NEJM Article Proposes Changes to Disclosing Academic-Industry Relationships
BY SANDER DUNCAN, AUGUST 23, 2010
Studies show that a majority of academic researchers have affiliations with companies in their industry, yet the disclosures of these relationships to an academic's institution may be incomplete or inconsistent. An editorial published recently in the New England Journal of Medicine addresses government and institutional oversight of relationships between academics and industry, recommending measures to increase transparency and simplify the disclosure process for scientists.
While companies promote innovation by sponsoring and advising research, empirical studies have revealed a bias in industry-sponsored research in favor of the sponsor. Currently, faculty members receiving funding from the NIH or other DHHS agencies must disclose to their institution industry support valued at $10,000 or more. The school must then report to the government how they are managing the support. There are no empirical data defining how frequently these disclosures are or are not made, nor is there extensive federal oversight of the subsequent institutional response.
The DHHS has proposed changes to the how the government regulates disclosure, including lowering the value limit to $5,000. After the public comment period ended in July, the authors offered suggestions to enhance the DHHS proposals. Citing $5,000 as “excessively high,” the authors proposed a disclosure threshold of $10 per gift or payment, or $100 per year, consistent with existing Affordable Care Act (ACA) mandates for industry gifts to physicians. In addition, the article advised developing an electronic, standardized federal reporting form through the DHHS to streamline the disclosure process for both academic institutions and federal regulators.
The authors advocated further research into the disclosure system, noting the lack of empirical evidence on the nature and frequency of faculty members failing to report relationships with industry. They encouraged the DHHS to publish their findings and use the data to guide future government action.
The article's proposals for federal oversight mirror some of the more stringent transparency measures currently enacted at the state level. Massachusetts, for example, requires manufacturers to report gifts to physicians with a value of at least $50, while both Massachusetts and Minnesota publish all disclosed data on a state-run website.
