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Flip on your television to a commercial station and you are likely to see ads for cars, snacks, and home appliances—and prescription medications. Some ads specifically target psychiatric illnesses: Only this week, I saw commercials for Latuda®(lurasidone HCI), a drug used to treat bipolar depression, and Abilify® (aripiprazole), an anti-depressant. In 1997, the Food and Drug Administration (FDA) relaxed regulations surrounding direct-to-consumer-advertising (DTCA) of prescription drugs, opening the door for broadcast commercials on radio and television. Since then, the medical community has debated the safety of such practices and how these drug commercials might alter both patient and physician behavior. This practice is of particular concern with psychiatric disease, where patients may be more susceptible to the power of direct advertising to seek out drugs they may not need. But, as a new review by researchers at Brown University’s School of Public Health points out, relatively little research has been done—and more is required so we can better understand DTCA’s overall influence on prescription drug use when it comes to managing mental health conditions.
In the US, our favorite television shows and radio programs are flanked by dozens of different advertisements. They are so prevalent that we may think that we are immune to them, but study after study shows that they do subtly alter our thoughts and purchasing behaviors. DTCA of medications is no different.
“Pharmaceutical companies spend a lot of money on these ads. And consumers do pay attention. They are aware of these drug ads and, according to patient reports, they have influence on how patients interact with their physicians,” says Richard Kravitz, a researcher at University of California Davis Center for Health Services Research in Primary Care. “Studies suggest they encourage requests for prescription medications, and we know that those requests in turn influence physician behavior.”
That’s cause for concern, says Barbara Mintzes, a researcher who studies the effects of DTCA of prescription medicines at the University of Sydney in Australia.
“DTCA of prescription medicines is different from other consumer advertising in that the person who sees the ad cannot just go out and buy the product. They need to go to their doctor and ask for a prescription to receive it,” says Mintzes. “And that’s for good reason. These medicines have a prescription-only status because they have been judged to be too toxic, or have too poorly understood toxicity profile, for a person to use the medicine safely without the help of a professional. And as these medicines are often for very serious health conditions, it’s important to get appropriate care.”
The United States is one of only two countries in the world that permits DTCA of prescription drugs. To keep patients safe, the FDA has a specific department, the Office of Prescription Drug Promotion (OPDP) that has issued strict guidelines concerning the development and use of such marketing programs. For example, ads for prescription medications are required to provide a toll-free telephone number so that consumers can ask questions or request more information, to mention all serious risks and side effects, and to directly state that consumers should seek guidance from a qualified medical professional before taking the drug. Even so, it may not be enough to avoid harm, Mintzes says.
“These campaigns are part of a broader campaign to stimulate sales of the promoted product. And as all medicines are capable of leading to both benefit and harm, this kind of advertising may lead to situations where people are taking medicines when they are more likely to be harmed than helped,” she says.
Advertising to psychiatric patients
Psychiatric medications are among the most heavily advertised medications, says Sara Becker, a researcher at Brown University’s School of Public Health. People with psychiatric conditions may be more susceptible to the effects of advertising, she says, so it’s important that we better understand how DTCA may affect prescriptions and usage in managing mental health.
“These drugs are some of the first medications that achieved blockbuster sales status after the FDA relaxed its regulations in 1997,” she says. “But we really know very little about how this kind of marketing is influencing patients’ decisions and their interactions with their doctors.”
To that end, Becker and colleague Miriam Midoun conducted an exhaustive systematic review of previously published studies to gather what we know about any changes in behavior in response to DTCA of psychiatric medications. After scouring the literature, the pair found only four studies that met their criteria.
“We found a handful of studies that looked at survey data about people’s attitudes toward DTCA, both patients and physicians, to see if they feel favorably, or if they think it will affect their behavior,” she says. “But there was very little concrete data that looked at behavior in real time. I was surprised at how little data there was, really.”
Becker says that across those four studies, some of the findings were consistent. “There is evidence that people actively requesting a medication they saw on TV or heard on the radio did seem to increase prescribing. That is, the sheer act of asking for medications resulted in more prescribing,” she says. “And that could be a good or a bad thing. If a person is seriously depressed and needs help, they were more likely to get the medication they needed. But if a patient asked for a medication who maybe didn’t meet the full criteria for depression and shouldn’t have gotten a medication, they were likely to get it as well.”
The results were published in the Journal of Clinical Psychiatry in September 2016. What Becker hopes people will take away from the study is the lack of comprehensive empirical studies examining this issue.
“This is not a black-or-white issue. The data suggest that DTCA may result in some at-risk patients getting the help they really need, but in over-prescribing for patients that don’t need those medications,” she says. “It’s a difficult thing to reconcile without more rigorous studies.”
Addressing the lack of studies
Becker says she isn’t certain why there aren’t more studies on DTCA being conducted. She says one possible explanation is a drop in public interest. “Interest in evaluating the effects of DTCA was greatest in the years following the change in FDA guidance,” she says. “And it seems that interest has declined as the new guidance has become the new norm.”
To date, the National Institute of Mental Health (NIMH) has not participated in research in this area regarding psychiatric medications—and spokesperson James McElroy says “there is none on the horizon.” A spokesperson from the FDA’s OPDP, Brenda Rose, says that the program does have an “active research program designed to investigated applied and theoretical issues in the communication of risk and benefit information in DTCA and professional prescription drug materials,” and outside studies are evaluated as they are published.
But while he agrees that more studies should be conducted, Kravitz says it is very difficult to design good studies to look at the effects of DTCA.
“A lot of the really critical variables are really hard to measure in the natural environment,” he says. “You can ask patients, you can ask clinicians, or you can directly observe what’s going on. No matter which approach you take, it’s only in a minority of visits where you see some kind of request and an even smaller minority in which these requests for DTCA drugs are made. So you need to make a lot of observations in order to pick up trends. It’s very difficult research to do. And it’s very resource-intensive, expensive research to do.”
Pharmaceutical corporations likely have studies looking at the effects of DTCA, Mintzes says, but these studies are not available to the public. It is also difficult to get funding to look at the influence of advertising and promotion on prescription drug use, but she hopes that medical community—including the psychiatric community—finds a way.
“We don’t have direct evidence about health effects on a broader scale. And there are reasons to be concerned based on the history of DTCA to date,” she says. “One is the role of advertising in shifting people’s perceptions of the threshold of normal life and a psychiatric condition that might respond to drug treatment. They blur the distinction between sadness as a normal human emotion and a major depression diagnosis. It’s a concern if they are being overprescribed. One, because some psychiatric medications are difficult to stop using. And that many ads target women when there is good reason to be cautious about exposure in pregnancy.”
Becker agrees—and hopes her review will inspire more research to make sure we are better serving patients with mental health conditions. “What we found is a rather mixed bag of results,” she says. “And they have some pretty profound public health implications—things that we need to better understand so we can make sure we are better helping patients.”