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In The Spotlight

By Michael E. Clark
April 01, 2003

On March 28, 2003, Tommy G. Thompson, Secretary of the United States Department of Health and Human Services (HHS), announced the publication of a proposed draft guidance to protect human-research subjects from the risks of harm possibly arising from researchers' financial conflicts of interests. See “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection,” which is posted at www.fda.gov/ohrms/dockets/GUIDANCES/DGUIDES.htm. Because of shrinking revenues, more and more physicians during the past decade have become involved with privately sponsored research as a way of augmenting their incomes, even though they have not necessarily understood the fraud and abuse risks involved, nor are they fully appreciative of the reasons for fully disclosing to patients they enroll in such studies these financial conflicts of interest.

As I noted in Fraud and Abuse Issues in Private Clinical Pharmaceutical Research, 3; Health Care Fraud & Abuse Newsl (Dec. 2000), “The Office of the Inspector General (OIG) issued a 'Fraud Alert' in August 1994 concerning payments by pharmaceutical manufacturers. [This Fraud Alert] … demonstrat[ed] the agency's continued concerns about certain pharmaceutical manufacturers improperly characterizing the payment of substantial funds to physicians as 'research grants' under circumstances where the grant recipients performed minimal services.”

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