Home Health Group Needs FDA Leaders Ousted Over Alzheimer’s Drug Approval

Group Needs FDA Leaders Ousted Over Alzheimer’s Drug Approval


Advocates Who Backed Approval Decry Value

Aducanumab had a rocky street to approval however had unwavering backing from the Alzheimer’s Affiliation and at the very 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 very least $1.4 million from Biogen and its accomplice Eisai since fiscal 12 months 2018.

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

“This worth is solely unacceptable,” the Alzheimer’s Affiliation mentioned 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 will additional deepen problems with well being fairness. We name on Biogen to alter this worth.”

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

“Shockingly, Medicare doesn’t reimburse sufferers for the costly PET scans necessary to find out whether or not somebody is acceptable 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 mentioned the advocates’ complaints had been laborious to fathom.

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

At $56,000 per 12 months, aducanumab is “egregiously overpriced for a drug that does not work,” Carome mentioned. “If the [Alzheimer’s Association] actually finds this objectionable, hopefully they will cease accepting cash from Biogen and its accomplice Eisai.”

One other advocacy group, Sufferers for Inexpensive Medication, recommended 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 Medication, mentioned in a statement.

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

Alicia Ault is a Lutherville, Maryland-based freelance journalist whose work has appeared in publications together with Smithsonian.com, The New York Occasions, and The Washington Submit. Yow will discover her on Twitter @aliciaault.