What, you might ask, are scientists employed by the federal government doing simultaneously consulting for two companies that are ostensibly direct competitors?
That is the question members of a House subcommittee asked top legal and ethics officials in the Department of Health and Human Resources in May, in response to complaints that scientists employed by NIH and FDA were allowed to engage in consulting practices that, at the least, gave the appearance of impropriety.
Lance Liotta and Emanuel Petricoin, who co-direct the joint NCI-FDA clinical proteomics program, were called before the House Energy and Commerce subcommittee on oversight and investigations to testify about the details of their relationships with two companies: Correlogic Systems and Biospect, now called Predicant Biosciences. Liotta and Petricoin are well known for their innovative approach to using surface-enhanced laser desorption ionization mass spectrometry, in conjunction with data analysis algorithms developed in collaboration with scientists at Correlogic, for identifying protein expression patterns useful as diagnostic tools.
James Greenwood, a Republican congressman from Pennsylvania who chairs the House subcommittee, characterized HHS approval of the overlapping consulting arrangements as “an outrage” due to conflict of interest. A closer look, however, reveals a more nuanced picture of how the arrangement evolved.
According to comments from subcommittee members and testimony from Liotta and Petricoin, events appear to have unfolded as follows: In April 2002 the two scientists and Correlogic signed a CRADA allowing the government researchers to collaborate on developing a test for ovarian cancer. Then, in the fall of 2002, Petricoin and Liotta received permission from ethics officials at the FDA and NCI to begin a consulting relationship with Biospect, a company now also developing biomarker-pattern-based diagnostic tests. The consulting agreement with Biospect covered R&D associated with diagnostic devices, serum handling, and microfluidics, according to subcommittee testimony, but not pattern analysis, which is Correlogic’s area of expertise.
Neither Liotta nor Petricoin informed Correlogic that they were also consulting for Biospect. In July 2003, when Correlogic found out, the company complained to NCI officials, who reevaluated Liotta and Petricoin’s relationship and approved it again. In his testimony, Liotta explained that he understood Correlogic to be a software company, and Biospect a scientific instrument company. According to Greenwood, Carl Barrett, Liotta’s supervisor, decided that Liotta’s consulting did not overlap with his official duties.
Were Barrett and other officials at the NCI and FDA wrong? Clearly, if the dual relationships were strictly kosher, it does seem odd that Correlogic remained in the dark about what sorts of advice Petricoin and Liotta were providing a potential competitor. At the least, it gives the appearance that the two scientists had something to hide. On the other hand, because ethics officials gave the go-ahead for Liotta and Petricoin to work simultaneously with the two companies, it seems unfair to imply that the scientists deliberately engaged in improper relationships as a means of earning extramural income. Said Petricoin in his testimony: “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.”
It’s understandable, then, that lawmakers and other critics of NIH and FDA are demanding the agencies tighten their rules governing employees’ outside consulting relationships.
Stricter interpretation of ethics guidelines should help repair some of the damage done to the reputations of scientists paid to operate in the public interest, as would making public the amount of income government researchers earn from consulting gigs with private industry. Government scientists are supposed to be unbiased arbiters of science. It should be clear that they in fact are.
John S. MacNeil, a senior editor at Genome Technology, can be reached at [email protected] web.com. His Sense/ Antisense column, which covers government research policy and regulatory issues, appears bi-monthly.