A "surprisingly" high number of Americans misunderstand the effectiveness of various types of medication and the side effects of drugs approved by the Federal Drug Administration, according to Lisa Schwartz, professor of medicine at Dartmouth Medical School.
In a Sept. 12 study in the Archives of Internal Medicine, Schwartz and her husband Steven Woloshin, also a professor of medicine at DMS, found that of 2,944 randomly chosen participants, 39 percent believed that the FDA only approves "extremely effective" drugs and 25 percent thought that the FDA only approves drugs without serious side effects. Both of those assumptions are false, according to the study.
FDA approval of a drug is based on whether that drug is shown to improve a health outcome better than a placebo, Mike Steinman, professor of medicine at University of California, San Francisco, said. The new drug does not have to be more effective than a drug that is already on the market, according to Steinman, who wrote a commentary on the study.
"The real question is not whether a drug is FDA approved, it's whether it's better than all the other available drugs," Steinman said in an interview with The Dartmouth.
Steinman, like Schwartz and Woloshin, advocates that patients be proactive in discussing prescription drugs with their doctors.
In the study, which was conducted in 2009, Schwartz and Woloshin examined how informational drug labels affect patients' ability to choose between prescription drugs.
In the first round of their experiment, Schwartz and Woloshin asked participants to choose between the vascular disease drugs Cholestat and the fictional Questor. The subjects were all told that both drugs were approved by the FDA Cholestat for its ability to lower cholesterol and Questor for its ability to reduce heart attacks.
Participants who received additional information about the drugs were more likely to select Questor, the better choice between the two for addressing vascular disease, according to the study. Of participants who received no additional information, however, 59 percent selected Questor. The addition of an informative label also increased the likelihood that participants would choose the better drug in a given situation, according to the study.
In the second round of the experiment, Schwartz and Woloshin asked participants to choose between fictional heartburn drugs Paxcid and Otherdrug. They were told that both drugs were equally effective and had the same side effects, but Paxcid was newly approved by the FDA, while Otherdrug had been approved eight years ago. In this case, Otherdrug was the better choice because it had been available to the public longer and therefore did not carry the inherent unknowns that a new drug like Paxcid might, according to the study.
Of patients who were told "it takes time to establish the safety of new drugs" or advised to "ask if there is a drug with a longer track record that you can use," 53 percent selected Otherdrug. Only 34 percent of patients who were given no additional information, however, selected Otherdrug.
Schwartz said she was not surprised that many participants chose the newer drug over the older, more reliable one.
"People think that anything that is new must be better, but with drugs, that's just not true," she said. "But I am surprised that even after being told that new drugs carry inherent risks of rare side effects, people still chose the new heartburn drug."
Schwartz and Steinman both cited large drug companies' marketing campaigns as the driving force behind both doctors' and patients' tendencies to choose new drugs over older ones.
"[Advertising] has a very powerful effect," Schwartz said. "Drug companies spend $4 billion on advertisement a year. The fact that this spending continues to be sustained tells you that it's effective. It's hard to expect that one sentence in a survey will have a huge effect, clearly we're competing against bigger attitudes promoted by consumer advertisement."
For the past nine years, Schwartz and Woloshin have been trying to work with the FDA to change the information provided in drug advertisements and included with prescriptions, Schwartz said.
The Obama administration's health reform law includes a provision requiring prescription drugs to include quantitative summaries about the effectiveness of drugs and their potential side effects, according to Schwartz.
Sens. Jack Reed, D-R.I., Jeanne Shaheen, D-N.H., and Barbara Mikulski, D-Md., recently wrote letters to Congress emphasizing the importance of including such quantitative summaries and asking the FDA to speed up its adoption of the recommendation, Schwartz said. As of yet, no such steps have been taken, she said.
In his commentary on Schwartz's and Woloshin's study, Steinman said that including informational drug labels was only the first step towards patients making more informed decisions when selecting prescription drugs.
"We need better systems for helping patients to learn how to talk to their doctors," he said. "It's not just enough to give people information. I think it's good to have a conversation about medicine with your doctor."
Steinman advised patients to look for background information about drugs from reputable sources on the internet that provide "consumer-friendly information about drugs," such as Medline Plus's website.
"I think it's an issue of working through practical issues," he said. "We're working in a complex economic environment. Drug companies may not benefit from giving patients more information and won't want to change."
