June 17, 2021 -- A high-profile Washington-based consumer advocacy group is calling for the removal of the FDA's acting commissioner and two other top officials, saying the agency's approval of the Alzheimer's drug aducanumab (Aduhelm) was "reckless."

In a letter to U.S. Department of Health and Human Services Secretary Xavier Becerra, Michael A. Carome, MD, director of the Public Citizen Health Research Group, said: "The FDA's decision to approve aducanumab for anyone with Alzheimer's disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency's standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency."

Public Citizen urged Becerra to seek the resignations or removals of the three FDA officials it said were most responsible for the approval: Janet Woodcock, MD, acting FDA commissioner; Patrizia Cavazzoni, MD, director of the Center for Drug Evaluation and Research (CDER); and Billy Dunn, MD, director of the CDER Office of Neuroscience.

"This decision is a disastrous blow to the agency's credibility, public health and the financial sustainability of the Medicare program," writes Carome, noting that Biogen said it would charge $56,000 annually for the drug infusion.

Aaron Kesselheim, MD, one of three FDA Peripheral and Central Nervous System Drugs Advisory Committee members who resigned after the approval, agreed with Public Citizen that the agency's credibility is suffering.

"The aducanumab decision is the worst example yet of the FDA's movement away from its high standards," Kesselheim, a professor of medicine at Harvard Medical School, and Harvard colleague Jerry Avorn, MD, wrote in TheNew York Times on June 15.

"As physicians, we know well that Alzheimer's disease is a terrible condition," they wrote. But, they said, "approving a drug that has such poor evidence that it works and causes such worrisome side effects is not the solution."

In his resignation letter, Kesselheim said he had also been dismayed by the agency's 2016 approval of eteplirsen (Exondys 51) for Duchenne muscular dystrophy. In both the eteplirsen and aducanumab approvals, the agency went against its advisers' recommendations, he said.

Advocates Who Backed Approval Decry Cost

Aducanumab had a rocky road to approval but had unwavering backing from the Alzheimer's Association and at least one other organization, UsAgainstAlzheimer's.

The Alzheimer's Association was particularly outspoken in its support, and, as reported by Medscape in March, was accused of potential conflict of interest by Public Citizen and several neurologists because the association had accepted at least $1.4 million from Biogen and its partner Eisai since fiscal year 2018.

The association applauded the FDA approval but, a few days later, it expressed outrage over the $56,000-a-year price tag.

"This price is simply unacceptable," the Alzheimer's Association said in the statement. "For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity. We call on Biogen to change this price.”

UsAgainstAlzheimer's also expressed concerns about access, even before it knew aducanumab's price.

"Shockingly, Medicare does not reimburse patients for the expensive PET scans important to determine whether someone is appropriate for this drug," George Vradenburg, chairman and co-founder of the group, noted in a June 7 statement. "We intend to work with Biogen and Medicare to make access to this drug affordable for every American who needs it.”

Public Citizen's Carome said the advocates' complaints were hard to fathom.

"This should not have come as a surprise to anyone," he told Medscape. "It's essentially the ballpark figure the company threw out weeks ago."

At $56,000 per year, aducanumab is “egregiously overpriced for a drug that doesn't work," Carome said. "If the [Alzheimer's Association] truly finds this objectionable, hopefully they'll stop accepting money from Biogen and its partner Eisai."

Another advocacy group, Patients for Affordable Drugs, commended the Alzheimer's Association. Its statement "was nothing short of courageous, especially in light of the Alzheimer's Association's reliance on funding from drug corporations, including Biogen," David Mitchell, a cancer patient and founder of Patients For Affordable Drugs, said in a statement.

Mitchell said his members "stand with the Alzheimer's Association in its denunciation of the price set by Biogen" and called for a new law that would allow Medicare to negotiate drug prices.

Alicia Ault is a Lutherville, Maryland-based freelance journalist whose work has appeared in publications including Smithsonian.com, The New York Times, and The Washington Post. You can find her on Twitter @aliciaault.

WebMD Health News

Sources

Michael A. Carome, MD, director, Public Citizen Health Research Group.

Aaron Kesselheim, MD

The New York Times: “The F.D.A. Has Reached a New Low.”

Alzheimer’s Association: “Next Steps for New Alzheimer's Treatment.”

George Vradenburg, chairman and co-founder, UsAgainstAlzheimer’s.

Patients for Affordable Drugs “Statement: Patients For Affordable Drugs Supports Alzheimer’s Association’s Denunciation Of Aduhelm’s Price Set By Biogen.”

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