Dr. Ned Feder: Ethical Problems at NIH - The Struggle Continues

My past battles with the NIH's leaders have recently been featured in stories on Pharmalot, The Chronicle of Higher Education, and Nature. As a scientist at NIH I pointed out that too many researchers funded by the NIH were privately receiving consulting fees and other payments from drug companies and similar businesses--payments seemingly authorized by the NIH. I argued that these financial arrangements should be disclosed publicly, not just provided to the institutions at which the researchers work and then stored in each institution's confidential files.

When I made the argument for disclosure, I considered it my duty, both as a scientist and a public servant, to do so publicly and to identify myself as an NIH scientist. I decided not to make the argument quietly within the NIH, where it would surely be ignored.

From 2002 to 2006 I discussed these issues in four Letters to the Editor (letters published in the Los Angeles Times, Nature, and The Scientist) and in many memoranda to top NIH officials, including its Director, Dr. Elias Zerhouni. The four letters and a few of the memos have just been posted by Pharmalot.

My efforts were widely known, but within the NIH they had no effect. However, pressure from outside made a difference. In 2005, after a series of scandals and almost two years of arm-twisting by members of Congress, the NIH was forced to announce new rules that put strict limits on private financial arrangments made by the government scientists working on the NIH campus. But the problem is far from being resolved. Elsewhere, in universities and medical schools across the country, non-government scientists receive about $20 billion annually in research funds from the NIH. Grantees who receive NIH research support are unaffected by the new rules. Where they get their money--in consulting fees, stock, stock options, and other mechanisms--is treated as a private matter generally known only to their institutions.

When I retired from the NIH in September 2006 and started working at POGO, I told Danielle Brian, POGO's Executive Director, that I'd tried hard and failed to make a dent in the NIH's conflict-of-interest problem. I said I'd like to work on other issues at POGO, since the problem at NIH seemed hopeless.

But I was wrong. Recently things have begun to change. Thanks largely to the efforts of Senator Charles Grassley (R-IA) and his staff, clear evidence has begun to emerge of improper and perhaps illegal practices at several major U.S. medical schools. For example, one senior medical researcher, an NIH grantee at Emory Medical School, failed to inform his institution about more than $1 million in private income from drug companies. Now the NIH, in response, is beginning to withdraw its many millions of dollars of grant support from some of these misbehaving researchers in academia. The medical schools are now racing to fix their well-hidden conflict-of-interest problems before they come to light.

The NIH's leadership must deal much more aggressively with these problems by putting a premium on transparency:

• NIH grantees, as a condition of receiving NIH funding, should be required to disclose their financial arrangements publicly. (This may require new legislation or regulations.) At the very least, the financial statements of all grantees should be filed at the NIH, where they can be scrutinized by government auditors. The statements could then also be made accessible through FOIA to journalists and other members of the public.
• NIH leaders should encourage scientists within the NIH to speak and write frankly and publicly about NIH policy, identifying themselves as NIH scientists. The NIH Director could easily make this happen, almost with the stroke of a pen.

Transparency and public disclosure are not a cure for the NIH's problems, but they are a good first step. A climate of openness is part of the tradition of science at its best. It would also reassure taxpayers if NIH policies were subject to scrutiny and public criticism by scientists inside the NIH. These scientists are the people best acquainted with the NIH's defects. But even if more liberal rules on public discussion are announced at NIH, it is hard to be optimistic that there will soon be a genuine climate of openness in which criticism can thrive.