This issue has always bothered me....."February 23, 2001
Proposed Baby-Drug Test With Placebos
Is Blasted by Consumer Watchdog Group
By Chris Adams
Staff Reporter of The Wall Street Journal
WASHINGTON -- A consumer watchdog group blasted a small biotechnology company for proposing a clinical trial of a respiratory drug in which some Latin American babies would get a placebo instead of medications that might help them.
Using a placebo in a similar trial in the U.S. would be unacceptable, according to Public Citizen, based here. The group called the proposed study a "landmark of unethical behavior" and urged top officials at the Food and Drug Administration and the Department of Health and Human Services to intervene to prevent the trial.
While the FDA can't stop a trial from taking place in another country, it can do so indirectly. In this case, the company wants the agency to endorse its methods since the trial data are likely to be submitted to the FDA in support of any resulting drug application.
The company, Discovery Laboratories Inc., of Doylestown, Pa., rejected the notion that the proposed trial was unethical. It said testing the drug Surfaxin using the method it proposed would speed up the development process, bringing the drug to market quicker. Measuring a new drug against a placebo requires far fewer patients than comparing it with an existing medication.
The FDA said the trial remains "under consideration" and that views on the trial within the agency are "quite varied." Robert Meyer, an official with the agency's drug division, agreed that such a study would "not be tenable" in the U.S.
The issues go beyond one drug trial. There is a big controversy over whether a patient in a drug trial should ever get a placebo if a proven remedy exists. At the same time, drug makers are increasingly conducting their trials in developing nations, where standards are more relaxed and costs lower. Often, sick and dying people in poor nations are faced with a stark choice: Participate in a study or get no health care at all.
Sidney Wolfe, director of Public Citizen's Health Research Group, said the study would essentially allow newborns with respiratory distress syndrome to die untreated. "For the study to take place ethically, all infants must be provided with a treatment either known or expected to be effective," he wrote in a letter to HHS Secretary Tommy Thompson.
The FDA hasn't endorsed the proposed trial, which was discussed at an internal meeting at the agency last month. However, Discovery Laboratories' chief executive officer, Robert Capetola, said, "We understand the FDA has a very favorable attitude toward this." He said his company proposed the trial in Latin America because it and a partner plan to market the drug there, if it is approved. Babies could die if the drug's approval is delayed, he said.
"We're taking the approach it's almost unethical not to do that," Dr. Capetola said. The company also said that if the drug is approved, it would be provided to Latin American patients at low cost. |
