If the CNBC reports from Friday and today can be believed, this is going to be a worse debacle than the Aduhelm fiasco.
Current Alzheimer’s questionnaire was not used by Lilly; rather, a previous version was selected by Lilly.
Tau was ignored because the advisory committee felt too many hospitals didn’t have the equipment needed to detect Its presence or absence. Requiring Tau detection would eliminate a large number of potential patients from being eligible for the drug because of the inability to test for it.
Only very, very early potential AD patients were selected for the study when an Amyloid beta plaque could be detected, but no symptoms of AD (according to the obsolete questionnaire) were detected.
If the researchers who believe that amyloid beta and tau are the key elements in the brain’s immune system are, in fact, correct, then that would be a surefire guarantee no patient with AD was selected.
Is there any chance in hell that any healthcare benefit provider will pay to treat a patient who is perfectly healthy has no symptoms and under these guidelines would have no chance in hell of having AD?
…. And who is going to initiate the process? Will it be the patient? Or will it be the doctor? And why would either one of them initiate it? There are no symptoms.
How often would they repeat the process once a year? Four times a year. Once every four years? … only patient older than 70 years old. Some other age restriction, no age restriction?
For most, if not all of my adult life, I had the highest respect for the FDA and its capabilities. Their behaviour with Biogen and now with Lilly strikes me as utterly irrational.
FWIW,
Ian
