Finally, A Healthy Interest In WomenSunita Wadekar Bhargava
Each year in the U.S., some 500,000 people suffer swelling in the joints and glands and other telltale signs of the sometimes-fatal immunological disease called systemic lupus erythematosus. About 90% of these victims are women, more than half of childbearing age. Yet many don't know they have the illness. And doctors don't know what causes it, nor do they understand why it attacks women mainly and strikes black women three times as often as white.
Until two years ago, in fact, no one was even trying to answer these questions. Then, researchers at the National Institute of Arthritis & Musculoskeletal & Skin Diseases in Bethesda, Md., took action. In 1991, they started distributing information about the disease to black women and launched studies to determine what causes the disease.
As the efforts to unravel this mystery show, women's health issues are becoming a priority after decades on the back burner. Until recently, most new drugs were tested mainly on men, and a disproportionate number were aimed at men. Then in 1990, a General Accounting Office study put the blame on the National Institutes of Health, the nation's premier medical research and development body. That year, the NIH launched the Office of Research on Women's Health (ORWH). And it gained an important patron when Dr. Bernadine P. Healy became NIH director in April, 1991.
Through the ORWH, the NIH is pushing health centers, particularly its various institutes, to include women in clinical trials for medicines, to start work on diseases that afflict women only, and to study whether maladies such as heart disease, AIDS, and cancer affect women differently than they do men. "Medical research is starting to shift toward women's health issues," says Joan Kuriansky, who chairs the Campaign for Women's Health, a Washington, D.C., advocacy group.
In fact, the NIH's focus is fueling "an explosion of interest from drug companies," says Dr. Florence P. Haseltine, founding president of the Society for Advancement of Women's Health Research. In the past year, Wyeth-Ayerst, Sandoz Pharmaceuticals, and Pfizer, among others, have set up female health care research departments. As of last December, says the Pharmaceutical Manufacturers Assn. (PMA), there were 263 medicines in development for women at 79 drug companies. The lure for drugmakers: Lucrative markets that should develop as millions of female baby boomers encounter fertility problems, then reach middle age and menopause.
MICE AND MEN. It will nonetheless take years to compensate for decades of neglect. Women are 52% of the U.S. population and face similar risk for many of the killers that hit men. But until now, research on such key problems as heart disease, lung cancer, and the effects of smoking--and on drugs to treat them--has been done mostly on mice and men, middle-aged white males at that. Researchers excluded women by arguing that pregnancy and women's fluctuating hormone levels could skew their results.
That's a risky oversight. Recent studies suggest that chemical differences between men and women create distinctions in their ability to absorb and metabolize up to 30% of all drugs. Women have more body fat than men, so some drugs may linger in their systems longer. The changes in hormone levels during the menstrual cycle also affect the behavior of drugs. These differences, says Dr. Lionel Edwards, chairman of the special populations committee of the PMA, can affect a drug's appropriateness and dosage. Without the right data, doctors can't tailor treatments for women.
FAIR SHARE. Such is the case with coronary heart disease. Women typically develop it 10 years later than men, and scientists have long interpreted this delay to mean that women are less affected by it. So, most prevention strategies and treatments for heart attacks are derived from research on men, including a landmark aspirin study financed by the NIH. Conducted by the National Heart, Lung & Blood Institute in 1981 on 22,000 male physicians, it found that men who take an aspirin every other day lowered their heart attack risk. But since women weren't included, researchers didn't know whether aspirin helps, harms, or has no effect on them.
That exclusion outraged women when it was cited in the GAO report. In 1989, the Congressional Caucus for Women's Issues urged the GAO to investigate whether the NIH discriminated against women in medical research. The GAO found that women weren't included in research and prodded the NIH to set up the ORWH. Since then, AIDS and cancer activists have joined in advocating that research on women's maladies should get more dollars.
Companies have reacted quickly. High on their lists are drugs to treat hot flashes caused by menopause, hypertension, congestive heart failure, osteoporosis, and breast, cervical, lung, and ovarian cancer. Since 1991, Sandoz Pharmaceuticals Corp. has stepped up its research on postmenopausal osteoporosis, the bone loss that affects 25 million U.S. women. "We are not only looking at drugs or treatment, but at a new delivery system," says Dr. Donnica L. Moore, associate director of the Sandoz Medical Education Center. Osteoporosis sufferers now take Sandoz' Miacalcin by injection, but Sandoz is testing a more convenient aerosol nasal spray. At Warner-Lambert Co., which has 21 compounds for women in development, reproductive biology is a top priority.
The NIH, meanwhile, has set an even more ambitious--and controversial--agenda. Its Women's Health Initiative, launched last year, is a $500 million, 10-year plan to study 150,000 postmenopausal women to determine how diet, exercise, and hormone therapy might prevent cardiovascular disease, cancer, and osteoporosis. One trial will examine whether a low-fat diet helps prevent breast cancer and heart disease. The NIH also will screen applicants for funding to make sure they include more women in their studies or provide a rationale for not doing so. It also is asking researchers to evaluate how drugs behave differently in men and women.
Last year, the NIH made cardiovascular diseases, osteoporosis, and cancer its top priorities, and the agency boosted research on women in all three areas. Already, one new program promises insights in preventing lung cancer, the No. 1 cancer killer of women. One finding--that more girls than boys start smoking in their teens--suggests that prevention efforts need to focus more on girls.
The NIH is also putting more muscle behind research on AIDS in women. The disease is spreading faster among women than men, according to the Centers for Disease Control, but until last year most AIDS research was done on young, white males. To redress the oversight, the NIH will spend $120 million for research on AIDS in women in fiscal 1993, up 56% since 1990.
GUARDIANS. These funds will help finance studies at the National Institute of Allergy & Infectious Diseases, an NIH affiliate. One will examine the effect of AIDS on 500 pregnant women and their offspring. Another, a five-year effort, will examine how the AIDS infection manifests itself in 2,500 HIV-positive women. Of great concern is the relationship of the infection to women's disorders. Early findings show that HIV-infected women have higher rates of abnormal pap smears and cancer of the cervix, and they react differently to sexually transmitted diseases.
The new priorities are tentative, so far. "In an ideal world, our office should not exist," says Dr. Vivian W. Pinn, director of the NIH's ORWH. "But we have to be there to make sure that the other NIH institutes and affiliates are spending money on women's research." And Congress has yet to give statutory authority to the ORWH, as the Women's Congressional Caucus has demanded. Unless this happens, advocates fear that women's concerns won't remain front and center at the NIH.
That would be too bad. It seems all too obvious that when it comes to doing medical research and developing drugs, women shouldn't be thought of as the same as men.
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