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POCKET SCIENCE

THE BALTIMORE SUN

SCIENTISTS are watching Harvard Medical School closely as the prestigious institution considers revising conflict-of-interest policies for researchers that are considered among the strictest in the nation.

The potential revisions, which some observers expect to allow greater financial ties between Harvard researchers and private industry, come as companies bankroll a larger share of experiments at academic institutions nationally. As the funding has grown, so have concerns that the lines between industry-sponsored drug research and academic pursuits are blurring, violating a once sacrosanct division designed to protect research from taint.

"All these traditional boundaries of public/private, govern- ment/nongovernment are being eviscerated," said Sheldon Krimsky, a Tufts University science policy analyst. "So perhaps it is not unusual that universities are beginning to fall into the same pattern - forgetting who they are."

At least 11 studies have shown that industry-sponsored research tends to result in pro-industry conclusions, according to a review by Yale University researchers published this year in the Journal of the American Medical Association. The article said industry's share of investment in biomedical research grew from about 32 percent in 1980 to 62 percent in 2000.

Industry funding at Harvard hasn't kept pace with other research institutions, a fact Krimsky attributes to its policies. While many institutions use guidelines that help them assess conflicts on a case-by-case basis, Harvard's policies include outright prohibitions. The policies ban faculty members or their families, for example, from owning more than $20,000 of stock in any company that owns the technology they are researching.

Full-time faculty also must seek the university's approval before taking an executive position with a for-profit biomedical company and can't spend more than 20 percent of their professional time on non-university work.

Perhaps as a result, Harvard's research dollars from industry stood at just $12.2 million - or what Krimsky estimated was 3.6 percent of the school's research budget - in fiscal 2000. By comparison, funding at Duke University stood at $109.8 million, accounting for 31 percent of its research dollars, National Science Foundation figures show.

Conflict of interest guidelines are designed to ensure researchers produce science with the best interests of patients - rather than profits - in mind. Harvard Medical School Dean Joseph B. Martin scrapped an earlier review of Harvard's policies after the 1999 death of a teen-ager enrolled in a clinical trial at the University of Pennsylvania's gene-therapy institute. The institute's director was a researcher who stood to profit from its discoveries, prompting a nationwide focus on conflicts in biomedical research.

But researchers at Harvard and other universities also want to move their ideas from the laboratory bench to pharmacy shelves, something companies usually do. With the cost of research climbing, many universities have looked for ways to increase ties with companies while managing the financial conflicts that arise.

At Harvard, two faculty committees - one focused on clinical research and the other on basic research - are reviewing the medical faculty's "Integrity in Science" policies, said Don Gibbons, Harvard Medical School's associate dean for public affairs. The committees are scheduled to present their recommendations June 26. Faculty members heading the committees didn't return calls.

The fact that the policy is under review has created a buzz among researchers nationally.

"My sense is research institutions are trying to encourage ... relationships with industry and Harvard's looking at its policy is likely to go along with this trend," said Mildred Cho, acting co-director of the Stanford University Center for Biomedical Ethics. "I think it's likely to be a loosening of the policy."

Proponents of industry-funded research believe researchers' financial conflicts can be managed in many cases by requiring them, for example, to put their stock in escrow. The case-by-case approach is backed by the Association of American Medical Colleges and practiced by institutions including the Johns Hopkins University and the University of Maryland, Baltimore.

At Hopkins, a medical researcher entitled to royalties on sales of a drug being researched must get approval of the university's Committee on Conflict of Interest before proceeding. How the panel rules might depend partly on the stage of the invention.

If it's on the market for one purpose and its inventor wants to do an early-stage test in patients to see if it might work for another, the Hopkins committee might approve it.

"A strict interpretation of Harvard's rules would say, 'No, never,'" said Dr. Curt Civin, a professor of oncology and pediatrics and the committee's chairman. "You might have the world's expert in this cancer research and he could no longer do this kind of research. That seems to throw out the baby with the bath water."

But if the invention has yet to be approved for any purpose, the inventor has lots of stock and is doing a pivotal clinical trial that could make or break the company, the committee is likely to turn the research down or require the inventor to divest.

"It's not the case that a conflict of interest means first-class science can't be done," said Dr. Laurence B. McCullough, a Baylor College of Medicine professor of medicine and medical ethics. But he said a diligent vetting of potential conflicts is essential.

"It creates ethical instability," McCullough said of a conflict. "It's like a nuclear reactor. It's inherently unstable. If you stop paying attention, you could have a Chernobyl on your hands. So you never stop paying attention."

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