Consumer Advocacy Group Wants FDA Leaders Ousted Over Alzheimer’s Drug Approval

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.