Two doctors have resigned from a prestigious panel after FDA approved a controversial Alzheimer's drug
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Two top neuroscience experts resigned this week from a committee that advises the FDA.
The doctors stepped down after the agency approved a controversial Alzheimer's drug called Aduhelm.
Their committee voted in November that the FDA shouldn't approve the drug.
Two top neuroscience experts have resigned from posts advising the US Food and Drug Administration following the agency's controversial approval of a new Alzheimer's disease drug.
Dr. David Knopman, a neurologist at the Mayo Clinic and member of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee, resigned from his position Wednesday due to the approval of the Alzheimer's drug Aduhelm. Neurologist Dr. Joel Perlmutter of Washington University in St. Louis resigned from the panel on Monday, according to STAT News.
"I felt that the advisory committee was mistreated and that their role was misrepresented to them, and I don't want to be a part of that in the future," Knopman told Insider.
Aduhelm, formerly known as aducanumab, was approved by the FDA on Monday. The treatment has been heavily debated in the scientific community because it failed one of its late-stage clinical trials, while another trial didn't give conclusive evidence that the drug helped with patients' memory and cognition issues.
Video: FDA approves 'controversial' new Alzheimer's drug (MSNBC)
Duration 5:57
Read more: Here are the 9 biggest biotech winners after the FDA took an entirely new approach to approve Biogen's Alzheimer's drug
The nervous system advisory committee voted in November that the FDA shouldn't approve the drug. Knopman wasn't a part of that meeting because he works with the the drug's manufacturer Biogen as a clinical trial investigator. He has publicly spoken out against approving the drug over the last eight months.
In an interview Wednesday, he said he was baffled by the FDA's decision to approve the drug under a special mechanism known as an accelerated approval, which will require Biogen to confirm the drug works by running a follow-up trial.
"The FDA, in using the accelerated approval mechanism, they could not endorse any evidence of demonstrable clinical benefit. That's what their press release said in so many words. That seems illogical to me," he said.
Perlmutter told STAT News that he resigned from the panel "due to this ruling by the FDA without further discussion with our advisory committee."
The FDA isn't required to follow the recommendation of its advisory committees, but typically does so.
Dr. David Knopman, a neurologist at the Mayo Clinic and member of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee, resigned from his position Wednesday due to the approval of the Alzheimer's drug Aduhelm. Neurologist Dr. Joel Perlmutter of Washington University in St. Louis resigned from the panel on Monday, according to STAT News.
"I felt that the advisory committee was mistreated and that their role was misrepresented to them, and I don't want to be a part of that in the future," Knopman told Insider.
Aduhelm, formerly known as aducanumab, was approved by the FDA on Monday. The treatment has been heavily debated in the scientific community because it failed one of its late-stage clinical trials, while another trial didn't give conclusive evidence that the drug helped with patients' memory and cognition issues.
Video: FDA approves 'controversial' new Alzheimer's drug (MSNBC)
Duration 5:57
Read more: Here are the 9 biggest biotech winners after the FDA took an entirely new approach to approve Biogen's Alzheimer's drug
The nervous system advisory committee voted in November that the FDA shouldn't approve the drug. Knopman wasn't a part of that meeting because he works with the the drug's manufacturer Biogen as a clinical trial investigator. He has publicly spoken out against approving the drug over the last eight months.
In an interview Wednesday, he said he was baffled by the FDA's decision to approve the drug under a special mechanism known as an accelerated approval, which will require Biogen to confirm the drug works by running a follow-up trial.
"The FDA, in using the accelerated approval mechanism, they could not endorse any evidence of demonstrable clinical benefit. That's what their press release said in so many words. That seems illogical to me," he said.
Perlmutter told STAT News that he resigned from the panel "due to this ruling by the FDA without further discussion with our advisory committee."
The FDA isn't required to follow the recommendation of its advisory committees, but typically does so.
Read the original article on Business Insider
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