In his latest effort to probe conflicts of interest in the drug and device industry, US Senator Chuck Grassley has written FDA commish Margaret Hamburg to ask how the agency determines whether the financial interests of clinical investigators may adversely affect patients in clinical trials and the "integrity and reliability" of the studies submitted for product approval.
As Grassley notes in his October 22 letter, the FDA requires manufacturers that submit applications and clinical studies for product approvals to file disclosure statements about the financial interests of investigators who are not full-time or part-time employees, but are or were involved in conducting studies submitted to the FDA.
Specifically, disclosures should include info about financial arrangements between a manufacturer and investigator where compensation could be influenced by the outcome of the study; significant payments to an investigator such as research grants, equipment, consulting fees or honorarium; a proprietary interest in a product held by the investigator, and significant equity interest in a manufacturer held by an investigator.
In explaining his interest, Grassley refers to a 2008 report from the Association of American Medical Colleges and the Association of American Universities that reiterated guidelines for overseeing financial interests in human research. Basically, this stated that anyone who holds a significant financial interest in research involving human subjects may not conduct such research and laid out some compelling exceptions (here's the report).
The letter was prompted by a review of documents Medtronic provided to the Senate Finance Committee, where Grassley is the ranking Republican, showing the device maker filed disclosure forms for seven docs, who all received “significant payments.” For instance, he writes Medtronic reported consulting fees ranging from almost $40,000 to one doc to almost $2 million to another. Three docs also received about $1 million in royalties, while another received several thousand dollars in Medtronic stock. The device maker also filed forms with the FDA for more than 50 other investigators, he adds, and almost all received significant payments, with two meeting three of four criteria for disclosure.
Over the past few years, Grassley has focused on undisclosed conflicts of interest among researchers who work for drug and device makers and, more recently, has scrutinized Medtronic, in particular, over concerns the company may have unduly influenced the choice of one of its former consultants for a senior position with the US Department of Veteran Affairs (look here and here).
Photo courtesy of Jerome Kassirer