"Trials on Trial"

My effort to call attention to the Food and Drug Administration's decision to withdraw from the Helsinki Declaration that protects people in clinical trials is finally starting to make waves. This week's Nature magazine (subscription required) editorialized that the FDA "should rethink its rejection of the Declaration of Helsinki."

The FDA argues that it should not be bound by Helsinki because of the declaration is devised by a group it does not control, and is subject to periodic revisions that could confuse trial sponsors or contradict U.S. law. But it is tempting to conclude that the FDA is dropping Helsinki not because it is changeable, but because the agency disagrees with the way it has been changing -- in particular with its constraints on the use of placebos.

And our earlier post received a trenchant comment from Abbey Meyers, the about-to-retire chief of the National Organization of Rare Disorders. She was a tremendous help to me when I was writing "The $800 Million Pill," and her thoughts on this subject deserve the wider notice that top billing for a few hours on this website gives them. So here they are:

Forget about Helsinki! What about the Common Rule? All federal government agencies that are involved in any way with clinical research signed on to the Common Rule EXCEPT THE FDA! They have not even had a bioethicist on staff until about three years ago when they hired one bioethicist. It's no wonder they approved clinical trials for the blood substitutes when human research protections were the last thing on their priority list, and it continues to be ignored not only in third world countries, but New York, Chicago, L.A., etc. And they wonder why fewer patients are volunteering for clinical trials!