Helsinki Discord? A Controversial Declaration

WASHINGTON—A long-awaited fifth revision of the Declaration of Helsinki, widely acknowledged as the foundation of medical research ethics, is receiving mixed reactions for discouraging placebos in clinical trials and mandating researchers to provide “best proven” therapy to participants after a trial. Patient protection advocates, who lobbied hard for the new language, hail the revision as a major step toward abolishing what they see as unethical research, especially in developing nations. Delon Human, MD, secretary general of the World Medical Association (WMA), which put forth the declaration, is equally enthusiastic. He says the revision is an ideal—not a “manual of protocols and procedures”—but that it sets an ethical standard “which I don’t think can be set high enough.” Or can it be? Some researchers and bioethicists are calling the recommendations on placebo use unwarranted and unnecessary, a possible bane to future research. And the US agencies responsible for protecting patients in medical studies, namely the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS), are noncommittal about whether they will subscribe to the revision, which provides no means of enforcement. “I think it’s scientifically and ethically incorrect,” said Robert Temple, MD, director of the FDA’s Office of Drug Evaluation. “We’ll have to see if the Declaration of Helsinki remains the ethical standard for the world.” Temple cautioned that he was speaking only for himself, not for the FDA, but he later added that he would try to persuade others in the agency to his point of view. Greg Koski, MD, PhD, director of the DHHS’s Office for Human Research Protections, simply said, “This is an area of active discussion in the department. There will be more information forthcoming as we try to offer some guidance to researchers.” Both the DHHS and FDA are reviewing the new declaration with one eye on their own policies and another on parallel ethics statements being prepared by the National Bioethics Advisory Commission and the Commission for International Organizations of Medical Sciences, part of the World Health Organization. If these groups issue statements straying from Helsinki’s policy—a very real possibility, according to several sources—researchers will have to play “pick the doctrine” when planning new studies.