FDA head calls for inquiry into Alzheimer’s drug review

Jul 9, 2021, 11:39 AM | Updated: 2:05 pm

WASHINGTON (AP) — The acting head of the Food and Drug Administration on Friday called for a government investigation into highly unusual contacts between her agency’s drug reviewers and the maker of a controversial new Alzheimer’s drug.

Dr. Janet Woodcock announced the extraordinary step via Twitter. It’s the latest fallout over last month’s approval of Aduhelm, an expensive and unproven therapy that the agency OK’d against the advice of its own outside experts.

Woodcock made the request to the Department of Health and Human Services’ inspector general, the watchdog agency that oversees the FDA and other federal health agencies. The move comes after numerous calls for a probe into the approval from medical experts, consumer advocates and members of Congress. Two congressional committees have already launched their own review.

“We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures,” Woodcock wrote on Twitter. Biogen pledged to cooperate with the inquiry.

Last month, the health news site Stat reported on the unusually close collaboration between Aduhelm drugmaker Biogen and FDA staff. In particular, the site reported an “off-the-books” meeting in May 2019 between a top Biogen executive and the FDA’s lead reviewer for Alzheimer’s drugs.

The meeting came after Biogen stopped two studies because the drug didn’t seem to slow the disease as intended. Biogen and the FDA began reanalyzing the data together, concluding the drug may actually work. The collaboration ultimately led to the drug’s conditional approval two years later, on the basis that it reduced a buildup of sticky plaque in the brain that is thought to play a role in Alzheimer’s disease.

FDA interactions with drug industry staff are tightly controlled and almost always carefully documented. It’s unclear if the May 2019 meeting violated agency rules.

When Biogen and FDA brought the drug before the FDA’s panel of outside advisers in November, the group was nearly unanimous in urging its rejection.

The FDA isn’t required to follow the group’s advice. And the FDA lead staff reviewer — who had been working with Biogen for months on the drug’s data — called it “exceptionally persuasive,” “strongly positive” and “robust.”

The consumer advocacy group Public Citizen called for an investigation into the collaboration after the November advisory meeting. The group’s health director Dr. Michael Carome welcomed Woodcock’s request for an inquiry.

“We’re pleased to see that belatedly she has made this request that should have been made months ago,” Carome said. “The signs of an inappropriate collaboration have been clear to us since November.”

The FDA has faced intense backlash since approving the drug, which costs $56,000 a year and requires monthly IVs.

Three of the FDA advisers who opposed the drug resigned over the decision. Among other issues, they protested that the agency did not disclose that it was considering approving the drug on a conditional basis, based on its effect on brain plaque, rather than any actual benefit to patients. Aduhelm is the first Alzheimer’s drug approved in that manner.

“I think all the different parts of the decision are worthwhile for an independent investigation,” said Harvard University researcher Dr. Aaron Kesselheim, one of the three advisers who resigned. “The trust that we have in FDA’s ability to make independent decisions is very important.”

On Thursday, the FDA took the unusual step of vastly scaling back prescribing information on the drug. The agency and Biogen announced the new label would recommend that it only be given to patients with mild or early-stage Alzheimer’s. That came after many doctors criticized the original label as too broad, because it said the drug could be given to anyone with Alzheimer’s.

Aduhelm hasn’t been shown to reverse or significantly slow the disease. But the FDA said that its ability to reduce clumps of plaque in the brain is likely to slow dementia. More than two dozen other drugs have previously tried that approach without yielding positive results. Biogen is required to conduct a follow-up study to definitively answer whether it really works. Other Alzheimer’s drugs only temporarily ease symptoms.

Woodcock has been serving as the agency’s acting commissioner since January. Previously she spent more than 25 years directing the agency’s drug center. While widely respected among government and drug industry circles, she has also been criticized for often pushing aggressively to approve new therapies, even when their benefits aren’t certain.

___

Follow Matthew Perrone on Twitter: @AP_FDAwriter

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

AP

Associated Press

LAPD officer who died was beaten in training, mother claims

LOS ANGELES (AP) — A Los Angeles police officer who died of neck injuries suffered during training had been beaten by fellow officers in an exercise meant to “simulate a mob,” according to a wrongful-death claim filed against the city by his mother. Houston Tipping, 32, was hurt May 26 at the police academy and […]
13 hours ago
Canada's Prime Minister Justin Trudeau arrives for the Leaders' Retreat on the sidelines of the Com...
Associated Press

Trudeau: US abortion ruling could mean loss of other rights

TORONTO (AP) — Canadian Prime Minister Justin Trudeau said Saturday the U.S. Supreme Court decision to overturn a constitutional right to abortion is a worrying setback that could lead to the removal of other rights Americans have. Trudeau called the court’s decision “horrific” and voiced concern that the ruling could someday allow a rollback of […]
13 hours ago
FILE - Tara Sweeney, a Republican seeking the sole U.S. House seat in Alaska, speaks during a forum...
Associated Press

Alaska Supreme Court ruling keeps Sweeney off House ballot

ANCHORAGE, Alaska (AP) — The Alaska Supreme Court on Saturday upheld a lower court’s ruling that will keep Republican Tara Sweeney off the ballot for the August special election in Alaska’s U.S. House race. In a brief written order, the high court said it affirmed the decision of Superior Court Judge William Morse, who agreed […]
13 hours ago
FILE - Spain's Prime Minister Pedro Sanchez gestures during news conference at the Presidential Pal...
Associated Press

Spain unveils emergency actions to curb soaring living costs

MADRID (AP) — The Spanish government has approved a package of emergency economic measures worth more than 9 billion euros ($9.5 billion) to try to temper the economic fallout from Russia’s invasion of Ukraine, Prime Minister Pedro Sánchez said Saturday. “This war, and its economic and social consequences, have produced an extraordinary uncertainty when it […]
13 hours ago
Associated Press

Officer suspended for off-duty actions at abortion protest

PROVIDENCE, R.I. (AP) — A Rhode Island police officer accused of punching a woman at an abortion protest while he was off-duty was suspended from his job with pay Saturday while the Providence Police Department conducts a criminal investigation into his actions. Jennifer Rourke, Rhode Island Political Cooperative Chairwoman and a state Senate candidate, told […]
13 hours ago
FILE - Local residents navigate the Amazon River near Leticia, Colombia, Sept. 7, 2019. Gustavo Pet...
Associated Press

New Colombian president pledges to protect rainforest

RIO DE JANEIRO (AP) — Gustavo Petro, Colombia’s first elected leftist president, will take office in August with ambitious proposals to halt the record-high rates of deforestation in the Amazon rainforest. Petro has promised to limit agribusiness expansion into the forest, and create reserves where Indigenous communities and others are allowed to harvest rubber, acai […]
13 hours ago

Sponsored Articles

(Courtesy Condor)...
Condor Airlines

Condor Airlines shows passion for destinations from Sky Harbor with new-look aircraft

Condor Airlines brings passion to each flight and connects people to their dream destinations throughout the world.
...
Carla Berg, MHS, Deputy Director, Public Health Services, Arizona Department of Health Services

Update your child’s vaccines before kindergarten

So, your little one starts kindergarten soon. How exciting! You still have a few months before the school year starts, so now’s the time to make sure students-to-be have the vaccines needed to stay safe as they head into a new chapter of life.
...
Arizona Division of Problem Gambling

Arizona Division of Problem Gambling provides exclusion solution for young sports bettors

Sports betting in Arizona opened a new world to young adults, one where putting down money on games was as easy as sending a text message.
FDA head calls for inquiry into Alzheimer’s drug review