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Biotech / Medical : 2022 Biotech Charity Contest -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (238)	12/29/2022 4:36:06 PM
From: technetium	Read Replies (1) \| Respond to of 267

Almost nobody has signed up yet. GET WITH IT FOLKS! Thanks.

To: Arthur Radley who wrote (238)	12/29/2022 4:43:19 PM
From: technetium	Respond to of 267

Investigation faults FDA, Biogen for Alzheimer’s drug approval washingtonpost.com “The biotechnology company Biogen and its regulator, the Food and Drug Administration, worked in concert, ignoring internal concerns from the company and skirting the agency’s own written guidance, to allow the Alzheimer’s treatment Aduhelm to receive accelerated approval and hit the market at a cost to patients of $56,000 a year, according to a scathing report released Thursday by two House committees. “The “unusual” collaboration, which resurrected Aduhelm three months after Biogen had canceled clinical trials, unfolded through at least 115 meetings, calls and email exchanges between the company and the FDA in a year, said the report by the Committees on Oversight and Reform, and Energy and Commerce. “The joint effort climaxed with staff from the agency helping Biogen draft a document used to brief the FDA’s advisory committee before it met to discuss Aduhelm on Nov. 6, 2020. Although the FDA often follows an advisory committee’s recommendation, it did not this time. After no member of the advisory committee recommended Aduhelm, the FDA changed course, allowing Biogen to move its drug to an accelerated approval process. “At the FDA’s suggestion, the drug was labeled for use by the nation’s more than 6 million Alzheimer’s patients, even though it had been tested only on people with early Alzheimer’s and mild symptoms, the report said... “… Aduhelm proved to be a financial dud, generating $3 million in revenue for all of 2021. ”In a statement responding to the report, Biogen said it had cooperated with the committees and “stands by the integrity of the actions we have taken.” Biogen’s statement also cited the FDA’s internal investigation, which concluded that there was no evidence of impropriety in the dealings between the agency and company. “Biogen stuck with the initial $56,000-per-year price tag despite projections that the drug could wind up costing Medicare up to $12 billion in a single year. Other Alzheimer’s treatments sell for much less. A year’s supply of Aricept costs less than $8,000; Exelon, a drug in the same family, costs about $8,800 for a year’s supply; and Namenda costs less than $3,000 per year...”