Group Desires FDA Leaders Ousted Over Alzheimer’s Drug Approval


Advocates Who Backed Approval Decry Price

Aducanumab had a rocky street to approval however had unwavering backing from the Alzheimer’s Affiliation and at the least one different group, UsAgainstAlzheimer’s.

The Alzheimer’s Affiliation was significantly outspoken in its help, and, as reported by Medscape in March, was accused of potential battle of curiosity by Public Citizen and several other neurologists as a result of the affiliation had accepted at the least $1.4 million from Biogen and its associate Eisai since fiscal yr 2018.

The affiliation applauded the FDA approval however, just a few days later, it expressed outrage over the $56,000-a-year price ticket.

“This worth is just unacceptable,” the Alzheimer’s Affiliation stated within the assertion. “For a lot of, this worth will pose an insurmountable barrier to entry, it complicates and jeopardizes sustainable entry to this therapy, and should additional deepen problems with well being fairness. We name on Biogen to vary this worth.”

UsAgainstAlzheimer’s additionally expressed issues about entry, even earlier than it knew aducanumab’s worth.

“Shockingly, Medicare doesn’t reimburse sufferers for the costly PET scans essential to find out whether or not somebody is suitable for this drug,” George Vradenburg, chairman and co-founder of the group, famous in a June 7 statement. “We intend to work with Biogen and Medicare to make entry to this drug inexpensive for each American who wants it.”

Public Citizen’s Carome stated the advocates’ complaints have been exhausting to fathom.

“This could not have come as a shock to anybody,” he informed Medscape. “It is basically the ballpark determine the corporate threw out weeks in the past.”

At $56,000 per yr, aducanumab is “egregiously overpriced for a drug that does not work,” Carome stated. “If the [Alzheimer’s Association] really finds this objectionable, hopefully they will cease accepting cash from Biogen and its associate Eisai.”

One other advocacy group, Sufferers for Inexpensive Medicine, counseled the Alzheimer’s Affiliation. Its assertion “was nothing in need of brave, particularly in gentle of the Alzheimer’s Affiliation’s reliance on funding from drug firms, together with Biogen,” David Mitchell, a cancer affected person and founding father of Sufferers For Inexpensive Medicine, stated in a statement.

Mitchell stated his members “stand with the Alzheimer’s Affiliation in its denunciation of the worth set by Biogen” and referred to as for a brand new regulation that might enable Medicare to barter drug costs.

Alicia Ault is a Lutherville, Maryland-based freelance journalist whose work has appeared in publications together with, The New York Occasions, and The Washington Submit. You’ll find her on Twitter @aliciaault.