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Report: Ethics violators getting light punishment from NIH

Associated Press

The majority of federal scientists investigated for improperly accepting personal money from drug companies or biotechnology firms escaped serious punishment, and investigators declined to proceed with several cases involving possible crimes, according to the National Institutes of Health.

Only two of the ethics cases brought to light in the past two years inside the NIH remain open. In both cases, the scientists remain on the federal payroll.

Most of the rest got off with just written reprimands or verbal warnings for failing to get proper permission for their outside work or were allowed to retire, NIH spokesman John Burklow told The Associated Press.

The NIH's handling of the ethics cases has renewed questions inside Congress about whether the government's premiere medical research agency is serious about policing conflicts of interests among its scientists who take private sector money.

Of particular concern is the case of Dr. Trey Sunderland, a prominent Alzheimer's disease researcher who took hundreds of thousands of dollars in money from a drug company with which he also collaborated in his government capacity.

Sunderland continues to collect a federal check nearly a year after he was recommended for termination. He already had offered to resign two years ago to take a private sector job but the government wouldn't let him, according to correspondence obtained by AP.

"In spite of the public changes that have been made at NIH, there really does not appear to be a cultural change where the institution and the members of the institution condemn the kind of behavior that apparently Dr. Sunderland has exhibited," said Rep. Joe Barton, R-Texas, chairman of the House Energy and Commerce Committee. "It's really, really disappointing."

One of Barton's subcommittees planned to hold a hearing Wednesday to press for more answers.

Burklow said Sunderland remains at NIH "because there is an open investigation."

Officials have told Congress that the Department of Health and Human Services' internal watchdog and the Justice Department both are investigating the scientist.

NIH investigated 103 employees after congressional hearings in 2004 and disclosures in the Los Angeles Times revealed many scientists weren't reporting their lucrative consulting deals with private companies as required. Forty-four employees were found to have violated ethics rules.

AP asked NIH to give an accounting of how those cases were resolved.

Burklow said two scientists got no punishment at all for infractions described as minor. Six left the agency before punishment could be meted out, and 10 were referred to the Health and Human Services inspector general for possible criminal investigation, he said.

The IG, the agency's internal watchdog, declined to pursue eight of those referrals, leaving them instead to face NIH administrative penalties such as suspensions ranging from a week to 45 days, Burklow said.

The rest, well over half, simply got written reprimands or verbal warnings.

Sunderland remains under investigation by the inspector general, who also is reviewing one other case. A government official, speaking only on condition of anonymity because the investigation is ongoing, identified the other researcher as Dr. Thomas Walsh, a prominent cancer scientist.

Sunderland and Walsh both committed "serious misconduct," so grave that they would be fired if they were civilians, according to reports written by NIH ethics officers.

Both are members of the Public Health Service Commissioned Corps, which provides medical help during disasters. So NIH sent its findings to that agency, which has yet to act on the NIH recommendations.

Both Sunderland and Walsh did private work for drug companies on government time, didn't seek approval or report their ties, and conducted research that overlapped their official duties in violation of federal law and regulation, the NIH ethics reports alleged.

Since the public revelations, NIH has banned outside consulting by agency scientists, a once widespread practice that allowed some researchers to eclipse their government salaries with corporate income.

Walsh, according to the NIH report, failed to report more than $100,000 in income from Merck & Co. and other drug companies between 1999 and 2004, and did not take leave time to do the consulting.

Reached at his NIH office on Monday, Walsh declined comment.

Sunderland ran afoul of the rules in earning more than $600,000 from the Pfizer Inc. drug company between 1996 and 2004 for consulting and lectures. NIH and congressional investigators also cited irregularities in his transfer of human tissue samples to Pfizer.

Lawyers for both scientists said they put in exceptionally long hours at their government jobs and that clerical problems were at least partly to blame for the lack of reporting.

Sunderland's lawyer said his client never intended to hide his dealings with Pfizer and that the government's failure to let him retire has cost him private sector opportunities and control of his Alzheimer's research.

"The bureaucratic inaction ... with respect to Dr. Sunderland's retirement request has unreasonably interfered not only with Dr. Sunderland's career but also with his important Alzheimer's research," Attorney Robert Muse wrote Congress on Monday.

Sunderland tried to retire two years ago and initially won approval in November 2004 from Dr. Thomas Insel, director of the National Institute for Mental Health, according to documents obtained by AP.

But less than six weeks later, NIH's deputy director Raynard Kington recommended that the Public Health Service Commissioned Corps deny Sunderland's departure, citing the ongoing investigation and potential "adverse effects" on the Corps' operations.

NIH recommended to the Corps in November 2005 that Sunderland be terminated, but he continues today on the government payroll.

Corps spokeswoman Christina Pearson said the agency has taken no action yet because there are "other reviews" it must coordinate with.

The Corps is concerned about the allegations surrounding Sunderland and Walsh, "and will take appropriate action should wrongdoing be found," she said.

Sunderland's problems could also impact the prestigious Journal of the American Medical Association, which requires authors to reveal any relevant financial affiliations at the end of their articles.

The scientist and an assistant did not disclose their Pfizer consulting agreements, in an April 23, 2003, article based on their Alzheimer's work with Pfizer.

Executive Deputy Editor Phil Fontanarosa said a correction explaining the Pfizer ties "most likely will be in order," once the government investigation concludes and JAMA editors review the outcome.