11 ms·
The catastrophic failure of FenPhen also cooled the industry's interest in obesity medication. Part of the problem is that it is so slow and expensive to bring
by siliconc0w 2y ago
The catastrophic failure of FenPhen also cooled the industry's interest in obesity medication.
Part of the problem is that it is so slow and expensive to bring a drug to market, which encourages risk aversion. It'd be interesting if we found better regulatory and financial engineering strategies here. There is a gigantic hidden graveyard of people who have died due not having access to medications that could have been produced and approved (which may have even been massively profitable) but were it just didn't make sense to try with today's incentives.
Maybe FDA works in classes where class 0 is entirely experimental and only available to terminal patients, class 1 is shown to be safe in animals and approved only for extreme cases, class 2 evidence of safety in humans and some evidence of efficacy, and class 3 is what we have today.
- Spooky23 2y agoThat just pushes the moral hazard down to the providers and patients. Given how big the industry is that peddles mostly bullshit vitamins and supplements, I think society is best served by a conservative FDA.
- tgsovlerkhgsel 2y agoClasses 0-2 could be experimental, non-commercial approvals that can be used as stepping stones to get long term data but not sold for profit.
- carlmr 2y ago>not sold for profit. The only way to ensure no profit would be to provide them for free. Which, granted, may be good still for the pharmaceutical companies to lessen the costs for approvals, but Hollywood accounting makes it impossible to have any price depend on profits, because profits are more an accounting fantasy than a fact.
- selimthegrim 2y agoRing 0 for drugs?
- ajmurmann 2y agoI personally like the idea of a "accredited ingestor". You get a certification indicating you understand enough about drug development and associated risks and then you are allowed to decide for yourself what you are willing to take. In general I am a big fan of FDA approval just becoming a stamp on a product like the Nintendo Seal of Approval and letting consumers and insurers decide what they make of it, but that would never fly
- vips7L 2y agoI write software for this industry, the thought of not involving the FDA genuinely scares me.
- ajot 2y agoI do admin work for a pharma-related company. I would never want to be in charge of verifying with my own body what treatment is safe and/or effective. Drug development and clinical trials are expensive for a reason. Not doing them in an orderly manner is more expensive.
- CamperBob2 2y agoFortunately, the position would be voluntary. You might be a big fan of the work the FDA does to keep us safe in light of past industry abuses, but keeping good drugs off the market - whether by outright fiat or by making them too expensive to develop, test, and deploy -- also has a terrible human cost. It's not clear that the FDA has found the right balance between risk reduction and upside potential.
- 0cf8612b2e1e 2y agoDrug development is a conservative industry. Even with researchers/companies/FDA all doing their best to develop good treatments, there are still many drug failures due to efficacy or safety. Being more lassiez faire is going to lead to direct harm of some patients. Is it a worthwhile tradeoff vs potentially addressing some unmet need is a tough calculus.
- 2y ago
- 0cf8612b2e1e 2y agoIt is a philosophical question: Would you rather people die due to taking a harmful compound or die due to lack of access to something that may have helped them. Access to experimental treatments also opens up more perverse incentives where desperate people are likely to try anything.
- ajuc 2y agoYou can have a class of drugs allowed if you're going to die anyway.
- PaulHoule 2y agoPeople in that state are highly vulnerable to fraud. See https://en.wikipedia.org/wiki/Amygdalin https://en.wikipedia.org/wiki/Amygdalin
- donbateman 2y agoThey are also vulnerable to dying. They should be able to try whatever drug they need and the government shouldn't be allowed to stand in their way.
- 0cf8612b2e1e 2y agoThe pharma companies are not clamoring for a huge surge in compassionate use (emergency use of unapproved drugs) either. Who is going to pay? Early stage drugs are still figuring out their manufacturing process, and quantities can be extremely limited. Say you give drug X to a sick patient and they die, what then? Was it because of the novel drug? Not a favorable position to have more deaths associated with your treatment. Can you draw any data from these patients to inform further trials? Also complicated because end stage patients have already exhausted other options and the interaction with other compounds can make disentangling this harder.
- PaulHoule 2y agoDeath is certain, getting ripped off less so.
- BurningFrog 2y agoIf the public could be made aware of the millions of Americans who have died from FDA being so restrictive, things would change quickly. I don't think that has any chance of happening though.
- jermaustin1 2y agoThe public is aware of the millions of Americans who have died from the FDA being so lax.
- doctorpangloss 2y agoCan you provide some examples?
- Something1234 2y agoThalidomide The therac-3 That one alzheimers drug a lot of people were pissed about cause it didn't work and was expensive.
- doctorpangloss 2y agoThose killed millions of people?
- cj 2y agoIf the goal is to shock people into thinking a certain way, 20,000 deformed infants has more or less the same shock-value as 1 million deaths. (Obviously talking about Thalidomide here)
- doctorpangloss 2y agoThalidomide was used and approved around the world, not just in the US. It’s an interesting example of something but not millions of deaths. But I get a sense that the original poster isn’t sincerely interested in talking about the complex question, how should the FDA regulate drugs? One thing’s for sure: High drama personalities have always had a tenuous understanding of the facts behind their “shock” and outrages. Or maybe one of the commenters has learned a valuable lesson about copy and pasting from chatbots.
- xkcd-sucks 2y agoOr even a graduated approval scale with categories of limited liability, etc.: For example, when Vioxx and other cox-2 inhibitors were withdrawn from the market, some employees really stocked up on the reps' samples. And in the present it is said that some vets prefer the off-label-for-humans options per [0] [0] https://www.merckvetmanual.com/pharmacology/inflammation/nonsteroidal-anti-inflammatory-drugs-in-animals#Robenacoxib_v3337720 https://www.merckvetmanual.com/pharmacology/inflammation/non...
- zoklet-enjoyer 2y agoI found some phentermine tablets next to my neighbors trash bin, still in the blister pack. So I thought maybe if I snorted one I'd get high. I didn't. Just got really jittery and nauseous then puked on a tree while a woman who looked like she worked for the government walked by (this was in the capitol city of another country). Would not recommend. And then I accidentally brought it back with me through customs.
- mewse-hn 2y agoSo just a normal weekend then?
- zoklet-enjoyer 2y agoIt wasn't that abnormal for my early 20s. I'd never imagine doing anything like that now.
- morkalork 2y agoNot knowing what FenPhen was I checked the wiki page and wow, it looks remarkably similar to those sketchy amphetamine analogs people sell on the internet like 3-FA, of course selling that as an anti-obesity drug was going to go sideways.
- hmottestad 2y agoNorway is big on oil and gas. One of the incentives we give out is a cost sharing model for the initial exploration phase. Not sure how that would translate, but an important factor would be that the health care providers (private or state) have some say in what kinds of illnesses need better drugs.
- pnw 2y agoThat's a nice incentive but Norway's tax policy is a major disincentive to any new venture. I'm currently helping a founder relocate his Series A company as a result. https://www.bloomberg.com/news/articles/2024-05-08/norway-risks-outflow-of-startups-dismayed-by-harsher-exit-tax https://www.bloomberg.com/news/articles/2024-05-08/norway-ri...
- hmottestad 2y agoI believe that that is more of a temporary thing. A lot of rich people have been avoiding taxes by moving to Switzerland. They run a company in Norway for several years, then move to Switzerland when things are profitable and they want to avoid paying their taxes to society. We pay tax on dividends in Norway, but if your company doesn’t pay out any dividends for 10 years then you don’t pay any taxes on them until the day you take the money out of the company. So you can run a company in Norway while paying quite little in taxes, then move to Switzerland and pay yourself all the dividends that have accumulated over the years. After 5 years you can move back and not have to pay a cent in taxes. The new tax laws are just a temporary blocker that incentivises any current owners to move out of Norway move before the new laws come into effect.
- ErikBjare 2y agoHow is it temporary?
- hmottestad 2y agoThe effects that we are seeing now are temporary. Once the exit tax is in place there are no incentives to quickly leave the country. What permanent effects it will have on the overall startup business is still to be seen.
- doctorpangloss 2y ago> The catastrophic failure of FenPhen also cooled the industry's interest in obesity medication. In the 90s, more Americans were willing to have an eating disorder to stay thin compared to today.
- skyyler 2y agoFen-phen was an obesity medication that caused valvular heart disease and pulmonary hypertension. If you've never heard of fen-phen, check out this article from Sept. 23, 1997 in the New York Times: https://archive.is/ottWQ https://archive.is/ottWQ Wyeth set aside $21.1 billion to cover the lawsuits. https://archive.is/k3Go4 https://archive.is/k3Go4 It was kind of a big deal. Not many people younger than ~30 have heard of it for some reason.