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FDA Head Calls for Investigation Into Controversial Aduhelm Approval

By Simon Spichak | July 12th, 2021
Image: Aduhelm, Biogen/AP. 

The head of the FDA, Dr. Janet Woodcock, calls for investigation into the agency’s own controversial approval of Biogen’s Aduhelm, the first drug approved to treat Alzheimer’s in almost 20 years. 

In June, the U.S. Food and Drug Administration (FDA) approved the first new drug for treating Alzheimer’s disease in almost 20 years. The drug, aducanumab, is being prescribed to patients under the brand name Aduhelm. Last week, the FDA revised the drug’s label, restricting its use of Aduhelm to people with early-stage Alzheimer’s. Now, members of Congress and even the head of the FDA are calling for an investigation into the process that led up to the controversial approval

One hallmark of Alzheimer’s is the deposition of protein plaques, called beta-amyloid, between neurons. Aduhelm received accelerated approval solely on the premise that reducing this biomarker would later improve the disease. However, this theory — the amyloid hypothesis — has faltered in clinical practice as drugs designed to reduce the deposition of these plaques have failed to improve symptoms in other clinical trials. Further, the decision to approve aducanumab faced immediate criticism, as Biogen’s trial data left much room for debate about the drug’s efficacy.

The FDA’s own statisticians brought up concerns about problematic analyses within the trials, and an independent advisory panel, composed of experts in neuroscience, recommended against the drug’s approval last year. Three of the members of this panel have since resigned over the FDA’s decision. 

Calls for Scrutiny of Aduhelm Approval Process

Reporting from STAT News revealed that Biogen, the co-developer of Aduhelm, worked unusually closely with FDA officials. Experts worry that this may lead to ineffective drugs receiving approval in the future. FDA Acting Commissioner Dr. Janet Woodcock announced the investigation on Twitter, where she attached a letter to the Department of Health and Human Services Inspector General Christi Grimm. 

“We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures,” Woodcock wrote on Twitter. “The trust of the American public, especially during these difficult times is of the utmost importance to the FDA — and we will continue to exercise transparency around our decision-making as allowed by the law.”

According to NPR, trust in the FDA may be at an all-time low. Woodcock’s calls for transparency about Aduhelm’s approval process may lay the groundwork to rebuild trust. 

Want to learn more about clinical trials
for Alzheimer’s and dementia?
Check out the Lilly Trial Guide.

In her letter to Grimm, Woodcock raised concerns over correspondence between Biogen executives and FDA officials through back-channels, stating she wants an investigation to determine if these communications “were inconsistent with FDA policies and procedures.”

Starting in 2019, Biogen worked closely with the FDA to reanalyze and contextualize evidence from their clinical trials. This was after the trial was stopped due to a lack of improvement in patients. 

It’s still unclear whether an investigation will occur and what it would entail. Grimm has the power to subpoena FDA documents and call for official testimony under oath. Any potential criminal complaints are then referred to the Department of Justice. Such investigations into the approval of drugs are extremely rare. But the scope of the investigation Woodcock has called for is limited to the interactions between Biogen executives and FDA officials.  

New York Rep. Carolyn B. Maloney, Chairwoman of the Committee on Oversight and Reform, and New Jersey Rep. Frank Pallone, Jr., Chairman of the Committee on Energy and Commerce raised broader concerns about Aduhelm to Congress in late June. In their joint issued statement, Maloney and Pallone wrote: “We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit.” California Rep. Katie Porter has also called for an investigation into the approval and pricing of Aduhelm.

Watchdogs expect that more and more information will continue to come out regarding the meetings between Biogen’s executives and FDA personnel.

The week after the FDA decision, the consumer Watchdog group Public Citizen wrote an eight-page letter asking the Secretary of Health and Human Services Xavier Becerra to fire Woodcock, writing: “Approving aducanumab despite the lack of evidence of effectiveness has raised false hope for millions of Alzheimer’s disease patients and their families, threatens to bankrupt the Medicare program… and will impede for years the development of other experimental treatments for this devastating disease.” 

After Woodcock’s announcement, Public Citizen responded on Twitter, writing: “The investigation of FDA’s close relationship with Biogen must look at the role Woodcock’s FDA played in permitting this.”

While there is excitement among patients about a new treatment, the drug is enormously expensive, it has side effects, and its efficacy will remain in question for, potentially, years to come, as its evaluation continues in an FDA-mandated, post-approval phase 4 trial. In the meantime, many people with Alzheimer’s will opt for Aduhelm, paying tens of thousands of dollars per year — for a drug that may not work. 

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