Shah: Closer Than You Think

Direct-to-patient advertising must improve significantly to be morally legitimate.

by Rachna Shah | 4/26/18 2:10am

Democrats and Republicans agree that change is needed in the pharmaceutical industry, whether it be via regulation or innovation. One of the areas often targeted in reform efforts is in the advertising of drugs, known as “direct-to-consumer” ads. In 2011, Pfizer spent 29 percent of its revenue on selling, information and administration expenses and only 13.5 percent on research and development. Despite the fact that television ads are dwindling in favorability among younger generations, they are still a prominent force in our society, as indicated by the amount of money allocated to them by pharmaceutical companies. While prescription drug ads can provide useful information to patients, their goal of promoting patient health is hindered by a lack of complete information.

In the late 1800s, vegetable compounds were advertised as a panacea for a variety of health complaints. Starting in 1905, such exaggerated drugs were differentiated from “ethical,” or regulated, ones. However, drug ads were exempted from product label regulation until the drug Elixir Sulfanilamide caused over 100 deaths in 15 states, leading to mass outcry and congressional action. The 1938 Food, Drug, and Cosmetic Act required new drugs to be proven safe before marketing, wherein safety was decided by the drug’s greater manufacturer. After further mishaps in the 1960s, Congress passed amendments giving regulatory authority to the Food and Drug Administration. From that point onwards, ads were required to include information regarding side effects and effectiveness.

Today’s popular lifestyle drugs developed in the 1990s, followed by a shift toward consumer-focused marketing by companies. After the American Medical Association asserted that drug ads could empower patients by providing sufficient information regarding personal health, DTC prescription drug advertising skyrocketed from $12 million in 1989 to $340 million in 1995. By 2000, every one dollar spent on advertising resulted in a quadrupled pharmaceutical retail sales increase. Today, drugs with DTC advertising are prescribed nine times as frequently as drugs without DTC advertising. Annual ad spending is approximately $6.4 billion in 2016.

One reason why this rise is dangerous is because pharma ads can misinform patients by promoting drugs before they are fully known. Drugs are most heavily promoted during the early stages of the product’s FDA approval cycle, before clinical trials can detect adverse events associated with the drug’s usage. For instance, in 1999, Merck used over $100 million to advertise Vioxx, a drug used to treat arthritis, making more than $1 billion in sales. Five years later, Vioxx was connected to a higher risk of stroke and heart attack. Vioxx is not alone; other drugs withdrawn from the market after health concerns were linked with them include Oraflex, prescribed for arthritis, and Propulsid, prescribed for gastric reflux. Such advertising incentivizes companies promoting newly developed drugs before full safety profiles are known. Forty-three percent of consumers believe advertised medications are “completely safe”: a false statement.

Even when important information is known about a drug, pharma ads may omit it. In one study of DTC ads, only 26 percent of ads described the treated condition’s causes and risk factors. As ads provide a thumbnail of a condition and a drug, the viewer may surmise that the drug is the only cure, omitting the importance of lifestyle changes in ameliorating a condition. Some ads even portrayed lifestyle changes as insufficient for controlling a condition. The words used in drug ads are predominantly qualifying terms such as “mild,” “usually” and “may,” which place usage of the drug as a benefit, rather than a risk.

A counterargument made in favor of DTC ads is that the accurate information provided by drug ads may be more important than any potential misinformation. For instance, DTC ads for statins, medications that reduce cardiovascular disease risk, have been shown to have overall positive effects on consumers by informing them about heart attack reduction drugs, potentially preventing costly hospital admissions that would otherwise have occurred. Thus, rather than banning DTC ads, the focus should be on upgrading their educational quality, such as through comparative effectiveness research. To further health literacy, empower patient decision-making and improve healthcare delivery and outcomes, DTC ads must improve, sooner rather than later.

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