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Message: The FDA's highly arbitrary decisions

I want to first thank BearDownAZ for reeling me (and my assertions) back in with his well-delivered sermon about making certain claims without proper clinical evidence and FDA approval.

I agree that a proper scientific process must be followed collecting irrefutable clinical evidence from multiple trials, having its results independently interpreted and judged, and finally then proceed to convincing the FDA for an approval.  

Yet, here we have Biogen and their single trial for Alzheimer Disease and a trial that was halted mid-way for futility.  And despite the rather scant evidence from a single, discontinued trial, and despite an independent panel rejecting the trial's evidence, Biogen gets FDA approval for Alzheimer Disease and a license to print money for what may well be just a pill with false hopes.

Seems like I am not the only one to "jump gun" on validating a drug's usefulness.  The FDA does it too!

https://www.cnbc.com/2021/06/07/fda-approves-biogens-alzheimers-drug-the-first-new-therapy-for-the-disease-in-nearly-two-decades.html

 

"In March 2019, Biogen pulled work on the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the drug after all.

Shares of Biogen soared in November after it won backing from FDA staff, who said the company showed highly “persuasive” evidence aducanumab was effective and that it had “an acceptable safety profile that would support use in individuals with Alzheimer’s disease.”

But two days later, a panel of outside experts that advises the U.S. agency unexpectedly declined to endorse the experimental drug, citing unconvincing data. It also criticized agency staff for what it called an overly positive review.

When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials.

Some doctors have said they won’t prescribe aducanumab if it does reach the market, because of the mixed data package supporting the company’s application.

Supporters, including advocacy groups and family members of those living with the disease desperate for a new treatment, have acknowledged the data isn’t perfect. However, they contend it could help some patients with Alzheimer’s, a progressive and debilitating disease."

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