With 16 Doctors on Review, Some Criticize Strict Policy

Administrators at Harvard Medical School say that a stricter conflict of interest policy is working just as it is supposed to--at present, 16 doctors affiliated with the school are on review for possible conflicts.

Yet some doctors are critical of the policy, suggesting that its restrictions may hinder otherwise productive relationships between researchers and pharmaceutical companies.

The new policy was implemented in 1990, after a faculty physician reportedly exaggerated the results of experiments with a drug produced by a company in which he owned stock.

Medical School Dean Daniel C. Tosteson '44 and an advisory committee revised the policy in order to prevent future improprieties. The guidelines were approved by the Medical School's Faculty Council in March 1990.

The current policy requires all physicians affiliated with the school to fully disclose all outside financial interests. The information, collected from over 10,000 Medical School affiliates, is analyzed by a standing committee.

When possible conflicts arise, a report is issued to the physician's supervisor at the appropriate hospital. Cases which cannot be resolved by the hospitals are then referred to a 10-member standing committee, appointed by Dean of Faculty Affairs Eleanor G. Shore.

Shore says 98 percent of the forms were returned last year.

"People were very helpful," says Standing Committee Chair Margaret Dale.

The standing committee mostly handles conflicts involving research. It determines on a case-by-case basis which activities should be continued and which should not.

In many cases, activities are ruled permissible only if an oversight mechanism of some kind is introduced.

Relations With Industry

While it seems that administrators are trying to keep Harvard research free of money's taint, many doctors and industry leaders question whether the current guidelines may actually serve to hamper important gains.

Dr. Mary Ellen Avery, Rotch professor of pediatrics, says that working relationships between physicians and biomedical companies can often make important experimental drugs available sooner to patients who need them.

"I think it would be a very unfortunate state of affairs if we didn't cooperate," says Avery, who last fall won the National Medal of Science for work in preventing infant lung disease. "The interdependence is pretty obvious. Industry can't treat any babies, and we can't manufacture pharmaceuticals."

By sponsoring expensive clinical trials with corporate funds, Avery says, biomedical companies can make the necessary Food and Drug Administration (FDA) approval easier to acquire for drugs. Avery says such trials were an important part of her own research.

At the same time, she says, certain safeguards must be in place so that researchers do not feel pressured to falsify data. The FDA currently prohibits doctors from owning stock in companies dealing in pharmaceuticals they are researching, she says.

"There's no incentive for cheating, as far as I can see," she says.

Dale, however, says the disclosure process has been instrumental in isolating the cases that have come before the committee so far.

"It would be hard to regulate something like this on an ad hoc basis," she says, nothing, "What we have found is that the vast majority of faculty is very honest and the conflicts have been quite readily resolvable."

Possible Conflicts

Though Medical School administrators refuse to release the names of physicians whose cases are being examined by the committee, The Boston Globe reported last year that Dr. Jonathan O. Cole, a Harvard psychiatrist, was under investigation for a possible conflict of interest.

Higginson Professor of Cellular and Molecular Physiology Howard Green may also have a conflict of interest of the type investigated by the committee. In 1986, Green founded BioSurface Technology, a company that cultures patients' skin cells for grafting back onto their skin after surgery. While most of the dermatologist's pioneering research on the technique was conducted while he was at MIT, Green now holds a post at Harvard.

Green did not return phone calls from The Crimson last week.