by Michael Kalichman
The medical challenges we face are numerous and generally wellknown. Just a few examples include heart disease, cancer, respiratory disease, and Alzheimer’s disease. From an altruistic perspective, there is a great deal to be gained from finding new and improved methods to diagnose, treat, and possibly prevent or cure these diseases. And from an economic perspective, there is clearly a great deal to be gained from finding those new and improved methods. Both academia and industry have roles in making this possible. Just two of the many local examples of such collaborations include a partnership between UC San Diego and Pfizer for identifying new drugs and the newly formed Center for Innovative Therapies, a UC San Diego-industry partnership to develop interventions for preventions, treatments, and cures.
On the one side, researchers in academic medical centers are highly motivated to better understand the world around us and to assist in making advances. Such centers are characterized by wide-ranging expertise, considerable experience, and access to the large patient populations and numerous tissue samples that are necessary to conduct medical research. On the other side, industry is motivated to develop new treatments, interventions, and tools that will advance the practice of medicine while also generating profits to ensure continued survival. Further, these companies have the resources to support the requisite research studies and the expertise and experience to develop, produce, and market the resulting products. On the surface, it might appear that academia and industry would be the perfect partners.
Unfortunately, several challenges threaten the integrity of this ideal partnership. Many of these challenges were highlighted just this past year in reports from the Association for American Medical Colleges1 and the American Association of University Professors.2 Although some concerns may be more a matter of perception than reality, it is clear that failures have occurred in academicindustry relationships (e.g., failure to report negative findings) and that prejudices exist about the trustworthiness of both partners (e.g., that academics seeking funding for research might at least unintentionally bias their research). Based on anecdotal examples and survey studies, it is clear that there are cases in which negative research findings are not published or publication is delayed.3 This selective reporting of findings risks misleading the medical and research communities.
For industry-sponsored research, this might occur because of decisions made on the part of either academia or industry. From the patient’s perspective, the bottom line is best illustrated by numerous studies of the medical research literature: Studies that report positive findings are more likely than studies that are critical if one or more authors have financial conflicts of interest.4 This result could be caused in many ways. From the perspective of academics, industry funding appears to follow positive results (i.e., a selective bias to publish only those studies that look good for its product). From the perspective of industry, it might be perceived that scientists will unwittingly (or perhaps sometimes intentionally) bias their results for the sake of continued research funding.
Collaborations between industry and academia are further challenged by differences in culture. The goal on the industry side is necessarily to find and develop products that will sell sufficiently well to justify substantial investment up front. Academics, on the other hand, tend to be motivated first by new knowledge and a better understanding of biology, disease, and options for intervention. Although not mutually exclusive, these discrepancies are only made worse by different time windows. Industry is often driven by quarterly reports, while academic time horizons are defined in terms of years (e.g., academic advancements and grant funding are based on intervals of two or three years or more).
Collectively, these problems with academic-industry partnerships may seem insurmountable. However there is good reason to be optimistic. First, despite these many barriers to success, the fact remains that many successful partnerships have resulted in mutual benefits to academia and industry. Although partnerships resulting in drugs worth more than a billion dollars are rare, and are increasingly unlikely, the patenting and licensing of new technologies is frequent. For example, UC San Diego’s Technology Transfer Office website reports overseeing “over 2,600 active innovations and more than 1,600 patents” across diverse disciplines including, but not limited to, physical sciences, information technology, and life sciences.
A second and equally important reason to be optimistic about the future is that academia and industry have options to strengthen and protect the model of collaboration. The solution is quite simple and grounded in principles of good scientific practice: openness and transparency. By being clear and realistic up front about goals and expectations, the risks of miscommunication and misunderstanding can be mitigated. And by being publicly clear about the relationship and its framing, the architects of such collaborations will be obliged to design agreements that will not only result in new products, but will also do so in a way that is visibly defined by the highest integrity in all respects.
Michael Kalichman is UC San Diego’s founding director both for the Research Ethics Program and for Ethics in the Clinical and Translational Research Institute. His areas of expertise include neuropharmacology and research ethics.
- Association of American Medical Colleges. 2012. “Implementing the Final Rule on Financial Conflicts of Interest in Public Health Funded Research.” https://www. aamc.org/download/277644/data/coi-rule.pdf (Association of American Medical Colleges 2012).
- American Association of University Professors. 2012. “AAUP Recommended Principles & Practices to Guide Academy-Industry Relationships.” http://www.aaup.org/file/industryall.pdf
- Blumenthal D, Campbell E., Anderson, M., Causino, N., Louis, K. 1997. “Withholding research results in academic life science. Evidence from a national survey of faculty.” Journal of the American Medical Association 277: 1224-8.
- Bartels, R., Delye, H., Boogaarts, J. 2012. “Financial disclosures of authors involved in spine research: an underestimated source of bias.” Eur Spine Journal 21: 1229- 1233.