6 ms·

Not US specific: * Ridiculously long patent validity periods. Let's put aside the fact that patenting a fucking molecule is even a thing, 20+ years is way too

• mtgx 10y ago
  Don't forget to add stuff like banning Canadian drug imports. Medicine absolutely should be validated before being sold in a country, but other than that, I see no reason why Canadian companies, or companies from other countries, couldn't sell a competing drug in the U.S. for whatever price they want. Obama played a big role in banning this type of imports. Just saying. And TPP/TTIP would make this problem much worse, and virtually irreversible, because then they can just say "well, we wish we could change the monopoly laws now, but it's in the treaty, you see...so tough luck."
  • Houshalter 10y ago
    There are ridiculous levels of regulatory capture. E.g. epi pens are off patent and there are many competing companies in Europe, but the FDA refuses to approve any of them. Or cancer drugs that have been used for decades in Europe very effectively with tons of data there to support them, but the FDA refuses to allow them. One time they even required a drug to have a trial with more patients than exist in the US with that disease. They kill way more people than they save by preventing terminally ill patients from getting life saving drugs. And raising the cost developing them. The FDA needs to be shut down. Perhaps replaced with something like a prediction market, where people can bet on how likely a drug is to pass a trial or even work in specific patients.
    • deleted 10y ago
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    • philh 10y ago
      > epi pens are off patent and there are many competing companies in Europe, but the FDA refuses to approve any of them Not entirely true: there's adrenaclick. But if a doctor writes "epipen", the pharmacist isn't allowed to give you an adrenaclick, even though that kind of substitution is usually allowed. http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-drugs-vs-chairs/ http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-dr...
      • vonmoltke 10y ago
        It's not allowed in this case because the FDA, rightly or wrongly, wants the patient trained in the use of the specific injector they are being prescribed. Having never needed one I don't know what the practical differences between the operation of an Epipen injector and Adrenaclick injector are, but the FDA seems to think they exist.
  • deleted 10y ago
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  • leakybit 10y ago
    One reason Pharma companies in other countries can sell drugs for far cheaper is that actual manufacturing costs of most drugs are pennies. Once an American company discovers a safe and effective drug, foreign companies can simply look at the publications on how to synthesize the drug and don't have to spend any cash on R&D.
• orbat 10y ago
  Would you actually want drug research to _not_ be regulated?
  • fivesigma 10y ago
    I want drug research (and approval) to _not_ cost billions of dollars per drug just to justify the salary of a few bureaucrats.
    • ekianjo 10y ago
      Not only it's expensive, but tons of existing drugs have been approved with loose standards (a single trial showing better efficacy than placebo, wow, big deal!). Every new drug should be benchmarked against the best drug in class, and period. Instead of that you end up with doctors who have no idea which drugs work the best and who rely on companies to "educate" them, with obvious conflict of interest.
      • jonlucc 10y ago
        That is the current standard (Ph 3 clinical trials against standard of care). There are rare exceptions to this, but the ones I can think of are drugs for which there is no current standard and drugs for which the current standard doesn't match the intended indication. In modern medicine, we don't just take diagnosed patients who meet criteria for a trial and let them progress without disease.
        • ekianjo 10y ago
          Thats why I mentioned "have been". But such drugs are still being sold.patented and used.
          • jonlucc 10y ago
            Yes; our system makes it very difficult to put horses back in the barn. I heard one physician say that Tylenol would not make it through today, or at the very least it would be prescription, because of the slim toxicity margin.
• ekianjo 10y ago
  Note that companies have also been fighting for such standards in order to prevent new entrants and restrict competition. So it's not just governments at fault, there is complicity between the two.
  • dexterdog 10y ago
    It's the same in every regulated industry: auto, insurance, finance, education. All it does is drive up the cost like crazy which gets passed on and people still get scammed, but pay extra for the privilege.
    • Retric 10y ago
      It defaults to higher costs, but that's not enough to say it's worse. I don't care if milk could cost half as much if it has a significantly higher chance of making me sick. On the other hand if I had less money I might be more willing to take risks. Thus, regulation is not an independent thing and depends on the economy it's operating in. PS: Historically milk was surprisingly deadly. Without regulation it would likely be much safer than that today, but not as safe as it currently is.
      • gravypod 10y ago
        You know that's the first time I've ever heard that argument. People usually just freeze and don't know how to respond. I'll have to think about this
      • dexterdog 10y ago
        You do realize that milk is heavily subsidized to be priced where it is, right? I would much rather pay a local farmer the market amount and have a relationship with him than to pay into the bureaucracy and support those subsidies with all kinds of taxes.
        • Retric 10y ago
          I don't actually drink / buy milk directly so the sticker prices has little meaning to me. As to having a personal relationship with a farmer, I grew up next to a farm. It's very much an industrial process.
• delecti 10y ago
  > Let's put aside the fact that patenting a fucking molecule is even a thing Assuming you don't find fault with the mere concept of patents, I am legitimately curious why patenting a molecule shouldn't also be possible.
  • PieterH 10y ago
    Because it's a discovery rather than an invention. Though the mere concept of patents is already a fraud, as is clear when you start to look closely the arguments. See http://hintjens.com/blog:31 http://hintjens.com/blog:31.
    • delecti 10y ago
      I would argue that any invention is a discovery of sorts. The inventor of the electric coffee maker didn't fundamentally alter the universe to cause it to be possible for a device to brew coffee. And even if you don't buy that argument (it's admittedly tenuous) the fact that it's a discovery wouldn't convince me that the discoverer shouldn't still get exclusivity rights, given the amount of research involved in discovering new molecules and shepherding them through the approval process. Could you possibly find something a little less conspiracy theory looking? Also something a little less manifesto.
      • hobs 10y ago
        > Could you possibly find something a little less conspiracy theory looking? Also something a little less manifesto. Clearly his own blog.
        • delecti 10y ago
          Oh, so it is. Good catch.
      • PieterH 10y ago
        It's my own blog. I spent two years fighting software parents in Europe as president of the largest NGO involved (FFII), and it was pretty clear that we were fighting a well organised and funded lobbying machine. After some years of analysis my conclusion was that software was not in fact a special case, and that all patents were a problem. Sorry to not have made it clear that I was linking to my own work.
• philh 10y ago
  > 20+ years is way too long a term I've heard that the approvals process eats up almost half of those years. (Or if not the approvals process, then something that's going on after they get the patent but before they're allowed to sell it.)
  • jonlucc 10y ago
    This is usually true. The patent is filed before you start clinical trials, because it must be described in publications. Those trials together often take 5 years or more. Only after that can you even file the New Drug Application or foreign equivalent. Edited to add: Also, people often lump the market exclusivity extensions in with the patent. The FDA offers companies and incentive to try their drugs in children. Without this, almost nothing would be approved for kids because the trials are ridiculously expensive (even compared to adult trials).
• rayiner 10y ago
  Is 20 years actually that long for a drug? Drugs tend to have 12-15 years of actual patented time in market given the time eaten up the approval process. It's not like software where that time lag might make the patented drug obsolete by the time it becomes generic. What "insurance laws" "subsidize" drug costs? The cost of regulatory approval is high, but that's justified because the economic cost of a bad or even just ineffective drug piles up very quickly. Reduce the life expectancy of 1,000 people by 10 years (or give them an ineffective alternative to a drug that could extend their life by 10 years) and that's a billion dollars of damages right there. Is there a cheaper solution than extensive clinical trials that accomplished the same result? It's not clear there is. Remember, what really makes approval so expensive is that most candidate drugs don't get approval. So the investment into all the drugs that don't work has to be recouped from the ones that do. But the fact that so many drugs fail at the clinic trial stage suggests we don't have better ways of predicting whether drugs will be safe and effective. Drug companies don't invest into drugs that don't pass approval for funsies. If they could determine a drug wasn't going to pass approval before the clinical trials, they'd do it. It'd be pure profit for them. Also, the fact that so many drugs don't pass approval suggests that the FDA is keeping a bunch of ineffective and harmful drugs off the market. The cost of getting rid of the FDA has to account for the cost of those bad and ineffective drugs. Also, getting rid of these things would not make the drug industry a "free market." In any advanced society, the government will pay for drugs for elderly and poor people. That creates an entity that can exercise monopsony power. Get rid of patents on drugs, then you get the free rider effect undermining R&D. And get rid of the FDA, and you end up with a market with huge information asymmetries that allow drug manufacturers to sell products that don't work without customers having a way to know that. These would destroy any hope of a functioning competitive market. You can't talk about markets while pretending only the parts of economics that comport with your world view exist.
  • dforrestwilson1 10y ago
    Define your expectation of an advanced society please. They don't come out of a mold. Perhaps an advanced society should involve one generation taking care of the next instead of the government?
• js8 10y ago
  > Astronomically high R&D costs, most of which is the cost of obtaining regulatory approval. And yet, IIRC, pharmaceutical companies spend about 20% of their revenues on research, but about 40% or more on marketing. These costs are galaxonomical!
  • aantix 10y ago
    The average number of emails you must send before a subscriber starts to consider you safe to buy from.. Eight. Assuming one's health has an even higher threshold, and that a pharma company can't exactly cold email everyone in the U.S, well... That's a lot of commercials to get the word out. That's 800,000+ doctors to educate on a new option.. Marketing always goes hand in hand with product development. I'd rather have a pharma company that's still in business charging $30,000/mo for a solution vs a company that charged the minimum, and thus has thrown away any chances of making successful products in the future.