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Differences help target needs

Sherry Marts is vice president for scientific affairs for the Society for Women’s Health Research. She received her doctorate from Duke University and did a post-doctoral fellowship at UNC-Chapel Hill.

Q: Why is sex-based research a big deal?

A: I think everyone is looking forward to the day when you can walk into the doctor’s office and take a drop of blood or spit and put it on a gene chip reader and essentially find out what’s the diagnosis, the prognosis, the potential treatment, your risk -- get all your questions answered based on your individual biological makeup.

We’re probably many years from that. What we are able to do now is use some of those tools to individualize medical care based on some very wide categories. Sex is a big one.

Q: Why has it taken so long for science and medicine to begin asking questions about biological differences between the sexes?

A: Essentially, there was this notion that you could study males and just extrapolate results to females. That approach was taken in developing and testing new medicines and a lot of laboratory investigations.

Your readers have heard stories about theories about female biology -- that our brains were smaller and we couldn’t be educated, or because we are the bearers of children, we were biologically destined to be homemakers. So there was a tendency in the first wave of the feminist movement to deny that there were differences, because those differences were used as an excuse for discrimination. It’s one of the things that our organization has been very conscious of. We’re really emphasizing that different doesn’t mean better or worse.

Q: What are some key differences?

A: There’s a clear example in that our livers may function differently, but ultimately, they function perfectly adequately. The classic example might be doing shooters in a bar. If a woman is the exact same weight and has the same fat and muscle and she ingests alcohol at the same rate as a man, she will get more inebriated faster than he will. Women’s stomachs (where alcohol is absorbed) empty slower than men’s, and women’s livers make less of the enzyme that breaks down your alcohol.

Think about the fact that alcohol is a drug, and for a long, long time, medicines that came out on the market were tested in very, very few women. So these medications were approved as being safe and effective based on testing on men, and then thousands, perhaps millions, of women were taking them. Think about what we’ve just learned about alcohol, and wouldn’t that give one pause that maybe this isn’t a good idea? That helped get study guidelines changed.

Q: Changed how?

A: , the Food and Drug Administration said you couldn’t put women of childbearing potential into a drug study unless the drug was for a condition that only affects women or it was a life-threatening condition for which there was no other therapy. That had been a fairly standard practice because of the concern that women’s hormonal cycles would make the study results too confusing. The excuse shifted after thalidomide to making sure we’re not giving women experimental drugs and then they get pregnant. Even if you were abstinent, if you were cycling and had a uterus, you were not in the study.

When the first cholesterol-lowering drug came out, and the American College of Cardiology wanted to write guidelines on what these medicines were good for and who should take them, they had to say, “We cannot tell you how to use these drugs in women because we don’t have enough information on how they work in women.”

In 1993, the FDA reversed their guidelines. Now you must include women and minorities unless there’s a good scientific reason not to; for example, it’s a male-only condition. Or they can make an exception if it’s a drug that is strongly suspected or known to cause birth defects.

We’re not clear that the FDA is looking closely enough at the differences that emerge.

There are three questions to ask: Is this drug safe and does it work in men? Second is: Is it safe and does it work in women? And third would be: Are there differences in the safety profile or effectiveness in men and women, and what does that tell us about the disease, the drug and the system it’s affecting, and what can we take away from that?

Q: What are some significant findings of sex-based research?

A: Several examples have had real significance in terms of health care. The first is with HIV infections. As more women were becoming infected with HIV, there was a realization that women advance from being infected to having full-blown AIDS at a lower viral load, at a higher T-cell count (which is a measure of how well your immune system works). Often times, the decision to start giving anti-HIV medications was made based on viral load and T-cell count. They would wait until the absolute last minute to give you anti-HIV drugs, because the virus could develop resistance.

There were some other issues dealing with side effects and dosing. That combination of not having the right dose and dosing schedule and giving the drugs way too late was having a detrimental effect on women with HIV.

Cardiovascular disease is the leading killer of women. But a woman’s symptoms of a heart attack are, on the whole, different than men’s. Cardiovascular textbooks talk about symptoms and list male-typical symptoms: the crushing pain, the profuse sweating, the numb left arm. Then they list atypical symptoms, and they’re all the ones for women, like discomfort in the center of the chest that is often interpreted as heartburn, nausea, jaw pain and shoulder pain.

Women were going to emergency rooms or doctors’ offices and saying they had chronic heartburn and a sore jaw, and the doctor would send them to the dentist and give them some antacids, when in fact they were having a heart attack.

Now, if a woman turns up with the symptoms, they get an EKG and, we hope, the care that they need. It’s been a struggle to get those atypical symptoms reclassified as women’s symptoms.

A third good example is lung cancer, the leading cancer killer of women. Women seem to be more susceptible of developing lung cancer at a lower level of exposure to smoke.

Q: What areas are promising for sex-based research?

A: There are several areas where we’re going to see some interesting breakthroughs. One is pain and pain relief. We’re learning that the experience of pain is very different depending on whether you are male or female. What we need to know is how it is that men and women experience pain differently and what does it mean in terms of effective pain relief?

Immunology is another area. Early studies show that women may have a less robust response to certain vaccines. What does it mean in how we design and give vaccines to men and women?

The other area is autoimmune disease, including things like Type 1 diabetes, multiple sclerosis, rheumatoid arthritis and lupus. Most of these affect more women than men.

We’re trying to get at how are our immune systems are different and what that means in terms of prevention, screening, diagnosis and treatment of disease.

Q: Meanwhile, what’s a patient to do?

A: Stay educated and up to date. Ask questions. Insist that your medical care take into account the most recent findings. Our Web site, www.womenshealthresearch.org, is a good source of general information. Another is the Office of Women’s Health in the U.S. Department of Health and Human Services, www.4women.gov.

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