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.