Tuesday, May 06, 2008

The FDA ditches the Declaration of Helsinki

As it has been threatening to do for years, the Food and Drug Administration in the United States has finally abandoned the Declaration of Helsinki as ethical standard to be used when evaluating data from clinical trials conducted abroad. But let us back up. Getting FDA-approval for a new tested drug is a big deal: you can make big money this way. But to do research in the United States on a new drug, you first have to submit an application for an investigational new drug (or IND). You can get around this by conducting your clinical trial outside US soil, and then seek FDA approval for the tested drug by submitting a new drug application (or NDA). Up to now, the FDA required that studies submitted in support for an NDA should have been conducted in a manner consistent with either with the Declaration of Helsinki or local laws, whichever is more protective of the participants in the trial. Now the FDA has changed that requirement: it is now enough that the foreign-based trial be conducted according to the Good Clinical Practices (GCP) of the International Conference on Harmonization.

So what is the difference? Someone with a stronger stomach than my own could go through the Declaration of Helsinki and GCP point by point, and try to discern every little ethical difference. Or look at the Federal Register, and evaluate the myriad justifications made by the FDA in favor of the change. For those unable, unwilling or uninterested in going through this regulatory potpourri, let me cut to the chase: the GCP overall is less ethically demanding than the Declaration of Helsinki, and thus encourages the outsourcing of clinical trials in developing countries in a regulatory atmosphere more supportive of pharmaceutical interests than protective of research participants or communities. As some commentators have pointed out, the FDA (and the pharmaceutical companies with whom it often shares beds) was never enamoured of the section in the Declaration of Helsinki that stated that a new drug should be 'tested against the best current prophylactic, diagnostic and therapeutic method', since that would limit the possibility for placebo-controlled trials. That is why GCP is apparently more attractive to them: it does not have any such requirement. Not only that: the GCP does not (unlike the Declaration of Helsinki) contain anything about conflicts of interest, the need to publish results, or post-trial availability of the tested drug to study participants or communities. In the end, GCP is ethics-lite.

The Declaration of Helsinki has its own problems, not the least of which are problems of ambiguity in its language and limited enforceability. But even its most uncharitable critic can see that the document has an ethical backbone. What impact the FDA's decision will have on clinical trials around the world remains to be seen, but the decision would seem to encourage pharmaceutical companies to cut ethical corners when working abroad.

8 Comments:

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I can just imagine how much it is to test a new drug in the USA! Winstrol

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