Do Post-Market Drug Trials Need a Higher Dose of Ethics?

Patients who sign up for trials testing more than one already approved intervention do not always know if one is being tested for harmful side effects

By Katherine Harmon
Scientific American
Originally published August 23, 2012

Here is an excerpt:

What you might not know—even after you sign up for the trial and have inked the informed-consent form—is that scattered reports are starting to suggest that the new medication might occasionally cause severe side effects. And the real reason the trial is being conducted with these previously released drugs is to test whether the new medication really is a lot riskier to everyone or just to a subset of patients.

If you found that out, would you still sign up for the trial? The problem is that many patients—and often even the institutional review boards that approve the trials—are never informed of these lingering questions.

This is one of the big ethical holes often left open in post-market trials, says Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics, who co-authored a new essay on this topic in The New England Journal of Medicine, which was published online August 22. She and a team of co-authors released a formal Institute of Medicine (IOM) report earlier this year recommending that the FDA improve this and other ethical aspects of post-market trials—especially those it requires.

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