Comment by scoopertrooper
3 years ago
70% of Phase 2 trials fail and 50% of Phase 3 trials fail[1]. Why should the default to be to approve drugs in the early stage of human experimentation?
Here are some interesting case studies of drugs graduating from Phase 2 trials only to fail Phase 3 trials on efficacy and safety grounds: https://www.fda.gov/media/102332/download
[1] https://www.parexel.com/application/files_previous/5014/7274...
Because (at least) for people with a high risk of dying, and operating under well-informed consent, that decision should be between patients and their doctors alone.
If we allowed any type of experimentation on dying patients as long as there was consent, dying patients would end up getting used as a Guineapigs by companies trying to get a lucky indication. It would certainly benefit the families left behind financially, but it would not be pretty. “Here’s a million bucks, please take these 40 drugs that will certainly kill you, but we’ll learn which one we should continue with”. And why even do toxicity studies or phase 1 and 2 trials? It’s cheaper to pay of poor people who are on the verge of dying and just pushing them over the edge.
The decision should be just because a patient and a doctor, because the consequences of such decisions are more far reaching than just those two. We have a well established framework for what a drug needs to prove before they can reasonable be allowed to be given to any human being, no matter their situation, and that barrier of entry is there for a multitude of good reasons. Discarding it just because a specific patient is at risk of dying or because you can get consent is not helping patients.
> It would certainly benefit the families left behind financially, but it would not be pretty.
You are very optimistic. Medics will sell expensive snake oil treatment to desperate families. For example, from the bottom of https://en.wikipedia.org/wiki/Breast_cancer#History
> In the 1980s and 1990s, thousands of women who had successfully completed standard treatment then demanded and received high-dose bone marrow transplants, thinking this would lead to better long-term survival. However, it proved completely ineffective, and 15–20% of women died because of the brutal treatment.
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If I was dying I'd rather be able to make a choice to my benefit rather than worrying about that it'd "be pretty" for onlookers.
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Such patients have opportunities to access experimental drugs, either in clinical trials, or through compassionate use waivers.
https://www.cancer.gov/about-cancer/treatment/drugs/access-e...
There's definitely a case to be made for early access to drugs for certain terminal illnesses in cases where there is compelling evidence that the drugs will pass Phase 3 trials. But, that should hardly be the 'default' as OP suggests.
Because it would degenerate into pharmaceuticals selling false hope in exchange for lab rats that are too far along to be saved even if the drugs work.
That being said I disagree with prescription pads. I should buy antibiotics for my kid without waiting four, five hours to be seen and processed
> I should buy antibiotics for my kid without waiting four, five hours to be seen and processed
Disagree. Antibiotics should not be taken lightly, especially by kids. Doctors have been far too liberal in prescribing them even when unnecessary and this has caused people to think antibiotics are to be taken like vitamins.
This antibiotic abuse causes issues that are out of scope to discuss here.
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The more we use antibiotics, the more opportunities there are for bacteria to evolve resistance.
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> Because (at least) for people with a high risk of dying
and who decides that?
Can a drug company give "gifts" to doctor who then recommend the patient use that company's drugs when he/she is dying?
After Phase 2, the drug has been proven safe.
In a sane and humane system, sick people would then be allowed to try it.
I just gave you a document containing 8 case studies where drugs were found to be not safe after having passed Phase 2 trials.
That happens after Phase 3 trials too.
This is about probabilities, and when lives are at stake, you should take some chances.
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The alternative is worse, unfortunately. See the recent Aduhelm debacle for example, with big pharma profiting from desperate people, with a drug that doesn't work.
Pharma would market a phase 2 trial drug as a “potential revolution in treatment. Only a select few can receive this treatment and as a result it costs 10x more than existing drugs. Ps. We don’t guarantee results.”
Is that really the outcome you want?
Fewer people dying and more people overpaying for ineffective treatment is potentially a good tradeoff. As a society we already funnel massive amounts of cash to new medical treatments, we just do it in a really inefficient way.
What I want is fewer people to die while waiting for the FDA to take years to approve already existing drugs.
You seem to care more about marketing than people's lives. We all have different priorities.
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Except vioxx. One of the biggest mistaken approvals of all time.
https://en.wikipedia.org/wiki/Rofecoxib#Withdrawal
I mean if they've already tried everything else and nothing on the horizon and I just heard 12 of 12 people with same cancer as me had gone into remission after treatment? I'd probably be more than happy to become #13