Doctors without borders: why you can't trust medical journals anymore.

• Author: Brownlee, Shannon

With financial ties to nearly two dozen drug and biotech companies, Dr. Charles B. Nemeroff may hold some sort of record among academic clinicians for the most conflicts of interest. A psychiatrist, a prominent researcher, and chairman of the department of psychiatry and behavioral science at Emory University in Atlanta, Nemeroff receives funding for his academic research from Eli Lilly, AstraZeneca, Pfizer, Wyeth-Ayerst--indeed from virtually every pharmaceutical house that manufactures a drug to treat mental illness. He also serves as a consultant to drug and biotech companies, owns their stocks, and is a member of several speakers' bureaus, delivering talks--for a fee--to other physicians on behalf of the companies' products.

But it was just three of Nemeroff's many financial entanglements that caught the eye of Dr. Bernard J. Carroll last spring while reading a paper by the Emory doctor in the prominent scientific journal, Nature Neuroscience. In that article, Nemeroff and a co-author reviewed roughly two dozen experimental treatments for psychiatric disorders, opining that some of the new treatments were disappointing, while others showed great promise in relieving symptoms. What struck Carroll, a psychiatrist in Carmel, Calif., was that three of the experimental treatments praised in the article were ones that Nemeroff stood to profit from--including a transdermal patch for the drug lithium, for which Nemeroff holds the patent.

Carroll and a colleague, Dr. Robert T. Rubin, wrote to the editor of Nature Neuroscience, which is just one of a family of journals owned by the British firm, Nature Publishing Group, pointing out the journal's failure to disclose Nemeroff's interests in the products he praised. They asked the editor to publish their letter, so that readers could decide for themselves whether or not the author's financial relationships might have tainted his opinion. After waiting five months for their letter to appear, the doctors went to The New York Times with their story--a move that sparked a furor in academic circles, and offered the public yet another glimpse into conflict of interest, one of the most contentious and bitter debates in medicine.

In his defense, Nemeroff told the Times he would have been happy to list his (many) relationships with private industry--if only the journal had asked. "If there is a fault here," he said, "it is with the journal's policy," which did not require authors of review articles to disclose their conflicts of interest.

And that is pretty much where the debate over conflict of interest in medical journals stands: Should research scientists who have financial stakes in the products they are writing about be forced to disclose those ties? To which the average person might reasonably respond, of course they should. But the more pertinent question is why scientists with financial stakes in the outcome of scientific studies are allowed anywhere near those studies, much less reviewing them in elite journals.

The answer to that question is at once both predictable and shocking: For the past two decades, medical research has been quietly corrupted by cash from private industry. Most doctors and academic researchers aren't corrupt in the sense of intending to defraud the public or harm patients, but rather, more insidiously, guilty of allowing the pharmaceutical and biotech industries to manipulate medical science through financial relationships, in effect tainting the system that is supposed to further the understanding of disease and protect patients from ineffective or dangerous drugs. More than 60 percent of clinical studies--those involving human subjects--are now funded not by the federal government, but by the pharmaceutical and biotech industries. That means that the studies published in scientific journals like Nature and The New England Journal of Medicine--those critical reference points for thousands of clinicians deciding what drugs to prescribe patients, as well as for individuals trying to educate themselves about conditions and science reporters from the popular media who will publicize the findings--are increasingly likely to be designed, controlled, and sometimes even ghost-written by marketing departments, rather than academic scientists. Companies routinely delay or prevent the publication of data that show their drugs are ineffective. The majority of studies that found such popular antidepressants as Prozac and Zoloft to be no better than placebos, for instance, never saw print in medical journals, a fact that is coming to light only now that the Food and Drug Administration has launched a reexamination of those drugs.

Today, private industry has unprecedented leverage to dictate what doctors and patients know--and don't know--about the $160 billion worth of pharmaceuticals Americans consume each year. This is an unsettling charge that many (if not a majority) of doctors and academic researchers don't want to acknowledge. Once grasped, however, the full scope and consequences of medical conflict of interest beget grave doubts about the veracity of wide swaths of medical science. As Dr. Drummond Rennie, deputy editor of The Journal of the American Medical Association (JAMA), puts it, "This is all about bypassing science. Medicine is becoming a sort of Cloud Cuckoo Land, where doctors don't know what papers they can trust in the journals, and the public doesn't know what to believe."

Clinical trial and error

How did we get to this point? What effect is industry influence having on the treatment of patients? And why are the medical journals not more vigilant to weed out papers that have been distorted by conflict of interest? The answers to these questions begin, oddly enough, with an amendment to U.S. patent law called the Bayh-Dole Act. Passed in 1980, Bayh-Dole for the first time permitted universities to commercialize products and inventions without losing their federal research funding, the seed money for innovative research. The brainchild of George Keyworth II, President Reagan's science advisor, who was watching the United States get beaten in world markets by the Japanese, Bayh-Dole was intended to stimulate advanced technological invention and speed its transfer from university labs into private industry, where it could be put to work spurring U.S. productivity.

It seemed like a win-win proposition. Indeed, Bayh-Dole has helped launch the biotech industry and has propelled several life-saving products to market. The basic research behind Gleevec, for instance, an incredibly effective new anti-cancer drug, was done by a university scientist. The drug's manufacturer, Novartis, stepped in and provided additional funding...