Enter any drug store in the United States, and you are instantly surrounded by thousands of drugs. They vary in size, color, strength and price. Some are easily obtained off the counter, while pharmacists hold others under lock and key. Despite the vast assortment available, they all have one process in common. Clinical trials. Before we can take them for our headaches, hypertension and hypoglycemia they all undergo the rigorous process of clinical trials. However, these trials have often resulted in the exploitation of vulnerable populations all over the world.
As with all trials involving human participants, the ethical implications of clinical trials are now facing greater scrutiny. Carl Elliot investigates the role of American participants in clinical trials in “Guinea-Pigging: Healthy human subjects for drug safety trials are in demand. But is it a living?” His article highlights a critical reason why trials have begun to move overseas. Several problems have arisen as a result of the globalization of clinical trials, and the medical community has started to take notice. In “Ethical and Scientific Implications of the Globalization of Clinical Research”, an article in the New England Journal of Medicine, Dr. Seth W. Glickman and his associates delve into the increasing trend of globalization and its consequences. Drs. Harold Shapiro and Eric M. Meslin perform the same level of scrutiny, but with a greater focus on the development of the trials, in “Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries.” Christopher Rowland of the Boston Globe presents the motivation for globalization in “Clinical Trials seen Shifting Overseas Tufts Study Cites lack of U.S. Subjects”. Finally Sandhya Srinivasan and Bebe Loff present a glimpse of the future of clinical trials in “Medical Trials in India”.
Clinical trials are an integral part of medical research. However, while the globalization of clinical trials will benefit the world in the long run, it has lead to some serious unethical conduct. In order to prevent this, the Food and Drug Administration in conjunction with both private and public Internal Review Boards need to take a stronger role in the regulation of clinical trials. This allows for the development of new drugs without the taint of exploitation. In order to understand the injustices associated with clinical trials overseas, one must first understand what attracted pharmaceutical companies to developing countries. The globalization of clinical trials is a result of two motivating factors, a larger participant group, and cost effectiveness.
Causes of Globalization
In the past most clinical trials by American companies occurred in the U.S. But as time went on and the quality of life in the U.S. improved, fewer people were willing to volunteer for clinical trials. Those that remained in the clinical trial market have turned it into a lucrative business. Elliot states “In some cities, like Philadelphia and...