M. Michael Wolfe, a gastroenterologist at Boston University, admits he was duped by the Pharmacia Corporation, the manufacturer of the blockbuster arthritis drug Celebrex prior to its purchase by Pfizer in 2003. 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.
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.
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 … than good." His Harvard center, meanwhile, was heavily funded by dioxin producers.
Worse yet, the universities' loyalties are now so conflicted that schools are increasingly willing to cave in to narrow commercial demands rather than defend their own professors' academic freedom or the public interest. When researchers at the University of Utah discovered an important human gene responsible for hereditary breast cancer, for example, they didn't make it freely available to other scientists, even though we -- the U.S. taxpayers -- paid $4.6 million to finance the research. The university raced to patent it, then granted the monopoly rights to Myriad Genetics Inc., a startup company founded by a University of Utah professor, which proceeded to hoard the gene and prevent other academic scientists from using it.
Professors, too, are increasingly driven by the bottom line. More and more, they not only accept industry grants to support their research but also hold stock in or have other financial ties to the companies funding them. Many experts fear this skewing of professors' research toward short-term commercial goals will impede long-term scientific and technological innovation. Financial entanglements between researchers and corporations have grown so common that the Securities and Exchange Commission (SEC) has investigated numerous academic researchers suspected of engaging in insider trading. In a case filed in Pennsylvania, the SEC charged Dale J. Lange, a Columbia University neurologist, with pocketing $26,000 in profits after Lange bought stock in a company that was about to release promising new findings concerning a drug to treat Lou Gehrig's disease. Lange had good reason to expect the stock to soar because he had conducted the confidential clinical trials himself. In 2000, an investigation by USA Today found that more than half the experts hired to advise the U.S. government on the safety and effectiveness of drugs -- a large number of whom are academics -- now have financial links to companies that will be affected by their conclusions.
So how does this growing web of academic-industry ties affect research outcomes? A vast body of work suggests that industry-funded research is far from impartial. In 1996, Stanford researcher Mildred Cho co-authored a study in the Annals of Internal Medicine that found that 98 percent of papers based on industry-sponsored research reflected favorably on the drugs being examined, compared with 79 percent of papers based on research not funded by industry. An analysis published in The Journal of the American Medical Association in 1999 found that studies of cancer drugs funded by the pharmaceutical industry were nearly eight times less likely to reach unfavorable conclusions than similar studies funded by nonprofit organizations. More recently, a systematic review of 1,140 clinical trial studies, published by researchers at Yale in 2003, concluded that, from cancer to arthritis to cholesterol, the evidence is overwhelming that when research is industry-sponsored, it is "significantly more likely to reach conclusions that [are] favorable to the sponsor" than non–industry-funded research.
In the area of health and drug research, of course, the results of such manipulation can be deadly. Running down the list of drugs recently pulled from the market or subject to increased health warnings -- Rezulin, the diabetes drug; Redux (or fen-phen), the diet drug; Retin-A, the anti-wrinkle cream; Neurontin, the epilepsy drug; Paxil, Zoloft, and the many other antidepressants now deemed ineffective for children -- one finds that a remarkable number of prominent university professors with close financial ties to the manufacturers played a central role in lobbying for these drugs to be approved, recommending them to other doctors, and, in many cases, urging that they remain on the market long after the problems or lack of effectiveness became known. Not infrequently, the university scientists who shill for the drug companies most aggressively are also the biggest-name professors in their fields.
In some respects, the whole debate reflects how far the academic world remains from dealing seriously with the issue; disclosure of potential conflicts of interest is, after all, a far cry from eliminating them outright, as many professions not only recommend but also require. In the legal profession, for example, attorneys are prohibited from taking on cases in which they have a financial interest or other explicit conflicts that might be seen to compromise their professional integrity. The same is true of judges. But when it comes to academia, neither the medical community nor the government (whether through Congress or the regulatory agencies) has taken up the task, instead proceeding under the assumption that universities can be trusted to manage these commercial interactions themselves. It's a nice idea. But are academic institutions really capable of performing this function? There is good reason to be skeptical: Far from being independent watchdogs capable of dispassionate inquiry, universities are increasingly joined at the hip to the very market forces the public has entrusted them to check, creating problems that extend far beyond the research lab.
Jennifer Washburn is a fellow at the Open Society Institute. Adapted from the book University, Inc.: The Corporate Corruption of Higher Education. Copyright 2005. Reprinted by arrangement with Basic Books, a member of the Perseus Books Group. All rights reserved. A longer excerpt appears in the February 2005 print edition of The American Prospect.
