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Professors, Inc.

Robert Hotz

Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?
Sheldon Krimsky.
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

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