I’d rather not cast aspersions on the beleaguered executives at Biogen, but last week’s news that the maker of the controversial Alzheimer’s drug Aduhelm had finally published results of its Phase 3 trials certainly invites some skepticism.
It’s not just that the report comes nearly three years after the company precipitously canceled its two earlier studies for want of desirable results, or that its publication comes only weeks before the Centers for Medicare and Medicaid Services (CMS) is scheduled to issue a final ruling on eligibility — and, more specifically, payment — for the pricey drug, or that the results do little to demonstrate actual cognitive improvement among Aduhelm’s users.
That is all true, but even those Alzheimer’s sufferers and their loved ones who celebrated the FDA’s accelerated approval of the drug last summer have to be scratching their heads about Biogen’s decision to publish the trial results in an obscure journal whose editor in chief, Paul Aisen, MD, served as the second author of the study. The move, to put it mildly, reeks of desperation.
High-profile research typically lands in the New England Journal of Medicine (NEJM), the Journal of the American Medical Association (JAMA), or other similarly respected publications. As Bloomberg points out, the “impact factor” (how frequently a journal has been cited in other publications) of Aisen’s Journal of Prevention of Alzheimer’s Disease is rated at 4.5, which almost comically pales by comparison to NEJM’s 91 and JAMA’s 56.
Aisen, a professor of neurology at USC’s Keck School of Medicine, tells Reuters that he was not involved in reviewing the study or in the decision to publish it in his journal. And Biogen spokeswoman Ashleigh Koss declined to comment on the publishing decision, saying only that the company was simply doing its job: “It has always been our intention for our Phase 3 data to be peer-reviewed to provide physicians with a greater understanding of the appropriate use of Aduhelm, and we have worked urgently to that end.”
“Urgently” may be the key word here. In January, CMS issued a preliminary decision on coverage for the drug, limiting reimbursement to Medicare beneficiaries who participated in clinical trials, and announced it would make a final ruling in April. This is obviously a crucial decision for Biogen, which is banking on the Medicare set as its primary market and has seen little interest in the drug (originally priced at $56,000 for a year’s worth of infusions) since the FDA’s controversial decision last June. The uptake has been so disappointing, in fact, that the company in December cut the price in half.
The latest research findings, however, are unlikely to cheer Biogen’s shareholders — the company’s shares have lost about half their value since the FDA’s decision — or do much to shift the thinking at CMS. Aduhelm “significantly reduced” levels of amyloid beta plaque and tau protein, compounds thought to contribute to Alzheimer’s, but critics have long argued that they need solid evidence that the drug actually delays cognitive dysfunction before they can fairly judge the drug’s efficacy.
Biopharma market analyst Evan David Seigerman called the data “minimally incrementally positive,” which may be enough to persuade many of the 6 million Alzheimer’s sufferers and their loved ones to give the drug a chance — if only Medicare would cover the bulk of the cost. Desperate times, after all, call for desperate measures. Just ask Biogen.