For Aduhelm, It’s All Over But The Shouting – But The Shouting Has Only Just Begun!

American Council on Science and Health ^ | 07/16/21 | Chuck Dinerstein

[Pining_4_TX]

The FDA perspective

If you need to get up to speed on the controversy, look here. The approval was based on three studies.

197 patients in a double-blind cohort study looking at increasing doses of aducanumab (Aduhlem). There was a dose-related improvement in both patients’ clinical improvement and reduction in visible Aβplaque (the anatomic biomarker of Alzheimer’s Disease found within the brain). These findings were statistically significant only at the highest dose, 10mg/kg monthly.

Two Phase III studies, involving roughly 1650 patients each, both double-blind, placebo-controlled. The first of these showed the same clinical improvement as the previous smaller study and improvement in tests that use other measures of cognitive function, memory, and activities of daily living. The authors write that the “P values …were impressively significant.” The second of the two phase III studies did not replicate the first.

Both Phase III studies were stopped for “futility” – because statistically, they would have been unable to achieve their objectives – in this instance, showing a clinical benefit in Alzheimer’s Disease patients. The measure of futility was determined before these studies began to reduce bias once the investigations were underway.

[Chode]

@$56,000 per year...

[arthurus]

And they can’t tell us yet if the stuff actually reduces the effects of the disease. The plaque being the cause of it is still only a best guess.

[Chode]

trust science... /s