U.S. drug trials proposal unethical, critics say

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The U.S. Food and Drug Administration is flouting ethical practice by proposing that international guidelines protecting patients need not apply to clinical trials conducted abroad, critics said on Thursday.

Peter Lurie, of consumer group Public Citizen, and Dirceu Greco, of the Federal University of Minas Gerais, Brazil, said plans to exempt overseas trials from the Declaration of Helsinki were an example of Washington ignoring global rules.

The declaration, drawn up by 82 national medical associations, requires that patients taking part in a clinical study be guaranteed continued access to drugs at the end of the study. 

It also places certain limits on the use of placebos, or dummy pills, in trials carried out in developing countries.

Currently, FDA rules require studies supporting a new drug application be carried out in line with the declaration or any local laws, whichever is more protective for patients.

But proposals made last year would weaken this so that overseas studies not conducted under an application for an investigational new drug need no longer comply with the declaration. Instead, they would simply have to meet good clinical practices.

Dr. Robert Temple, FDA’s associate director for medical policy, said he felt the “ethical necessities” of a trial were “well-covered” by the good clinical practice standards.

He said he understood the reasons behind the requirement to supply post-study medicines but that it was unclear.

If patients take part in a four-week study of a blood pressure medicine, “does that mean the sponsor of the trial owes them blood pressure treatment for the rest of their life? That does not seem like an obvious ethical necessity.”

He also noted that other countries were free to impose additional mandates on studies done within their borders.

“We are in no sense telling other countries what to do. They can impose any requirement they want,” Temple said in an interview.

But Lurie and Greco said such “U.S. exceptionalism” was a growing trend, reflected in Washington’s decision to either withdraw from or not endorse the Kyoto Treaty on climate change, the Treaty on the Limitations of Anti-Ballistic Missile Systems, the Biological Weapons Convention, the Comprehensive Test Ban Treaty and the (land) Mine Ban Treaty.

“It should not be surprising, therefore, that this flair for exceptionalism has also infected U.S. policies on human experimentation,” they wrote in this week’s edition of the Lancet medical journal.

“It would be tragic if the U.S. tendency to arrogantly flout international mores claimed the declaration as another victim, even as the President (George W. Bush) touts the universalism of human rights.”

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