NIH Grants: Trust But Don’t Verify

Senator Charles E. Grassley wants universities to enforce the rules regarding conflicts of interests by scientists holding grants from the National Institutes of Health. And he wants NIH to crack down on scientists who go astray.

Good luck, Senator. Certainly, no one will excuse the suspicious academic-industrial dealings that have aroused Grassley’s ire, such as unreported payments linked to favorable reports on pharmaceutical drugs and medical devices. But, among all the parties involved, there’s no desire to add cops to the beat, or, as Grassley chillingly suggests, to subject offenders to philanthropy’s equivalent of capital punishment: cancellation of grants. “If University X isn’t doing their job, they [NIH] pull one grant,” the Senator told the Chronicle of Higher Education in July, adding “that’s all they have to do, it would send a very clear signal.”

Grassley, Republican of Iowa, best known as a guardian of whistle-blowers who disclose misdeeds in federal agencies, has extended his campaign for rectitude to NIH and its relationship with grantees who are heavily engaged in corporate dealings. In June, he disclosed that three psychiatrists at Harvard Medical School — Joseph Biederman, Thomas Spencer, and Timothy Wilens — had failed to disclose to Harvard the full extent of their financial dealings with industry. While the three reported receipts totaling several hundred thousand dollars from 2000-2007, according to press reports, Biederman and Wilens each received over $1.6 million, and Spencer received over $1 million. A Harvard spokesman acknowledged that under-reporting may have occurred.

In August, Grassley focused on the business dealings of an NIH grantee at Stanford, Alan F. Schatzberg, a psychiatrist with extensive holdings in a start-up company that potentially could profit greatly from Schatzberg’s drug research. Stanford said Schatzberg had “appropriately disclosed” his financial relationship with the firm and that his NIH research was not involved with the company’s drug trials. But under Grassley’s skeptical gaze, Stanford agreed to the appointment of a principal investigator with no connections to the company.

The federal rules regarding conflict of interest are clear except where they’re foggy: Scientists receiving NIH and private research funding must disclose to their university any outside income exceeding $10,000 or holdings above five-percent of company equity. If a conflict of interest is deemed to exist, the university is required to resolve it and report the outcome to the NIH institute that provided the grant.

After that, clarity declines. Although universities are required to report conflicts of interest, and their treatment, to NIH, careers have been built on the complexities of defining and identifying conflicts of interest and methods of managing and eliminating them. Moreover, NIH’s 24 grant-making institutes are encouraged, but not required, to forward conflict-of-interest reports from universities to a central point in NIH’s sprawling structure: the Office of Extramural Research.

Thus, the rules clearly require some effort by universities and some surveillance by NIH. Nonetheless, they are indolently applied, perhaps even regarded with indifference, according to a report in January by the Inspector General (IG) of the Department of Health and Human Services, NIH’s parent agency. “Nearly half of the institutes were unable to provide any financial disclosure reports for fiscal years 2004 through 2006,” the IG report stated, noting a trust-but-don’t-verify methodology: “Many institutes rely solely on grantees’ assurances that they are appropriately reporting and managing, reducing, or eliminating financial conflicts of interest.”

For aficionados of the conflict-of-interest tango, this is essentially a repeat finding, several times over. For example, in 2001, what was then known as the General Accounting Office (now the Government Accountability Office) surveyed five major research universities and reported that none had “formal processes for verifying that individuals fully disclosed their financial interests.” Then, as now, expressions of dismay, and assurances of commitments to right behavior, resonated through the research enterprise.

In response to the IG’s recent findings, NIH Director Elias Zerhouni concurred with the recommendation for increased oversight of conflict-of-interest compliance but then opted out from concrete measures. Under current federal regulations, Zerhouni argued, universities are required to police themselves. “Routine collection of the details of the nature and management of [federal conflicts of interest] would effectively, if not legally, transfer the locus of responsibility … from the grantee institutions to the Federal Government.” No need for that, he concluded.

Compliance with conflict-of-interest regulations, from strict to non-existent, varies among universities. But enough schools are sufficiently lax about them to feed the impression of squalid dealings in the supposedly pure realm of health research. Whether that has anything to do with Congress’s budgetary neglect of NIH in recent years is difficult to establish. But with Grassley on the warpath and winning headlines, time is ripe for academic science and the NIH to recognize that the old system doesn’t work. ♦