Drug Dosage Was Approved Despite Warning

Four months before a best-selling Alzheimer’s drug was set to lose its patent protection, its makers received approval for a higher dosage that extended their exclusive right to sell the drug.

 “It doesn’t really have much benefit, but does substantially more harm,” said Dr. Steven Woloshin, one of the co-authors of the journal article and a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice.

The drug, Aricept 23, was approved in July 2010 against the advice of reviewers at the Food and Drug Administration.

They noted that the clinical trial had failed to show that the higher dosage — 23 milligrams versus the previous dosages of 5 and 10 milligrams — met its goals of improving both cognitive and overall functioning in people with moderate to severe Alzheimer’s disease.