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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
(Score: 0) by Anonymous Coward on Friday May 12 2017, @11:28AM (2 children)
Isn't all government meddling bad? Free market, all drugs should be allowed until proven guilty by consumers not buying the stuff.
(Score: 0) by Anonymous Coward on Friday May 12 2017, @02:03PM
Hmmm, were there some snake oil sales-people back in your family tree?
(Score: 0) by Anonymous Coward on Friday May 12 2017, @04:42PM
I agree with the absurdity, but I think there's another side you might not be considering.
The FDA often approves drugs that end up ineffective or even dangerous. I think a lot of our protections tend to result in people, over time, gradually ceasing to think for themselves. This is dangerous since it can lead people who would otherwise behave responsibly to engage in unsafe behavior. The opiate 'epidemic' is probably the most clear of this. There are some people that might not be willing to smoke a joint, but feel safe and secure chugging down opioids after a minor injury because of the guise of safety around the whole show. Or people popping back xanax at the mildest mental discomfort again because of the same charade of safety around it all. 'It's legal so it must be safe.' And doctors have a huge conflict of interest here since they're supposed to inform patients to the best of their ability, but there's big bucks to be made pedaling these drugs.
People are seriously messing up their lives because they think because something is legal and regulated that it can't be so bad for you. I think we have the worst sort of regulation in that it seems, on the surface, to be effective yet we simultaneously have regulated organizations handing out opiates, drugs like xanax, and even antibiotics like they're candy. So people feel very secure, yet they're not.