U. S. Food and Drug Administration
FDA Consumer
October 1996

Inside FDA: Office of Women's Health

This is one in a series of articles on FDA activities and concerns.

When FDA's Office of Women's Health announced that 1995 annual funds were available for agency research projects, Mary Lou Tortorello, a microbiologist with FDA's Center for Food Safety and Applied Nutrition, knew just the project to propose. She wanted to develop a rapid test for Listeria monocytogenes, a microorganism widespread in the environment that may contaminate many types of foods. She thought the test could have a major impact on women's health, since Listeria can cause miscarriages and stillbirths in pregnant women.

"By current standard methods, it takes at least four days to detect Listeria in food, and that's only if everything works as it is supposed to," says Tortorello. "A rapid test could really enhance food safety."

Tortorello's research is one of more than 50 projects within the agency that have been funded by the Office of Women's Health since it was established in July 1994.

The office, with a $2 million annual budget, promotes testing of FDA-regulated products in women, supports research and education to increase knowledge of women's health issues, and forms partnerships with other government agencies and advocacy groups to advance women's health objectives.

Women's health issues of particular concern to OWH include:

• cardiovascular disease
• cancer screening and treatment
• sexually transmitted diseases, including HIV
• contraception, pregnancy and childbirth
• hormone replacement therapy for menopause
• osteoporosis and other diseases affecting older women
• autoimmune diseases.

Historically, women have been neglected in clinical trials for new drugs, devices, and biological products. Attention to remedying this situation was integral to the genesis of the Office of Women's Health and is one of its major issues, explains Audrey Sheppard, acting director of the office.

One of the first projects the office funded in 1994 was a study to determine how women newly diagnosed with breast cancer obtained clinical trial information. "There's a great misunderstanding about the National Cancer Institute's Physician Data Query [PDQ] clinical trial database," says Patty Delaney, project coordinator and cancer liaison in FDA's Office of AIDS and Special Health Issues. Not every trial is included, she explains, only trials sponsored by NCI and a few others submitted voluntarily by nongovernment sponsors. "If a manufacturer is conducting one on its own, it is likely not to be in NCI's database."

The project, conducted by a contractor for FDA, involved calling more than 100 different telephone numbers that supplied cancer information. Results showed there was no simple, comprehensive way to find out about all the current clinical trials on breast cancer. University medical centers and other research sites often only offered information on studies they were conducting, and when asked where someone could get information on other studies, callers were usually referred to NCI's cancer hot line, (1-800) 4-CANCER.

Because there is no centralized source for information on all current clinical trials, "patients and their doctors have trouble finding suitable trials, and manufacturers have trouble filling trials," says Marietta Anthony, Ph.D., a microbiologist with the Office of Women's Health.

Based on these conclusions, the National Action Plan on Breast Cancer, an organization funded by both private groups and the Department of Health and Human Services, awarded FDA $100,000 to assist NCI in getting drug, biologics and device manufacturers to voluntarily add their breast cancer clinical trials to the PDQ database.

The office has also funded research projects and studies to:

• Develop a computer model to simulate the potential for a virus to break through a protective barrier such as latex, used in surgical gloves and condoms.
• Develop a pilot tracking system to monitor the participation of women in clinical trials.
• Examine the effects of the anti-breast cancer drug tamoxifen (marketed as Nolvadex) on the rat uterus. Preliminary studies of women taking tamoxifen, which can delay or prevent relapse in patients who have undergone surgery for breast cancer, have shown that the drug poses an increased risk of cancer of the uterus.
• Determine if changes in female sex hormone levels that occur during the menstrual cycle, pregnancy and menopause affect the activities of cytokines (hormone-like proteins that act as communicators between cells). Limited evidence suggests that the cause of systemic lupus erythematosus, an immune-system disease that mainly affects women, may be linked to the interaction of these cells.

"These workshops provided really practical nuts and bolts information on diseases and conditions, prevention and diagnosis, and remedies," says Sheppard.

Some critical health problems of minority women include cervical cancer, which is approximately three times higher among black women than white women; heart disease, which is the leading cause of death in Latino women; and hypertension, stroke, diabetes, lupus, and other chronic diseases, which are responsible for a disproportionate number of deaths in young African-American women.

Other education projects funded by the Office of Women's Health include:

• Mammography Quality Standards Act brochure for consumers
• Mammography Quality Standards Act speakers kit to help FDA and state radiation control personnel explain MQSA requirements, as well as FDA's programs and policies for mammography facility accreditation and inspection
• Women of Color Outreach project to expand minority women's involvement in the FDA policy development process
• Hispanic Women's Health Conference in Miami on May 9 and 10, 1996
• Asian Pacific Islander Group outreach to encourage use of screening tests such as mammograms and pap smears. Asian language translations of FDA educational materials were distributed at health conferences, community activities, and medical centers in California.
• Women's Health Internet Initiative to provide information about women's health issues related to food safety, nutrition and cosmetics. Its World Wide Web address is http://www.cfsan.fda.gov/~dms/wh-toc.html.

In partnership with women's organizations, the office is initiating a new public education campaign titled "Women's Health: Take Time to Care." The campaign will target middle-aged and older women, with special emphasis on women who are medically underserved.

As the Office of Women's Health continues to define its role, "we really do see ourselves as not just coordinating and educating," says Sheppard, "but also determining where there needs to be advances in thinking, in policy, and in regulation."

More information about women's health can be found on FDA's Website.

Isadora B. Stehlin is a member of FDA's public affairs staff.

FDA Consumer magazine (October 1996)

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