FDA Must Also Take Steps to Restore Confidence in Agency’s Review of Failed Treatment
WASHINGTON, D.C. – The U.S. Department of Health and Human Service’s Office of Inspector General (OIG) must investigate the unprecedented and inappropriate close collaboration between the U.S. Food and Drug Administration (FDA) and Biogen regarding the company’s application for approval of the Alzheimer’s disease drug aducanumab, Public Citizen said today in a letter to OIG.
After aducanumab’s two identical phase 3 trials were stopped at the halfway point because a preliminary analysis found that they were unlikely to show the drug benefitted Alzheimer’s patients, the FDA and Biogen worked collaboratively to salvage the drug. They jointly relied on dubious analyses that over-emphasized the results of one phase 3 trial suggesting the drug may work at a high dose, but disregarded data from the other phase 3 trial showing no benefit of the drug at any dose. The FDA and Biogen co-authored an unprecedented joint briefing document on aducanumab that was heavily biased in favor of the drug.
Public Citizen told the OIG that by engaging in this collaboration with Biogen, the FDA dangerously compromised its objectivity and independence during the review process for aducanumab.
A lone FDA statistician, who evidently was not involved in FDA’s close collaboration with Biogen, authored a scathing critique of the biased analyses conducted collaboratively by the agency and the company. He concluded there was insufficient evidence that aducanumab was effective.
In early November, members of an FDA advisory committee harshly criticized the analyses of clinical trial data conducted by the FDA and Biogen, the collaborative review process and the biased joint briefing document. Ten out of 11 members of the committee opposed approval of the drug. It appears that without the intervention of the committee, the FDA was prepared to rush to market a drug lacking substantial evidence of effectiveness for treating Alzheimer’s.
“The circumstances surrounding its collaboration with Biogen are a black eye for the FDA that further undermines public confidence in the agency,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group and author of the letter to the OIG. “They demand the Inspector General’s immediate attention.”
In a separate letter to the FDA, Public Citizen is asking the agency to temporarily remove the head of the office that collaborated with Biogen pending the completion of the requested OIG investigation, reassign all further review and decision-making regarding aducanumab to staff not involved in the collaboration with Biogen and assess whether any similar collaborations between the agency and other drug companies have occurred that may have undermined the integrity of the review process.
“Approving aducanumab despite a lack of evidence of effectiveness would 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,” said Carome.