Login
Subscribe
In my August column, I lambasted the Food and Drug Administration (FDA) for its reckless June decision to approve drugmaker Biogen’s monoclonal-antibody drug aducanumab (ADUHELM) for the treatment of Alzheimer’s disease despite the lack of evidence that the drug is effective for slowing cognitive decline in patients with the disease.[1]
In December 2020, Public Citizen’s Health Research Group called for an investigation by the Department of Health and Human Services’ (HHS’) Office of...
In my August column, I lambasted the Food and Drug Administration (FDA) for its reckless June decision to approve drugmaker Biogen’s monoclonal-antibody drug aducanumab (ADUHELM) for the treatment of Alzheimer’s disease despite the lack of evidence that the drug is effective for slowing cognitive decline in patients with the disease.[1]
In December 2020, Public Citizen’s Health Research Group called for an investigation by the Department of Health and Human Services’ (HHS’) Office of Inspector General (OIG) into the unprecedented and inappropriately close collaboration between Biogen and the FDA during the analysis of data from the key clinical trials of aducanumab.[2] This close collaboration before and after the submission of the company’s marketing application for the drug dangerously compromised the integrity of the FDA’s review.
Finally, after months of foot-dragging, the HHS OIG on August 4 announced that in response to concerns raised about the FDA’s process for reviewing and approving aducanumab, it will review and assess how the FDA implemented the accelerated approval pathway for this drug and a sample of other drugs approved under this regulatory pathway.[3]
The OIG’s decision to launch its probe came in the wake of stunning new disclosures in a detailed exposé published by STAT on June 29 that appeared to provide further evidence of the inappropriately close collaboration between the FDA and Biogen long before the agency decided to approve aducanumab.[4] This collaboration reportedly began with an “off-the-books” May 2019 meeting between Dr. Billy Dunn, the director of the FDA office responsible for the review of Alzheimer’s disease drugs, and Biogen Chief Scientist Al Sandrock.
According to STAT, after a subsequent June 14, 2019, meeting between Biogen and the FDA, the company and the agency “established a ‘working group collaboration’ consisting of company employees and agency review staff. The group met or communicated almost daily in June, July, and August of 2019, working to collect and analyze [aducanumab] data for inclusion in the planned marketing submission. The group decided to pursue a standard FDA approval based on data on how patients had fared on cognitive surveys.”
The circumstances described in the STAT exposé paint a damning picture of FDA drug regulators who surrendered their independence and objectivity and essentially began working on behalf of Biogen rather than serving the public.
The FDA’s decision to approve aducanumab was a disastrous blow to the agency’s credibility, public health and the potential financial stability of the Medicare program. It is imperative that HHS OIG thoroughly investigate this decision and the circumstances that preceded it. The OIG’s probe must examine why and how Acting FDA Commissioner Dr. Janet Woodcock fostered a culture within her agency that permitted and encouraged such an inappropriate collaboration with regulated industry.
References
[1] FDA’s reckless decision to approve aducanumab for Alzheimer’s disease. Worst Pills, Best Pills News. August 2021. https://www.worstpills.org/newsletters/view/1416. Accessed August 18, 2021.
[2] Public Citizen. Letter to the Department of Health and Human Services Office of Inspector General investigation of the Food and Drug Administration’s inappropriate close collaboration with Biogen before and after the submission of the biologics license application for aducanumab for treatment of Alzheimer’s disease. December 9, 2021. https://www.citizen.org/wp-content/uploads/2560.pdf. Accessed August 18, 2021.
[3] U.S. Department of Health and Human Services, Office of Inspector General. Review of the FDA's accelerated approval pathway. https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000608.asp. Accessed August 18, 2021.
[4] Feuerstein A, Herper M, Garde D. Inside ‘Project Onyx’: How Biogen used an FDA back channel to win approval of its polarizing Alzheimer’s drug. June 29, 2021. STAT. https://www.statnews.com/2021/06/29/biogen-fda-alzheimers-drug-approval-aduhelm-project-onyx/. Accessed August 18, 2021.
