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SAN FRANCISCO (WOMENSENEWS)–Women’s health advocates are concerned about the growing prevalence of aggressive, “direct-to-consumer” drug advertisements that they say exploit the tendency of women to make health-care decisions for themselves and their families and dangerously encourage self-diagnosis.

In an effort to increase their market shares, pharmaceutical companies have begun running the ads in which prescription drugs are advertised to the general public like any other consumer product. Women are increasingly targeted for prescription drugs for menstruation problems, breast cancer, weight loss and other health concerns. And the ads sometimes promote what is called off-label uses, that is, taking the drug to treat one problem when the drug was approved to treat a different problem.

Critics say that by encouraging patients to ask for drugs they may not need, pharmaceutical companies are undermining the judgment of health professionals and increasing the risk of over-use or incorrect use of medications.

Until five years ago, drug manufacturers were required to include nearly the entire consumer warning label in all forms of their advertising. But the Food and Drug Administration loosened this restriction in 1997 by allowing companies to promote drug benefits without a lengthy summary of potential side effects, contraindications and information on the effectiveness of the drug.

Now, as long as viewers are given information about the major risks of a drug and directed to other sources of information, such as Web sites or toll-free numbers for more detail, drug company officials are free to imply whatever they think is necessary to urge consumers to ask their doctors for their drugs.

Pharmaceutical advertising is one of the fastest growing categories of advertising, according to Pharmaceutical Research and Manufacturers of America. In 1990, 10 different medicines were advertised directly to consumers. In 1997, that number rose to 79, the industry group says. The ads “bring patients to see their doctors . . . they empower patients to participate in their own health care,” says Meredith Art, the association’s spokeswoman.

Preliminary findings of a recent FDA survey show that the ads are working: More people are aware of brand-name prescription drugs now then ever before. In 1999, 72 percent of patients recalled seeing or hearing a drug ad in the three months before the survey. In 2002, 81 percent of patients remembered ads, according to the FDA survey.

In addition, almost 25 percent of this year’s respondents had asked their doctor for a specific, brand-name prescription drug; 69 percent of those patients got the prescription they asked for. In 1999, 13 percent asked about a specific drug, of which 50 percent received it.

Women Make 60 Percent of Health Care Decisions

“Women are a great market for everything,” says Barbara Brenner, executive director of Breast Cancer Action in San Francisco, referring to the popular pharmaceutical wisdom that women often make health decisions for their whole families, not just themselves.

A recently published Kaiser Women’s Health Survey backs up this assumption. The report, released last month, found that nearly 60 percent of women in the United States reported that they were the primary decision-makers in their families about health and health insurance, with 22 percent making the decisions jointly with their spouses.

The Kaiser survey also found that women use more prescription drugs than men–half of non-elderly women used prescription drugs on a regular basis, compared to only 31 percent of men. When the elderly are factored in, women make up an even bigger share of the prescription drug market: Women ages 65 and older outnumber men by almost 6 million and use of prescription drugs increases as patients grow older.

Mindful of these facts, pharmaceutical companies have used direct-to-consumer ads to promote their drugs to women, hoping to capture this lucrative consumer group. Eli Lilly and Company marketed Evista as having benefits for breast cancer patients, even though the FDA has only approved the drug for osteoporosis. Likewise, Nolvadex (more commonly known as tamoxifen), which is made by AstraZeneca Pharmaceuticals, is marketed to healthy women as a breast cancer prevention drug, even though there is no evidence that the drug works in that capacity and may even be more likely to hurt than help many women.

Shopping Cart Rage Becomes Icon for Rare Disorder

The best-known example of this practice is the marketing of Sarafem, the only FDA-approved drug for premenstrual dysphoric disorder, or PMDD. In November 2000, the FDA reprimanded Eli Lilly for its Sarafem ad showing a woman pulling a shopping cart who yanks the cart with ferocity because it refuses to budge. The concurrent audio states, “Think it’s PMS? It could be PMDD . . .”

In the first six months following Sarafem’s release, Eli Lilly spent $17 million in direct-to-consumer advertising and more than $16 million in drug promotion to doctors and in scientific journals to promote their new, brand-name patented fluoxetine hydrochloride pills. About 202,000 prescriptions for Sarafem were written in the first six months the drug was available; meanwhile the pharmaceutical corporation has lost 80 percent of its Prozac market share to generic antidepressants.

The FDA cited Eli Lilly for “trivializing the seriousness of PMDD.” But critics point out that the agency did not cite the company for trivializing the woman and her life in the ad, or for suggesting that every angry outburst is related to PMS or another medical condition.

According to the FDA, “The advertisement never completely defined or accurately illustrated PMDD and there is no clear distinction between premenstrual syndrome (PMS) and PMDD communicated.” This may be because PMDD is not yet accepted as an illness by the American Psychiatric Association and is only listed in the appendix for the Diagnostic and Statistical Manual of Mental Disorders, or DSM-IV, the reference manual for identifying and diagnosing mental illnesses. According to Lilly spokeswoman Debbie Davis, “PMDD affects 3 to 5 percent of [menstruating] women in America . . . Sarafem was created to serve those in the market with PMDD.”

Sarafem also has the same active ingredient–fluoxetine hydrochloride–as Prozac, an antidepressant also manufactured by Eli Lilly. Critics charge that Eli Lilly introduced Sarafem in part to extend the life of its patent; Sarafem was introduced in July 2000, just one year before the Prozac patent expired.

Davis insists that the drugs are different. “The active ingredient for Sarafem and Prozac is the same, but the education material for treating PMDD is different.” She added that Sarafem has its own identity to differentiate it from Prozac.

Jin In completed her Master’s degree this spring at the University of California, Berkeley School of Public Health.

For more information:

Prevention First:

Sarafem Web site:

Tamoxifen Web site: