Now THIRD member of advisory panel quits in protest at FDA's decision to approve first Alzheimer's drug in 20 years that he and his colleagues say doesn't work

 A third member of an FDA advisory panel has resigned in protest over its approval of the first new drug for Alzheimer's disease in 20 years. 

Aaron Kesselheim, a Professor of Medicine at Harvard Medical School who had served on the Food and Drug Administration´s advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down. 

He quit days after the FDA approved the drug made by Biogen Inc, which is called called aducanumab, and will be marketed as Aduhelm. 


'My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees...because I didn´t think that the firm recommendations from the committee in this case...were appropriately integrated into the decision-making process,' Kesselheim said in an email.

Kesselheim and his colleagues Dr Joel Perlmutter and Dr David Knopman were upset after the FDA ignored their warnings that aducanumab had not actually been shown to slow the brain-destroying disease. All 11 members of their committee voted against approving it. 

FDA bosses said they approved the drug after deciding that it could manage some symptoms of Alzheimer's, including anxiety and insomnia, saying that aducanumab was 'reasonably likely' to benefit Alzheimer's patients. 

Professor Aaron Kesselheim, pictured in 2018, has stepped down from an FDA advisory committee over its decision to approve a new treatment for Alzheimer's

Professor Aaron Kesselheim, pictured in 2018, has stepped down from an FDA advisory committee over its decision to approve a new treatment for Alzheimer's

Another adviser, Joel Perlmutter, resigned Tuesday, amid claims the treatment offers no real benefits to sufferers
Neurologist David Knopfman, who quit the board over the same treatment on Monday

Drs Joel Perlmutter, left, and David Knopfman, right, also quit the board earlier this week over the decision to approve the drug aducanumab, which will be marketed as Aduhelm 

Biogen Inc, which is based in Cambridge, Massachusetts, says a year's treatment of Aduhelm is set to cost around $56,000. 

Biogen thinks that around 1.5 million Americans could be eligible to receive its new treatment, which they say may allow patients to live independent lives for longer, but not act as a cure for Alzheimer's. 

The drug works by clearing a protein called beta-amyloid, which causes plaques to form in the brains of Alzheimer's sufferers. 

That protein is thought to begin forming years before Alzheimer's patients show any symptoms, meaning treatment should be given as early as possible.   

Aduhelm is designed to work by clearing plaques in the brain which cause memory loss associated with Alzheimer's

Aduhelm is designed to work by clearing plaques in the brain which cause memory loss associated with Alzheimer's

A scientist is pictured working on the development of Aduhelm. Its manufacturers claim people who take the drug will be able to live independent lives for longer

A scientist is pictured working on the development of Aduhelm. Its manufacturers claim people who take the drug will be able to live independent lives for longer 

He and the other two medics who resigned were all members of an outside advisory committee. Perlmutter, who resigned Tuesday, is a neurologist at Washington University, while Knopman, who works as a neurologist at the Mayo Clinic, quit Wednesday.  

The FDA on Monday gave the drug 'accelerated approval,' based on evidence that it can reduce a likely contributor to Alzheimer´s, rather than proof of a clear benefit against the disease. 

They added that aducanumab was 'reasonably likely' to benefit Alzheimer's patients. 

Aducanumab was only tested in patients in the early stages of Alzheimer's, and not among people whose condition had progressed and left them unable to care for themselves.  

The FDA, whose HQ in White Oak, Maryland, is pictured, has yet to comment on the resignations, but insists approving the drug will benefit Americans living with alzheimer's

The FDA, whose HQ in White Oak, Maryland, is pictured, has yet to comment on the resignations, but insists approving the drug will benefit Americans living with alzheimer's 

Kesselheim also cited FDA's decision to approve Sarepta Therapeutic Inc's drug, eteplirsen, for Duchenne muscular dystrophy in 2016 as another example of the regulator approving a drug against the recommendations of its advisory committee.

The 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence that the drug was effective.

Around six million Americans have Alzheimer's. The degenerative condition attacks the parts of the brain needed for memory, reasoning, communication and basic daily tasks.

During its final stages, sufferers lose their ability to swallow. 

Alzheimer's is the most common cause of dementia, and is expected to become an increasing burden on health systems worldwide in the coming years, amid rising life expectancies.  

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