Stanford Report Online



Stanford Report, November 1, 2000
Loose policies threaten academia/industry biotech collaborations

BY CHRISTOPHER VAUGHAN

Universities and academic medical centers have come to depend on collaborations with commercial enterprises to pursue biomedical research, yet many institutions lack ethics policies specific enough to protect the integrity of the institution, its faculty or their research, according to a study conducted by Stanford researcher Mildred K. Cho, PhD. A lack of clear guidelines on the interactions between industry and academia can lead to serious conflicts of interest, Cho said. "Conflicts of interest are a concern because they can potentially affect the quality, outcome and dissemination of research, as well as affect the public's perception of, and trust in, universities and researchers," Cho said.

The study was published in the November 1 issue of the Journal of the American Medical Association (JAMA), along with another study on the topic and warnings from and David Korn, MD, and JAMA editor Catherine DeAngelis, MD, that such problems can threaten the very foundation of biomedical research.

Cho and her colleagues began the study by surveying the 100 institutions receiving the most funding from the National Institutes of Health in the year 1998. Of the 89 written policies they received from these universities, Cho found that very few (19%) specified limits on faculty financial interests in corporations sponsoring their research. Such financial interests could potentially lead researchers to enhance or suppress portions of their research that would have a large effect on the financial well-being of the corporation.

In addition, rules on financial disclosure generally varied widely among these institutions. "Fifty-five percent of the policies required full disclosure from all faculty, while 45 percent required disclosure only of principle investigators and those doing research," Cho said.

Another potential problem with corporate sponsorship of academic research is that researchers may delay the publication of their research. This strategy gives sponsoring companies a jump on their competitors, but is contrary to the academic mission of free dissemination of information through full and prompt publication of research results. Cho and her colleagues found that only 12 percent of the written policies specified limits on permissible delays in publication.

In addition, very few of the policies prohibited specific practices that could be detrimental to students' education. For instance, a financial conflict of interest could lead a researcher to compel a student to work on company-sponsored research, even though the project is not best for the student's academic career. "We found that only four percent of the policies prohibited students from working on company-sponsored projects in which the researcher has a financial interest," Cho said.

Many policies did list various methods that universities could use to manage conflicts of interest, but the situations in which they would use these methods were generally not specified, Cho said. "The method most frequently stated was disclosure [of the potential conflict of interest] to the institutions, followed by disclosure to the public, monitoring and oversight of the research activities, and divestiture or prohibition of financial interests," Cho said.

Cho and her colleagues point out that the lack of specificity in these policies can sometimes be beneficial for universities in the short term. The general nature of the universities' conflict of interest policies give the institutions flexibility in addressing the complex and rapidly changing nature of industrial academic ties, Cho said. Cho and her colleagues also noted that policies do not always reflect actual practice, and that other relevant regulations, such as state or local laws, may not have been included in the institutional policies they reviewed. "However," Cho adds, "It would be to the long-term benefit of faculty, institutions and companies to develop clear and specific policies that protect universities' primary missions of education, research and dissemination of knowledge."

"Wide variation in the management of conflicts of interest among institutions may cause unnecessary confusion among industrial partners or competition among universities for corporate sponsorship," Cho said. Such competition could erode academic standards and lessen public confidence in university research, Cho and her colleagues conclude.

Also in the November 1 issue of JAMA was a study demonstrating the growing reach of corporate financial interests into academic laboratories. Lisa A Bero, PhD, and Elizabeth A. Boyd, PhD, of the University of California, San Francisco, found that a growing number of UCSF researchers are reporting financial relationships with industry sponsors that go beyond grants for specific research. Such interests may include paid speaking, engagements or consultancy contracts. The pattern at UCSF is likely typical of most top-tier medical schools, the authors speculate.

The two studies together prompted publication of an editorial in JAMA and a commentary by David Korn, MD. Korn is a former dean of the Stanford University School of Medicine who is now affiliated with the Association of American Medical Colleges (AAMC). Korn urges academic medical centers and professional societies to come together to define and enforce high standards of conduct for individuals and organizations collaborating with industry.

Such high standards are essential for public understanding and support of biomedical research, Korn writes. Recent reports alleging a linkage between financial conflicts of interest and the deaths of research participants "should be a clarion call to the academic medical community to come together to address these critical issues," Korn said.

Korn's feelings were echoed by JAMA editor Catherine D. DeAngelis, MD, in an editorial. Without adequate policies and procedures to manage conflict of interest, DeAngelis said, academic institutions and their faculty "are in grave danger of losing the support and respect of the public."

"Without this support and respect, trust in new medical discoveries and their applications will not be forthcoming," DeAngelis said. "Without trust, medical research is doomed."