Healthy Skepticism Library item: 15265

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Mundy A.
Grassley Says Knee Device Maker Was ‘Calling the Shots’ at FDA
The Wall Street Journal Health Blog 2009 Mar 10
http://blogs.wsj.com/health/2009/03/10/grassley-says-knee-device-maker-was-calling-the-shots-at-fda/

Full text:

Sen. Chuck Grassley is busy again, asking for information about the FDA’s approval last fall of a knee implant made by ReGen Biologics.

After a WSJ article about a controversy involving the approval appeared Friday, Grassley sent letters to the FDA and ReGen, based in Hackensack, N.J., asking for documents about their interactions, particularly those leading up to an FDA advisory committee meeting about the device held Nov. 14.

The Iowa Republican, who has been investigating the drug and device divisions of the FDA for several years, said his inquiry is based on emails that “make it look like the device maker was calling the shots and the FDA was going out of its way to accommodate the company.”

The Grassley letter also mentions a study that ReGen sponsored to support approval of its device. One of the study’s nine authors was William Rodkey, ReGen’s VP of scientific affairs, and Grassley says another was J. Richard Steadman, a company director. See ReGen’s directors here.

Even though an FDA memo mentions the company positions of the two men, slides prepared by the agency for its advisory committee meeting “did not mention that these two authors were affiliated with ReGen,” the Grassley letter says. The director of the FDA’s device center, Daniel Schultz, told the WSJ that the agency wasn’t trying to hide anything.

The ReGen-backed study was published in the Journal of Bone and Joint Surgery in July 2008, which also didn’t mention the authors’ company connections. The editor of the journal, James Heckman, said he wasn’t aware of the specific company ties of then men, but that the journal’s disclosure form only asks authors to report receiving more than $10,000 in a year from a sponsor company for work outside the study research itself.

Readers, said Heckman, should be “nervous” if they see a disclosure that one or more authors got more than $10,000 (such authors aren’t specifically named under the policy). But he said it isn’t his role to list business affiliations of the authors. “My motto is caveat lector,” he said: Let the reader beware.

ReGen told the WSJ that the medical journal’s disclosure policies had been followed, adding, “ReGen believes that the disclosure in the article made it clear that authors had financial connections to ReGen.”