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Free-market folks could argue: what's the point of the FDA here? The organizations that bear the cost of the medicine have decided that there isn't enough evide
by axg11 5y ago
Free-market folks could argue: what's the point of the FDA here? The organizations that bear the cost of the medicine have decided that there isn't enough evidence of benefit from Aduhelm and further clinical evidence is required.
Perhaps the FDA's involvement should stop at Phase 2? Allow the free market to decide whether the clinical trial and efficacy results are sufficiently positive. The current setup encourages Pharma companies to design trials for the purpose of gaming the FDA.
- refurb 5y agoThe FDA decides if it’s safe and effective. Payers determine if it’s worth the money. Not sure your point?
- clcaev 5y ago> Payers determine if it's worth the money. As I understand, Medicare (Part B) pays "market rate" for this drug and cannot act as an independent payer and negotiate, yet, they seem as the primary market? This market price would be set by the secondary, and much smaller, market of private payers.
- rayiner 5y agoThey aren’t the primary market. Except for drugs used in hospitalizations and certain other settings, Medicare itself doesn’t cover drugs. Drug coverage is under Part D plans offered through private insurers, who do negotiate prices. The goal is to have a many-to-many market. When you have a one buyer to many seller market, you open yourselves up to monopsony, which can drive prices below the efficient level.
- axg11 5y agoMy point (a view shared by the article and many others) is that the FDA decided Aduhelm is safe but did a terrible job of deciding that it is effective. Safety is also not absolute. All medicines have adverse effects, safety is then relative to the benefits of the medicine.
- refurb 5y agoAccelerated approvals are just that - accelerated and don't require the same standard of proof of efficacy. Just like Avastin for Breast Cancer - it got accelerated approval, turned out it didn't work, so approval was recinded. The goal is to give patients access to potentially effective medications. They do this because people bitch when the FDA says "no".