Germain's full-time job is deputy director of the National Institutes of Health's Laboratory of Immunology, which explores how the immune system protects against infections, cancer and other maladies.
His annual government salary is $179,900 -- but his consulting income surpassed it in one recent year and nearly matched it another year.
He has taken fees from a company collaborating formally on research with his laboratory. Another company's founder collaborated with Germain in his NIH capacity. Four more of his clients had grants or research agreements with the institute that houses his lab. He made plans last spring to begin consulting with a new client, a venture capital firm that invests in nascent biotechnology companies.
In written responses to questions from the Los Angeles Times, Germain, 55, said he had always followed NIH rules and had consulted with the approval of agency officials. He said he had not made government decisions affecting companies that paid him.
"I have a well-regarded reputation both inside and outside of NIH for adhering strictly to the rule preventing me from revealing or using specific knowledge of my NIH research during consulting activities and for keeping all outside activities from having any bearing on the conduct of my activities as a [government] employee," Germain said.
By consulting for the companies, he said, "my general insight into immunology and related biomedical sciences can be used to help develop new drugs and treatments for Americans." He said he provided the law firm with "expert opinion on immunological matters." His advice to the investment fund, Germain said, concerned "whether or not I believe that a particular technology or approach has a strong scientific base."
His consulting work also provides his family with "greater financial security," he said. "This is of special importance to me because as a former Hodgkin's lymphoma patient, it was difficult until recently to obtain adequate life insurance coverage while being at increased risk for an early death."
Germain, a graduate of Harvard Medical School, has been deputy director of his laboratory, housed in the National Institute of Allergy and Infectious Diseases, since 1987.
He was warned about conflicts of interest two years ago by an NIH lawyer, Karen Santoro.
But the lawyer's concern focused only on Germain's investments in mutual funds composed of biotech and health-care companies, some of which held contracts with his NIH lab. "Each underlying company may pose a potential conflict," Santoro told Germain in a May 11, 2001 e-mail.
Two companies on the mutual fund list were consulting clients for Germain. Yet Santoro's e-mail said nothing about the fees and stock options they and other companies were paying him.
Germain, in an e-mail to Santoro three days later, agreed to exchange his securities for "holdings that are not concentrated in the health and biotech areas."
Germain told The Times, "Ms. Santoro was fully aware of all my consulting arrangements and compensation."
Many firms for which Germain has consulted have sought to develop products in the same frontiers he or others at the NIH explore, including:
* Genetics Institute, a Massachusetts-based branch of an industry titan, Wyeth.
In 2001, Genetics Institute and Germain's lab entered a formal collaboration called a cooperative research and development agreement, or CRADA, to study the effect that genes have on the immune system. That same year, Genetics Institute paid Germain $37,500 in fees. Germain accepted $25,000 last year.
From 1992 through 2002, the company paid him a total of $322,749, according to Germain's annual income-disclosure reports.
Officials at the NIH have continued to approve Germain's consulting with Genetics Institute despite a provision in the agency's policy manual forbidding employees from taking fees paid by a company that is collaborating with their labs. While the policy remains on the books, a 1995 memo from the NIH director said it would be enforced only if the researcher was directly involved in the collaboration.
Germain said that he was not informed in advance that Genetics Institute and his NIH lab had taken steps to formally collaborate. When he did learn this, Germain said, he approached his institute's ethics office.
"The decision was that my consulting arrangement, having predated the [collaborative agreement], did not need to be terminated," Germain said.
* Mojave Therapeutics Inc., a biotech company developing treatments for cancer and viral diseases.
From 1998 through 2002, the New York firm paid Germain $93,929, plus stock and stock options worth up to $15,000. Germain has been a member of Mojave's scientific advisory board.
Mojave calls itself a leader in developing "heat-shock" proteins as potential therapeutic agents.
