6 ms·

Why do you think software business model can't be applied to drug development? On of the biggest problem with drug research is that it's highly regulated by go

by esspem 16y ago

Why do you think software business model can't be applied to drug development? On of the biggest problem with drug research is that it's highly regulated by government, so it's too costly for a small startup. Remove this regulations and you'll get a software-like situation with thousands of startups and new drugs. e.g. read this: http://daniellefong.com/2010/02/11/how-law-shapes-the-business-landscape-and-a-patent-puzzle/ http://daniellefong.com/2010/02/11/how-law-shapes-the-busine...

barmstrong 16y ago
Exactly what I was thinking....the main reason drug development cost all those millions (and I believe about 10 years on average) is the FDA. We should be careful not to let one mistake justify another.
hugh3 16y ago
While the current FDA system may be overkill, do you really want the market flooded with new drugs whose effects aren't well understood?
- cousin_it 16y ago
  That depends on whether you prefer to die from taking an untested drug or die because the drug isn't invented yet. A severely ill person would probably prefer a chance of the former to the certainty of the latter. Also you have to account for the odds of both these events: which one do you think will happen more?
  - ErrantX 16y ago
    That's something of a straw man though. Because the vast majority of people taking drugs aren't dying. If new drugs created in the deregulated industry were only given to terminal cases as a last resort it might work; otherwise it is just endangering everyone else (taking drugs).
    - cousin_it 16y ago
      Nobody's endangering you. You're free to take only drugs approved by the newly private FDA Corp.
      - ErrantX 16y ago
        And how do you objectively decide which ones are safe and which have been tested sufficiently to your requirements? As an individual deciding a drug is safe to use should not require you to read all the relevant research etc. - you need a safe, objective marker. i.e. law and regulation.
        esspem 16y ago
        You will decide it because of mark "FDA approved" (or any other drug testing agency you trust) on the drug.
        ErrantX 16y ago
        And how do you trust those commercial, unregulated, agencies?
        jerf 16y ago
        I measure "trust" by actions, not words. When you buy a product, you aren't just saying you trust it, you are trusting it. Trust is a verb, not a state of being. Unless you are very unusual and are completely off the grid, you've probably solved the question of how you personally decide how to trust a wide variety of commercial agencies of highly varying degrees of regulation and highly varying degrees of life-threateningness. Possibly without realizing it. In theory it may be unsolvable, in practice it doesn't seem to be. It should be pointed out that this isn't theoretical, either. People die because the FDA forces them to not take drugs, even when death is essentially assured in the short-term anyhow. It's a well-known problem. If the FDA was more advisory, I suspect it would be a net good. I really can't imagine people en masse running down to WalMart and buying Dangerousol (now with twice the danger!) any more than they manage to now. (Which you can't ignore either, the FDA is not perfect.)
  - hugh3 16y ago
    Quite right. My statement was based on my judgement that I (or perhaps other individuals less circumspect than myself) am more likely to die from an inadequately tested drug than from the lack of a drug which would have been invented in an FDAless free-for-all. Or another scenario: maybe the drug to treat my disease has been invented, but nobody knows about it because it hasn't been properly tested and is competing with thirty other startup drugs (mostly useless, some harmful) which claim to treat the same disease. How is my doctor supposed to magically know which one to prescribe me?
    - dantheman 16y ago
      The FDA also tests for effectiveness so if a drug isn't effective enough then it doesn't get through.
    - esspem 16y ago
      Do not use inadequately tested drugs, buy only FDA approved drugs. Why do you want to forbid other people to buy drugs not approved by FDA?
- esspem 16y ago
  Do you really want the market flooded with new software, whose effects aren't well understood? You can find effective software despite almost no government regulation, why do you think it won't work for drugs? I'm sure a lot of private rating agencies evolve in the such free market of drugs.
  - praptak 16y ago
    There's a lot of totally crappy software on the market. The key difference is that you can try a better application after getting burned by a bad one. Not necessarily so with drugs - they can do unrecoverable damage.
    - esspem 16y ago
      You can use only drugs approved by FDA, nothing would change for you in "no regulation" market.
      - th 16y ago
        I think this shift in policy would require an enormous cultural shift. Currently, our society mostly trusts the drugs available on our store shelves. A deregulated market would require consumers to be much more critical in order to continue to function.
  - dustingetz 16y ago
    software doesn't kill people
    - pbhjpbhj 16y ago
      Tell that to Toyota.
    - dustingetz 16y ago
      should i revise to iphones don't kill people?
ErrantX 16y ago
Woah. I'm a big advocate of deregulation of many things but doing it to drugs seems a very dangerous idea. In the first place these are things that can seriously affect your health - it makes sense to demand these are tested before they can be sold to people. Secondly it would give more credence to the anti-drugs and pseudo-medicine movements. At the moment at least the govt. agencies can make a decision on if a drug is safe or not; with that out of the way it becomes even more of a PR war. :D (additionally I would argue that the bar for entry into drugs research is higher than it is into software development, I don't think you could evolve an environment as diverse and self sustaining as the software world)
- dantheman 16y ago
  You seem to discount the amount of people that are dying due to the slow development cycle of drugs. If there was regulation there would be more experimentation, perhaps more people would die from the effects of new drugs -- but you could choose to only use drugs that have been stable and well studied while those who have nothing left to lose could use medicine directly off the chemists work bench.
  - thaumaturgy 16y ago
    You seem to discount the number of people that think homeopathics are an effective medicine.
  - ErrantX 16y ago
    > perhaps more people would die from the effects of new drugs I'd argue this is almost certainly a given. But the problem is not those who die now - but those who are taken ill much later down the line. Ten years or whatever. > but you could choose to only use drugs that have been stable and well studied while those who have nothing left to lose could use medicine directly off the chemists work bench. I entirely agree with the sentiment there (it would be great to see the wider liberalisation and faster iteration of new drug trials for example). but (and I feel this is a big caveat) how do people decide which drug is stable and well studied. It is not necessarily sufficient to trust the pamphlet or advertising the company gives you. I don't know. Maybe it is cynicism but I suspect that if drug research were deregulated the standard of drugs produced would decline rapidly. And finally; I am not so sure drugs research would explode with innovation. We would get drugs to market faster, sure, but there is a standard of entry into drug research that still requires funding, education and resources.
Locke1689 16y ago
Uhh no. The biggest problem with drug research is the ridiculously high amount of initial capital it takes to develop a drug. You can't just throw out buzzwords like "startups" and "software" like they're a panacea.
- esspem 16y ago
  I think you are wrong. There are a lot of small pharmaceuticals startups. http://www.newsobserver.com/2010/04/14/436028/drug-startup-arbor-is-sold.html http://www.newsobserver.com/2010/04/14/436028/drug-startup-a... http://www.facebook.com/group.php?gid=2355897150 http://www.facebook.com/group.php?gid=2355897150 http://industry.bnet.com/pharma/10006932/biotech-start-up-flexion-takes-the-stodgy-out-of-big-pharma-rd/ http://industry.bnet.com/pharma/10006932/biotech-start-up-fl...
  - Locke1689 16y ago
    There isn't actually a single company that has succeeded in bringing drug development under millions of dollars in that list. The closest is the last one, but that company hasn't actually produced any results yet.

by esspem 16y ago

barmstrong 16y ago

Exactly what I was thinking....the main reason drug development cost all those millions (and I believe about 10 years on average) is the FDA. We should be careful not to let one mistake justify another.

hugh3 16y ago

While the current FDA system may be overkill, do you really want the market flooded with new drugs whose effects aren't well understood?

cousin_it 16y ago
That depends on whether you prefer to die from taking an untested drug or die because the drug isn't invented yet. A severely ill person would probably prefer a chance of the former to the certainty of the latter. Also you have to account for the odds of both these events: which one do you think will happen more?
- ErrantX 16y ago
  That's something of a straw man though. Because the vast majority of people taking drugs aren't dying. If new drugs created in the deregulated industry were only given to terminal cases as a last resort it might work; otherwise it is just endangering everyone else (taking drugs).
  - cousin_it 16y ago
    Nobody's endangering you. You're free to take only drugs approved by the newly private FDA Corp.
    - ErrantX 16y ago
      And how do you objectively decide which ones are safe and which have been tested sufficiently to your requirements? As an individual deciding a drug is safe to use should not require you to read all the relevant research etc. - you need a safe, objective marker. i.e. law and regulation.
      - esspem 16y ago
        You will decide it because of mark "FDA approved" (or any other drug testing agency you trust) on the drug.
        ErrantX 16y ago
        And how do you trust those commercial, unregulated, agencies?
        jerf 16y ago
        I measure "trust" by actions, not words. When you buy a product, you aren't just saying you trust it, you are trusting it. Trust is a verb, not a state of being. Unless you are very unusual and are completely off the grid, you've probably solved the question of how you personally decide how to trust a wide variety of commercial agencies of highly varying degrees of regulation and highly varying degrees of life-threateningness. Possibly without realizing it. In theory it may be unsolvable, in practice it doesn't seem to be. It should be pointed out that this isn't theoretical, either. People die because the FDA forces them to not take drugs, even when death is essentially assured in the short-term anyhow. It's a well-known problem. If the FDA was more advisory, I suspect it would be a net good. I really can't imagine people en masse running down to WalMart and buying Dangerousol (now with twice the danger!) any more than they manage to now. (Which you can't ignore either, the FDA is not perfect.)
- hugh3 16y ago
  Quite right. My statement was based on my judgement that I (or perhaps other individuals less circumspect than myself) am more likely to die from an inadequately tested drug than from the lack of a drug which would have been invented in an FDAless free-for-all. Or another scenario: maybe the drug to treat my disease has been invented, but nobody knows about it because it hasn't been properly tested and is competing with thirty other startup drugs (mostly useless, some harmful) which claim to treat the same disease. How is my doctor supposed to magically know which one to prescribe me?
  - dantheman 16y ago
    The FDA also tests for effectiveness so if a drug isn't effective enough then it doesn't get through.
  - esspem 16y ago
    Do not use inadequately tested drugs, buy only FDA approved drugs. Why do you want to forbid other people to buy drugs not approved by FDA?
esspem 16y ago
Do you really want the market flooded with new software, whose effects aren't well understood? You can find effective software despite almost no government regulation, why do you think it won't work for drugs? I'm sure a lot of private rating agencies evolve in the such free market of drugs.
- praptak 16y ago
  There's a lot of totally crappy software on the market. The key difference is that you can try a better application after getting burned by a bad one. Not necessarily so with drugs - they can do unrecoverable damage.
  - esspem 16y ago
    You can use only drugs approved by FDA, nothing would change for you in "no regulation" market.
    - th 16y ago
      I think this shift in policy would require an enormous cultural shift. Currently, our society mostly trusts the drugs available on our store shelves. A deregulated market would require consumers to be much more critical in order to continue to function.
- dustingetz 16y ago
  software doesn't kill people
  - pbhjpbhj 16y ago
    Tell that to Toyota.
  - dustingetz 16y ago
    should i revise to iphones don't kill people?

ErrantX 16y ago

Woah. I'm a big advocate of deregulation of many things but doing it to drugs seems a very dangerous idea. In the first place these are things that can seriously affect your health - it makes sense to demand these are tested before they can be sold to people. Secondly it would give more credence to the anti-drugs and pseudo-medicine movements. At the moment at least the govt. agencies can make a decision on if a drug is safe or not; with that out of the way it becomes even more of a PR war. :D (additionally I would argue that the bar for entry into drugs research is higher than it is into software development, I don't think you could evolve an environment as diverse and self sustaining as the software world)

dantheman 16y ago
You seem to discount the amount of people that are dying due to the slow development cycle of drugs. If there was regulation there would be more experimentation, perhaps more people would die from the effects of new drugs -- but you could choose to only use drugs that have been stable and well studied while those who have nothing left to lose could use medicine directly off the chemists work bench.
- thaumaturgy 16y ago
  You seem to discount the number of people that think homeopathics are an effective medicine.
- ErrantX 16y ago
  > perhaps more people would die from the effects of new drugs I'd argue this is almost certainly a given. But the problem is not those who die now - but those who are taken ill much later down the line. Ten years or whatever. > but you could choose to only use drugs that have been stable and well studied while those who have nothing left to lose could use medicine directly off the chemists work bench. I entirely agree with the sentiment there (it would be great to see the wider liberalisation and faster iteration of new drug trials for example). but (and I feel this is a big caveat) how do people decide which drug is stable and well studied. It is not necessarily sufficient to trust the pamphlet or advertising the company gives you. I don't know. Maybe it is cynicism but I suspect that if drug research were deregulated the standard of drugs produced would decline rapidly. And finally; I am not so sure drugs research would explode with innovation. We would get drugs to market faster, sure, but there is a standard of entry into drug research that still requires funding, education and resources.

Locke1689 16y ago

Uhh no. The biggest problem with drug research is the ridiculously high amount of initial capital it takes to develop a drug. You can't just throw out buzzwords like "startups" and "software" like they're a panacea.

esspem 16y ago
I think you are wrong. There are a lot of small pharmaceuticals startups. http://www.newsobserver.com/2010/04/14/436028/drug-startup-arbor-is-sold.html http://www.newsobserver.com/2010/04/14/436028/drug-startup-a... http://www.facebook.com/group.php?gid=2355897150 http://www.facebook.com/group.php?gid=2355897150 http://industry.bnet.com/pharma/10006932/biotech-start-up-flexion-takes-the-stodgy-out-of-big-pharma-rd/ http://industry.bnet.com/pharma/10006932/biotech-start-up-fl...
- Locke1689 16y ago
  There isn't actually a single company that has succeeded in bringing drug development under millions of dollars in that list. The closest is the last one, but that company hasn't actually produced any results yet.