Reference Reviews

Doug’s Student Reference Room

The Pharmaceutical Industry, edited by Jamuna Carroll. 212 pp. Detroit, MI.: Greenhaven Press, 2009. ISBN: 978-0-7377-4238-1. $37.40.

In the spring of 2009, the Food and Drug Administration (FDA) approved the anti-depressant drug Lexapro for treatment of major depressive disorder (MDD) in adolescents, which, after Prozac, was the second drug approved for such cases. The makers of the drug point to two studies that show the drug’s effectiveness but dismiss two other inconclusive studies, citing the difficulty in doing depression studies generally. While the logic of this rationale is muddy at best, what is clear is that, according the National Institute of Mental Health, MDD affects about five percent of adolescents, that the effects of such depression are significant and that a combination of therapy and medication may be the most effective treatment of a serious problem. This case illustrates many of the thorny issues around the pharmaceutical industry in this country. Is pharmaceutical research safe and free from bias? Does the FDA do an adequate job regulating prescription drugs? Are the marketing practices of the pharmaceutical industry ethical and in the best interest of the public? These key questions are explored in a new volume in the Greenhaven Press Opposing Viewpoints series, in addition to a critical fourth question: Is the cost of prescription drugs in the U.S. appropriate? The preface to the first chapter on safety and bias reviews historical examples of flagrant unethical trials, including the CIA mind control studies of the 1950s and the Tuskegee study, in which more than 400 black men were not told they had syphilis—a study that continued for 25 years after an effective treatment had been developed. While the preface establishes the need for effective protocols, it does not introduce the more subtle issues around bias and safety brought out in the essays which follow—that more open reporting of clinical trials may reduce bias through public oversight, that apparent bias is sometimes a function of private industry entering research later in the process after better odds of success, that more rigorous reporting standards may hinder private investment. The second chapter’s preface similarly focuses narrowly on one aspect of the topic—in this case, off-label prescribing of drugs—while the essays that follow deal not only with this important issue, but with terminal patients taking unapproved medications; pharmacists dispensing behind-the-counter drugs without doctors’ prescriptions; and the efficacy of “black box” warning labels on anti-depressants for youths. The third chapter’s preface describes the role of data-mining in pharmaceutical company marketing without introducing other aspects of marketing that are a critical part of the debate, including whether or not direct advertising of prescription drugs to the public is in the public interest. In spite of these omissions, the selections for each chapter, including those of the last chapter exploring the costs of prescription drugs, do examine the critical issues around the pharmaceutical industry, reinforcing the point that there are many shades of gray and that the path in the best interests of the public has not been established. The reasoned arguments looking at all sides of the issues in this volume represent the best of what the Opposing Viewpoints series has to offer. Highly recommended for high school and community college libraries.