Conflicts of interest aren’t easy to resolve. That’s why they call them conflicts.
So the 200 ethics, compliance and conflict-of-interest officers attending the Cleveland Clinic’s Sept. 20 conference—A National Dialogue on Biomedical Conflicts of Interest and Innovation Management—heard many differing opinions and much public soul-searching about how to stimulate and support innovation in university research facilities and academic medical centers without surrendering ethical values.
They heard government regulators and grantmakers talk about new efforts to encourage transparency through disclosure—and what consequences face them if they fail to adopt those measures.
That’s becoming increasingly difficult given the many subtle and obvious temptations from pharmaceutical companies and devicemakers sponsoring or purchasing the fruits of that research. The conference brought together some of the top names in academia, research and business to grapple with issues researchers face daily.
Inventing the next breakthrough drug or miracle device has delivered wealth and prestige to individuals and universities, making reputations and attracting other bright minds, clinical studies and research grants from government agencies and the private sector. But in a few cases, ethical lapses and decisionmaking driven more by profit than by patient safety have cost lives, created negative press and brought shame, lawsuits and even criminal charges to the doorsteps of some of the best-regarded institutions in the country.
Philip Pizzo, M.D., dean of the Stanford University School of Medicine, says: "Some people will always do the right thing. Most need guideposts. But a handful will violate the law."
He says Stanford officials know there will be conflicts of interest, but says leaders there help the faculty to manage those to support innovation. Pizzo says Stanford accomplishes that through extensive transactional and annual disclosure statements that include declaring financial interests, including more than $10,000 in equity in a private company.
"Our institution will divest an interest in any company doing clinical trials at Stanford," Pizzo says. He says the free meals and gifts to physicians, researchers and staff create a "too close" intermingling of interests that could influence decisionmaking, and says Stanford has eliminated "all things that create confusion in the public mind and cost public trust … breaking the shackles of marketing."
Former Merck & Co. Chief Executive OfficerRoy Vagelos, M.D., says those holding financial interests in a prospective product should not be allowed to conduct human research testing of those products. Vagelos says he tried but failed to get rid of the pharmaceutical sales representatives who market drugs to physicians, better known as "detailers."
He says educating physicians about drugs is important to both manufacturers and physicians, but suggests a different environment, such as a conference, where doctors can learn without being pitched or bribed with gifts.
He says the drug companies don’t give away lunches and gifts out of pure generosity, but explains their studies tell them that the giveaways do influence physician prescribing behavior.
However, Thomas Stossel, M.D., an entrepreneur and Harvard University professor, says the disclosure requirements from universities and federal agencies are becoming onerous and intrusive. Stossel says the transparency movement discourages the best and the brightest from entering the commercial arena: "Are we solving problems? I don’t think so." He says the excessive disclosure requirements of private ownership and conflicts of interest violate individual privacy and could discourage innovation.
While Stossel is not alone in his opinions, the tone of the audience responses seemed to indicate a grudging acceptance of tougher rules and greater disclosure to rebuild and maintain public trust. "There’s a growing sentiment of distrust," says former U.S. Attorney General Richard Thornburgh, or an erosion of public trust. Thornburgh, a Pfizer board member, says if the biomedical establishment can’t regulate itself, "We can expect increasing government involvement. Appearance is everything. Vigilance requires attention to conflicts of interest on personal and institutional levels."