Corporate-funded studies a concern

Think you'll help humanity by participating in a clinical trial?

Sheldon Krimsky and Paul Gelsinger would say you're helping the rich get richer.

At a conference for Krimsky's new book, Science in the Private Interest, both argued that universities across the nation are selling their soul to private industry -- and that Penn is among the worst offenders.

"They were on my list of the top 25" institutions receiving private funds, said Krimsky, a Tufts University professor of urban and environmental policy and planning.

In order to argue that universities are becoming more commercialized, Krimsky used the National Science Foundation's semiannual reports on research funding to chart the growth rate over time.

In the 2001 edition, the NSF reported that industry-sponsored research and development at Penn was $28.2 million, he said.

Although total research and development expenditures for that year was $469 million, Krimsky said that it is the rate of change that is important -- "It doubled between 1996 and 1997."

Krimsky acknowledged that, at this time, the average industrial funding "throughout all the universities are in fact about 7 percent of the total R&D;," but some universities are receiving as much as 30 percent of their research funds from industry.

This increasing commercialization is leading to potentially dangerous conflicts of interests, he said.

"It really doesn't matter how much funding industry contributes to universities -- all you need is one corrupting situation to foul the waters of the university," he said, noting that Jesse Gelsinger's death did this at Penn in 1999.

Gelsinger was an 18-year-old participant in a clinical trial supervised by Penn Professor James Wilson at the Institute for Human Gene Therapy. He died of complications shortly after the trial began in 1999.

"In clinical trials, prior to Gelsinger, it was just assumed that disclosure statements didn't really need to disclose much about the financial interests of the university or the principle investigators," Krimsky said, noting that both Penn and Wilson had financial interests in Genovo, a for-profit biotechnology company funding the trial.

If the trial had succeeded, all three could have profited.

"I didn't have a clue when it first happened that there were any [bioethical] problems at all," said Paul Gelsinger, Jesse Gelsinger's father and vice president for CIRCARE, a clinical trial advocacy group.

Gelsinger did not think about the bioethical implications until investigative reporters uncovered the conflicts of interest, he said.

"This big can of worms opened up right in front of my eyes," he said.

"When people sign up for clinical trials, they should have some understanding that some of this may be helping humanity, but some of it may be making some people extremely wealthy," Krimsky added.

Other critics believe Krimsky's view is too simplistic.

"Money is not everything," Arthur Caplan, director of Penn's Center for Bioethics, wrote in an e-mail.

"In the long run, money could have been made for the investigators... so that certainly did motivate them, but I think in academic settings ambition and the drive to make a breakthrough also are important sources of conflicts of interest," he argued.

Questions about motives aside, universities have come to depend on industry funding, so "the challenge is to figure out how to manage them," Caplan added.

Others believe Penn's research structure can adequately prevent conflicts.

Director of the Office of Regulatory Affairs Joseph Sherwin noted that administrative research protocols exist to prevent industry interests from swaying the research system.

The Independent Review Board, which approves research requests, is "separated from the approval of the funding aspects of a protocol," Sherwin said, adding that they are aware of who is providing the money.

While the IRB examines potential conflicts of interest, "there's also a separate committee that looks at those conflicts."

"We see our role as protecting the patient, regardless of the source of funding," he added.

"It's not effective enough," Gelsinger said, noting that these protocols existed before his son's death. "They're university employees who want to keep their jobs by not creating waves."

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