I read today in the NY Times an article about the extension of a patent on the best-selling Alzheimer’s drug Aricept. In order to keep the lucrative patent protection, the drug’s maker, Pfizer, just radically upped the dosage in the tablets. After study of the effects of the new dosage, the researcher recommended against its approval. Serious side effects, including nausea and vomiting (especially problematic for the elderly, frail and mentally impaired) and increased death rates (now, that is a pretty serious side effect), showed up. Here’s the decision by the F.D.A:
Nevertheless, the drug was eventually approved by Dr. Russell Katz, director of the F.D.A.’s neurology products division, who acknowledged that side effects from the higher dose “could lead to significant morbidities and even increased mortality,” but concluded that the drug most likely improved overall functioning even though the study did not show that.
OK, no good results were shown, lots of bad results, including increased death, were observed, and the drug gets approved? Can someone help me with this one?