Healthy Skepticism Library item: 14981

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

Mandatory Medical Disclosure Gains Traction
CSPI Newsroom 2009 Jan 26
http://www.cspinet.org/integrity/press/200901261.html

Full text:

Sens. Charles Grassley (R-IA) and Herb Kohl (D-WI) last week introduced legislation requiring manufacturers that sell goods to government health care programs to report payments to physicians greater than $100 in a publicly-available Internet database. The disclosures made under the Physician Payments Sunshine Act would detail the value and date of the payments and include consulting, honoraria, food and entertainment, research support and stock ownership. The legislation echoes recommendations included in a perspective in the New England Journal of Medicine (subscription required) last week.

The proposed law does not extend to requiring companies or others sponsors of clinical trials to report conflict-of-interest information to the FDA before physicians begin enrolling their patients in the trials. Such reporting is necessary, according to a new Health and Human Services inspector general’s report, if the agency is going to monitor “the potential for bias that may compromise the safety of human subjects and the integrity of research data.” The report found just one percent of nearly 30,000 investigators listed on new drug and device applications in 2007 reported conflicts of interest to the agency, despite estimates in the Journal of the American Medical Association that “between 23 percent and 28 percent of academic researchers had financial interests in medical companies,” according to the inspector general’s report.

Meanwhile, the voluntary movement among academic medical centers toward greater disclosure accelerated last week when Harvard Medical School Faculty Dean Jeffrey S. Flier announced he will chair a committee to review the current Faculty of Medicine Policy on Conflicts of Interest and Commitment, according to the Harvard Crimson. Cleveland Clinic and Duke are among the medical schools that have recently begun disclosing all faculty members’ corporate ties on their websites. And Park Nicolett, a health care provider in Minnesota with more than 8,100 employees, will begin disclosing their physicians financial ties to medical device and drugmakers, the Minneapolis Star Tribune reported.