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Medicine's Rude Awakening to the Commercial World

The Lancet, Editorial:Volume 355, Number 9207
March 11, 2000

Today's universities are increasingly encouraging their scientists and doctors to be entrepreneurial and to commercialise their intellectual property. However, the collaboration between industry and academia or the combining of private and public interests can easily end in tears.

In a lengthy, and costly, legal battle with Nottingham University, UK, Simon Fishel, the former scientific director of the Nottingham University Research Unit in Reproductive Medicine, was found "in breach of contract" for not seeking official consent for private work in fertility institutes abroad (see Lancet 2000; 355: 817 [PubMed] ). Under the university's rules, members of non-clinical academic staff may devote up to 20% of their time to outside paid activities, providing their academic and other duties are fulfilled. But they need to apply to the university for permission. Mr Justice Elias ruled that although the university can, in principle, seek to recover damages arising out of this breach, in fact no financial losses occurred and Fishel did not have to pay back any profits from his own work. Details of his activities abroad were discovered by the university, although long known by staff and colleagues, when a computer was handed back after his resignation in 1997 and deleted data were recovered from the hard drive. Why were proceedings only started after his departure to set up a rival institute?

In a similar 'accidental' discovery, Roy Anderson, a professor of zoology at Oxford University and the director of the Wellcome Trust Centre for the Epidemiology of Infectious Disease, now faces an inquiry into his activities as director and a 30% shareholder of the biomedical consultancy company International Biomedical and Health Sciences Consortium. Anderson had been suspended in January after formal complaints concerning his alleged comments about a newly appointed member of staff. The ensuing investigations focused attention on his business links and Oxford University and the Wellcome Trust are now seeking to establish whether Wellcome-funded facilities have been used improperly. Although the Wellcome guidelines state that 'Trust-funded researchers may not consult for a commercial organisation in which they hold a significant equity interest unless the consultancy relates to an area and field outside the research funded by the Trust', we suspect that in many cases there is room for differing interpretations. Loose guidelines are only of advantage to researchers provided a mutual understanding prevails. Once the goodwill arrangements turn sour, legal and other disputes become inevitable. Universities, funding bodies, and scientists would be better served by drawing up carefully thought-out agreements before any collaborative efforts with industry or the private sector begin.

When scientists start their own companies, independent of a public institution, commercial interests may dominate. The moderating influence of regulatory bodies then becomes critical. Last week the US Food and Drug Administration halted human gene-therapy experiments conducted by Jeffrey Isner, chief of cardiovascular research at the St Elizabeth's Medical Center in Boston and founder of Vascular Genetics Inc, a spin-off company of Human Genome Sciences (see page 908 ). Vascular Genetics was established in 1997 to commercialise the development of gene-therapy products such as vascular endothelial growth factor-2 (VEGF-2). William Haseltine, chairman and chief executive of Human Genome Sciences, the company which owns the patent rights on VEGF-2, said that he did not foresee major problems from the delay. Human Genome Sciences itself caused an outcry when it won the US patent on the human gene coding for CCR5, a cell-surface receptor used by HIV to gain entry into a cell, one of 117 US patents issued to the company so far. The application was filed in 1995, before the connection to HIV was known.

This is a new world for biomedical scientists. Some dislike it; others enter reluctantly while some do so with enthusiasm. All are on a learning curve, as are their employers and funders. Regulatory authorities and public institutions need to set appropriate ground rules--and need to ensure they are followed--to minimise the potential for harm to patients and the scientific community alike.