America’s approval of an Alzheimer’s drug is premature

admits that it is not proven that the new drug, a monoclonal antibody to be sold under the name Aduhelm, actually works. The approval is misguided. It risks raising unrealistic expectations, wreaking financial harm on health-care systems, damaging the’s reputation for scientific impartiality and perhaps even diverting attention from more hopeful approaches to treating dementia.

An “amyloid hypothesis” holds that the protein is not just a symptom of the disease, but a prime cause. This is widely believed . But it is just a hypothesis . Thehas demanded a further trial, even as the drug goes into use, and has warned it may pull the drug if it is unsatisfactory. Biogen has said that the trial may take nine years. And if the drug is in wide use, withdrawing it would be difficult.

At $56,000 a year, the cost of Aduhelm treatment will create huge problems for health insurers and providers. Certainly the stockmarket has rewarded Biogen’s shares in the belief that a new blockbuster drug has just been given clearance. It is recommended only for people in the early stages of Alzheimer’s, diagnosed by a costlyscan, and will require a course of monthly intravenous administration at a medical facility. Patients will require close monitoring as many develop brain swellings.

That the evidence argued against the approval of Aduhelm does not mean that research into treatments for dementia is going badly. On the contrary, whereas a few years ago some pharmaceutical firms were withdrawing from the field, having written it off as a dead end, some neurologists now expect big breakthroughs. A better understanding is emerging of how the risk of developing dementia can be reduced, by living a healthier life.

Dementia remains one of the 21st century’s greatest health, social and economic problems, and, for some neurologists, anything that stimulates greater efforts to understanding and treating it is welcome. That is why even some of those who have been baffled by the scientific basis of theduhelm approval have applauded it. Surely, however, hope lies not in lowering standards out of desperation, but in following the science.

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Two members of U.S. FDA advisory panel resign over Alzheimer's drug approvalTwo members of a panel of outside advisors to the U.S. Food and Drug Administration have resigned in protest at the agency's decision to approve Biogen Inc's (BIIB.O) Aduhelm for treatment of Alzheimer's disease despite the committee’s recommendation against doing so. newborn NotaryServices SpainNATO Navy_JAG AF JAG
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Two members of FDA panel resign in protest over Alzheimer's drug approvalThe 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence.
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Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drugA third member of a key FDA panel has resigned over the agency's controversial decision to approve Biogen's new Alzheimer's drug, Aduhelm, CNBC has learned. Things that make you go hmmmm FDA is a scam. just like the IRS Amyloid plaques are a symptom more than a cause, so I am skeptical but we will see
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Third member of FDA advisory panel resigns over Alzheimer's drug approvalA third member of a panel of outside advisers to the U.S. FDA has resigned in protest over the agency's decision to approve Biogen Inc's Alzheimer's disease treatment despite the committee's recommendation against doing so. The FDA is as bent as a dog’s hind leg. And the drug is completely unproven. Good on those advisors. I understand desperation of the patients and the families. There is NO evidence this very expensive nostrum works. Approving this drug came down to giving a key to the US treasury to the manufacturer, since most of the cost will be paid by Medicare. 1/ Anyone investigate the financial ties of the members of the FDA? Just a thought.
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NPR Cookie Consent and ChoicesMy RA treatment thru medicare is $6,000 A MONTH. I’m on disability. I live on $900/ month. Needless to say, my RA goes untreated. SenSanders We hope this sets off a wave of conscience-fueled resignations at pharmaceutical companies, which though they have helped with Vaccines they are raking in the money and hurting poor people - not the Beloved Community we are supposed to create on Earth. The pricing of this drug is not feasible for most. It's already crazy expensive to pay for a loved ones care in 24/7 in a nursing home.
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Two doctors have resigned from a prestigious panel after FDA approved a controversial Alzheimer's drugBusiness Insider tells the global tech, finance, markets, media, healthcare, and strategy stories you want to know.
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