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
Drug development and clinical trials are expensive for a reason. Not doing them in an orderly manner is more expensive.
Everyone understands the case when (A) you approve something that later turns out to kill people.
The other case (B), when you don't approve something that would have saved lives is much less understood, but those people are just as dead as those from case A.
One famous case B is when the FDA only approved beta blockers 17 years after other major countries. This cost ~10k US lives per year, or ~170k lives total.
Because A errors produces headlines and scandals, while B errors are just the normal deaths we are used to, the FDA is heavily incentivized to minimize A errors, regardless of the B error rate.
The point is that case B is both harder to notice and at least potentially _much_ worse than case A. And it's the case that the FDA currently errs towards.
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.
So... that leaves more flexible regulation as a worthwhile approach going forward. I like the idea of making limited human trials easier to carry out and less costly in general.
I also find it a bit patronizing that a federal agency determines whether or not a drug they've deemed safe has enough upside potential for me. That's a value judgement I'd like to make for myself.
Sorry if this sounds harsh, but the FDA's inability to approve drugs inside of a decade has personally impacted me quite a bit.
Being more lassiez faire is going to lead to direct harm of some patients. Is it a worthwhile takeoff vs potentially addressing some unmet need is a tough calculus.
should that be officially legitimized in any way by the FDA? fuck no.
As soon as you break down the barrier in any way, companies will spring up exploiting it and promising miracle cures etc. even if you want to do RCs the FDA keeping a minimal wall there benefits you.
Given how big the industry is that peddles mostly bullshit vitamins and supplements, I think society is best served by a conservative FDA.
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.
Access to experimental treatments also opens up more perverse incentives where desperate people are likely to try anything.
The perverse incentives is also a very real issue.
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.
In particular drugs should still be checked for efficacy before getting on that list.
But requirements for long term safety and side effects when people die in a year should be relaxed.
What am I missing? For non-terminal diseases, it's a bit murkier, but still I don't follow the analogy.
I do think we’re overly cautious with drug approvals and I think we should be more open to leaving the decision to patients and their medical teams, but it’s not as simple as saying someone’s terminally ill, so just do whatever. Reducing it down to the trolley problem makes it seem much more black and white and immediate than it really is.
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.
https://www.bloomberg.com/news/articles/2024-05-08/norway-ri...
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.
What permanent effects it will have on the overall startup business is still to be seen.
Even better, you have to pay Norway on your unrealized capital gains but they won't credit you on future losses from the startup. Essentially they have socialized the profits and privatized the losses.
You don’t sound like a person who likes taxes much. In Norway they are very important since we have good infrastructure in most areas such as telecom, roads, trains, airports, electricity and water. We also have great healthcare. And lots of benefits for parents with children.
In the 90s, more Americans were willing to have an eating disorder to stay thin compared to today.
Wyeth set aside $21.1 billion to cover the lawsuits. https://archive.is/k3Go4
It was kind of a big deal. Not many people younger than ~30 have heard of it for some reason.
[0] https://www.merckvetmanual.com/pharmacology/inflammation/non...
I don't think that has any chance of happening though.
The therac-3
That one alzheimers drug a lot of people were pissed about cause it didn't work and was expensive.
(I don't think this affects your argument directionally, but worth noting.)
Aside, but this is high class discussion culture I haven't seen on the Internet in a while.
(Obviously talking about Thalidomide here)
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.
It has since been approved for cancer where its benefits outweigh the side effects, but it doesn't negate that the FDA prevented harm to babies by blocking it in the 60s.
I supposed 6 is kind of like 1 million, for large values of 6.
Politicians can puff themselves up by only grandstanding about the former -- but that doesn't make for good policy!
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.