Wednesday, May 21, 2008

FDA Eliminating Protections for Test Subjects

Recently, I've discussed the FDA's efforts to enforce a policy of pre-emption, which would prohibit lawsuits against manufacturers whose products had been approved by the agency. In doing so, I've stressed that the policy is extremely reliant upon the manufacturers being honest and employing scientific ethics with regard to testing and follow-up procedures.

Now the FDA is piling on, gutting rules governing clinical trials in foreign, usually developing, countries.

With 80 percent of clinical trials failing to recruit sufficient numbers of test subjects on deadline, drug companies increasingly export their trials to developing countries, where sick, undertreated patients abound. It’s faster, it’s cheaper, and it’s easier to conduct the placebo-controlled trials that companies and the FDA prefer. There is precious little oversight of these trials.

Unlike for domestic trials, the FDA does not require advance notice before drug companies take their trials outside US borders. And with 90 percent of trials failing to gain FDA approval, a massive number of trials are conducted, fail, and then vanish with no agency review at all—and little public record, if any at all.

Virtually the only thing currently regulating these overseas trials is the Declaration of Helsinki, when the FDA chooses to enforce it, which isn't often. Reading the rules, it's hard to imagine what objections the FDA could have. Essentially, it stipulates that participants must be volunteers and stand to benefit from their participation and that the research must follow basic scientific principles. Not all that stringent and, for the most part, common sense. Nevertheless, "the FDA has been agitating against the DOH since the late 1990s."

The FDA is replacing the deposed DOH with "Good Clinical Practice Rules." One can imagine how that might play out in the current environment:

Unlike Helsinki, which describes ethical principles agreed upon by the international medical community, GCP rules are bureaucratic regulations crafted by regulatory authorities and drug industry trade groups, behind closed doors.

One of the many running themes of the last 8 years. It's one thing to allow profit under an economic system. It's entirely another to allow it by taking advantage of uninformed poor subjects in developing countries and then foisting the products of those unregulated trials onto an unsuspecting American public which no longer has even the basic right to hold anyone accountable.

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