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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 can one “harmonise” the practice of numerous unethical experiments conducted by researchers with no “internalised ethical values?” How can one “harmonise” wholesale failure to internalise ethical values?” As the ethicist Arthur Caplan said, “In many ways, rats and mice get greater protection as research subjects in the United States than do humans.”2
Efforts to change the Declaration of Helsinki that come from the US should be recognised for what they represent. The United States and the US Federal Drug Administration have abdicated oversight of human subjects research, as indicated by a recent report of the US Department of Health and Human Services inspector general, “. . . federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.”2
Sadly, I think that it is time for the rest of the world to look away from the US for moral leadership. Perhaps it is time to turn to the Canadian Ottawa Statement, to which the authors approvingly refer.
Competing interests: JHN read and commented on the authors' original draft.