The way that prescription drugs are advertised on TV could be better, especially when it comes to communicating the risks and side effects of medicines. Now the Food and Drug Administration is calling for research into how the ads could be improved.
The problem, as Michael Wolf, a health services researcher and cognitive scientist at Northwestern University's Feinberg School of Medicine describes it, is that most ads work like this:
"There's a woman doing yoga in the park with her golden retriever and whether or not you need a particular medication, you have patients coming in to their doctor saying, 'Should I be taking x drug, because it looks good?'"
At the end of the ad, Wolf says, you get "a laundry list of possible side effects and warnings associated with use" delivered at a rapid-fire pace.
That rat-a-tat recitation of side effects has become a joke, says Dr. Steven Woloshin, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice.
He points to "Saturday Night Live" sketches, one of which features a fake drug to give women just one period a year. Among the long list of side effects that rolls out at the end, the ad says, "Do not take Annuale if you plan to ever become pregnant, as it may turn your baby into a fire-monster ... In the days around your period, you may develop a leathery tail."
This week, the FDA proposed a study to consider shortening the "major statement" — that's the long list of risks. In an email to Shots, an FDA spokeswoman points out that part is "often too long" or may not "include adequate risk information or leave out important information."
One proposal is to list only risks the FDA calls "serious and actionable" in TV ads, and then to point out in a generic way that there are other risks, too. The FDA is looking for public comments on the study, and researchers will finalize the study design afterwards.
Less information can be more
The FDA has been considering this issue for years, along with academics and drugmakers, says Northwestern's Wolf. He says the current proposal — cutting back on the information and referring people to more sources — is the way forward. Part of his research focuses on making prescription drug labels easier to understand, and he says the challenge is similar.
"It's almost the exact same thing we do to pill bottles. We try to cram as much as we can in a very small amount of space and expect people to get everything," says Wolf, who is also a member of the FDA's advisory committee risk communication. "When you do that, you end up losing everything."
He points to an earlier study he co-authored that found, among other things, that the order of information affects whether people remember it or not. From a list of five instructions on a prescription drug bottle, people tend to remember what they read first, and everything that comes after is less and less memorable. Wolf says this just gets harder if something is read very quickly, as is the case with drug ads on TV, so a shorter list makes sense in theory.
"You can imagine ... now instead of having to talk about eight things in 11 seconds, I can talk about two or three, then you can slow down your speech rate," he says. Speaking slowly can increase comprehension.
But some doctors say there are broader problems with drug ads that the FDA's research proposal wouldn't address.
This is advertising, not education
The Pharmaceutical Research and Manufacturers of America points out on its website that prescription drug advertising is meant to get accurate information about diseases and treatment options directly to patients. Yet, it doesn't work that well, says David Grande, who co-authored a journal article weighing the evidence for and against direct marketing of prescription drugs to consumers.
"Direct consumer advertising is really good at one thing and that's increasing the sale of drugs," says Grande, an assistant professor of medicine at the University of Pennsylvania.
He points out sometimes that can be good for undertreated conditions, but advertising can also lead to overtreatment. For example, a study using actors trained to pose as patients found that doctors are more likely to prescribe antidepressants if patients ask for them.
Grande says the ads need to do a better job of presenting risks.
"People need to really see some objective numbers about how valuable these drugs are and what kind of benefit they might have," he says. "Right now, benefits tend to be described in very emotional terms and that can make people overestimate how beneficial the drug can be for them."
Uncertainty or harm?
It's good that the FDA is studying a better way of advertising drugs, but it's not enough to make a difference, says Dr. Lisa Schwartz, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice. She says many advertisements feature new drugs, and there's often some uncertainty about how a drug will actually work, even if it has FDA approval.
For instance, she co-authored a recent article about two weight-loss drugs, that the FDA approved in 2012. Her article notes that although the drugs come with warnings about depression and heart disease, neither drug is actually marketed in Europe because of safety concerns. She says warning is very different from saying the FDA was worried about the effects enough to require further study of the drugs' risks after they hit the market.
FDA has encouraged doctors to report bad drug advertisements and marketing. Schwartz says that's not enough.
"By the time there are any complaints about an ad, it's already run its course and it seems like we don't have a very good monitoring system for this information," she says. "It relates to this general problem ... a reactive rather than a proactive situation around direct consumer advertising."