The P&S Journal: Spring 1998, Vol.18, No.2
Ethics in Medicine
The Commercialization of University Medical Research
By Joan Lippert
A university’s mission is to seek the truth and serve society. A corporation is a business entity driven by profits, which are on occasion at odds with society’s best interests. But the fact is that in the past two decades, universities and industry have come together to work on projects that benefit them both.
Columbia was among the first universities to form a technology transfer office—now called Columbia Innovation Enterprise (CIE)—in 1982. Today, Columbia ranks as the top private university in revenues generated from technology licensing, at $50.3 million in fiscal year 1997. Only the public University of California system has greater revenues. The university now has nearly 250 active license collaborations with industry and receives royalties on numerous health care technologies and biotech products such as tissue plasminogen activator, a clot-dissolving agent that can reduce the damage from a heart attack; erythropoietin, which signals bone marrow to make red blood cells; Xalatan, a new drug to treat glaucoma; Avonex for multiple sclerosis; and Rheo Pro for restenosis. Licensing arrangements often grow out of industry sponsorship of the research that yielded the discovery. Revenue from research contracts was $10.9 million at Columbia for 1997.
The catalyst for the industry-university relationship was the Bayh-Dole Act, born in 1980 when Congress became aware that the government owned valuable technology and innovations but had no resources to market the inventions. The act allows a university to retain the title to federally funded discoveries (most university research is federally sponsored). Industry has followed the Bayh-Dole lead: The act was a foundation for the biotechnology industry and allowed for major commercial advances in other technology-intensive industries as well.
Even though the corporate contributions to universities are relatively small—in the realm of 15 percent in terms of total academic research funding—those contributions can be critical to the survival of some researchers. “We used to have a crisis of not enough NIH grants being given, but that severe cutting of the number of grants has been alleviated. But the crisis of not enough money within a grant to do the work it contains is continuing,” says Dr. Michael Gershon, chairman of anatomy and cell biology. “For several years the NIH has been cutting the amount of money in its grants, and as a result when we do get a grant, there isn’t always enough money to do the research. Unless additional funds can be obtained, we can’t do the work. So while the total funding from industry is not large, particularly in comparison to the monies supplied by NIH, industry has become a critical partner.”
This new partnering with industry has brought challenging ethical conundrums. Among them:
• Threat to objectivity: conflict of interest.
A January 1998 New England Journal of Medicine review of articles published in the medical literature found that authors whose studies favored calcium-channel blockers were significantly more likely to have accepted financial support from a calcium-channel blocker manufacturer than study authors who were neutral or critical.
“You shouldn’t ignore findings from a study like this,” says Dr. Barron Lerner, the Angelica Berrie Gold Foundation assistant professor of medicine at the P&S Center for the Study of Society and Medicine. “Columbia, like other institutions, receives substantial research support and it must be attentive to the possibility that such support might bias researchers.”
How might funding influence research results? The simplest relationship is that of researcher-investor: Good news about a company product from a Columbia lab could inflate stock prices. But at Columbia, university policy resolves this conflict: “If researchers have equity, they can’t take research funds,” says Jack Granowitz, executive director of CIE, which negotiates all industry-university contracts.
Ethical conflicts are also kept to a minimum because integrity is “embedded in the structure” of scientific research, says Dr. Claudio Stern, chairman of genetics and development. For instance, the NIH requires that pre- and post-doctoral trainees supported by NIH training grants receive formal instruction in the responsible conduct of research. (For more information, see “Ethics in Medicine: Teaching What is Neither Black Nor White,” P&S Journal, Fall 1997.)
Dr. Lerner agrees that many studies that come out of the university-industry relationship are excellent, “but in other cases, the way results are presented or framed may reflect the agenda of the organization that supplied the money. For example, studies have shown that presentations by speakers at continuing medical education conferences may be biased toward the products of the pharmaceutical companies that are sponsoring the events.”
To prevent bias in Columbia studies, every department has an Institutional Review Board (IRB) that looks critically at all proposed studies. From there the work goes to the central IRB. “We review every protocol, examining the risks and benefits,” says Dr. Donald Kornfeld, IRB chairman. “We are also concerned with possible conflicts of interest where there is industry support. We insist that all investigators tell us if they have any equity interest in a company sponsoring their research. If they do, then another investigator must take responsibility for acquiring and evaluating the outcome data. The patients are also told in the consent form, which they must sign, that a faculty member, and in some cases the university, may profit from a successful outcome. Of course, we also review the research design to be sure that the patient population isn’t skewed in favor of one drug or device over another.”
More difficult to evaluate are studies that are never published. “Sometimes researchers themselves will hold research results back,” says Dr. Lerner. “If they’re getting funding through a given company or organization and publish a study that deflates the funder’s balloon, when they go back for funding again they could be rejected. Investigators must confront difficult ethical challenges; incentives might potentially affect their better judgment.” A study by Dr. David Blumenthal of Massachusetts General Hospital found that about 5 percent of more than 2,000 academic scientists said they had delayed the release of “undesired results” for more than six months.
• Threat to free flow of information: requests for confidentiality.
By nature, a business is competitive and secretive. The mission of a university is to spread knowledge. An often-cited example of this clash was so egregious that universities have taken steps to assure it never happens again. A pharmacy professor at the University of California at San Francisco accepted a $250,000 grant from Boots Pharmaceuticals to compare levothyroxine (Synthroid) with other brand-name and generic versions. She signed a contract that prevented her from publishing her findings without the pharmaceutical company’s permission. It turned out that all versions of the drug she studied worked equally well, a finding that neither she nor Boots had foreseen. Boots delayed publication of the findings.
Today, UCSF and other universities have centralized contract review. Says Dr. Samuel Silverstein, chairman of physiology and cellular biophysics, “Almost all Columbia contracts give the drug company a month or two to review what we’re doing [before publication], but all preclude the commercial supporter from having veto power.”
The university does not even have to keep research results under wraps until the researcher has applied for a patent, since CIE is able to file a patent in a matter of days, if necessary. However, about 7 percent of researchers in the Blumenthal study said they had withheld information for more than six months to keep ahead of competitors.
• Threat to university work: time conflicts.
It’s well-accepted that researchers are not only subject to the publish-or-perish rule, but also under pressure to bring in outside support, be it industrial, federal, or other. Says one Columbia researcher, “I don’t know anyone who has not attracted support and survived here.” Researchers may spend inordinate time trying to make themselves attractive to sponsors. In the opinion of Dr. Robert Canfield, Irving Professor of Medicine, “There is a profound disinclination on the part of scientists who must spend most of their time competing for grants to give their time for teaching.”
Researchers are also more accountable now for the way they spend their money and may resent having to spend more time tracking research costs directly, says Steven S. Ross, associate professor of professional practice in the Graduate School of Journalism, who has served on the University Senate budget committee. The accountability may mean less room on campus for the dreamer or the absent-minded professor of yesteryear. “If a researcher goes off on a little tangent, it could cost hundreds of dollars,” says Dr. Ross.
• Threat to university ideals: cost conflicts.
When a project is industry-funded only, little question exists who should get first option on licensing. But industry-only projects are rare and usually short-term, and many projects are supported by grants from a variety of sources—the NIH, pharmaceutical or biotech companies, and voluntary health agencies, for instance. If the private concern then receives an exclusive license to the resulting product—and charges high industry prices to consumers—the public might question whether that conflicts with the university’s mission to serve society, say some critics.
A lot of questions, then, and slowly evolving answers. Still, most researchers believe that on balance the university-industry relationship is one worth wrestling with because of the potential benefits. Jack Granowitz summarizes: Faculty members benefit because they get money for research so they’re not totally dependent on federal funding. The university benefits because it gains additional funding for research and education. Industry benefits because it gets intellectual property rights and association with Columbia. Inventors also receive a portion of the royalties for their research. The public benefits from new research, treatments, and medications that might not otherwise have been discovered.