Hired Education

M. Michael Wolfe, a gastroenterologist at Boston University, admits he was duped by the Pharmacia Corporation, the manufacturer of the blockbuster arthritis drug Celebrex. (In 2003, the company was purchased by Pfizer.) In the summer of 2000, The Journal of the American Medical Association asked Wolfe to write a review of a study showing that Celebrex was associated with lower rates of stomach and intestinal ulcers and other complications than two older arthritis medications, diclofenac and ibuprofen. Wolfe found the study, tracking 8,000 patients over a six-month period, persuasive, and penned a favorable review, which helped to drive up Celebrex sales.

But early the next year, while serving on the Food and Drug Administration's (FDA) arthritis advisory committee, Wolfe had occasion to review the same drug trial again, and was flabbergasted by what he saw. Pharmacia's study had run for one year, not six months, as the company had originally led both Wolfe and the Journal to believe. When the complete data was considered, most of Celebrex's advantages disappeared because the ulcer complications that occurred during the second half of the study were disproportionately found in patients taking Celebrex.

"I am furious," Wolfe told The Washington Post in 2001. "I looked like a fool. But ... all I had available to me was the data presented in the article." Remarkably, none of the Journal study's 16 authors, including eight university professors, had spoken out publicly about this egregious suppression of negative data. All the authors were either employees of Pharmacia or paid consultants of the company.

Celebrex, an anti-inflammatory drug similar to Vioxx, is once again in the news due to concerns that it may be associated with the same cardiovascular risks that caused Vioxx to get yanked from the market. In recent months, we've heard a great deal about conflicts of interest at both the FDA, the agency that approves drugs for public safety, and the National Institutes of Health, where publicly funded scientists moonlight as consultants for the very companies that manufactured the drugs they are testing. Still largely ignored, however, is the role played by the once-autonomous ivory tower and the university scientists who, either knowingly or unknowingly, facilitate the pharmaceutical industry's manipulation of drug testing by lending it an aura of objectivity.

Today, market forces are dictating what is happening in the world of higher education as never before, causing universities to look and behave more and more like business enterprises. Instead of honoring their traditional commitment to teaching, disinterested research, and the broad dissemination of knowledge, universities are aggressively striving to become research arms of private industry. Faced with declining government funding, they are avidly seeking to enhance their role as "engines" of economic growth, promising state legislators and governors that they will help drive regional economic development by pumping out commercially valuable inventions.

This radical redefinition of the university's mission can be traced back to the economic stagnation of the 1970s. Propelled by heightened competition from Germany and Japan, Congress passed landmark legislation in 1980 that allowed universities to automatically retain the rights to intellectual property stemming from taxpayer-financed research. The intent of the legislation, popularly known as the Bayh-Dole Act (its sponsors were Senators Birch Bayh and Bob Dole), was to stimulate innovation and speed the transfer of federally financed research to industry. What it accomplished in the process was the introduction of a dangerous new profit motive into the heart of the university.

As a result, schools now routinely operate expensive patenting and licensing operations to market their faculty's inventions, extracting royalty income and other fees in return. They invest their endowment money in risky startup firms founded by their professors. They run their own industrial parks and venture capital funds. They publish newsletters encouraging faculty members to commercialize new research by launching independent, faculty-owned companies. Star professors consult for, or hold equity in, the same firms that manufacture the drugs they are studying, while also often accepting generous fees to join corporate advisory boards and speakers' bureaus. Sometimes these professors even hold the patent to the drug or device being tested. In a study of 800 scientific papers published in leading journals of medicine and molecular biology, Sheldon Krimsky, a professor of public policy at Tufts University, found that slightly more than a third of the lead authors based at research institutions in Massachusetts had a significant financial interest in their own reports. So pervasive are such ties that journal editors now frequently complain that they can no longer find academic experts who do not have a financial interest in a drug or therapy the journal would like to review.

Research suggests that publicly funded science, most of it performed at universities, was a critical contributor to the discovery of nearly all of the 25 most important breakthrough drugs introduced between 1970 and 1995. If university scientists lose their independence, who will perform this pathbreaking research and objectively evaluate the safety and effectiveness of drugs already on the market? Conflicts of interest are more than an academic concern. When it comes to health policy, they pose a serious threat to public health.

With the possible exception of business schools, the nation's medical schools have been more infiltrated by industry than any other sector of the university. Pharmaceutical companies sponsor daily lunches for medical students at which they market their latest drugs; they ply professors with fancy dinners, gifts, luxurious trips, and free prescriptions designed to influence medical decisions and prescribing habits. The drug industry also spends millions of dollars financing clinical drug research at the academy, but increasingly this money comes with many more strings attached. After conducting a thorough review of the medical literature for The New England Journal of Medicine in 2000, Thomas Bodenheimer, an internist at the University of California, San Francisco, concluded that academic investigators were rapidly ceding to industry control over nearly every stage of the clinical research process.

In the past, for example, it was common for university scientists to initiate the research protocol. Now, studies are frequently conceived and designed in the company's own pharmacological and marketing departments, thus removing this formative stage of the research from academic hands almost entirely. The company then shops the study around to various academic institutions (and a growing number of competing for-profit subcontractors that run clinical trials) in search of investigators to conduct the research. As university medical schools have grown more dependent on industry grants to sustain their operations, their professors have become increasingly willing to accept an industry-initiated protocol without modification, even though the study may be largely designed to secure a company's market position. Should a professor reject the study or insist on changes, another university scientist will very likely be more solicitous.

Industry also encourages the use of ghostwriters on scientific papers. This means an article or review bylined by a prominent academic might in fact have been written by a medical-communications company working for the drugmaker, with the "author" paid an honorarium to attach his or her name to it.

When Wyeth-Ayerst sought to boost market demand for Redux, one part of the once highly popular "fen-phen" diet-drug combination, the company hired a company called Excerpta Medica to help draft the manuscripts and pay doctors to review and sign the articles. One of the many doctors who signed Excerpta's papers was Richard Atkinson, a renowned obesity expert at the University of Wisconsin-Madison. Atkinson denied having any knowledge of Excerpta's connection to Wyeth, but as an independent academic, he nonetheless agreed to lend his name to a company he apparently knew little about. (Excerpta maintains that all its authors were told of the company's association with the manufacturer.) In a deposition on January 15, 1999, Wyeth-Ayerst executive Jo Alene Dolan admitted that her company had written the article for Atkinson, stressing that all drug companies ghostwrite articles. Shortly before the article could be published, Redux was pulled from the market because of its association with serious heart and lung problems.

Scientists who perform industry-sponsored research are also asked routinely to sign legal contracts requiring them to keep both the methods and the results of their work secret for a period of time. Research conducted by David Blumenthal and Eric Campbell, health-policy researchers at Harvard University, suggests that data withholding and publication delays have become far more common over the last 25 years, particularly in molecular biology, medicine, and other life-science disciplines, where commercial relationships have grown dramatically in recent years. In a survey of 2,167 life-science faculty, Blumenthal found that nearly one in five of them had delayed publication for more than six months to protect proprietary information.

Industry also manipulates academic research by suppressing negative studies altogether. Recently, it came to light that a whole class of popular antidepressants -- including such heavily prescribed drugs as Paxil, Zoloft, and Prozac -- are largely ineffectual in treating childhood depression and actually increase the risk of suicide. One of the main reasons this information was not available to doctors and the broader public, it turns out, is that the academic investigators who led these studies either allowed industry to bury their research or were complicit in downplaying negative findings in their own published papers. How prevalent is such corporate meddling? The question has received surprisingly little scholarly attention, but what research does exist is not encouraging. One survey of major university-industry research centers in the field of engineering, for example, found that 35 percent would allow corporate sponsors to delete information from papers prior to publication.

But all the blame for the eroding objectivity of university researchers does not rest with industry. Universities themselves are complicit: They are so financially invested in their professors' research through patents, equity, and other financial holdings that their disinterested pursuit of knowledge has been gravely compromised. For instance, when the Harvard Center for Risk Analysis' longtime director, Professor John D. Graham, was nominated by President George W. Bush to become the government's "regulatory czar" at the Office of Information and Regulatory Affairs (part of the Office of Management and Budget), it helped to expose just how extensive Harvard's financial conflicts really were. Congressional hearings revealed that Graham's center solicited tobacco money and worked with the tobacco industry to disparage the risks of secondhand smoke. (Harvey Fineberg, a dean at the Harvard School of Public Health, demanded that one check from Philip Morris be returned. In response, Graham wrote to the company asking if it might send the $25,000 back to the Harvard center via the Philip Morris subsidiary Kraft Foods instead.) Graham's center also argued that cell-phone use by drivers should not be restricted, even though its own research, which was funded by AT&T Wireless Communications, showed that such use could lead to a thousand additional highway deaths a year. As a member of the Environmental Protection Agency's scientific advisory board subcommittee on dioxin, a known human carcinogen, Graham argued that reducing dioxin levels might "do more harm