In painstaking process of revising WMA's Declaration of Helsinki, every word counts

One phrase set the stage for an ideological dispute.

By Paul R. McGinn, amednews correspondent. Jan. 1/8, 2001.

Edinburgh, Scotland -- All he wanted to change were two words in the Declaration of Helsinki.

But in the end, Dr. Dirceu Greco failed to persuade the World Medical Assn. to change the newest revision of its ethical principles on clinical research.

It wasn't for want of trying, however. The Brazilian professor of internal medicine and official observer at the WMA meeting lobbied anyone who would listen -- and even those who wouldn't -- to change the two words in the declaration to protect the interests of thousands of participants in medical trials around the world from unscrupulous researchers and greedy pharmaceutical companies.

"Now there is a gap," he said, separating the air with his hands. "And now," he added, punching the space with his fist, "people will drive through it."

That gap appears in a particular provision of the just-revised declaration, said Dr. Greco, who chairs the ethics review committee at the Federal University of the State of Minas Gerais in Belo Horizonte.

The provision declares that all patients in a clinical trial -- treatment group and control group alike -- should, at the end of the study, "be assured of access to the best-proven prophylactic, diagnostic and therapeutic methods identified by the study."

Dr. Greco objected to the words, "identified by." [...]

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