Declaration of Helsinki Abandoned

Earlier this year the FDA made a decision that would replace the Declaration of Helsinki (DOH), a system put in place in the 1970s by the U.S. and several other countries to govern drug trials on humans, with a system called Good Clinical Practice (GCP). http://www.thenation.com/doc/20080602/shah In charge of this new system is the International Conference on Harmonization which consists of drug regulators and pharmaceutical representatives from the U.S., EU and Japan. Instead of the standards set in place by DOH, which outlined principles emphasizing that “extreme care must be taken in making use of a placebo-controlled trial” where proven therapies exist, this new system practically allows pharmaceutical companies to dictate their own ethical rules in conducting experiments.

Though the DOH wasn’t a perfect system either, as it had undergone numerous revisions and had been characterized as being too vague, it was much less biased than the system in place now. The significance of this change is that the FDA will now permit pharmaceutical companies to conduct clinical trials in which the control group could be treated with placebos. Instead of old treatments being tested against new treatments, this change allows new treatments to be tested against placebos. This is a departure from the DOH which restricted the use of placebos ensuring that the patients would not be denied already proven life saving treatments. The argument for using placebo groups in less developed countries rests on the justification that those patients wouldn’t have access to traditional treatments anyway, so the placebo experiments are merely testing the new treatment against the existing “standard of care”—meaning no treatment.

It’s obviously unfair that trials which would never be conducted in the U.S. are being conducted elsewhere, but what worse is that this new system approved by the FDA allows pharmaceutical companies to conduct trials on their own terms. At least the provisions by the DOH provided that patients would obtain access to the study drug after the trials ended and that the communities in which the drugs were tested would likely receive benefits from the research—but the GCP does away with these restrictions.

It’s well known that lack of consent is common in poorer countries, but under this new system, there will be far less oversight on pharmaceutical companies than there was previously. I wouldn’t be surprised if many of these patients were coerced into these experiments due to lack of any alternative treatments. The lack of informed consent combined with coercion leads me to consider that much of what’s going on bears resemblance to the crimes perpetrated by those found guilty in the Nuremburg Trials.