NIH Conflict Findings Left Out

WASHINGTON —  A blue-ribbon panel that examined conflict of interest at the National Institutes of Health found permissive practices that were not detailed in its final report last week, internal agency documents show.

The documents also show that top aides to NIH Director Elias A. Zerhouni were allowed to review and comment privately on the panel’s draft findings.

Congressional investigators have expressed interest in the circumstances surrounding compilation of the report, issued Thursday. The next day, the chairman of the House Oversight and Investigations subcommittee, Rep. James C. Greenwood (R-Pa), wrote to Zerhouni, seeking “all records relating to the minutes and records of closed sessions of the Blue Ribbon Panel, as well as all drafts of the report.”

Greenwood, whose letter was co-signed by the chairman of the House Energy and Commerce Committee, Rep. Joe Barton (R-Texas), said the information from the NIH would aid in “understanding the basis for the panel’s observations and findings.” Greenwood’s subcommittee plans to question Zerhouni and other NIH officials about conflict-of-interest matters at hearings today and next week.

The NIH is the nation’s premier agency for medical research, spending $27.9 billion this year. Zerhouni appointed the panel after articles in the Los Angeles Times in December documented hundreds of payments by drug companies to NIH scientists, totaling millions of dollars, and reported that more than 94% of the agency’s top-paid employees were not required to publicly disclose outside income.

The panel recommended that top agency officials -- totaling scores of management positions -- be banned from accepting payments of any kind from drug companies. The panel also said that all NIH employees should be prohibited from accepting company stock or stock options as compensation.

On the other hand, the panel said that a majority of NIH scientists should be allowed to accept fees or other income from industry, and that those payments in many instances need not be publicly disclosed.

The internal documents show that the panel was concerned about how little is known about the extent of financial ties between drug companies and NIH personnel. According to minutes of a closed-door meeting in early April, the panel “was surprised to learn that many people do not disclose at all. The panel thinks there needs to be an internal review that picks up significant financial interests.”

One panelist, Dorothy K. Robinson, who also is general counsel at Yale University, said that, generally, NIH’s “rules on conflict of interest are really too narrowly defined.” The rules, she said, employ “very tight words or phrases of art and do not capture appearances that are quite problematic.” An NIH document reciting Robinson’s comments was obtained by The Times.

Another panelist, Stephen D. Potts, a former director of the U.S. Office of Government Ethics, encouraged his colleagues to recommend wider public financial disclosure. In an e-mail on March 18 he said, “I learned at OGE that sunshine is the best disinfectant and saves taxpayer dollars because less will have to be spent to identify violators. The press and the public do a remarkably good job.”

Potts added that The Times articles “did expose abuses and, if the conduct described cannot be sanctioned under existing rules, the rules should be amended to proscribe the conduct.”

Zerhouni has called repeatedly over the last five months for greater “transparency” in the NIH’s handling of conflict of interest. He appointed the panel to recommend any policy changes it deemed necessary. But the panel’s proceedings were carried out mostly behind closed doors.

The panel met privately at NIH offices in Bethesda, Md., on seven occasions, from March 1 through April 28. It convened meetings during parts of four days that were open to the public.

Directors of some NIH research centers or institutes voiced concern about whether information they provided to the panel could be subjected to public release, according to the internal documents. Moreover, Zerhouni’s top subordinates were given opportunities to privately review and comment upon the committee’s draft recommendations, the internal documents show. The drafts were circulated by scientific policy advisors within Zerhouni’s office, whom he had assigned to assist the panel.

A spokesman for Zerhouni, John Burklow, said that the director’s staff “only provided information as requested” to the panel. “They asked us to review the report for accuracy,” Burklow said.

One of Zerhouni’s top aides, Dr. Michael M. Gottesman, told the panel that the NIH’s scientific mission could be undermined if all agency scientists were banned from paid consulting for drug companies. “I addressed the general issue of what might be lost to the NIH and the public if all NIH scientists were not allowed to consult with private industry and academia,” Gottesman said in an interview.

The internal documents show that Gottesman, the NIH deputy director in charge of the agency’s in-house, or “intramural” research, clashed with a high-level colleague, Dr. Raynard S. Kington, a physician-administrator who also holds the title of deputy director and whom Zerhouni assigned in January to take charge of a range of NIH ethics policies.

On April 22, Kington wrote in an e-mail to Gottesman and four other officials that he feared the panel members did not understand that in some institutes and centers at the NIH “there is not a bright line” between those involved with intramural research and those involved with outside, “extramural” research.

For instance, the in-house scientists at the NIH help decide whether they and the agency participate in cooperative research projects with various drug companies. Because of their government roles, the scientists also are well positioned to advise, for pay, universities or other outside research entities interested in NIH grants.

“I think (and I think many outside people would agree) that our IM [intramural] scientists should not consult with universities and other institutions that are funded by us,” Kington said.

Gottesman responded by e-mail, telling Kington and the other officials -- each of whom assisted the panel in preparing the report -- “I must respectfully disagree.”

In its final report, the panel disregarded Kington’s advice, saying that if the in-house scientists are not directly involved in dispensing NIH research grants, they should be allowed to consult with universities receiving those awards.