In June, I ran a post asking: “Did the FDA Just Make a Huge Mistake?” I was puzzled why approval had been granted, over the objections of the agency’s expert advisory panel, for Aduhelm (aducanumab-avwa). The drug’s efficacy was clouded, and possibly severe side effects had occurred, including brain bleeds and falls.
Aduhelm is expensive, estimated at $56,000 a year per patient, and requires infusions. Many commentators worried that with Alzheimer’s disease on the rise in our aging population, this one drug alone might impose a huge burden on Medicare.
Looks like the real-life scenario has played out differently. The manufacturer, Biogen, reported that the drug’s sales from July through September were $300,000, far below the company’s expectations—and those of Wall Street, where analysts were anticipating $12 million in sales over that three-month period. But it appears that only 100 patients were treated with the drug.
According to The New York Times,
“Uptake has been substantially slowed by concerns among insurers, physicians and families that the drug is backed by little evidence of effectiveness while coming with significant risk of potentially serious side effects.”
Biogen’s CEO said the company still has confidence in Aduhelm and expects that once payers decide to cover it, use will increase. But there hasn’t been a groundswell of enthusiasm.
The Times reported:
“Several prominent academic medical centers, including the Cleveland Clinic and Mount Sinai Health System in New York, have decided not to give the drug to patients. Several regional Blue Cross Blue Shield health plans have declined to cover it, and in August, the Department of Veterans Affairs decided not to add the drug to its formulary of available medicines.”
This is the drug whose approval led several members of the expert advisory committee to resign in protest. One of them called the FDA’s action “probably the worst drug approval decision in recent US history.”
The decision has even generated serious second thoughts within the FDA, which has called for an investigation into the approval process. Some have charged the process bypassed the agency’s independent role and resulted from a too-cozy relationship with the drug’s manufacturer.
I’m relieved this costly, unproven drug that so many knowledgeable folks said should never have been approved hasn’t sapped money out of the system and doesn’t seem to have harmed anyone thus far.
Yet I also feel a sense of sadness for those individuals and families whose faith in its therapeutic value to alter the course of this terrible disease have been dashed.
We must hope that the FDA’s examination of how Aduhelm gained the agency’s approval in the first place will yield more independent, scientifically sound decision-making that serves patients and their families far better.
One important change would be to ensure the agency has a permanent Commissioner, rather than its current Acting Commissioner. President Biden is reportedly moving in that direction: he’s been talking with a well-regarded former FDA Commissioner, Rob Califf, about resuming that role.
The President is seeking a nominee who is likely to be confirmed by the Senate—not any easy task in itself these days.