The US Food and Drug Administration (FDA) has proposed that clinical trials conducted in other countries need not comply with the Declaration of Helsinki, "the stone tablet of medical research ethics, according to critics.
The proposed changes in FDA rules "might lead to studies that are less ethical, so drugs might be approved for use in the United States on the basis of studies that don't meet US standards," says Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group, a nonprofit consumer advocacy group based in Washington, DC.
The charge, made by Lurie and Dr. Dirceu Greco of the Federal University of Minas Gerais in Brazil, was quickly rebutted by Dr. Robert Temple, associate director for medical policy at the FDA's Center for Drug Evaluation and Research.
Problems With Placebos?
The debate centers on two changes that were proposed by the FDA in February 2004 and are still under consideration.
One would allow the use of a placebo in trials to assess the effectiveness of a drug. even when there is a known effective treatment for the condition The other change proposed would eliminate the requirement that any person who participates in a clinical trial be given the best available treatment for the condition after the trial ended.
"It is unethical to use a placebo in a trial when there is a known effective treatment for the condition," Lurie says.
Temple counters that the Declaration of Helsinki no longer rules out trials using a placebo, a change that was made in 2002. But Lurie says the change was forced through by the United States, which was acting on behalf of major drug companies. The alternative to a placebo trial is a trial that matches one drug against another. "The basic problem is that if you see no difference in such a trial, you don't know whether both drugs worked or neither worked," says Temple.
After A Trial Ends
Pharmaceutical firms are seeking to eliminate the rule requiring continued treatment for participants after a trial ends. "Companies don't want to be saddled with responsibility to patients after studies are done, charges Lurie.
Temple says that there are a number of difficulties" in providing such care. Researchers often don't know what the results of a trial mean until well after it is over, he says. And Temple questions whether lifetime care is warranted for participants in short-term trials. "If you are in a blood pressure study for six weeks, does that mean you are owed blood pressure therapy for the rest of your life?" he asks.
Lurie and Greco link the FDA-proposed changes to what they call "recent US actions which have placed that nation at odds with prevailing opinion and standards in the international community." Temple says the FDA "has gotten various comments on the proposed rules and we are reading them."