A neurologist who receives up to $20,000 annually from biotech corporations has been expelled from an FDA advisory council.
After it was discovered that Dr. David Weisman had financial links to the biotech firms Eisai and Biogen, who are responsible for a contentious Alzheimer’s medicine, the agency withdrew him from the board of directors as a temporary voting member.
Lecanemab, marketed as Leqembi, was given fast clearance in January, but since then, questions regarding its performance and adverse effects have surfaced.
Dr. Weisman, a Pennsylvania-based scientist, revealed he was no longer on the committee in a tweet Monday, which caught the attention of medical professionals who mentioned his preference for lecanemab.
The FDA told DailyMail.com in a statement, “As with human resources, the FDA does not comment on matters related to individual members of an advisory committee.”
Dr. Weisman is still employed by Eisai and Biogen behind the drug, which the committee will consider for approval later this week.
The companies also developed the drug aducanumab – or Aduhelm – which has proved controversial over clinical data and its approval.
Dr. David Weisman, a neurologist, will no longer advise the FDA committee on the approval of Alzheimer’s drugs. He works for Abington Neurological Associates in Pennsylvania
Dr. Weisman, of Abington Neurological Associates, did not respond to a DailyMail.com request for comment.
He tweeted Monday: “I’m not up [the committee] ? for entirely unrelated reasons,” he said in response to a post about his membership.
?Even qualifying was a great honor. I hoped to be worthy of patients and science.?
In April, the neurologist was approved as a temporary voting member of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS).
At the time, the FDA said he was needed because of his “extensive experience” and “unique qualifications.”
The agency stated in a waiver: ?Any potential for a conflict of interest is more than offset by the strong need for Dr. Weisman in this matter.’
But he has now been removed from the committee ahead of the Lecunemab meeting on June 9.
Lecanemab works by removing a sticky protein from the brain that is believed to make Alzheimer’s worse.
In a study involving 1,795 participants with symptomatic early-stage Alzheimer’s, lecanemab slowed clinical decline by 27 percent after 18 months of treatment compared to those who received a placebo, Yale medicine reports.
Dr. Weisman, a Pennsylvania-based scientist, revealed he was no longer on the committee in a tweet Monday, which caught the attention of medical professionals who mentioned his preference for lecanemab.
It appears from the above waiver that he was paid by both Biogen and Eisai while also serving on the committee
Christopher van Dyck, MD, director of Yale’s Alzheimer’s Disease Research Unit, said the main side effect is an infusion-related reaction, which can include transient symptoms such as flushing, chills, fever, rash, and body aches.
There is also the possibility of amyloid-related imaging abnormalities with edema or fluid buildup in the brain, which Yale said occurred in 12.6 percent of the trial participants compared to 1.7 percent in the placebo group.
The third issue was amyloid-related imaging abnormalities with cerebral hemorrhage, found in 17.3 percent of study participants.
“The drug’s label contains warnings about brain swelling and bleeding and that people with a gene mutation that increases their risk of Alzheimer’s disease are at greater risk of brain swelling with treatment,” Yale Medicine said.
A waiver revealed that Dr. Weisman was paid up to $15,000 a year by Biogen for advising on Aducanumab and helping research the drug.
He also earned up to $5,000 a year from Eisai for his involvement in the Phase II trial of the drug lecanemab, which involves patients who visit his practice.
Dr. Weisman was also one of dozens of signatories to a letter to the FDA published in May urging her to approve lecanemab.
Lecanemab has proven controversial as it received accelerated approval status from the FDA despite concerns that it was too expensive – at $26,500 a year.
At the time, the FDA also deemed it only “reasonably likely” that the drug would help fight the disease.
Phase III trials have now shown it slows memory decline by 27 percent, and they must decide next month whether or not to approve the drug.
It comes after the agency faced warnings that its bad reputation prevented it from shutting down misinformation online.
It has recently come under fire for its roll-out of Covid boosters, its slow response to the baby food crisis and its too close collaboration with biotech companies.
Experts say the litany of scandals has undermined public confidence in the agency, which will be an uphill battle to rebuild.
Dr. Seema Yasmin, a medical disinformation expert at Stanford University in California, said, “The question I start with is, ‘are you a trusted messenger or not?’
“In the context of the FDA, we can highlight multiple incidents that have damaged the agency’s credibility and increased distrust in its scientific decisions.”
Dr. Leticia Bode, a disinformation expert at Georgetown University in Washington DC, added, “It’s not fair, but it doesn’t take too many negative stories to unravel public confidence.”
Neurologist paid up to $20,000 a year by biotech companies removed from FDA dementia panel