In a report from Michigan State University, researchers suggest that the U.S. Food and Drug Administration’s decision to approve aducanumab for the treatment of Alzheimer’s disease raises at least three major ethical issues that need to be addressed:
Billions of dollars in Medicare resources (which is to say, taxpayer dollars) are at risk of being unjustly squandered.
Physicians must choose between facilitating this unjust squandering and denying desperate patients and families access to this drug.
Patients and families are having false hopes legitimated and encouraged when physicians prescribe aducanumab.
The drug’s approval was contrary to the nearly unanimous judgment of an FDA advisory committee that there was little reliable evidence of significant benefit.
And given the drug’s $56,000 annual price and the 3.1 million people who are candidates for the drug, the total cost to Medicare or a private insurer would be $174 billion per year.
An additional $93 billion in health care costs would be needed to cover infusion costs and the brain scans needed to monitor the risk of drug side effects, which include brain swelling or small-vessel brain bleeds.
The team says if the drug reversed and cured Alzheimer’s, it would make ethical and economic sense to fully fund access to it.
Medicare should require Biogen, the manufacturer, to provide aducanumab at cost—between $2,500 and $5,000 per year—(plus a modest profit) while it conducts further research to establish whether the drug is safe and effective.
This is the best nonideal resolution people can achieve, given competing pressures from intense patient demands and the need for the just and prudent allocation of limited health care resources.
If you care about brain health, please read studies about things that can increase brain damage in people with COVID-19, and keeping your brain active may delay Alzheimer’s dementia 5 years.
For more information about brain health, please see recent studies about where you live can greatly affect heart, brain health, and results showing this common food oil in the U.S. can change genes in the brain.
The study is published in Hastings Center Report. One author of the study is Leonard Fleck.
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