44 Violated Ethics Rules, NIH Director Tells Panel

By Rick Weiss
Washington Post Staff Writer
Friday, July 15, 2005

An internal investigation of 103 current and former employees of the National Institutes of Health has found that 44 violated conflict-of-interest rules and 37 did not, while 22 are still under review, according to interim data supplied by NIH Director Elias A. Zerhouni to a congressional committee.

"We discovered cases of employees who consulted with research entities without seeking required approval, consulted in areas that appeared to conflict with their official duties, or consulted in situations where the main benefit was the ability of the employer to invoke the name of NIH as an affiliation," Zerhouni said in a letter to the House Committee on Energy and Commerce.

Of the 44 found to have committed violations, the cases of nine have been referred to the inspector general of the Department of Health and Human Services for possible criminal prosecution, according to the letter, released yesterday.

Another 27 may be subject to lesser administrative penalties. Eight violators are no longer employed by HHS and so are beyond the reach of administrative actions, according to the letter, which was described in yesterday's Los Angeles Times.

The investigated employees were not named in the letter.

Zerhouni sent the synopsis last week to Rep. Joe Barton (R-Tex.), the committee chairman, who had requested an update in March. The committee has been looking into allegations of conflict of interest at NIH for nearly two years, and estimates of the degree of misconduct have varied widely during that time.

NIH officials previously said that a majority of those under investigation had been exonerated, but the letter provides a first glimpse of actual numbers.

In February, amid congressional assertions that abuses were widespread, Zerhouni banned the kinds of activities questioned by the investigation -- primarily paid consulting work for pharmaceutical and biotech companies -- for all of NIH's 17,000 employees.

Nonetheless, the letter to Barton is sensitive because the details of the rule changes are still in flux. Most notably, HHSand the department's Office of Government Ethics are still considering whether to force thousands of employees to divest all their biotech and drug company stock holdings, as originally proposed, or to call for more targeted restrictions in stock ownership.

The department has twice delayed the implementation of the stock ownership restrictions while reconsidering its initial plan, criticized by employees as unnecessarily extreme.

"These findings indicate that the ethical problems [at NIH] are more systemic and severe than previously known," Barton said in a prepared statement yesterday. "They also demonstrate the need for NIH to issue the final ethics rule as soon as possible."

NIH spokesman John Burklow acknowledged that the system of oversight for conflicts of interest had grown in need of a "systemic overhaul." But that situation, he suggested, is largely behind the agency.

"That's why we worked with the department and the Office of Government Ethics to develop new rules that came out in February, which will protect the integrity of the science and at the same time be fair to employees," Burklow said.

In the letter to Barton, Zerhouni reiterated his long-standing belief that citizens ultimately benefit from "collaborations and other scientific interactions between NIH personnel and nongovernmental researchers." He blamed the abuses largely on a loosening of NIH ethics rules that occurred during the Clinton administration.

The completed portion of the investigation covered 81 current and former employees suspected of not having reported their outside activities to NIH officials. The employees came under suspicion after the House committee sent letters to 20 pharmaceutical companies asking for lists of all NIH researchers doing consulting for them. The panel compared the names on those lists with the names on file at NIH of those having filed proper disclosures of outside work. The names of the 81 were on the company lists but were not in the NIH records.

Most of the 22 remaining employees under review identified themselves in response to a June 2004 agency-wide directive from Zerhouni, which asked all employees who had failed to file disclosures of outside activities to step forward.

Burklow said the agency has completed its investigation of those 22 but cannot publicly report how many have been exonerated until the department signs off on the results.

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