Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 23 March 2012 | By Alexander Gaffney, RAC
An article in The British Medical Journal (BMJ) claims the US Food and Drug Administration (FDA) approved a higher-dose version of Eisai's blockbuster Alzheimer's drug Aricept 23 (donepezil) despite the concerns of its reviewers at FDA, reports The New York Times.
FDA review staff noted their concerns about the drug's safety and efficacy, according to The Times, finding little evidence of the drug's effectiveness in a 1,400-person clinical trial, but finding a substantial increase in side effects.
Despite recommendations from a clinical reviewer and statistical review at FDA, Aricept 23 was ultimately approved by the Director of FDA's neurology products division, Dr. Russell Katz in July 2010.
The choice was not one that benefited patients, argued Dr. Steven Woloshin, the BMJ article's author.
"It doesn't really have much benefit, but does substantially more harm," said Woloshin.
Sidney Wolfe of the group Public Citizen Agreed with Woloshin's assessment.
"Rarely do we see such a dangerous difference between what pretty much everyone in the neurological division thought and what its leader thought," said Wolfe. "That's a huge slap in the face to all the people who spent much more time reviewing this drug than he did."
New York Times - Drug Dosage Was Approved Despite Warning
BMJ - How the FDA forgot the evidence: the case of donepezil 23 mg
Tags: Neurology Products Division, Woloshin, Wolfe, Katz, Alzheimer's, Donepezil, Aricept, BMJ, Latest News, staff, review