Healthy Skepticism Library item: 11744

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Declaration of Helsinki: Dead
BMJ 2007 Oct 13; 335:(7623):736
http://www.bmj.com/cgi/content/extract/335/7623/736

Abstract:

Servicing the overarching interests of the drug and medical device industry, the United States has apparently successfully intervened in the past (and still tries) with provisions that weaken the protection of human subjects, taking the document farther and farther from the principles and intent of the Nuremberg Code. The World Medical Association, it appears, has been party to medical malpractice in its most wanton manifestation. Fortunately, unlike the Nuremberg Code, most courts of law do not rely on the Declaration of Helsinki for guidance.

The answer to Goodyear et al’s question-“Declaring Helsinki-alive or dead?”-seems to be that the Declaration of Helsinki is dead on the basis of no brain waves, no heart beat, and a rapidly bloating, blow fly infested, stinking cadaver.1

Cynically, one must ask “what is the purpose of current efforts to “harmonise” the ethics and legalities of clinical trials in countries with no device regulatory system?” How . . .