The U.S. Food and Drug Administration’s controversial decision to approve aducanumab for the treatment of Alzheimer’s disease raises at least three major ethical issues that need to be addressed, a new article in the Hastings Center Report:
- Billions of dollars in Medicare resources (i.e., taxpayer dollars) are at risk of being unfairly squandered.
- Doctors must choose between facilitating this unfair waste and denying access to this drug to desperate patients and families.
- Patients and families have false legitimate and animated hopes when doctors prescribe adducanumab.
The drug’s approval was contrary to the almost unanimous judgment of an FDA advisory committee that there was little reliable evidence of a significant benefit. And considering the $ 56,000 annual price of the drug and the 3.1 million people who are drug candidates, the total cost of Medicare or a private insurer would be $ 174 billion a year. An additional $ 93 billion health care expenses would be needed to cover the costs of the infusion and the brain scans necessary to control the risk of drug side effects, which include swelling of the brain or bleeding in small vessels.
“If the drug reversed and cured Alzheimer’s, it would make ethical and economic sense to fund access to it completely, in my opinion,” writes Leonard Fleck, a professor at Michigan State University’s Center for Bioethics and Social Justice. “But he doesn’t.”
Fleck concludes with a proposal to minimize the ethical issues mentioned above and set an important precedent for ongoing similar drugs. Medicare should require Biogen, the manufacturer, to provide aduncanumab at a cost — between $ 2,500 and $ 5,000 a year — (plus a modest profit) while conducting research to determine if the drug is safe and effective.
Fleck suggests that “this is the best non-ideal resolution we can achieve, given the competitive pressures that form intense patient demands and the need for a fair and prudent allocation of limited health resources.”
He adds: “Other pharmaceutical companies could expect the same reduced profits … if they could not decisively prove that their drugs obtained substantial clinical benefits at a reasonable cost. It would be an unforgettable hard love. ”
Leonard M. Fleck, Alzheimer’s, and Aducanumab: Unfair Benefits and False Hopes, Hastings Center Report (2021). DOI: 10.1002 / hast.1264
The Hastings Center
Citation: Alzheimer’s and adducanumab: Unfair Benefits and False Hopes (2021, June 28) Retrieved June 28, 2021 at https://medicalxpress.com/news/2021-06-alzheimer-aducanumab-unjust-profits-false.html
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