Upcoming 60 Minutes Features Importance of Sex-Specific Research
Posted by on February 7, 2014 - 4:21pm

Dr. Teresa Woodruff of the Women’s Health Research Institute has been a consistent voice advocating for sex-based research.  Recently, Dr. Woodruff consulted with CBS on an upcoming feature to shed light on the importance of sex as a research variable—due to the imbalances between male and female research subjects resulting in inadequate health care for women. In a reaction to the FDA recalling the recommended dosage for women taking Ambien, CBS announced today that their 60 Minutes feature this Sunday will investigate drug dosage differences between men and women. Ambien, a popular sleep drug, was discovered to have adverse effects in women last year. Researchers found that women metabolize Ambien differently than men, which leads to a higher percentage of the drug in the female body. The FDA responded to this incident by halving the previously recommended dosage, just in women.

Last year’s Ambien debacle is merely the tip of the iceberg; it is just one example of the importance of sex differences in research! The truth is, little is actually known or studied about how drugs affect women differently than men. Despite ever-growing evidence of sex differences in health research and care, there are no official standards mandating the observation of sex as a variable in drug and device studies. A report on the incidence of adverse drug reactions published at Johns Hopkins Hospital in 1965 revealed “a striking correlation between incidence and the sex of the patient.” This 49-year-old study revealed that women accounted for 73% of the adverse drug reactions tested—and numbers have hardly improved in the half a century since this study was published. This is appalling. The knowledge of adverse drug reactions in women has been publically stated for nearly 50 years! We have this knowledge. We've known this for half a century. It is time to act on this knowledge.

Dr. Woodruff and the Women’s Health Research Institute as a whole are thrilled that 60 Minutes is broadcasting about the potentially catastrophic events that can occur if drugs are not moderated for use on female patients. Dr. Woodruff and colleague Dr. Melina Kibbe were honored to serve as crucial collaborators on this CBS feature. It’s critical that discussion sparks action on this issue. Addressing the differences between men and women at the research level will lead to more accurate science and better-tailored health care for women. Be sure to tune into CBS on Sunday, February 9th at 7:00pm ET to get the full story!

Watch a preview of the feature HERE.

FDA Advocates for Sex as a Research Variable
Posted by on January 24, 2014 - 3:14pm

Men and Women are physiologically different, and it is essential to ensure adequate participation of both sexes in research studies in order to determine sex-based differences in disease presentation, prevalence, and treatment. A press release from Mary Ann Liebert, Inc. Publishers revealed a study that tested the participation rate of women in post-approval studies mandated by the Food and Drug Administration (FDA). Out of their sample size, researchers found that only 14% of studies “included a multivariate analysis that included sex as a covariate” and a meager 4% “included a subgroup analysis for female participants.” These shocking results mean that women are not getting adequate attention in clinical trials, which may result in harmful drug or device reactions in women.

Women vary from men in genetics, hormones, body size, sex-specific physiology, diet, sociocultural issues, and more—therefore, it is incorrect to assume that women and men will react the same way when tested for medical devices and drugs. Most researchers limit sex-based research to areas that are inherently sex-biased, for instance obstetrics and gynecology more often involves women, while urology more often involves men. However, men and women differ in nearly everything from their hearts to their knees—and research needs to keep these differences in mind. If researchers neglect to include sex as a variable in their research, devices and drugs can be approved for public use without fully understanding the reaction such drugs could have on women.

In response to this growing concern, the FDA has implemented new procedures to ensure participation by sex is evaluated in post-approval study reviews. This is certainly a step in the right direction towards recognizing and evaluating sex-specific health responses to new research.

Source: Journal of Women's Health

Weight Management v. Weight Loss: Why Some Women Respond to the Former and Not the Latter
Posted by on September 3, 2013 - 1:30pm

A recent study published by researchers at Duke University highlighted the fact that some populations of women are more receptive to weight-management interventions than programs advertising weight loss. Weight loss is difficult across all populations and many programs aimed at reducing the pounds may end up providing only a temporary reprieve.  As weight gain and obesity are ever-increasing concerns, some researchers have tried to tackle this problem from another angle.  Instead of designing weight loss programs, health enthusiasts should focus on weight management initiatives for certain populations.

Duke University researcher Gary Bennett, PhD, who headed this study, found that African-American women responded more favorably to a weight control program than the traditional weight loss regime. On average, premenopausal African-American women have more weight gain per year than women of other racial and ethnic groups.  Furthermore, by the time African-American women are 59, twice as many “have class 2 obesity as do white women and three times have the prevalence of class 3 obesity.”  Current obesity treatments are not as effective for this population of women, and their underrepresentation in clinical trials studying weight loss interventions points to a dire need for understanding and implementing positive approaches to fight obesity. Re-angling the strategy towards prevention of weight gain requires a less-intensive intervention strategy, which many women are more responsive to.

The clinical trial involved overweight and class 1 obese women between the ages of 25 to 44.  The women were randomly placed in either a health clinic’s usual care cohort or the experimental “Shape Program.” The intervention program had five primary components: tailored behavior modification goals, weekly self-monitoring by interactive voice response, 12 monthly counseling calls by a registered dietitian, tailored skills training, and a 12-month YMCA membership. After the 18 month trial, patients in the “Shape Program” had a “mean weight loss of more than 2 pounds versus continued weight gain” in the control group. These positive results have inspired Duke researchers to continue unlocking the motivations behind weight management and weight loss in women. Furthermore, this research provides an opportunity for clinicians to breach the subject of weight management with their patients through a new lens.

To read more about this study, please click here.

 

Why is sex-based research so important?
Posted by on February 28, 2012 - 9:38am

Research has shown that sex (male vs female) as a variable contributes to differences in the safety and efficacy of drugs, biologics, and devices.   Biologics include vaccines and plasma.   Devices can range from drug eluting stents and pacemakers to implants and contact lenses.

To better understand the biologic basis for sex differences, women's organizations have been advocating for the participation of women in clinical trials.   Several federal offices dedicated to women's health have also worked to ensure mandates that require inclusion of women in federally funded studies are met.  Unfortunately, many privately funded researchers are not mandated to include women, though some have learned the wisdom of doing so.    When both sexes are represented in preclinical (animal) and clinical (human) research, a better understanding of the mechanistic basis for disease susceptibility and response to therapy can be achieved.  This is the first step to personalized medicine.

When we speak of 'sex', we are talking about biology, i.e., the physical characteristics that make us male or female.    'Gender' refers to the differences between man and women due to cultural or social variations in a particular sex (feminine vs. masculine).   Both are important when we do research.

So where do we stand today?   A recent Institute of Medicine report found that women were less than 40% of many research study populations.   When it comes to preliminary animal research (which is used as a basis for future human studies) the data is even worse.  Only 22-42% of studies published in journals on neurosciences, endocrinology, physiology, pharmacology, reproductive medicine and biology reported the sex of the experimental  animals. Furthermore, even when both sexes are included, rarely do researchers report the differences in outcomes by sex.

So what can we do?   Participate in a clinical trial if you have an opportunity.    If your doctor prescribes a medication or procedure that is relatively new, you might ask if the studies included women.    There is an unexplained complacency among the public that research is fairly distributed among the sexes.  The truth is, we still have lots to learn about women-specific health.