The Impact of Bias on Research Publications

Doctors, medical researchers, sociologists, and others have raised concerns about the impact of bias on research publications. Researchers have found that medical journal articles written by individuals who received pharmaceutical industry funding are four to five times more likely to recommend the tested drug than are articles written by those without such funding. Similarly, researchers have found that research studies suggesting a drug is effective are several times more likely to be submitted and accepted for publica- tion than are those that suggest it is ineffective. Concern about such biases led the New England Journal of Medicine (one of the top two medical journals in the United States) to forbid authors from publishing articles on drugs in which they had financial interests. The policy, however, was dropped quickly because it proved virtually impossible to find authors who did not have financial conflicts.

Even more astonishing than pharmaceutical industry funding of university- based researchers is the growing practice of paying such researchers to sign their names to articles written by industry employees. For example, between 1988 and 2000, 96 articles were published in medical journals on the popular antidepressant Zoloft. Slightly more than half of these were written by pharmaceutical industry employees but published under the names of universi- ty-based researchers. Moreover, these ghostwritten articles were more likely than other articles to be published in prestigious medical journals.

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Regulating Drugs In the United States, ensuring the safety of pharmaceutical drugs falls to the Food and Drug Administration (FDA). But during the same time period that the profits and power of the pharmaceutical industry grew, the FDA’s power and funding declined as part of a broader public and political movement away from “big government.” These two changes are not unrelated: The pharma- ceutical industry now routinely provides funding of various sorts to staff members at government advisory agencies, doctors who serve on FDA advisory panels, and legislators who support reducing the FDA’s powers.

Under current regulations, the FDA must make its decisions based primar- ily on data reported to it by the pharmaceutical industry. Yet the industry is re- quired to report only a small fraction of the research it conducts. For example, the company that produced the antidepressant Paxil had considerable data indicating that among teenagers Paxil did not reduce depression but could lead to suicide.