Is this surprising? A new study finds that 39 percent of the public mistakenly believes that the FDA approves only extremely effective drugs and 25 percent believe the FDA only approves meds that lack serious side effects. What to do? The authors of the study, which appears in the Archives of Internal Medicine, urge the agency to improve the quality of information conveyed to consumers.
For now, though, the findings suggest that consumers "may not get the benefit from drugs they think they're getting, or they may expose themselves to more harm than they think," co-author Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice and the VA Outcomes Group, tells the Associated Press.
To test their hypothesis, the researchers created a pair of fictitious drugs for cholesterol and another pair for heartburn. Then, 2,944 adults were asked a few questions. For instance, they were asked which cholesterol pill they would choose if both were free and lowered cholesterol, but only one had shown evidence of reducing the risk of a heart attack.
And guess what? Seventy-one percent chose the drug that reduced heart attacks, but they did so thanks to a reminder that the other pill only lowered cholesterol. But among those who did not receive a cautionary message - "ask for a drug shown to reduce heart attacks or ask for one with a longer track record" - only 59 percent chose the better pill (read the abstract here).
As for the heartburn meds, the participants were told both were equally effective and also free, but one was approved by the FDA in 2001 and the other in 2009. In this case, 53 percent chose the older drug when given a warning about the newer med - "as with all new drugs, rare but serious side effects may emerge after the drug is on the market when larger numbers of people have used the drug." Among those who did not receive the warning, only 34 percent chose the older heartburn med.
"What can this warning-based approach teach us about improving prescribing? It depends on whether one sees the study results as a glass half-empty or half-full," writes Michael Steinman of the San Francisco VA Medical Center in an accompanying commentary (see here). "On the one hand, a simple warning improved patient decision-making. On the other hand, seemingly irrational decisions persisted to a striking degree."
How so? He notes one in three people chose a drug with no evidence of a benefit despite explicit instructions to ask for a drug known to offer a benefit. And half of the participants chose a newer heartburn med, despite directions to ask for a drug with a longer safety record. "It's not only patients who make such illogical decisions," he adds. "Physicians are equally well established in our proclivity to favor new, relatively untested medications and to prescribe contrary to guidelines." He tells the AP, by the way, that much of what docs learn about new drugs is affected by pharma marketing.
Woloshin tells the AP that the problem could be helped with fact boxes that are similar to the nutrition fact boxes on packaged foods. Presumably written in easy-to-understand language, these boxes would tell consumers how well a drug works compared to other drugs and include side effects. The AP reminds us that health care reform requires the US Department of Health & Human Services to report to Congress on evidence for fact boxes, but this will not happen for at least three years.