US attempting to flout ethical practice for patient trials abroad

03/23/05

EMBARGO: 00:01H (London time) Friday March 25, 2005. In North America the embargo lifts at 6.30pm ET Thursday March 24, 2005.

The US Food and Drug Administration (FDA) has proposed that observing a widely accepted code of medical ethics that protects patients who take part in trials is not necessary for studies conducted abroad, states a comment in this week's issue of THE LANCET.

The 2000 Declaration of Helsinki, produced by 82 national medical associations, states that: "At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified in the study" and places some limits on the use of placebos in developing country studies.

Current FDA regulations require studies submitted in support of a new drug application to have been done in a manner consistent either with the Declaration of Helsinki or any local laws, whichever is more protective for patients. In June 2004, the FDA proposed that clinical research projects abroad that are not conducted under an application for an investigational new drug need no longer comply with the Declaration and need comply only with a document describing good clinical practices. The document, written with only government and drug industry input, is much weaker regarding patient protections than the Declaration.

The FDA has led the charge against many substantive improvements in several international ethics documents. Its efforts have been least successful with the Declaration of Helsinki, explaining the FDA's motivations, suggest the comment authors.

Peter Lurie (Public Citizen's Health Research Group, Washington DC, USA) and Dirceu Greco (Federal University of Minas Gerais, Brazil) write that 'US exceptionalism' for prevailing opinions and standards in the international community is not new. For matters that affect public health, in the past decade or so, the USA has either withdrawn from or failed to endorse the Kyoto Treaty on climate change, the Treaty on the Limitations of Anti-Ballistic Missile Systems, the Biological Weapons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. For the first time, this attitude would now apply to research ethics.

Dr Lurie concludes: "The Declaration of Helsinki is the standard-bearer for international research ethics and enjoys particular respect in the developing world. It would be tragic if the US tendency to arrogantly flout international mores claimed the declaration as another victim, even as the President touts the universalism of human rights."

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