Life Science Compliance Update

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July 02, 2008

Grassley: Letters on NIH Conflict of Interest

This past week, Senator Grassley sent letters around Capitol Hill calling on Congress and NIH leaders to identify conflicts of interest in taxpayer sponsored medical research.  He outlined that:

“There’s mounting evidence that the NIH hasn’t done due diligence in keeping track of industry payments to medical researchers”, Grassley said. “With the objectivity and integrity of research at stake, along with public trust in the system, there are plenty of reasons for Congress to step in to establish penalties for grantees who fail to report financial conflicts and to bring transparency to taxpayer funded medical research.”

Current federal law requires the NIH to monitor financial conflicts of interest by requiring the institutions who receive grants to collect and manage information on the money that their researchers receive from drug and device makers and others in industry. Recent reports have revealed that this tracking is not happening in individual cases. In addition, the Inspector General for the Department of Health and Human Services reported in January that the NIH does not adequately monitor its extramural grants for conflicts of interest. Extramural research is research supported by funds from the NIH for researchers and organizations outside the NIH through a grant, contract or cooperative agreement.

Grassley said that NIH leaders need to send a clear message that hiding conflicts of

interests due to either sloppiness or sneakiness will not be tolerated. “The monetary value and prestige of NIH grants is significant enough that the possibility of losing a grant for not complying with reporting requirements ought to be a strong incentive to follow the rules,” he said. With almost $24 billion in NIH research grants awarded this year, Grassley said that he hopes lawmakers with primary responsibility for directing those funds will also step in and make the rules meaningful and shed light on what’s happening.

He did acknowledge that the Director of the NIH pledged to “significantly enhance the identification and management of FOCIs (financial conflicts of interest)” in a June 20, 2008 letter to Grassley. The Director also said that NIH is considering gathering public comments to modify the regulations that govern NIH extramural grants.

In an earlier New York Times article, Dr. Norka Ruiz Bravo, the institutes’ deputy director for extramural research stated: “For us to try to manage directly the conflict-of-interest of an N.I.H. investigator would be not only inappropriate but pretty much impossible”.  

She believed that the system was nonetheless working well. The health institutes conducted an audit in 2006 of 18 sites and found numerous problems with the way universities handled conflicts of interest, particularly with how well they took account of financial conflicts that arose after a grant was awarded.

“I think it is working to the extent that people are being honest,” Dr. Ruiz Bravo said, “and I think most people are honest.”

Dr. Ruiz Bravo said the health institutes would soon mandate that the institutes and centers provide her office with a report about each conflict reported to them by universities. But, she said, these reports will still lack details about the conflicts and how they are managed.

It is clear that the NIH needs to provide more oversight on managing conflict of interest, but they are not absent as the Senator suggests.  Just how intrusive those will be is up to NIH and Congress.

For key documents:

Press Release from Senator Grassley calling on Congress and NIH leaders to identify conflicts of interest in taxpayer sponsored medical research

Zerhouni response to Grassley's June 4th letter

New York Times story, Researchers Go Unchecked, Report Says

HHS OIG – Report: National Institutes of Health: Conflicts of Interest In Extramural Research

New York Times story, Researchers Fail to Reveal Full Drug Pay

Letter to Senate Appropriations Committee Chairman and Ranking Member

Letter to Senate Labor-HHS Subcommittee Appropriations Chairman and Ranking Member

Letter to House Appropriations Committee Chairman and Ranking Member

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