Great. Speaking from first- and second-hand experience, the FDA is way more loosey-goosey than people think as long as you’re paying the right people.
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.
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.
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.
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.
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.
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.
It's not clear how that relates to respiratory medicine.
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.
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.
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".
>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.
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?