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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) by c0lo on Friday May 12 2017, @06:41AM

    by c0lo (156) Subscriber Badge on Friday May 12 2017, @06:41AM (#508519) Journal

    At least two of those do masquerade as medicine for consumption.

    I have no problems with them existing on the market, as long as they are not advertised as medicine or prescribed by medicine doctors.

    Why not on watered down medicine? Why not herbs sold as medicine?

    As I said above, as long as it is not sold or prescribed as medicine or advertised as "clinically proven to...", I have no problem with them existing on the market without FDA having to spend a cent on their efficacy.
    They can even use the "may help in x/y/z" on their labels.

    You see, I'm OK to use baths with Epsom salts for (post-effort) muscular pain relief and hawthorn berries as a coronary and periphery vasodilator: true, they aren't certified for human treatment (only recommended for horses [horseandhound.co.uk]) but I found they work to the same effects on me (and I'm making no recommendations here for any other humans, YMMV).
    Banning them will make me unhappy!

    --
    https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
    Starting Score:    1  point
    Karma-Bonus Modifier   +1  

    Total Score:   2