鈥淲HO holds the patent on this vaccine?鈥� Jonas Salk was asked in 1955 amid
worldwide acclaim for his creation of the first polio vaccine. 鈥淲ell, the
people, I would say,鈥� Salk replied, adding: 鈥淭here is no patent. Could you
patent the Sun?鈥�
That quaint episode in entrepreneurial innocence dates back to a bygone era
in science, when the thrill of discovery, collegial recognition and service to
mankind were the principal motivations in university-based research. In the
contemporary culture of science, that trio survives. But to a disturbing extent
it has been joined and overshadowed by a new force: money, and the opportunity
for professors and their institutions to make gobs of it by selling their skills
and knowledge to industry. Along the way, some of the great values of science
have been trampled, including truthfulness, openness with colleagues, the public
well-being, and responsibility to students.
In the plaintive words of Kary Mullis, the Nobel-prizewinning inventor of the
polymerase chain reaction: 鈥淧robably the most important scientific development
of the 20th century is that economics replaced curiosity as the driving force
behind research.鈥�
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That development is cheered, rather than mourned, by the reigning
scientist-businessmen and politicians, impatient for practical returns from
spending on research. Science for the sake of science, they agree, is a costly
anachronism. Its successor is science for profit.
Industrialised nations, without exception, have adopted schemes to breach the
ivory towers, encourage entrepreneurial spirits, and link the corporate sector
to the once-sheltered monastics of university science. Industry now finances
about 9 per cent of the R&D in American universities, and academe鈥檚 annual
proceeds from royalties and other payments from industry total about $1
billion. In the fast-moving biomedical sciences, the productive professor
without stock options is a rarity鈥攐ften pitied for missing out on the
booty.
Is there anything to lament in this fruitful partnership of brains and
commerce? Is corporate money really corrupting science, as is often contended
these days?
For grounds for concern we need only tune into the anguished cries emanating
from many inhabitants of academe as they have become acquainted with a simple
fact of capitalist enterprise: companies exist to make money, and virtually
everything they do is focused on that goal鈥攊ncluding deals with
universities.
鈥淲e鈥檙e adopting a business model instead of an education model,鈥� a
chemist at Virginia Polytechnic Institute and State University complained in a
1997 study conducted by the Research Corporation, a foundation that promotes
technology transfer from academe to industry. 鈥淭he rationale is collaborations
[with industry] are good because they bring in money . . . There can be
benefits, but you鈥檙e not training students any more; you鈥檙e bringing them in to
work to satisfy a contract. The emphasis shifts from what鈥檚 best for the student
to the bottom line.鈥�
This shift in emphasis has pervaded broad sectors of academic research. For
example, finding qualified scientists without industrial ties to evaluate
pharmaceutical drugs is increasingly difficult, said Marcia Angell last year
when editor-in-chief of The New England Journal of Medicine (NEJM). She
noted that sometimes 鈥渨e鈥檝e had to give up because the first five or six people
on the list all had conflicts鈥�.
A conflict of interest looks particularly bad when something goes wrong. In
1999, an 18-year-old volunteer died in a clinical trial at the University of
Pennsylvania鈥檚 Institute for Human Gene Therapy following infusion with an
experimental gene solution. Afterwards, it was revealed that he had not been
informed of adverse reactions in patients given similar treatments or of the
related deaths of several experimental monkeys. It was later disclosed that the
institute鈥檚 director held a financial interest in the experimental treatment.
There is no suggestion the two are linked, but a conflict can cloud people鈥檚
perceptions.
Financial dealings between researchers and industry 鈥渉ave got entirely out of
control鈥�, said Greg Koski on moving from Harvard Medical School to the
directorship of the federal Office for Human Research Protections (OHRP) last
year. He described the system for protecting research volunteers as
鈥渄测蝉蹿耻苍肠迟颈辞苍补濒鈥�.
In recent years, several medical school professors in the US have been
heavily fined by the Securities and Exchange Commission for insider profiting on
drugs they鈥檝e tested for pharmaceutical firms. The risk to patients is clear.
Researchers receiving financial support from drugs companies tend to report
favourably on their products in supposedly objective scientific papers,
according to studies published in NEJM and The Journal of the
American Medical Association.
Some efforts at reform have evoked resistance from leading scientific
organisations that should know better. For example, draft guidelines from the
OHRP for exposing and controlling conflicts of interest were rejected as
鈥減remature鈥� by the Association of American Medical Colleges, which insists that
universities be permitted to develop their own systems of safeguards.
But the good news is that recent assaults on scientific integrity have
stimulated an immune reaction in many influential quarters. Last month, more
than a dozen of the world鈥檚 leading medical journals announced that authors
would henceforth be required to provide assurances that their findings were not
distorted to suit their sponsors. A joint editorial explained: 鈥淭he use of
clinical trials primarily for marketing, in our view, makes a mockery of
clinical investigation and is a misuse of a powerful tool.鈥�
Last year, Harvard Medical School dropped plans to loosen its
conflict-of-interest regulations. It retained its limit of 20 per cent on
the proportion of time researchers can spend on outside activities, and its
limit of $20,000 on the amount of stock they can hold in companies that
finance research in their laboratories. Following several cases in the US in
which the government has shut down university research programmes that were in
violation of patient-protection rules, many universities have begun to tighten
surveillance of industry-sponsored clinical trials.
Academe鈥檚 zest for industrial money ironically comes at a time when a
beneficent Congress has almost doubled the budget of the National Institutes of
Health鈥攖o a colossal $23 billion鈥攊n a mere five years.
There鈥檚 plenty of money out there, but also never enough, which guarantees that
academe and industry will continue their tango. The results, in fact, can be
greatly beneficial for society, but the side effects can also be injurious.
The antidotes are plain to see: insistence on full disclosure of financial
dealings, transparency in all relations with sponsors, and tender care of
science鈥檚 great traditions of collegial civility. If the professional societies
of science encourage public disclosure and condemn sordid behaviour in pursuit
of financial gain and glory, it would have a civilising effect on the whole
scientific community.
As for Jonas Salk鈥檚 question about patenting the Sun: sounds improbable, but
that鈥檚 what lawyers are for.