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"Open Source" Drug Development Company Launched 140

First time accepted submitter awjourn writes "During his years working in pharma R&D, Tomasz Sablinski was frustrated by the industry's need for secrecy and its utter inability to design patient-friendly drug trials. So he founded Transparency Life Sciences, a company that's developing three drugs based on input from patients and physicians, who log onto the company's site and voice their opinions about how drugs should be designed and tested."
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"Open Source" Drug Development Company Launched

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  • Careful... (Score:4, Insightful)

    by pspahn ( 1175617 ) on Thursday February 23, 2012 @11:09PM (#39143693)

    Open sourcing things like education, arts, and soft/hardware is one thing. Messing with the pharmaceutical companies is entirely another.

    I wish them luck.

  • Re:Careful... (Score:5, Insightful)

    by Rich0 ( 548339 ) on Thursday February 23, 2012 @11:29PM (#39143805) Homepage

    Nobody is going to sue them. They'll do just fine when it is just a few low-paid workers working on concepts - that is the cheap part and it is done by all kinds of start-ups/etc.

    Eventually they'll get all excited that they have the next cure for cancer and there will be newspaper articles about how it kills cancer cells in a test tube. That probably happens every other week in some lab somewhere across the country. The big question is - does it work in people, and does it have some nasty side-effect? This is a relatively simple question to answer - you just need to kill a few hundred lab rats first (hmm, suddenly operation "Transparency" is either keeping very quiet about this or they're going to be protested into oblivion). Then, if the lab rats do reasonably well you start doing clinical trials.

    How do clinical trials work? Simply, you throw a lot of money at a lot of doctors to convince them to take the time to suggest to their patients that the drug might help them. Some doctors will follow the protocol and collect good data. Other doctors will try to get anybody then can find to take the drug whether or not they're a good candidate per the protocol and collect extra fees, and they'll add lots of noise to your data. After you repeat this a few thousand times you'll have run through tens of millions of dollars - mostly spent on getting doctors to participate (most of the patients don't get much of anything), and to some extent on clinical testing (though you don't have to pay lab techs nearly as much as independent doctors.

    When that's all done the answer will come back that it doesn't work at all, and you've just wasted $20M. So, you start all over again and burn through another $20M, and then do that another 5-10X until you get lucky. That is assuming somebody keeps dishing out that kind of cash for you to operate. Once you get through all that you can go ahead and put your drug on the market. At that point anybody who gets the sniffles when they take it will probably try to sue you, but assuming you're charging $5/pill you can probably still make a good profit. Of course, then everybody calls you a sellout and talks about how cheap drugs are to make and that some Indian company can do it for 5 cents a pill. Naturally the Indian company didn't fork out $20M 10X over 5-7 years trying to get it right, so its expense base is way lower. Or, you can sell it cheap if the people who forked over the original $200M didn't care to make a profit. More power to them if they can find that kind of money - I think it is probably the future of drug development (though likely with governments paying the bill - right now they almost never pay for trials since they aren't really all that innovative).

    Lots of companies discover drugs - including some start-ups that have grown into major companies in the last 15 years. The reason nobody has come out with a brand new medication that costs the same as Tylenol isn't because there is some grand conspiracy. The problem is that the success rate is low, and the cost of clinical trials is very high.

    I don't really see the comparison with open source software. It sounds like they're taking suggestions, which is nice, but it isn't like anybody can just whip up some pills in their garage, test them out on homeless people, and report in if they work OK.

  • by postglock ( 917809 ) on Thursday February 23, 2012 @11:48PM (#39143899)
    Despite the claims on their website that "Transparency Life Sciences is the world’s first drug development company based on open innovation", the Open Source Drug Discovery [] group (based in India) has been doing this for over three years now, focusing on tuberculosis. I'm also aware of "Open Source Drug Discovery for Malaria".
  • Re:Careful... (Score:5, Insightful)

    by ozmanjusri ( 601766 ) <aussie_bob@[ ] ['hot' in gap]> on Thursday February 23, 2012 @11:48PM (#39143901) Journal

    Nobody is going to sue them.

    Suing will be the least of their problems.

    They'll be subject to huge FUD and smear campaigns from the get go, have supply and distribution channels blocked, approvals refused and so on ad nauseum.

    It's a shame, but efforts like this to open up our society scare the hell out of governemnt and business interests.

  • by Okian Warrior ( 537106 ) on Thursday February 23, 2012 @11:50PM (#39143909) Homepage Journal

    When that's all done the answer will come back that it doesn't work at all, and you've just wasted $20M. So, you start all over again and burn through another $20M, and then do that another 5-10X until you get lucky.

    Yep. It definitely won't work, because we know that things never change and there's no other possible way that things can be done. You probably didn't think Wikipedia was a good idea either.

    It's obvious that the current system is flawed, and easily argued that the system is ineffective. We need other options.

    You're unwilling to try new approaches, and you don't think anything will come of it. Fine, you're welcome to your opinion.

    But we need change. We need it so much in so many different areas that we're willing to give up a tiny bit of safety to take a chance on something better. The chances of going bankrupt because of an idiot doctor, an inattentive nurse, or a heartless insurance company are so high that the risk/reward equation is heavily tipped in the other direction.

    Doctors are allowed to try experimental treatments on their own patients. I see no reason why an open-source drug company couldn't partner with some meticulous and well-meaning doctors who are willing to try something different on the off-chance that it works out.

    With full knowledge and consent of the patient, I don't see anything wrong with this.

    And that's just off the top of my head. I'm sure there are other approaches to be taken...

    But we won't know unless we try them.

  • Re:Careful... (Score:5, Insightful)

    by Charliemopps ( 1157495 ) on Friday February 24, 2012 @12:50AM (#39144173)
    "Or, you can sell it cheap if the people who forked over the original $200M didn't care to make a profit."
    GlaxoSmithKline Pharmaceuticals makes over $8 billion dollars a year on 1 drug alone... Advair.
    It's $450 for a 30day supply.
    Their patent has run out, but they either sue or bribe the FDA into scuttling any efforts of anyone that attempts to make a generic.
    Of course, there's a generic in India that sells for $30/month
    I literally can not breath without taking this.

    So, I agree... they should make a profit. I don't even want the drug to be "cheap"
    But is $8 billion a year enough profit? Would it hurt them if it were only... I dunno... 2 Billion?
    And I don't want it for free... but $450? Really? Could be do it for $100? I don't need the fancy box it comes in... or to hear all those ads... the dispenser is right out of startrek. Dumb it down a bit. I just want to be able to afford to breath again.

    You're already Rich as fuck GlaxoSmithKline. You've got swimming pools full of money. Please... price your drug back down out of the "Holy fucking shit" range so I can breath again... or at least let someone else do it for you.
  • by Z34107 ( 925136 ) on Friday February 24, 2012 @01:13AM (#39144273)

    Yep. It definitely won't work, because we know that things never change and there's no other possible way that things can be done

    There's "no other possible way that things can be done" because most of them are illegal. Unless you want to get rid of the only part of the FDA's mandate it can actually carry out with any efficacy.

  • Re:Careful... (Score:3, Insightful)

    by pepty ( 1976012 ) on Friday February 24, 2012 @04:30AM (#39145001)
    Over the past ~fifteen years the big pharma companies spent 4 to 12 billion dollars on R and D per approved drug.

    No, that does not include marketing; Pharma companies would much rather have their marketing dollars recognized as such every quarter, they're not going to bury that budget in research.

    Prices are set at absolutely the highest prices the market will bear, but that's true in pretty much every market, even ones without giant sunk costs.

    The marketing more than pays for itself in higher sales; they wouldn't do it otherwise. The big cash sink for Pharma companies is stock buybacks: over the past decade their research efforts have failed so often that they've basically admitted that buying their own stock is a better way for them to compensate their CEOs, er, I mean protect shareholder value.

    The main difference between pharma and every other business is just that business as usual becomes absolutely asinine when people's health is involved.

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