The golden path from the ivory tower of academic science

Dianne Nicol, University of Tasmania

Sheldon Krimsky Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?, Rowman and Littlefield, 2003 (pp. 247). ISBN 0-74251-479-X (paperback) RRP $54.95.

Scientific research conducted at universities, government laboratories, and other public research institutions has entered the so-called post-academic era (Ziman2000). The current trend is for scientists to favour applied or commercially orientated science over pure or academic science. There are several reasons why a scientist might find it difficult to resist the urge to join this movement. The challenge is particularly acute in biomedicine, where, perhaps more than in any other scientific discipline, the significance of new discoveries is closely matched by the size of the profits to be made from their commercial development.

Consider a naive undergraduate student embarking on a career in biomedicine, seeking to ‘make a difference’ and ‘do good work’ in ‘the public interest’. It is likely that she will have to spend many years earning her academic spurs, first as an impoverished graduate student, then through a seemingly endless series of postdoctoral positions. Now at the zenith of her career in a top university, our scientist is faced with having to find funds to buy the latest new piece of equipment, to keep her laboratory stocked with reagents and to support the next generation of keen young post docs, graduate and honours students. Public funding is getting more and more scarce and funding agencies are requiring evidence of national benefit. The university’s technology transfer office requires her to report any commercial opportunity likely to arise out of her team’s research, no matter how remote. Collaborations with industry partners are viewed favourably in promotion applications and patents are becoming recognised measures of academic excellence. Colleagues are seen to be reaping the benefits of entering into commercial arrangements, both professionally, through increased research funding, and personally, through shareholdings, consultancy fees and the like. It is not surprising that our scientist might seriously consider a move to the ‘dark side’.

Such a move is not entirely without justification from the public interest perspective. The public can and does reap significant rewards from post-academic science. By focusing on applied research in collaboration with an industry partner, our scientist has some assurance that the results of her research may actually be put into practice. Let’s assume that she has discovered a gene mutation that has a link to a particularly pernicious hereditary form of cancer. Her partner company soon has a test kit on the market, and also initiates a new collaborative venture with her research team, exploring gene therapy and drug discovery options for the treatment of cancer sufferers.

Krimsky’s main target is the science of biomedicine.

Why, then, should we be worried about these actions? Consider the impact on the public interest when the company patents the gene and threatens to sue diagnostics facilities for patent infringement unless all tissue samples are sent to its laboratories for testing (doubling the cost of testing). Consider the adverse effect on the scientific traditional of free and open exchange of knowledge when all of the research team’s articles are vetted by the company’s intellectual property managers prior to submission to peer reviewed journals, and anything that might possibly compromise future patent applications is deleted. Presenting research results at conferences is even more problematic because it is difficult to know what can and can’t be disclosed to colleagues. Consider also the pressure that the company might exert on the research team to ignore adverse results in their research to ensure the success of the company’s products. Finally, consider the consequences when our scientist actively encourages families carrying the gene mutation to participate in a clinical trial to test a new therapy, when she fails to disclose that some participants are suffering adverse side effects, and when one of the participants suffers a severe reaction to the therapy and dies.

These and other considerations are the focus of Sheldon Krimsky’s Science in the Private Interest. Krimsky’s main target is the science of biomedicine. He notes on page one that ‘In such a picture, university science becomes entangled with entrepreneurship; knowledge is pursued for monetary value; and expertise with a point of view can be purchased’.

Krimsky provides a comprehensive account of the multiplicity of ways that the integrity of academic biomedical science could be threatened by commercialisation. He uses data from his own research and other reputable sources, peppering his discussion with illustrative case studies. The first chapter of the book starts with general discussion of conflict of interest, and describes four paradigm cases that provide a reference point for the rest of the book. The first case occurred in the 1980s, the decade during which the commercialisation of academic science probably started in earnest. This case study describes how a Harvard ophthalmologist ran a clinical trial for a new eye ointment without telling the participants that he and his colleagues founded the company that manufactured the ointment. It is alleged that he also changed previously approved protocols for the trial and selectively reported results. Despite this, charges filed against him with the State Medical Board were dropped. The second case study is of a University of California scientist who received funding from a pharmaceutical company for research into hypothyroidism. One term of the research contract required her to keep her research results confidential. Only after publicity in the Wall Street Journal was she able to publish findings that were likely to have adverse economic consequences for the company. The third case study focuses on what happens when government scientists oversee drug studies at the same time as consulting for drug companies. The fourth describes how approvals processes for dangerous vaccines are ‘replete with conflicts of interest’.

This kind of work achieves its end by jolting us from our complacency.

Later in the book Krimsky also refers other well-known examples of potential conflict of interest. He discusses the tragic case of Jesse Gelsinger, who died after participating in a gene therapy clinical trial sponsored by a biotechnology company in which the director of the trial had financial interests. He discusses the federal investigation into the highly respected Fred Hutchinson Cancer Research Center (‘The Hutch’) for ‘egregious’ conflicts of interest spanning some 30 years. He discusses patenting of genes and receptor molecules, trade secrecy, conflict of interest, in all of its forms, ghost authorship (also referred to as ‘honorary authorship’ in which distinguished academic scholars are named as authors of articles actually written by paid freelancers), and bias in reporting the results of research. These and the catalogue of other matters Krimsky describes are likely, if brought to the public’s attention, to adversely affect public trust in the scientists themselves and the results of their scientific endeavours.

Krimsky’s account is a polemic that it does not pay a great deal of attention the many thousands of scientists who carry out their research ethically and with due regard to the Mertonian norms of universalism, communalism, disinterestedness and organised scepticism (Merton 1973). Nevertheless, in keeping with documentary filmmakers like Michael Moore (Fahrenheit 9/11) and Morgan Spurlock (Super Size Me) who that present their viewpoints in a similar vein, this kind of work achieves its end by jolting us from our complacency. These and other works force us to reflect on our society and to question the true intentions of those members of society to whom we might otherwise offer our unconditional support.

Krimsky’s account focuses primarily on case studies involving biomedical researchers in the United States, although he does mention the well known Canadian Olivieri affair, where a haematologist was threatened with legal action for disclosing to participants in a drug trial severe adverse side effects of the drug (pp. 45–47). Fortunately, there is scant evidence of allegations of similar forms of conduct in Australia, aside from two notable examples, recently brought back into the public spotlight by Dr. Norman Swan in ABC radio broadcasts of The Science Show and The Health Report (Australian Broadcasting Corporation 2002; 2004). However, we should not be too complacent, as a recent editorial in the Medical Journal of Australia illustrated. Commenting on the partial retraction of an article in the prestigious UK journal The Lancet following allegations of research misconduct, the editorial notes ‘The Medical Journal of Australia has not had such sensationalist experiences (yet!)’ (Chew 2004).

It is simplistic to see commercialisation as either ‘good’ or ‘bad’.

Krimsky’s premise is that the growing trend towards commercialisation of academic science inevitably leads to conflicts of interest. Perhaps one of the reasons that we have seen so little evidence of the types of conduct discussed by Krimsky in Australia’s scientific community is because of an early reluctance to adopt the commercialisation model. Australia has an enviable scientific record, particularly in biomedicine, as noted in a comprehensive report on our health and medical research strategies (Commonwealth of Australia 1999). However, that same report noted that the research community is significantly less successful in commercialising its research, and recognised the need to enhance technology transfer between research and industry and to stimulate flow of medium to long-term venture capital. This highlights the importance of commercialisation from the national interest perspective: it is both necessary and desirable for Australian science to be commercialised by Australian industry in order to benefit the national economy and to ensure that the products of commercialisation are available to the Australian community. But conflicts of interest and other concerns do become more acute in the new commercialised research environment. Hence, it is simplistic to see commercialisation as either ‘good’ or ‘bad’. We need to recognise the benefits of commercialisation, but at the same time acknowledge and guard against the risks.

Commercialisation strategies in the Australian research sector have improved significantly since 1999. This drive to commercialise has been bolstered by a series of federal and state government initiatives, the most significant of which is our National Biotechnology Strategy (Biotechnology Australia 2000). In 2002–03 I conducted an empirical study with my colleague Jane Nielsen on patenting and commercialisation issues facing the Australian biomedical industry (Nicol & Nielsen 2003). We found that although there are still some research institutions in which commercialisation is not a core activity, the number is ever decreasing and for most, commercialisation is a reality, albeit an unwelcome one for some. Although we did not explore the issue of conflict of interest, we found that the traditional practice of timely publication of research results was widely recognised and respected and that endeavours were made to reduce impediments to publication to the minimum extent necessary to protect future patent rights. Time will tell whether the commercialisation of biomedicine leads to increased reports of conflicts of interest and other forms of misconduct in Australia or whether appropriate procedures are being put in place to deter such conduct.

Krimsky’s book makes us hanker for the good old days when science was pure.

Krimsky’s book makes us hanker for the good old days, when science was pure and scientists were true to their academic calling, when they wore tweed suits and smoked pipes. However, he does not leave us totally without hope. The last two chapters of the book highlight the importance of public-interest science, particularly focusing on the unique status of the university as the wellspring of knowledge and the social value of academic freedom. He calls for protection of the academic institution and its values by separating the roles of the knowledge producers and care givers from those stakeholders with financial interests in these matters.

Recently the Australian Law Reform Commission and Australian Health Ethics Committee undertook a joint inquiry on the protection of human genetic information in Australia. Published in 2003, the final report of the inquiry, Essentially Yours, calls for a range of reforms to the regulation of human genetic research, including, most notably, improving consent procedures, encouraging best practice in research and strengthening review procedures by Human Research Ethics Committees. Should these recommendations be implemented, they will go some way towards reducing the risk that the types of conduct reported by Krimsky could become commonplace in Australia. Our scientists, university administrators, regulators, funding agencies, and governments should all heed Krimsky’s call and respond to the recommendations in Essentially Yours, lest public trust in the great achievements in biomedical research is lost and it becomes ‘an enemy of its own promise’ (Chalmers & Nicol 2004, p. 130).

REFERENCES

Australian Broadcasting Corporation 2002, ‘Scientific & Financial misconduct’, The Science Show, 13 Apr 2002 [Online], Available: http://www.abc.net.au/rn/science/ss/stories/s531406.htm [2004 Aug 7].

Australian Broadcasting Corporation 2004, ‘Follow up on Bruce Hall affair’, The Health Report, 2 Feb 2004 [Online], Available: http://www.abc.net.au/rn/talks/8.30/helthrpt/stories/s1036825.htm [2004 Aug 27].

Australian Law Reform Commission and Australian Health Ethics Committee 2003, Essentially Yours: The Protection of Human Genetic Information, Report No. 96, Australian Law Reform Commission, Sydney.

Biotechnology Australia 2000, Australian Biotechnology: A National Strategy, Commonwealth of Australia, Canberra [Online], Available: http://www.biotechnology.gov.au/library/content_library/BA_Biotech_strategy.pdf [2004 Aug 28].

Chalmers, D. & Nicol, D. 2004, ‘Commercialisation of biotechnology: Public trust and research’ International Journal of Biotechnology, vol. 6, nos 2/3, pp. 116–133.

Chew, M. 2004,’What conflict of interest?’, Medical Journal of Australia, vol. 181, no. 1, pp. 4–5.

Commonwealth of Australia 1999, The Virtuous Cycle—Working Together for Health and Medical Research: Health and Medical Research Strategic Review, Australian Government Printing Service, Canberra.

Krimsky, S. 2003, Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research? Rowman and Littlefield, Lanham, US.

Merton, R. 1973, The Sociology of Science, University of Chicago Press, Chicago, US.

Nicol, D. & Nielsen, J. 2003, Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry, Centre for Law and Genetics Occasional Paper No. 6, Hobart.

Ziman, J. 2000, Real Science, Cambridge University Press, Cambridge, UK.

Dianne Nicol is a senior lecturer in the Law Faculty and a senior research fellow in the Centre for Law and Genetics at the University of Tasmania. She has a PhD in science and an LLM. Her research interests include patent law, commercialisation and regulation of biotechnology and regulation of scientific research.