A 3rd member of a Meals and Drug Administration (FDA) skilled advisory panel has resigned over the company’s controversial approval of an Alzheimer’s drug this week.
In a resignation letter despatched to performing FDA Commissioner Janet Woodcock on Thursday and shared with The Hill, Aaron Kesselheim, a professor of medication at Harvard Medical College, mentioned the approval of Biogen’s Alzehimer’s drug “was most likely the worst drug approval resolution in current U.S. historical past.”
FDA authorized the drug, known as Aduhelm, over the objections of its 11-member exterior advisory panel, which voted practically unanimously final November to not suggest approval, citing an absence of proof that the drug is efficient. Ten members voted no, one voted unsure.
The company is just not required to observe the group’s recommendation, however the overwhelmingly unfavorable vote made the company’s endorsement a shock. The choice set off a firestorm of criticism, particularly when Biogen introduced the value tag could be $56,000 for the remedy course.
An evaluation from the nonpartisan Kaiser Household Basis launched Thursday discovered the drug may value seniors on Medicare $11,500 in annual copays. If even a fraction of Alzheimer’s sufferers on Medicare are prescribed Aduhelm, it could value this system practically $29 billion a yr.
Aduhelm is the primary new Alzheimer’s remedy authorized in practically 20 years, however it’s not a remedy. The remedy, which is delivered intravenously, is meant to cut back the quantity of plaque within the brains of Alzheimer’s sufferers.
Alzheimer’s teams and affected person advocates cheered the transfer, arguing that the potential for enchancment was vital, as a result of it may give sufferers extra time.
However the FDA acknowledged the drug had not demonstrated a transparent scientific profit by way of truly slowing the development of the illness. As a substitute, officers argued that by eradicating the plaques, Aduhelm “in all fairness doubtless” to learn sufferers, and will probably sluggish cognitive decline.
The company determined to approve the drug below its accelerated approval pathway, and gave Biogen 9 years to finish its scientific research.
In his letter, Kesselheim mentioned the accelerated approval risk was not talked about in the course of the advisory panel assembly.
“On the final minute, the company switched its assessment to the Accelerated Approval pathway primarily based on the debatable premise that the drug’s impact on mind amyloid was doubtless to assist sufferers with Alzheimer’s illness. However this pivotal query was not mentioned on the Advisory Committee assembly, and its premise was particularly excluded from dialogue,” he wrote.
In his letter, Kesselheim additionally cited the FDA’s 2016 resolution to approve eteplirsen to deal with Duchenne muscular dystrophy, which additionally went in opposition to the advisory committee’s advice.
“The selections by FDA directors to disregard the Advisory Committee’s clear suggestions led to their approval of two extremely problematic medicine that provided little proof that they might meaningfully profit sufferers affected by these devastating situations. This may undermine the care of those sufferers, public belief within the FDA, the pursuit of helpful therapeutic innovation, and the affordability of the well being care system,” Kesselheim wrote.
Kesselheim’s resignation follows these of neurologist David Knopman of the Mayo Clinic and neurologist Joel Perlmutter of Washington College in St. Louis.