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New Ethics Rules Cost NIH Another Top Researcher

By Michael S. Rosenwald and Rick Weiss
Washington Post Staff Writers
Saturday, April 2, 2005; Page A01

James F. Battey, chief of the National Institutes of Health's high-profile human-stem-cell program and director of that agency's deafness institute, will retire in September after more than 20 years at the agency, citing his inability to comply with strict new conflict-of-interest rules that have roiled the NIH internally and prompted a backlash in the broader science and business communities.

Battey is the fourth high-profile researcher to announce plans to leave since the new rules were unveiled in early February and is the first institute director to do so.

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Agency scientists say the departures are emblematic of the new reality at NIH, in which rules curtailing what stocks researchers can own and regulating their relationships with drug companies, scientific organizations and even medical journals have set the agency against a trend of encouraging closer ties among researchers, firms and think tanks.

In interviews recently, agency scientists said they have confronted problems as small as being turned down from accepting token travel reimbursements to professional conferences and as large as, in Battey's case, being expected to divest holdings from a trust fund he manages for his family.

"The new rules imposed an insurmountable problem for me," said Battey, who has applied for the job of president of the new California Institute of Regenerative Medicine. "I manage a family trust . . . which supports the education of my father's seven grandchildren, and it contains assets I'm told I'd have to divest. That would cost a lot of money, and I can't do that to my family."

Yesterday, in a memo e-mailed to employees, a group of senior agency scientists detailed a legal opinion they recently received that made clear just how broad the new rules are.

"Basically this means anything NIHers do outside -- whether getting paid for it or not, from singing in a jazz group to selling art or jewelry, from volunteering at charity organizations to membership in a school or community organization to developing their own small business completely unrelated to biomedical science -- requires prior NIH approval," the memo says. "We find this very disturbing. It is intrusive and scary. It suggests the NIH owns our lives away from work."

The backlash has moved beyond the agency's Bethesda campus. A renowned Duke University physician has postponed accepting a job running the National Institute of Environmental Health Sciences. Scientific organizations have protested to government officials, and biotech companies have complained about the loss of NIH scientists from advisory boards and consulting deals.

"For a small company like us, it's a huge blow," said Ginette Serrero, chief executive of Columbia biotech start-up A&G Pharmaceutical Inc. The rules forced a senior NIH cancer researcher to remove himself from the firm's scientific advisory board.

"Having someone from the NIH on your board is a tremendous value, for advice, and because it gives you a lot of credibility" with investors, Serrero said. "It's not like you can turn around and replace someone like that with the flick of a finger."

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