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posted by martyb on Friday May 12 2017, @03:50AM   Printer-friendly
from the cheques-and-balances dept.

Dr. Lowe, from In the Pipeline, writes of how the efficacy requirements of the FDA save US taxpayers money:

Remember solanezumab? That was the amyloid-targeting antibody that Eli Lilly kept on investigating in trial after trial, looking for some effect on Alzheimer’s. Last November, the final, final word finally came down that it really, truly, does not work. To recap, mouse model results with a similar antibody were published in 2001. Phase I results of solanezumab itself were published in 2010, and Phase II results were published in 2012.

The authors of the NEJM [New England Journal of Medicine] paper would like to point out that under the current system, the cost of investigating all this was largely borne by the drug’s developers, not the patients and not the taxpayers

[...] Under a system designed to speed up drug approvals, people might have started taking it back in 2010-2012, when the Phase I and II results showed no adverse effects.

[...] We have a very tightly regulated and opaque market indeed in this country for prescription drugs and every other form of health care, and it’s not a very good place to discover prices or utilities. You could imagine a system where these things could be done better than we’re doing them, but such a system would be pretty far from what we have going now.

[...] The NEJM paper estimates, pretty conservatively, that had solanezumab been given conditional approval back in 2012 or so, that we – meaning Medicare, for the most part, which is to say all taxpayers, but also insurance companies and patients – would have spent at least ten billion dollars injecting Alzheimer’s patients with an expensive placebo. No one would have gotten the tiniest bit better. False hope all around, with no benefit, and billions of dollars down the tubes.

Note: Bold added by submitter.

http://blogs.sciencemag.org/pipeline/archives/2017/05/09/there-are-failures-you-know
http://www.nejm.org/doi/full/10.1056/NEJMp1701047
https://en.wikipedia.org/wiki/Solanezumab
https://en.wikipedia.org/wiki/Alzheimer%27s_disease
https://soylentnews.org/article.pl?sid=16/11/27/0147228
https://soylentnews.org/article.pl?sid=17/02/16/0116248


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  • (Score: 2, Troll) by frojack on Friday May 12 2017, @03:59AM (9 children)

    by frojack (1554) on Friday May 12 2017, @03:59AM (#508457) Journal

    How did you manage to turn this into a political rant?

    Are you seeing a doctor about your rage-hate issue?

    --
    No, you are mistaken. I've always had this sig.
    Starting Score:    1  point
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  • (Score: 3, Insightful) by Whoever on Friday May 12 2017, @04:02AM (5 children)

    by Whoever (4524) on Friday May 12 2017, @04:02AM (#508458) Journal

    So you are not concerned about Trump's stated desire to stop the FDA from reporting on the effectiveness of drugs?

    This is a great story abut the FDA saving Americans billions of dollars, yet we know that this administration wants to prevent the FDA from performing this type of assessment.

    You don't think that there is a political issue here?

    • (Score: 0, Troll) by frojack on Friday May 12 2017, @04:19AM (2 children)

      by frojack (1554) on Friday May 12 2017, @04:19AM (#508466) Journal

      yet we know that this administration wants to prevent the FDA from performing this type of assessment.

      You know exactly what the liberal press wants you to know.
      You really should see a doctor about that hate issue you have.

      --
      No, you are mistaken. I've always had this sig.
      • (Score: 2) by Whoever on Friday May 12 2017, @04:54AM

        by Whoever (4524) on Friday May 12 2017, @04:54AM (#508478) Journal

        So are you claiming that I am wrong?

        Or do you think that an snarky comment will further your point of view?

      • (Score: 3, Insightful) by aristarchus on Friday May 12 2017, @05:16AM

        by aristarchus (2645) on Friday May 12 2017, @05:16AM (#508490) Journal

        I don't know, frojack. I can't recall. Hmm.

    • (Score: 2) by JoeMerchant on Friday May 12 2017, @02:30PM (1 child)

      by JoeMerchant (3937) on Friday May 12 2017, @02:30PM (#508624)

      The FDA just prevented Abbot labs from collecting ten billion dollars to offset the costs of their research on this drug over the past 16+ years. They prevented the release of a mostly harmless, potentially helpful agent into the market to allow the market to decide for itself whether or not it is worth tens of thousands of dollars to try to bring their senile partners, parents and friends back from Alzheimers.

      On the flip-side, yes, it probably has a success rate no better than sugar pills, and, if Abbot were permitted to market the sugar pills at the same price as the failed drug it would probably do more good than marketing the "mostly harmless" drug to a desperate public willing to try anything.

      So, the question is: should we allow big businesses like Abbot to risk billions trying to develop drugs like this, or are they "too big to fail" - should the taxpayers and/or public be placed in the position of bailing out big drug companies that go this far down the rabbit hole pursuing an ineffective drug?

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      • (Score: 0) by Anonymous Coward on Friday May 12 2017, @04:53PM

        by Anonymous Coward on Friday May 12 2017, @04:53PM (#508713)

        ...potentially helpful...

        Do you know how I know you didn't even read the headline, let alone the summary of the article?

        So, the question is: should we allow big businesses like Abbot to risk billions...

        Um, that's what business is.

        ...should the taxpayers and/or public be placed in the position of bailing out big drug companies...

        NO. (This needs to be in 72 point font, but sadly there's no way to do that on this site. Actually, this needs to be visible from space, and by visible from space I mean visible from the other side of the known universe with nothing more than a cheap toy telescope.) Taxpayers should NEVER be forced to bail out ANY company, bank, or any other organization for that matter. They made their bed, they get to sleep in it. If not bailing them out crashes the economy, it shows that the economy was defective and needed fixing or replacing anyway. When it gets rebuilt, perhaps people will learn from their mistakes (sadly it seems everyone has forgot the great depression already) and prevent these entities from getting so large in the future.

        "too big to fail"

        That's an idea created by the big business cock-suckers on capitol hill in order to justify their continued welfare payments to banks and corporations. (Republicans aren't anti-welfare, they're anti-people. Welfare is completely fine as long as it's going to a business and not a person.) It exists in the same realm as the easter bunny, the tooth fairy, and unicorns that shit rainbows and piss happiness.

  • (Score: 0) by Anonymous Coward on Friday May 12 2017, @04:15AM (2 children)

    by Anonymous Coward on Friday May 12 2017, @04:15AM (#508465)

    Are you seeing a doctor about your rage-hate issue?

    I was, but the doctor diagnosed an incurable personality disorder, and then gave up on me.

    • (Score: 0) by Anonymous Coward on Friday May 12 2017, @08:16AM

      by Anonymous Coward on Friday May 12 2017, @08:16AM (#508536)

      Don't worry. The next doctor will simply prescribe you an ineffective drug and keep you coming back for checkups until you or your insurance (if you still have it) will no longer pay.

    • (Score: 2) by JoeMerchant on Friday May 12 2017, @04:00PM

      by JoeMerchant (3937) on Friday May 12 2017, @04:00PM (#508670)

      >>Are you seeing a doctor about your rage-hate issue?

      >I was, but the doctor diagnosed an incurable personality disorder, and then gave up on me.

      Happens all the time, it's bad for drug sales - we need to teach these doctors to keep trying.

      --
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