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Risky research

Is corporate money compromising public research? >From their inception, America's publicly funded universities have conducted research with a simple mission: to advance and disseminate scientific knowledge. Researchers' careers blossomed based on publication and merit; success led to increased funding for further research; and the concept of "owning" the results of their efforts was not a primary consideration.

Today, however, that simple mission has been clouded by a rapid increase in privately funded research - research that is conducted at public universities but funded by private business. And many researchers are concerned that their independence is being eroded.Industry ties. There is ample evidence to support that concern: * In conducting an ongoing survey of biological scientists (last conducted in 1996), Fred Buttel, a rural sociologist at the University of Wisconsin, detected a trend. He says, "When asked for their views of university-industry relationships, a number of researchers in the sample expressed growing concern over closer ties with industry. Compared with their responses in 1989, significantly more agricultural college researchers in 1996 said that growing links with industry would result in their research becoming too oriented to industry needs, reduce their opportunity to study basic biology and inhibit open communications." Those surveyed in 1996 strongly agreed that private sponsorship of research is essential because of inadequate public research funding and said that receipt of grants or contracts is now nearly as important in determining faculty promotions as their publication record.

*At the 1995 annual meeting of the National Agricultural Biotechnology Council (NABC) - a gathering of academicians from 22 universities - the Research and Policy Committee report stated that, by large measure, the concern that dominated discussion was whether research agendas were unduly influenced by industry.

The report also noted that researchers were uncomfortable with the increasing pressure to seek industry funds, and they agreed that "there is a need to maintain some balance between public sector and industry control over research agendas to ensure the kind of freedom of inquiry essential for scientific advancement."

*A survey of more than 2,000 scientists published in the Journal of the American Medical Association (JAMA) revealed that 20% of the researchers had delayed publication of their research results for more than six months. The most common reasons that they gave for delaying publication were that they were preparing a patent filing, protecting the proprietary value of their research and trying to enhance their lead over competitors.

Paranoia? The startling conduct of the makers of a synthetic thyroid drug illustrates how real the list of concerns has become. In 1987, Knoll Pharmaceuticals enlisted Betty Dong, a researcher at the University of California at San Francisco, to compare its drug - Synthroid - to three other, much cheaper alternatives. When her study showed that the alternatives worked just as well, Knoll refused to allow the work to be published. Dong's contract prohibited publication unless approved by the company.

Eventually, JAMA asked five experts to review the study, and they found no fault. Only after the FDA pressured the company did it agree to publication. In a letter to JAMA, Dong wrote, "The difficult, sobering and painful lessons learned should be remembered by all when collaborations between industry and academia occur."

At issue are the "rules" under which researchers agree to conduct industry-funded research. With the push to increase outside funding, researchers can have difficulty saying no. In a study conducted at Carnegie Mellon University, 53% of surveyed scientists said they had agreed to delay publication, and 35% said they had agreed to contracts that allowed sponsors to remove information from their research at publication.

Bill Baumgardt, retired director of agricultural research at Purdue University, says collaborative research can be an asset for any university if conducted on the proper terms.

"The most critical aspect of sponsored research lies in the terms of the agreement," Baumgardt says. "First, of course, comes publication of the results. All research should be published essentially without delay, which allows no more than six months due to review procedures.

"Second, ownership of any patents that result from the research must be held by the university, and ownership of the patents needs to be separated from licensing. Licensing terms usually are not difficult to negotiate. You just work through that process until both parties are satisfied.

"Third, if for some reason the research can't be published, it must be separated from the university. Some institutions have private research corporations, for example, that can handle that.

"And finally, if publication is an issue, no graduate student should be allowed to work on the project. You can't delay a grad student's progress for a commercial objective."

Funding pressures. Baumgardt is equally candid about how researchers are pressured to attract outside funding to boost their careers. "There is no doubt that there is pressure to attract outside funding," he says. "State support is decreasing, federal funds are stable, but public funding is not keeping pace with the explosion of ideas, particularly in the field of biotechnology. So it is a matter of industry funding, and scientists have to be entrepreneurs.

"The importance of publication has not diminished at Purdue. But I think the dimension of fund-raising has been added. It doesn't replace publication as a measure of success; it's just in the mix. But what you have to watch out for is a review committee that puts too much weight on the size of a grant. You want productive, innovative, creative people first. Where the money comes from or the size of the grant is immaterial [to promotion and tenure]."

What concerns Baumgardt more than funding sources is the trend toward secrecy - a trend that inhibits the advancement of science as a whole. "To some extent private funding has inhibited communication among researchers," he says. "But my observation is that the nature of competition is overtaking the concept of cooperation. There is a concept of 'me-ism' in research today, and it is accelerating.

"I would inject a different tangent, as well. Many research scientists also do consulting work for industry. And it's a good thing, overall, because it gets you out there in the business world and keeps you up to date with what's going on. Consulting agreements, however, come with confidentiality agreements and you are bound by those. What is happening, I think, is that scientists are beginning to apply those consulting concepts to research that is funded by industry. They aren't differentiating between research agreements and consulting agreements."

New direction. Obviously, institutional research is moving into uncharted waters. No single example highlights this more than the unprecedented agreement between Novartis and the University of California at Berkeley.

Last November Novartis announced a $25 million, five-year research agreement with the university that gives Novartis the exclusive right to negotiate licensing agreements on any patentable discoveries coming from the department's laboratories. Certainly, this collaboration casts industry-funded research and technological patents in a new light.

Three years before this announcement, at the NABC annual meeting, Ronald Sederoff of North Carolina State University and Laura Meagher of Rutgers presented a prescient paper that addressed such alliances. They said, "Biotechnology arose from several decades of research based upon the free exchange of information and materials. Most research during these crucial formative years was 'basic' and was supported by public funds or foundations. Little consideration was given to intellectual property, and new information was released and made available through publications or conferences.

"If many of the fundamental advances made during this time had been patented, it is unlikely that the field of biotechnology would have developed by this time. It is instructive to consider how the past 45 years of progress would have been constrained if each major discovery or new process was patented and licensed.

"If a major shift occurs from public funding to industrial funding, and if current intellectual property protection strategies continue to be pursued, the nature of the university research enterprise related to biotechnology could change in dramatic ways."

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