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Group DEMANDS FDA Officials Be Replaced After the Worst Alzheimer's Drug-Approval Decision in US History!! 3 FDA Advisers Resign in Protest!!

Posted By: RumorMail
Date: Sunday, 20-Jun-2021 11:31:21
www.rumormill.news/175142

Someone near and dear to me was recently diagnosed with RA.
The drugs that the arthritis center prescribed for him were mind boggling, dangerous and in some cases deadly.

Methotrexate: Originally designed as a cancer treatment, it wasn't doing it's promised job as well as it should. So, they now give it to RA patients. 10 pills in 1 day @ once per week. If you ever want to read a horror story, look up it's side effects..

Lynda

PS He's no longer taking it..
****************************

FDA officials asked to step down after contentious Alzheimer’s drug approval

Three experts resigned in protest. Watchdog says it’s FDA brass that should leave.

A leading advocacy and watchdog group is calling for the ouster of three top officials at the Food and Drug Administration—including its acting commissioner—after the regulator issued a highly contentious approval last week of the unproven and now highly priced Alzheimer’s drug Aduhelm (generic name: aducanumab).

The call for fresh FDA leadership comes atop a chorus of harsh criticism over the decision, which outside researchers and industry experts have called “disgraceful” and “dangerous,” among other things.

Since Aduhelm’s approval was announced June 7, three expert advisers to the FDA have resigned in protest, with one calling the decision “probably the worst drug-approval decision in recent US history.” The three experts were part of an 11-member advisory committee that reviewed the clinical data for the Alzheimer’s drug last November and voted nearly unanimously against approval (10 voted against, 1 voted “uncertain”).

On Wednesday, advocacy group Public Citizen only increased the din of criticism, calling the FDA’s approval “reckless.” The FDA’s decision “showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency,” Michael Carome, director of Public Citizen’s Health Research Group, said in a statement. “The sheer recklessness of the FDA’s approval of aducanumab cannot be overstated. This decision is a disastrous blow to the agency’s credibility, public health and the financial sustainability of the Medicare program.” The latter point refers to the fact that Aduhelm’s developer, Biogen, set the drug’s list price at $56,000 for a year’s supply.

In a letter addressed to Xavier Becerra, secretary of the Department of Health and Human Services, Dr. Carome and Public Citizen called for the immediate resignation or removal of three top FDA officials, whom they described as “most responsible” for the approval. They are: acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, and CDER Office of Neuroscience (ON) Director Billy Dunn.

“New leadership of the FDA and CDER is a prerequisite for restoring the agency’s credibility and reversing the slide in the agency’s standards for ensuring the safety and effectiveness of new drugs,” Carome said in the letter. “You should direct the next Acting FDA Commissioner to consider whether the agency’s approval of Biogen’s BLA for aducanumab should be withdrawn.”


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Articles In This Thread

Group DEMANDS FDA Officials Be Replaced After the Worst Alzheimer's Drug-Approval Decision in US History!! 3 FDA Advisers Resign in Protest!!
RumorMail -- Sunday, 20-Jun-2021 11:31:21
Documentary, “Overload: America’s Toxic Love Story”, Free to Watch Online June 23-30
RumorMail -- Sunday, 20-Jun-2021 11:35:40

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AN EXPLANATION OF THE FACTIONS