ACADEMIA-INDUSTRY – ALLIANCE AT WHAT COST?
Academia -Industry relationship
The Academia-industry collaborations involve transforming an intelligent laboratory research into an industrial application of that knowledge, to provide goods and services for the society. The Bayh-Dole Act, enacted in 1980, details the rules and regulations for collaborations between private industry and research institutions, such as universities and since then, financial relationships between them have grown. In biomedical research, these relationships often pair academic research expertise and facilities with industry resources for technology transfer in order to bring innovations from the laboratory bench to hospital bed. These collaborations benefit society by leading to the development of new medical treatments, diagnostic tools, or other practical applications of the research (GAO 02-89, 2001; Brockway and Furcht, 2006).
The researchers at the university institutes perform research and generate new knowledge or intellectual property for the industry. In return, they receive research support, honoraria, consulting fees, equity, and/or other payments. The interchange with industry colleagues facilitates the flow of knowledge and materials, enhances productivity, and enables the university researchers to participate in the application of their research (Brockway and Furcht, 2006).
The extent and nature of industry-academia collaborations have increased in size and complexity. As scientific questions become more complex, securing government funds to carry out the large-scale collaborative and interdisciplinary research needed to answer them is difficult. Due to limited funding from the government, financial partnership with industry is even more important for many academic investigators to achieve their research objectives (Blumenthal, 2003; Brockway and Furcht, 2006). A survey reported that industry supported 62% of biomedical research in the United States in 2000, almost double the proportion in 1980, while government support declined. A review article observed that a quarter of academic investigators have affiliations to industry that could influence research and publication, and roughly two thirds of academic institutions hold equity in start-ups that sponsor research performed at the same institutions (Bekelman et al., 2003).
Relationships have benefits and risks
The University and Industry benefit from each other’s infrastructure and resources that comes from an enormous investment of both public and private funds. The Industry gets to hold on research innovations and the academic’s ability to approach scientific problems from angles that are not encumbered by commercial concerns. The university faculty and students get an opportunity to investigate real-world problems and determine solutions that can generate economic and social benefit. Universities, industry, and public would be well-served when the university industry collaboration is enabled (Stossel, 2005).
The academia-industry relationship gives an impression of being honestly motivated, highly productive, mutually beneficial and supportive of the best interests of patient care. However there are some tricky and problematic issues affecting the relationship. These are integrity of research, ownership of data, publication and disclosure, and conflicts of interest. It is worthwhile to reflect on these carefully (Yamada, 2005).
Integrity of Research
The physicians trust on clinical trials for drug efficacy and safety, as major evidence, to prescribe medications worth billions each year. The average cost of developing one new drug is estimated to be $300 million to $600 million. The industry with its ultimate goal of profit would like to make optimal use of these studies. They base their studies on a hypothesis: “our new drug is safe and has better efficacy than the current/competitor”. Further, they tend to have bias design of experiments and interpretation of data to favor their products. They would prefer a study to boost the image of an expensive drug that is still under patent. Moreover, to be economical, they would like to have brief trials and test drugs on patients with simpler problems (milder disease with fewer coexisting conditions) than doctors typically encounter in daily practice (Vedantam, 2006). In a survey of clinical trials of non steroidal anti-inflammatory drug for arthritis, only 2.1% of subjects were 65 years of age or older. Arthritis is more common in the elderly population, who tend to have increased side effects (Rochon et al., 1994). The industry studies can be misleading in a number of ways. In a survey of cardiovascular trials published between 2000 and 2005, a direct correlation of positive findings and funding from profit organizations was noted. The study also reported that these trials were more likely to use surrogate rather than true clinical endpoints (Ridker and Torres, 2006). At times they would use different mode of drug delivery or use too low a dose of a competitor’s drug. In an assessment of clinical trials to compare fluconazole and amphotericin B, Johansen and Gotzsche (1999) observed that they used oral amphotericin B and not intravenous, amphotericin B. This is in order to favor fluconazole, because oral amphotericin B is poorly absorbed. In the end if nothing works, they will resort to statistical techniques to show their drug in the best light
The problem is not just that industries fabricate results, but also researchers want drug companies to sponsor more studies. As a result, there will be a number of studies sponsored by different drug manufacturers, each favoring its own product over the others. In such a scenario of conflicting results, the confidence of clinicians and patients could be eroded and even cast doubt on medications that are genuinely superior (Vedantam, 2006).
Publication and Disclosure
In the academic world, there is a traditional rule; for career advancement (to obtain tenure and receive full professorship), one has to secure research grants and publish papers. Thus, the old saying “publish or perish” is a reality. In the competitive world of modern science, even publishing is not just enough. Researchers are expected to publish in the high impact and prestigious journals possible (Science, Nature, or Cell). If researchers do not publish papers, they are less likely to receive grants, and as a result, less likely to progress in career. In contrast, for pharmaceutical industry, the vital thing is the new-drug application to the FDA. A journal article is worth nothing without the FDA approval. However, publication in prestigious journals along with FDA approval is just like icing on the cake that would influence physicians to prescribe the company’s product. (Bodenheimer, 2000)
Publications in journals determine the future of the drug. With so much importance attached to publication, the pharmaceutical industry would prefer to hold judicious power itself rather than the researcher. In an assessment of life-science faculty members, 27% of those with industry funding went through delays of more than six months for publishing their study results (Blumenthal et al., 1997). A survey of sponsored academic research found that 58% of companies required investigators to withhold results for more than six months. This secrecy cost dollars and lives. Chalmers (1990) argues that the results of large numbers of clinical trials are never published. This is more probable in the case of adverse results. In a clinical study to determine the effect of deferipronein in thalassemia patients, researchers observed that the drug was ineffective and also increased hepatic fibrosis. The investigators had signed a contract with Apotex, the sponsoring company, prohibiting them from publication of results for three years after the study without the company’s consent. As a result, the company, threatened legal action if researchers published the findings. (Olivieri et al., 1998; Phillips and Hoey, 1998)
Conflict of Interests
A conflict of interest is a situation where professional judgment may be biased by financial or other interests. There are concerns over financial interests of the research investigators and institutions. This may lead to a possible situation, wherein academic investigators with significant financial interests in the research may focus attention on the financial rewards of the research, compromising its integrity and the safety of human subjects (AAU, 2001).
JAMA Fiasco
A group of 13 physicians published in JAMA (Journal of the American Medical Association), describing the risk of depression relapse and antidepressant in pregnant women. The study, funded by the National Institute of Mental Health, questions the common assumption that hormones produced during pregnancy protect women from depression. A total of 201 pregnant women with a history of depression were enrolled in the study between 1999 and 2003. The women were taking medications such as Prozac, Zoloft, Effexor and Paxil. To play safe, for ethical reasons, the patients were not randomized for placebo/no treatment. Instead, the decisions regarding treatment were made by the patients themselves under the guidance of their individual clinicians. Researchers found that 68% of the women who stopped taking antidepressants relapsed into depression during pregnancy. In addition, 26% of the women who continued taking their medication during pregnancy also became depressed. The authors concluded that stopping the use of antidepressants during pregnancy greatly increases the risk of relapse (Cohen et al., 2006). It was perfect news for the manufacturers of antidepressants, with questions looming over the safety of their medications when used during pregnancy. Everything seemed to be just right in the study except one thing. Subsequently, it was revealed that the researchers failed to disclose more than 60 financial relationships to pharmaceutical companies. Most of the 13 authors were paid as consultants or lecturers by the makers of antidepressants. The lead author — Lee Cohen, director of Massachusetts General Hospital’s Center for Women’s Mental Health, is a consultant to three antidepressant manufacturers, a paid speaker for seven of them and has his research work funded by four drug makers. None of those ties were reported in the study. Dr Cohen and his colleagues maintained that it was not relevant to disclose their ties with industry in the paper in part because the study was funded by the government, not drug maker (Armstrong, 2006). Such incidents ruin the academia’s reputation as independent truth seeker and reduce public trust in research. Henceforth, more often questions will be raised on integrity of research, researchers and science journals.
The media and the public are not naïve to believe that the enormous industry funding does not affect biomedical research. The industry sponsors would like to have research results that support their products, and researchers are aware of this, consciously or not. A number of evaluations of studies point out consistently that the industry-sponsored studies were significantly more likely to reach conclusions that were favorable to the sponsor than nonindustry studies and also reveal that industry ties are associated with both publication delays and data withholding. Thus, there is growing public concern that industry funding leads to distortion and misinterpretation of research and undermines its core values of objectivity, independence, and free exchange of ideas (Andreopoulos, 2001).
What is needed?
The universities exist to do research that benefits mankind — while the goal of industry is to make a profit — there is concern that the integrity of science is at risk by this different value system. To restore a balance between these contradictory values systems, to overcome the issue of conflicts of interest and promoting progress while maintaining public trust in research is not an easy task (Johns et al., 2003). The government, university research institutes, professional societies and scientific journals have framed rules and policies to guide and manage academia-industry relationships. There is a need for strong, clear and precise policy for the investigators. They need to understand their role and uphold the research values of objectivity, transparency and accountability in academic–industrial research relationships. The Federation of American Societies for Experimental Biology (FASEB) has proposed a set of guiding principles that can help investigators foresee challenges in industry relationships and guide their decision-making to overcome these challenges (FASEB, 2006).
Academia-industry relationships represent a union of wisdom and wealth. The relationship is vital and indispensable for the biomedical enterprise. The challenge is to be open and guide these relationships to get the best and overcome the weakness of bias. This can be achieved through individual and shared responsibility (investigators, institutions, industry, government, journals, and societies). The Journals play an important role, as they communicate research results to the public. It is essential to preserve the public trust through maintaining objectivity, transparency, and accountability (FASEB, 2006).
REFERENCES:
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