In Defense of the Helsinki Declaration

Author Sonia Shah on the Nation website blasts the Food and Drug Administration for repealing U.S. adherence to the Declaration of Helsinki and substituting the agency's Good Clinical Practice guidelines to govern clinical trials run in foreign countries. I'm glad somebody picked up on our story from last week.

One reader of that earlier story suggested researchers operating in developing countries must offer local standards of care to the comparison arm of a trial, and can't get away with only offering a placebo. But what are the local standards of care? A close reading of the FDA's 1996 "E6" guidance on Good Clinical Practice (see page 39) says only that the clinical trials must comply with "applicable regulatory requirements" in the local country.

You wouldn't have to be much of a lawyer to interpret that to mean that if the local standard of care was less than what was globally available (think about an expensive anti-cancer drug, for instance), or if there was no local standard of care, then a new drug being tested in a clinical trial could be compared to either a placebo or an older ineffective medicine and still be in compliance with the E6 Good Clinical Practice guideline.

There is much room for mischief in such guidelines, especially in poor countries with inadequate regulations and lax oversight bodies. Contract research organizations are popping up all over the world to conduct clinical trials for the global pharmaceutical industry. The U.S. should be helping these countries police those groups better, not passing regulations that will make it harder for them to protect their own citizens.