Harvard Medical School puts strict ethics rules under microscope

Busts around the atrium of the Tosteson medical center in Harvard Medical school of the famous Harvard medical doctors through out the school’s history. David L Ryan/Globe Staff/Globe Staff

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Harvard Medical School is reevaluating rigid conflict-of-interest rules that aim to shield scientific research from corporate influence amid complaints by some professors that the restrictions slow the process of turning discoveries into research tools and treatments.

The school strengthened its conflict-of-interest regulations just five years ago, at a time of widespread concern about physicians and researchers accepting payments from pharmaceutical companies.

The medical research landscape has changed since then, however: Government funding for research is more difficult to obtain, and large drug companies have sharply reduced their investment in early-stage research. To fill the gap, many professors are launching startups.

There’s now a growing national debate about whether “overly strict conflict-of-interest policies have hurt innovation,” said Eric Campbell, a Harvard Medical School sociologist who studies the policies in the medical field.

Or as Dr. Donald Ingber, a Harvard Medical School professor of vascular biology, put it: “If there were conflict-of-interest policies so that Thomas Edison couldn’t be involved in the company he formed to create the electric light, we’d still have gas lamps.”

The medical school this summer began surveying all of its 10,000 faculty members about its policies, among the strictest in the nation. In a letter to faculty that raised concern among some watchdogs who want tough rules retained, dean Jeffrey Flier said the school will look broadly at the policies, with a particular focus on two restrictions.

The review will examine what’s known as the research support rule, which bars faculty who own equity in a company from receiving research grants or contributions from that company. Secondly, it will look into the clinical research rule — which Campbell said is the only one he knows in the nation to prohibit faculty from conducting clinical trials on a company’s products if they have equity in or earn at least $10,000 in income from that company.

A committee of faculty and staff is collecting feedback on whether those rules are too strict, too lenient, or just right.

Some academic watchdogs are wary of the review.

“What a pity it would be to back away from the conflict-of-interest policy, such as it is,” said Dr. Marcia Angell, a retired Harvard Medical School professor and former editor of the New England Journal of Medicine. She has called for even tougher regulations but said at minimum, the existing rules should be preserved: “Something is better than nothing.”

The school would not make administrators available to discuss the review until after it’s completed. A spokesman declined to give a timetable.

The regulations under review have frustrated some faculty at the medical school.

Biology professor Ingber, for instance, led the team that developed a widely acclaimed tool known as “organs-on-a-chip.” Ingber then started a company called Emulate, Inc., to produce these chips, which contain tiny replicas of organs such as the lung, liver, gut, and skin. They’re designed as an alternate way to test new drugs without using animals.

Emulate may soon start giving the chips for free to labs for beta-testing. Ingber wants to be one of the testers. But because he has equity in the company, the medical school rules bar him from accepting any kind of sponsorship from Emulate — including free samples of the product he invented.

To Ingber, who directs Harvard’s Wyss Institute for Biologically Inspired Engineering, that rule doesn’t make sense. “I have more expertise than anyone in the world on the use of these chips,” he said.

He can, of course, buy the chips from Emulate at full cost to use them in his lab. But he’d be using federal grant money to do that — money that he’d rather spend on the research itself.

Ingber said he’s concerned about how the rule affects not just his own work, but the work of his institute, whose mission is to translate discoveries into startups or licenses for commercial products. To accomplish that mission, “there has to be a way to connect with industry in a seamless way,” he said.

Ingber said the strict conflict-of-interest policy makes it difficult for Harvard to recruit and retain talent.

Dr. Charles Serhan, Harvard Medical School professor of anesthesiology, called for changes to both rules under review.

Serhan said professors like him didn’t set out to be entrepreneurs but have felt compelled to launch companies to test their discoveries because the pharmaceutical industry has moved away from basic research, shifting the risk to academic scientists and their institutions. Federal grant money has also become harder to get, prompting academics to launch startups that can collect funds from investors.

He was tripped up by both rules in question after discovering a compound to treat inflammatory disease more than a decade ago. Because he had a sliver of equity in Resolvyx, the company producing the drug, the clinical research rule barred him from testing the drug on human cells in his lab. He had to wait for other labs to do it.

Serhan said the other labs lacked his expertise and thus it took longer than it should have to move the drug toward the marketplace. If he could have participated in testing it, he said, “things would go faster, and we’d build scientific value faster.”

Serhan said the clinical research rule makes sense for research on human beings, where the risk is higher, but he argued the rule should be revised to allow early-stage tests on human cells in the lab. And he agreed with Ingber that the sponsored research rule slows the pace of innovation. “The barrier’s got to come down,” Serhan said. He called the rules “stifling for biomedical research.”

Angell dismissed these arguments. People who invent a medical technology or discover a drug molecule should not be the one to test it, she said, at least, not if they could gain financially if results look promising.

“You can’t evaluate something in which you have a financial interest,” she said.

Angell said she worries that by reopening its conflict-of-interest rules, Harvard Medical School will “be going along with the times — and the times are that everything is for sale.”