In its continuing investigation into how the National Institutes of Health (NIH) awards research grants and contracts, the House Energy and Commerce Committee is seeking to determine whether Richard D. Klausner steered a $40 million contract to Harvard University while director of the National Cancer Institute (NCI) and during the time he was a candidate to become the school's president.

In a lengthy letter delivered this week to NIH, Harvard, and other organizations, Rep. Billy Tauzin (R-La.), committee chairman, and Rep. James Greenwood (R-Penn.), chairman of the Subcommittee on Oversight and Investigations, questioned “whether Harvard University received favorable treatment” in receiving funds in March 2002 to help create the school's Molecular Target Laboratory (MTL).

Klausner “appears to have personally and substantially participated in the MTL initiative that NCI awarded to Harvard University at a time when he had disqualified himself from personally and substantially participating in any matters affecting Harvard,” the letter stated.

Klausner, who is currently director of the global health program at the Bill and Melinda Gates Foundation in Seattle, called the committee's allegations “bizarre” and “baseless.”

“This is all innuendo,” he told The Scientist last night. “The record is completely clear and absolute, and the committee staff knows it very well. In not a single instance did I have anything to do with the process at any time.” The Harvard contract “was a completely above-board process,” Klausner added. Klausner also said he was “annoyed” by the House committee's allegations of impropriety.

The House committee has requested that NIH and Harvard provide documents relating to the MTL contract initiative and presidential search process. Similar demand letters were delivered to the Science Applications International Corporation (SAIC), the nation's largest contract research and engineering organization, which held a prime NCI contract, and to Infinity Pharmaceuticals, a relatively new drug discovery company that uses chemical genomics technology developed at Harvard. Klausner is a member of Infinity's board of directors.

Harvard received a 5-year, $40 million subcontract in March 2002 to build the MTL under the direction of chemical biology professor Stuart Schreiber, a leading researcher in chemical genetics at Harvard for more than decade. Now called the Initiative for Chemical Genetics (ICG), the target laboratory was intended to build on high-throughput assay activities at Harvard's Institute of Chemistry and Cell Biology (ICCB) to identify specific small-molecule gene probes. The ICCB-ICG public database now includes more than 200,000 small molecules.

The Harvard subcontract was part of a prime contract awarded to SAIC that supports intramural research at NCI–Frederick's Center for Cancer Research in Maryland. “It is not apparent that funding a subcontract for a MTL at Harvard University in Cambridge, Massachusetts, is consistent with the stated mission of the SAIC contract for NIH intramural research in Frederick, Maryland,” the committee's letter stated. A spokesman for SAIC did not respond to a request for comment.

But Klausner defended the subcontract mechanism because the MTL “was supposed to be a managed process. That is exactly what you do by contracts,” he said. “It is completely standard and appropriate.”

Klausner “conceived, helped design, and promoted the [MTL] initiative,” the committee letter stated. “He held meetings on the MTL before the earliest solicitation notice was issued; he held meetings with the prime contractor on the MTL; he appointed and supervised the source selection official; and he even provided technical background on the MTL pre-solicitation conference.”

Klausner headed NCI from 1995 to 2001. In June 1999, he recused himself from dealing with matters relating to Harvard because he was being considered for the university's presidency. According to the committee, ethics rules disqualified him from participating in matters relating to Harvard until sometime in late summer or fall 2000. The committee implies the decision to award the contract to Harvard was nevertheless made during this time period, a contention Klausner rejects.

The letter acknowledged that Klausner told committee staff that he was in compliance with ethics rules and that he believed there was no connection between the MTL award and Infinity Pharmaceuticals. “Nevertheless, questions raised by the evidence and information outlined in this letter… warrant further investigation,” the letter stated.

Kevin Casey, Harvard University's senior director of federal and state relations, told The Scientist: “We are currently in the process of reviewing the letter from the committee, taking it under advisement. Harvard, as an institution, has not sought to influence or interfere with the scientific peer review process of any grant. We intend to cooperate fully with the committee.”

John Burklow, associate director for communications at NIH, said, “NIH plans to initiate an internal review of the matters raised by the committee and will continue to cooperate with the committee.”

The House committee is also questioning Klausner's relationship with Infinity Pharmaceuticals. “There is a high level of coincidence of relationships and communications between Dr. Klausner and certain individuals connected with Infinity Pharmaceuticals and Harvard University,” the letter stated. Schreiber is listed as an “observer” on Infinity's board. There are “some indications that Dr. Klausner's role may have begun while he was still director of NCI,” the committee stated.

Steven Holtzman, Infinity's president and chief executive officer, said the company “has no specific relationship of any nature with Harvard or the MTL.”

“Rick Klausner is an adviser to the company and a member of the board of directors, but he became affiliated with the company subsequent to his departure from the NCI,” Holtzman told The Scientist. “No big deal.”

In June, Tauzin and Greenwood announced they were investigating whether Klausner and other current and former senior NIH officials had violated federal ethics laws by accepting “lecture awards” and other cash gifts from universities and research institutions that receive NCI and NIH research grants. Of particular interest was Klausner's receipt in 2000 of a $3000 cash award plus transportation and lodging expenses from the Arizona Cancer Center, an NCI-designated comprehensive cancer facility at the University of Arizona Health Sciences Center in Tucson.

Burklow said yesterday that the general counsel's office at the Department of Health and Human Services determined in July that Klausner had not violated ethics rules relating to the lecture awards and other gifts.