8 ms·

That's what you get if your governments give monopoly on making drugs to huge corporations. Patens and enormously costly "approvals" (rather than strict liabili

That's what you get if your governments give monopoly on making drugs to huge corporations. Patens and enormously costly "approvals" (rather than strict liability) are the root of the problem.

Scoundreller 8y ago
I don't think we'd have 99% of these novel clinical compounds if it weren't for patents. As for approvals, I don't know why we have each country doing its own approvals, instead of international groups that individuals can choose whether they want to trust or not. Are Europeans sufficiently different than Chinese, Indians, Australians, Canadians, Germans or Americans to warrant independent safety approvals? If they're using different metrics to process approvals, why? Shouldn't the same inputs result in the same outputs?
- spectrum1234 8y ago
  Why wouldn't these compounds evolve to be open source? Barriers to entry wouldn't be billions in R&D if every stepping stone was open sourced.
  - pkaye 8y ago
    The real question is who will pay for testing drug safety and efficacy. Take Auryxia which is literally ferric citrate. Its used by kidney patients to control phosphorus levels and boost iron. Why did it take so long to get tested and approved as a drug when the formula was "open source" for a long time? Well one company did the time and effort and suddenly it is considered a valuable drug. The value came from proving the safety and efficacy and someone has to be willing to fund it.
    - Retric 8y ago
      Drug tests are not inherently that expensive. FDA trials run about 1% of the cost of each new drug. https://www.jhsph.edu/news/news-releases/2018/cost-of-clinical-trials-for-new-drug-FDA-approval-are-fraction-of-total-tab.html https://www.jhsph.edu/news/news-releases/2018/cost-of-clinic... The long line of failed drugs are the real issue.
      - refurb 8y ago
        No offense but the article you referenced is misleading. Sure, just the trial might cost that little if it’s an orphan disease, but it’s also ignoring all the other stuff that goes along with running a trial. Things like manufacturing, compliance, data analysis, etc. When you look at the total cost of R&D for a drug, it’s typically 1/3 for discovery and 2/3 for development (clinical trials). If your drug is used in any reasonable sized population, development is easily in the hundreds of millions of dollars. You are correct about the failure rates though.
- BurningFrog 8y ago
  If approvals were about science, one approval would be good enough worldwide. In reality, approvals are also about politics.
- refurb 8y ago
  Well, considering the US avoided the thalidomide tragedy because they decided approval in Europe was t good enough, you’re unlikely to see a scenario where it gets approved simply because someone else approved it.
  - baud147258 8y ago
    The thalidomide tragedy didn't happen in France too, because of a new law adding stricter controls on drugs.
darawk 8y ago
...and what do you think you get if you don't do those things? The answer is no drugs at all.
- claudiawerner 8y ago
  Is it? I remember seeing a paper in which they found no empirical evidence that patents actually help in medicine. I'd be interested to know if you have any information on it.
  - darawk 8y ago
    I'm not sure how that could be the case. I'm not familiar with that paper, but I would be curious to see its logic. It's hard to imagine that completely removing the financial incentive to create a thing would engender more of that thing.
- averros 8y ago
  This is totally false, as there are other parties which are interested in developing new drugs: academic researchers, insurance companies, and patients. The drug research is paid for by patients and insured as it stands now, but the FDA/pharma cartel monopolized drug development using patents and the hugely expensive approval process. Now, pharmas are interested in profitable drugs which don't as much cure the diseases but rather allow mainenance of chronic conditions for years and years. Actual effective cures are not a priority. Interests of insurers and patients are quute different: they would love quick, cheap, and effective cures. It's all about incentives.
  - darawk 8y ago
    > This is totally false, as there are other parties which are interested in developing new drugs: academic researchers, insurance companies, and patients. Why would an insurance company be interested in developing new drugs? Health insurance companies don't lose money if you die. How do you propose that academic researchers fund their work, all the way through the approval point? > The drug research is paid for by patients and insured as it stands now, but the FDA/pharma cartel monopolized drug development using patents and the hugely expensive approval process. Do you think the process is expensive because of the pharma companies, or do you think the pharma companies are the way they are because the process is expensive? > Now, pharmas are interested in profitable drugs which don't as much cure the diseases but rather allow mainenance of chronic conditions for years and years. Actual effective cures are not a priority. This is a thing people say, but it's not really true. It'd be great if all you had to do to create more cures was snap your fingers and change the incentive structure. But the fact of the matter is that cures are harder to create. Incremental improvements are easier. So you get more of them. Pharma companies do in fact still cure things when they can, see the recent HepC cure.
pkaye 8y ago
What country has had success with using the strict liability approach?

That's what you get if your governments give monopoly on making drugs to huge corporations. Patens and enormously costly "approvals" (rather than strict liability) are the root of the problem.

Scoundreller 8y ago

I don't think we'd have 99% of these novel clinical compounds if it weren't for patents. As for approvals, I don't know why we have each country doing its own approvals, instead of international groups that individuals can choose whether they want to trust or not. Are Europeans sufficiently different than Chinese, Indians, Australians, Canadians, Germans or Americans to warrant independent safety approvals? If they're using different metrics to process approvals, why? Shouldn't the same inputs result in the same outputs?

spectrum1234 8y ago
Why wouldn't these compounds evolve to be open source? Barriers to entry wouldn't be billions in R&D if every stepping stone was open sourced.
- pkaye 8y ago
  The real question is who will pay for testing drug safety and efficacy. Take Auryxia which is literally ferric citrate. Its used by kidney patients to control phosphorus levels and boost iron. Why did it take so long to get tested and approved as a drug when the formula was "open source" for a long time? Well one company did the time and effort and suddenly it is considered a valuable drug. The value came from proving the safety and efficacy and someone has to be willing to fund it.
  - Retric 8y ago
    Drug tests are not inherently that expensive. FDA trials run about 1% of the cost of each new drug. https://www.jhsph.edu/news/news-releases/2018/cost-of-clinical-trials-for-new-drug-FDA-approval-are-fraction-of-total-tab.html https://www.jhsph.edu/news/news-releases/2018/cost-of-clinic... The long line of failed drugs are the real issue.
    - refurb 8y ago
      No offense but the article you referenced is misleading. Sure, just the trial might cost that little if it’s an orphan disease, but it’s also ignoring all the other stuff that goes along with running a trial. Things like manufacturing, compliance, data analysis, etc. When you look at the total cost of R&D for a drug, it’s typically 1/3 for discovery and 2/3 for development (clinical trials). If your drug is used in any reasonable sized population, development is easily in the hundreds of millions of dollars. You are correct about the failure rates though.
BurningFrog 8y ago
If approvals were about science, one approval would be good enough worldwide. In reality, approvals are also about politics.
refurb 8y ago
Well, considering the US avoided the thalidomide tragedy because they decided approval in Europe was t good enough, you’re unlikely to see a scenario where it gets approved simply because someone else approved it.
- baud147258 8y ago
  The thalidomide tragedy didn't happen in France too, because of a new law adding stricter controls on drugs.

darawk 8y ago

...and what do you think you get if you don't do those things? The answer is no drugs at all.

claudiawerner 8y ago
Is it? I remember seeing a paper in which they found no empirical evidence that patents actually help in medicine. I'd be interested to know if you have any information on it.
- darawk 8y ago
  I'm not sure how that could be the case. I'm not familiar with that paper, but I would be curious to see its logic. It's hard to imagine that completely removing the financial incentive to create a thing would engender more of that thing.
averros 8y ago
This is totally false, as there are other parties which are interested in developing new drugs: academic researchers, insurance companies, and patients. The drug research is paid for by patients and insured as it stands now, but the FDA/pharma cartel monopolized drug development using patents and the hugely expensive approval process. Now, pharmas are interested in profitable drugs which don't as much cure the diseases but rather allow mainenance of chronic conditions for years and years. Actual effective cures are not a priority. Interests of insurers and patients are quute different: they would love quick, cheap, and effective cures. It's all about incentives.
- darawk 8y ago
  > This is totally false, as there are other parties which are interested in developing new drugs: academic researchers, insurance companies, and patients. Why would an insurance company be interested in developing new drugs? Health insurance companies don't lose money if you die. How do you propose that academic researchers fund their work, all the way through the approval point? > The drug research is paid for by patients and insured as it stands now, but the FDA/pharma cartel monopolized drug development using patents and the hugely expensive approval process. Do you think the process is expensive because of the pharma companies, or do you think the pharma companies are the way they are because the process is expensive? > Now, pharmas are interested in profitable drugs which don't as much cure the diseases but rather allow mainenance of chronic conditions for years and years. Actual effective cures are not a priority. This is a thing people say, but it's not really true. It'd be great if all you had to do to create more cures was snap your fingers and change the incentive structure. But the fact of the matter is that cures are harder to create. Incremental improvements are easier. So you get more of them. Pharma companies do in fact still cure things when they can, see the recent HepC cure.

pkaye 8y ago

What country has had success with using the strict liability approach?