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It started back in September 2004, with Merck’s withdrawal of the prescription pain reliever Vioxx from the market, amid reports of increased risk of heart attack and stroke. While Pfizer kept its Cox-2 inhibitor, Celebrex, on the market, the drug manufacturer abided by the Food and Drug Administration’s request to cease advertising for it. Then came concerns over pediatric use of antidepressants and, most recently, a growing debate over the safety of AstraZeneca’s cholesterol-lowering medication Crestor. (For some, this may have felt like déjà vu — Baycol, another cholesterol-lowering drug, was pulled from the market for similar reasons three years ago.)
The headlines raise several important questions. Has the line between science and marketing been changed forever? Will we start to see a lag in new product acceptance and usage, while patients wait for post-marketing surveillance to uncover unexpected side effects? More importantly, how can healthcare consumers be expected to trust our educational and marketing messages when, as an industry, we can’t seem to agree on a product’s safety?
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Consumers weigh in on the topic
In November 2004, the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) released a timely report that sheds light on the changing view of DTC advertising. The report is based on two patient surveys conducted in 1999 and 2002, and one physician survey conducted in 2002 — well before the rash of negative publicity began. While the findings indicate that DTC advertising has important benefits, such as increasing awareness of diseases and treatments, encouraging patients to ask their physicians questions and helping them to ask more informed questions, it also noted potential negative effects, as well.
Both patients and doctors agreed that advertisements overstated the drugs’ efficacy and minimized their risks. Fewer patients in the 2002 survey, than in 1999, indicated that DTC advertising was useful in terms of their interactions with their doctors and their healthcare decision-making. Of those who said a DTC ad caused them to look for more information, 61 percent were specifically searching for information on side effects.
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Healthcare consumers need education
The percentage of respondents who reported they do not usually read any of the brief summaries in DTC print advertisement has risen from 31 percent in 1999 to 41 percent in 2002.
Source: FDA’s Division of Drug Marketing, Advertising and Communications
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 In fact, we may be reaching a saturation point when it comes to the availability of health information. The Internet has certainly played a major role in this evolution. Consumers have access to so much information, some of it conflicting, they often don’t know how to make an educated decision. Instead, patients tend to bring stacks of paper to their physicians and demand a particular prescription, sometimes just because a friend or family member is taking the medication. Almost half of the doctors surveyed by DDMAC reported feeling some pressure to prescribe drugs patients asked for as a result of DTC ads. Too much of the wrong information doesn’t necessarily improve the health status of the individual.
Managed care’s cautious position
Several of the large insurers, such as WellPoint, Premera Blue Cross and Kaiser Permanente, have been and continue to take a cautious position. New drugs typically need prior approval before a prescription is written or require a larger patient co-payment. Cost is one consideration; another is time to analyze additional medical evidence for safety. Their philosophy tends to be: Use the medication that is already known to be safe for the majority of patients — and also in the mildest dosage proven to be effective.
What’s unknown is how consumers, who appear to embrace new pharmaceutical products quite quickly, will do so when safety is called into question. Complicating this situation are low literacy levels among certain populations and language barriers by those who do not understand the information being communicated by drugmakers.
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The potential impact of DTC spending
According to TNS Media Intelligence/CMR, direct-to-consumer pharmaceuticals are the 10th largest industry category in U.S. advertising and contributed approximately $3.4 billion in 2003 measured media spending. Industry experts vary in their opinions as to whether the current media attention will dramatically change this trend. Perhaps there may be some hesitation at first, but consider what happened after Vioxx was pulled from the market. At first, Pfizer took advantage of this void by releasing an aggressive campaign that touted it was “no more, no less” than what you needed for joint pain. We also saw over-the-counter medications, such as Wyeth’s Advil, respond with an increase in advertising.
Not surprisingly, consumers may question the amount pharmaceutical companies spend on advertising in
comparison to what is spent on research and development — including premarket clinical trials that are designed, in part, to prevent drugs with adverse side effects from getting to market. Pharmaceutical Research and Manufacturers of America (PhRMA) reported that, in 2003, its member companies spent $35 billion on research and development, while the entire industry spent $25.3 billion on all combined drug promotion activities.
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Of $25.3 billion spent on drug promotion activities, $16 billion was spent on free samples that help patients start therapy right away, eliminating the need for a prescription in order to try a given medication therapy.
Source: Pharmaceutical Research and Manufacturers of America
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| The best prescription — and use of budget dollars — may just be patient-focused education. It should be written at a basic reading level and available in several languages, as well as different formats, such as ads, brochures, Web sites, CD-ROM and video programming. Presenting well-balanced information, clearly stating potential benefits and side effects, should help boost product and brand credibility. Consumers learn in many different ways and are influenced by a variety of channels. Only time will tell if the perception of DTC advertising is truly harmed by recurring negative press. |
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Maggie Smith, Product Manager at First Marketing, supports Healthy Solutions and (Pi) Patient Interaction with product development and market strategy. You can contact Maggie at msmith@first-marketing.com.
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