As a member of the united states, the Food and Drug Administration's panel of foreign consultants, resigned in protest at the decision of the authority to approve Biogen Inc. ' s, Alzheimer's disease, the treatment, despite the committee's recommendation to do so.
Aaron Kesselheim, a professor of medicine at Harvard Medical School, who has served in the nervous system drug advisory committee, since 2015, told Reuters that he was leaving the group on Thursday.
The FDA has confirmed for the first time in 18 years, as the Market is one of the anti-Alzheimer's drug.
"My main point was that the FDA should review the how to and the use of the consultation committee, because I don't think it would be a solid recommendation from the committee in this case have been properly integrated into the decision-making process," Kesselheim said in an e-mail message.
He was led to the decision of the FDA-approved drugs, Sarepta, Therapeutic, Inc. Eteplirsen for the treatment of Duchenne muscular dystrophy (dmd) in 2016, as an example of how the authority has confirmed the drug, which is contrary to the recommendations of the advisory committee.
The first, "the State News" about her departure.
On Tuesday, the advisory panel member who voted against the approval of the University of Washington neuroscientist Dr. Joel Perlmutter, had resigned from the committee, that this is the Aduhelm approval.
A third member of a panel of outside advisers to the U.S. Food and Drug Administration has resigned in protest over the agency's decision to approve Biogen Inc's Alzheimer's disease treatment despite the committee's recommendation against doing so.
Aaron Kesselheim, a Professor of Medicine at Harvard Medical School who had served on the FDA’s advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel.
FDA approves Biogen Alzheimer’s drug for first time in 18 years
"My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees ... because I didn’t think that the firm recommendations from the committee in this case ... were appropriately integrated into the decision-making process," Kesselheim said in an email.
Please visit the elephants, the touch, the heart of China. May be the reason why they had left the house.
Neurological director of the Mayo Clinic, Dr. David Knopman, " he said, resigned on Wednesday.
In November, an 11-member committee can be said to have voted unanimously in favour of the Market, the drug was approved, with reference to the convincing evidence of its effectiveness.
The FDA, on Monday received the drug as a "quick checkout", which is based on evidence that it may reduce the likelihood of contributing to the development of Alzheimer's disease, rather than as evidence, specifically to benefit from this debilitating disease.