University-Industry Collaborations: For a Few Bucks More

With permission, I presented this case as a scenario for the final examination in a course I give on the responsible conduct of research. The students in the course are graduate students in the biomedical sciences and fellows from various clinical departments who are entering academic careers.

The students and I agreed that this sort of behavior should not be happening at a well-managed university.

Susan, the graduate student, has been exploited by her PI. While he is her supervisor, Dr. Centrifuge can't really be called a mentor or advisor 1. A mentor has the fiduciary responsibility to think first of the welfare of the trainee, something many supervising PIs just aren't very good at.

Mentoring is an art that requires skills and attitude that are in short supply in this case. No mentor worth her salt would have allowed a graduate student to get involved in a project that might compromise her chance of completing her thesis, even if the student wanted to do it.

On the other hand, and here my students were silent, Susan was not a passive actor in this case. She should have assessed the possibility that this part of her work could not be published and consulted with her committee in advance. Graduate students and other trainees should realize that they become responsible for the research record as soon as they begin to do science. They will spend an important part of their life completing their degree and depend on PIs and mentors for guidance and direction. They have an obligation to make sure that they don't sign up with a PI of dubious reputation either in ethics or in mentoring.

Dr. Centrifuge and his university also have responsibilities to society. Much public money is spent on them and they are entrusted with the education of our youth, as well as the development and protection of the scientific record. They have a moral obligation to maintain high standards in both arenas. But institutions have no independent soul. They depend on their leadership for establishing and sustaining a culture of excellence, and the leadership is only a temporary custodian of the institution's reputation. Some leaders believe that money buys excellence and will do almost anything to raise more money--such as making a deal with BigPharmaCo. In this instance, BigPharmaCo's shares came with strings attached, and the strings came home to roost.

Most research universities have language in their contracts with funders indicating that the sponsoring agency can only delay publication of the results of research for 30 or at most 60 days. Had the university a contract containing such a clause, Susan and the public would have been protected. Generally, pharmaceutical companies conduct their studies at numerous institutions and perform the analysis in house. They own the data and very often choose not to publish negative results. The Food and Drug Administration does not require them to publish such studies, only the reported adverse events. Of course, the drug will not be approved unless other studies demonstrate efficacy. But this distorts the research record in favor of positive results and, as David Blumenthal notes in The New England Journal of Medicine, almost all drug study reports are positive. There have been numerous reports of bias in the design as well as the reporting of drug trials. Luckily, some of the leading journals have just agreed on new standards for reporting clinical trials, and the gross conflicts of interest 2 in this case would not have gone undisclosed.

Both Dr. Centrifuge and the university must defend the right to publish. My students did not recognize this case as a threat to academic freedom. Academic freedom mandates that institutions protect rather than inhibit the right and duty of faculty to report their scholarly work. Lives have been lost to protect academic freedom. In the 1950s during the McCarthy era, careers ended tragically because fearful institutions fired numerous professors. The Loyalty Act required that we sign affirmations for federal or state employment. We vowed, never again. Finally, Dr. Centrifuge and his institution have a fiduciary responsibility to society to protect the public against unsafe and/or ineffective medications. To allow a few bucks to influence public safety and academic freedom is outrageous and would never occur at the vast majority of research institutions.

References1. S. J. Bird and R. L. Sprague, "Mentoring and the Responsible Conduct of Research: Reflections and Future," Science and Engineering Ethics 7, 451 (2001).

2. Editorials, Ann. Int. Med. 135, 463 (2001).

* Stanley G. Korenman is associate dean for ethics at the UCLA School of Medicine.

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