By Raja Mishra, Globe Staff, 6/9/2003

Harvard Medical School is considering loosening its regulations governing the financial ties between faculty researchers and private drug companies, according to school officials, a process whose outcome could help set the tenor and pace of medical research here and around the country for years to come.

The policy review comes at a time when big drug makers Merck, Pfizer, and Novartis are moving significant portions of their research operations to the Boston area, hoping proximity to Harvard's world-leading medical school will result in new, profit-making drugs.

Under the current regulations, considered among the toughest in the nation, Harvard researchers cannot own more than $20,000 of stock in companies that finance research in their lab. They cannot receive more than $10,000 in consulting fees from those companies. And they cannot spend more than 20 percent of their time on non-Harvard research.

''There are people who are very unhappy'' about the current limits, said Margaret Dale, Harvard Medical School's associate dean for faculty affairs, who monitors the faculty for conflicts of interest.

Some Harvard faculty members, as well as some drug company officials, said the medical school should set higher limits on financial ties between researchers and companies, medical school officials said. This, said proponents of loosening the policy, would speed the conversion of scientific discoveries at Harvard into life-saving medicines by rewarding the faculty members who helped the research.

But others at the medical school, as well as some medical ethicists interviewed, said Harvard should keep its current policy in place. This would, they said, send medical researchers across the country an important message about minimizing corporate influence over academic research.

''Others look to [Harvard] as the standard of integrity in science. If they start to lower the bar, they would be tarnishing their standards of integrity,'' said Tufts University science policy analyst Sheldon Krimsky.

Two faculty committees charged with reviewing the policy are scheduled to issue their recommendations on June 26, with a faculty vote to follow. The process is closely guarded, and Harvard officials declined to name the members of the panels or detail their discussions. Within the faculty ''there are people on all sides of the spectrum,'' Dale said.

Because of Harvard's prestige and history of limiting corporate influence in research, its decision will influence other medical schools.

Many of them also are reexamining their conflict-of-interest policies at a time when industry-academia collaboration is accelerating and the public has become increasingly wary of the influence of money on medical science.

''Harvard is clearly an institution of enormous standing, and people watch what it does,'' said Dr. David Korn, a vice president at the American Association of Medical Colleges and a former dean of Stanford University's medical school. ''They're among the very strictest in the nation and have been for years.''

Harvard was on the cusp of changing the policy four years ago, but the sudden death of Jesse Gelsinger, a subject in a University of Pennsylvania medical trial, persuaded Joseph B. Martin, Harvard's medical dean, to scrap the process and leave the policy untouched. Gelsinger, 18, was killed after a gene therapy experiment , and it was later revealed that one of the researchers involved had financial ties to a company set to profit from the research.

Martin, in a Globe interview at the time, said the decision not to loosen Harvard's conflict-of-interest policy was ''the right thing to do, the responsible thing to do at this juncture.''

Martin refused to be interviewed about the current reexamination of the policy, saying through a spokesman that he did not want to undermine the deliberative process underway.

One of the two 10-member faculty committees, led by Dr. Barbara J. McNeil, chair of Harvard's department of health-care policy, is examining the policy for doctors conducting clinical trials with patients. The other, led by biological chemistry and molecular pharmacology professor Dr. Christopher T. Walsh, will deal with basic science researchers, whose work typically does not involve humans.

The intellectual climate surrounding the process has been influenced by Harvard president Lawrence H. Summers, who in repeated public and private comments has suggested to faculty members that the medical school's conservative policies may prevent medicines that could help thousands from reaching the marketplace, said several Harvard officials.

In an address just after taking office in 2001, Summers told hundreds of doctors and researchers at Harvard-affiliated Beth Israel Deaconess Medical Center: ''We have to think creatively and flexibly about how to work with the private sector, how to support entrepreneurship, and how to make sure research moves from the bench to the bedside.''

With Novartis, Merck, and Pfizer just miles away from the medical school's Longwood campus -- in the case of Merck, just blocks -- and dozens of biotechnology companies nearby, Harvard officials expect informal contacts and formal ties between medical school researchers and companies to deepen in the years to come.

''Ideally, there's going to be a cross-fertilization of ideas,'' said Harvard Medical School's associate dean for research, Susanne Churchill, who envisions frequent joint seminars, workshops, and symposia with Harvard faculty and Novartis staff that leads to extensive collaboration.

In particular, Harvard officials expect more research collaboration aimed at converting basic biological findings into medicines. Harvard researchers turn out more basic discoveries about the human body than perhaps any institution in the world. And pharmaceutical companies can spend millions to find compounds that work as drugs and test them on patients. But the middle step, determining whether basic biological discoveries have wider medical applications, is often too costly and time-consuming for academics and too risky for companies.

But drug companies said they should be able to give more financial support to academics, who often are the most skilled at making these intermediary advances, to speed the drug-making process along.

''Industry will tell you that they are handicapped in their ability to do that intermediate stage thing by our conflict-of-interest policies,'' said Churchill.

Big drug companies, Churchill said, are increasingly desperate to capitalize on Harvard research to help fill their fast-emptying product pipelines.

''Novartis, Merck, Pfizer understand they have to look to us,'' she said. She added that the medical school must set a conflict-of-interest policy that balances industry needs while protecting academic freedom. ''This is an incredible opportunity, if we can figure out how to reach out.''

But former New England Journal of Medicine editor Dr. Marcia Angell said, ''Harvard Medical School would be unwise to loosen its restrictions. It should tighten them.''

''Academic medical centers need to keep their missions distinct from the mission of investor-owned businesses,'' said Angell.

Critics such as Angell worry that researchers with deep financial ties to companies will face pressure to place test results in a positive light, devise research agendas that fulfill corporate needs, and withhold data from publication to benefit companies.

George Annas, a Boston University medical ethicist, said all financial ties between researchers and companies should be banned.

''Should you have any equity in a product you're testing? It seems to me the answer should be no,'' he said.

At Harvard, increasing willingness to reach out to private industry may be part of a generational shift. Churchill, who helps manage faculty dealings with businesses, said there is an ''increasing entrepreneurial awareness'' among medical school students, citing in particular the student-run Harvard Biotechnology Club, which has invited industry heavyweights to club meetings.

''It's not a bad thing to benefit from the fruits of your labor,'' said Churchill of the new attitude. ''It's OK. ''

Raja Mishra can be reached at rmishra@globe.com.

This story ran on page A1 of the Boston Globe on 6/9/2003.
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