May 30, 2007Dr. Nissen claiming attack by FDA
An e-mail sent to several health reporters by a top Food and Drug Administration spokesperson appears to be intended to damage the reputation of Dr. Steven Nissen of the Cleveland Clinic. He is the prominent cardiologist who recently published an important study of the diabetes drug Avandia.
In fact, Dr. Nissen claims to be the target of a smear campaign. The e-mail, which sarcastically refers to him as “St. Steven,” includes an anonymous blog that accuses him of favoring some drug companies over others.
Dr. Nissen is the lead author of a study published last week in the New England Journal of Medicine. It indicated that GlaxoSmithKline’s Avandia may raise the risk of heart attacks. He was displeased about what he considers an attack on his personal integrity and professional reputation.
He says that Douglas Arbesfeld has abused his position and should instead address the scientific questions addressed in the NEJM article.
Arbesfeld, among the FDA’s top spokespeople, came to the agency after working at Johnson & Johnson. He admits sending the e-mail but insists he was did not mean to impugn Dr. Nissen’s reputation. The FDA issued a statement distancing itself from his words.
He insinuated that Dr. Nissen is tougher on manufacturers that do not support drug trials at the Cleveland Clinic. Dr. Nissen says, “The idea that I would somehow be selective in my criticism to those companies that don’t bring clinical trials [to the Cleveland Clinic] is extremely offensive and absolutely untrue.” He gave the example of when he criticized COX-2 drugs such as Celebrex (a Pfizer product) while he was working on a Pfizer clinical trial.