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Health-care reform: Consumer-friendly drug labels

Consumer Reports News: January 08, 2010 04:42 PM

Lawmakers are working— largely behind the scenes—at merging the health reform bills passed by the House and the Senate. There are many differences between the bills, with the “biggest” variations, like the public option or abortion coverage getting the most attention. But there are other differences that would impact a larger number of consumers. Among them is a provision in the Senate plan to make drug labels more consumer friendly by providing benefit and risk information in a table, or “drug facts box,” similar to a nutritional label on food products.

Currently, drugmakers write the information leaflets that you get with your prescription drugs based on information from clinical trials, but they’re rarely written in a way that’s easy for consumers to understand. Even the published trials don’t always present that information so clearly. And advertisements are required to list potential side effects, but may give a misleading picture of your actual risk. (See our AdWatch series for more on this.)

Take the sleep drug Lunesta. Ads for the drug say it works quickly, and “can give you and your restless mind the sleep you need.” But they don't say how well the drug actually worked in clinical trials, and neither does the drug label.

A sample drug facts box, (see chart, which you can click to enlarge) created by researchers at The Dartmouth Institute for Health Policy and Clinical Practice, does. The average user fell asleep just 15 minutes faster using Lunesta, rather than a placebo, and slept for an average 37 minutes more a night. And “Lunesta patients still met criteria for insomnia and reported no clinical meaningful improvement in next-day alertness or functioning,” report the Dartmouth researchers in a recent editorial in the New England Journal of Medicine. While the ads briefly mention a list of possible side effects, they don't say how likely it is that you'll experience them. The drug fact box does.

Would providing an informational drug box help consumers understand the benefits and risks of the drugs they are considering? The Dartmouth researchers have tested them in studies that clearly show that consumers really do have a better understanding of the drugs when reading a drug facts box. 

In a study published in 2009 in the journal Annals of Internal Medicine, the researchers tested 450 subjects on their comprehension of either print advertisements or drug facts boxes. The subjects were divided into groups that looked at two drugs for heartburn and two drugs to prevent heart disease. In each case the researchers had chosen one drug that was clearly superior.

In the end, 68 percent of those shown the drug facts box for the two heartburn drugs and said they would choose the superior drug, versus just 31 percent of those shown the advertisements. For the drugs used to prevent heart disease, 72 percent of those shown the drug box were able to correctly quantify the actual risk reduction of one of the drugs. Only 9 percent of those reading the print ad were able to do so, and the majority overestimated the benefit—65 percent of them by 10 times or more.

The Senate bill would require health authorities to test these labels and report their results to Congress. If successful, the new labeling could be adopted in about three years. But there's nothing to prevent the Food and Drug Administration from adopting them sooner. And an advisory panel for the FDA has recently recommended the agency adopt drug information boxes like these.

Consumers Union supports the measure. Whether drug fact boxes are implemented through health care reform or through FDA rulemaking, the evidence is clear: The information would help consumers choose the best medications to treat their conditions and avoid unwanted side effects. These simple reforms could contribute to better health care for anyone taking prescription medications.

—Kevin McCarthy, associate editor

Chart courtesy Dartmouth Medicine

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