Study wants FDA to mandate boxes that clearly state how well medication works
MONDAY, Feb. 16 (HealthDay News) -- People could make better decisions about which drug to choose if all ads carried a facts box clearly stating the medication's pros and cons, a new study suggests.
"People just don't have access to information about how well drugs work," said Dr. Steven Woloshin, an associate professor of medicine and community and family medicine at Dartmouth Medical School and co-author of the study. "They get exposed to billions of dollars of ads, but the ads don't tell them the most fundamental information they need."
A facts box would provide that information, Woloshin said.
Currently, drug advertising can be deceptive, Woloshin said. "For example, they say this drug reduces your risk of stroke by 30 percent, but they won't tell you 30 percent of what," he said. "That can be very misleading."
The U.S. Food and Drug Administration requires pharmaceutical companies to list the risks associated with a drug but not its benefits, Woloshin said. "But in order to make any sense of side effects, you have to know what's the benefit," he said. "Is it worth exposing myself to the chance of these side effects? You only can decide that if you know how well the drug works."
For the study, published in the Feb. 17 online edition of Annals of Internal Medicine, Woloshin's team conducted two trials to see what choices consumers would make when shown drug ads that did and did not include a fact box -- essentially a table that quantified outcomes with and without the drug. Participants looked at ads for two prescription heartburn medications and two cardiovascular drugs.
Overall, the researchers said, the addition of facts boxes to prescription drug ads resulted in consumers making better choices of drugs for their symptoms and being better informed about the benefits of drugs used for prevention.
When asked which drug they would choose for bothersome heartburn, for instance, 68 percent of those who had seen ads with facts boxes picked what the researchers referred to as "the superior drug," compared with 31 percent of those who had looked at ads without facts boxes. About 80 percent of the facts-box group, versus 38 percent of the others, realized that the side effects of the two drugs were similar, the study said.
After looking at the cardiovascular drug ads, 72 percent of those who saw ads with facts boxes correctly described the risk reduction associated with the drugs, the study found. Just 9 percent of those who saw the standard ads -- without facts boxes -- were able to do this, it said.
"The box worked really well," Woloshin said. "People liked it. They were able to understand the information, and they were much more likely to choose the better of two drugs with the box than with the standard ad."
The ads used in the study were for drugs that require a doctor's prescription and can't simply be bought directly by consumers, but that was appropriate, Woloshin said.
"There are studies that show that doctors will often give patients the drugs they are interested in," he said. "So patients are not having discussions about the benefits and harms; [doctors] are just acceding to the patient's request."
But having ads with facts boxes would allow people to have meaningful discussions with their doctors about which drugs would be best for them, "rather than just coming in influenced by a slick advertisement," Woloshin said.
"The FDA ought to be doing this," he said. "They ought to have these facts boxes on drug ads so people get creditable information on how well their drugs work."
A spokesman for the Pharmaceutical Research and Manufacturers of America (PhrMA), which represents drug research and biotechnology companies, said it is not opposed to giving consumers the data needed to make informed decisions.
"Consistent with recently updated guidelines, PhrMA is committed to a fair balance of risk and benefit information in all direct-to-consumer advertising," spokesman Greg Lopes said.
Dr. David L. Katz, director of the Prevention Research Center at Yale University School of Medicine, agreed that better informed patients make better drug choices.
"Direct-to-consumer drug advertising is controversial in medical circles, largely out of concern that drug companies will talk patients into preferences not in their best interest," Katz said. "But I often encounter the opposite problem in my patients. After hearing the litany of potential side effects of a drug, they absolutely refuse to take it."
For a truly informed decision, Katz said, people need information about both the benefits and the harms of a given drug, and the relative risks and rewards of taking it or not.
"This study addresses that issue and suggests that when patients are given more complete information about drug risks and benefits, they use the information well and reach better conclusions," he said. "I like the idea."
"Marketing drugs directly to patients may be fine, provided they are given enough information to make sense of their options," Katz said.
The Kaiser Family Foundation has more on direct-to-consumer advertising.
SOURCES: Steven Woloshin, M.D., associate professor, medicine and community and family medicine, Dartmouth Medical School, Hanover, N.H.; David L. Katz, M.D., M.P.H., director, Prevention Research Center, Yale University School of Medicine, New Haven, Conn.; Greg Lopes, director, communications, Pharmaceutical Research and Manufacturers of America, Washington, D.C.; Feb. 17, 2009, Annals of Internal Medicine, online
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