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University-Industry Collaborations: Whose Data?

At first glance, the idea of a collaborating with a company can be very appealing. Perhaps the company is offering your lab a lucrative, multiyear contract. Or maybe it is dangling a more intellectual lure--like being on the ground floor of a major breakthrough, such as a cure for cancer.

But whatever the reasons may be for considering an academia-industry partnership, both parties should look long and hard before they leap.

Why? Well, to put it simply, academia and industry have disparate goals, objectives, and obligations. To remain competitive, companies must make a profit by producing a novel product that will benefit many, so they hold their cards close to their chests.

But academics seek new knowledge and have obligations to the scientific community and society at large to communicate that knowledge--allowing everyone to see their hand. Not surprisingly, these different ways of practicing science can lead to trouble if they're not dealt with at the outset--when, for example, an academic researcher in an industry-funded study wants to publish results that could negatively affect the industrial sponsor's bottom line.

Such were the issues we wanted to address with the following case study, which we presented to various experts for their opinions:

Susan, a Ph.D. candidate in epidemiology, has just finished analyzing her findings from a large-scale clinical trial for a drug touted to increase intelligence. BigPharmaCo gave Dr. Centrifuge, Susan's PI, grant money to finance the project 4 years ago, during Susan's first year as a student in his lab. Susan's university also received shares in BigPharmaCo as part of the deal. At the time, the intelligence study sounded very exciting to Susan, and she immediately volunteered to join the project.

But now, Susan is writing up her thesis and wants to include the data from the clinical trial--data indicating that the new drug does not affect intelligence at all. When she asked Dr. Centrifuge for the data notebooks, he told her that she should not use the clinical trial results in her thesis. A representative for BigPharmaCo had called earlier in the week and was not happy with the outcome of the trial. Fearing a drop in the value of their stock, BigPharmaCo refused to allow Dr. Centrifuge to publish the lab's findings. Dr. Centrifuge has also been feeling pressure from the university, whose BigPharmaCo shares may drop in value once the data are made public.

We asked our essayists to ponder what each of the players--Susan, Dr. Centrifuge, and the university--should do. Will Susan still be able to write her thesis and graduate? What about Dr. Centrifuge? He's answerable not only to BigPharmaCo, the sponsor of his study, but also to Susan as her mentor and to the university as his employer. How should he manage these conflicting responsibilities? And don't Susan and Dr. Centrifuge, as members of the academic scientific community, have a still larger obligation to disseminate their results? How far should a university go in imposing restrictions on their professors and trainees? Is it really fair for the school to pressure Susan and Dr. Centrifuge for its own financial gain? Finally, and perhaps most important, what should all of our characters have done to avoid this scenario from happening in the first place?

Unfortunately, this is not a purely theoretical exercise. Conflicts over data ownership and disclosure do occur, maybe more frequently than we'll ever know. In November 2000, Science published an article (subscription required) describing a very similar real case brought to light by James Kahn of the University of California, San Francisco (UCSF), a principal investigator in a large industry-sponsored clinical trial. The clinical trial was halted in 1999 when it became obvious that the drug under investigation was not effective. After the trial was stopped, the researchers sought access to the full data set so they could prepare a manuscript on the study. Instead of data, they got a memo from the company placing new conditions on their access, requiring that the researchers obtain approval of "the content, analysis, results, and discussion" before publishing their paper, and limiting that access to a 1-year period. The initial contract had only stipulated that manuscripts be reviewed to ensure that no proprietary information was included. Kahn and his colleagues balked at the sponsor's new demands and published their paper anyway.

But what's to deter a company from imposing such demands? A small step has recently been taken by a group of prominent medical journal editors, including the editors of the Journal of the American Medical Association, The New England Journal of Medicine, and The Lancet, who have revised their policies on accepting manuscripts. Now, authors of papers submitted to the participating journals must spell out the exact role of an industry sponsor, and many of the editors "will ask the responsible author to sign a statement indicating that he or she accepts full responsibility for the conduct of the trial, had access to the data, and controlled the decision to publish."

Industry reaction to the new editorial policy is mixed. One industry insider (who wished to remain anonymous) said to Next Wave, "The feeling I got was that the editors, as members of the scientific community, were saying to the drug companies 'Give us your millions and go away.' " But this isn't a view publicly shared by all company representatives. Steve Linberg, senior vice president for drug development at Cato Research, says, "we deal with preventing that situation [posed by Next Wave] all the time. We would make sure that the university would have the right to publish." Cato often collaborates with universities on clinical trials and requires that investigators who are under contract submit manuscripts a month or so ahead of publication to check for accuracy. Linberg says his company "does not reserve veto power." Thus, Cato has "no problem" with the new editorial policies.

Read on to find out what our panel of experts thinks:

Jonathan R. Alger, an assistant general counsel at the University of Michigan, Ann Arbor, cautions that all graduate students should find out as much as they can about the contracts and agreements associated with their research to avoid what happened to Susan. "Knowledge is power," he says.

Thomas Callarman, director of the Institute for Manufacturing Enterprise Systems and former associate dean of graduate studies at Arizona State University in Tempe, explores the multiple obligations of Susan, Dr. Centrifuge, and the university.

Stanley G. Korenman, associate dean for ethics at the UCLA School of Medicine, presented our case study to his class to ponder as part of their final exam. Korenman fills us in on what he and his students thought about the scenario.