NIH Grants

Each year, the NIH distributes an estimated $24 billion in extramural funds. In fiscal year 2007, HMS received $172 million in grants from the NIH and MGH received $300 million. NIH investigators must disclose to their institution any “significant financial interest” that may appear to affect the results of a study. Significant interest is defined as $10,000 in value or 5% ownership in a single entity.

In his Congressional Record statement, Grassley criticized the NIH’s oversight of the extramural program as being “lax” with nobody ensuring that COIs are being monitored.

In response, an NIH spokesman told the press that if violations of NIH policy have occurred and research integrity is compromised, “we will take all the appropriate action within our power to hold those responsible accountable.”

Asked how the government and public could ensure that the results of clinical trials are unbiased, Torrey responded that clinical trials should be supported by NIMH with its $1.4 billion budget and not by the pharmaceutical industry.

“NIMH was a leader in supporting drug trials in the 1970s but then got out of the business in the 1980s and ceded it to drug companies,” said Torrey, who used to work at NIMH. In addition, NIMH should require its grant applicants to submit full disclosure of all funds being received from pharmaceutical companies. For clinical trials, he said, the review committee should consider COI as part of the criteria in its deliberations.

Grassley, along with Sen Herb Kohl (D, Wis), is offering another approach—the Physician Payments Sunshine Act (S. 2029)—that would require drug and medical device manufacturers with revenues of more than $100 million to report publicly any payments that they make to physicians within certain parameters.

As of 2007, 5 states and the District of Columbia have laws mandating state disclosure of payments made to physicians by pharmaceutical companies.⁶ Other states are considering similar proposals, but Grassley favors a national law.

Torrey said he supports Grassley’s efforts and mandatory disclosure, and Robert Hendren, DO, and Larry Greenhill, MD, president and president-elect of the American Academy of Child and Adolescent Psychiatry (AACAP), respectively, recently submitted a letter to The New York Times.

“Researchers in all areas and specialties of medicine need to be forthright about their funding sources,” they said. “This congressional bill, along with educational efforts under way at AACAP, will go far in reinforcing the trust families have in our profession.”