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
UNINFORMED CONSENT?: Some trials performed after treatments are approved fail to inform participants that one or more of the treatments being tested might have more serious side effects than they realize.Image: iStockphoto/monkeybusinessimages
Say you have high blood pressure. There's a new blockbuster drug on the market, and your doctor lets you know about a new clinical trial you can join that is testing the new treatment against an old tried-and-true one. What's not to like? You're going to be taking, under the care of experts, one of two U.S. Food and Drug Administration–approved medications.
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./.../
No comments:
Post a Comment