Direct-to-Consumer Advertising of Prescription Drugs: Vices and Virtues

Guest Writer: Dr. Ella Cortinas

It is impossible today to turn on the television, walk along the street, or turn on the radio without being subjected to multiple advertisements for prescription drugs. The United States pharmaceutical industry spent over $6 billion in 2018 on advertising prescription drugs directly to consumers. In the 1960s, regulations for drug advertisements were established by the Food and Drug Administration (FDA) to ensure no false or misleading information was provided to the public. Proponents of DTC prescription drug advertisements contend that the ads inform patients about diseases and possible treatments, encourage seeking medical advice, help remove stigmas associated with medical conditions, and provide needed sales revenue to fund costly research and development of new drugs. Opponents contend that DTC drug ads misinform patients, promote drugs before long-term safety-profiles can be known, medicalize and stigmatize normal conditions and bodily functions, waste valuable medical appointment time, and have led to our society’s overuse of prescription drugs. Ultimately, marketing campaigns select what information and by what modality the information is presented to the consumer. It is important to note that on a global scale, the only two countries where direct-to-consumer (DTC) advertising of prescription drugs is legal is in the United States and New Zealand.

A strong argument towards Direct-To-Consumer prescription drug ads is that it has encouraged patients to seek medical advice. A 2010 Prevention Magazine survey reported that 29 million patients talked to their doctors about a medical condition after seeing DTC prescription drug ads, leading to an increase in discussions about behavioral and lifestyle changes. The survey continued to report that these patients admit that they would not have otherwise discussed these issues with their provider. It was also noted that patients with lower incomes and education levels who were less likely to seek medical care in general were more likely to see a doctor after seeing DTC prescription drug ads. An FDA survey from 2013 found that 48% of doctors agree that DTC ads "inform, educate, and empower" patients. 18% of people responding to the survey said DTC ads reminded them to take their medications. DTC ads therefore are a positive gateway for patients to seek medical care, and to remain compliant with their respective prescription medications.

Another positive and substantial argument towards DTC is that these ads inform patients about diseases or medical conditions and possible treatments, and encourage patient compliance with treatment instructions. According to a 2004 FDA survey, 88% of the physicians who had patients ask about drugs seen in DTC ads reported that the patients had the conditions the drugs treat and were thus able to get treatment. The removal of stigma makes it easier for patients to acknowledge their health issues and feel more able to discuss problems with their physicians. The advertisements for Viagra, for example, have made male sexual dysfunction and treatment commonplace. Ads for drugs treating mental illnesses like depression have contributed to de-stigmatizing mental health issues. The de-stigmatization of these issues has allowed physicians to aid a greater number of patients, and has allowed for more open and honest communication between patients and physicians.

Furthermore, it is well established that medical research and development in the United States is one of the most advanced and competitive on the global market. DTC prescription drug ads create revenue for drug companies, which can be used for research and development to create advances and improvements in pharmaceuticals. Drug development is costly, and thus pharmaceutical companies are required to subsidize that expense through advertising. For every $1 spent on DTC ads, sales of prescription drugs rose by $4.20. Much of this revenue is returned directly to the research and development divisions of these companies. Pharmaceutical companies may therefore allocate more funds to pharmaceuticals that are less profitable or do research on more rare conditions that would otherwise not be feasible.

Inversely, there is a plethora of opposing arguments against DTC advertisements. A substantial and important concern is the underlying corporate aspect of pharmaceutical companies, which ultimately intend to sell a product and increase revenue for their shareholders. The most concerning of these arguments is that Direct-to-consumer drug ads misinform patients. In a 2013 survey, 63% of physicians believed DTC prescription drug ads misinformed patients and 74% of physicians believed DTC prescription drug ads overemphasized the benefits of the drugs. According to a study published in the Sep. 2013 issue of Journal of General Internal Medicine, 60% of claims made in DTC prescription drug ads aired from 2008 to 2010 "left out important information, exaggerated information, provided opinions, or made meaningless associations with lifestyles.” DTC drug ads are often above the recommended 8th grade reading level for mass-distributed information, meaning many consumers cannot understand the information presented. As well, most DTC prescription drug ads spend more time on benefits than negative side effects. A 2018 study published in the Journal of General Internal Medicine found that "few broadcast DTC ads were fully compliant with FDA guidelines," and that the "overall quality of information provided in ads was low." This raises the concern that many advertisements are orchestrated by marketing campaigns with the intent to sell a product rather than attempt to provide complete and factual information to the consumer.

Another concern is the safety and efficacy of the pharmaceutical drugs on the market. According to a 2013 survey, 68% of doctors agree that prescription drugs are marketed before safety profiles can be known. Although the FDA does not approve ads before they air on TV or radio, 50% of consumers surveyed thought DTC prescription drug ads were approved by the government. The lack of transparency can cause dangerous consequences for patients. Between the 1970s and 2014, at least 35 drugs were pulled from the market, most due to safety concerns.

The psychological aspect of DTC ads on the mental welfare of patients must also be taken into account. Many DTC prescription drug ads tell consumers that normal attributes, such as normal aging processes, are medical conditions which require drugs to remedy. DTC ads fuel the thought that normal conditions are "bad," resulting in the stigmatization of non-problematic conditions. Consequently, DTC prescription drug ads encourage over-medication: 81% of doctors surveyed in 2013 said that DTC prescription drug advertising promotes drug overutilization. Furthermore, DTC prescription drug ads tend to emphasize that drugs, as opposed to lifestyle changes, are needed to improve health. The “quick fix” and “magic pill” rhetoric leads patients to have unrealistic expectations of medicine and health, and tends to create a vicious cycle of needing more medications to fix the side effects of prior medications. Health care professionals may feel pressured by DTC prescription drug ads to prescribe drugs that may not be in the best interest of the patient. A pertinent example is a survey of practitioners for an article published in the Journal of Clinical Oncology, stating that 74% had a patient request an inappropriate drug, and 43% responded that they felt pressured to prescribe the inappropriate drug. This subsequently results in more prescriptions and less appropriate prescribing. 80% of doctors surveyed in 2013 thought DTC prescription drug ads weakened doctor-patient relationships. According to the 2011 article -”patients who are convinced by an advertisement that a drug will solve their problems often mistrust a doctor’s advice if the doctor suggests an alternate solution: “if a patient is denied the requested drug, the patient may stop thinking about the doctor as a learned intermediary and ignore important information from the doctor.” Many doctors complain that it takes a lot of appointment time to explain to a patient why a specific drug may not be the best or most appropriate option, instead of spending that time discussing appropriate treatment options, tests, screenings, and lifestyle changes.

The need for increased regulations and enforcement towards set policies is of the utmost importance. The FDA regulates DTC, but opponents say that the policies are too relaxed and inadequately enforced. Though the United States may be divided on this issue, it is important to look at these issues in a global context as well. The United States comprises 5% of the world’s population but accounts for 42% of global prescription drug spending. The World Health Organization (WHO) stated in 2000, "Advertisements to the general public should... not generally be permitted for prescription drugs”. In 2007, the WHO group on DTC prescription drug ads "made a unanimous recommendation to prohibit direct-to-consumer advertising." All other countries ban all forms of DTC prescription drug ads - with the small exception of Canada, which allows selectively limited forms of ads.

As the US strongly values freedom of speech, as well as the economic drive towards consumerism and capitalism, it would not be possible to transition towards policies that would ban all forms of DTC advertising campaigns. Mimicking the policies of Canada would likely be the most effective and accepted form of policy change in the United States. The Canadian FDA regulates DTC in 2 ways: it prohibits the advertising of any drug to the public as a treatment, preventive or cure for serious diseases, and it prohibits the advertising of prescription-only medicines (regardless of indication). It explicitly states that help-seeking and reminder advertisements, but not product claim advertisements, are legal.

Though the Canadian policy has many intricate nuances and factors that must be taken into consideration, the basic idea of allowing DTC with stricter guidelines and with stricter penalties for violations is what makes a limited DTC appealing. Changes such as these in the current US FDA would preserve the proponents arguments towards DTC (such as increasing awareness for diseases, encouraging patient-physician communication, reminders to take medications), while limiting the negative aspects that are of concern (notably misinformation and over-prescription).

Direct-to-consumer pharmaceutical advertising has grown exponentially during the past decades and is the most prominent type of health communication that the public encounters. Research suggests that DTC may be both beneficial and detrimental to the public health: both viewpoints can be supported with evidence, and may be seen as well-balanced. It can therefore be concluded that though there are many positive aspects to direct-to-consumer pharmaceutical advertising, the vices of such marketing campaigns may ultimately be to the detriment of the United States Public health - thus, change to current US policies to limit and control DTC, with stricter regulations on “big pharma” is needed to insure public safety and health.