It’s been a long time coming. After more than 20 years of waiting, the FDA finally approved a new drug for Alzheimer’s disease. There’s just one problem: Not everybody thinks the drug does what its maker, Biogen, says it does, or that it even should have been approved.
Unlike Dr. Dale Bredesen’s ReCODE protocol, which identifies your disease subtype or combination of subtypes so an effective treatment protocol that works can be devised, this new drug, aducanumab (brand name Aduhelm), is a monthly intravenous infusion given to Alzheimer’s diagnosed patients.
Biogen is charging $56,000 a year for the treatments; diagnostic testing, imaging and related provider costs are additional. But does it work? Biogen says it’s the first drug to address the process of Alzheimer’s progression rather than simply treat symptoms.
The controversy lies in the fact that the FDA approved the drug despite abysmal clinical trial evidence of its efficacy. Since the FDA also told Biogen to conduct another clinical trial to see whether the drug actually works or not — reserving the right to rescind its approval if the new trial doesn’t produce satisfying results — the patients taking it now essentially will be part of the drug trials.
And what’s wrong with that? According to The New York Times, “The FDA advisory committee, along with an independent think tank and several prominent experts — including some Alzheimer’s doctors who worked on the aducanumab clinical trials — said the evidence raised significant doubts about whether the drug is effective. They also said that even if it could slow cognitive decline in some patients, the benefit suggested by the evidence would be so slight that it would not outweigh the risk of swelling or bleeding in the brain that the drug caused in the trials.”
SOURCE: The New York Times June 7, 2021