March 5, 2024

Double standard for US clinical ethics, activists allege

The US Food and Drug Administration wants one standard for research ethics at home and another for clinical trials in developing countries, health activists have complained. The FDA has proposed that investigations into new drugs in other countries need no longer comply with the Declaration of Helsinki, the international gold standard of research ethics. Peter Lurie, of the Public Citizen’s Health Research Group, and a Brazilian public health expert argue in The Lancet that this is another example of “arrogant” American exceptionalism. In developing countries, they allege, the FDA wants to use placebos for studies of treatable life-threatening conditions and does not want to supply effective drugs to all participants at the end of clinical trials.

The debate over research ethics echoes protests over American attitudes towards other international agreements. The Declaration of Helsinki, it seems, is too open to manipulation by anti-American groups. Amendments to the 1964 document are voted upon by 82 national medical associations. Government input is minimal because government agencies cannot be members. The US favours less exacting guidelines issued by the International Committee on Harmonisation. These are negotiated by the regulatory authorities and drug industries of the US, the EU and Japan.