Finding the line

As the boundaries separating academe and industry are redefined at Yale and other universities, questions arise about potential conflicts of interest: When money talks, will faculty focus their research on areas with the greatest possibility for commercial return? Will administrators guide appointments into research areas with the potential for more lucrative licenses? Will professors shirk their teaching duties to focus on outside businesses?

Underlying the questions is a concern that closer ties to the private sector have the potential to undermine universities’ academic, educational, health care and public-service missions. Yale sometimes takes an equity stake in companies started by the Office of Cooperative Research (OCR), and licensing income—driven in large part by the success of d4T, an anti-HIV compound discovered in Yale laboratories—has grown rapidly, totaling more than $46 million for the fiscal year ending last June 30. The money, which goes to support research and other University activities, represents more than 11 percent of Yale’s total research expenditures.

Myron Genel, M.D., a Yale professor of pediatrics and the founding chair of Connecticut United for Research Excellence Inc. (CURE), worries that Yale and other universities risk harming the traditional character of medical schools that makes them so intellectually productive. “There is increasing concern that excessive emphasis on the commercial potential of academic research may damage the collegial, traditional nature of academic institutions,” says Genel.

Perhaps more significantly for the longer-term health of today’s financially strapped medical centers, will all of this commercial activity reduce the public’s willingness to support biomedical research? “What’s at stake,” Genel says, “is the public perception of academic institutions. Nationally the academic medical community is vigorously attempting to sustain public support for the missions of medical schools and teaching hospitals. I believe we must keep our house in order on high-profile issues such as conflicts of interest by academic investigators, or, for that matter, on the part of our institutions. It is difficult to make the case that academic medicine is for the public good on the one hand if we are perceived as for sale on the other.”

To prevent the reality from arising or such a perception from emerging, Yale has set rules limiting faculty work consulting for outside companies and for avoiding conflicts of interest in undertaking research on behalf of commercial enterprises (See Conflict-of-interest policy). It has also undertaken a review of its current policies on conflicts of interest and commitment and on human subject protection to make sure they are up to date and appropriate. Under the existing rules, all faculty members must file an annual conflict-of-interest form that is reviewed by the provost and a standing committee. Faculty are at Yale to teach and carry out research and, to avoid so-called conflicts of commitment, they are permitted to work only one out of every seven working days for an outside organization. They also cannot undertake clinical trials on behalf of a company in which they hold a significant equity stake—one that could compromise, or appear to compromise, the results of the trial.

While research findings can sometimes be scrutinized for commercial value by sponsors prior to publication—a first look in return for support—all findings remain Yale’s intellectual property to license out as it deems appropriate. Also, Yale will not accept any outside support that limits publication of research findings. “The more close ties we have with industry,” says Sara Rockwell, Ph.D., professor of therapeutic radiology and director of the Office of Scientific Affairs, “the more potential there is for conflicts of interest. Everything needs to be looked at to make sure that our research is free of the taint of a potential conflict of interest. It not only protects the research, it protects the faculty. One of the most awful things that can happen is to have your research findings accused of being tainted because of bias.”

The topic, a hot one at nearly every university in the United States, was the subject of a National Institutes of Health conference in August, with discussion focused on the ethical questions inherent in closer ties between academe and the private sector. At Yale, according to Vice President and General Counsel Dorothy K. Robinson, the University is reviewing its conflict-of-interest policy and procedures “with an eye to making them more robust and providing clearer guidance. We want to be sure that the University addresses the full range of issues that can arise.”

Still, most agree that the new push into biotechnology development in New Haven need not undermine the core missions of the University. “We feel very comfortable,” says Bruce D. Alexander, vice president and director of New Haven and state affairs, “that we can reconcile the traditional values of the University with respect to objective scientific research and the commercial application of that research to foster new companies that will improve the quality of people’s lives and cure human diseases.”

OCR Director E. Jonathan Soderstrom, Ph.D., finds that Yale faculty are not overly concerned with pursuing the commercial value of their work. From the OCR’s perspective, the danger is that, if a new finding does not have patent protection prior to publication, no outside commercial entity will develop it because they will not be able to prevent competitors from copying the idea or product. “It’s not unusual for us to learn about something on Friday that’s set to be published on Monday,” he says. “We’re always in a race with the faculty because they’re not going to wait for us. They are more worried about publishing and tenure. The race here is to get the next cover of Nature and win Nobel prizes. If their desire was to get rich, they wouldn’t have come to a university like Yale. I don’t see that culture changing, and that’s a good thing.”

Sitting in his cramped pharmacology department office, every inch of his desk covered with papers, Henry Bronson Professor Yung-Chi Cheng, Ph.D., does not look like a captain of one of the world’s fastest-growing, most-high-tech industries. “The financial aspect is not a driving force,” he says. “My belief is that some of those medicines will turn out to be very useful for health needs which cannot be fulfilled by current approaches. That’s my incentive for this.”