Caveat emptor

American Journal of Pharmaceutical Education,  Summer 1999  by Zito, S William

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I recently attended a presentation intended to stimulate thinking about industry-funded research and entrepreneurial opportunities for faculty, the college and the university. The program was responding to the static or decreasing budgets that academic research has been confronting for some time. I was excited and supportive of this avenue for scientific advancement, because industry funding can be an opportunity to enhance resources for research. I personally have had research support in the form of grants from private industry and completed those studies with a very positive attitude about industry-funded research.

However, during the question and answer period of the presentation, several colleagues expressed concern about the inherent differences between university research and industry research. They felt that university research exists primarily to benefit society and create new knowledge whereas industry has an additional motivation, namely, to make a profit. Their concerns raised some questions. Are the two agendas mutually exclusive? Can the profit incentive influence the scientific method and create serious ethical problems? The more I thought and read about it, the more I realized that the issue deserves wide discussion and debate.

In retrospect, a number of events seem to be fueling the current interest in industry-funded research and entrepreneurial incentives for academia. In the late '70s and early '80s as budgets decreased and public funding of research projects declined, university scientists began seeking private sources of funding. At the same time, it became apparent that many lucrative discoveries, especially in the biotechnology arena, were buried in academic laboratories where there were no incentives to bring them to the marketplace. This led, in 1980, to the passage by Congress of the Bayh-Dole Act, which allowed researchers and universities to patent discoveries from federally funded research. This law, in effect, lifted a ban on campus entrepreneurship. Scientists could seek private support for their research and industry could advance the commercial development of academic discoveries. Along with this, the merging of pharmaceutical companies led to an increase in outsourcing of many research and clinical studies thus increasing the opportunities for industry-funded research and contracts to academic centers.

These events have certainly benefited academia as they have lead to support for programs and projects that otherwise might not have been funded. In fact, industry/university alliances have produced many widely utilized clinical tests, medical technologies and new drugs. For example, 3TC, a synthetic Taxol analog and Hemophilus b conjugate, the vaccine for bacterial meningitis, were produced from such alliances. The Merck Genome Research Institute gave Lexicon Genetics, Inc. $8 million to create 150 new strains of "knock-out" mice. Lexicon Genetics, in turn, promised to make them available at nominal cost to academic centers studying gene function(I). Private investment in academic life science is up from less than four percent in the '60s to 12 percent today(2). These are all positive outcomes that are undeniably good for scientific progress.

So where's the rub? Is there an ethical dilemma? It may very well be connected to the profit incentive, the money. The profit motive might drive marketing departments to encourage or mandate the suppression of positive findings on competing products. The recent experience of Dr. Betty Dong, a clinical scientist at the University of California, San Francisco serves as a good example. Dr. Dong published a double blind, randomized pilot study that suggested that Synthroid(r) had greater bioavailability than its generic competitors. Seeing an opportunity to show the superiority of Synthroid(r), Boots Pharmaceutical offered to support a larger double blind, randomized clinical trial. When the results failed to demonstrate the superiority of Synthroid, the company conducted a campaign to suppress and discredit the study results in 1990. Eventually the media attention overcame the proprietary issues and Knoll Pharmaceuticals, which purchased Boots in 1995, agreed to allow the results to be published(3,4). This is by no means the only case.

Another industry supported researcher, Dr. Nancy Olivieri, was threatened with legal action by Apotex, a Canadian drug company, if she published criticisms of its drug LI, related to the clinical trials they were sponsoring at the Hospital for Sick Children in Toronto(5). Simarly, Dr. David Kern, director of occupational medicine at Brown University, was pressured by a local company and his University not to publish his findings about Flock Worker's Lung, a new lung disease outbreak at the company's plant(6).

Some may argue that these cases are rare and relatively insignificant when compared to the positive effects derived from industry/university partnerships. Yet there remain other more subtle effects that need to be addressed, For instance, the need for research money might push an inordinate number of scientists to gear their research toward commercial application rather than into areas that push back the frontiers of scientific knowledge. The commercial success of their research can induce scientists to leave academia and establish companies of their own or in collaboration with their industry partners. In addition, concern over patent rights and potential commercialization often leads to secrecy agreements and delayed publication of results. A survey published in the Journal of the American Medical Association(7) reported that close to 20 percent of the life-science researchers questioned, held up publication by more than six months for several reasons. Specifically, to complete patent applications; to protect their scientific lead; to slow the dissemination of undesired results, or to allow time to negotiate a patent. Also, approximately nine percent of the respondents reported refusing to share research results with other university scientists. This need for secrecy can delay the career goals of the graduate students conducting these projects and is an inherent impediment to the free exchange of information essential to scientific progress.