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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 Soylentbob on Friday May 12 2017, @05:29AM

    by Soylentbob (6519) on Friday May 12 2017, @05:29AM (#508496)

    Wouldn't that dilute the term "medicine"? Consumers should be informed that "medicine" means FDA approved, and FDA approved means proven to be effective and reasonably safe (a cancer-drug is IMO reasonably safe if it really eradicates the cancer but causes a 10 percent chance of developing diabetes a decade later. A cough syrup with the same side-effect is not *reasonably* safe.

    If consumer want to buy Homeo-, Naturo- or Psychopathy-products, snake oil, ape excrement, sugar-water, powdered beetle or dried weeds, they can do that, if they are uncertain if it is a medical product or not, they learn to look for the term "medicine".

    Consumer protection laws just have to ensure that there are certain protected classifications. "Medicine" means well-tested, effective, relatively safe, FDA approved. "Food" means harmless to eat, not sure if in US any approval is required, but vendor is liable that the product is in reasonable amounts safe for consumption. Everything else means, put it in any orifice you want, swallow it if you want, but on your own risk, and if you do it to your child and put your child at risk, you go to jail.

    Starting Score:    1  point
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