Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SUNDAY, November 20, 1994 TAG: 9411220018
SECTION: HORIZON PAGE: F1 EDITION: METRO
SOURCE: KEITH STONE LOS ANGELES DAILY NEWS
DATELINE: LOS ANGELES LENGTH: Long
Will the virus she discovered in her blood six years ago drag her down the same path, past the same symptoms, that it typically does with men?
Why do infected men seem to live longer than infected women, and do the standard AIDS treatments work as well for women as they do for men?
Exactly which gynecological problems signal the advance of AIDS, and how can they be delayed?
``We have a lot of questions, and when people keep shrugging their shoulders - you just want to wring their necks,'' the 35-year-old Los Angeles woman said.
The reason no one has had answers for Lucey lies in a single fact: All major observational studies of AIDS in the United States have focused mostly on men since the illness was first recognized in 1981.
True, AIDS first appeared in gay men, and men account for about five times as many cases as do women, but government records show the illness has begun to spread more rapidly among women than men and now is the fourth leading cause of death for women.
Despite the mounting toll on women, when Lucey and hundreds of thousands of other women look for the latest advances in treatment, they are forced to rely on information gleaned largely from male studies.
No one can tell them whether male studies translate entirely to women, or at least enough to conclude that doctors are doing all they can to treat nearly 15,000 women with AIDS and those who carry the virus.
``And it is scary,'' said Lucey, who believes she contracted the virus through drug use.
Now - nearly 12 years into the AIDS epidemic - government researchers have finally launched a large-scale, long-term study of how women react to the human immunodeficiency virus, which causes acquired immune deficiency syndrome.
In October, clinics in Los Angeles and nationwide began enrolling for the Women's Interagency HIV Study. It will run in tandem with a smaller study of women, the HIV Epidemiology Research Study, which the federal Centers for Disease Control and Prevention opened in April 1993.
Enrollment in the WIHS - the first and largest U.S. study of its kind - is under way at several Los Angeles clinics and nationwide.
Sandra Melnick, project officer for the study, acknowledges that the research was too long in coming, but she said limited money had to be spent first on men because they made up the bulk of the cases.
``The need had to be compelling to warrant the expenditure of tens of millions of dollars,'' Melnick added. ``It is not a malevolent type of thing. It is triage, until there were enough cases to point the way.''
It has been only in recent years researchers, doctors and women themselves have begun to suspect that AIDS attacks women differently from men. ``But it is an unknown,'' Melnick added. ``We can only know that in large- scale studies.''
With a budget of nearly $10 million for the first of four years, WIHS will follow 2,000 infected women and 500 women at high risk for infection.
WIHS essentially mirrors a government study of AIDS in men that began 10 years ago - at the start of the epidemic.
So far the men's study is responsible for several key discoveries, including benchmarks for when antibiotics and antiviral drugs should be administered for the greatest benefit.
The project officer for the men's study, Dr. Lewis Schrager, said he believes it is reasonable to adapt the findings about men to women. But he concedes that some may not apply fully.
For that exact reason, many women and researchers bemoan the late start.
``It makes me sad. I certainly wish we had started 10 years ago,'' said Dr. Alexandra Levine, a principal investigator for WIHS and a nationally prominent AIDS researcher at the University of Southern California.
``The loss of that time,'' Levine predicted, ``will equal a loss of survival time for many women, and certainly quality time for many women.''
At the same time that WIHS signals a recognition of AIDS' attack on women, top National Institutes of Health officials vow that it also reflects a change in their attitude toward research into women's health.
Lucey, a longtime AIDS activist, is not so sure. She recalls with skepticism how through history medical research has largely abandoned women.
``It has been a long time and we have a long way to go, and when there are changes they are not always for the best - so you have to go back and change their changes,'' Lucey said.
Levine has also witnessed the exclusion of women.
``In a general sense, we live in a male-dominated society, and it is men who are the researchers, and the men who are the politicians giving the money,'' Levine said.
The examples are legion:
The landmark Physician's Health Study in 1988 investigated whether aspirin prevents heart disease, following 22,071 men and no women. The Multiple Risk Factor Intervention Trials, conducted before 1987, studied coronary risk in 15,000 men, but no women. It was nicknamed appropriately: ``MR. FIT.''
In a major study on aging, only men were followed from the inception of the research in 1958 until 1978 when women finally were allowed to take part.
Even today, the standard of care for lowering cholesterol levels is based largely on recommendations from a study of 4,000 men.
Drug dosages for all adult illnesses are based on research done on the average 170-pound man.
For the past 16 years, Food and Drug Administration guidelines barred women of child-bearing potential from taking part in early drug studies, unless their illness was life threatening.
Drug companies understood that FDA guideline to include a restriction on women with AIDS, said Ruth Merkatz, director of the FDA Office of Women's Health. New guidelines eliminate the restriction, but the National Task Force on AIDS Drug Development reported in October that discrimination continues.
Surgical instruments are designed for the larger male heart and sometimes are too large to be used on women.
Cardiologist Bernadine Healy says that because heart attacks have been viewed as a male problem, women are not treated as aggressively when they walk into an emergency room with the same symptoms.
Healy refers to that phenomenon as the ``Yentl syndrome,'' after the Isaac Bashevis Singer story about a woman who must pose as a man in order to study the Talmud.
``We see things through the lenses of men, and many of the doctors up until now have been men looking at diseases studied in men,'' said Healy, who was named the first female director of the NIH in the agency's 107-year history.
``I don't think there is a month that goes by where I don't pick up a journal and see a study focused on only men,'' Healy said.
Regardless, Healy believes progress has been made and will continue. ``We have achieved a culture shift,'' she said.
That shift was wrought largely by the Congressional Caucus for Women's Issues, which in 1988 pushed the NIH to focus more money and energy on studying women's health.
The NIH responded in 1990 by establishing the Office of Research on Women's Health. In 1991, the NIH began the Women's Health Initiative, a $628 million, 14-year study of 163,000 postmenopausal women.
And in March, the NIH set forth sweeping new regulations to ``ensure women and minorities are included as subjects'' in clinical research, without regard to the cost of including them.
In recognition that women react differently to AIDS, the CDC in 1993 expanded the list of AIDS-defining illnesses to include, among others, one unique to women - invasive cervical cancer.
Two months ago, the FDA opened its Office of Women's Health, naming Merkatz as director. There is no Office of Men's Health.
``The norm had always been, in scientific investigation we usually started with men and applied it to women,'' Merkatz said. ``But women are different than men physiologically.''
No one knows that better than Laura Iozia, a 44-year-old woman in the Los Angeles-area community of La Puente who says she was infected with HIV at least nine years ago by a boyfriend.
``I've been on this road of no information for a long time,'' Iozia said.
Every month, Iozia adds the latest and best information about AIDS treatments to a 2-foot stack in her living room. For the most part, the research is focused on AIDS in men, which she says makes her uneasy.
``We all know men and women are chemically made up differently from each other. How can what is happening to you be happening to me for sure?'' she asked.
When Iozia, a payroll clerk, began having chronic yeast infections in 1988, she said her doctor told her it was unrelated to her HIV infection. Now doctors believe the two conditions are tied together, but it remains unclear.
Iozia said she is losing bladder control, but no one can tell her whether other infected women have the same problem. And she faces the same unanswered questions about the spots she is beginning to see before her eyes.
``But I am only 44 years old, I shouldn't have this stuff going on,'' she said.
by CNB