Traditionally, a woman’s role has always been that of wife, mother, caregiver. “Women are the glue that holds the family together,” said Leona Cunningham, a certified nurse midwife at Indiana Regional Medical Center, in Indiana County. “And, oftentimes, they tend to get run over because they put all their personal needs aside.” It’s time, she said, to give care to the caregiver. To that end, a survey released in March by the Pharmaceutical Research and Manufacturers of America details nearly 400 medicines in the pipeline to target diseases and conditions that have a higher prevalence in women than in men. The list of hopefuls includes drugs for breast cancer, ovarian cancer, diabetes, arthritis, depression, Alzheimer’s disease, lupus, urinary tract infections, irritable bowel syndrome, osteoporosis and multiple sclerosis, according to the survey. Additionally, researchers are zeroing in on three leading killers: heart disease, lung cancer and stroke — with more than 190 promising medications currently being developed and tested. All of the potential medications are either in human clinical trials or awaiting U.S. Food and Drug Administration review, the survey reports. “This research is a continued pursuit,” said PhRMA spokesman Court Rosen. “In 2001, pharmaceuticals were targeting 30 diseases that disproportionately affected women, with 358 medicines in development. So, our member companies continue to aggressively look for new and better treatments for these diseases that affect women.” It won’t be easy, experts say. Tufts Center for the Study of Drug Development estimates the journey from test tube to prescription bottle will take anywhere from 10 to 15 years. Moreover, only five in 5,000 compounds entering preclinical testing will make it to human testing; only one of those five will be approved for sale. The price tag: more than $800 million. “It’s important to remember that number includes the costs associated with all your failures,” said Rick Koenig, spokesman for GlaxoSmithKline, a globally based pharmaceutical company. “And most things fail.” “It’s an unbelievably expensive endeavor,” said Lisa Rohan, assistant professor of pharmaceutical sciences at University of Pittsburgh’s School of Pharmacy. “If you start with discovery — new chemical entities that might have some applicability as a drug — only one in maybe 20,000 make it to the market. There is just an incredible amount of screening a potential drug must go through.” The discovery process begins in the laboratory, Rohan explained, with a “chemical and physical evaluation” of the potential molecule or compound. If preclinical studies show the molecule to be safe and stable, a drug’s sponsor then can file an Investigational New Drug application with the FDA. Upon approval, a potential new drug begins its tour of duty in a series of clinical trials. Phase I trials involve 20 to 100 healthy volunteers who sign on to test the effects a potential drug may have on the human body as well as a safe dosage range. Phase II volunteers — between 100 and 500 patients with the disease — help determine a drug’s overall effectiveness. During Phase III trials, physicians closely monitor patients for any side effects, hoping to establish whether or not the new approach is better than current medical practices. “The more advanced stages of clinical trials are usually huge studies with thousands of patients at multiple sites,” said Rohan, also an assistant investigator at Magee-Womens Research Institute in Pittsburgh. “That’s where you incur the bulk of the expense. Those are extremely costly.” Once all trials are complete, the sponsor can file a New Drug Application with the FDA. These documents typically exceed 100,000 pages and, in 2003, required an average of nearly 17 months to review. After a thumbs-up from the FDA, the new medicine becomes available for prescription. Last year, the agency approved 72 new drugs and 21 new molecular entities, which are active substances that have never been approved in any form in the United States that eventually may make their way into approved drugs. The agency also approved 131 new or expanded uses for already approved drugs. Of these, several were specific to women: Boniva, for treatment and prevention of postmenopausal osteoporosis; Estrasorb, a topical estrogen therapy; Ovcon 35, the first chewable oral contraceptive tablet; and Seasonale, a new 91-day oral contraceptive regimen. On the horizon• Some health care professionals say the development of a vaccine targeting Human Papilloma Virus, or HPV, infections, is critical. “Honestly, I think we need that vaccine very badly,” said Dr. Roy Clark, who has an obstetrics and gynecological practice in Greensburg and Mt. Pleasant. “We’re seeing more and more precancerous changes of the cervix in women who are younger and younger. And what they’ve discovered over time is the vast majority of those precancerous and cancerous changes of the cervix are related to specific high-risk types of HPV infection.” Koenig said GlaxoSmithKline is preparing to open a four-year Phase III study of its Cervarix vaccine, designed to prevent cervical cancer by targeting HPV. The trial will take place at more than 90 cities in 14 countries and will seek to enroll 13,000 women ages 15 to 25, he said. He added that the company also has a cutting-edge drug in the works for solid-tumor cancers. A “first-ever” dual kinase inhibitor, designed to block a cancerous cell’s signaling pathway, is entering Phase III studies in breast cancer patients. “This is an important project for us, one that we’re devoting a good bit of resource to,” Koenig said. New Jersey-based Aventis Pharmaceuticals Inc., spends more than $3 billion a year on general research and development. “Our focus is on all health issues — oncology, respiratory, rheumatoid arthritis, diabetes and cardiovascular diseases,” a company spokeswoman said. “But we recognize that several of these diseases have a greater incidence in women.” At the Windber Research Institute in Somerset County, researchers “have the opportunity to really look at how medicine is evolving rather than be constrained by how it’s been,” said Dr. Michael Liebman, chief scientific officer. Established in 2001 as a nonprofit biomedical research facility, WRI concentrates research efforts on cardiovascular disease and women’s health — specifically breast cancer, gynecological cancers and the effects of menopause. The facility also collaborates with Walter Reed Army Medical Center, in Washington, D.C. — allowing scientists to study and compare tissue samples from more than 10,000 women annually. Yet Liebman concedes there is much more to women’s health than tissue samples. “Frankly, I don’t think we yet understand all the issues,” he said. “The aging process is going on as an undercurrent below all diseases in women. If we don’t take that into account — and we don’t right now — then we don’t have the best measures of how to look at what’s normal versus what’s abnormal.” Jean Lynn, program director of the George Washington University Breast Care Center, in Washington, D.C., cited a lack of risk-factor awareness as a stumbling block in women’s health. “My field of study is breast cancer, but I have to say women don’t realize heart disease is really their No. 1 one killer,” she said. “They’re a lot more afraid of getting breast cancer. I think we need a lot more public service announcements. A lot more education so women know exactly what’s what.” Dr. Rosaly Correa-de-Araujo, senior adviser of women’s health for the Agency for Healthcare Research and Quality, in Maryland, agrees. “We cannot anymore just show gender-based research evidence,” she said. “We have to have a follow-up agenda; take the extra step in making sure somebody is going to adopt the research. But it can sometimes be very difficult to change behavior.” “I think we’re making progress,” said Dr. Susan Wood, director of the FDA’s Office of Women’s Health. Its $3.6 million annual budget is used to fund research and outreach programs. “Women’s health is not only about reproductive issues or breast cancer,” she added. “It’s a comprehensive picture, ranging from cardiovascular diseases to safe medication use. We recognize that the woman is often the caregiver of the family, and if we improve the health of the woman, the health of the family is often improved as well.”

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