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What a drug label doesn't tell you -- but should

August 12, 2009 |  2:00 pm

Labels The Food and Drug Administration requires a lot of detailed information on the labels that come with prescription drugs. But labels don't provide doctors and patients with information on how the medication compares to other drugs. That's a serious oversight that should be corrected, according to the authors of an essay appearing today in the New England Journal of Medicine.

When drugs are in development, they are usually compared with placebos and are ultimately approved because they are safe and more effective than the placebo. But studies typically don't test whether New Drug A is better than Old Drug B. Indeed, the fiercely competitive nature of the pharmaceutical business means that manufacturers often create "me too" drugs that are quite similar to existing drugs, say the authors of the essay, from Stanford University's Prevention Research Center. New drugs are typically heavily advertised and cost more.

"If the FDA label were required to indicate what is known and not known about a product's superiority to other treatments, clinicians, patients, and payers would likely be less willing to pay more for a new treatment without proof that it improved health outcomes," the authors state. And manufacturers would have an incentive to conduct comparison trials.

Labels should carry what the Stanford researchers call "comparative effectiveness" information. The labels could say something like, "Although this drug has been shown to lower blood pressure more effectively than placebo, it has not been shown to be more effective than other members of the same drug class," the essay suggests.

The drug development process is lengthy and expensive. But consumers deserve honest information about what is known and not known about medications.

"A few products will be breakthroughs that improve health outcomes; most will offer little, if any, advantage over existing treatment," the authors state. "At the time of FDA approval, it is rarely clear whether a new drug or device falls into the first or second category."

-- Shari Roan

Photo credit: Scott Olson / Getty Images

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