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Member of FDA's Expert Panel Resigns Over Controversial Alzheimer's Therapy Approval

posted by Fnord666 on Friday June 11 2021, @08:33AM   
from the I-quit! dept.

An Anonymous Coward writes:

Member of FDA’s expert panel resigns over Alzheimer’s therapy approval:

Following the Food and Drug Administration's polarizing authorization of the Alzheimer's therapy Aduhelm on Monday, a member of an agency advisory committee that recommended against the drug's approval has resigned.

Neurologist Joel Perlmutter of Washington University in St. Louis, a member of the FDA's expert panel for nervous system therapies, told STAT in an email that he had quit the committee on Monday "due to this ruling by the FDA without further discussion with our advisory committee."

The advisory committee, which convened in November, couldn't have been more openly skeptical of the drug, also known as aducanumab. Ten of the 11 panelists found that there was not enough evidence to show it could slow cognitive decline. The 11th voted "uncertain."

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Original Submission

• It's not one - it's now three! It's not one - it's now three! (Score: 5, Interesting) by janrinok on Friday June 11 2021, @02:04PM (3 children)

  by janrinok (52) on Friday June 11 2021, @02:04PM (#1144245) Journal

  Three F.D.A. Advisers Resign Over Agency's Approval of Alzheimer's Drug [nytimes.com]:

  In a powerful statement of disagreement with the Food and Drug Administration's approval of Biogen's controversial Alzheimer's drug, three scientists have resigned from the independent committee that advised the agency on the treatment.

  "This might be the worst approval decision that the F.D.A. has made that I can remember," said Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women's Hospital, who submitted his resignation Thursday after six years on the committee.

  He said the agency's approval of the drug, aducanumab, which is being marketed as Aduhelm, a monthly intravenous infusion that Biogen has priced at $56,000 per year, was wrong "because of so many different factors, starting from the fact that there's no good evidence that the drug works."

  Two other members of the committee resigned earlier this week, expressing dismay at the approval of the drug despite the committee's overwhelming rejection [nytimes.com] of it after reviewing clinical trial data in November.

  The committee had found that the evidence did not convincingly show that Aduhelm could slow cognitive decline in people in the early stages of the disease — and that the drug could cause potentially serious side effects of brain swelling and brain bleeding. None of the 11 members of the committee considered the drug ready for approval: Ten voted against and one was uncertain.

  ...and...

  (...) Dr. David Knopman, a clinical neurologist at the Mayo Clinic, wrote in an email to F.D.A. officials informing them of his resignation from the advisory committee on Wednesday: "Biomarker justification for approval in the absence of consistent clinical benefit after 18 months of treatment is indefensible."

  Dr. Knopman, who had recused himself from the November meeting because he had served as a site principal investigator for one of the aducanumab trials, added that "the whole saga of the approval of aducanumab, culminating on Monday in the accelerated approval, made a mockery" of the advisory committee's role.

  Starting Score:	1		point
  Moderation		+3
  Interesting=2, Informative=1, Total=3
  Extra 'Interesting' Modifier		0
  Karma-Bonus Modifier		+1
  Total Score:		5

• Re:It's not one - it's now three! (Score: 0) by Anonymous Coward on Friday June 11 2021, @03:24PM

  by Anonymous Coward on Friday June 11 2021, @03:24PM (#1144261)

  > starting from the fact that there's no good evidence that the drug works."

  There was also ~30% chance of cerebral hemorrhage or effusion, ie leaky brain. Not to mention that none of the trial results were published besides in a powerpoint presentation, so who knows what more details would tell us.

  Parent

• Re:It's not one - it's now three! (Score: 0) by Anonymous Coward on Friday June 11 2021, @06:59PM

  by Anonymous Coward on Friday June 11 2021, @06:59PM (#1144344)

  it's kind of strange that these docs didn't already know that the FDA is a big pharma legitimizing operation. gang of suited whores.

  Parent

• Re:It's not one - it's now three! (Score: 1) by js290 on Friday June 11 2021, @07:57PM

  by js290 (14148) on Friday June 11 2021, @07:57PM (#1144369)

  We can have universal health by shutting down the USDA & FDA...
  What If There Was a Cure for Alzheimer’s Disease and No One Knew? by Mary Newport MD [coconutketones.com]

  Parent