The Food and Drug Administration is expected to soon decide whether to approved a new drug, aducanumab, intended to slow the progression of Alzheimer’s-related symptoms. The need for better treatments for Alzheimer’s is not in question. However, debate is ongoing regarding whether this particular drug merits FDA approval.
A recent New York Times opinion piece argues against aducanumab’s approval, citing what the authors claim is a lack of demonstrated efficacy, coupled with the possible increased difficulty in getting people to enroll in clinical trials for other emerging treatments, if an approved treatment is already on the market. A separate Washington Post news article describes some of the arguments for and against approval.
This debate touches on many of the issues we face in the human research protection field. When designing research projects, we must consider the ethics of enrolling people in clinical trials when an approved treatment for the disease being studied is available. However, how do we proceed when the efficacy of that approved treatment is questioned? And what is the appropriate course of action when the disease in question doesn’t have many good treatment options, and patients may be eager to try anything that might help? What are the ethical considerations behind providing a drug that may be very expensive?
June 7, 2021, update: The FDA has approved this new drug, with a caveat — a post-approval study to collect more data about efficacy will be required. The story reports the drug is expected to cost $56,000 per year for individual patients.
June 8, 2021, update: The plot thickens, with a member of the FDA advisory committee that recommended not approving the drug resigning after the approval.
June 18, 2021, update: It seems we’re up to three resignations from the FDA advisory committee now.
If you have trouble accessing the articles, please contact the IRB Blog Archival Sources division after June 7 at paalediths@uams.edu.