Playing Puppet Master to Science
Since the end of the Cold War, U.S. scientists have had to knock on corporate doors for the research funds once lavished on them by a government eager to maintain American technological dominance. The resulting corporate-academic partnership has produced research projects of considerable value, but not without sometimes generating bitter conflict between scientists and business.
The last two years have shown that while private funding can inspire scientific inquiry, the withdrawal of funds can suppress it. Disputes have arisen as drug companies attempted to stymie the marketing of cheap, generic substitutes for their profitable, brand-name medications. They have pursued that effort by funding independent research studies to show that the generics are not therapeutically similar, or “bioequivalent,” to their big-selling products. However, some of these studies have concluded just the opposite. And in some cases, when researchers sought to publicly disclose these findings, drug companies silenced them by threatening long and costly legal trials.
Last month, for instance, Food and Drug Administration researchers announced that three generics were just as therapeutically effective as Eldepryl, a popular medication for Parkinson’s disease. The maker of the drug, Somerset Pharmaceuticals, promptly sued the FDA. In this case, the researchers were protected by the deep pockets of the federal government, which will also defend the FDA scientists in a coming hearing.
Academic institutions with limited funds, however, are often unable to muster the legal resources to shield their researchers from financial or legal intimidation by big pharmaceutical houses. The situation has become an “insidious problem,” says Steven A. Rosenberg, chief surgeon of the National Cancer Institute.
The most troubling case occurred last year. Britain’s Boots Pharmaceuticals managed to prevent a UC San Francisco researcher from publishing a peer-reviewed paper that concluded that U.S. health care costs could be trimmed by $356 million a year if one of Boots’ drugs was replaced by cheaper but equally effective generics. Boots had given the researcher $250,000 to study the drug and she had signed a restrictive contract. When her research did not jibe with Boots’ expectations, the company threatened to sue, claiming the researcher had deviated from technical provisions in the contract.
An obvious way to curb these conflicts is to require that university lawyers review private contracts before academic researchers sign them. This solution, however, goes only part of the distance, for some researchers, concerned that aggressive oversight might scare off private funders, have found ways around such university rules.
A more promising solution lies in the nascent efforts of private institutions like the National Judicial College to provide judges with the training necessary to evaluate the complex biotechnology disputes that increasingly crowd court dockets. A growing number of studies show that the judicial system is often unable to determine which testimony is science and which is sophistry.
Corporations like Boots have a right to hire teams of experts to attack research they claim is scientifically invalid. But the 1995 case does underscore the need for the federal government to seek to safeguard the integrity of scientific research. One way it can do so is by resisting legislative calls for diminished funding.
The combined budgets of the National Institutes of Health and the National Science Foundation amounted to $223 million last year. Funding such as this has produced major economic benefits, one example being the growth in the automotive and aerospace industries that came out of math and computer research. Perhaps just as important has been the way government funding has helped to protect scientists from corporate pressure. This is money well-spent.
