June 17, 2021 — A excessive-profile Washington-based completely mostly user advocacy community is inquiring for the removal of the FDA’s acting commissioner and two other high officers, announcing the company’s approval of the Alzheimer’s drug aducanumab (Aduhelm) became as soon as “reckless.”
In a letter to U.S. Division of Properly being and Human Companies and products Secretary Xavier Becerra, Michael A. Carome, MD, director of the Public Citizen Properly being Compare Community, said: “The FDA’s resolution to approve aducanumab for anyone with Alzheimer’s disease, irrespective of severity, confirmed an comely brush aside for science, eviscerated the company’s standards for approving restful medication, and ranks as one amongst the most irresponsible and egregious choices in the history of the company.”
Public Citizen urged Becerra to procure a look on the resignations or removals of the three FDA officers it said had been most to blame for the approval: Janet Woodcock, MD, acting FDA commissioner; Patrizia Cavazzoni, MD, director of the Heart for Drug Overview and Compare (CDER); and Billy Dunn, MD, director of the CDER Situation of job of Neuroscience.
“This resolution is a disastrous blow to the company’s credibility, public successfully being and the monetary sustainability of the Medicare program,” writes Carome, noting that Biogen said it could probably perchance well imprint $56,000 yearly for the drug infusion.
Aaron Kesselheim, MD, one amongst three FDA Peripheral and Central Worried Machine Treatment Advisory Committee people who resigned after the approval, agreed with Public Citizen that the company’s credibility is suffering.
“The aducanumab resolution is the worst instance but of the FDA’s sail a long way from its excessive standards,” Kesselheim, a professor of medication at Harvard Scientific Faculty, and Harvard colleague Jerry Avorn, MD, wrote in TheContemporary York Times on June 15.
“As physicians, each person is aware of successfully that Alzheimer’s disease is a awful condition,” they wrote. But, they said, “approving a drug that has such unlucky evidence that it works and causes such worrisome aspect results is now not any longer the solution.”
In his resignation letter, Kesselheim said he had furthermore been dismayed by the company’s 2016 approval of eteplirsen (Exondys 51) for Duchenne muscular dystrophy. In each and every the eteplirsen and aducanumab approvals, the company went against its advisers’ ideas, he said.
Advocates Who Backed Approval Decry Cost
Aducanumab had a rocky avenue to approval nevertheless had unwavering backing from the Alzheimer’s Association and no longer lower than one other organization, UsAgainstAlzheimer’s.
The Alzheimer’s Association became as soon as particularly outspoken in its wait on, and, as reported by Medscape in March, became as soon as accused of doable warfare of hobby by Public Citizen and a variety of alternative neurologists on legend of the association had accredited no longer lower than $1.4 million from Biogen and its companion Eisai since fiscal yr 2018.
The association applauded the FDA approval nevertheless, about a days later, it expressed outrage over the $56,000-a-yr imprint tag.
“This imprint is just unacceptable,” the Alzheimer’s Association said in the assertion. “For a range of, this imprint will pose an insurmountable barrier to earn entry to, it complicates and jeopardizes sustainable earn entry to to this remedy, and could perchance well extra deepen complications of successfully being equity. We name on Biogen to trade this imprint.”
UsAgainstAlzheimer’s furthermore expressed considerations about earn entry to, even sooner than it knew aducanumab’s imprint.
“Shockingly, Medicare would now not reimburse sufferers for the costly PET scans indispensable to search out out whether someone is appropriate for this drug,” George Vradenburg, chairman and co-founding father of the community, famed in a June 7 assertion. “We intend to work with Biogen and Medicare to earn earn entry to to this drug practical for every American who desires it.”
Public Citizen’s Carome said the advocates’ complaints had been laborious to fathom.
“This have not got reach as a shock to anyone,” he told Medscape. “Or no longer it is in actual fact the ballpark figure the firm threw out weeks ago.”
At $56,000 per yr, aducanumab is “egregiously overpriced for a drug that would now not work,” Carome said. “If the [Alzheimer’s Association] in actual fact finds this objectionable, with any luck they’ll reside accepting cash from Biogen and its companion Eisai.”
One other advocacy community, Patients for Cheap Treatment, recommended the Alzheimer’s Association. Its assertion “became as soon as nothing looking brave, especially in light of the Alzheimer’s Association’s reliance on funding from drug firms, in conjunction with Biogen,” David Mitchell, a cancer affected person and founding father of Patients For Cheap Treatment, said in a assertion.
Mitchell said his people “stand with the Alzheimer’s Association in its denunciation of the value put by Biogen” and known as for a brand restful law that could perchance well allow Medicare to negotiate drug costs.
Alicia Ault is a Lutherville, Maryland-based completely mostly freelance journalist whose work has seemed in publications in conjunction with Smithsonian.com, The Contemporary York Times, and The Washington Submit. Yow will come across her on Twitter @aliciaault.
