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This idea is reflected in what’s known as the “right to try” movement, which aims to allow patients greater latitude to try drugs that have not received full FDA approval outside of a clinical trial. The agency has a long-standing “expanded access” program that allows patients to use unapproved drugs 카지노사이트
to expand patient access to experimental therapies. The spirit behind these rules — giving patients with serious or life-threatening conditions every opportunity to find treatments that work — is understandable, but critics say they do little but provide false hope. 카지노사이트
in support of the drug, starting with advertisements on the internet. Despite these efforts, the controversy over the FDA’s approval of Aduhelm has led to a rocky launch for the product. Two major medical centers 카지노사이트
is reviewing whether to approve payments for use of Aduhelm. The overwhelming majority of people with Alzheimer’s are 65 and older, and thus are covered by Medicare. Medicare almost always covers FDA-approved drugs, but if it were to reject Aduhelm, that would be a major blow to the product and its owner, Biogen 카지노사이트
Sen. Joe Manchin, a West Virginia Democrat, demanded that Dr. Janet Woodcock, the acting commissioner of the FDA, be fired, even though the agency has said she played no role in the Aduhelm decision. Manchin said the Aduhelm approval process “brings into question the current interim leadership 카지노사이트
In a call with stock analysts in July, Michel Vounatsos, the chief executive of Biogen, acknowledged “confusion and criticism” surrounding the approval of Aduhelm but said the company was proceeding with its product launch. “I want to be clear that Biogen stands behind the integrity of the review process,” Vounatsos said.
All of which leaves perhaps the most important question: What should Alzheimer’s patients and their families do? The question is especially difficult because, at the moment, neither insurance nor Medicare will cover the cost of Aduhelm.
“I think some patients and family members, even when presented with the lack of clinical efficacy, concerning side effect profile and out-of-pocket costs, will opt to roll the dice because they feel they have nothing to lose,” he said. “There is no question that patients, family members and physicians are all desperate for a medication that helps. That’s what makes the false hope of Aduhelm particularly cruel.”
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