Education and Debate: Declaration of Helsinki should be strengthened -- For and against
The World Medical Association is debating the next revision of the Declaration of Helsinki which covers issues surrounding using patients in medical trials. This week's Education and Debate section in the BMJ carries for and against arguments over the morality of carrying out placebo controlled trials when there is an existing accepted treatment for a condition.
In a placebo controlled trial involving patients, some individuals receive the treatment under test, and others are given a placebo -- a chemically inert substance given in place of a drug. Professors Kenneth Rothman and Karin Michels of Boston USA argue that placebo comparisons are unethical if there is a demonstrably effective treatment as they would be denying this treatment to people in need of it. They write: "The Declaration of Helsinki explicitly forbids the use of a placebo group if an accepted treatment exists."
Professors Rothman and Michels argue that the World Medical Association is under pressure from the US Food and Drugs Administration (FDA) to revise the Declaration. The FDA, they write, requires many trials to include a placebo group. "The most glaring defect in the FDA's position is that scientific arguments, right or wrong, are placed ahead of ethical concerns" say the two Boston authors. They want to see the Helsinki Declaration strengthened and become universally acknowledged as "the inviolable standard for ethical conduct of human experiments."
Professor Michael Baum of University College London criticises the Boston authors for taking such an absolutist stance and suggests the issues are not as simple as they have suggested.
Contacts:
Professor Kenneth Rothman, Dept Epidemiology & Statistics, Boston University Medical centre, US Email: kRothman@bu.edu
Professor Michael Baum, Department of Surgery, University College London, UK