Next step: Create the demand

Direct, emotional ads for prescription drugs are everywhere. But they're just one way to get to the consumer.

By Melissa Healy
Los Angeles Times Staff Writer

August 6, 2007

WITH vast and profitable markets up for grabs, drug companies are aggressively reaching beyond doctors and taking their marketing messages directly to consumers.

Some of their promotional strategies have become hard to miss. Nightly news broadcasts -- a beloved habit for aging Americans -- are brought to you by the makers of prescription medications for high cholesterol, arthritis, Alzheimer's disease and erectile dysfunction; an Internet search for a specific symptom, or a visit to any popular health site, will bring up sponsored links and blinking ads for at least one prescription medication used to treat that symptom; fans of NASCAR see Viagra advertised every time No. 6 Mark Martin's car rounds the track. And women paging through a magazine for tips on reducing clutter can scarcely avoid the faces and personal stories of actresses who are managing their depression, osteoporosis or hot flashes with a brand-name pill.

In 1997, the FDA loosened regulations governing the advertisement of prescription medications directly to consumers. The change set off explosive growth in marketing aimed at a general audience long on interest and -- compared with physicians -- short on professional skepticism. Today, drug makers spend roughly $5 billion a year to run advertising campaigns that use many of the same appeals that marketers use to sell breakfast cereal and toothpaste.

A study published in the Annals of Family Medicine's January-February issue analyzed the messages of 38 advertisements then running during prime-time TV and found that 95% used emotional appeals to sell the medication, often framing prescription-drug use as a means to regain lost control over some aspect of life. None mentioned lifestyle change as an alternative to product use, although roughly 1 in 5 advertisements suggested it might be a useful complement to the drug. One in 4 described the causes of the disease the advertised drug treats, who is at risk for it or how frequently the condition occurs in the population. The study's authors, led by UCLA researcher Dominick L. Frosh, suggested that without such information, consumers would have little reason to see prescription medication as a solution that involves risks as well as possible benefits.

In all, 58% portrayed the advertised drug as a medical breakthrough -- a pharmaceutical twist on Madison Avenue's "new and improved" message.

"It is time to ban direct-to-consumer advertising of prescription drugs," wrote Dr. Kurt Stange, editor of the Annals, in an accompanying editorial. The advertisements consumers see "distort the relationship between patients and clinicians. [They] manipulate a patient's agenda and steal precious time away from an evidence-based primary care clinician agenda that is attempting to promote healthy behavior, screen for early-stage treatable disease and address mental health."

Even after 23 major pharmaceutical companies agreed to a new slate of voluntary guidelines limiting their advertising, Stange wasn't buying it. Self-monitoring, he wrote, "is not working . . . and cannot realistically be expected to work."

PhRMA, the drug manufacturers' industry group, says direct-to-consumer advertising empowers patients to take an active role in their healthcare and spurs them to discuss symptoms, diseases and treatment options with their doctors that might otherwise go unraised. The industry group frequently cites a 2002 survey of consumers that found that 43% were spurred by a prescription-drug ad to look for more information about the drug or their health.

Although direct-to-consumer advertising has spurred the most political and professional debate, it is only the most visible means of prescription-drug marketing aimed at the consumer. To build markets and encourage consumer loyalty to their products, drug makers have invested heavily in a tactic known to public relations professionals as "third-party marketing." Through voices, groups and activities that seem independent of them -- but frequently are not -- drug companies have found another way to get their messages to consumers.

'Third-party' approach

ACCORDING to an article published in the British Medical Journal in 2003, the top five public relations firms specializing in healthcare earned $300 million in 2002. These firms "are expert at 'third-party technique' -- helping the drug industry separate the message from what could be seen as a self-interested messenger," wrote authors Bob Burton and Andy Rowell.

Last October, a commentary in the New England Journal of Medicine detailed one little-noticed third-party marketing venture. Underwritten by Eli Lilly, the campaign was designed to increase the use in hospitals of a drug commercially known as Xigris, for the treatment of sepsis, or blood poisoning. A preliminary study had suggested some safety concerns with Xigris, and an FDA advisory panel had urged more thorough study of the drug before its approval. But in 2001, the FDA approved its entry into the market. The controversy appeared to sap first-year sales of Xigris, which fell short of Lilly's expectations.

Lilly's response was to secure the services of a small public relations firm, New York-based Belsito and Co. Belsito would begin spreading the word to physicians and media outlets specializing in medical news that Xigris was being rationed and that physicians were being "systematically forced," because of the drug's high cost, to decide which patients would live and which would die. A $1.8-million educational grant from Lilly would fund the creation of a group of physicians and bioethicists -- named the "Values, Ethics and Rationing of Care Task Force" -- to study this rationing and its ethical implications. And a Surviving Sepsis campaign was launched "in theory to raise awareness of severe sepsis and generate momentum toward the development of treatment guidelines," wrote Dr. Peter Q. Eichacker and two fellow investigators based at the National Institutes of Health, in the NEJM.

Lilly's financial inspiration of the campaign aimed at physicians, patients groups and the media was not apparent to many of the audiences reached. But its effect was quite clear, concluded a case study of the campaign done by the Council of Public Relations Firms: Sales of Xigris "have begun to trend upwards. Through the first quarter of 2004, Xigris sales were up 36%."

In such campaigns, public relations companies operate as off-site extensions of a drug company's marketing department. But sometimes, the relationship of a drug company and a third-party voice is more complex. The tie between patient-advocacy groups and drug companies is a good example.

Drug makers richly support the nation's proliferating patient-advocacy groups, and only a handful of the charitable organizations refuse the sponsorship of pharmaceutical firms, says Georgetown University's Dr. Adriane Fugh-Berman, who has studied these ties. That link presents rich marketing opportunities for corporate sponsors with an interest in reaching the patients the organizations advise and represent, Fugh-Berman says. But it also raises real questions about the independence of patients groups, she adds.

In marketing trade publications, the value of patients' groups is widely touted. As friends and allies to potential customers, groups dedicated to patients who suffer from a specific condition can be powerful marketing tools. Patients seek information and emotional support from these groups, and trust them as an unbiased source of advice. Groups that empower patients to seek treatment are eager to foster awareness of their disease and, in the process, expand their membership. When they are successful, patients groups have a natural market-building effect.

But drug makers have the deep pockets, and patients groups -- until they're very large and well-established -- are constantly scrambling for money. As a result, according to those calling for reform, the relationship is not always an alliance of equals.

"There's an inherent conflict of interest," says Merrill Goozner, editor of Integrity in Science, a publication of the Washington-based watchdog group the Center for Science in the Public Interest. "The question becomes, 'Are you doing the best for the patients you represent, or are you doing the best for your sponsors?' "

Goozner says that patient-advocacy groups are especially vulnerable to carrying drug companies' messages, untempered by skepticism, directly to their members. "They're desperate" for a cure or treatment, he says. "And no one likes to be told that this latest breakthrough is not all it's been cracked up to be," especially when it's being pushed by a company that's been generous with funding, he adds.

Last October, the magazine New Scientist published a survey gauging the dependence of randomly selected U.S. patients' groups on drug manufacturers. Combing through the tax returns, annual reports and voluntary disclosures of 29 nonprofit patient-advocacy groups, the publication found that most accepted financial backing by companies developing or producing drugs used to treat patients supported by the group. In some groups, such as the American Heart Assn., the drug makers' financial backing was huge ($23 million in 2005) but represented a small portion (4%) of revenue. For seven groups, donations from interested drug companies represented more than one-fifth of revenue. The Depression and Bipolar Support Alliance said it received more than half of its 2005 funding from the drug industry, and the Colorectal Cancer Coalition got 81% of its funding from drug makers.

New Scientist's probe found that some donations appeared directly tied to marketing interests. In 2003 and 2004, when the drug giant Pfizer was developing a drug to treat restless leg syndrome, it was a major donor to the Restless Legs Syndrome Foundation. But in 2005, after Pfizer announced it had abandoned development of the potential drug, its donations to the patient group dried up.

Many of the best-known groups, including the Alzheimer's Assn., American Cancer Society and American Diabetes Assn., typically have a board of physicians who vet the scientific accuracy of the information they provide to patients. And most solicit "unrestricted" grants that allow them freedom to use the drug makers' donations as they see fit.

But even large groups often provide a gateway to the products of corporate sponsors, say those who have surveyed them. Many list FDA-approved medicines available to treat the disorder that is their focus and provide Web links that lead patients directly to marketing sites. And many offer their corporate sponsors access to their members, a potential gold mine of direct-marketing opportunity.

The corporate-donor pitch posted on the website of the national infertility patient group, Resolve, is typical of many patient groups. "Whether you become a site sponsor, a resource partner, or a sponsor of Resolve's chats, [the group's website] is the ideal place for your company to market its products and services to thousands of men and women across the country," the appeal states. Among the benefits the group lists for becoming a member of the group's "Corporate Council" are access to data on utilization of the group's programs and services and "the opportunity to establish topics and sponsor special briefings for patients, the medical community and public policy makers." Serono and Organon, both makers of prescription medication used to treat infertility, are among the group's corporate sponsors.

Patient groups also mobilize patients -- sometimes armies of them -- to push for coverage of prescription drugs by insurance companies and states' Medicare and Medicaid agencies. To pharmaceutical companies, this can make or break the market prospects for a new drug because 80 million Americans -- among them, the heaviest prescription-drug users -- receive healthcare coverage through Medicare and Medicaid, and roughly 155 million have prescription drug coverage through private insurance companies.

Strength in numbers

WHEN insurers balk at reimbursing patients for new prescription medications, these groups typically swing into action, rallying sufferers to appear before public and consumer panels, contact lawmakers, and provide media outlets a human face to attach to a cause. Infertility patients mobilized by Resolve, for instance, have been extremely effective in extending states' insurance coverage of infertility treatments. Groups such as the Depression and Bipolar Support Alliance have fielded experts and patients who have done the same for psychiatric conditions. And a wide range of patient groups, most with substantial backing from the makers of erectile dysfunction drugs, have mounted successful campaigns to get wary insurers to cover drugs such as Levitra, Viagra and Cialis.