New York Times Examines Ethics of Overseas Drug Testing

The New York Times on Friday examined U.S. biotechnology companies' decision as to "what, if anything, they owe the patients who served as test subjects" in clinical trials conducted outside of the United States. An increasing number of clinical trials are being conducted overseas, in part because fewer U.S. patients are enrolling in clinical trials and fewer U.S. doctors are willing to undertake stringent testing and reporting requirements for U.S. clinical trials, according to Dr. Eugene Braunwald, a Harvard medical school physician who heads an academic group that administers cardiology clinical trials. U.S. patients who participate in clinical trials can purchase the medications if they are approved or apply to special programs to get the treatment at a discount or free if they cannot afford them, the Times reports. However, "there is no industry consensus about what to do internationally, especially when drugs are not lifesaving," according to the Times. Companies sometimes opt not to make the treatments available in the countries where they were tested or market the prescription drug without establishing a system to provide the treatment to clinical trial participants after the study ends. Carl Feldbaum, president of the Biotechnology Industry Organization said the issue is something the industry will "have to come to grips with" as more drugs are developed, adding, "It's not that we are lacking compassion, but the economics are tough" (Kolata, New York Times, 3/5).