This report created a tremendous response from Congress. By 1990-2, the NIH mandated that any research carried out on diseases that affected both men and women had to include women in meaningful numbers. By 1993, the Food and Drug Administration (FDA) followed suit with a mandate that new drugs would not be approved for use by women if women were not included in drug trials.

We stand at the beginning of a new century and we still do not have a clear idea of women's health. Many have the "bikini view" of women's health--breast cancer and reproductive concerns. These represent the chief efforts of many women's health centers. The fact that women also have functioning hearts, brains, bones, skin, livers and other essential organs has not seemed to penetrate. I was just asked to review a brilliant 1,300-page volume on women and health. Even in the year 2000, over half the book was devoted just to reproductive concerns and autoimmune diseases.

	Discussion
	Why do many scientists and doctors think there is a need for gender-specific medicine? What are some reasons for the disparities in recent research on men and women for diseases that affect both groups?

In 1994, the Institute of Medicine published probably one of the most useful treatises on women and health research, Women's Health Research: Ethical & Legal Issues of Including Women in Clinical Studies. Among other things, it reports that fully two-thirds of all research on diseases affecting both men and women has been done exclusively on men.

Parenthetically, this disparity stems not from men hating women or holding them in low regard. The actual intent of excluding women from research stems from both economics and an effort to protect women. A fear exists that the reproductive capacity of a pre-menopausal woman or the well-being of a fetus conceived during a clinical investigation might be impaired. The liability for such a consequence might bring a pharmaceutical company to its knees, as silicone breast implants brought Dow to bankruptcy.

Who should care for women is also a hotly debated issue. Many people feel that the female gender guarantees more empathetic and sensitive care for the female patient. I think that such a prejudice is just that: a prejudice. The idea that only women can head women's health programs is just as ludicrous. I think that women's health centers all over the country ought to be staffed by the best talent, medically speaking, that can be offered, regardless of gender.

Launching gender-specific medicine
The most important questions for gender-specific medicine are: How are we going to make a case for physicians to treat patients with the sex of the patient in mind? and How are we going to stop looking at women and men as a homogeneous group of patients for whom the same interventions are good enough?

The answers reside in proving that the new science we are developing--when put into practical use--actually achieves better outcomes for both men and women. Until we have data showing that all of this new information improves the way we are currently doing business, we will be absolutely without any ability to persuade anyone that what we're doing is worth implementing.

One of our aims at Columbia University is to persuade our deans and our president to support a pilot gender-specific medical practice, paying careful attention to the outcomes from deploying new information. While we think that we can improve the quality of life and increase the longevity of patients through the practice of gender-specific medicine, it still has to be demonstrated. Of all the barriers to improving this science, that proof is the most important.

Backlash against women's health
We face a backlash against women's health. Anybody who thinks we don't is not out in the world. I chose several male colleagues for the advisory board of the Partnership for Women's Health at Columbia. They are powerful scholars, they are males, and they are interested in the intellectual challenge of whether or not they actually have to go to the expense and time of repeating their research, this time on female subjects.

	Thinking Point
	How have health insurance companies, doctors, researchers and the public at large reacted to the recent emphasis on women's health?

This question of balancing gender in research exists even at the animal-research level. One of the best stories I can tell about Michael Rosen, M.D., professor of pharmacology and pediatrics at Columbia University College of Physicians and Surgeons, is how he rushed up to me one day and said, "Here are the results of our research. Look at the data." I said, "This is wonderful, but it's done in males. Now, are you going to repeat it in females?" He did, and the exciting results, I think, made him a convert.

If you go to a general conference on health, and you are announced as the token woman who is going to talk about, for example, coronary artery disease in women, men literally stand up and leave the room. Typically, conferences on women's health are populated entirely by nurse practitioners, nurses and female physicians of all shapes and descriptions. One of the most exciting things about our annual conference--which was billed as the first on gender-specific medicine--was the equal attendance by men and women.

Pharmaceutical companies often have nothing except a marketing point of view when they talk about women's health. A woman always heads their women's health group. If you ask the size of the check they can sign to support any research or activity about women's health, their answers will demonstrate that it is not very important. The important negotiations go on at the acme of power in the company and have very little to do with the women's health team. I can tell you that from personal experience.

Academic medical centers do not give power to women without kicking and screaming. Our professorships come late if they come at all. To stop for any reason--to raise children or deal with the responsibilities of dependents, both parents and children--exerts a penalty. And perhaps it should. The bottom line is that, in general, no heads of clinical departments are women. We have one woman chair of a clinical department at Columbia, in anesthesiology. The female deans are invariably deans of students. It's as though being female means having a motherly function, rather than the intellectual capacity to actually lead a complex entity like an academic medical center.

Finally, the lay public is beginning to think that women's health has gotten enough attention. People in the audience make many asides when you bring up the subject of breast cancer. Both men and women say, "If I hear another word about breast cancer, as though it were the only issue in the world, I will certainly die of boredom." So I think until we stabilize women's health in another way, and in a more convincing, data-based way, we are not going to be seeing women's health on the radar screen for much longer.

Seeking private-sector support
More research is not just a luxury to be funded by feminist advocates for more political justice to women. In fact, it offers an opportunity to improve health care at all levels.

Although our partnership is not NIH-based, all of us have sat in on NIH study sections, and I served as co-chair of a task force looking at an agenda for women's health research in the next century. Now we want to see whether we can persuade the private sector to support a program like ours, which is long-term and hard to fund, since the science is so new. We offer the carrot that the difference between men and women might turn into a commercial bonanza of gender-specific products. Of course, we have also been proving our premise with outcome studies, which will make a difference.

Procter & Gamble gave us about $4 million to start this work. We spoke to about 500 members of their research and development (R&D) group. We had to be really creative about what our science to date might mean for their ability to generate new products. Fortunately, we seem to have been persuasive.

We have a unique database called GenCite, culled from 12 databases worldwide that report the major differences between the sexes in all disciplines of medicine. In building the database, our Scientific Advisory Committee devised a search strategy that picked out all the important literature within the last 10 years on differences between the sexes. We have finished bone and a segment on nutrition. The site is on the Web and it can be accessed by anyone for free. Individual companies have chosen specific areas of interest of GenCite to support.

The scientists who supervise the formation of GenCite have the task not only of devising the search strategy but also of basing research upon their findings. We are about to publish our first two position papers, one on bone and one on nutrition. These papers summarize the most important differences between men and women, identify the individuals most competently considering gender as an important variable, and formulate the most important new questions raised by the gender-specific information. We also issue requests for research proposals, which we hope will receive funding from the companies who support us. So far it has been a successful way to answer the questions we think are the most interesting.

We need--and we think we are getting--better models of normal human function and how disease works. It's nice to see the circles expanding that were formed by the falling of the first pebble into the water. Companies like Procter & Gamble are not just working directly with us but are sending representatives to Columbia to canvas the whole university in a rather interesting way. They want to discover if areas exist in which product developments can be accelerated through a union with us. This is one of the achievements of this program of which I am most proud.