Member of the FDA Advisory Board resigned after regulatory approval, Controversial The treatment claims that it “did not show good evidence that it worked.”
Dr. Aaron Kesselheim, a professor of medicine at Harvard University and also working at Brigham and Women’s Hospital, called it “the worst drug approval decision in US history these days” in his resignation.
“It had important side effects,” Kesselheim told Dr. Taranarula of CBS News. “The FDA has completely switched gears in the last six months and approved the drug based on the theory of surrogate markers for amyloid plaques, which was told not to be considered by the advisory board in November.”
Many critics have blown up the FDA’s Aduhelm approval.Clinical trials have shown that it may reduce amyloid plaques, which are believed to be markers of..
However, it is not clear whether it delays or prevents the actual symptoms, and the FDA’s independent advisory board recommended that authorities refuse the drug.
Kesselheim and two other members resigned after the FDA ignored the advice.
The first patient who did not participate in a clinical trial got the drug last week.
According to the FDA, side effects include headache, ARIA-edema, ARIA-H microbleeding, ARIA-H brain surface hemorrhoids, and falls.
“If the FDA allows a company to approve a drug based on prematurely discontinued or reanalyzed trials, it will set a precedent as it tells other companies. Strict trials too. I will do it. “
He said both patients and doctors rely on the FDA to maintain “reasonable standards.”
“In most cases, I want to think that the FDA is making the right decision,” he said. “In such cases where the FDA thinks I made the wrong decision, I think we need to better understand why the decision was made this way.”
Biogen told CBS News that it provided the FDA with 2.2 million pages of data and analysis from eight clinical trials. “Adulhelm’s dataset was very complex and our review was thorough,” an FDA official told reporters.
An FDA adviser who declined to approve a drug for Alzheimer’s disease says there is no “good evidence that it works
Source link An FDA adviser who declined to approve a drug for Alzheimer’s disease says there is no “good evidence that it works