Many consumers believe drugs do not receive FDA approval unless they are extremely effective and don’t have major side effects. At the same time, it’s a commonly held belief that new drugs are always safer than drugs that have been on the market for many years.
Neither is actually true.
Those were the findings of a national survey of 3,000 people undertaken by the Dartmouth Institute for Health Policy and Clinical Practice and the VA Outcomes Group. The results were published in the Archives of Internal Medicine this month.
The survey showed that four in 10 people believe the FDA approves only “extremely effective” drugs, and one in four mistakenly believes the FDA gives the nod only to drugs that don’t have serious side effects.
“These drugs get advertised so heavily, it’s easy for people to assume they are better or safer,” said the study’s co-author Steven Woloshin, professor of medicine, and community and family medicine, at Dartmouth College, as well as co-director of the university’s Center for Medicine and the Media. “But people over-interpret what FDA approval means. New, in a drug, often just means more uncertainty.”
Woloshin said the FDA approves a new drug when its benefits outweigh any known risks. This doesn’t mean the drug’s benefits are especially significant compared to drugs already on the market. And, he said, risks for some drugs appear only after they’ve been on the market for years. Consumers, in general, don’t know any of this.
The answer, believes Woloshin, lies in drug fact boxes, labels that would show up in drug ads and on drug packaging explaining in laymen’s terms how the drug stacks up when compared with others on the market. A section of last year’s healthcare reform law required the Department of Health and Human Services to review the evidence on drug fact boxes and file a report to Congress on whether to recommend requiring them. In its report, filed in March, the department said it needed at least three more years to come to a decision.
“That’s a strange position, given the body of published, peer-reviewed research showing that drug boxes improve consumer decision making,” wrote Woloshin and his colleague and co-author Lisa M. Schwartz in a New York Times op-ed piece in July.
To test the idea themselves, Woloshin and Schwartz included in their survey information on fictional drugs, two for heart disease and two for heartburn, and asked respondents to choose the better drugs based on the information given.
Participants were informed that both heart-disease drugs were free and both lowered cholesterol, but only one was known to reduce heart attacks. Not surprisingly, 71% chose the drug that reduced heart attacks when reminded in a warning the other one only lowered cholesterol levels. “It is not known whether it will help patients feel better or live longer,” the warning read.
When not given the warning, 59% made the better choice, said Woloshin.
Participants were then told that the fictional heartburn drugs worked equally well and were free, and that one was approved by the FDA in 2009 and the other in 2001. A caution read: “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.” Fifty-three percent chose the older drug after reading the warning, compared to 34% who chose the older drug when they did not receive the warning.
“The simple warnings made a big difference,” said Woloshin. “Twenty or 30 words improved the proportion of people choosing the better drugs.”
“Federal regulations already require disclosure of important side effects,” wrote Woloshin and Schwartz in their New York Times column. “But there is no rule about how this data should be presented, and no requirement at all to provide data on how well drugs work compared with placebos or other drugs.”
With the FDA putting off making a decision about drug fact boxes for now, Woloshin says others are likely to begin working on it. “It will be important to make this type of information available to consumers, independent of the FDA.”