How does drug advertising impact the health care of consumers? AP Seminar 2017 Word Count: 1397 Janie G. Kressman America is one of two countries where direct to consumer drug advertising is legal; along with New Zealand, who’s planning a ban.1 Direct-to-consumer advertising (DTCA) dates back to the 1700’s when drug compounds and patent medicines were printed in newspapers, but were often exaggerated or deceiving. Ever since then, DTCA has been an increasingly controversial issue. Proponents assert that DTCA informs and promotes consumers to seek medical aid. However, opponents presume that companies can be misleading or deceptive in their promotions. At the beginning of the twentieth century, drugs were classified as “ethical” and listed in the United States Pharmacopoeia (USP), which was regulated by the American Medical Association’s Council of Pharmacy and Chemistry, or as patent medications, that were made of unknown ingredients and not regulated. Then in 1914, the Federal Trade Commission (FTC) was created to regulate interstate advertising. The Wheeler-Lea Act of 1939 allowed the FTC to prosecute “unfair acts” aimed at customers.2 Because many consumers faced further issues with drug advertising, in 1969 the Food and Drug Administration (FDA) issued advertising regulations that required drug ads to be a true statement of information relating to the side effects, contraindications, and effectiveness.3 Before 1970, pharmaceutical advertising was aimed primarily at health professionals, not consumers. But, as the issue of misleading DTCA became more common and more cases reached the Supreme Court relating to consumers being misinformed, new legislation was required. It wasn’t until 1997, when the FDA required drug companies to list side effects on their ads. The presence of drug advertising for consumers has become increasingly prevalent in the last two decades, “Pharmaceutical advertising has grown more in the past four years than any other leading ad category,” said Jon Swallen, chief researcher at Kantar Media, a consulting firm that tracks multimedia advertising. DTCA can be beneficial for pharmaceutical companies, health care providers and consumers, however, sometimes ethical concerns are raised when the accuracy of these ads are examined. Consumer Benefits In 2002, the FDA conducted two surveys of patients, and one survey of physicians to evaluate the effects of DTCA on public health and doctor-patient interaction. These surveys explored patient and physician perspectives on DTCA as it relates to the overall healthcare experience. Findings indicate that DTCA has important positive and negative effects. The results of their research showed, “DTC advertising is very good at increasing awareness of products and may serve as stimulus for consumers to seek more information about their health and the drug product. Patients who asked about a specific brand of drug were more likely to be prescribed the drug they asked about, compared to patients who simply asked if treatment was available for their condition”.4 Thus, a number of people use DTCA to gain awareness about their health care options. Another consumer related outcome from DTCA is that positive advertisements can induce the placebo effect. Elizabeth Almasi and Dr. Randall Stafford, who’s study has been supported by a Stanford University Presidential Scholars Award and a research grant from the United States Agency for Health-care Research and Quality, are two supporters of this theory.5 The Harvard medical review says the Placebo Effect is, “The idea that your brain can convince your body a fake treatment is the real thing. The placebo effect is more than positive thinking — believing a treatment or procedure will work. It’s about creating a stronger connection between the brain and body and how they work together,” says Professor Ted Kaptchuk of Harvard-affiliated Beth Israel Deaconess Medical Center. Almasi and Stafford believe that if a patient sees an ad where a drug is improving one’s condition, then when the consumer takes the drug they will elicit positive connections and have prior expectations that can improve the effectiveness of the medication. When consumers lack background knowledge before taking a drug, they may not know what to expect, therefore, having accurate information about a drug is beneficial for the consumer’s treatment plan. What Consumers Don’t Know However, in opposition to the positive correlations of the Placebo Effect, Noble Prize winner, Dr. Peter Mansfield, has identified that heightened expectations from advertisements may lead consumers to believe that they should be taking that drug simply because they see a convincing ad for it, even if other medications or nonpharmacological interventions are available. Mansfield also believes that contemporary DTCA aims to persuade rather than inform, and he has found evidence from a content analyses study that the information provided is usually flawed and incomplete.6 Supporting Mansfield’s claim, an academic study by Dr. Faerber and Dr. Kreling that analyzed commercial segments of drug advertisements from 2008 through 2010 found that, only 33% of drug advertisements were objectively true, 57% were potentially misleading, and 10% were classified as false.7 They concluded that television advertising presents little information about harms or non-drug alternatives, and frequently include emotional and persuasive appeals. Misleading ads intended to lure consumers into purchasing a drug can convince consumers that a drug is beneficial for them even if it isn’t. With patients receiving biased information they feel like they know what’s best, which leads to patient-physician disconnect and lawsuits against pharmaceutical companies. In 2009 the FDA went after GlaxoSmithKline for online ads marketing its migraine medicine, but omitted potentially life-threatening side effects. In the same year drug maker Allergan, was also under fire for claiming Latisse would produce thicker lashes; but failed to mention dreadful side effects, including, hair growth outside the treatment area, a permanent darkening of eye color, bacterial infections, and blindness. Also in 2009, the FDA investigated Eisai, a company that claimed in a clinical study, Dacogen helped 38% of patients with a rare blood cell disorder. However, the FDA found that the real figure was much less impressive at only 20%.8 A study from researchers at Dartmouth College, in N.H., and the University of Wisconsin-Madison found that 60% of prescription drug ads and 80% of over the counter drug ads were found to be misleading or false. “The FDA doesn’t block or grant permission for an ad to air but instead reviews the ad once it’s live and notifies the drug companies when it spots an untruth”.9 The negligent enforcement of approving false or misleading ads before publication, has had an egregious effect on consumers. In 2011 a pharmaceutical company, Boehringer, was enticing consumers through a variety of media; however, there were 3,781 FDA reports of adverse events, including reports of severe bleeding, 542 patient deaths, and other side effects that led to an eruption of lawsuits.10 Boehringer, was only one of many companies that was forced to pay millions of dollars in lawsuits due to their misleading, exaggerated, or false ads. Drug company, Bayer spent millions of dollars advertising its IUD birth control; Mirena. Claiming it was perfect for busy moms because women didn’t have to worry about taking a pill every day. However, women faced side effects such as perforation of the uterus and infertility. According to Elizabeth Whitman, a Columbia University graduate, and writer for Modern Healthcare, “In 2016, Germany-based Bayer incurred impairment losses of $413 million in connection with the Essure device”.11 For millions of consumers, inaccurate drug advertisements have had serious, life-altering consequences; and even resulted in death. Therefore, DTCA can be the root of many health care issues that consumers face. Conclusion Although some pharmaceutical companies may promote a drug for the sole purpose of informing consumers, many drug advertisements aimed at consumers have been proven to be more persuasive than informative, misleading, exaggerated, or false. Michelle Llamas, whose work has been published in The Journal of Palliative Medicine and in an academic book review for Nova Science Publishers, found that 78% of patients understood drug benefits but only 40% understood the risks.12 Also, many consumers have misconceptions about the regulation of DTCA. Approximately 50%, thought that DTCA had to be submitted to the government prior to their publication; and 43% believed that only “completely safe” drugs were allowed to be directly advertised to consumers.13 To benefit consumers, physicians, and pharmaceutical companies, the FDA should regulate advertisements prior to their publication. By only publishing ads that are pre-approved by the FDA or AMA, it is probable that consumers would be better informed about the realities of certain drugs with less biased and false information.