The deep reach of the pharmaceutical industry into academic and clinical medicine sets up ample opportunity for conflicts of interest on the part of biomedical researchers. To minimize the risks that such conflicts could introduce bias into the scientific literature, most publications impose reporting regulations that make transparent any financial stake that an individual researcher may have in the subject of his or her publications. Similarly, most institutions regulate the nature and scope of such financial agreements.
However, there appears to be significantly less oversight when it comes to an individual researcher’s ability sign away freedom of inquiry and publication. In a commentary in this week’s Chronicle of Higher Education, Harvard School of Public Health professor Marc Lipsitch points out that few universities have explicit regulations to prohibit researchers from signing consultation agreements that severely curtail their freedom to express their opinions or choose the direction of their research. And in the absence of such regulations, Big Pharma are starting to ask for precisely these types of contractual restrictions. Lipsitch reports his own experience:
“Recently, however, I received a request from a large pharmaceutical company to assist in the design of a clinical trial, and the proposed terms seemed to require that I sign away my right to criticize the product. One provision would prohibit me from entering into “any agreement or relationship to render services as … adviser or consultant to, any other individual, firm, or corporation that would be inimical to or in conflict with” the aspects of the company’s business covered by the agreement. Another would forbid me to engage, in any capacity, directly or indirectly, in “any business,” with or without compensation, relating to the class of products under discussion—not just for the term of the contract, but for the year after as well. Those provisions could restrain me from providing candid advice to a regulator, a government official, or the editor of a peer-reviewed journal about the class of products on which I was consulting, even if the advice were based on publicly available information.”
Lipsitch of course rejected those terms, but the request left him wondering what guidelines are in place regarding these types of agreements. He investigated, and the results appear to be a cause for concern. His funding agency, the NIH, referred him to his employer, Harvard University. When he inquired at Harvard:
“Harvard administrators replied that they did not review private agreements between faculty members and companies and told me to check the university’s policies on conflicts of commitment and interest….Harvard’s conflict-of-commitment policy forbids faculty members to undertake activities that take excessive time or intellectual energy away from their research and teaching. The conflict-of-interest policy focuses on the risk that a faculty member might benefit financially from a research project, compromising objectivity in teaching or research or hindering fair treatment of trainees. Neither policy, however, directly deals with whether faculty members can sign away their academic freedom.
Though some universities have instituted stronger regulations and oversight, Harvard is not unusual in its laissez faire approach to such contracts. Lipsitch makes a compelling case that this needs to change if we hope to preserve free and open inquiry in the field of biomedical science. How many of our colleagues are contractually compelled to remain silent in ongoing scientific debates? It is a disturbing question.
M. Lipsitch (2010) The Risk to Academic Freedom That Lurks in Corporate Consulting Contracts. Chronicle of Higher Education. June 27th.
Marc Lipsitch and the author of this article, Carl Bergstrom, are co-authors and co-PIs in the area of mathematical epidemiology of infectious disease. Bergstrom was not involved in any way in the work described in this article.