisors in the review process, public records, and political accountability at the top).
When an unconstitutional law is passed, it's law. Until a court strikes it down. If an unconstitutional law is passed and then struck down by a court, that's not the system failing. That's individuals within the institution failing but the institution as a whole working exactly as intended.
> I'll put my hand up to perform ethically at my job and not allow regulatory capture.
But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day. Which, speaking as someone who has turned down similar types of government jobs because I could make 5x in the private sector, is quite a bit more of a sacrifice than I think you realize. (This isn't meant to excuse unethical behavior, btw, it's just that your comment is literally not responsive to GP's and GP is exactly right -- those jobs suck and if we want fewer failures like this one maybe we, the people, as the employer, should be at least paying market rate.)
That doesn't seem to be what he asked. He asked us to Try telling someone in a position of serious power who is going to loose his kid next year to back off.
It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug, ostensibly in blatant and clear violation of their own protocols. Presented with that non-sequitur, I chose to restate the event in play.
I was given another.
So, it's a shitty job because people yell at you for <=$100K (his reason) and also you could be making $500+k elsewhere (my reason).
> It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug
Your basic complaint is that those particular government workers were either corrupt or incompetent. I don't disagree with that assessment.
But if you can't understand why people take industry jobs for $500K instead of government jobs for $100K, especially when the government job additionally requires "telling someone in a position of serious power who is going to loose his kid next year to back off", then I'm not really sure what to say.
And if you can't understand how "the job is shit and doesn't pay well" has downstream effects like incompetence and corruption, then, well, I'm not really sure what to say.
Most problems with failed governance in the USA basically boil down to "Want competence and ethics? Pay market rates & don't fucking outsource." See also: the Obamacare website debacle.
The damning thing is the point it got up to, before the "checks and balances" came into play that we have to consider this as an exception rather than the rule.
IMHO The scientific advisory resigning is itself the point where the failure of the process became apparent. Because, I am pretty sure "if you disagree then you should resign", is NOT part of the approval process. I mean, it is not within the framework that you are trying to portray as being robust.
The solution now seems to be to simply not allow that medication to be used if the patient doesn’t match the parameters of the trial. Some portion of those people then die because the current ‘standard of care’ is the same toxic shit they have been pumping i to veins for the past 30 years to little or no effect.
You might be able to buy off the FDA, but it's a lot more work to buy off all the regulatory authorities of the world, at short notice.
That is kind of naive. Because you don't buy off FDA, you keep it on your payroll.
If you don't already have it on your pay roll, then you make deals with someone who already have it on their payroll.
Is that so hard to see?
Where can I read about all these studies, indvidually, say for example, for Moderna vaccine?
Also - Covid vaccines were under intense public and medical scrutiny, during every bit of their development.
Good government and transparency tend to go together.
"Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection" - "there was a 56% reduction in mortality; p=0.004 .. with favorable clinical recovery and reduced hospitalization."
https://academic.oup.com/ofid/advance-article/doi/10.1093/of...
"Ivermectin was associated with decreased mortality in patients with COVID-19... The certainty of evidence for mortality reduction was low."
https://www.sciencedirect.com/science/article/pii/S187140212...
The latter really seems more compelling to me.
"The Moderna COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19."
https://www.fda.gov/media/144638/download
None of this is to say that the vaccines aren't safe or shouldn't be used. They should be, especially for those at risk. The vaccines may well be better than Ivermectin and so far it appears that way. But there is some nuance here and it's valid if people want an alternative until the shots are FDA approved and have long term data. Many are not engaging in critical thinking when it comes to this issue and suddenly have complete trust of big pharma. Which I find bizarre.
William C. Campbell and Satoshi Ōmura won the Nobel Prize "for their discoveries concerning a novel therapy against infections caused by roundworm parasites". Not viral respiratory system infections.
I wasn't first in line to get any of these vaccines. Distrust of anything new is pretty rational!
But hundreds of millions of doses delivered, with a complication rate significantly less than the disease itself... that's pretty powerful evidence, no?
Especially compared against drugs that have yet to convincingly beat placebos in any large trial?
Personally, I find it bizarre that anyone can weight those two sets of evidence so differently.
Yes. But there is a problem. This implies an unrestricted flow of information. If there is censorship (self and imposed) going on, then you cannot take this perception for granted.
Is there censorship going on regarding these issue. Absolutely, there is. I think we can all agree on that.
So how much is the ongoing censorship skewing the issue? We have no idea. May be the censorship is done in good faith for noble ends, but may be it is not, again we don't know.
Also as seen in Vioxx issue, even a 100000 additional heart attacks can go un-noticed in a country, even without explicit censorship. We know smoking causes cancer now. But decades ago, people have been smoking for a long time without actually noticing the problem on large enough scale.
This why we do systematic research based on data collected in large scales.
Also one have to wonder why the systems such as VAERS depend on voluntarily reporting, that gives very little credibility to the data collected. Why is not made mandatory to report on adverse events? If you go to the VAERS cdc page, the covid vaccines are not even included in the list of vaccines to include for VAERS reportable events as prescribed by law.
So according to some studies, less than 1% of actual events in reported in VAERS. Even with such a low amount of reporting, we know that reports of blood clots and heart inflammation is concerning. So what is the true picture?
So the point that I am trying to make is that, "We have used these things, or have been using these things for a while without problems", is a poor proof of safety.
https://grftr.news/why-was-a-major-study-on-ivermectin-for-c...
If a long life has taught me anything, it's that puzzlingly loud claims of conspiracy are often generated noise to conceal the fact that something simply isn't true.
It's not clear how that relates to respiratory medicine.
BTW, I've joined the legions who are addicted to TWiV. It's a time commitment for sure, but it's fascinating how different the perspective is on important topics (like delta variant) than the mainstream press.
[1]: https://bmcinfectdis.biomedcentral.com/articles/10.1186/s128...
> Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population.
I think one would at least use any of the protocols that were being used by the doctors who are seeing an efficacy.
Nobody is 'smearing' the drug or even the people talking abot it.
They're saying 'stop telling the public about it because it's not approved yet and potentially dangerous'.
Whatever Donald Trump says - people believe. And they will go out in droves, self diagnose, self medicate, demand doctors prescribe them the 'cure' (when the doctor knows they shouldn't) etc..
And the amount of stupid conspiratorial memes that come up are pretty shocking. I avoid FB fro this reason and TikTok had a bunch of that for a bit, but I think they've shut down Ivermectin talk.
I quite like Joe Rogan, but he's not a doctor, and neither is his partner in goofydom Brett Weinstein, they have zero medical credibility on the issue, they should straight up not be talking about the drug.
If there is some kind of coverup, or there's hard evidence and the FDA is refusing to look at it, or if someone in Big Pharma bribed someone else ... then that's a story, but this is not that.
Oxford has just launched a trial for Ivermectin, and there are others. When the results come in, and if it works and is safe, then CNN et. al. will talk about it and parameterize it appropriately. We'll all hear about it pretty quickly.
The CDC can't stop Joe Rogan from talking about it and the haven't tried, but they can say 'STFU' until we have done the actual science, which is reasonable.
By this logic, this applies to every single person that aren’t doctors who shouldn’t be talking about the vaccine or the drugs. This includes data scientists and politicians. I’ve watched Dr. Pierre Kory’s full interview with Brett and seems clips of his testimony in front of the senate. He is extremely credible and should have a voice in this as a COVID-19 critical care doctor and who has done meta analysis of the drug (https://covid19criticalcare.com/wp-content/uploads/2020/11/F...). I think people like Joe and Brett help amplify voices of people like Dr. Pierre Kory similar to politicians who amplifies Dr. Fauci
Scientists and Doctors should be talking about it in scientific forums and communities. Politicians should be reiterating the 'current consensus'.
People shouldn't be talking about it in public / tabloid forums because the information is vague, misrepresented and will be taken entirely out of context.
I totally support people taking contrarian positions.
I think we should probably assign people towards being 'The Devil's Advocate'.
The issue is not 'freedom of expression and open dialogue' - it's one of 'crude populism and misinformation'.
It's about how information is propagated, and how people react to it.
What we need is a policy of absolute honesty with a one-strike-and-your-out-forever punishment for any health authority that engages in propaganda, even if they had good intentions. Credibility matters. It matters a lot. All of these coy little word games and character assassinations being conducted in the name of the common good is achieving the exact opposite result. As it stands now, the credibility of the medical community might be forever tarnished especially since there appears to be no attempt to get it back but rather endless doubling downs on the slime tactics that should be to exclusive province of political campaign directors and used car salesmen.
Won't work, unless there are multiple health authorities – but the average person isn't going to keep track of the reputation of multiple small health authorities, so the authorities will have comparatively less reputation at stake.
You are onto something, though. Consider fleshing it out a bit before reading what other people are talking about. (ROT13: cerqvpgvba-onfrq zrqvpvar)
You aren't kidding. That whole hydroxychloroquine thing was a mess.
My father is kind of scared of the COVID vaccine - understandable.
But he gets his 'flu shot' (and a bunch of other things) by the doctor all the time.
He has zero problem running all the other tests, taking pills and taking the 'flu shot' which is literally a vaccine!
But he also reads stupid conspiracy theory stuff on Facebook and watches Fox News, and I believe to this day he has not been vaccinated.
That's how powerful misinformation can be.
My bet is that he'll probably take Ivermectin if he's heard about it on Facebook a bunch of times as being that 'safe drug that the government tried to hide'.
My father is not a dumb man, and neither are most of the people involved in this - but about 40% of the population can't effectively deal with information. They will take the drug depending whether Biden or Trump told them to take it.
>But he gets his 'flu shot' (and a bunch of other things) by the doctor all the time.
Does make a lot of sense to me. Because not all vaccines are the same. Infact their contents can be vastly different (It has to be, given that they protect against different diseases, you know).
So Just because you are Ok with one vaccine, does not mean that you should be Ok with all vaccines.
Sounds like common sense to me. Don't you agree?
But the hesitancy I've witnessed is not based on a kind of logic or reasoning, rather just an 'instinct'.
If all you read is weird FB posts, tabloids then the sum totality of the 'decision' will just be 'no'.
Fox News I think illustrates how this can happen. Fox hasn't taken a Covid or vaccine denying position. In fact, you could probably find that officially they have been 'on the side of the vaccine'. But since so much of the coverage is questioning, cynical, downplaying and contrarian - and - they have not actually been overtly supporting the vaccine programs ... it's easy for people to be 'net vaccine hesitant' if that's their information source.
So while at the very same time that a news organization can be '100% technically correct' on everything, the channel might become noisy and the net result is lack of clarity.
My father doesn't have an argument about 'it was made too fast', it's more like 'Oh, there's that goddam Fauci again, telling us what to do!'. He personally dislikes Dr. Fauci, at least in part because of the media he's consuming.
He believes that coronavirus is real, and oddly, has even been in the hospital for some minor things where there were insane protocols he was more than fine with following (i.e. masks everywhere, everyone taking it seriously) - but at the same time, when the subject comes up he says 'Oh it's a bunch of bull**t' , kind of in a huff. Also - he lives in rural area that has mostly not been affected.
Public Communications is not about making just rational arguments - it's about information clarity, emotions, credibility, how much fog and misinformation is thrown about, all of the specious and frankly totally false bits of Social Media etc..
CNN went to somewhere in the Midwest and interviewed a bunch of people in a small town and they largely reacted the same way:
"We just do thing differently here"
"It's not a big deal for us"
"We just don't need it"
While the 'it was made very rapidly' logic (and other reasonable arguments) are sometimes made ... that's really not it.
That's why in a crisis, information discipline is so important.
I firmly believe that if Republican apparatus and media were very committed to vaccination especially with public messaging, then about 25% more Americans would be vaccinated.
Imagine if the President of the USA was using his Twitter to try to get people vaccinated. Imagine if he held 'vax rallies' where free tickets went to anyone vaxxed. Imagine if he asked Country Music stars to support the effort. Instead of 'technically supporting vaccination while publicly being cynical about it'. That's what it boils down to.
What about the advocacy? I would go further and say that not even advocacy, but the general behaviour to trust the authority, is an instinct, rather than rooted in logic or rationality.
Because there is really no reason to trust CDC/FDA, after so many instances where these have caught to act diametrically opposite to the interests of the public (For some examples, look at real event portrayed in documentaries like 'what lies upstream' and 'Dark Waters'). Time and again, these agencies get away with little more than a pat on the wrist.
But people still, instinctively trust them. It is very sad, as you say.
>He personally dislikes Dr. Fauci
To be frank, it is hard to like someone who declares himself as the embodiment of scientific truth.
Once you trust someone, then you don't have to scientifically validate everything they say.
Also - there's tons of coverage of the vaccine. There are dozens of rich nations, each with dozens of Health Agencies doing public work, it's impossible to keep a secret.
You're borderline conspiracy theory if you think there's 'no trust' in the CDC/FDA. There's tons of trust.
What's 'sad' is people' inability to grasp that institutions are not perfect. Police, government, military, etc..
The US has military has committed some pretty terrible atrocities, and yet 'trust' in it is very high.
Same with police: they've been known to arbitrarily kill and imprison people unnecessarily - and yet they have high levels of trust.
The CDC are Health Officials for God's sake, that people wouldn't trust them as much as the military is sad.
"To be frank, it is hard to like someone who declares himself as the embodiment of scientific truth."
Now you're resorting to crude populism ... He's done no such thing.
When you're talking daily to wall of reality and science-deniers, it will get frustrating.
I don't care about Dr. Fauci, but his opponents try to create contrarian conditions regarding him in an attempt to get clicks and rile people up. They're vile.
It's wild to see people grasping at random anti-parasitics as some sort of miracle cure when (if you're over the age of the 12 and in the US) you can literally walk into any pharmacy and get a real miracle cure for free.
I am not sure how that can be correct. Because each vaccine is different, and can vary drastically in what the contain.
Now, if you say, all FDA approved vaccines are generally safe, then that might make a little more sense. Then you are at least qualifying something apart from just the name "vaccine".