A high-profile, Washington-primarily based user advocacy group is inquiring for the elimination of the US Food and Drug Administration’s (FDA’s) appearing commissioner and two other top officials, announcing that the company’s approval of the Alzheimer’s drug aducanumab (Aduhelm, Biogen) modified into as soon as “reckless.”
In a letter to the US Department of Health and Human Products and companies Secretary Xavier Becerra, Michael A. Carome, MD, director of Public Citizen’s Health Study Community, acknowledged: “The FDA’s decision to approve aducanumab for anybody with Alzheimer’s disease, no topic severity, showed an stunning brush aside for science, eviscerated the company’s requirements for approving original remedy, and ranks as one of many most irresponsible and egregious selections within the historical previous of the company.”
Public Citizen entreated Becerra to search the resignations or the elimination of the three FDA officials it acknowledged had been most liable for the approval — Performing FDA Commissioner Janet Woodcock, MD; Heart for Drug Review and Study (CDER) Director Patrizia Cavazzoni, MD; and CDER’s Office of Neuroscience Director Billy Dunn, MD.
“This decision is a disastrous blow to the company’s credibility, public health and the monetary sustainability of the Medicare program,” writes Carome, noting that Biogen acknowledged it might perchance possibly perchance well price $56,000 per annum for the infusion.
Aaron Kesselheim, MD, one of three FDA Peripheral and Central Anxious Machine Treatment advisory committee contributors who resigned within the wake of the approval, agreed with Public Citizen that the company’s credibility is suffering.
“The aducanumab decision is the worst instance but of the FDA’s flow faraway from its high requirements,” Kesselheim, a professor of remedy at Harvard Scientific College, and Harvard colleague Jerry Avorn, MD, wrote within the Novel York Times on June 15.
“As physicians, everybody knows smartly that Alzheimer’s disease is a terrible situation,” they wrote. On the opposite hand, they added, “approving a drug that has such unhappy proof that it actually works and causes such worrisome aspect effects is no longer the respond.”
In his resignation letter, Kesselheim acknowledged he had also been dismayed by the company’s 2016 approval of eteplirsen (Exondys 51, Sarepta Therapeutics) for Duchenne muscular dystrophy. In each the eteplirsen and aducanumab approvals, the company went in opposition to its advisers’ suggestions, Kesselheim acknowledged.
Advocates Who Backed Approval Decry Charge
Aducanumab had a rocky avenue to approval however had unwavering backing from the Alzheimer’s Affiliation and no much less than 1 other group, UsAgainstAlzheimer’s.
The Alzheimer’s Affiliation modified into as soon as in particular outspoken in its reinforce, and, as reported by Medscape Scientific Files in March, modified into as soon as accused of seemingly warfare of curiosity by Public Citizen and several neurologists for the explanation that affiliation accepted no much less than $1.4 million from Biogen and its associate Eisai since fiscal one year 2018.
The affiliation applauded the FDA approval however, just a few days later, expressed outrage over the $56,000-a-one year price mark.
“This price is completely unacceptable,” the Alzheimer’s Affiliation acknowledged within the statement. “For a great deal of, this price will pose an insurmountable barrier to fetch admission to, it complicates and jeopardizes sustainable fetch admission to to this therapy, and might perchance possibly extra deepen problems with health equity,” the affiliation acknowledged, including, “We call on Biogen to interchange this price.”
UsAgainstAlzheimer’s also expressed concerns about fetch admission to, even sooner than it knew aducanumab’s price.
“Shockingly, Medicare does no longer reimburse patients for the dear PET scans well-known to search out out whether or no longer somebody is acceptable for this drug,” illustrious George Vradenburg, chairman and cofounder of the group, in a June 7 statement. “We intend to work with Biogen and Medicare to fetch fetch admission to to this drug affordable for every American who needs it,” Vradenburg acknowledged.
Public Citizen’s Carome acknowledged the advocates’ complaints had been exhausting to fathom.
“This assign no longer need arrive as a shock to anybody,” Carome suggested Medscape Scientific Files, including, “it be in actual fact the ballpark figure the firm threw out weeks ago.”
“Fifty-six-thousand-bucks is in particular egregiously overpriced for a drug that does now not work,” Carome acknowledged. “If the [Alzheimer’s Association] actually finds this objectionable, confidently they’ll terminate accepting money from Biogen and its associate Eisai,” he added.
“The Alzheimer’s Affiliation is recognizing that the genie is out of the bottle and that they’ll have distress reining within the inevitable bustle-away costs,” acknowledged Mike Greicius, MD, MPH, associate professor of neurology at Stanford University’s Wu Tsai Neurosciences Institute, Stanford, California.
“Moreover to the ask-popping annual price that Biogen has invented, I am hoping the Alzheimer’s Affiliation can be infected by the dangerously free and mighty FDA labeling which does no longer require screening for amyloid-positivity and does no longer restrict use to the milder forms of disease studied within the Segment 3 trials,” Greicius suggested Medscape Scientific Files.
But every other advocacy group, Patients For Cheap Treatment, counseled the Alzheimer’s Affiliation. Its statement “modified into as soon as nothing trying courageous, especially in light of the Alzheimer’s Affiliation’s reliance on funding from drug companies, including Biogen,” acknowledged David Mitchell, a most cancers patient and founding father of Patients For Cheap Treatment, in a statement.
Mitchell acknowledged his contributors “stand with the Alzheimer’s Affiliation in its denunciation of the price build of dwelling by Biogen” and known as for a original legislation that can allow Medicare to negotiate drug prices.
Alicia Ault is a Lutherville, Maryland-primarily based freelance journalist whose work has looked in publications including Smithsonian.com, the Novel York Times, and the Washington Post. It’s seemingly you’ll perchance perchance well possibly fetch her on Twitter @aliciaault.
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