The head of the FDA is calling for an investigation into her agency’s controversial decision to approve a new Alzheimer’s drug

Janet Woodcock
Interim FDA Commission Janet Woodcock.

  • Interim FDA Commissioner Janet Woodcock has asked for an outside investigation into an Alzheimer’s drug approval.
  • The agency approved the drug, Aduhelm, last month, despite a lack of evidence showing the drug slowed the disease.
  • Officials from Biogen and the FDA worked closely together to revive the drug, raising concerns.
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The top leader at the US Food and Drug Administration is asking for an investigation into the agency’s controversial decision to approve an expensive new Alzheimer’s disease treatment.

Janet Woodcock, acting commissioner of the FDA, published a letter Friday asking the federal government’s top inspector to investigate if FDA staff worked inappropriately with biotech company Biogen to approve the new drug.

“To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General, in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” she wrote in the open letter.

The drug in question, Aduhelm, was approved by the agency last month and has caused an uproar in the scientific community. Three of the agency’s scientific advisors resigned following the decision.

Documents released by the FDA last month show that people within the agency thought that the drug should not have been approved because human testing data didn’t show it worked, but their concerns were overridden by top staff.

Biogen officials used back channels to get the drug approved after a late-stage clinical trial failed in March 2019, according to a report from STAT News.

The interactions pre-dated Woodcock, who became interim commissioner in January when the Biden Administration took office. She has been with the FDA for more than two decades and is one of the top contenders to permanently take the role, according to biotech analysts.

After the FDA approved Aduhelm, Biogen set its price at about $56,000 a year. Analysts estimate the US Medicare program could pay anywhere from $6 billion to $29 billion per year for Aduhelm, according to a recent New York Times analysis.

Biogen’s stock, which surged when the FDA approved Aduhelm, declined 3.2% to $357.09 a share on Friday afternoon.

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A third member of a prestigious FDA panel has resigned over the approval of a controversial new Alzheimer’s drug

A doctor observes medical scans of a patient's brain.
  • A third member of an FDA expert panel has resigned over the agency’s accelerated approval of a new Alzheimer’s drug.
  • The committee voted against approving the treatment. The FDA isn’t required to follow the panel’s recommendation but usually does.
  • Aduhelm failed one of its late-stage clinical trials and didn’t produce conclusive results in another trial.
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A third member of a Food and Drug Administration expert panel has resigned over the approval of a controversial new Alzheimer’s drug.

In a resignation letter obtained by CNBC, Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, “was probably the worst drug approval decision in recent US history.”

Kesselheim joins two other former members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, who resigned from their positions earlier this week, as the backlash against the agency’s accelerated approval process continues to mount.

Aduhelm, formerly known as aducanumab, was approved by the FDA on Monday, despite the prestigious advisory committee voting against the approval of the treatment in November. Though the FDA isn’t required to follow the panel’s recommendation, it typically does so.

The drug has been a point of debate in the scientific community for years, because it failed one of its late-stage clinical trials, and another trial failed to produce conclusive evidence that Aduhelm helped patients with memory and cognition issues.

But facing ongoing pressure from Alzheimer’s patients’ friends and family, the FDA decided to approve the drug under accelerated approval, a special mechanism that allows authorization on the condition that Biogen runs a follow-up trial to confirm the drug works. The method is usually used for cancer medications, according to CNBC.

In his resignation letter, Kesselheim said the FDA switched its review to the accelerated pathway “at the last minute” based on a “debatable premise” about the drug’s effectiveness, CNBC reported. He also said it was clear to him that the agency is not “presently capable of adequately integrating the committee’s scientific recommendations into its approval decisions.”

“This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system,” Kesselheim wrote.

The FDA did not immediately respond to Insider’s request for comment.

Dr. David Knopman, a neurologist at the Mayo Clinic whose resignation from the central nervous system panel was first reported by Insider’s Allison DeAngelis, said he was baffled by the FDA’s decision and felt the advisory committee had been “mistreated.”

“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,” he told Insider. “That seems illogical to me.”

“I don’t want to be a part of that in the future,” Knopman added.

Neurologist Dr. Joel Perlmutter of Washington University in St. Louis also resigned from the panel on Monday.

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A medical conference held in late February in Boston may have caused up to 300,000 coronavirus infections, new study finds

A sign marks a Biogen facility, some of whose employees have tested positive for the coronavirus after attending a meeting in Boston, in Cambridge, Massachusetts, U.S., March 9, 2020.   REUTERS/Brian Snyder
A sign marks a Biogen facility in Cambridge

  • A late February medical conference in Boston, Massachusetts may have led to 300,000 cases of the novel coronavirus, a new report found. 
  • The Biogen medical conference took place on February 26, and 27, and had been directly linked to 100 cases through contact tracing, 
  • By studying and tracing the genetic code of the virus, scientists determined up to 300,000 cases could be attributed to the conferences through November 1.
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A Biogen medical conference in late February led to between 205,000 to 300,000 COVID-19 infections from February to November of this year, according to a study in the peer-reviewed journal Science by the American Association for the Advancement of Science.

The number does not account for transmissions of the virus after November 1. 

According to the report, published Thursday, contact tracers had initially traced about 100 cases to the conference at the outset of the pandemic in the US, sparking concerns that it had been a super spreader event. According to the report, scientists studied the genetic code of COVID-19, which like all viruses, mutates as it spread, as CBS News noted.

Tracking the genetic code of the virus allowed the researchers draw their conclusions about how the virus spread following the February conference. 

“We don’t think these strains had a propensity to spread more than any other,” Jacob Lemieux, the lead author of the study, told CBS News. “We suspect that these types of events have been happening over and over again, and are major contributors to the propagation and spread of SARS-cov2 throughout the world.

 “The conditions that allow these super-spreading events to occur are very much still with us and will continue to be with us for a long time,” he added.

In the four counties that comprise the Boston region, 51,000 – about half – of the cases of COVID-19 until the beginning of November had genetic markers that linked the cases to the conference, according to the report. The virus also spread from the conference to other states at the beginning of March, when the conference attendees returned to their home states, according to the article.  

In total, COVID-19 cases linked to the Biogen conference were found in 29 states, according to the report, with 29% of the cases with the genetic marker from the conference found in the state of Florida, the report found. The scientists also found cases in Indiana and North Carolina. 

Lemieux told CBS the conference attendees “tended to be younger, healthier, and were traveling more, and we found that they went to a lot of different places,” leading to the high level of spread from the conference compared to other superspreader events that had far smaller implications.

Cases of the virus linked to the Boston conference were also found beyond the US, including in Australia, Sweden, and Slovakia, the scientists found.

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