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.
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.
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.
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.
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.
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.
Strokes, heart attacks, circulatory issues, etc are likely pretty common in that population and any increase there after treatment may go unnoticed as a change. If you do recognize it they'd have to stop treatments entirely as you wouldn't know whether its a risk to everyone or specific to some combination of age, comorbidities, and/or other medications.
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.
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.
> Imagine if an early covid vaccine had killed thousands. That would have had a massive chilling effect on vaccine uptake. You're making it sound like the chilling effect would be a bad thing, when it would actually be the correct response. There are plenty of examples in the history of medicine of the cure being worse than the disease.
We had safer vaccines available though so switching to them is even better, which we did.
> You're making it sound like the chilling effect would be a bad thing, when it would actually be the correct response.
That chilling effect would still exist when the vaccine was safe, making it the incorrect response. Conversations like this make it very clear why we need to be very careful about vaccine safety and we should never release a vaccine that will kill thousands EVEN if that vaccine would save lives overall.
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.
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.
The pharma industry has been consistently producing what would easily be called life saving miracles in any other context. Anyone unable to see that is the biased one.
But lets be real, you almost certainly already know that. So you very likely fall into the category of people who intentionally misrepresent the data so you can pretend that vaccines are a bad thing.
Of course it is possible that the highly political, near-religious atmosphere during the Covid-Circus biased the reporting for the mRNA vaccines in the other direction. But this has to be objectively studied. That never happened. One of the many things that make me deeply distrust the mRNA vaccines.
Your very general statement "so you can pretend that vaccines are a bad thing" shows your propaganda. I am vaccinated against several pathogens. But the topic "immune system" is really complicated, the knowledge up to date is not sufficient to force people. Especially vaccination of children has to be thoroughly justified. Search on Google Scholar for "Peter Aabye".
You mean before vaccines became extremely politicized? I think we can safely assume those numbers aren't useful anymore now that the well has been poisoned.
>But this has to be objectively studied.
There were plenty of double blind studies on the covid vaccines. Those are the gold standard. I'm not even sure what you are asking for here.
I asked for studies on the reliability of VAERS data about the Covid vaccines.
RCTs are just one brick of the science building. And of the plenty you think exist, I have encountered only a few good ones, yet. The Cleveland Clincs study is one of them, but they justctested for infection and didn't include the outcome all-cause mortality or hospitalization for some unknown reasons. The US veterans study seems to prove a lower mortality for vaccinated, but the cohort is for sure not representative. Btw, those two showed a clearly monotonic increasing probability of acquiring a Covid19 infection with number of vaccinations.
RCT fanatism is not helpful.
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.
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.
If a vaccine is rolled out and kills thousands, the example you gave, why shouldn't some people take notice of that and be concerned? Is there no level of risk that would also make you consider not taking a new and untested, or under tested, vaccine?
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.
The FDA approved it via accelerated approval. The intent being "allow access to promising medicine while additional data is collected".
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.
EMA has some people that were recruited from Big Pharma.