FDA Considers Placebo Tests on Latin American Infants
The FDA is considering a Discovery Laboratories Inc. proposal to conduct a drug experiment -- regarded as "unethical" in the United States -- that would "leave hundreds of sick, premature infants in Latin America without proven lifesaving medications," the Washington Post reports. In the study, researchers would test three groups of infants suffering from respiratory distress syndrome, providing the first with Discovery's experimental drug Surfaxin, the second with traditional medication and the third with a placebo. Although researchers in the U.S. cannot use placebos on study participants suffering from potentially fatal illnesses with proven treatments, Discovery -- which is based in Doylestown, Pa. -- could legally conduct the experiment outside the United States. Still, Discovery hopes to receive FDA approval to ensure that the agency would accept the findings "as proof the drug is safe" if the company ever decided to market Surfaxin in the United States. Robert Capetola, president of Discovery, said that the proposed study could "shave 18 months off the development of an important drug," adding, "We think it would be totally unethical not to conclude it and get it to patients quicker" (Flaherty/Stephens, Washington Post, 2/23). According to Discovery spokesperson Brad Miles, the proposed study would "provide valuable information and hasten approval" of a drug that will "save lives" (Rubin, USA Today, 2/23). Capetola added that infants in some Latin American hospitals have no access to established drugs and would receive "better care" in the experiment because Discovery would donate ventilators and antibiotics to treat them (Washington Post, 2/23).
However, "consumer watchdog group" Public Citizen called the experiment a "landmark of unethical behavior" and urged FDA and HHS officials to prevent the study (Adams, Wall Street Journal, 2/23). "One expects drug companies to be profit-driven and act accordingly. But the FDA's job is to stop this kind of unethical behavior, not to endorse it," Dr. Peter Lurie, deputy director of the Public Citizen's Health Researh Group, said, adding, "The fact that the FDA is considering this study is beyond belief" (Public Citizen release, 2/22). In a letter to HHS Secretary Tommy Thompson, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, wrote, "For the study to take place ethically, all infants must be provided with a treatment either known or expected to be effective" (Wall Street Journal, 2/23). Lurie also said that the experiment would include Latin American families "in a test of a product that would ultimately be too expensive for them to afford," pointing out that treatment for respiratory distress syndrome in the United States costs between $1,100 and $2,400(Washington Post, 2/23). "The researchers have hit upon the idea of experimenting on the poorest of the poor," he said (Neergaard, AP/Philadelphia Inquirer, 2/23). However, Capetola said that Discovery would sell Surfaxin, if it proves successful, at a reduced price to Latin American nations participating in the study.
According to Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, Discovery's proposed experiment remains "under consideration." She added that the agency has a "division of opinion" about the "ethical questions" that the study raises (Washington Post, 2/23). The Wall Street Journal also reports that opinions of the study within the agency remain "quite varied." However, Capetola said, "We understand the FDA has a very favorable attitude toward this" (Wall Street Journal, 2/23). HHS spokesperson Bill Hall said that Thompson "would not get involved in a regulatory issue," adding, "That's for the FDA to decide" (Washington Post, 2/23).