The United States and New Zealand stand alone among developed countries in allowing direct-to-consumer advertising (DTCA) for prescription drugs on television, in magazines, and online.
Supporters of this practice argue that such advertising is beneficial to public health in that it educates consumers on common conditions and available treatment options and empowers patient engagement in health care decision making. But many public health experts point out that the negative consequences of DTCA include escalating drug spending, an oversimplified understanding of illness and treatment, a devaluation of preventive health behaviors, and inappropriate hype for drugs that may have incomplete safety profiles.
Researchers have found that consumers tend to believe that the safety and efficacy claims made in U.S. drug advertising are reliable because this advertising is regulated by the Food and Drug Administration (FDA). However, pharmaceutical companies do not have to submit advertisements for prior FDA approval, and many advertisements give inadequate data on a drug's safety or cost or efficacy.
In addition, many of the most heavily advertised drugs are newly developed and little evidence exists about their long-term safety. In more than one case, an aggressively marketed drug has later been recalled or withdrawn from the market owing to emerging adverse effects, or has had a black box warning added to its packaging.
DTCA may also have the effect of undermining preventive health behaviors in favor of using medications to treat many common conditions and diseases. Frosch and colleagues, writing in Social Science and Medicine, have argued that the presentation of information in advertising may mislead consumers who lack adequate health care knowledge to believe they have inherited conditions such as high cholesterol or type 2 diabetes, when in many cases poor diet and inadequate exercise are equally or more important contributing factors. In such cases, consumers may conclude that only prescription drugs can prevent or manage these conditions.
While DTCA can encourage consumers to communicate with their health care providers about medical problems, it may also lead to the treatment of risk factors as diseases. For example, research published in 2013 by Niederdeppe and colleagues into the use of statins as a primary prevention strategy among consumers at low risk for cardiac events found that exposure to statin advertising was associated with increased diagnoses of high cholesterol as well as medication use.
And there may be a snowball effect to such consumer engagement. While DTCA is well known to increase prescription requests, Dieringer and colleagues found that consumers who took five or more prescription drugs reported a much higher level of responsiveness to DTCA than those who took none.
While many consumers believe the information they get from DTCA helps them to take a more active role in their health care, a survey by Polen and colleagues published in Health Marketing Quarterly suggests that not all consumers have the necessary background and knowledge to accurately interpret this information. Twenty-seven percent of consumers reported that DTCA left them confused about the medication being promoted and nearly 18% stopped taking medications after the mention of the drug's adverse effects-a worrisome finding, since discontinuing prescribed medications can lead to serious and even life-threatening consequences.
Another consequence of DTCA may be an increase in the costs of popular drugs. Law and colleagues, writing in the Archives of Internal Medicine, found that during the first four years of DTCA for the drug clopidogrel, the number of prescriptions did not increase-but Medicaid programs spent an extra $207 million purchasing the drug.
In light of the potential harms that likely accompany any benefits consumers may gain from DTCA, the FDA should consider more stringent regulation of this type of advertising or its complete ban.