Taking enough time to endure a new acne medication or Viagra alternative etc is reasonably safe is very much worth spending some extra time.
Edit: This does seem to be focused on needed medications without close equivalents but that’s a fairly arbitrary line.
It’s not an easy choice, especially when the risks are often hypothetical and the benefits so clear.
It’s interesting looking at lists like this and considering where things broken down. https://en.m.wikipedia.org/wiki/List_of_withdrawn_drugs
If you're looking to treat relatively health people for most of their lives (say a drug that precent type I diabetes), the FDA will scrutinize the hell out of it.
If you're looking to treat someone who is dying (e.g. metastatic cancer), then the FDA is much more lenient in their analysis.
the approval then means that companies can target people who are desperate with extremely expensive snake oil. The victims of this have no recourse if/when the drug has caused problems.
I thought the FDA summed it it up well in the article:
>“We would expect every once in a while that we would be wrong,” with an accelerated approval, she said. “Otherwise, we aren’t taking any chances, we are still making them wait too long to get their hands on this therapy that will extend their lives.”
Vinay Prasad is a cancer expert and an outspoken critic of too fast approvals of drugs. He has done research on it, I could e.g. find this:
https://jamanetwork.com/journals/jamainternalmedicine/fullar...
The results for conventional fixed-sample randomized clinical-trial designs suggest that for terminal illnesses with no existing therapies such as pancreatic cancer, the standard threshold of 2.5% is substantially more conservative than the BDA-optimal threshold of 27.9%. However, for relatively less deadly conditions such as prostate cancer, 2.5% is more risk-tolerant or aggressive than the BDA-optimal threshold of 1.2%. We compute BDA-optimal sizes for 25 of the most lethal diseases and show how a BDA-informed approval process can incorporate all stakeholders’ views in a systematic, transparent, internally consistent, and repeatable manner.
Interestingly, the paper linked shows that in some respects, fast tracked drugs have a better track reccord. This shouldnt be surprising as the best drugs are fast tracked.
>18 drugs failed to improve overall survival (in 6 of 15 accelerated approvals and in 12 of 21 traditional approvals)
Doesn’t work = efficacy trials
Is harmful = safety trials
iirc the safety trials come first. A lot of drugs get stalled in efficacy trials because they might only work for some patients and the sample set is small or poorly chosen.
I see no reason to stall drugs that are proven safe, even if they might not be effective for all patients, as long as there is full disclosure and informed consent. Freedom to choose is a good thing.
Phase I determines safety. Phase II determines efficacy. Phase III is larger scale, randomized, and blind to give the FDA more information on the range of potential adverse effects and the effectiveness of the drug. FDA is supposed to care about both. The acceptable safety of a drug is relative to the effectiveness of it (i.e. a drug may be more dangerous or have more adverse effects, but it’s deemed “worth it” due to the effectiveness of the drug while of course maintaining a minimum safety risk for all drugs). In other words, both safety and effectiveness are both supposed to be taken as equal halves of the whole by the FDA.
I do.
For every treatment you are taking, you could have been taking some other treatment that might be more effective.
If we have no idea whether or not a drug is more effective than placebo, we should not be administering it.
However, there are many cases where there is no alternative drug or treatment that has been tested for efficacy, and so you’re stuck with hospice as standard of care.
It’s one thing for a doctor to recommend administration of a medication, it’s another thing entirely to make it unavailable for those that are in a position to make the choice for themselves.
Because they don't want the side effects of proven treatments, and they hope that snake oil will help them.
If people were rational about their health, homeopathic supplements, and other similar bullshit wouldn't be a billion dollar industry.
If you can't prove that your treatment works, you shouldn't be advertising it as a medical treatment. Advertise it as a non-medical non-treatment.
Being ineffective can be very dangerous as a person taking a drug expecting it to alleviate their condition finds no relief and thus dies from their condition.
You did not fully read and comprehend the parent post.
I wish I could buy my own life sustaining hormone that I've been using for 20 years and understand better than most doctors outside endocrinology.
A lot of harm is done to diabetics by denying them better treatments and tools in the name of avoiding extreme highs and lows.
I immediately thought that type of failure should be recoverable without a hospital visit and surgery and tried to figure out why it wasn't.
My mind immediately set to making it so and was held back by the fear I could go to prison for practicing medicine without a license.
"I love you. I wish I could fix you. I could fix you."
"I know you could. I wish you could."
My chief complaint is that the FDA is overly restrictive. They force manufacturers to make the products expire earlier to head off concerns about them working less efficiently near the end of the cycle. Diabetes is a disease who's treatment is entirely about guesstimating but the FDA does not take that into account when approving devices.
Normally that kind of failure would be quickly recoverable without a hospital visit/surgery, I’m sorry that this one was not.
This isn't theoretical--someone already wound up in the hospital "hacking their diabetes". And the FDA came down on the companies involved in manufacturing the devices--even though they had NO involvement.
I'm sympathetic and recognize that modern technology could be doing MUCH more for diabetic patients. However, my measure of importance is how much money is being thrown at the problem. And there simply doesn't appear to be very much money being tossed around for a medical system that will have to go through FDA approval.
This should be obvious.
Because there are people and groups drinking bleach and treating it as a cure-all for diseases. I don't think going back to the old American Wild West of snake oil selling for diseases is a good idea.
It's ok to do those things but not try to care for yourself?
In my own little corner (diabetes) it’s been nice to get monitoring tools earlier than they once would have been approved, and for my medical team to confidently plan for equipment changes based on future approvals.