3 ms·

no. the upfront costs for pharma development are prohibitive. the chances of a new molecule making it through clinical trials is really small. the economic cri

no. the upfront costs for pharma development are prohibitive. the chances of a new molecule making it through clinical trials is really small. the economic crisis has put a lot of emphasis on efficacy for inclusion on various formulary schemes, be it private ones like in the US or state-run ones like in EU. now you need an approved product that is also not only marginally better than existing stuff. just takes away some nasty side effect? no reimbursement for you, pharma-economics trumps this. so, you have run ups of 10 years to line up a single new drug. scientists, the whole approval chain, supply chain, etc. then you get approval and your drug is good enough to be reimbursed, hooray. as the FDA process is public, your generic competitors have been watching - now that you have proven everything, they can flood the market and can undercut you significantly as they do not need to recuperate the initial investment of 10 years. you have this happen once or twice and then say fuck it. let's play the lottery, better ROI. the whole patent system was invented for a reason. it makes perfect sense for pharma. abolish it there and drug development will only happen through government programs.

loup-vaillant 14y ago
We have problem A, which is alleviated by crutch B. Therefore, do not remove the crutch. No. If there is a problem with the FDA approval system, let's fix that. Unless it's even more hopeless than reforming (or abolishing) the patent system? > the whole patent system was invented for a reason. Yes, but it doesn't matter in the slightest. What matters is what the patent system actually does, and the consequences of removing it. Speaking of which: > abolish it there and drug development will only happen through government programs. Probably. However, it may not be so bad if we fix problem A, namely the FDA. Also see "Against Intellectual Monopoly"[1], which talks about the pharmaceutical industry in its 9th chapter. [1] http://www.dklevine.com/general/intellectual/againstfinal.htm http://www.dklevine.com/general/intellectual/againstfinal.ht...
- pinaceae 14y ago
  I don't get your point. The FDA approval system is not the problem. It is scientific and one of the toughest approval processes worldwide. It has improved dramatically in the last 15 years. Speeding up the process would be dangerous as it is about human health and side effects take time to surface. You want to be really sure before you approve a new molecule. Contergan showed what can go wrong. And the FDA process being public is a good thing too. Transparency is important. Just like openly documented patent claims.
  - loup-vaillant 14y ago
    Okay, if we can't help it, let's have an expensive approval procedure. I'm willing to accept this cost is a necessary evil. That doesn't mean however that patents are the only solution. There are other forms of government interventions. We could make a Manhattan project dedicated at lengthening healthy life expectancy, for instance (who wouldn't like to live a few more healthy decades?). Or we could grant more money to private parties making promising claims. Or we could grant prizes for achieving particular goals (like finding a cure or a vaccine for such and such disease). > Transparency is important. Just like openly documented patent claims. The document is a good thing. The monopoly that goes with it is another matter. Promising a monopoly over inventions speed inventors up, but granting one such monopoly slows everyone else down. Plus the costs induced by the patent approval system, and litigations. I doubt this is a good trade-off.
- rayiner 14y ago
  > We have problem A, which is alleviated by crutch B. It's not a crutch. It's "we have textbook market failure A, which is alleviated by textbook government intervention B; we can remove the intervention, but we have to substitute one of the other textbook interventions suitable for addressing market failures." > If there is a problem with the FDA approval system, let's fix that. First, the FDA approval system is a major but not the biggest cost in getting a new drug to market. Making it dramatically cheaper wouldn't eliminate the underlying problem. Second, the FDA process is thorough and therefore expensive for good reason. The drug market is problematic because its exceedingly difficult to trace a condition to a particular drug, and because conditions sometimes show up years after treatment with a particular drug. And the cost of letting a bad drug through is astronomical. A popular drug like Vioxx might be used by 50 million people worldwide. David Graham, and FDA scientist, estimated that Vioxx caused 90-140k preventable heart attacks, and estimated 25-55k preventable deaths from those heart attacks. What's the cost of this damage? How much would you have to be paid to have a heart attack? Remember the target demographic of Vioxx, middle aged men with decent jobs that provide health insurance to be able to afford an expensive medication, is one of the most expensive demographics in terms of lost income from premature death. Between premature deaths and heart attacks, the actual cost of the Vioxx mistake could be $50-$100 billion in the US. Merck had spectacular lawyers and ended up settling for a fraction of that, but that's the nature of class-action settlements--the tortfeasor only ever pays pennies on each dollar of damage their products cause. The public bears the rest of those costs.
  - loup-vaillant 14y ago
    > It's not a crutch. It's "we have textbook market failure A, which is alleviated by textbook government intervention B; we can remove the intervention, but we have to substitute one of the other textbook interventions suitable for addressing market failures." Oops. Of course. Thinking of patents as a form of government intervention enlarge the solution space. I was seeing a dichotomy (or spectrum) patent/no-patents, but I did not think about exploring other dimensions. > First, the FDA approval system is a major but not the biggest cost in getting a new drug to market. What are the biggest costs? Knowing that could determine the best course of action.
- btilly 14y ago
  What problem do you want to fix? If we do not want babies born with flippers in this country, then we need expensive approval tests. (Those who don't get the reference should look up thalidomide - which the FDA kept out of the USA.) Those currently cost an average of something like $150 million per drug. The temporary monopoly provided by patents lets us get those costs recouped. That said I don't think that pharmaceuticals are the poster child for patents. And in a comment on the blog I offered the example of using hookworm to treat Crohn's disease. The FDA has ruled that it would require their approval. But no patent is possible, and therefore nobody is trying to get it approved. And the result is that the most promising known treatment for hundreds of thousands of sufferers of Crohn's disease is, and will remain, illegal to even consider offering in the USA.
  - loup-vaillant 14y ago
    I thought the FDA approval system where too big, inefficient, and didn't always addresses the right problems. I also thought solving this would significantly reduce costs, and therefore work towards removing the need for government intervention like patents. The other comments around here show that I was probably mistaken. We probably need the FDA as it is now (or close to that), and we probably need something else to compensate for FDA's unavoidable flaws, and the sheer difficulty of doing research. It just doesn't need to be patents.
deleted 14y ago
[deleted]

loup-vaillant 14y ago

We have problem A, which is alleviated by crutch B. Therefore, do not remove the crutch. No. If there is a problem with the FDA approval system, let's fix that. Unless it's even more hopeless than reforming (or abolishing) the patent system? > the whole patent system was invented for a reason. Yes, but it doesn't matter in the slightest. What matters is what the patent system actually does, and the consequences of removing it. Speaking of which: > abolish it there and drug development will only happen through government programs. Probably. However, it may not be so bad if we fix problem A, namely the FDA. Also see "Against Intellectual Monopoly"[1], which talks about the pharmaceutical industry in its 9th chapter. [1] http://www.dklevine.com/general/intellectual/againstfinal.htm http://www.dklevine.com/general/intellectual/againstfinal.ht...

pinaceae 14y ago
I don't get your point. The FDA approval system is not the problem. It is scientific and one of the toughest approval processes worldwide. It has improved dramatically in the last 15 years. Speeding up the process would be dangerous as it is about human health and side effects take time to surface. You want to be really sure before you approve a new molecule. Contergan showed what can go wrong. And the FDA process being public is a good thing too. Transparency is important. Just like openly documented patent claims.
- loup-vaillant 14y ago
  Okay, if we can't help it, let's have an expensive approval procedure. I'm willing to accept this cost is a necessary evil. That doesn't mean however that patents are the only solution. There are other forms of government interventions. We could make a Manhattan project dedicated at lengthening healthy life expectancy, for instance (who wouldn't like to live a few more healthy decades?). Or we could grant more money to private parties making promising claims. Or we could grant prizes for achieving particular goals (like finding a cure or a vaccine for such and such disease). > Transparency is important. Just like openly documented patent claims. The document is a good thing. The monopoly that goes with it is another matter. Promising a monopoly over inventions speed inventors up, but granting one such monopoly slows everyone else down. Plus the costs induced by the patent approval system, and litigations. I doubt this is a good trade-off.
rayiner 14y ago
> We have problem A, which is alleviated by crutch B. It's not a crutch. It's "we have textbook market failure A, which is alleviated by textbook government intervention B; we can remove the intervention, but we have to substitute one of the other textbook interventions suitable for addressing market failures." > If there is a problem with the FDA approval system, let's fix that. First, the FDA approval system is a major but not the biggest cost in getting a new drug to market. Making it dramatically cheaper wouldn't eliminate the underlying problem. Second, the FDA process is thorough and therefore expensive for good reason. The drug market is problematic because its exceedingly difficult to trace a condition to a particular drug, and because conditions sometimes show up years after treatment with a particular drug. And the cost of letting a bad drug through is astronomical. A popular drug like Vioxx might be used by 50 million people worldwide. David Graham, and FDA scientist, estimated that Vioxx caused 90-140k preventable heart attacks, and estimated 25-55k preventable deaths from those heart attacks. What's the cost of this damage? How much would you have to be paid to have a heart attack? Remember the target demographic of Vioxx, middle aged men with decent jobs that provide health insurance to be able to afford an expensive medication, is one of the most expensive demographics in terms of lost income from premature death. Between premature deaths and heart attacks, the actual cost of the Vioxx mistake could be $50-$100 billion in the US. Merck had spectacular lawyers and ended up settling for a fraction of that, but that's the nature of class-action settlements--the tortfeasor only ever pays pennies on each dollar of damage their products cause. The public bears the rest of those costs.
- loup-vaillant 14y ago
  > It's not a crutch. It's "we have textbook market failure A, which is alleviated by textbook government intervention B; we can remove the intervention, but we have to substitute one of the other textbook interventions suitable for addressing market failures." Oops. Of course. Thinking of patents as a form of government intervention enlarge the solution space. I was seeing a dichotomy (or spectrum) patent/no-patents, but I did not think about exploring other dimensions. > First, the FDA approval system is a major but not the biggest cost in getting a new drug to market. What are the biggest costs? Knowing that could determine the best course of action.
btilly 14y ago
What problem do you want to fix? If we do not want babies born with flippers in this country, then we need expensive approval tests. (Those who don't get the reference should look up thalidomide - which the FDA kept out of the USA.) Those currently cost an average of something like $150 million per drug. The temporary monopoly provided by patents lets us get those costs recouped. That said I don't think that pharmaceuticals are the poster child for patents. And in a comment on the blog I offered the example of using hookworm to treat Crohn's disease. The FDA has ruled that it would require their approval. But no patent is possible, and therefore nobody is trying to get it approved. And the result is that the most promising known treatment for hundreds of thousands of sufferers of Crohn's disease is, and will remain, illegal to even consider offering in the USA.
- loup-vaillant 14y ago
  I thought the FDA approval system where too big, inefficient, and didn't always addresses the right problems. I also thought solving this would significantly reduce costs, and therefore work towards removing the need for government intervention like patents. The other comments around here show that I was probably mistaken. We probably need the FDA as it is now (or close to that), and we probably need something else to compensate for FDA's unavoidable flaws, and the sheer difficulty of doing research. It just doesn't need to be patents.

deleted 14y ago

[deleted]