A significant portion of Taiwan grew up during authoritarian rule, and the anti-nuclear movement was heavily tied to the democracy movement of the 1980s-90s - especially because CKS tied his own ambitions to nuclear capacity - both for energy and potentially weapons.
It's very difficult to separate the two given that the 80s-90s generation is in power in Taiwan.
What was real was that a bad design that the company operating the plant was warned about repeatedly, survived an earthquake, but didn't survive a tsunami. As a result, there was an evacuation. And nobody died from anything directly related to the power plant itself, only due to the evacuation. Multiple times more people died in an oil tank fire in another city due to the same earthquake+tsunami. And during its lifetime Fukushima saved countless lives by not emitting air pollution.
On the "generating reliable power for a country" scale, everything is a tradeoff. There is no perfect solution that just works with no downside, especially in geographically challenged countries such as Japan.
Fukushima was perfectly fine after the earthquake. The tsunami is what provoked the accident by knocking out the backup generators.
This is not a scenario most plants are remotely vulnerable to. It's reasonable to ask if peoples' worries about a Fukushima repeat are grounded in reality.
Picture the situation: someone you love has just been diagnosed with a death sentence disease with no know treatment. The FDA just chose not to outlaw a promising but unproven new treatment for it. Now you get to choose whether to take it or not. And somehow the FDA are evil twisted bad guys!?
And your loved one dies of the disease at the exact same time they would otherwise have died of it, but now only after having gone through lots of expensive treatment and suffered a bunch of side effects.
The FDA is definitely the evil and twisted bad guys if they can't stop snake oil sellers from stating that their products cure disease X just because the snake oil guy us friends with someone high up in the FDA.
The FDA, like other regulatory agencies, exists for a reason: to help prevent people from being ripped off, or worse, by snake oil salesmen. I’d rather we not go back to the days when hucksters and charlatans were selling marked-up dyed water or poison to desperate people out of a horse-drawn carriage.
> One explanation for drug bans is that regulators know more than consumers about product quality. But why not just communicate the information in their ban, perhaps via a “would have banned” label?
Because product labeling is cheap-talk, any small market failure tempts regulators to lie about quality, inducing consumers who suspect such lies to not believe everything they are told. In fact, when regulators expect market failures to result in under-consumption of a drug, and so would not ban it for informed consumers, regulators ex ante prefer to commit to not banning this drug for uninformed consumers.
Completely false comparison because the drug in question did provw safety though the clinical trial, only effectiveness that could not be determined. People should have options that are not certain death.
The tricky business is defining effectiveness (and the target population). This drug was not effective at the specified clinical end-point for one set of patients. But it did show promise for other end-points (production of a normal dystrophin transcript).
For complex diseases with a range of severities, failing the specified clinical endpoint is not the same as selling dyed water.
Is production of a normal dystrophin transcript a real clinical endpoint, or just a biomarker that's supposed to correlate for one? It's not immediately obvious how normalizing production of a protein involved in muscle function is beneficial, if it doesn't actually improve muscle function.
Absolutely. But DMD has a spectrum of severities, and it seems possible that for some patients, producing some normal transcript would make a real difference, so that until more people are treated, we cannot know when more normal transcripts make a difference.
What about the obvious middle position, where the FDA continues to do everything it does and labels drugs as safe and effective, but then theres also non-FDA approved stuff that won't be labeled as FDA approved and you can do it if you want.
The middle of the road solution: let quacks scam desperate people suffering from incurable diseases, as long as the quacks don't put the wrong kind of label on their snake oil bottle.
>theres also non-FDA approved stuff that won't be labeled as FDA approved and you can do it if you want.
I assume (even if you didn't realize it) that you mean the $100 Billion plus/year dietary supplements market[0]? That's already (and has been for centuries) in place.
> The FDA, like other regulatory agencies, exists for a reason: to help prevent people from being ripped off, or worse, by snake oil salesmen.
This is obviously false given the existing supplements business. The idea that we have a way to prevent people from being ripped off is naive. But even so, the "reason" for the FDA doesn't change its incentive structure: allowing a drug that kills a few people will reflect badly on it, while disallowing a drug that would have saved millions of lives likely would have little consequence for the decision makers.
The carve out for supplements was created by Congress in 1994 during the Clinton administration, long after FDA was established, so I don’t think it is a false statement.
IMO, the FDA's authority should be limited to making sure that the snake oil does indeed contain genuine oil from genuine snakes.
They could put a label on it to the effect of "We don't think this stuff works, and it might even be harmful", but they should not be allowed to ban it outright.
The current situation is one-sided:
FDA approves something harmful -> people are harmed and their friends and family start calling for the FDA's heads.
FDA doesn't approve something helpful -> people are also harmed, but most of them don't even know they were harmed. There's little chance of an angry mob showing up at the FDA's door.
The FDA is biased in favor of rejection, not approval.
There is a reasonable argument for a regulatory agency to make sure that the peddlers of medication are not selling you something that needlessly will harm you.
There is a weaker but still defensible argument that they should stop others from selling you flu medication that isn't proven to work. But one could imagine a less restrictive reality where such drugs simply must be labeled clearly and you make your own decisions. In fact, there's already a weird carve-out like that for "natural" substances, so you can for example buy artemisinin as a "supplement" if you want to...
But what's the humane argument for "protecting" people with terminal or otherwise devastating diseases from trying drugs that can plausibly work, and were created by people acting in good faith, and that had some clinical trials done, but the trials weren't as thorough as a committee wanted them to?
"Yeah, he died, but at least we stopped him from potentially wasting some money."
I’m going to assume the clinical trial bar exists for a good reason unless proven otherwise. The current system is battle tested at this point and is a significant improvement over the situation that predated the current regulations in terms of safety and efficacy.
And, yes, protecting people - both from being injured and from being ripped off - is a feature of modern society, not a bug.
It was only introduced in 2018 (federally), so it is a relatively recent development, mostly due to pressure from terminally ill patients and their relatives.
Another thing that is being discussed is that the FDA should allow use of drugs that were approved in other developed countries, without requiring separate clinical trials in the US. American patients aren't that different from British or French patients, after all.
I actually agree with the last paragraph. It does make some sense to have some sort of reciprocity with other trusted nation-states. However, there is obviously going to be some forum shopping as a result, and the country with the lowest bar (as opposed to the highest standards) is going to become the one that bears the lion’s share of the evaluation burden.
If we're going to do this, the nations involved should have a rotation, so that 1/you can't predict which nation is going to get a particular evaluation job and 2/to eliminate the "free rider" problem (which exists today in other contexts, such as unfairly burdening the USA with the majority of Western defense spending).
My city has extensive education and occupational licensing requirements if you want to work at a nail care salon. The assumption that bureaucracies left to their own devices always reach an optimum state and then stop expanding is pretty hard to support.
The FDA had 7,500 employees in the 1990s and 18,000 now. Has the world of food and drug gotten 2.5x more perilous? Or is it possible that, just like in tech, every departmental fiefdom wants more resources and more authority with no special regard for what the trade-offs are?
Another plausible (and less sinister) explanation is that pharmaceutical invention and discovery has accelerated since the 1990s and more applications are being submitted to FDA every year that requires more staff to process them in a timely fashion.
Personally, I think it's egregious to deny people possible treatments, particularly in cases like that. I think FDA should be very strict on approvals (i.e. giving it that stamp), but should not be gatekeeping people. If people want to take non-FDA approved stuff, I don't see why regulatory and/or law enforcement should care. There's an incredible amount of paternalism inherent in the current system that nobody ever seems to question, and that blows my mind.
Now that said, I have a huge problem with this skipping. FDA rules need to be applied consistently and follow the process. I'm sympathetic to the desired outcome, but the problem is the system is set up as a gatekeeper. Fix the system, don't try to hack around it like this. That just further undermines trust and faith in the system.
> If people want to take non-FDA approved stuff, I don't see why regulatory and/or law enforcement should care.
Well, among other things, if anyone makes money selling colored water, it encourages others to sell colored water. It also encourages companies that are trying to sell actual drugs to skip that expensive "testing" phase. Bad money usually chases out the good (https://en.wikipedia.org/wiki/Gresham's_law) so it's likely that we will devolve into a system where very few drugs are adequately tested.
I'm not saying it never happens, but if a law, policy, or agency reduces big corporation profits, then it's almost always because lots of people were dying.
If so many people were buying non-FDA approved drugs that drug-makers stopped pursuing FDA approval, I think that would be quite indicative that there are some serious issues with the FDA process. At a minimum, that would demonstrate severe system mistrust. Some pressure to improve might be good for them. If the FDA process were bad enough, there would also be a possibility of new standards bodies emerging to provide some third party system. FDA could learn from these and adapt to be better.
I just can't imagine that people would widespread start using drugs that aren't approved though. That's definitely something to watch out for though.
> If so many people were buying non-FDA approved drugs that drug-makers stopped pursuing FDA approval, I think that would be quite indicative that there are some serious issues with the FDA process. At a minimum, that would demonstrate severe system mistrust
Or, it might indicate a financial incentive to get consumers to mistrust a barrier to profit. People in the aggregate are not the most rational actors, in no small part due to information asymmetry. Self interest does not necessarily yield optimal or even good results.
For example, take the new trend of waiving inspections when purchasing homes to outcompete other buyers. This is legally allowed in some places and is getting more common in places where it's a seller's market and there's lots of potential buyers.
Now I'm not so pompous enough to think that even after reading a few articles or books that I can reliably tell structural damage from easily repairable shoddy work. At least not enough that on a million dollar home purchase, I could risk being out of a home for a while or a couple of hundred thousand dollars.
But there are some buyers for whom this is not an impediment: ones who have enough capital that a bad house or two wouldn't make a big dent in their bottom line, and ones who don't truly understand the kind of risk they're taking and think they have a decent deal on their hands.
The result is that waiving inspections to buy homes is the new standard to be able to compete as a buyer at all, meaning there is now incentive to not fix serious issues in homes or even patch over them to make them less visible. Financial incentive for selling a better product reduces because the bad ones will sell. Quality of homes on the market goes down. Meanwhile those who can compete to buy the better deals are now a smaller population, but they still need homes. Price efficiency goes down because on average people are buying worse homes for more money.
The argument against it is soaking the health care system for unlimited funds until it collapses or simply becomes unaffordable.
For the horrible things at the edge of treatability and beyond there are always many promising ideas most of them worthless or bad and the price people are willing to pay is either all their money or all everyone's money depending on whether insurance covers it.
If you don't allow insurance to cover it then only a handful of rich folks get soaked but this is politically difficult to maintain.
Insurance already has plenty of leeway to deny coverage for medications, even ones that are FDA approved. If the political unpopularity mattered that much, I'd expect it to already be the case.
Despite the thorny nature of insurance they do already cover lots of things that don't do much good or aren't very efficient. Also medicaid/medicare are more susceptible to political considerations.
well, "best" is subjective, but IMHO the best argument against it is that some companies would skip FDA altogether and try to go direct to market, and would use marketing tactics to undermine faith in the FDA and convince people that the lack of FDA approval doesn't matter.
Personally, I do think this would happen, but I think there are better ways to combat this than to use force of law to gatekeep which molecules people are legally allowed to put into their own bodies. We could (and should) still require them to provide evidence for any claims they make, and failure to provide evidence opens them up for liability. There are situations in which paternalism seems justified, but I think in this we've gone way overboard.
AFIAK FDA doesn't regulate what you, yourself, are legally allowed to consume but rather what companies are allowed to market as drugs and legally distribute as such.
For example you can bring your own non-FDA approved drugs with you to the US for personal consumption. I found the following document, section 9-2 covers this topic: https://www.fda.gov/media/71776/download?attachment
That's a fair point, although the FDA (IIUC) has power to say whether some drug must be gated behind a prescription or can be over the counter. For over-the-counter stuff I think you have a good point, but for prescription drugs (which I'm sure is all or nearly all of the interesting drugs) they are gatekeepers.
You would still have FDA and the approval process, and it could continue to be strict (or even stricter). If vendors are lying about their product being FDA approved, that would be illegal (just like it is now). I don't see how this would change anything in that regard.
I'm surprised how many people are either forget or intentionally misrepresent the actual real-world scenario of letting people handle medical advice by themselves.
We already did this experiment 1-Javascript-Framework-lifecycle-equivalent ago.
> Now you get to choose whether to take it or not.
The question is who is paying for these treatments? Drug companies are not shy about charging tens of thousands of dollars a year for a course of treatment that may or may not help. Insurance companies and Medicare partD will probably be reluctant to reimburse. Drug companies have large incentives to get patients to pay out of pocket, and no, they won't refund if the product is not effective.
Perhaps if the FDA were to create a new class of approval that states: Drugs under this class are shown to not cause harm but are also not proven to be helpful. They may be taken, but drug companies may not charge for supplies until efficacy is shown in controlled conditions.
The primary issue here is there are plenty of Snake Oil salesmen ready to tell you anything you want to hear and have no qualms about taking "somebody's" money.
I am sure creating a new class such as this, will also create a host of unintended consequences though.
Your imagined situation relies on the supposition that the new treatment is "promising" - how often do you think this is the case?
A person facing death from disease is desperate, and desperate people are easily taken advantage of. This is part of the reason the FDA exists - to protect desperate people from being ripped off.
The FDA can and should prevent unproven medicines that are not ready for human trials from being used without due diligence.
Except that the FDA frequently denies treatments lacking evidence of benefit except in these two cases. The real problem is that it costs too much to bring new treatments through a clinical trial
The point was that people are up in arms about either outcome: FDA denies approval, people get angry. FDA allows approval, people get angry.
> The real problem is that it costs too much to bring new treatments through a clinical trial
As opposed to what? Just letting anything go? We basically have that situation in the alternative medicine world and the grifters are out in full force peddling things that we know don’t work the way they claim. Imagine how bad it would be if we waived away clinical trial requirements.
> The point was that people are up in arms about either outcome: FDA denies approval, people get angry. FDA allows approval, people get angry.
What people want is approval through a fair, orderly process.
If the tests and reports and expert opinions and panel decisions are needed, their results should be respected - for every drug maker.
If the tests and reports &c. aren't needed - they shouldn't be required.
If there's some more nuanced approach required, like experimental exceptions for drugs specifically for people who are otherwise terminally ill, it should be codified.
The approach of "spend a load of money on studies, then maybe the boss ignores the results" seems very open to corruption.
At the very least, FDA should allow use of medications that were approved in Japan or the EU.
Requiring separate US clinical trials is an unnecessary burden for the manufacturer, and will likely result in higher prices or unavailability of some medications.
Even in programming we frown upon "reinventing the wheel". This is reinventing the wheel with a fantastic price tag.
The links from OP are paywalled but the first few visible lines are enough to cast significant doubt for me on whether the treatment is even "promising":
> [Sarepta's] gene therapy for Duchenne muscular dystrophy failed to improve muscle function compared to a placebo in a large clinical trial
> the drug failed a large, Phase 3 trial last year ... three review teams ... wrote that the data Sarepta submitted "cast significant uncertainty regarding the benefits of the treatment".
I'm not sure what makes this treatment "promising" other than the gushings of the CEO. Are you arguing that we should give new treatments a free pass on regulations as long as its for a death-sentence disease and the CEO has connections?
I’d like to see a payment structure more like a bounty for efficacy. If you think you can cure DMD, you know up-front what you’ll get paid, and it depends on how well it works, dosing schedule, side effects, etc. If your drug is safe but barely works, you get paid a tiny bit of money. If DMD patients’ families want the drug and the manufacturer is willing to sell it at the appropriately low price, fine.
IMO the actual failure here is the fact that Sarepta can charge $3.2M for a product without demonstrated efficacy.
This is a good point. Doctors can prescribe drugs approved for disease X off label to treat disease Y even when effectiveness against Y has not been proven. In this case, the drug has not been approved for any disease so it can't be prescribed. Just goes to show how arbitrary the rules are.
If we've gotten to Phase III, the risks and side effects are understood as well as they would be for a doctor prescribing off label. While I might not call it arbitrary, I would say it's an unappreciated edge case.
A customer base of people with profoundly serious troubles at the edge of desperation who are looking for any glimmer of hope. An industry who's incentivized to charge astronomical amounts to an untapped market to recoup costs. A drug that seems to have failed based on multiple trials and 3 separate expert review teams. Now remove the approval requirements. What could possibly go wrong?
It's easy to yell paternalism but this doesn't look like a case of paper pushers getting in the way of a promising drug to me. Also, history is littered with examples of why "buyer beware" does NOT work, and a vast literature on information asymmetry, adverse selection, "The Market for Lemons", etc etc. Also, the FDA already has mechanisms to speed up new drugs getting to patients when the benefit is clear early on, AFAIK.
Oh no, now I must use my own brain and make the cost-benefit analysis for myself. I wish it was in the hands of some people who neither know nor give a shit about me or my loved one
The author clearly needs to add to his skills the ability to give advice while not being condescending. In particular the bit about how in the good old days everyone had excellent social skills and calligraphy but now youngsters have done away with decency in favor of smartphones.
In the "good old days", I had crap social skills, and my handwriting was g*d-awful. The baseline has now moved so much lower, I have no problems with either.
The set of norms is changing, some things are way easier than they used to be, and others are way harder, as the technology makes things previously impossible or impractical, the normal way of doing things.
For example, I can reliably drive to novel places on the other side of Chicagoland without a map.... something those raised on Google maps just can't do. Once I've been somewhere, I can find my way back again. I learn new areas quickly.
On the other hand, I'm not likely to know about some really cool thing that was less than a mile from my location, unless I drove past it at some point.
We used to spend hours every day interacting outside playing with all the other kids on the block, exploring neighborhoods, etc... that's almost entirely evaporated for many kids, in exchange they are much more proficient in computer mediated communications.
The thing I worry about the most is managing risks. We used to take risks as kids, as part of that play and exploring, doing stupid shit, and only getting our parents involved if things went bad. Now with kids protected in a bubble from anything, and having their lives mostly planned... reliably estimating danger isn't as common a skill as it used to be.
Rousseau's book Émile was written in the mid-18th century and talks about educating the youth. It's interesting to read about his view of education and the similarities and differences to today. Your last paragraph makes me think you would like that book.
> For example, I can reliably drive to novel places on the other side of Chicagoland without a map.... something those raised on Google maps just can't do. Once I've been somewhere,
The shift away from physical maps is a primary factor in my shift away from exploring.
I liked duckduckgo a couple years ago before it started insisting on showing results in the language associated to my IP address. Since then I've liked brave a lot better.
Duckduckgo used to advertise that they were all about getting out of the filter bubble but they insist on throwing a bunch of irrelevant totally unrelated garbage in their search results based on my IP address. The service has really gone downhill and I can't even blame it on bing
I’ve been getting weird results for a while: somewhere around the end of the first page of results or beginning of the second I get results which have nothing to do with my queries. Instead they look as if someone entered geoip result for my ip address as text of the query. Maybe those are some LLM experiments and that’s part of the prompt now?
Actually, California population (for example) has fallen by >400k over the last several years. The first falling year was 2019, 2020 saw a small rise (<50k), 2021 saw a fall of >300k, 2022 a fall of ~150k, and 2023 a fall of ~50k.
That includes both births/deaths and in/out migration. Population growth rate has been generally falling since 1990 (except for a peak in 2000) and significantly so since the GFC in 2009. However, prices have skyrocketed.
China has overbuilt their population by 10-100million (yes, and there are even more outrageous numbers) homes over the last 10-15 years, and yet prices in Shanghai/ Beijing/ Shenzhen still exceed NYC or SF by 50%. They have a falling population.
Crowding is huge in California though. The starting point was "multiple unrelated families living in one house." If the population has dropped by 1% but you started with 3 families per house, you still have (to some rounding error) 3 families per house.
China has the confounding issue where it has both poor social security systems and a mistrusted, dysfunctional stock market and financial system, so everyone shoves money into real estate for retirement.
This is not even a new problem. The imperial landed gentry was so named because bureaucrats would shovel their money into land.
A net migration out of California does not mean an increase in available housing. There are a lot of families (adults+kids) where the children grew up and then can’t afford a home in California and left the state. A household of 4 then becomes a household of 2 but the housing supply stays the same.
The price finds whatever level it needs to maintain a population that fits within the housing supply. Obviously population can’t grow that much against a fixed housing supply; once the vacants and spare bedrooms are filled up, people just get priced out. This is Malthusian NIMBY policy working exactly as intended.
Population geography also shifts from rural to urban and from declining to rising cities even as the total population size holds constant or shrinks. The fact that there is space for you on a farm or in a coal-mining town is cold comfort to someone with a STEM degree and a job offer at a corporate headquarters.
Did you forget to factor in that it is a replacement rate? Sure, more people are born every year, but plenty of people pass along in one way or another (mortality, downsizing, various care facilities).
but it's not necessarily needed in dense urban centers. Plenty of laptop class people could secure housing in rural areas for a fraction of the cost of what they're paying now.
One of the many things contributing to pricing, is that not enough road corridors are being built or widened.
It's harder live further out, when traffic slowdowns extend commute time 10x. And governments love the idea that expensive roads can be waved away using environmentalism as an reason.
Yet these same governments don't build fast transit either, and without fast amd efficient transit, trips take far far longer than a car.
At this stage we should be building both, as we're that far behind.
The point is, there is a move for 'dense urban areas'. Pack 'em in. Increase that housing density. Yet there is another way in North America, where there is often an endless bounty of space. Better transportation corridors.
Better transportation corridors means that housing costs plateau, because it's just easier to drive 10 minutes more, 20 minutes more, than spend 4x for housing.
That said, even the laptop class often does need to commute:
* Many remote workers have to attend once a week, or more often.
* People make lives, friends, contacts, have relatives in specific areas.
* Every once in a while, you may need to go to "the city" for something important. Medical treatment or specialists, specialty products, etc. Not everything can be shipped, or is shipped.
Anyhow, it seems you sort of missed the point, that is... the faster you can get into a city, the further you can live from the city and still be part of it.
A device that can bring surveillance and social media and its accompanying society-breaking stressors to him at any place and time in an unceasing torrent of shit...
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