For a more detailed rundown of Friday’s meeting, with slides from the presentations, click here.
A panel of outside experts resoundingly concluded Friday that clinical data did not support the approval of Biogen’s much-watched Alzheimer’s drug, aducanumab, while providing a rebuke to the Food and Drug Administration, whose reviewers had given the medicine a glowing appraisal.
Aducanumab has been a focal point for the pharmaceutical industry because the need for a medicine to treat Alzheimer’s is desperate, in both human and economic terms, and because of the huge financial windfall that would accrue to Biogen if the drug were approved. But the way the clinical studies were conducted generated controversy. They were initially stopped because they seemed unlikely to provide a benefit; a re-analysis of the data showed that one of two studies appeared to show a benefit while the other did not.
Speaking as a layman, not a medical person, I am infuriated that the FDA might approve yet another useless drug to fight Alzheimers. Aricept, Namenda, and the Excelon Patch do no good yet once started, you are afraid to stop because there is nothing else. Meanwhile the march to loss of dignity continues to the point you wish for death. I have no respect for the FDA.
The FDA seems to have given up on pretending they work for the people. It’s all about servicing the careers of FDA employees, who hope to get a job in industry after their stint at the agency. They are all just a bunch of sycophants to industry executives. We saw Sarepta, now this, and everything in between.
Billy Dunn, should resign or be replaced- NOW! Full stop.
The first question that his group crafted for the Advisory Panel had the gall to ask the Advisory Committee to literally endorse “cherry picking” clinical trials.
“Does Study 302, viewed independently and without regard for Study 301, provide strong evidence that supports the effectiveness of aducanumab for the treatment of Alzheimer’s disease? ”
No one who thinks that it is okay to flatly ignore clinical trials that don’t give the desired read out has any business working at the FDA.
To Stephen Hahn- do the right thing!
it seems like that after all that happened in this Trump infused FDA, they just stopped pretending they are a serious overseeing agency with scientific integrity altogether