$8,300, a far cry from the $56,000 the company is seeking. The institute charged that the FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms.” It estimated that Biogen could rake in “well in excess of $50 billion per year” while waiting for evidence to confirm that patients were actually benefiting. The FDA’s approval process itself was rife with ethical conflicts . In one highly improper move, a top FDA official held an off-the-record meeting with a key Biogen executive in 2019, apparently violating long-standing rules and practices designed to keep the approval process transparent and unbiased. The revelation by the medical news site STAT caused such an uproar that the acting head of the agency felt obliged to ask the inspector general of the Department of Health and Human Services to investigate the circumstances that led to the drug’s approval. That inquiry is not yet complete, but the emerging evidence suggests an overly cozy relationship between the regulators and the industry. On September 1, two House committees launched a joint investigation into the appropriateness of the FDA’s handling of Alduhelm. This sorry saga has left me wondering whether the accelerated approval process itself might be considered an unethical approach to regulating a drug whose clinical value is so uncertain and
approval process often gives companies a “commercial end run” around FDA regulation. The companies are required to do further controlled studies to verify the drug’s clinical benefit. If the results are negative, the FDA may withdraw its approval, but it does not have to and often fails to. The agency gave Biogen nine years, until 2030, to complete follow-up studies on Aduhelm. So, the company will continue to earn tens of billions a year on a drug whose clinical value might never be proven. The approval of Aduhelm was welcomed by the Alzheimer’s Association, an advocacy group for patients and their families, which complained only about the high price tag because it would make it unaffordable for many patients. However, the association has its own ethical issues ; it receives funding from the drug industry and from Biogen itself. One top geriatrician considers the association “a big promoter, almost a marketer, for Biogen.” Experts have proposed several ways to force down exorbitant drug prices. These include revising the formula that determines what Medicare pays for drugs, allowing the national insurance program to negotiate lower drug prices, and tying prices in this country to the lower prices charged abroad. One intriguing idea is to have the Centers for Medicare and Medicaid Services initiate a process that could require companies and prescribing physicians, as a condition for reimbursement, to provide continuing data on their patients that could be compared with a comparable group of patients that did not receive Aduhelm. That could provide useful information even if Biogen’s required clinical trials are never completed. Another potentially important reform, suggested by Peter Bach, would limit manufacturers to a ten percent profit over the cost of manufacturing and distributing the drug, thus providing a reasonable return without allowing companies to charge what the market will bear based on hope and wishful thinking. None of these proposals may come to pass or, if enacted, prove effective. But surely, they are worth a try. Desperate patients deserve access to the best available treatments, but the price has to be affordable for patients and the American healthcare system. l PHIL BOFFEY is former deputy editor of the New York Times Editorial Board and editorial page writer, primarily focusing on the impacts of science and health on society. He was also editor of Science Times and a member of two teams that won Pulitzer Prizes The views and opinions expressed are those of the author and do not imply endorsement by the Dana Foundation.
whose ability to slow mental decline will be hard to measure. Once the drug is on the market, it will be difficult—if not impossible—to recruit enough patients for the follow-up trial that is supposed to document definitively whether Aduhelm really works. Few patients are likely to volunteer for a trial in which they might well get a placebo when they can probably get Aduhelm prescribed directly by a physician. Elisabeth Rosenthal, M.D., who is editor-in-chief of Kaiser Health New s, wrote recently that the accelerated
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