The U.S. Food and Drug Administration’s approval of a controversial Alzheimer’s drug has led to the removal of its commissioner 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, offering hope to about 35 million people worldwide living with the disease. But the decision angered scientists who say the treatment doesn’t work and shouldn’t have been approved, and that the regulator ignored scientific advice.
“The agency has long occupied this esteemed position in the world of drug regulators…. This is threatened by this case,” said Peter Lurie, president of the Center for Science in the Public Interest, a group of independent defense.
Aducanumab, which it costs $ 56,000 a year, is the first drug that aims to slow the progression of the disease itself rather than treat its symptoms.
Three FDA board members left in a quick succession after the decision, saying the regulator’s decision lowered their standards. Last year the panel opposes unanimity to approval of aportanumab.
Aaron Kesselheim, one of the members who resigned, said it was “probably the worst drug approval decision in recent U.S. history.”
The contentious approvals are reminiscent of similar decisions taken by the FDA in recent years where drugs with questionable effectiveness have had approval. In 2016, the regulator came under criticism for its approval of eteplirsen, a treatment for people with Duchenne muscular dystrophy – a debilitating disease where muscles are lost over time.
In 2015, the FDA Authorized pink Viagra, a libido stimulant for women, despite twice being rejected for concerns that the benefits did not outweigh the side effects.
“This is very reminiscent of [eteplirsen]”, Said Bruce Ovbiagele, a member of the FDA’s advisory committee that opposed the approval of both the Alzheimer’s drug and muscular dystrophy. He said the two decisions are based on evidence. scientific weaknesses.
“The FDA could have put pressure on community advocates and the fact that these devastating diseases don’t even have modestly effective treatments,” he added.
Many members of the scientific group point to a strangely close collaboration between Biogen and the FDA as an example of the regulator becoming too connected with the companies it monitors.
The FDA and Biogen have released a joint information document for the company’s application, a curious move between a regulator and its regulated company. “Gradually the barriers start to fall and soon you will be co-authoring a briefing document together,” Lurie said, adding that “in small increments” the agency has grown too close to the pharmaceutical industry.
The agency said: “The FDA often works closely with industry to help promote drug development, understand emerging data, and advise on best approaches for development plans, particularly in areas where there is it is a significant need for treatments for devastating diseases. “
Some critics have accused Janet Woodcock, the head of the FDA, of allowing her to cultivate this close relationship. He also supervised the approval of various painkillers while opiate epidemics raged in the United States.
Woodcock was appointed incumbent commissioner this year while the search for a permanent chief continued. It is considered a shoe for the role and some believe that such a major drug approval would not have been made without a hint from it.
“A decision of this magnitude with this kind of potential controversy would have to end up being green at a higher level than Dunn,” Ovbiagele said, referring to Billy Dunn, head of the FDA’s neuroscience unit. .
The FDA said the data submitted for adducanumab “was very complex, and our review was complete.” All drug reviews “are a team effort. No person makes isolated decisions on any approval, policy or safety matter,” he added.
Woodcock did not respond to a request for comment on the calls for its removal or said it is too close to the industry.
A healthcare investor, who refused to be appointed, said: “In the industry, everyone keeps their mouths shut. The Big Pharma companies have been completely quiet, because they know that if they say something in Janet’s favor, it would be toast. But everyone says, ‘Listen, you know with Janet, at least we know what to expect’ ”.
Thursday, Joe Manchin, the West Virginia senator, he wrote a letter to President Joe Biden encouraging him not to nominate Woodcock as permanent head of the regulator. “Dr. Woodcock is not the right person to lead the FDA,” he wrote, adding that he “has repeatedly ignored public health concerns” regarding the opioid epidemic.
Michael Carome, director of the health research group at Public Citizen, said the agency “is too often making decisions that are in the best interests of pharmaceutical companies and their shareholders rather than in the best interest of public health. and their patients. ”
Last week, Carome wrote to the U.S. secretary of health organizing 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 indiranumab to the agency’s credibility as a science-based regulatory agency… Cannot be overestimated,” he wrote, adding that “the regulatory catch of agency by industry ”has been agreed.
The FDA has been accused of favoring a revolving door environment this month when it emerged that former commissioner Stephen Hahn would take a job at Flagship Pioneering, the investor who founded Moderna. Hahn was head of the FDA when Modern’s Coverna-19 vaccine was approved last year.
The green light for adducanumab may set a precedent for future drug approvals and comes when the FDA seeks to restore confidence in itself and its science after controversies during the pandemic – such as endorsement then refusal to use hydroxychloroquine to treat Covid-19 patients.
“This was the opportunity for the agency to say we were pushed during Trump, but it’s back to business as usual, meaning the FDA is the gold standard for scientific rigor.” , said Lurie. “This one [approval] puts the agency back. . . they flashed the ball. “