US researchers call for drug labels to disclose lack of comparison with other medicines

The labeling information that comes with prescription drugs tells you what is known about the medication, but researchers from the Stanford University School of Medicine in the USA think it is high time that the labeling tell you what is not known.

The researchers want the US Food and Drug Administration to require drug manufacturers to state how new medications compare with similar, existing treatments. In many instance, they say, these statements would indicate that there is no evidence that a new drug is more effective than older ones. They believe this information would make patients and health care insurers less likely to pay for newer treatments without evidence that they lead to improved patient outcomes. It would also spur drug and medical device companies to design more informative clinical trials to test a new product's superiority over existing therapies.

Drug and device manufacturers benefit from an unacknowledged information gap that develops as more and more products are tested against placebo, but not each other, said Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center. Dr Stafford is the lead author of an essay that was published on-line August. 12 in the New England Journal of Medicine, calling on the FDA to require more informative labeling of new drugs and medical devices. His co-authors are Philip Lavori, professor of health research and policy, and Todd Wagner, health economist at the Veterans Affairs Palo Alto Health Care System and consulting assistant professor of health research and policy at the medical school.