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US Congressional Subcommittee Blasts NIH/ FDA Approval of Liotta, Petricoin Consulting

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The US Congressional Subcommittee on Oversight and Investigations, which is investigating consulting and awards ethics at the NIH during a series of hearings this week, has called NCI and FDA approval of consulting activities by Emanuel Petricoin and Lance Liotta of the NCI-FDA Clinical Proteomics program “an outrage,” ProteoMonitor has learned

Petricoin and Liotta testified on Tuesday regarding consulting deals that the pair had with South San Francisco-based Biospect, now called Predicant Biosciences. The subcommittee alleged that the deal represented a conflict of interest with the pair’s April 2002 CRADA with Correlogic to develop a test for ovarian cancer. CRADAs allow for the government to collaborate with outside organizations on R&D work.

Petricoin and Liotta received permission in fall 2002 from the FDA and NCI, respectively, to consult for Biospect, which is also trying to develop biomarker-pattern-based diagnostics. According to the subcommittee, the consulting agreement covered the areas of diagnostic devices, serum handling, and microfluidics, but not pattern analysis — which is the service that Correlogic was providing to the partnership.

In July 2003, according to the Congressional subcommittee, Correlogic complained to NCI deputy director Anna Barker that the deal represented a conflict of interest. The NCI reevaluated the deal and reapproved it. “The NCI recognized that Biospect and Correlogic did business in the same area, but [director of the Center for Cancer Research at the NCI] Carl Barrett, Liotta’s supervisor, decided that the consulting was restricted to areas that did not overlap with Liotta’s duties,” James Greenwood, chairman of the subcommittee, said during the hearings. Explained Liotta in his testimony, “My understanding was that Correlogic was a software company, in contrast with Biospect, that I understood to be a scientific instrument company. When I began consulting with Biospect, I understood Biospect was in the early stages of developing a new instrument and scientific technology which employed its proprietary chemistry to separate and identify molecules.”

Nevertheless, Greenwood in his prepared statements sided with Correlogic. “The NCI and FDA allowed government scientist partnerhips with Correlogic to secretly provide consulting services without the knowledge or consent of Correlogic to Correlogic’s competitor. What happens to public trust?” he said. He said that Correlogic should have been notified and consulted about the arrangement.

Joe Barton, chairman of the Committee on Energy and Commerce which manages the subcommittee, took the charge one step further, alleging that the consulting agreements were partly responsible for a delay in bringing an ovarian cancer test to market. “As a result of these secret deals, progress appears to have slowed ... [on the] prompt commercialization of a life-saving ovarian cancer diagnostic test,” he said.

Both Petricoin and Liotta ended their relationships with Biospect prior to the hearings. Petricoin cited a conflict with an FDA policy against consulting with companies that are regulated by the FDA, which Biospect now apparently is. Liotta cited “new information obtained within the last week” in which he learned that “Biospect requested certain information from the NIH. For me, this caused concern. As a result, I terminated my relationship with Biospect effective immediately,” he said.

In their testimonies, both Petricoin and Liotta insisted that they went through all the proper approval channels and would never have agreed to consult had they felt there was a conflict of interest. “I would never knowingly pursue or continue any outside activity which I felt was in conflict with a career spent as a scientist in the pursuit of public and patient benefit,” Petricoin said.

Petricoin’s attorney, Chuck Morton, of the firm Venable, told ProteoMonitor, “Drs. Petricoin and Liotta categorically deny that there was anything about their activity with Biospect that distracted their loyalties or attention from their efforts at NIH.” He added that he felt that “while Chairman Greenwood was concerned at the beginning, at the end of the testimony, at least with respect to them, there [seemed to be] far less concern than there had been at the beginning.”

The subcommittee announced this week that it would extend its mandate to investigate activities at the FDA. The FDA is subject to stricter ethics guidelines than the NIH due to its regulatory nature, but oversight is still not strong enough, according to the committee.

Representatives from Biospect and Correlogic could not be reached for comment as of press time.

Transcripts of Petricoin and Liotta’s testimony and a webcast of the hearings can be found here.

— KAM

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