Last week, the World Medical Association (WMA) failed to amend the Declaration of Helsinki on treatment provision after a study ends. The amendment that stalled the WMA meeting was to ensure access to the "best proven" therapy identified in a study (see Delayed decision on Helsinki declaration).
The language of the clause in question — paragraph 30 — is opposed by the US government and western pharmaceutical companies, who have been pressuring the WMA to change the wording (for example, by talking about "every effort to ensure" provision of treatment). They say that paragraph 30 unfairly burdens researchers and their sponsors with responsibilities that should lie with the local health-care system.
Yet, according to this Lancet editorial, paragraph 30 articulates the important ethical principle that patients in a trial in the developing world should reap the same benefits as those in the developed world. The article argues that the required ethical standard is beyond debate, and that researchers and trial sponsors from the western world should stop dwelling on their own problems and get to grips with what it is like to be ill in a resource-poor country.
Reference: The Lancet 362, 1005 (2003)
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