Science for sale

Can researchers make money and serve the public good? Perhaps

Sheldon Krimsky’s new book, Science in the Private Interest (Rowman and Littlefield Publishers Inc., 2003) has its origins in field work he conducted in 1979 while studying hazardous waste sites in Massachusetts.

A professor of urban and environmental policy and planning, Krimsky led a team of students to determine whether the chemical company W.R. Grace had polluted wells in Acton, a suburb west of Boston.

Sheldon Krimsky says university research is a national treasure that deserves to be protected. © Jodi Hilton

“When we were about to release the report,” he recalls, “the vice president of W.R. Grace went to see [then-president] Jean Mayer to try to stop its release.”

In his book Krimsky writes: “Fortunately for me and my students, President Mayer was not persuaded by the visitor’s request and reminded Grace’s representative that the university must protect the academic freedom of faculty to educate, write and speak as they deem appropriate for their discipline.”

Telling the story now, Krimsky recalls, “I kept thinking, W.R. Grace has no foothold at Tufts. But I wondered what it would have been like if it had been the other way? The freedom to publish is so important to our university and to our culture. There are not that many places where people are free to do research without the influence of institutional values, not in government or business and not even in nonprofit institutions.”

Krimsky began what was to become an ongoing study of the financial ties between university scientists and corporations, finding it increasingly likely that researchers will have some financial stake in the research they are conducting. While physicians on the staffs of medical schools may earn money as corporate consultants, university scientists may be on the payroll of a company developing a drug or treatment for a disease. Some scientists serve on advisory boards of corporations or own stock in companies they are writing about.

Billion-dollar Cells
But there are other ways in which a conflict of interest can take place. One of the more egregious examples Krimsky recounts in his book is the story of John Moore, a leukemia patient at the UCLA Medical Center in the 1970s. Moore was seriously ill, but to the surprise of his clinicians, recovered after his spleen was removed. Baffled by his recovery, clinicians took samples of his blood and bone marrow to determine how he managed to overcome his illness. It was discovered that Moore’s spleen cells produced unusually large quantities of proteins such as interferon and interleukin, which are known to stimulate the immune system.

In the 1980s, one of the UCLA scientists cultured a cell line from Moore, and in collaboration with his university, applied for a patent for the “Mo” cell line. The line was sold to a pharmaceutical company for $15 million and in turn earned billions in sales.

Moore sued the university and the researchers, saying they failed to disclose their financial interest in his cells and that he was entitled to a share in the profits. He lost his effort to share in the profits, but the California Supreme Court found that his physicians had an obligation to disclose their financial interest in his cells, saying that a personal interest in the procedure could have affected their clinical judgment.

Krimsky says that public policy changes in the 1980s moved universities from the proverbial ivory tower to a world in which they are now partners with industry and government. One change was the 1980 U.S. Supreme Court decision that allowed the patenting of life forms. “This decision opened up entrepreneurship in universities,” Krimsky says. “Now there was the ability to patent an organism or a gene, even if you didn’t create it.” A second change was the 1980 Bayh-Dole Act, which gave universities title to inventions made with support from federal funds.

Financial Stakes
These policy changes, Krimsky says, resulted in opportunities for researchers and universities to earn money. He likes to point out that when Jonas Salk discovered the polio vaccine in 1952, neither he nor the March of Dimes, which supported his research, ever patented the vaccine or received any royalties, a situation that would be starkly different today.

In a 1996 paper, Krimsky asked the question, “If you picked up an article from a reliable journal, what would be the likelihood that the lead researcher had a financial interest in the subject?”

The answer, he said, was that one of three articles showed the potential for conflict of interest. “We made the scientific community aware that in quantitative terms, conflict of interest is very high…”

“Disclosure,” he said, “is a necessary part of the solution, but it is not sufficient. It’s the first stage of asking questions about sponsorship of research. But even if everyone discloses that connection, we will not have a body of disinterested scientists. If a judge stands up in court and says, ‘I’m going to be sending this convicted felon to a for-profit prison in which I have financial equity,’ it would not be accepted. Yet investigators testing drugs have companies in the wings. The key is separating the sectors.”

In his book, Krimsky proposes setting up principles for solving the problem. First, he says, “everyone has the right to make money, but there is an obligation to disclose financial interest when you write an article about your work. Second, we need to reform the way drugs are tested. Now it’s a vertically integrated industry. The drug companies pay for the research, own the data and decide what gets published. They fund the education of physicians; they fund journal articles. As a result, they have an enormous influence on studies that get published and the outcome of studies.”

Krimsky has proposed a national institute of drug testing that would choose investigators to study drugs and would also own data found by the investigators. Meanwhile, he is increasingly concerned about the role of universities. “The consequence of commercialization,” he writes, “is that secrecy has replaced openness; privatization of knowledge has replaced communitarian values, and commoditization of discovery has replaced the idea that university-generated knowledge is a free good.”

Krimsky warns that the commercialization of university science eventually will deplete the public interest roles of scientists who have contributed so much to society.

“Protecting the integrity of America’s research institutions,” he writes, “is like protecting a unique natural resource such as the Grand Canyon from being exploited for its unrealized wealth in precious metals.”