New Medicines In Development For Women
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What's also new is not just that this research is being conducted, but how it's being conducted. Researchers are approaching conditions common to both sexes using a newly defined approach called "gender-based research." This approach involves studying both the similarities and differences in men and women with respect to the mechanism of a disease; potential differences in reactions to preventive and therapeutic measures; how diagnosis may differ; and how this condition and/or its treatments may further react with concomitant conditions, other medicines, and hormones (especially birth control pills and hormone replacement therapy).

Heart disease provides a good example of the importance of gender-based differences and the need for continued gender-based research. The leading killer of both men and women, we know heart disease develops approximately 10 years later in women. When women are diagnosed with heart disease, however, their condition is typically far more advanced than in men; they often have different symptoms; and ironically, they may be treated less aggressively. Nearly 44 percent of women who have heart attacks die within a year-compared to 27 percent of men. Disappointingly, medicines in development specifically for women with various types of heart disease and stroke (the number three killer of women) are not included as part of this report. This therapeutic area is of such significance that PhRMA published a separate report, New Medicines in Development for Heart Disease and Stroke (1999) which summarizes the 115 new medicines in development for heart disease and 21 new medicines in development for stroke. This report, however, gives no gender-specific information about those clinical trials.

This century we will see a great increase in new medicines developed from the revolutionary research techniques developed in the 1990's using genetic engineering and biotechnology to discover and develop more effective and targeted medicines. Many of the medicines currently in the pipeline for women attack diseases in novel ways. These include:

• two genetically engineered medicines that inhibit a protein believed to trigger rheumatoid arthritis and that may be able to slow joint destruction;
• a vaccine to provoke the body's immune system to attack breast tumors;
• a gene therapy for ovarian and other cancers that delivers a tumor-suppressor gene right to the cancer site.

Tremendous strides have been made in the development of medicines for various cancers, with corresponding results in improved outcomes. This report also lists 27 ongoing clinical trials in drug development for breast, cervical and ovarian cancers by the National Cancer Institute (NCI), a division of the NIH, conducted both independently and with pharmaceutical company partners. Perhaps most exciting are several vaccines in development by various companies to prevent breast, cervical, and ovarian cancer in women. Disappointingly, however, even though lung cancer is the leading cancer killer of women (and men), drugs in development for the treatment of lung or other non-reproductive cancers were not included in this report, which focused only on cancers of the breasts and reproductive organs in women. Because cancer is the second leading cause of death of all Americans, however, PhRMA has published a separate report, New Medicines in Development for Cancer (1999) which summarizes the 354 new medicines and vaccines in development to prevent and/or treat numerous types of cancer, including 58 new medicines in development to treat lung cancer; 63 for breast cancer; 58 for skin cancer (including melanoma, the most serious form of skin cancer, whose incidence has grown 4 percent a year since the 1970s); and 46 for colon cancer, the second leading cancer killer of both men and women.

With the exception of being able to assume that the 47 medicines in development to treat prostate cancer are for men, and that the medicines in development to treat breast and female reproductive cancers are for women, this report does not give any other gender-specific information about the clinical trials being conducted.