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Commentary

WHAT'S NEEDED ON PRESCRIPTION LABELS
Steven Wolosin, Lisa M. Schwartz, The Boston Globe, 4-20-05

Doctors trying to understand prescription-drug labels are overwhelmed by a litany of potential side effects and disclaimers. Most often, the information provided by drug manufacturers and the FDA canít tell doctors what they really need to know: is this the right treatment for this patient?

Woloshin and Schwartz are proposing a change to drug labeling to help consumers and doctors: a box much like the nutritional labels now found on food packaging, that would compare the average benefits and risks to other medications commonly used for the same conditions.

If FDA wants consumers to have the information needed to make good choices, it should think outside "black box" warnings. Last year we tested consumer reactions to the benefit part of a Vioxx prescription drug facts box. Before seeing the box, fewer than 20 percent of people believed that Motrin was as effective as Vioxx for arthritis pain. After seeing the box, this proportion almost tripled. The 200 consumers in our study found the box easy to understand, and more than 90 percent preferred ads with a box rather than the standard version without it. If drug companies are allowed to continue direct-to-consumer advertising (the United States is one of two countries allowing it), they should have to provide a prescription drug facts box to tell consumers how much help they can expect from this drug and how big the benefit (or risk) is compared to others with more-established safety records.

Drug labeling is confusing enough for professionals, let alone consumers. But Woloshin and Schwartz miss the point: for an individual arthritis sufferer, Vioxx might provide better pain relief.

Drugs donít work on average, they work for individuals. Developing personalized medicineódiagnostics that help physicians match treatment to a patientís genetic background or particular disease stateóis the objective way to increase safety and efficacy. The reality is that any label, not matter how well meaning, is still just a statisticianís best guess. More guessing is not what we need.



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