Statement: FDA’s Decision to Approve Aducanumab for Alzheimer’s Disease Shows Reckless Disregard for Science, Severely Damages Agency’s Credibility

Agency Inappropriately Collaborated with Biogen to Rush Lucrative Unproven Treatment

WASHINGTON, D.C.  The U.S. Food and Drug Administration (FDA) today announced its approval of aducanumab for treatment of Alzheimer’s disease despite the nearly unanimous conclusion of an independent panel of experts convened by the agency in November that there was not sufficient evidence that the drug was effective. In December Public Citizen called for an investigation of the unprecedented and inappropriately close collaboration between the Biogen and the FDA during the analysis of data from the key clinical trials of the drug. Dr. Michael Carome, director of Public Citizen’s Health Research Group, released the following statement:

“The FDA’s decision shows a stunning disregard for science and eviscerates the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

“The close collaboration between the FDA and Biogen before and after the submission of the company’s marketing application for aducanumab dangerously compromised the integrity of the agency’s review and culminated in a biased agency assessment of the drug that discounted the results of the negative trial. The circumstances of this collaboration must be investigated by the U.S. Department of Health and Human Services Office of Inspector General.

“The approval was based on seriously flawed analyses of two identical phase 3 trials that were stopped at the halfway point because a preliminary review of the data found that the trials, if continued to completion, were unlikely to show the drug benefitted Alzheimer’s patients. One trial showed no benefit, and the other only suggested possible minimal benefit at a high dose.

“Approving aducanumab despite the lack of evidence of effectiveness plus the well-documented risk of serious harm will raise false hope for millions of Alzheimer’s patients and their families, potentially bankrupt the Medicare program because of the drug’s projected exorbitant price and impede for years the development of other experimental treatments for the disease.”