Harvard Colleagues Clash Over F.D.A.

In a very public war of words, two Harvard colleagues have been debating the effectiveness of the Food and Drug Administration following publication of a new book, “Reputation and Power: Organizational Image and Pharmaceutical Regulation at the F.D.A.,” by Daniel Carpenter, a professor at the university.

In a sharply critical review in the New York Review of Books, Dr. Marcia Angell, a former editor of The New England Journal of Medicine and longtime critic of the drug industry, slammed a fellow professor’s take and the agency itself by offering nine ways to overhaul it.

In turn, Dr. Carpenter issued a pointed response and a 12-page letter.

The exchange between Harvard professors — Dr. Angell is a senior lecturer at the medical school, Dr. Carpenter is a professor of government — exposes an unusually personal clash along with contrasting portrayals of how well the F.D.A. does its work.

Dr. Angell wrote: “Since the F.D.A. is what stands between the public and an aggressive, profit-driven industry, its independence from the industry it regulates is of fundamental importance. This is not an issue that receives much attention from Daniel Carpenter in his imposing new book.”

Dr. Angell went on from there to list what she believes the agency should do to change. She said the $400 million the industry has paid in what are called user fees since enactment of the Prescription Drug User Fee Act of 1992 has distorted F.D.A. financing by adding drug approvers, but not enough staff for post-marketing surveillance and truth-in-advertising. That law, she says in one of her nine recommendations, should be repealed.

Dr. Carpenter responded with a vigorous defense of his views and an attack on Dr. Angell for what he termed “factual errors and profound historical mischaracterizations.”

He wrote: “These errors and mischaracterizations, among many others, demonstrate the risk of converting a book review into a personal soapbox to rehearse talking points the reviewer has been making elsewhere for a decade. In that time, science, the F.D.A., and scholarship itself have been passing by Angell’s hollow and specious portraiture.”

Dr. Angell then added a rebuttal, in a note posted at the end of Dr. Carpenter’s letter on the review’s Web site. “He seems unable or unwilling to admit that the agency is not doing its job,” she wrote.

Dr. Angell’s nine proposals are summarized on a Web site posting Thursday from Vera Hassner Sharav, director of the Alliance for Human Research Protection and an F.D.A. critic. (The full exchanges in the New York Review of Books require a subscription.)

.