by Li Zha
Boston, MA has a very high concentration of biopharmaceutical companies and life science research. Residents in the area are bombarded by direct-to-consumer advertising of health care services and products even during their daily commute. On an average day, commuters can expect to see ads for clinical studies of depression or anorexia, as well as drugs that have just been approved by the Food and Drug Administration (FDA). Earlier in 2016, one of the most eye-catching of drug ads came on the scene—station-wide, cream-yellow murals that were installed at two subway stations in downtown Boston.
These wall advertisements, together with other marketing materials in wide circulation, are sponsored by Boston-area comany Alkermes, the manufacturer of Vivitrol, an FDA-approved drug for treating patients with opioid dependence. In the US, many pharmaceutical companies market new prescription drugs through direct-to-consumer drug ads. These ads lead consumers to ask their doctors for prescriptions of often expensive new drugs although existing options can be as effective and more affordable. According to American Medical Association Board Chair-elect Patrice A. Harris, M.D., “Direct-to-consumer advertising inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.” The US is one of the two countries in the world that allow such ads, and their contents are tightly regulated by the FDA.
However, despite stringent regulations, a significant percentage of consumers do not believe that drug ads include sufficient information about prescription drugs. In the National Cancer Institute’s 2011 mail survey 46% and 52% of 3,959 respondents were unsatisfied with the coverage of benefits and risks, respectively. Moreover, physicians are also disappointed in direct-to-consumer drug ads. In 2015 the American Medical Association has called for a ban of drug ads because they are believed to mislead patients and drive healthcare costs higher. To address these concerns, the FDA is working on revising the regulations of direct-to-consumer drug ads, in the hope that new regulations will help better educate consumers about the benefits and risks of prescription drugs.
How do drug ads convey risks to patients?
Ads for prescription drugs like Vivitrol are tightly regulated because perscription drugs can impose significant risks to patients. When patients pick up a flyer ad, they will immediately notice sprawling lists of risk disclaimers that are intended to inform them of medical risks. For example, Vivitrol’s disclaimer reminds patients to “[g]et emergency medical help right away if you have trouble breathing; become very drowsy with slowed breathing; have slow, shallow breathing; feel faint, very dizzy, confused, or have unusual symptoms.”
Risk disclaimers are required for direct-to-consumer drug ads. The FDA regulates these ads as rigorously as advertisements that target physicians and other healthcare professionals. Both must include a summary of side effects and effectiveness written in a neutral, non-misleading tone. Therefore, disclaimers of risks populate much of the ad space both medicine journals and brochures and signs that directly target consumers.
Whereas drug ads on paper may easily meet the requirement for risk disclaimers, how could ever-growing lists of warnings be broadcasted over radio or on TV without putting consumers to sleep? Having realized the infeasibility, in 1999 the FDA formally modified the disclosure requirement. In lieu of a full list, required were the major risks of the advertised drug and means for locating the FDA-approved package labeling. The latter was why consumers routinely heard “call 800-xxx-xxxx to find out more” or spotted hovering website links as a part of TV commercials. Ever wondering why so many drug ads dominate your TV screen after midnight? Only then could pharma companies find the cheapest hours for broadcasting risk disclaimers.
Have risk disclosures always been effective?
YAZ was once a popular birth control pill manufactured by Bayer, partly because it was advertised as the first multi-purpose option. “All birth control pills are 99% effective… but there’s one Pill that goes beyond the rest.” Displayed on TV screens were brightly colored balloons labeled with symptoms such as moodiness and acne. The balloons were released by several women, floated away, and disappeared into the sky, while the theme song “Good-Bye to you” was played in the background. The fast-moving visuals distracted the audience from risk disclosures and left the audience with the impression that YAZ could alleviate symptoms beyond the ones approved by the FDA.
The YAZ advertisements were powerful; however, consumers eventually started to complain about side effects and later severe cases of blood clots emerged. In 2008, the FDA stepped in and wrote a lambasting warning letter about two TV commercials for YAZ. They criticized Bayer for airing misleading TV ads that “broaden the drug’s indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug.” The third accusation associated with the distracting visuals was particularly scathing:
“The[se] complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed… The overall effect … is to undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that YAZ is safer than has been demonstrated by substantial evidence or substantial clinical experience.”
Bayer responded to the warning letter by terminating the commercials and running a corrective TV advertisement, and eventually updated the risk warning label on all YAZ packaging. In subsequent years the company has settled thousands of lawsuits on the ground of negligence as outlined in the warning letter.
The tale of YAZ highlights one of the most crucial functions of drug ads—educating consumers about risks associated with prescription drugs—and the detrimental outcomes when risks are not properly conveyed or fully understood. The case likely accelerated the proposal of a stricter rule in draft form in 2012. Six categories of television advertisements will need to be reviewed by FDA before they are shown to the public, including initial television advertisement for a new drug and an expanded use of a previously approved drug. Although it is unclear how the draft guidance will evolve into its final form, the FDA has already geared up toward improving the effectiveness of risk education through drug ads.
How can drug ads be improved to better convey risks?
In the National Cancer Institute’s 2011 mail survey, about 50% of respondents believed that drug ads should include more information about the benefits and risks of prescription drugs. In addition, consumers are more likely to find drug ads lacking if they are not equipped to comprehend information therein. The results imply that the format and content of drug ads should be modified to help patients better grasp the risks of prescription drugs. The question is how.
Currently, the Office of Prescription Drug Promotion Research at the FDA is conducting a series of studies on the effectiveness of risk education through drug ads. The office is studying whether the presentation of numbers or drug comparisons helps to illustrate risks, and exploring the utility of animation and web/ mobile technology in risk education. In the next few years, findings in the ongoing studies will guide the design and implementation of future drug ad regulations.
However, risk education should not stop at eliminating misleading drug ads. In the age of data overflow, consumers make decisions by integrating information they hear from drug ads, physicians, friends, patient advocacy groups with whatever they read on the Internet. Therefore, a balanced approach of risk education should go beyond improving regulations, and aim to help all consumers evaluate sources of information as well as discriminate their levels of credibility. Ideally, all patients should be able to locate credible information tailored to their needs. It is imperative that the FDA teams up with healthcare providers, pharmaceutical companies, and other federal agencies to provide accessible information about risk for everyone.
Li Zha is a fifth-year graduate student who studies how human gut bacteria impact cancer development.
For more information
On the regulatory history of direct-to-consumer advertising- Hutt, P.B. et al, Food and Drug Law: Case and Materials, 4th edition, pp915-923.