Neurologist with ties to biotechs off of panel
The Food and Drug Administration has removed a neurologist with financial ties to Biogen and Eisai — which jointly develop and market a pair of controversial Alzheimer’s drugs — from an upcoming advisory panel meeting to review one of those treatments.
David Weisman was cleared two months ago by the agency as a temporary voting member of an advisory committee that will meet Friday to consider whether a drug called lecanemab, which is promoted by the companies, should be fully approved by the FDA. The drug was given an accelerated approval earlier this year based on evidence suggesting it can help people with mild cognitive decline.
The drug, branded Leqembi, is being closely watched due to uncertainty over the extent of its effectiveness, concerns over side effects, controversy over the FDA approval process for an earlier Alzheimer’s drug from the same companies, and debate over Medicare coverage. And the stakes are high, given the clamor for Alzheimer’s treatments that can make even a small difference in patients.
In a tweet on Monday, however, Weisman wrote that he was no longer on the committee. His comment came after a back-and-forth exchange with other physicians who expressed anger at his conflicts of interest. “[For what it’s worth], I’m not on the AdCom — for entirely unrelated reasons,” he maintained, without explaining why he will not participate in the panel.
An FDA spokesperson declined to comment. Weisman confirmed the FDA move but declined further comment.
In April, the FDA approved Weisman as a temporary voting member due to his “extensive experience and background in Alzheimer’s disease,” and because his “expertise in this particular matter is necessary in the interest of public health,” according to a letter noting a waiver was issued for conflicts of interest. A temporary voting member is an added expert with specialized knowledge.
Those conflicts included his work serving as a principal investigator in a study for a different Alzheimer’s drug, aducanumab, that the companies market. His employer, Abington Neurological Associates, is one of the sites selected for the study, which began last October and is scheduled to end in 2026. Weisman is being paid between $5,000 and $15,000 annually for his role in the study.
The FDA letter cited yet another clinical trial run by his employer and with Weisman as a principal investigator. This Phase 2 study involves lecanemab, the same drug that is the subject of the upcoming FDA advisory panel meeting. But the FDA maintained the panel meeting will focus on Phase 3 study results. Weisman is being paid up to $5,000 for his work on this trial, the letter noted.
Two years ago, Weisman received more than $17,000 from Cambridge-based Biogen for speaking, training, and education sessions that were not related to consulting or continuing education, according to OpenPayments, a US government database that collects monies paid to physicians by drug and device makers. He received slightly more than $1,000 in consulting fees in 2020.
The FDA, however, is sometimes also concerned with intellectual conflicts of interest, which may be considered another form of bias. In such cases, the agency may have concerns that an advisory committee member has expressed distinct views that suggest the proposed committee member would not offer an impartial recommendation about a medicine.
Last month, Weisman was one of dozens of physicians who signed an open letter sent by the Alzheimer’s Association to the FDA that urged full approval of lecanemab. The missive also maintained that the Centers for Medicare & Medicaid Services should revisit its coverage policy toward the drug, which it has since done, although in a way that did not please the advocacy group.