FDA Loosens Rules for Overseas Drug Trials

(MoneyWatch)  Merrill Goozner, a former Chicago Tribune reporter turned public-health advocate (he heads up the Integrity in Science Project at the Center for Science in the Public Interest), notes an interesting and almost wholly overlooked Food and Drug Administration decision that may have the effect of subjecting clinical-trial volunteers in poor nations to unwarranted risks. Assuming his take is correct, I have to agree that it's something of a scandal that the mainstream press, and even leading pharma bloggers, have so far failed to cover the story.

The gist is this: The FDA has formally abandoned a previous requirement that international drug trials must conform to the Helsinki Declaration, a human-rights accord that, among other things, requires clinical trials of new drugs to compare them to the best available existing therapy instead of a placebo -- i.e., nothing. It sounds abstruse, but as Merrill writes, it may have a big impact on the risks run by trial participants in the Third World:

[T]o the U.S. Food and Drug Administration and the drug industry, to which it had grown increasingly close over the course of the 1990s, [the Helsinki Declaration] contradicted its longstanding policy of only requiring trials showing that a new drug was "better than nothing," i.e., better than placebo, to win regulatory approval. If the drug industry were to closely adhere to the Helsinki Declaration, it would always have to run comparison trials if an effective drug were already available.

Rather than accede to international norms, the FDA and the U.S. government in the succeeding years lobbied hard to get the WMA to amend its rules. And it has, several times. For instance, it now allows use of placebo-controlled trials for less serious illnesses. But the basic guidelines protecting human trial subjects' access to best available therapies remained intact.

Now that the FDA has officially repudiated that standard, however, drugmakers are free to test new drugs against placebo or an inferior "local" standard of care. Worse, Merrill argues that the new rule will push more trials overseas, where the FDA won't be monitoring them by requiring their registration in a public database.

What will this mean for the concept of "informed consent" in a poor country? Imagine for a moment that you live on $2 a day in, say, Tanzania, and have high blood pressure. Since the disease isn't life-threatening, you skip buying the available anti-hypertensives being sold in the village pharmacy because you can't afford it. Now say you learn while visiting the village clinic that an international pharmaceutical company is recruiting patients for a clinical trial testing a new anti-hypertensive drug. If you join the trial, you may only get the placebo. But there's a 50-50 chance you will get the new drug, which hasn't been proven yet, but might work.

Are there risks associated with taking this new drug? Well, so far, none that the doctors think are serious enough to cancel the trial, but it says right on the form that something may turn up in the clinical trial in which you are being asked to participate. You sign up. After all, a 50-50 chance of getting a drug, that has a good chance of working (the drug industry wouldn't be here testing it if it didn't, right?) is better than no drug at all. And how much risk could it be, anyway?

Is that really non-coerced, informed consent?

Short answer: No, it's not. And the approach here is bad news for anyone worried about drug safety, ethical research standards, or both.