Biomedical Research Disaster in the Making

An article in The Lancet states that for many years the US Food and Drug Administration (FDA) has required that foreign clinical studies supporting applications for drug licensure comply with the Declaration of Helsinki. However, on Oct 27, 2008, the FDA formally discontinued its reliance on the Declaration and substituted the International Conference on Harmonization's Guideline for Good Clinical Practice (GCP).

According to The Lancet article:

Requirements in latest revision of Declaration of Helsinki2 but absent in GCP6

• Investigators to disclose funding, sponsors, and other potential conflicts of interest to both research ethics committees and study participants
• Study design to be disclosed publicly (eg, in clinical trial registries)
• Research, notably that in developing countries, to benefit and be responsive to health needs of populations in which it is done
• Restricted use of placebo controls in approval process for new drugs and in research done in developing countries
• Post-trial access to treatment
• Authors to report results accurately, and publish or make public negative findings

The article calls for an immediate return to the old rule while the matter be reconsidered.

Comment: I agree with the authors that the new rule should be suspended untyil the Obama administration can reconsider the matter. The change, made by a Bush administration more interested in pandering to its (industrial) constitutencies than in protecting the public, creates undue risks for people in developing nations. It will also result in foreign policy problems for the United States. JAD