Recently, my friend Mike from back in high school sent me a link to an editorial in the Washington Post, "Why we may never know whether the $56,000 Alzheimer's drug actually works." It was written by Elizabeth Rosenthal, author of An American Sickness. She makes the case that, because of the nature of the FDA's provisional approval system and the chronic nature of Alzheimer's disease, Biogen may simply never be able to complete a credible testing process for Aduhelm.
Biogen is committed to years of further testing as a condition of the approval. So here's one question: How do you recruit people for the new drug trials required by the FDA's process? People interested in the drug can already get it -- if they can get their insurance to pay for it. So why should anyone volunteer for the drug trial knowing they could draw the short straw and spend years on the placebo? If another, better treatment is approved, opting for that treatment means you will be removed from the Aduhelm trial.
Rosenthal notes that the accelerated approval process the FDA used for aducanumab has been applied to some cancer treatments in the past, and the FDA considers these efforts to have been wisely chosen. This accelerated process is only used in situations where the disease in question is grave, and there is no alternative treatment. In the case of the cancers in question, the diseases progress relatively rapidly, and you get a decisive answer to the question of efficacy quickly enough. But for Alzheimer's disease? The time frame for a convincing trial stretches out over a time period when the patient's health is likely deteriorating from multiple causes.
Anger toward Biogen and the FDA has been growing ever since the approval of Aduhelm was announced. Two House committees have already announced their intentions to investigate both Biogen and the FDA. My sense is that the situation will become increasingly unpleasant for all involved.
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