Yeah, I don't think it's good to grab onto anything in particular.
That being said, the risks with certain drugs are very low. Hydroxychloroquine has some serious side effects and appear to marginally improve results, hence they revoked the EUA.
Does full FDA approval make a meaningful difference, though?
If anything, it seems like if someone doesn’t want to rely on the current EUA (because of limited data, incentives, etc.) then they shouldn’t suddenly be okay with the FDA’s full authorization.
Banned? Perhaps you are under the impression that the data has been reviewed by the FDA?
IIRC, the EUA analysis is in flight (for a December timeframe) and that is to ascertain that the data is up to the mark and not to take what the companies have announced at face-value.
Someone else answered correctly saying an EUA can't be issued if an already licensed drug can help. I would further that point by saying to actually go dig up the true source of that policy on the FDA's website in your country (not someone's summary or interpretation). It's a great exercise that will leave you with some sort of ground truth in this mess.
Same as in coding, you eventually reach a point where you learn that when in doubt, you must read the source.
I’ve got a little bit of FDA experience, but of course no COVID-19 EUA experience. Based on what we submitted to the FDA and the comments we received, I would personally think it most likely there were many issues with AZ’s materials, at least as far as their attempts to seek approval from the FDA went.
EUA means Emergency Use Authorization. Emergency, yes, that's what Covid is. As such, leadership means taking some calculated risks. What FDA essentially does is "you can't get fired for buying IBM". They stick to "we don't have any data for this and that", "this is what the science shows", and people out there are dying. A perfect demonstration of lack of leadership.
I've seen in mentioned in a few articles criticizing unapproved tests, but it was more about the potential for this than actual testing. I think one was on CNN, but a quick search doesn't turn it up. There's just too much noise in the new-sphere right now to easily find a specific article from a week or two ago if you don't remember something ultra specific about it. You get, um, lots of false positives in your search results ;)
I had heard that the FDA rejected the outside the US data, stating it would not be sufficient for approval. They are supposed to be in constant communication with the regulators, so nobody is submitted EUA until its basically a sure thing.
I wasn't being literal. The point is the FDA is overly cautious to the point that they're harming the health of patients. Slight deviations between the US and EU are understandable, 10x is questionable.
I have no idea how these things work, but what struck me is the "restrictive" tone in the EU ("We couldn't find an adequate study proving or disproving, therefore we assume it's dangerous until proven otherwise") vs. what I view as a "permissive" view in the US ("We couldn't find an adequate study proving or disproving, therefore we assume it's safe until proven otherwise").
When it comes to things I put in my body, I would personally prefer the EU approach.
Yeah but the article and some others are making it seem like something unique to the FDA. It seems to be a global issue and they all need to improve their quality control and testing processes.
This suggests FDA approval doesn’t say much about whether something works—presumably it still says something about safety. At any rate, whether or not FDA approval means much, to a certain subset of people it ostensibly did, since the objection that there was only an EUA was fairly common.
Only three of the events were withdrawals, meaning that only 1.3% of approved drugs were recalled off the market. Consider that this is a really impressive error rate. Scientific studies are allowed to be wrong 5% of the time; the FDA is wrong 1%.
The others were “boxed warnings” and “safety communications”. These are often pretty minor. I can’t read the full study you linked, so I don’t have their examples, but some of the most recent FDA boxed warnings are:
Last year, the FDA added a new boxed warning to all opiates and benzodiazepines (drugs which have been around for the better part of a century) telling doctors that really, no, seriously, don’t prescribe these together. People have known not to prescribe them together for the better part of a century, but the FDA decided they should be louder about it so they added a new boxed warning. Also, I’ve prescribed opiates and benzodiazepines together several times when it’s been clinically necessary, and as long as you’re not an idiot about it it’s fine (but please don’t try mixing opiates and benzodiazepines at home without your doctor’s permission!).
There’s a boxed warning on Ritalin that it might cause heart problems in kids. Later research has shown this is probably false, but the FDA worried about it one time ten years ago and decided to add a boxed warning, which nobody ever got rid of. Ritalin remains as popular as ever.
In 2006, the FDA added a boxed warning to warfarin, a blood thinner which at that time had been out 52 years, saying that if you took too much of it, it could make your blood too thin.
This year, the FDA released a safety communication, discussing a very common antiseptic used by millions of people yearly, that, over the last fifty years of use, about one person per year has had a serious allergic reaction to it, and if you have a serious allergic reaction to it, you should call 911.
Maybe another way of making this point is to list the psychiatric drugs that have gotten boxed warnings sometime after they were released: every antidepressant, every typical antipsychotic, every atypical antipsychotic, every benzodiazepine, lithium, Depakote, Lamictal, etc. You may recognize this as every single psychiatric drug (except BuSpar, which doesn’t work).
What I’m saying is that an FDA boxed warning isn’t “Oh god, how did this poison ever make it through the approval process?!”. It’s an incremental update to existing safety regulations on a generally good drug as more evidence comes in and people’s priorities shift.
The study says on average these drugs were out for four years before the FDA added the warning. That’s probably because these are rare side effects that only appear after many people have been taking the drugs for several years. For example, if one in every million people who uses antiseptic soap has an allergic reaction, we can’t very well ban antiseptic soap until we try it on a million different people. That’s why post-marketing surveillance is a natural and important part of the regulatory process.
Another example: antipsychotics are not FDA-approved for dementia. I don’t even know if any company has ever tried to get antipsychotics FDA-approved for dementia. Giving demented people antipsychotics is a bad idea if there’s any other option. But people do it anyway, and then the demented people get heart problems and die. The FDA eventually figured that out and put a boxed warning on antipsychotics not to give them to demented people if possible. This didn’t show up before approval because nobody wanted them to be given to demented people so there was no study about whether it was a good idea.
My point is that boxed warnings are a natural part of pharmacology, that some new side effects being found post-approval means the system works, and that the FDA continues to have a 98.7% accuracy in approving drugs that don’t need to be withdrawn later.
> When the FDA approves drugs and medical devices, it doesn’t need to keep tabs on how they evolve.
The FDA clearly keeps an eye on ongoing developments.
If your company produces an FDA approved drug, be aware you might get a visit by them to check on you, especially if you reported - oh yes, that’s mandatory - an unexpected deviation from your normal FDA approved processes.
And from the reactions I have seen by such companies, those FDA visits are no fun thing to look forward to either, even here in Europe.
Fair enough, my understanding was there was nearly a categorical ban on research w/ schedule 1 drugs. I am pleased to see this is not the case. Thank you for the correction.
That being said, the risks with certain drugs are very low. Hydroxychloroquine has some serious side effects and appear to marginally improve results, hence they revoked the EUA.
If you want to dive into the data, I recommend: https://c19early.com/
A lot of the papers are sub-par (so are the COVID-19 spread, symptomology, PCR tests, etc). Even the CDC PCR testing protocol (shown to be erring in Nov 2020) is having its EUA revoked: https://www.cdc.gov/csels/dls/locs/2021/07-21-2021-lab-alert...
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