More MS news articles for Aug 2001

BMA Criticises FDA and EMEA Objections to Helsinki Placebo Guidelines

LONDON (Reuters Health) Aug 29 - The British Medical Association on Thursday criticised objections raised by American and European drug agencies to the new Helsinki guidelines on the use of placebos in clinical trials.

The revised version of the Declaration of Helsinki, issued last October, states that wherever possible, new treatments should be tested against the best existing therapies rather than against placebo.

Both the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) believe this is unduly restrictive. FDA policy is to require a placebo control in most trials of drugs or medical devices. In a statement issued earlier this year, the EMEA warned that although the efficacy of some new drugs could be demonstrated without a placebo arm in the clinical trial, for approval of others placebo-controlled testing is essential.

Vivienne Nathanson, head of health policy at the BMA, told Reuters Health that the objections raised by the drug agencies are "really sad." She accused the agencies of interpreting the new guidelines much too strictly.

She explained that nothing in the Declaration specifically bans the use of placebo-controlled trials, adding that it is necessary to judge each proposed trial on its own merits. For example, she said, while it would be clearly unethical to test a new anti-hypertensive agent against placebo, it would be ethical to test a new drug for a self-limiting condition such as migraine against placebo.

Likewise, if an established treatment is far from ideal because of serious side effects, it would be ethical to test a new treatment against placebo.

Nathanson said she sees no need to redraft the guidelines but admitted there would almost certainly be pressure to do so at the next meeting of the World Medical Association, scheduled for New Delhi in October.

Copyright © 2001 Reuters Ltd