Gender-specific health care new but growing
Gender-specific health care new but growing
Pharmacy a leader on informational front lines
"Women are not just small men." That may seem obvious, but Marianne J. Legato, MD, FACP, founder and director of the Partner ship for Women’s Health at Columbia University in New York City, says that’s how the health care industry has viewed women for years. Legato says medical researchers and health care providers must begin to consider the fact that differences exist between the sexes in virtually every system of the body, and use that information to tailor health care to specific needs.
Legato led a panel discussion on gender-specific medicine at the October conference of the Academy of Managed Care Pharmacy held in Atlanta. "The goal should be to use the differences between men and women to improve our current models of health and illness and to enable us to develop more effective remedies to prevent and treat illness," she says.
Gender-specific medicine is still in its infancy, but some of the first and best information has come from pharmacy. "Pharmacy gives us good information on how women metabolize drugs," Legato explains. "Medicine is behind in learning about the differences between women and men."
Phase I clinical trials long have been conducted primarily on the male population. Dosages and therapies were designed for the male body and prescribed for women without any consideration of gender and the effects it might have.
The U.S. Food and Drug Administration mandated the inclusion of women in drug trials in 1993, and the National Institutes of Health published its Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research in 1994. Women still are underrep resented in clinical trials, however, and Legato says researchers have not yet come to terms with the thorny ethical issue of conception and pregnancy during a drug study.
"I think we have to reconsider the way we study drugs in both men and women. We have to address these difficult ethical and liability issues. And until we can come up with some better alternatives such as computer modeling or using tissue parts instead of the whole patient, we aren’t going to make much progress."
Legato praises some drug companies for getting on board, whether their interests are ultimately financial or altruistic. Her work at Co- lumbia, for example, much of which has focused on cancer research, is funded largely by Procter & Gamble.
"Companies are interested because gender differences will affect the way they develop drugs, since they must now include women," she says, adding that there are commercial opportunities for pharmaceutical companies to adapt existing products to address gender differences and to develop gender-specific products.
Ruth Merkatz, PhD, RN, CDE, says Pfizer is taking advantage of those opportunities. It did extensive research on how the selective serotonin reuptake inhibitor Zoloft affected men and women when used to treat post-traumatic stress disorder. She is the director of the Women’s Health team at Pfizer Inc. and is on the scientific editorial board of The Journal of Gender-Specific Medicine (JGSP), where Legato is the editor-in-chief.
"In this case, some studies showed it worked much better in women than in men for this condition, although it has been recommended for use in both genders. The discussion really focused on whether we are really looking at a different mechanism of the disease in women and men. So for me, it was exciting to see this work really making a difference."
Merkatz says the 1990s have been revolutionary in terms of broadening the way drugs are tested and understanding the physiological differences between men and women and how to treat diseases in both genders. Advocates of gender-specific medicine say more changes and research are needed.
Inside the pharmacokinetics
Mary J. Berg, PharmD, is a professor at the College of Pharmacy at the University of Iowa in Iowa City. She’s also on the scientific editorial board of JGSP, which includes a regular feature on drugs and gender. Berg writes in the Septem ber 1998 issue that pharmacokinetics and pharmacodynamics should be studied together to form the basis of solid gender-specific pharmacology, instead of considered separately, as they traditionally have been.1
"This is because a medication may have a shorter half-life but greater sensitivity in one of the sexes that requires no difference in dosage between men and women. With methylprednisolone, for example, the pharmacokinetic parameters of clearance and half-life are faster in women, thereby causing lower levels of the drug in women as compared with men.
"However, the pharmacodynamic measurement of cortisol suppression requires smaller levels of methylprednisolone in women, making females far more sensitive to the effects of this drug. Therefore, despite the gender differences between pharmacokinetics and pharmacodynamics, men and women should receive the same dose of methylprednisolone normalized for weight," she writes.
Janice Schwartz, MD, is professor of medicine and chief of clinical pharmacology and geriatric medicine at Northwestern University Medical School. She’s also a contributor to JGSP. In the September/ October 1999 issue, Schwartz writes, "We are increasingly recognizing that the physiologic differences between men and women result in altered responses to drugs in women compared with men. This is an exciting and rapidly evolving area."2 She summarizes some of the emerging data on gender-related differences in response to pain medication, specifically opioids, nonsteroidal anti-inflammatories, selective cyclooxygenase-2 (COX-2) inhibitors, and other agents. Her focus is on the clinical consequences of those data.
She found that with opioids, pain relief with fewer side effects than morphine-like medications may be achieved with kappa-opioids in women but not men, and that quantitative differences in responses to NSAIDs may occur in men and women. COX-2 inhibitors are effective in both genders, but women are more likely to have sulfa allergies, which are a contraindication to these drugs. Schwartz concludes that no gender-related differences have been found in response to topical lidocaine. "These differences suggest the importance of developing gender-specific strategies for pain relief, and highlight the need for further investigation of gender-related pain treatment strategies."
Direct to consumer
Another concern is simply getting the information out. "We’re trying," says Legato. "We have a series of pamphlets available for patients, and we’re involved in educational campaigns. I talk to women all over the country. They love the information. I think it is sometimes a reflex for physicians to tell a woman, I’ve never heard of that, so you must be hysterical or something.’ I think women are now more confident about pushing for answers and better information."
Merkatz agrees. "The era of women just going to a doctor and being told what to do is over. In terms of the drugs they take, I think they should know the name; they should know why they are taking it and what the side effects are. My real goal is for them to ask the doctor or pharmacist if the drug has been tested in women as well as men, and whether there are differences in the way the drug will affect them in comparison [to men]."
References
1. Berg MJ. Drugs, vitamins, and gender. J Gender-Specific Med 1998; 1(1). On-line at www.mmhc.com/jgsm/articles/ JGSM9809/Berg.html.
2. Schwartz JB. Gender differences in response to drugs: Pain medications. J Gender-Specific Med 1999; 2(5). On-line at www.mmhc.com/jgsm/articles/JGSM9910/pharm.html.
• Marianne J. Legato, MD, FACP, Founder and Director, The Partnership for Women’s Health at Columbia University, New York, NY. Telephone: (212) 305-9514.
• Ruth Merkatz, PhD, RN, CDE, Director, Women’s Health Team, Pfizer Inc., New York City. Telephone: (212) 733-2721.
• The Partnership for Women’s Health. Web: partnership.hs.columbia.edu.
• The Journal of Gender-Specific Medicine. Web: www.mmhc.com/jgsm/index.shtml.
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