Science in the Private Interest: Has the Lure of Profits
Corrupted Biomedical Research?
Rowman and Littlefield Publishers, Inc., 2003. xiv + 247 pp. $27.95.
Many scientists, particularly those doing biomedical research, are
no longer looking solely for the truth—they are also seeking
their fortunes. And when the pursuit of commercial advantage
compromises scientific integrity, the public safety and public trust suffer.
As arbiters of technical disputes, scientists in America contribute
almost as much to public policy, regulation and law as to basic
research. For example, they regularly testify in front of
legislators, who are now grappling with cloning, genomics and stem
cell biology. Advances already on the horizon promise a control over
human biology and behavior that makes today's innovations seem
primitive. Yet it is becoming increasingly hard for Congress, the
courts, the general public and the media to find knowledgeable
scientists without any financial stake in a biomedical controversy
or regulatory debate.
That difficulty is what so concerns Sheldon Krimsky, a policy
analyst at Tufts University who for two decades has been one of the
country's leading experts on the consequences of the
commercialization of science. Krimsky has distilled a professional
lifetime of experience as a skeptical scholar of the changing
scientific culture into a new book, Science in the Private
Interest. Shrewd, unsparing and never shrill, this book ought
to be obligatory reading for anyone who values the role that science
plays in the political life of the United States.
With a scholar's care and an idealist's unswerving allegiance to
unfettered scientific inquiry, Krimsky explores the true public cost
of the transformation of university-based research into a tool of
commercial self-interest. The integrity of America's research
institutions needs the same sort of protection from exploitation as
a unique natural resource, he says:
Universities are more than the wellsprings of wisdom. They
are the arenas through which men and women of commitment can speak
truth to power on behalf of the betterment of society. The patchwork
effort to reconcile the values of academic science with the values
of business enterprises misses the hidden loss to society as a
result of a hybrid institution. When universities . . . are turned
into private enterprise zones, they lose their status as independent
and disinterested centers of learning.
Commercial funding today is the lifeblood of biomedical research,
Krimsky observes. Federal laws and regulatory changes since the
early 1980s have given scientists and schools more freedom to profit
from their work. The result has been the creation of a new national
research economy dominated by private interests.
Krimsky believes that reforms designed to speed the products of new
research to the public have led instead to the creation of a kind of
chain-store science. Seemingly independent university research
centers have melded into a vast Wal-Mart of laboratory expertise in
which technical judgments and clinical conclusions are too often
tailored to commercial interests.
Commercial funding, whether it comes in the form of direct grants
and consultant fees or through gifts of research materials, stock
options and travel expenses, affects every aspect of a researcher's
behavior, analysts have found. It molds the kinds of scientific
questions researchers ask and the way they frame their experiments.
It shapes the public advice scientists offer, the political
judgments they make about the potential risks of discoveries, and
the role they play in influencing the medical decisions people make.
Krimsky's book contains many instances of the mingling of
experimental science with entrepreneurial ambition and venture
capitalism. A more recent example can be found in the February 26
issue of Nature, in an essay on the future of gene therapy
by Marina Cavazzana-Calvo, Adrian Thrasher and Fulvio Mavilio. The
authors were involved in clinical trials using such therapy to treat
children for a rare immune disorder in 2002, when two of the
children developed leukemia-like conditions that were apparently
caused by the retrovirus carrying the therapeutic gene. Similar
experiments everywhere immediately came under scrutiny, as the
public and policymakers tried to understand the ramifications. The
Nature essay maintains that "The current
'gene-therapy-causes-cancer' mood and uncertainty about the effects
of tighter regulations is discouraging scientists from starting new
clinical trials, and scaring investors and the biotechnology
industry away from the field." The authors are worried that
"in the absence of industrial investment it is unlikely that
gene therapy will eventually deliver on its promises."
In a comprehensive assessment of the effect of commercial funding on
biomedical research, Yale University investigators Justin E.
Bekelman, Yan Li and Cary P. Gross reported last year in the
Journal of the American Medical Association
(289:454–465) that so many medical researchers have joined the
pursuit of profit that the integrity of clinical findings is
suspect: About one fourth of them have industry affiliations.
Moreover, the universities that are expected to police the integrity
and ethics of their faculty themselves have widespread commercial
interests and serious potential conflicts. One raw measure of the
growing institutional appetite for proprietary research, the number
of patents awarded to universities, grew from 96 in 1965 to 3,200 in
the year 2000, according to Krimsky.
The massive infusion of private funding for research and development
has changed the basic character of many universities, Krimsky
contends, turning bastions of independent scholarship into
"Professors Incorporated." Many of these schools are
equity partners in start-up companies whose research they are
expected to monitor. Even the specialists in the ethics and morality
of science—routinely called on by Congress and the media to
weigh objectively the pros and cons of new research—find
themselves tangled up in ethical conflicts.
To highlight the pitfalls, Krimsky offers a series of
well-documented case studies: A physician doesn't tell his patients
in a clinical trial that the unproven drug they are taking is made
by a company he founded; a scientist loses control of her work by
signing a corporate research agreement, and the company quashes her
unfavorable clinical findings; a federal researcher oversees drug
studies while consulting for the companies that stand to profit from
them; regulators approve a dangerous vaccine despite obvious
conflicts of interest.
As industry-backed research has grown, an increasing number of the
more than 35,000 technical journals are tightening their policies on
conflicts of interest. But such financial disclosure policies, meant
to alert the public to the possibility of bias in published
research, are honored more in the breach than in practice, Krimsky
says. Indeed, disclosure is at best a stopgap measure.
Krimsky worries most that the pursuit of private profit spells the
demise of science conducted in the public interest. He mourns the
steady erosion of the moral sensibility of science. "If we
contaminate the wellspring of knowledge by mixing in other
interests, in particular corporate agendas," he writes,
"then we lose the pure reservoir for dispassionate and
independent critical analysis." He goes on to warn that
"Certain institutions must be protected by tradition, law or
regulation from taking on conflicting roles." As he points out,
"nothing less than the public interest function of the American
academic enterprise is at stake."—Robert Lee Hotz,
Los Angeles Times