Docs Propose New Info Box for Drug Ads

Feb. 27, 2009— -- What do you really know about the drugs you're taking?

Dr. Steven Woloshin and Dr. Lisa Schwartz of Dartmouth University say that the answer for many people is "far too little." And they hope that a new study, which they plan to present to the U.S. Food and Drug Administration today, will result in the addition of an easily comprehensible box of information on the benefits and risks of a drug to its direct-to-consumer advertisements.

In a report slated for publication in the Annals of Internal Medicine April 21, Woloshin and Schwartz study the effects of a "drug facts box" on consumer understanding of the medicine. The informational box outlines in plain terms the risks and benefits of a particular drug. It was printed on consumer-targeted advertisements for the drugs and displayed numerical tables that showed the benefits and risks of the advertised drug.

The researchers found that the consumers who received this additional information, on average, had a better understanding of the drug in question than those who did not.

"We think it is very important that consumers get credible, accessible information about how well drugs work and about their side effects," Woloshin says. "Otherwise, they really don't have the ability to participate meaningfully in important decisions such as, 'Do the potential benefits of this medication outweigh possible harms?'

"We think the net result of better information will be better decisions and better health."

Before Rollout, Mixed Reviews

Several experts say that having the extra information on printed ads would help consumers make healthier decisions.

"Most drugs only work for a fraction of people who take them and the benefits compared to placebo are often small," says Merrill Goozner, director of the Integrity in Science project at the Washington, D.C.-based Center for Science in the Public Interest. "Giving people easily understood information about the actual benefits of drugs could help offset the unrealistic expectations created by direct-to-consumer advertising."

Expecting Too Much From Facts Box

Goozner adds that such a system could also affect the way that doctors prescribe drugs. "This kind of information could also could encourage more rational prescribing by clinicians, who themselves are often unaware of the absolute benefits and risks of drugs," Goozner said.

Bruce Lambert, professor in the Department of Pharmacy Administration at the University of Illinois at Chicago, agrees that the additional info is a good idea. "The current format of drug ads does not always communicate this information in a way ordinary people can understand," he says. "The new format being proposed to FDA may have the potential to convey this type of information more clearly."

On the other side of the debate is Dr. Henry Miller of The Hoover Institution at Stanford University, who says that Woloshin and Schwartz are "dreaming" when it comes to the potential of such an informational tool.

"The estimation of a drug's benefits and risks is sometimes so difficult that experts on FDA advisory panels often disagree, and even experienced practicing physicians may be uncertain which pain reliever, antibiotic or statin to prescribe for a given patient," he says.

And Miller adds that information on the drug's approval is already available for those who care to see it; on its Web site, the FDA posts a "summary basis of approval" that includes both the data for the drug, as well as the FDA's rationale for approving it.

More Information = Less Drugs?

Then there is the question of whether additional information highlighting the potential harms of a drug, however unlikely those harms may be, would scare some consumers away from an effective and beneficial drug.

In an accompanying editorial to the new study, Dr. Jerome Avorn and Dr. William Shrank of Harvard Medical School in Boston, who are, in general, supportive of the idea of an additional informational box, nonetheless point out this concern.

"Respondents shown the innovative ads reported that they were less willing to take the statin or platelet inhibitor advertised, even when one was needed, a worrisome outcome," the editorial reads.

On the flip side of this argument, the numerical tables could help consumers understand the true odds of experiencing a side effect, reassuring them about a drug's safety. Listing such information could be seen as an antidote to the FDA-mandated flurry of risks and side effects common to most every prescription drug advertisement, which may deter some consumers from a needed drug.

Still, Lambert says he believes one of the better possible outcomes of such a strategy could be that consumers end up taking fewer drugs overall.

"Doctors must be much more conservative in their use of drugs, using non-drug therapies before drug therapies, using time-tested old drugs before new ones, discontinuing drugs that don't work, respecting patients' own aversion to risk, [and] starting only one drug at a time," he says.