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Showing content with the highest reputation on 09/29/21 in all areas

  1. Harry Binswanger has already made an airtight case against the FDA; go to him if you need one. Both links are damning, but don't completely overlap. Having said that, a quick visit to In the Pipeline this morning has provided two additional strikes against government control of medicine (and drugs in particular), although its author -- like most people today might -- merely hopes for reform of that unreformable, illegitimate agency. Having already expressed outrage that the agency's questionable approval of adcuanumab, a very expensive Alzheimer's drug, Derek Lowe notes some interesting fallout. I think it is more interesting than he does, especially the following:Image by Myriam Zilles, via Unsplash, license.Out in the health-insurance world, which is where any such drug launch is really going to play out, many large insurance companies are holding back on approval for payment or have said outright that they will not cover the drug. They are understandably concerned about the possibility of paying for a treatment in a huge population with a $56,000/patient/year price tag that will leave its recipients exactly as sick as they were before (if not somewhat more injured, frankly)... [bold added]Private industry to the rescue! you might hopefully add, as I did. Indeed, insurance companies might well perform safety and efficacy testing if there weren't an FDA -- and you can already see here that the profit motive would stop an ineffective drug from getting the de facto seal-of-approval of being deemed worthy of insurance coverage. Strike One was the garbage drug approval. Yes. The FDA shouldn't even be at bat: People should be free to take snake oil if they want, just as insurance companies should be free not to cover it. But it's there. Here's the next pitch, and it comes in the next few sentences of that same paragraph:... The Veteran's Health Administration is doing the same, saying that there's not enough evidence of benefit. Many of these organizations say that they're waiting on a decision from Medicare, but that's a confusing situation, too. The Centers for Medicare and Medicaid Services has recently advised state that their Medicaid programs must include it as a covered outpatient drug. It's the national Medicare determination that everyone's really waiting on, though. [bold added]So a questionable approval of a dubious drug by the FDA might -- despite free-market elements of our economy acting as a partial backstop -- still put everyone on the hook to pay for it. Strike Two. Aducanumab should be a last-ditch drug (or high-end snake oil) for the wealthy, but it might about to be normalized at everybody's expense, instead. And here's Strike Three:[O]n the regulatory side, this decision has been a mud bomb: rare-disease companies are wondering why they're being asked for more data when Biogen wasn't, and other companies with vague, not-really-statistically-significant Alzheimer's data are lining up to get their approvals on this basis as well. This is not a precedent the agency should have set.So much for the whole damned idea that the free market needs government to set safety standards and prevent fraud. Abolish the FDA. -- CAVLink to Original
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