WASHINGTON, DC—The US Food and Drug Administration (FDA) will conduct a “comprehensive review” of all outside consulting agreements its employees have with pharmaceutical and biotech companies to make sure the arrangements are legal, acting FDA commissioner Lester M. Crawford announced yesterday (May 18).

The FDA's action comes on the heels of Congressional investigations into the awarding of millions of dollars in consulting fees and awards to scientists and officials at the National Institutes of Health (NIH).

Also yesterday, NIH officials said that NIH Director Elias A. Zerhouni has decided to require all NIH employees to disclose the amount of compensation they receive from outside consulting “as a condition of their employment” with the agency. Current ethics rules do not require employees to submit this information, and Zerhouni risks litigation from employees who might not wish to comply, the officials said.

Members of the Subcommittee on Oversight and Investigations yesterday questioned two government scientists—one from the FDA and the other from the NIH—over their consulting arrangements with Biospect Inc., a South San Francisco life sciences company seeking to develop protein biomarkers to detect and diagnose diseases. The consulting arrangements, approved in late 2002, might have gone unnoticed except that Biospect is a competitor to another biotech company, Correlogic Systems in Bethesda, Md., with which the two scientists were inventors and co-principal investigators in a joint FDA/National Cancer Institute (NCI) cooperative research and development agreement (CRADA) begun in April 2002.

Lance A. Liotta, chief of NCI's pathology laboratory, and Emanuel F. Petricoin, lead microbiologist with FDA's Center for Biologics Evaluation and Research, told the panel that they did not know that Biospect was a competitor to Correlogic and that their respective ethics officers had approved their consulting deals. After a congressional inquiry this month, FDA officials determined that Biospect was a “significantly regulated entity” with which FDA employees are barred from consulting. Last week, Liotta and Petricoin ended their consulting relationships with Biospect.

“As a result of these secret deals, progress appears to have slowed on a public–private partnership that could lead to prompt commercialization of lifesaving, ovarian cancer diagnostic tests,” Joe Barton (R-Tex.), chairman of the House Energy and Commerce Committee said. “Public trust has been damaged.”

Subcommittee Chairman Rep. James C. Greenwood (R-Penn.) said that the situation could damage future public–private partnerships. “What company will want to enter a CRADA with NIH if this is the way conflict-of-interest issues are managed? This isn't transparency. This is an outrage.”

Officials at Biospect, now known as Predicant Biosciences, did not return a call for comment yesterday.

The subcommittee yesterday also explored “the strange story” of how Richard Klausner, as NCI director in 1997, received the $40,000 Dickson Prize Award from the University of Pittsburgh after authorizing a $300,000 government payment to help settle a lawsuit against the university. “One does not need to have an intricately detailed knowledge of federal law and regulations on ethics to see the obvious 'appearance' problems” with this scenario, said Jack Maskell, a legislative attorney with the Congressional Research Service.

The university had wanted to give Klausner the prize a year earlier, but NIH ethics officials had advised Klausner against it. After the lawsuit was settled, Harriet Raab, then general counsel for the Department of Health and Human Services (DHHS), asked a DHHS ethics officer to find a way for Klausner to receive the prize. Edgar M. Swindell, the ethics officer who is currently associate general counsel for ethics, did so by noting that pending litigation had ended.

“It's not a decision I look back on with fondness and pride,” Swindell told the panel yesterday. “I can assure you, we don't operate under this kind of advice under the current administration.”

Klausner, who is now director of the Global Health Program at the Bill and Melinda Gates Foundation in Seattle, did not respond to requests for comment from The Scientist. The subcommittee has previously questioned whether Klausner improperly steered a $40 million contract to Harvard University and had violated federal ethics laws by accepting lecture awards and other cash gifts from universities and research institutions receiving NCI and NIH research grants. Klausner has termed those allegations “bizarre” and “baseless.”