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By
Leigh Morgan The nation’s pharmaceutical companies are paying close attention to an often overlooked group of healthcare consumers—women. A recent study by the trade group Pharmaceutical Research and Manufacturers of America (PhRMA) found that 144 companies are either awaiting government approval or are conducting clinical trials for 373 new medicines aimed at women’s needs. The drugs target a range of diseases that usually affect only women, such as breast cancer; diseases that affect women disproportionately, such as Alzheimer’s; and diseases that are among the top 10 killers of women, including heart disease and stroke. Drugmakers are also developing contraceptives, fertility treatments, hormone therapies, and antidepressants. Advances in science, government regulation shifts, and the bottom line all have coincided to boost women’s healthcare clout, according to experts. "Women have one of the strongest voices in medicine now," said Kristine Harper, MD, MBA, clinical research physician for Eli Lilly, a company that has pioneered advances in tissue-specific estrogen receptor therapies. "Women recognize this and are beginning to appropriately demand that they be taken seriously," she said. Opening drug studies to women The pharmaceutical market shift reflects a growing understanding that women should not be excluded from studies of promising new medicines—including drugs that could treat life-threatening illnesses—because of possible unplanned pregnancies. The practice of exclusion stems from the 1970s, when scientists discovered that drugs such as DES and thalidomide caused birth defects, said Marietta Anthony, PhD, deputy to the acting director in the office of women’s health at the Food and Drug Administration (FDA). "The spillover is that women were excluded from more and more clinical trials, even women who were sterile or postmenopausal," she said. As a result, many companies have relied on male test participants to develop medicines intended for women. In 1993, the FDA required drugmakers to include more women in clinical trials. The agency proposed another regulation in 1995 that would force the industry to analyze research data by gender, and a third regulation last year that would allow women of childbearing age to participate in clinical trials. Consumer clout Women account for about 52 percent of the global population, outlive men by an average of seven years, and tend to take more medication than men, according to Anthony. Women have always been a strong behind-the-scenes force in the medical marketplace since they tend to make most of the health-related decisions for their families, Harper said. Women also have more buying power than ever, with the salary gap between the sexes continuing to shrink. As women baby boomers enter menopause, the pharmaceutical industry has started to address what many have called an "unmet need" for postmenopausal drugs. "We need companies making medicine for those illnesses that primarily afflict women," said Jeff Trewhitt, spokesperson for PhRMA. "When there’s a healthcare need, there’s a business potential as well. The two do walk hand in hand." Trewhitt started noticing a steady climb in new product development geared toward women about four years ago. The trend underscores a big investment in female consumers, he said, since the cost of research in the last 20 years has almost doubled to as much as $600 million per product. In 1998, PhRMA’s companies will commit more than $20 billion dollars to new drugs. What’s cooking? Wyeth-Ayerst, which opened its Women’s Health Research Institute in Pennsylvania in 1993, produces the nation’s best-selling drug, the estrogen Premarin. The company is also providing medicines for a massive, long-term research study of postmenopausal women across the United States. The Women’s Health Initiative will follow some 68,000 women through 2007 to monitor a series of illnesses, including osteoporosis, cancer, and heart disease. "Women live about one-third of their lives after menopause, and the market is growing for that demand," said Richard Lyttle, PhD, assistant vice president of the Women’s Institute. "We have the premier drug for treatment [of estrogen loss], so it benefits us from a business standpoint as well." Benet DeBerry-Spence, director of global new business for Illinois-based Searle—the first company to produce an oral contraceptive—says the competition for women’s products has intensified. To stay on top, Searle has expanded beyond its reproductive portfolio to target ailments that disproportionately affect women. The company also plans to produce drugs for heart disease and stroke. Last year, New Jersey-based Johnson & Johnson acquired two companies that create minimally invasive devices to benefit women. One company produces an outpatient alternative to traditional hysterectomies, the other produces a gentler method for performing breast tumor biopsies. Spokesperson John McKeegan said the recent merger reflects an effort at Johnson & Johnson to cater to female consumers. "We see women’s health as a growing area," he said. |