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.

Editor's note: The Dec. 18, 2000, issue had two stories about the revision of the Declaration of Helsinki. This follow-up piece provides a behind-the-scenes look at just one of the battles involved in the revision.

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."

"The provision would work very well for therapeutic trials," he acknowledged. "But if we talk about vaccine trials, it may be a big problem because it can be interpreted in a different way."

He gave an example: "I am going to start a trial with an HIV vaccine, placebo against the vaccine. As a researcher I have to give all kinds of advice for people not to get infected. But I would expect that some will not take my advice and engage in risk behavior and get infected."

"Ethically, I believe that any person who got infected in such a trial should have access to the best-proven drugs for the treatment of their HIV. But because of the words 'identified by,' I don't have to give anything because the best-proven drugs for HIV that the person should receive were not 'identified by' the study," he added. "The vaccine was the only thing 'identified by' the study."

"If we could just change those words 'identified by' to 'relevant to,' then every patient involved in a study, regardless of where they live in the world, would be assured access to the best therapeutic methods relevant to the study."

Dr. Greco's appearance in Edinburgh wasn't his first venture into the declaration's debate.

In July 2000, Dr. Greco wrote in New Scientist that he worried that drugmakers, in a bid to save money, would pressure the WMA to change the declaration to allow researchers to use placebo-controlled trials even when there was a proven treatment against which to test an experimental drug.

Dr. Greco wasn't alone. Virtually every major journal, including JAMA, the New England Journal of Medicine, British Medical Journal and The Lancet, heard from authors who echoed these fears.

Although the WMA heeded the concerns of Dr. Greco and like-minded physicians about placebo-controlled trials, the organization refused to change its stand about guaranteeing a right to drug treatment regardless of the type of trial involved.

For the WMA, which had already spent a day and an hour laboring over the wording of its latest revision of the declaration, Dr. Greco's last-minute amendment was a step too far, too late.

"Under the language suggested by Dr. Greco, every woman who participated in a breast cancer diagnosis study should get every effective known treatment for breast cancer, because she made herself available for early diagnosis," said Nancy Dickey, MD, who headed the WMA working party to revise the declaration. "But the breast cancer study wasn't about treatment; it was about diagnosis," said Dr. Dickey, a former AMA president. "Ostensibly, the participant did not only take the risk, but she got a profound benefit in that she might have found the cancer at a curable stage. In my opinion, the wording 'identified by' would appear to be a more equitable solution, which says the population that is willing to undergo the trauma, the risk, the discomfort of the burdens of the study, should receive the benefit of the study."

She added that Dr. Greco's amendment could place such onerous duties on researchers that they might ignore the declaration altogether.

Dr. Greco's amendment did reach the WMA general assembly floor but failed after gaining the support of only a few medical associations.