‘Dark irony’
Even as the medical community waits for Biogen to present clear evidence of a benefit for aducanumab, clinics specializing in AD may get a financial boost, said Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, and codirector of Penn’s Memory Center.
Some clinicians see the arrival of the drug as a “win” for the field despite lingering concerns about its approval, said Dr. Karlawish at a panel discussion held July 12 by the nonprofit Hastings Center, a bioethics research institute. Dr. Karlawish is a fellow at Hastings.
In May, Dr. Karlawish published an article in STAT titled “If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it.” Dr. Karlawish told this news organization that he was a site investigator for Biogen studies of aducanumab and has worked on studies sponsored by Lilly and Eisai.
During the discussion July 12, Dr. Karlawish said he had altered his view and now might be a “reluctant prescriber.” This shift is because of his commitment “to preserve, protect and defend their autonomy” of patients with AD.
He also noted the drug could draw more money into the field to help care for patients with AD by providing increased access to diagnostics. Additionally, funds provided to clinics for administering aducanumab will aid specialty memory centers, “which have been basically impoverished since their creation,” Dr. Karlawish said.
“There is a dark irony that it takes a questionably beneficial drug to bring in the revenue to finally get memory centers up and functioning,” Dr. Karlawish said, adding that there needs to be “a larger conversation about how a big, vast, and problematic disease is being treated.”
Aducanumab’s approval shows that diseases in the U.S. are not fully considered as diseases until they have “a business model, and much of that business model relies on the pharmaceutical industry,” he noted.
Dr. Woodcock’s ‘personal commitment’
In early July, the FDA took two highly publicized steps to address criticism of its handling of the aducanumab approval. It revised the drug’s label to limit its use to patients with mild cognitive impairment likely related to AD or those in the mild stages of the disease.
In addition, Janet Woodcock, MD, the FDA’s acting commissioner, took to Twitter and posted a letter she sent to the Office of the Inspector General that called for a federal investigation into the drug’s approval that would examine agency staff interactions with Biogen.
AHIP spokesperson Kristine Grow said July 12 that her organization is still seeking a national Medicare coverage decision, but that the label revision was a “step in the right direction.”
“Patients with Alzheimer’s disease, and their families and caregivers, deserve safe, effective treatments. We applaud the FDA for this label adjustment, which brings indicated patients a bit closer to those included in clinical trials,” Ms. Grow said in an interview.
“At the same time, we remain concerned about the limited clinical evidence demonstrating efficacy and the serious safety risks that aducanumab poses for patients. We look forward to additional information from the FDA and other regulators, including CMS’ coverage guidance for patients who are Medicare eligible,” she added.
The controversy surrounding the approval of aducanumab is drawing more attention to the lack of a confirmed FDA commissioner. But in her letter to OIG, Dr. Woodcock wrote as if she intends to remain at the helm of the agency for at least a while longer. She wrote in her letter that OIG has her “personal commitment” that the FDA will fully cooperate if the investigative unit decides to undertake a review.
Dr. Woodcock also urged that a review be conducted as soon as possible, noting “should such a review result in actionable items, you also have my commitment to addressing these issues.”
A former FDA adviser who resigned over the agency’s handling of aducanumab said July 12 there needs to be a broader investigation of the FDA’s actions.
Attending the Hastings Center event was Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, Boston, one of three former members of an FDA advisory committee who resigned over the agency’s handling of aducanumab. Dr. Kesselheim said in an interview that he has no financial relationships to disclose in connection with this discussion.
“I would suggest that instead all aspects of this approval process should be investigated,” Dr. Kesselheim said, including the relationship between FDA and Biogen.
Dr. Karlawish said he was also concerned that Dr. Woodcock’s request for an investigation was “very narrow,” and noted members of Congress have said they are examining the FDA’s handling of this drug.
In a July 9 joint statement, House Committee on Energy and Commerce Chairman Frank Pallone Jr (D-N.J.), and House Committee on Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) said they were “pleased” by Dr. Woodcock’s announcement, but they will keep digging into ongoing questions about the drug. In their view, the OIG review of FDA staff interactions with Biogen officials would complement their committees’ “robust investigation of this matter.”
“We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers,” Mr. Pallone and Ms. Maloney added.
A version of this article first appeared on Medscape.com.