[evandijk70]

Not just safety, but also effectiveness. FDA checks whether the trial(s) to prove the drugs effectiveness were run correctly (eg. the randomization, the control group, etc.), if the statistical analysis was done right, if the endpoints are appropriate (response to treatment is not always objective) etc. etc.

The FDA (and EMA in Europe) are the only thing that protects desperate patients from fraudsters, charlatans and pharma-companies just looking for a return on their investment.

[bhickey]

Ideally this is what would happen. In practice there have been very public failures in being overly cautious and aggressive.

While Aduhelm reduces Aβ it has no clinically significant effect. Still, the FDA approved it. Mercifully it'll be discontinued in November.

The covid vaccine represented a huge policy failure by the FDA. While people in nursing homes died in droves we got small clinical trials. When you've got 90 year olds in a congregate setting facing a 50% chance of death, maybe it's time to stop pretending thalidomide may be lurking around every corner. The pediatric trials were just as bad. Due to their sizing it was statistically impossible to detect rare adverse effects. Yet, vaccination was delayed for children while these fruitless trials ran.

In my own experience I had a low cost, high throughput covid testing protocol ready to go in early April 2020. It took the FDA until August 2020 to provide templates and another month to grant emergency use authorization. We could've drastically ramped up testing when it was needed most of the FDA has treated an emergency like an emergency.

[_heimdall]

Is it your opinion that trials for the Covid vaccine should have been skipped to vaccinate people earlier, or that proper trials should have actually been done to know the efficacy and safety before testing it on the public?

[bhickey]

Either would've been preferable to what was done. Waiting on a provably fruitless trial in the midst of pandemic is regulatory homicide.

Throughout 2020, more than 9% of all people in nursing homes died of covid. Depending on age case fatality rates were upwards of 50%. The vaccine should've been offered to these people on a compassionate use basis. Even at the time it was obvious that actual harm posed by the virus vastly outweighed any hypothetical risk of adverse vaccine reaction. Drastically expanding the vaccinated population through compassionate use would have rapidly provided efficacy and safety data.

[_heimdall]

> Throughout 2020, more than 9% of all people in nursing homes died of covid. Depending on age case fatality rates were upwards of 50%.

That's just about most difficult population to determine primary cause of death for. Most people in nursing homes have multiple comorbidities and a long list of medications. Its easy enough to know when someone died with Covid, its much more difficult (if not impossible) to know after the fact whether that's what caused their death or if the infection began after an existing condition worsened and weakened their immune system further.

> Drastically expanding the vaccinated population through compassionate use would have rapidly provided efficacy and safety data.

That wouldn't have helped get efficacy or safety data for the general public though. Vaccinating that population could absolutely have helped determine efficacy for that population and I agree it feels like a reasonable action given the potential risks for that population, but the data wouldn't be useful for the general public that are younger and/or in better health prior to infection.

[bhickey]

> That's just about most difficult population to determine primary cause of death for.

Nursing home quality, COVID-19 deaths, and excess mortality https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8776351/

At the peak, excess nursing home mortality was nearly 6000 per week. Quibbling about "died with covid" versus "died of covid" isn't a useful exercise. Dead is dead and the excess mortality came from somewhere.

[_heimdall]

> Quibbling about "died with covid" versus "died of covid" isn't a useful exercise.

It isn't quibbling when the specific topic is whether or not to treat a population with an untested vaccine (assuming the trials were skipped for at risk populations as proposed above).

In a general sense, I totally agree the "with" versus "of" debate isn't useful. But when considering giving an at risk population an untested vaccine, how is that not important? Any intervention could have downsides, and more importantly an preventative intervention for a secondary infection may not be worth the risk depending on the risk profiles.

One tricky question that would have to be answered is whether the excess deaths were related to changes in nursing home treatment and general conditions. Nursing homes were effectively locked down in many areas, reducing human contact and potentially negatively impacting care. Vaccines would have no impact there, and if the untested vaccine has negative side effects we would have only made things worse.

[linuxftw]

People in nursing homes died from untreated illness. They were completely locked down, and isolated from friends and family. They weren't allowed to be transported to actual hospitals. Anyone with simple bacterial pneumonia was left to die.

In the UK, nursing homes were discovered to be sedating patients and not administering water and nutrition. I wouldn't be surprised to learn the same happened in the US.

[pfisch]

If something would've gone wrong with rushing the vaccine like that it would've given the anti-vax people a massive boost and the vaccine refusal rates would've skyrocketed.

The refusal rates were already too high with anti-vax people making up lies/distorting data. If they actually had real data things would've been much worse.

[r00fus]

> If something would've gone wrong

Anti-vaxxers simply don't care about truth vs. falsehoods. They don't care about the actual 3-phase clinical trial with tens of thousands of participants.

[AnimalMuppet]

How about telling the public the truth? Say something like, "This particular vaccine has not been tested up to normal FDA standards. It may not be as safe as other vaccines. But we are convinced that it will do more good than harm, given the danger of Covid for the unvaccinated."

You could let the public make an actual decision based on actual information, rather than telling them little, projecting false certainty, and then trying to force them to do what you think is the best course. I mean, look, not everyone can be treated like adults. But I think the majority of people can. Tell them the truth, and let them decide.

[pfisch]

You're not thinking it through. Lets say that vaccine ends up killing thousands of people.

That event will then be used in a way that is wildly out of context as fodder by all the anti-vaxxers out there to scare people into not getting vaccinated later when the vaccine is safer.

For the next 50 years anti-vaxxers and scammers will be using that event to scare people about vaccines.

It is not worth the risk because of the potential outcomes.

[_heimdall]

How do we define an acceptable refusal rate? The vaccines were largely untested and given under emergency use authorization. Shouldn't it be reasonable for people to choose for themselves whether to take part in the vaccine campaign or not, especially when we can't provide solid data to support safety or efficacy?

At the end of the day, in my opinion, there is no magic number for vaccine acceptance that is a metric to define beforehand. Refusal rates are a backward looking metric only and simply reflect the willingness to participate and trust in the general public.

[pfisch]

How many doses would we need to give out to not call them "largely untested"?

Far more covid vaccines were given out to more people then almost all prescription medications have been. They were FDA approved officially in 2021, and at the end of the day all of the covid vaccines given an EUA were much safer than even mundane things like driving a car.

High vaccine uptake rates save lives. Pretending otherwise requires you to misrepresent the data.

[someuser2345]

Something did go wrong; of the 3 vaccines the FDA approved, 1 of them had to be recalled due to causing fatal blood clots.

[pfisch]

Which effected almost no one, yet here you are talking about it. Imagine if an early covid vaccine had killed thousands. That would have had a massive chilling effect on vaccine uptake.

[refurb]

> Still, the FDA approved it.

The FDA approved it via accelerated approval. The intent being "allow access to promising medicine while additional data is collected".

[wbl]

Remember the pandemic? The FDA had safety and effectiveness data by end of August for the vaccine and were unprepared to do an analysis in less than a few months. Nor did they consider drafting the party boys of the Ozarks to get the efficiency data faster. As a result the winter of 2020-2021 saw thousands of preventable deaths.

There's also the part where distribution was done in a way that deliberately killed people so that racial equality goals could be met. Perhaps the worst example of this kind of thinking were teachers in SF getting vaccinated but school not starting again.

[zoobab]

"The FDA (and EMA in Europe) are the only thing that protects desperate patients from fraudsters, charlatans and pharma-companies just looking for a return on their investment."

EMA has some people that were recruited from Big Pharma.