FDA Seeks Weaker Ethics Rules for Medical Trials, Critics Claim

But an agency official denies the accusation

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HealthDay Reporter

THURSDAY, March 24, 2005 (HealthDay News) -- The U.S. Food and Drug Administration has turned its back on the rest of the world by proposing that clinical trials done in other countries need not comply with the Declaration of Helsinki, "the stone tablet of medical research ethics," critics contend.

The proposed changes in FDA rules "might lead to studies that are less ethical, so that drugs might be approved for use in the United States on the basis of studies that don't meet U.S. standards," said Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group, a non-profit consumer advocacy group based in Washington, D.C.

The charge was made in an editorial in the March 26 issue of the journal The Lancet written by Lurie and Dr. Dirceu Greco of the Federal University of Minas Gerais, in Brazil.

It was quickly rebutted by Dr. Robert Temple, associate director for medical policy at the FDA's Center for Drug Evaluation and Research.

The editorial criticism centers on two changes that were proposed by the FDA in February 2004 and are still under consideration. One would allow use of a placebo, an inactive substance, in trials to assess the effectiveness of a drug, even when there is a known effective treatment for the condition. The other 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 placebo in a trial when there is a known effective treatment for the condition," Lurie said.

The Declaration of Helsinki no longer rules out trials using a placebo, Temple said, a change that was made in 2002. But Lurie said the change was forced through by the United States, acting on behalf of major drug companies "who stayed in the background, allowing the FDA to carry the torch for them. The change thus appears to have come from a government agency, rather than companies that have an economic interest in the issue."

The alternative to a placebo trial is a trial matching one drug against another, which would present "a major problem in interpretation," Temple said.

"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," he said.

Eliminating the rule requiring continued treatment for participants after a trial ends is also being sought by pharmaceutical firms, Lurie charged, because "companies don't want to be saddled with responsibility to patients after studies are done."

Temple replied that there are "a number of difficulties" in providing such care. "You often don't know what a trial shows until well after the trial is done," he said. "Often there is a lot of difficulty in figuring out what it means. And take 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?"

The editorial links the FDA-proposed changes to what it called "recent U.S. actions which have placed that nation at odds with prevailing opinion and standards in the international community," such as failure to endorse the Kyoto Protocol on climate change, and the Treaty on Limitation of Anti-Ballistic Missile Systems.

"This generally exceptionalist attitude that the United States has brought to foreign policy now is something that is coming to roost in health-care ethics, degrading the United States in the health-care field internationally," Lurie said.

Temple said he could not comment on that charge. He did say the FDA "has gotten various comments and we are reading them on the proposed rules." It is impossible to say when a decision on the rules will be issued, he said.

More information

The full text of the Declaration of Helsinki is provided by the World Medical Association.

SOURCES: Peter Lurie, M.D., deputy director, Public Citizen's Health Research Group, Washington, D.C.; Robert Temple, M.D., associate director for medical policy, U.S. Food and Drug Administration's Center for Drug Evaluation and Research, Bethesda, Md; March 26, 2005 The Lancet

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