Tue. Dec 7th, 2021

The U.S. Food and Drug Administration’s approval of a controversial Alzheimer’s drug has called for the commissioner to be removed amid criticism that the drug regulator is too close to Big Pharma.

This month, the FDA approved the first new Alzheimer’s drug in nearly two decades, which offers hope to approximately 35 million people worldwide living with the disease. But the decision angeres scientists who say the treatment is not working and should not be approved, and that the regulator has ignored scientific advice.

‘The agency has long held this valued position in the world of drug regulators. . . It is threatened by this case, ”said Peter Lurie, president of the Center for Science in the Public Interest, an independent advocacy group.

Aducanumab, what costs $ 56,000 a year, is the first drug to claim that it slows the progression of the disease itself rather than treating its symptoms.

Three members of the FDA’s advisory panel quickly stopped consecutively after the decision, saying the regulator’s decision lowers its standards. Last year, the panel unanimous approval against it of aportanumab.

Aaron Kesselheim, one of the members who resigned, said it was “probably the worst decision on drug approval in recent US history”.

The controversial endorsement is reminiscent of similar decisions taken by the FDA over the past year, where drugs with questionable efficacy have gained traction. In 2016, the regulator was criticized for approving eating sprays, a treatment for people with Duchenne muscular dystrophy – a debilitating disease in which muscles lose weight over time.

In 2015, the FDA , a promotion of libido for women, despite being twice rejected over concerns that the benefits do not outweigh the side effects.

‘It’s very reminiscent of [eteplirsen], ”Said Bruce Ovbiagele, a member of the FDA’s advisory committee who opposed the approval of both Alzheimer’s and muscular dystrophy drugs. He said both decisions were based on weak scientific evidence.

“The FDA may have struck under the pressure of community advocates and the fact that these devastating diseases do not even have modest effective treatments,” he added.

Several members of the scientific group point to an extraordinarily close collaboration between Biogen and the FDA as an example that the regulator becomes too entangled with the companies it oversees.

The FDA and Biogen have released a joint information document for the application of the company, a strange move between a regulator and its regulated company. “Inside, the barriers are starting to fall and soon you will be writing an information document together,” Lurie said, adding that the agency has come too close to the pharmaceutical industry in small increments.

The agency said: “The FDA often works closely with industry to promote drug development, understand emerging data and provide advice on the best approaches to development plans, especially in areas where there is a great need for treatment for devastating diseases. “

Some critics have blamed Janet Woodcock, the head of the FDA, for allowing this close relationship to be cultivated. She also supervised the approval of many painkillers while the opioid epidemic raged across the US.

Woodcock was appointed acting commissioner this year while the search for a permanent chief continued. She is considered an entry for the role and some believe that such a large drug approval would not have been made without a nod from her.

“A decision of this magnitude with this kind of potential controversy will eventually have to rise to a higher level than Dunn,” Ovbiagele said, referring to Billy Dunn, head of the FDA’s neuroscience unit.

The FDA said that the information submitted for aducanumab was very complicated and that our investigation was thorough. “All medicine reviews” is a team effort. “No one makes separate decisions on any approval, policy or security matters,” he added.

Woodcock did not respond to a request for comment on calls for her removal or claimed she was too close to the industry.

One healthcare investor, who did not want to be named, said: ‘In the industry, everyone keeps their mouths shut. The Big Pharma companies were completely silent about it because they know that if they say anything in support of Janet, it will be toast. But everyone likes: ‘Listen, at least you know we know what to expect with Janet’. ”

On Thursday, West Virginia Sen. Joe Manchin wrote a letter to President Joe Biden requesting him not to appoint Woodcock as permanent head of the regulator. “Dr. Woodcock is not the right person to lead the FDA,” he wrote, adding that she had “repeatedly ignored public health” regarding the opioid epidemic.

Michael Carome, director of the health research group at Public Citizen, said the agency “too often makes decisions that are in the best interests of pharmaceutical companies and their shareholders, rather than the best interests of public health and their patients.”

Last week, Carome wrote to the U.S. Secretary of Health demanding the removal of Woodcock, as well as Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research, and Dunn, director of the FDA’s Office of Neuroscience.

‘The damage caused by the FDA’s reckless approval of aducanumab has damaged the agency’s credibility as a science – based regulatory agency. . . can not be overemphasized, ‘he wrote, adding that’ regulatory survey of the agency by the industry ‘has taken place.

The FDA is accused of cultivating a revolving door environment this month when it emerged that former commissioner Stephen Hahn would take a job at Flagship pioneering work, the investor who founded Moderna. Hahn was head of the FDA when Moderna’s Covid-19 vaccine was approved last year.

The green light for aducanumab could set a precedent for future drug approval and come as the FDA seeks to regain confidence in itself and its science following controversy during the pandemic – such as the approval of the rejection of the use of hydroxychloroquine to treat Covid-19 patients.

“It was a chance for the agency to say we were pushed around during Trump, but it’s normally busy again, which means the FDA is the gold standard for scientific rigor,” Lurie said. ‘It [approval] reset the agency. . . they dropped the ball. ”

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