Those of us without evidence of cognitive impairment certainly remember the hubbub over the release of Aducanumab, the first FDA-approved drug to treat Alzheimer’s Disease. A short, to-the-point research letter in JAMA clarifies why it has the potential for abuse – and what the FDA needs to do to prevent it.
The FDA’s controversial approval of Aduhelm, the drug intended to treat Alzheimer’s Disease, has resulted in resignations from their advisory committee and now investigations, both internal and Congressional. The FDA and editors of JAMA Internal Medicine are speaking out before the investigational circus comes to town.
There has been a lot of ink spilled, and bytes spent this week discussing the FDA’s approval of aducanumab, brand-name Aduhelm, for the treatment of Alzheimer’s Disease. I have mixed feelings; there are advantages to a Phase 4 study, but how do you say no to hope?
Is Biogen's Alzheimer's drug a historic achievement or red herring? There are plenty of opinions on both sides. Nonetheless, it received FDA approval despite an unanimous downvote from its own expert panel. What is going on here? No one knows, but to me, it just doesn't smell right.
Dietary supplement companies are not renowned for their ethical business practices. But 16 companies may have redefined the word "sordid" by peddling useless supplements to Alzheimer's patients and their families. At least they got swatted down by the FDA. But how much did they suck from desperate families before the FDA warning letters went out? And how do these guys sleep at night?
A group at Mount Sinai Medical School has made a rather startling discovery. People who died from Alzheimer's Disease had brains that contained more of two herpes viruses than controls. Could we have been looking in the wrong direction for therapies for this disease? This is a potentially huge discovery.