31 ms·

If you have first-hand knowledge of the FDA’s torpor, get in touch

• mellosouls 3y ago
  Contextual discussion from a couple weeks ago: https://news.ycombinator.com/item?id=36827438 https://news.ycombinator.com/item?id=36827438
• xphos 3y ago
  Was listening to this podcast about netstates and FDA and just general regulations. The guest is clearly align against regulation at large but does raise several strong points about structural risks and abuses by the FDA. It's really long but lex is a great host https://youtu.be/VeH7qKZr0WI?t=12306 https://youtu.be/VeH7qKZr0WI?t=12306
  • ramraj07 3y ago
    I don’t know anyone who’s informed disagrees that the FDA needs significant reform now. In fact the only good thing I can think of coming from the Trump era it would have been operation warp speed, which could have been the seed that started this reformation. But alas. Nope.
• huitzitziltzin 3y ago
  Any parent who waited months and months and months after getting their own vaccine before they could vaccinate their own kids against COVID-19 has first-hand experience with this. If ever there was a time to be more slightly more innovative about the approval regime, a widespread active pandemic was it. The FDA failed completely on that dimension and millions of kids paid for it in various ways, especially for a vaccine which is ex post completely safe and even at the time was obviously safe.
  • engineer_22 3y ago
    I'm sorry I may be misinformed, I was under the belief that C19 was unlikely to be dangerous to children?
    • cempaka 3y ago
      The CDC itself had language on their website to the effect that Covid posed less risk than influenza to young children. Pre 2020 freakout, would we ever have approved an influenza vaccine using a novel delivery method on the basis of less than two years of testing in humans, and less than one year in the young cohort? The FDA's "torpor" is easily overcome when incentives are aligned in that direction.
      • bozhark 3y ago
        If enough people will die the FDA can’t really reason why it took so long to react.
        • cempaka 3y ago
          The FDA played a big role in the opioid crisis by permitting manufacturers to claim for years that the narcotics being prescribed were not habit forming. "Preventing deaths" is not necessarily the incentive they're responding to.
          • lillecarl 3y ago
            There's a dramatised version of this story on Disney+ called "Dopesick", it's very good, but not great PR for the US. There's also the movie "Dark Waters" about DuPont and Teflon if you want to trust your government even less.
          • ghufran_syed 3y ago
            The government, through JCAHO, also helped create the opioid crisis, with their push for the healthcare system to treat pain as the "fifth vital sign". Note that while JCAHO is supposedly a non-profit, JCAHO accreditation is a requirement for receiving medicare and medicaid funding from the government, which makes it a pretty big stick to beat the healthcare system with. Of course, now that large amounts of patient harm are recognized as a result, the regulators and bureaucrats are extremely quick to dodge any responsibility, summarized well here with quotes from various JCAHO publications in the past: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139759/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139759/
  • cempaka 3y ago
    Actually, an adolescent subject was paralyzed by the Pfizer vaccine during the trials, and children were never at any serious risk from COVID (which it was clear at that point the vaccines did not prevent anyway), so the FDA's decision to authorize it in those age groups was reckless indeed. Fortunately a solid majority of parents made the correct choice at any rate. "ex post completely safe" is your head just completely in the sand about all the myocarditis that has been inflicted?
    • xp84 3y ago
      Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to? Arguably, having a ton of unvaccinated kids going to school and swapping the virus back and forth constantly and then infecting their families could have been a big contributor to how long this pandemic lasted. If you’ve ever met kids, you know school is basically a series of viral infections constantly. Not to mention the stress it caused to the schools and childcare and thus to the families because exposure notices were so constant, forcing kids home constantly.
      • whimsicalism 3y ago
        > Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to? I would dispute that in the context of young adolescents and children, as I do not think that is known at all. Global covid 19 myocarditis risk in the year after taking the vaccine is 0.02% and vaccine myocarditis risk for adolescents is 0.01%. If myocarditis risk is at all similar to other severe covid symptoms, then it is likely from these stats that there is higher myocarditis risk from the vaccine for young people than from the possibility of being infected with covid and getting myocarditis. That said, not all myocarditis is created equal and my understanding is vaccine associated myocarditis is generally milder. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9743686/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9743686/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9802621/#ref3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9802621/#ref3
      • cempaka 3y ago
        > Arguably, having a ton of unvaccinated kids going to school and swapping the virus back and forth constantly and then infecting their families could have been a big contributor to how long this pandemic lasted. Vaccinated kids did this too. "The pandemic," to the extent one ever really existed, was ended by Omicron being so infectious that even the "careful" ones were forced to face Covid and see that it wasn't really that bad, and that all their assiduous efforts to avoid infection were largely for nought anyway. I got my first infection from my kids attending school during the Delta wave. We were fine (although I didn't just sit at home and do nothing which was what the treatment advice amounted to at the time). Much like school shooting drills, the stress that was caused by exposure notices, testing, and the like was all a problem of the overreaction in response to the underlying phenomenon, and not the phenomenon itself. Certainly none of it could have been reduced by a higher rate of vaccination, since the vaccines were thoroughly ineffective against transmission at that point. > Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to? I do dispute this, yes, given that a huge Israeli population study found no increased risk of myocarditis in Covid-recovered subjects in 2020 pre vaccines. I also dispute that the comparison would matter at all even if it were true, because the risks of myocarditis from the shots and from the virus are cumulative, not mutually exclusive, since the shots do not prevent Covid. There is not some tidy choice to be made between mutually exclusive outcomes of "myo risk from the shots" and "myo risk from the virus." In every case where someone has developed heart issues after both vaccination and infection (including in a friend of mine who had 3 shots of Moderna), their doctors will invariably attribute it to the virus, and usually won't even report it as a potential side effect of the vaccine, so they seem to have zero confidence at all in vaccination's ability to reduce myocarditis risk from COVID infections.
  • BenFranklin100 3y ago
    Nothing is completely ‘safe’. Even too much water can cause hyponatremia. The correct question is does the potential benefit outweigh the potential harm? For adults over the age of 40, the vaccine was a no-brainer. For very young children — where the risk was always very low — the question was more complicated. The European Medicines Agency was even more cautious than the FDA in approving the Pfizer vaccine for 5-11 year olds. I haven’t been following the story recently so I don’t which European countries, if any, have approved the vaccines for children under the age of 5.
  • Gibbon1 3y ago
    I don't have kids but watching my friends go through that was obnoxious. I remember a comment from someone in the vaccine industry. He said the number of vaccines that don't cause problems for adults but causes problems when given to children is zero. Worse the initial trials for children underdosed the vaccine. I think the mistake being made was the FDA and vaccine companies trying to placate lunatics.
    • whimsicalism 3y ago
      Sure, but given that there are adverse effects from pretty much all vaccines and covid is generally (ie. in the data not anecdotes) not really risky for children - you are potentially causing more risk from side effects than you are preventing. This neglects the second order effects of who the children might infect, which imo is the real justification for covid vaccination of children who are not immune compromised.
    • crote 3y ago
      The same does not apply to drugs in general. There are plenty of medications which are fine for grown adults but a big no-no for developing children. The Covid vaccine was not just another generic influenza vaccine, it was the first-ever approved mRNA vaccine. It works in a completely novel way and although side effects in children were unlikely, there was simply not enough data to rule it out completely.
    • mongol 3y ago
      Strange, since I don't work in the vaccine industry and can provide an exsmple: Pandemrix. It caused narcolepsy for some children, in a certain age. https://en.m.wikipedia.org/wiki/Pandemrix https://en.m.wikipedia.org/wiki/Pandemrix "At the end of March 2011, an MPA press release stated: 'Results from a Swedish registry based cohort study indicate a 4-fold increased risk of narcolepsy in children and adolescents below the age of 20 vaccinated with Pandemrix, compared to children of the same age that were not vaccinated.' The same study found no increased risk in adults who were vaccinated with Pandemrix"
• redeux 3y ago
  First, this is incredibly sad and I feel for Jake. However, I suspect his plea and guarantee of anonymity will go unanswered. I don’t know Jake from a hole in the wall, and I suspect that’s the case for anyone in his target audience. So, there’s nothing to back a reasonable expectation that he would hold up his end of the bargain. In fact, if he’s about to die there’s little incentive for him to keep his guarantee. I’m not saying he would break his promise, but it’s a risk. I think he would be much more likely to get someone to speak up if he worked with a reputable, professional journalist that has a history of protecting their sources.
  • nocoiner 3y ago
    I grieve for this man and his family and loved ones, and I don’t know that I’d have the fortitude to fight for anything in the circumstances he’s facing. But I’m not sure what the goal is here. If there are experimental drugs that may be helpful, then I think any patient in his situation should have the ability to receive them if they want. But I don’t think that FDA should move faster on approving treatments for velocity’s sake alone. In a perfect world with unlimited resources, I’m sure it would be possibly to quickly assess the efficacy and safety of every new compound. Obviously, as indicated by the continued existence of cancer, this is not that world.
    • BurningFrog 3y ago
      Just having some kind of "decriminalized" state instead of only "approved" and "illegal" could make things a lot saner. And kill fewer people.
    • noduerme 3y ago
      Just asking: If you had some chimerical target molecule in mind that you thought was worth trying to treat yourself with, how much would it cost to have it synthesized somewhere?
      • nocoiner 3y ago
        I am possibly not following your comment - I have no idea how much it would cost to have it synthesized. I would guess a pretty binary distribution between “surprisingly cheap” and “staggeringly expensive.” Are you saying the point of the post is that he is soliciting evidence of unapproved compounds that the FDA is sitting on that might be useful to treat his condition, and if he can find out about them, he’ll have them synthesized? That’s pretty brilliant if so. If that was the message though, it completely eluded me.
• voldacar 3y ago
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  • bozhark 3y ago
    You… realize what you’re saying? Mate?
    • tbrownaw 3y ago
      Something along the lines of "the people harmed by this government agency are being surprisingly civil"? Nobody seems to be doing FDA offices like some people did police stations a couple summers ago. Which makes sense for any number of reasons, but I could see people thinking it doesn't.
      • nocoiner 3y ago
        Are you talking about when that FBI office got shot up? I too abhor political violence.
    • coryrc 3y ago
      I know, right? Bureaucrats and politicians should get away scot-free no matter how many people suffer.
      • nocoiner 3y ago
        Well, uh, that’s what democratic accountability and elections are for, instead of targeting federal employees for assassination.
        • itsanaccount 3y ago
          When those two things are equally effective absolutely. When was the last time that was ya think?
    • voldacar 3y ago
      Entirely.
• greatfilter251 3y ago
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• downvotetruth 3y ago
  Since the 1970s Caries vaccine (https://en.wikipedia.org/wiki/Caries_vaccine https://en.wikipedia.org/wiki/Caries_vaccine) has been under development. Streptococcus mutans was modified in the 2000s to not produce acid (BCS3-L1) with the hope to end cavities, gingivitis, etc., but has seemingly disappeared maybe to reappear in 2033 when the patent expires. Hope to be able to stop brushing teeth before I die or at least still have some left to chew food.
  • gymbeaux 3y ago
    Source? Reminds me of Novamin, which is absent from all toothpastes in the US but not in Europe, Canada, et al
    • pests 3y ago
      I got pretty deep into bioglass a few weeks ago. It's a calcium sodium phosphosilicate that attaches to your teeth and eventually regrows into basically real bone. The mechanism of action is very interesting.
      • vlovich123 3y ago
        Is there a product on the market doing this already?
        • salad-tycoon 3y ago
          Don’t think they are the same thing but there’s HPA toothpaste. I bought some from “Boka.” Guess it’s popular in Japan for some time.
        • bayindirh 3y ago
          In Europe, there's Sensodyne Promine Repair+. Recently I was eating some dried mulberries and I chewed a stone (it was hidden inside a cluster), rendering two of my teeth sensitive and probably damaged my enamel. Using this for 2.5 months now, and my teeth are neither sensitive, nor I feel that damage anymore. I'll continue a couple of more tubes of this, and It'll be probably completely repaired.
• mlinhares 3y ago
  It’s an incredibly hard place to be, if they approve a drug that eventually is proceed to cause more harm than good, they’ll hang, if they don’t approve, there’s little consequence. It’s the same problem of being lenient to criminals, if they do nothing and become good citizens that do not commit crime anymore, you gain nothing as a politician, if they commit a crime your career is over. Given society itself doesn’t value the risks as they should be, why are we expecting the agents of society itself to behave in a manner that will harm them?
  • slavboj 3y ago
    People keep saying this I have seen no evidence that anyone at the FDA "hangs" when they approve a drug with unexpected negative outcomes.
    • xp84 3y ago
      While you’re right technically that we don’t see direct repercussions on particular regulators, I think the sentiment itself is close enough to true, because what would probably happen if they ever did rush something to market that caused a bunch of problems is that everyone would suddenly scream for essentially, and return to the extreme conservatism that we are used to seeing from them today. To put it another way, public outcry, which seems to only stem from bad approvals and not bad denials/delays, will probably always push hard on any version of the FDA causing them to reach an equilibrium point which ends up surprisingly far on the conservative side of the scale. This sucks and I don’t know what to do about it besides the stupid solution I wish for of just having a smart, benevolent, powerful, and incorruptible monarch in charge of everything.
    • pirate787 3y ago
      The FDA's cultural topor and designed bias against approval is almost entirely from the Thalidomide disaster. https://pubmed.ncbi.nlm.nih.gov/21507989/ https://pubmed.ncbi.nlm.nih.gov/21507989/ https://www.gvsu.edu/cms4/asset/F51281F0-00AF-E25A-5BF632E8D4A243C7/kefauver-harris_amendments.fda.thalidomide.pdf https://www.gvsu.edu/cms4/asset/F51281F0-00AF-E25A-5BF632E8D...
  • 3y ago
• MilStdJunkie 3y ago
  I remember in the early aughts I could get a bottle of Colchicine for four bucks. Thanks to that walleyed expression of human avarice, the 2006 United States Unapproved Drugs Initiative, it became someone's IP and - presto! - went to sixty bucks. So, well, sorry, guess you just gotta grunt your way through a crippling weeklong gout attack. Thanks a bundle. Lord knows, it's good to be made safe from a pharmaceutical invented three thousand years ago from a goddamn flower.
  • lotsofpulp 3y ago
    The government admitted it too: https://www.hhs.gov/sites/default/files/covid-19-unapproved-drugs-initiative.pdf https://www.hhs.gov/sites/default/files/covid-19-unapproved-... The root problem is US taxpayers should be directly paying for these studies to prove and disprove medicines, but apparently, the budget for that is not politically possible, and instead we have politicians giving away monopoly rights so the burden of the study will fall mostly on afflicted people who need the medicine. It is crazy how there is so much crowing about high medicine prices, when the US already has world class research in the form of higher education facilities, and it could just officially research and develop medicines and put them in the public domain.
    • jonhohle 3y ago
      Not politically possible == pharma has plenty of money to line politician’s pockets and poor college students do not
      • delusional 3y ago
        Can't you "just" vote for other politicians that aren't susceptible to be paid off by big pharma?
        • mandmandam 3y ago
          Ah; username. In case you're not kidding though, no. A politician who pisses off big business in America loses even the support of their own party. The media ignores them, smears them, then grinds them into dust to make an example of them. Their social media pages are de-ranked, and an army of bots highlights their weak points while attacking their strong points. Their opponents in every election get funded just enough to win, however much that is; even elections against others in their own party. And if they're still somehow successful after all that, there's other, darker things that can happen.
• xp84 3y ago
  Really grateful to know you’re still with us. I really appreciated your last post on here, and it also made me want to cry. I lost both my parents to cancers and every person we lose is a tragedy that we should be willing to do much more to forestall. Thanks for reading. And for everyone, appreciate every day that you get.
• nurple 3y ago
  The FAA, similarly, has effectively killed air transport save for the wealthy or the airlines. I look out my window everyday and it pains me greatly to see the skies empty. It’s hardly a hobby even these days to fly unless it’s in furtherance of a ticket to fill a job.
  • skybrian 3y ago
    There was a big dip during the pandemic, but it looks like it mostly recovered? See: https://fred.stlouisfed.org/series/RPM https://fred.stlouisfed.org/series/RPM
    • nocoiner 3y ago
      I think he’s talking about general aviation which is … not in great shape, though the rumors of its demise are still overstated a bit. The main thing that made general aviation a far less accessible proposition were the lawsuits against the manufacturers in the 70s and 80s, the crushing verdicts and the over engineered basic planes based on suits that had been lost. That’s why a new Cessna 172 is three-quarters of a million dollars. If I have a particular complaint with the FAA, I don’t think the requirements for a third-class medical are terribly compatible with the modern view of good mental health and treatment. But I understand the box they’re in on this, and don’t have any bright ideas.
      • delfinom 3y ago
        >The main thing that made general aviation a far less accessible proposition Meh, where I live, what made general aviation inaccessible is the fact that boomers and geriatrics have filled basically every airfield parking lot with planes they are keeping indefinitely in storage. The only ones using the planes are the guys able to pay for the private corp owned hangers >That’s why a new Cessna 172 is three-quarters of a million dollars. There are people bypassing this for "recreational" level flying by simply using the experimental labeling on planes A KitFox (Kit or Factory built) runs from just $50k to $150k https://kitfoxaircraft.com/ https://kitfoxaircraft.com/
  • 3y ago
• light_hue_1 3y ago
  I'm sympathetic, but it's far too easy to say "the FDA should move faster". The FDA moves at the speed of all of the other Western regulators. What happens when you're seriously hurt by a treatment because the FDA moved too fast? Aren't you going to sue everyone involved? Aren't people going to be outraged and demand that everyone at the FDA gets fired. Do the people at the FDA want to be dragged in front of Congress? How is your doctor going to feel when your experimental treatment kills you? When someone dies while taking one of the drugs, even if it's unrelated to the drug, how far behind will development of that drug be? If the drug is suspected of causing serious harm they might never get to run trials, all because they gave it to people without any controls and any ability to tell if the drug is harmful or not. This can seriously set help for everyone behind. One of the cornerstones of modern scientific ethics is that you cannot take advantage of people in a power imbalance. If a company can put something out there, and try to convince people who are desperate to take it, now you're just experimenting on people in a massive power imbalance. And of course the companies that will convince people to do this are those with the most amount of money, not with the most helpful product. This isn't about risk tolerance. This is about building a long-term system that advances treatment for everyone. Almost certainly nothing that we have would help the person in these desperate conditions. The FDA moving faster won't help. If you really want to help, advocate for funding NSF and NIH. We barely spend anything on cancer research. That's what will make the difference.
  • chpatrick 3y ago
    What if the patient is dying anyway and wants to try an experimental drug?
    • crote 3y ago
      What if a company wants to prey on desperate people who want to do everything to avoid dying, including paying boatloads of money for "experimental" drugs which are just plain old quackery?
      • chpatrick 3y ago
        Nothing is protecting desperate people from quackery right now either, only from drugs that might actually help.
• epistasis 3y ago
  I am very interested in improving approval times, approval costs, and accelerating as much as possible and improving the current situation. But having done one filing and read tons of filings and talking to others, I don't have many complaints with the current setup. The closest I have to a complaint is the attitude of a single person who served on an approval committee who wrote advice to those making applications, and that person seemed to have little acceptance of their own role in the process, specifically the high cost of saying "no" unnecessarily. As with any approval body, their decisions have huge penalty for incorrectly saying "yes" but zero penalty for incorrectly saying "no". But the FDA, of all the approval bodies I have dealt with, such as IRBs, has managed the best in my experience. My experience may not be representative though. Edit: thinking again, I do have one request, pandemic related. I think the FDA should rely more heavily on artificial standards for evaluating diagnostic tests for infectious agents. A key bottleneck in Covid19 diagnostics was obtaining clinical samples to validate new tests, and allowing more validation is synthetic samples would have greatly expanded testing capacity more quickly.
  • roflc0ptic 3y ago
    > their decisions have huge penalty for incorrectly saying "yes" but zero penalty for incorrectly saying "no". The FDA acting out this incentive scheme _is_ the problem. The issue is the opportunity cost: "I default to no, because while that may cost millions of lives, I don't incur responsibility for their deaths." The incentives should change to "I am responsible to take informed risks to maximize the wellbeing of the population." There is a literal death toll from their inaction, and it doesn't get counted in the equation. It's possible to design a system that takes that into account; that's what's being argued for.
    • epistasis 3y ago
      I would agree that these sorts of agencies should take a proper risk/benefit analysis. And I would argue that the FDA is by far the best at taking this approach, despite lawmakers not yet officially making it their mandate. They have been responding to criticism over the past few decades.
• DANmode 3y ago
  How about the other side, where the FDA allows things like Singulair/Montelukast to remain in the market despite plenty of evidence of widespread harm? It's a destructive drug, and anyone given it without a medical background (and some with one!) would never guess the degree of side-effects it offers, because of the innocuous feelings toward the class of drug that it is.
  • lwhalen 3y ago
    I actually just stopped my daily montelukast pill a few months ago. No side effects, I just hated having to take a daily. I was told - years ago - that it was practically benign. What am I missing?
    • Herodotus38 3y ago
      The FDA issued a black box warning for increased reports of suicidal thoughts in 2020: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug https://www.fda.gov/drugs/drug-safety-and-availability/fda-r...
      • DANmode 3y ago
        At least one doctor's got the clue! Thanks.
      • lwhalen 3y ago
        Thanks for this. I had no idea! I definitely did not have any suicidal thoughts while on it, but it sounds like I was a lucky one.
    • DANmode 3y ago
      > I was told - years ago - that it was practically benign. Cheers for proving the point, and I'm glad you didn't struggle getting off it it, like some.
  • crote 3y ago
    And don't forget thalidomide! It was initially marketed for anxiety, sleeplessness, and morning sickness over in Europe. This led to a massive amount of birth defects and newborn fatalities. Luckily the FDA did not approve it. The FDA reviewer was early in her career and was essentially given thalidomide to look over as an "easy start", but luckily she had an interest in fetal development and refused to approve it until fetal interactions were shown to be safe. It resulted in a huge battle with the manufacturer which was only resolved by it being linked to birth defects in the rest of the world - after which they withdrew their application.
• emmanueloga_ 3y ago
  Tangentially, it is the first time hearing the world "torpor", I would understand even "lethargy" [0] which I don't think is that used in common speech (but more than "torpor" for sure). The use of this word for this particle blog post is to say the least interesting [1] (I would at least use one of the many more popular synonyms). TBH I thought it was the name of a drug or some chemical substance :-p. 0: https://www.thesaurus.com/browse/torpor https://www.thesaurus.com/browse/torpor 1: https://trends.google.com/trends/explore?q=torpor&date=now%201-d https://trends.google.com/trends/explore?q=torpor&date=now%2...
  • TylerE 3y ago
    They are different concepts. Torpor essentially just means "slow and lazy", scientifically it refers to a down regulation of body temperature and/or metabolism, but doesn't reflect on the REASON for it. Lethargy is slowness specifically caused by how you feel - fatigue, nausea, dizziness, sleepiness, that sort of thing. Languid is a closer synonym to torpor, although it can actually refer to either meaning, essentially (slow OR tired).
  • chrisbolt 3y ago
    Relevant West Wing: https://youtu.be/4eP2epXYW9M https://youtu.be/4eP2epXYW9M
  • deleted 3y ago
    [deleted]
  • euroderf 3y ago
    We are told that bears here in Finland don't hibernate, they go into torpor. There is a distinction. (They "torporate"?)
  • topspin 3y ago
    Torpor is the wrong word. Full stop. The FDA isn't merely a lazy, indifferent regulatory body suffering some sleepy malaise. The FDA is actively beholden to "special" interests and the decisions made by the FDA are a function of both these interests and its own mandate. Threading those needles is complex so processes at the FDA move slowly; it takes a lot coordination to safely and profitably answer to all the masters involved. "Safely," here, has nothing at all to do with medicine. The correct word is "corruption," but using the correct word would immediately alienate the entire professional class to which Seliger hopes to appeal. Seliger understands this and has employed a friendlier word, implying nothing more terrifying than innocent dysfunction. Such is the lot of one that seeks to discuss the consequences of corruption with those that cannot tolerate the impuning of anything Government, with the possible exception of the DOD.
• ixtli 3y ago
  Yeah I have no desire to defend the FDA here but summarizing this as “I care about the dying while this government agency is only concerned with politics” does a massive disservice to the argument. It is political will that is responsible for the existence of the FDA and we live in a time of massive epistemological crisis specifically in the subset of the population of the US that votes. That and some subset are ideologically bent on dismantling regulatory bodies in general. Ignoring this reality probably jeopardizes any potential benefit of the FDA
  • aydyn 3y ago
    > It is political will that is responsible for the existence of the FDA and we live in a time of massive epistemological crisis specifically in the subset of the population of the US that votes. That and some subset are ideologically bent on dismantling regulatory bodies in general. Ignoring this reality probably jeopardizes any potential benefit of the FDA Can you please say this in english for people who aren't terminally caught up to politics du jour? FDA is in drastic need of reform, ask anyone who deals with them directly (and is willing to be honest). That's not a political or ideological statement.
    • CuriousCosmic 3y ago
      > Can you please say this in english for people who aren't terminally caught up to politics du jour? Not OP but I believe they are referring to the fairly sizeable part of the voting population who believe that we need to deregulate everything and dismantle any agency that is responsible for regulations. That and the increasing distrust by the right of medical professionals and scientists makes for a dangerous combination.
      • monero-xmr 3y ago
        People wouldn’t distrust “The Science” and all manner of government institutions if they weren’t so obviously corrupted. But like everything human, they are fallible: https://en.m.wikipedia.org/wiki/Replication_crisis https://en.m.wikipedia.org/wiki/Replication_crisis I personally refuse to blindly accept anything. Science is a work in progress. “Professionals” started just like I started - as a novice. I don’t need to be told what to think.
• akira2501 3y ago
  Albuterol Inhalers. Used to use CFC as the propellant. CFCs got banned. So, the FDA lets GSK _re-patent_ the same *medication* but just with a new propellant. What propellant did they use? R-134a. The same HFA that everyone switched to after CFC was taken out of use for refigeration. It wasn't even a novel change. Inhalers went from $5 generics to $90 brand name only overnight. Of course, GSK also secured further patents that prevented things from primatine mist from existing at all. Disappeared from the market and primatine tablets were the only thing left. Oh.. and R-134a is getting phased out again soon. Just in time for the GSK patents to be renewed, I guess. So, they're going to leave people who need a simple medication for breathing issues without anything on the market, _again_. I wonder if they'll even get the single year of "generic tease" again.
  • p-e-w 3y ago
    The CFC ban really threw the baby out with the bathwater. We went from "let's put this stuff into every household item, and release it into the atmosphere by the billions of tons" to "nothing must ever contain CFCs ever again, including critical medical products that use only insignificant amounts". Similar mistakes were made with asbestos and dental amalgam, where the panicked removal often released more contaminants than would have been during the item's entire lifetime otherwise, and the substitute materials were later found to have their own problems. There's a big lesson in this for future regulatory action regarding environmental issues.
    • crote 3y ago
      Interestingly this did not happen with lead. The regulations for that have significant exceptions for things like medical technology, aviation, military use, and equipment only used by trained professionals. And of course the one big massive hole: aviation fuel.
      • p-e-w 3y ago
        Lead is still everywhere: In fishing ballast, in curtains, in camera stands, ... I used to love removing those little lead pellets from curtain weight ropes. It wouldn't have crossed my mind to so much as wash my hands afterwards. I've seen children chewing on fishing lead, and nobody seemed to even be aware there's a risk involved. I mean, people used to ADD LEAD TO THEIR WINE(!!!) by the grams to give it that "heavy sweetness". Still, it took centuries for the population at large to notice that this might be a problem.
• darkclouds 3y ago
  "“I am dying of squamous cell carcinoma, and the treatments that might save me are just out of reach:" Sometimes I think its better to die, when you get off the treadmill, you may well see that life isnt good after all. Thats why I'm all for euthanasia, I'd even propose a sort of turn up unannounced to the local incinerating crematorium, optionally leave a few beyond the grave messages, lethal injection and job done. There's too many people selling hope in a variety of disguises.
• ruuda 3y ago
  There is the example of the required lipids in parental nutrition not being approved causing baby deaths that could easily have been prevented. Eliezer Yudkowski writes about it extensively in Inadequate Equilibria, but some of it is also in https://www.lesswrong.com/posts/x5ASTMPKPowLKpLpZ/moloch-s-toolbox-1-2 https://www.lesswrong.com/posts/x5ASTMPKPowLKpLpZ/moloch-s-t.... It offers an explanation for why some issues that are easy to fix don't get fixed anyway.
• RektBoy 3y ago
  American healthcare :coffee emoji:
• jijji 3y ago
  One thing I'm seeing recently is the issue of peptides such as tirzepatide (brand name: "Mounajro". FDA approves it as a Type-2 Diabetes medication only, yet doctors were prescribing it for its dramatic effects on weight loss due to its appetite suppressant properties. I know doctors that are now refusing to prescribe it due to not wanting to get in trouble with either the FDA or DEA. The street price for this medication is $1,000 USD per month at most pharmacies in the United States today, which consists of four injections (once per week at 5mg per injection. The prohibitive cost of such a peptide naturally makes one look at labs overseas, which typically charge $1,000 USD per gram, equal to about four years of the peptide injections at 5mg per week dosage. It is sad that we have been forced to become our own pharmacists at home in order to get the drugs we need at reasonable pricing. This goes with all compounds, not just this example.
  • sterlind 3y ago
    the DEA wouldn't care. tirzepatide isn't scheduled, nor is it a drug of abuse.
    • haldujai 3y ago
      Neither would the FDA, we can prescribe off-label all we want.
• robertlagrant 3y ago
  It's not just the FDA. The EU's new MDR requires far more scrutiny on the part of the notified body, to the extent that the bodies are mostly deciding not to bother and ducking out of the medical device game. There is an enormous backlog of things that are almost exclusively approvals of paperwork to demonstrate the process you followed was the process you wrote down.
  • seehafer 3y ago
    The European Commission is likely going to keep extending out their MDR transition timeline indefinitely. That or allow thousands of devices to get taken off the market.
    • robertlagrant 3y ago
      Yes. It's going extremely badly.
• A_D_E_P_T 3y ago
  The below is from Eliezer Yudkowski's book "Inadequate Equlibria." "Some babies have digestion problems that require direct intravenous feeding. Long ago, somebody created a hospital formula for this intravenous feeding that matched the distribution of “fat,” “protein,” and “carbohydrate” in breast milk. "Just like “protein” comes in different amino acids, some of which the body can’t make on its own and some of which it can, what early doctors used to think of as “fat” actually breaks down into metabolically distinct elements like short-chain triglycerides, medium-chain triglycerides, saturated fat, and omega-6, omega-9, and the famous “omega-3.” “Omega-3” is actually several different lipids in its own right; vegetable oils with “omega-3” usually just contain alpha-linolenic acids, which can only be inefficiently converted to ecosapentaenoic acids, which are then even more inefficiently converted to docosahexaenoic acids, which are the actual key structural components in the body. This conversion pathway is rate-limited by a process that also converts omega-6, so too much omega-6 can prevent you from processing ALA into DHA even if you’re getting ALA. "So what happens if your infant nutrition was initially designed based on the concept of “fat” as a natural category, and all the “fat” in the mix comes from soybean oil? "From a popular book by Jaminet and Jaminet: > ""Some babies are born with “short bowel syndrome” and need to be given parenteral nutrition, or nutrition delivered intravenously directly to the blood, until their digestive tracts grow and heal. Since 1961, parenteral nutrition has used soybean oil as its source of fat. And for decades, babies on parenteral nutrition have suffered devastating liver and brain damage. The death rate on soybean oil is 30 percent by age four. In a clinical trial, of forty-two babies given fish oil [after they had already developed liver damage on soybean oil], three died and one required a liver transplant; of forty-nine given soybean oil, twelve died and six required a liver transplant. The death-or liver-transplant rate was reduced from 37 percent with soybean oil to 9 percent with fish oil." "When Jaminet and Jaminet wrote the above, in 2012, there was a single hospital in the United States that could provide correctly formulated parenteral nutrition, namely the Boston Children’s Hospital; nowhere else. This formulation was illegal to sell across state lines. "A few years after the Boston Children’s Hospital developed their formula—keeping in mind the heap of dead babies continuing to pile up in the meanwhile—there developed a shortage of “certified lipids” (FDA approved “fat” for adding to parenteral nutrition). For a year or two, the parenteral nutrition contained no fat at all which is worse and can kill adults. You see, although there’s nothing special about the soybean oil in parenteral nutrition, there was only one US manufacturer approved to add it, and that manufacturer left the market, so… "As of 2015, the state of affairs was as follows: The FDA eventually solved the problem with the shortage of US-certified lipids, by… allowing US hospitals to import parenteral nutrition bags from Europe. And it only took them two years’ worth of dead patients to figure that out! "As of 2016, if your baby has short bowel syndrome, and has already ended up with liver damage, and either you or your doctor is lucky enough to know what’s wrong and how to fix it, your doctor can apply for a special permit to use a non-FDA-approved substance for your child on an emergency basis. After this, you can buy Omegaven and hope that it cures your baby and that there isn’t too much permanent damage and that it’s not already too late. "This is an improvement over the prior situation, where the non-poisonous formulation was illegal to sell across state lines under any circumstances, but it’s still not good by any stretch of the imagination. Now imagine trying to explain to a visitor from a relatively well-functioning world just why it is that your civilization has killed a bunch of babies and subjected other babies to pointless brain damage." "“It’s not that we’re evil,” you say helplessly, “it’s that… well, you see, it’s not that anyone wanted to kill those babies, it’s just the way the System ended up, somehow…”"
• refurb 3y ago
  As someone who has actually interacted with the FDA on numerous occasions, I've actually found them to be quite fair, scientifically driven and pretty proactive when it comes to enforcing their mandates of regulating the drug industry. Sure there have been high profile instances of political interference, but that's the folks at the top, not your average FDA employee.
• DonsDiscountGas 3y ago
  The FDA aren't mustache-twirling villains here. I'm pretty sure they're responding to public pressure; nobody cares about an invisible graveyard the same way as a visible one. Heck, we have people outraged about the emergency approval of a vaccine which saved millions of lives. So maybe this effort will be successful by using the FDA as a foil, but ultimately we need to convince the public at large to change their/our attitudes.
• kotaKat 3y ago
  CPAP and APAP. Why the hell do I need a prescription for literally any of it at this point? Automatic-adjusting PAPs have been on the market for decades with no patient harm, and I shouldn't need to have to keep getting scripts for new masks. Even Canada allows over-the-counter CPAP/APAP sales.
• ShadowBanThis01 3y ago
  "Torpor" can also take the form of failing to promptly disclose, or force the disclosure of detrimental effects. Ask the people whose hearing has been ruined by COVID vaccines.
• AbrahamParangi 3y ago
  I think that some people have a revealed preference that new treatments not make it to market because it would enrich the already wealthy, even if that means progress is slower.