MENTALLY ILL: Drug Trials Criticized
Some 850 seriously ill schizophrenia patients were given placebos rather than proven medications over the last decade, the Boston Globe reports. At least one of the patients committed suicide and "[u]p to 70% of the patients ... had to withdraw from the trials." Paul Ling, a leader of the Consortium for Psychotherapy in Massachusetts, said the studies treat "the mentally ill like lab rats." While the practice of using placebos to determine the efficacy of a new drug has long been the FDA's "gold standard," mental health advocates have argued that the practice exploits patients who are often too ill to understand the consequences, especially when medications known to work already exist. "How could you possibly put somebody on placebo when they could commit suicide?" asked Harvard Medical School epidemiologist Karin Michels.
Not Getting Any Better
According to a Globe analysis of unpublished experimental data submitted to the FDA in the 1990s for four antipsychotics -- Zyprexa, Risperdal, Serlect and Seroquel-- many of the participants "were so severely ill that their ability to understand the risk of being given a sugar pill was questionable." Further, the researchers even anticipated a high dropout rate among those receiving placebos. Indeed, the Globe found that in a 1997 study, 35 out of 51 placebo participants dropped out of the study, and the researchers concluded that "as expected, lack of efficacy was the primary reason for withdrawal." While pharmaceutical companies continue to stick to the use of placebos in clinical trials, the FDA and the National Institute of Mental Health are expected to take up the issue in an FDA-sponsored symposium next month. LeRoy Walters of Georgetown University's Kennedy Institute of Ethics, said, "When there is a drug that has been demonstrated by convincing evidence to be safe and effective for a life-threatening disease, one should not go back after that point and use placebos in future trials." Kenneth Rothman, professor at the Boston University School of Public Health and editor of Epidemiology, said, "Some people ... think you can't do a study without a placebo -- they're wrong" (Kong, 3/21).