The Food and Drug Administration has agreed to review a marketing application submitted by Biogen for aducanumab, its treatment for Alzheimer’s disease, the company announced Friday.
The aducanumab application was granted priority review, which means the FDA will render an approval decision no later than March 7, 2021.
According to Biogen, the FDA “plans to act early” if possible on the application, and that an advisory committee will be scheduled so that outside experts can review the aducanumab data. A date for that meeting has not yet been set.
About the Author Reprints
It has been clear for almost 20 years that a low dose of lithium is sufficient to slow, and sometimes even reverse, degenerative neurological conditions. Multiple Sclerosis is a prime example. Studies such as one in Denmark have shown that higher lithium levels in the water supply reduce incidence of Alzheimer’s. A study sponsored by the Alzheimer’s Organization is investigating whether daily use of the “pediatric” 150 mg dose of lithium is sufficient to reduce incidence of Alzheimer’s. Results are expected in 2022, unless the Covid virus has disrupted the study. Low dose lithium is cheap, safe, and widely available. Why look for another failure from Big Pharma?
Is anyone currently treating AD patients with lithium?
Is anyone currently treating AD patients with lithium? Approved or unapproved?
There is a psychiatrist, Dr. Phelps, in Oregon, who has been treating patients whose parental history suggests high risk with low-dose lithium. A Cornell psychiatrist wrote in the New York Times, “Should We All Take a Little Bit of Lithium?” Many in the mental health community prescribe it in low doses. Neurologists tend to regard it as poison, which in “therapeutic” doses, it can be, to the kidneys and thyroid. An additional benefit of lithium is that it boosts the immune system against the virus, as does a little bit of CBD.
Last year, Biogen stopped a pair of late-stage studies, concluding the drug demonstrated no benefit in patients with early-stage Alzheimer’s. Five months later, Biogen announced a new analysis of the same studies, declaring that, for patients who got enough of the drug for a sufficient period of time, aducanumab had a positive effect on brain function.
In other words, that’s a post hoc analysis, sort of like painting the target on the side of the barn after you’ve fired the shot. This could be the basis for another study, this time with the null hypothesis specified before the clinical trial, but it absolutely should not be used to obtain approval at this time.
I’m reminded of Lilly’s trials of solanezumab. After the last one failed, they called in an outside statistical analysis firm to look at the data, and they think they found an effect with a certain subset of patients. So now, they’re going back into the clinic with a redesigned study to look at whether solanezumab is effective for that subset. That’s the only way to be sure your post hoc analysis found a real effect and not something turned up by random chance.
I would be skeptical that this drug will do anything other than make the family members of Alzheimer’s patients feel as though something is being done. My husband is experiencing late stage AD as have several of his brothers before him. I predict this drug will do lots for the bottom line of its manufacturer, but like its predecessors do nothing to change the course of the disease . As everyone knows now who knows anything about AD, the scientists have not yet identified a cause.
“If approved, aducanumab would become the first medicine to slow the cognitive decline of Alzheimer’s disease.” Nonsense. It doesn’t work, and FDA approval won’t make it work. It will just rip off vulnerable patients and make Biogen gazillions.
I been told that I have this disease. Please let me know if trials come around.