The unhealthy alliance between academia and corporate America

Public confidence in the objectivity of research may be eroded

Academia's relationship with private industry changed in the United States when Congress passed the Bayh-Dole Act in 1980.¹ This law enabled universities to patent their discoveries and license them to private corporations. This policy fostered collaboration between academia and industry, which created jobs and products of immediate commercial value. But the delicate balance between academic and corporate expectations has swung too far toward private profit at the expense of public trust. Universities are threatened by a growing public concern that industry funding distorts research and undermines its traditions of objectivity, independence, and free exchange of ideas.

This concern is most pronounced in clinical medicine when new pharmaceutical agents and diagnostic procedures are tested on patients.² Physicians find the injection of industry into the patient-doctor relationship “a serious threat” to the safety of human subjects in clinical trials.³ The American Society of Gene Therapy and the American Society of Human Genetics have explicitly asked members to avoid holding equity in companies that sponsor clinical trials they oversee. And the National Bioethics Advisory Commission, a panel that advises the president, has called for legislation to regulate research that studies human participants.

Universities initiate about a third of university-industry partnerships. Total research support from industry in 1999 exceeded $4 billion.⁴ But this support has come at a high price. Industrial liaisons have set university researchers on a collision course by nurturing conflicts of interest,⁵ secrecy,⁶ and in some cases, unethical behavior.⁷ Corporate sponsorship is short term and narrowly focused on quick commercial payoff at the expense of basic research—and it comes with strings attached.

Commercialization has accelerated another problem not widely recognized—a “brain drain” of scientists fleeing academe for industry's greener pastures.⁸ Seasoned faculty, young physician-scientists, and scientific trainees are jumping ship to accept lucrative job offers in biotechnology companies with stock options and other perks that universities cannot match. Carnegie-Mellon, Duke, Princeton, and other private research universities have faculty openings in emerging fields such as computational biology that they cannot fill.⁹

Past efforts to bring new discoveries from “the bench to the bedside” were simple and informal. Professors who shared common interests with their industry counterparts would form a consulting relationship under well-defined rules consistent with the values of the university. Administrators were content to leave the technology transfer “business” to individual faculty while using patent and conflict-of-interest rules to maintain institutional balance.

In recent years, however, universities themselves have been pursuing industrial ties, becoming engaged in the venture capital game, and running businesses. The Chronicle of Higher Education reported that in 1999 universities spun off 275 start-up companies.¹⁰ But these are distractions that will impede the advancement of knowledge on which future innovation depends.¹¹

What most people do not appreciate is how industrial affiliations have the potential to erode a system that was originally grounded in science and scholarship. The controversial deal between Novartis and the University of California provides a cautionary tale.¹² Under the agreement, the University of California at Berkeley will receive $25 million of unrestricted support for genetic research at the College of Natural Resources. Novartis can acquire the rights of as much as 30% of discoveries. Company officials will be represented on the college's governing board, and Novartis staff will be headquartered in a nearby building to monitor proprietary data distribution. A critical question is how much faculty attention is transferred to private interests before the university no longer operates in the public interest. What will be the effects on graduate students working on company projects, and what interference might faculty encounter if the company suppresses publication of data it does not like? To be fair, the university has a policy forbidding restriction clauses on publication rights. What creates the problem in the Novartis case is the appearance of conflict, which is just as bad.

A dispute involving researchers at the University of California at San Francisco (UCSF) and the Immune Response Corporation illustrates another problem. The corporation funded a multicenter study directed by UCSF researchers of a drug to treat AIDS. When the study apparently showed that the drug did not work as expected, the company tried to block UCSF scientists from publishing their report in the Journal of the American Medical Association. The report, however, was published. The company reportedly threatened to sue the UCSF researchers for publishing incomplete proprietary data and said it would seek damages.¹³ This case, while extraordinary, is not isolated, according to a Carnegie-Mellon study of university-industry centers.

Most universities have policies regarding conflicts of interest to protect them from violating their public trust. But studies have found that most guidelines are unclear and vary among institutions.¹⁴ Objectivity in research cannot be guaranteed when the rules are obscure and researchers wear too many hats. An example is a faculty member who serves as dean, adviser, co-patentee, and potential beneficiary. In the past, such involvement would raise conflict-of-interest questions. Today it gets little attention. How, then, can universities assure the public that the research findings are credible?

Universities need clear policies for managing relationships with industry. The prestigious Institute of Medicine, working with research universities, should consider organizing a national summit with corporate leaders to develop a better understanding of how industrial partnerships work and how they can be improved. A similar summit convened by the presidents of major universities at Pajaro Dunes, California, in 1982 produced a statement of principles about corporate goals and academic values but no hard, detailed analysis.¹⁵ Updating those principles in light of the experience of the past 20 years would seem appropriate. And it would be timely because university-corporate collaborations involve biotechnology and, with this, a raft of new environmental and ethical concerns.¹⁶

Policymakers must take into account the sources of the strengths of US science, which are its sense of purpose and strong connection to the tax-paying citizens who support it. This connection will be destroyed if universities continue to allow industry money to influence their research and educational agendas.

Figure 1.