Posted by on August 26, 2013 - 11:00am

The United States Food and Drug Administration recently approved the first non-hormonal solution to hot flashes associated with menopause; it is the drug Brisdelle.  Nearly 75% of menopausal women experience hot flashes, which are extreme feelings of warmth accompanied with redness and sweating.  While hot flashes can spread over the entire body, they are mostly concentrated in the face and neck. Hot flashes are the most common side effect of menopause, and while the exact cause of hot flashes is unknown, a great deal of research is conducted on alleviating this discomfort for women. This new drug Brisdelle offers a non-hormonal alternative to the hormone therapy options currently available.

Brisdelle contains paroxetine mesylate, a serotonin reuptake inhibitor, which differs from other FDA-approved hot flash treatments that contain the hormones estrogen and progestin. Brisdelle underwent two randomized, double-blind, placebo-controlled studies with 1,175 postmenopausal participants and was found to produce positive results compared to the placebo control. The drug is taken once a day and some side effects include nausea, vomiting, fatigue, and headache.  The director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, Hylton V. Joffe, M.D., M.M.Sc., expressed that Brisdelle is a breakthrough product for women “who cannot or do not want to use hormonal treatments” for hot flashes associated with menopause. Brisdelle can now be added to the many treatment options available to women who experience symptoms related to menopause.

To read more about Brisdelle, click here.

 

Posted by on June 18, 2013 - 10:39am

 

Policy changes are necessary to decrease the death rate of pregnant women in developing countries.  Research, according to Dr. Stacie E. Geller, does not end once scientists publish.  The true battle is implementing that research to affect global change.  Dr. Stacie E. Geller, Director of the Center for Research on Women and Gender at the University of Illinois at Chicago College of Medicine, puts research into practice by providing safe, affordable medication to pregnant women in developing countries.  Dr. Geller spoke last week at a forum held at Northwestern University's Feinberg School of Medicine and presented her research on Postpartum Hemorrhaging (PPH) and its dangers to women in developing countries.

In 2008, there were an estimated 358,000 maternal deaths occurring during childbirth, 99% of these deaths occurring in developing countries. Such global disparities are reflected in the limited access to skilled birth attendants, restricted access to medications, rudimentary delivery facilities, and complications surrounding reliable transportation and communication in developing countries.  Postpartum Hemorrhaging (PPH) is the leading cause of maternal mortality worldwide, accounting for 30-50% of all maternal deaths in Africa and Asia alone.  While the drug Oxytocin is used to prevent PPH in developed countries, developing countries do not have the resources to preserve and administer this drug.  Dr. Geller began studying the drug Misoprostol as an alternative to Oxytocin to be used in developing countries due to its low-maintenance storage and cost-effectiveness.

Dr. Geller, along with a team of researchers traveled to communities in India and Ghana to study Misoprostol for prevention of PPH in home-birth settings.  Their research proved that Misoprostol provides a safe and efficacious alternative to Oxytocin in these communities, but Dr. Geller didn’t stop there.  She worked with the Indian Ministry of Health to approve the use of Misoprostol for PPH prevention by Auxillary Nurse Midwives (ANMs). In Ghana, Dr. Geller engaged with health stakeholders at all levels, conducted community sensitization and trainings, monitored the safe use of Misoprostol, and empowered women to take control of their health.  Furthermore Dr. Gellar’s success strengthened the networks of health providers, decreased maternal mortality and morbidity (due to PPH), and established a model for all of Ghana and other developing countries.  Dr. Geller was a primary advocate credited for Misoprostol’s addition to the WHO’s list of essential medications for the prevention of PPH in 2011, an accreditation which has a lasting global impact.

Dr. Geller stresses the importance of political will in enacting policy changes from scientific research.  Government engagement is critical in reducing maternal deaths, and a scientist’s work is not over once research is published.  Advocating for women’s sexual and reproductive rights, their access to equal treatment, and their right to effective medicine should inspire all researchers to utilize their knowledge to facilitate global change.

To read more about Dr. Stacie Geller and her ongoing research, please click here.

 

Posted by on May 31, 2013 - 8:09am

Did you know that 15% of women are diagnosed with Hypoactive Sexual-Desire Disorder (H.S.D.D)?  This disorder is characterized by a lack of female desire coupled with significant emotional distress, primarily in post-menopausal women.  A recent article in The New York Times placed Dutch psychopharmacologist Adriaan Tuiten in the spotlight for his new research studies on sex differences.  Tuiten, who has spent his career studying biological and psychological interactions, may have unlocked some the intricacies of female desire via his study on possibly the first, successful female-desire drug.

The publicized misnomer that this drug will be a “female Viagra” simplifies its actual complexity.  Ongoing studies in this field since 1998 unequivocally show that the male and female impetus for desire differs significantly, especially in the brain.  While both male and female desire stem from similar areas of the brain, studies show that, over time, female desire wanes at a significantly higher rate than observed in males.

How can women combat this atrophy of desire?  Tuiten tested and observed 420 female subjects beginning in the fall of 2011 to answer just that.  His drugs Lybrido and Lybridos are expected to be presented shortly to the F.D.A., and may be on the market by 2016 following a larger-scale trial.

Guest Author:  Megan Castle

 

 

 

Posted by on May 25, 2013 - 2:27pm

Did you know there are differences in the physical, psychological, social, and spiritual effects of substance use and abuse on women and men?  Those differences have implications for treatment in behavioral health settings.  The U.S. Substance Abuse and Mental Health Service Administration (SAMHSA)  offers two reports that emphasize  gender-specific research and best practices, such as common patterns of initiation of substance use among women and men and specific treatment issues and strategies.   These reports  demonstrate how important it is to advocate for sex and gender based research across all body systems, something  our Institute is striving to make happen.

Get the Guide Addressing Women   |

Get the Guide Addressing Men

Posted by on April 16, 2013 - 10:27am

Women are much less likely than men to be diagnosed with mesothelioma cancer – an approximate four-to-one ratio – but there is little to suggest a gender-based defense or susceptibility. The discrepancy centers more on blue-collar occupations and workplaces that have been dominated traditionally by males.

Mesothelioma is a rare cancer caused by exposure to asbestos, a naturally occurring mineral that played a major role in the building of America throughout much the 20th century. Although the use of asbestos has dropped dramatically in recent decades – by comparison very little is actually used in America today – the risk of exposure lingers from all that remains in the buildings and the products left behind.

There also is the lengthy latency period (10 to 60 years) between exposure to asbestos and symptoms that can be diagnosed. An estimated 3,000 cases of mesothelioma are diagnosed annually in the United States. The average life expectancy for a patient is only one year, but of course this can fluctuate because of a patient’s age, race, gender and a number of other demographics.

“People still are getting sick from being exposed to asbestos,” said Ken Rosenmen, M.D. Division of Occupational and Environmental Medicine chief at Michigan State University. “Asbestos was once a useful product – and that’s why it was used so much – but we’re still paying the price for that.”

Michigan State University has been tracking mesothelioma cases throughout the state since 1985, reporting that only 25 percent of the cases involved women, which is comparable to trends throughout the country. The United States Centers of Disease Control (CDC) tracked 18,083 mesothelioma deaths during a recent six-year period and found that 19 percent (3,485) of cases occurred in women.

One study from Turkey determined that 160 women and only 115 men – from a pool of 100,000 exposed people – were at risk for mesothelioma cancer.

More definitive, though, is the type of mesothelioma that varied from men to women.  Among the men, 90.2 percent of cases were pleural mesothelioma (forming in the lungs), 8.3 percent were peritoneal mesothelioma (abdomen), and 1.1 percent was from other regions. Among the women, 71.1 percent of cases were pleural, 24.3 percent were peritoneal, and 3.1 percent were from other regions.

Mesothelioma for both men and women is generally difficult and slow to diagnose because symptoms often mirror those of less serious illnesses. Although millions of people year after year are exposed to asbestos in either the home or the workplace, only a small percentage develops mesothelioma.

There are stories about mesothelioma survivors, both men and women, with either pleural or peritoneal mesothelioma on the Wall of Hope section at Asbestos.com. Regardless of sex, both men and women can survive much longer with mesothelioma cancer than in the past thanks to innovative treatments.

Guest Author Tim Povtak has been a writer for Asbestos.com since 2011. Prior to joining Asbestos.com, he was an award-winning newspaper journalist.

 

Posted by on April 10, 2013 - 12:17pm

Last week Health Canada released an official warning on the association of increased risk of bone fracture with the frequent use of Proton-Pump Inhibitor (PPI) medications, used to treat symptoms of  acid reflux and gastroesophegeal reflux disease (GERD).   While an important step, this warning, like the U.S. FDA’s before it, does not go far enough in ensuring that the public is aware of the immense risks posed by continuous dosages of PPI pills, particularly to women.

According to the alert, “several scientific studies suggest that PPI therapy may be associated with a small increased risk for fractures of the hip, wrist, or spine related to osteoporosis, a disease resulting in the weakening of bones.”  They added that “the risk of fracture was higher in patients who received multiple daily doses of PPIs and therapy for a year or longer. Additional risk factors for osteoporosis, such as age, gender and the presence of other health conditions, may also contribute to the increased risk of fractures.”[1]  Though the alert mentions that gender could also contribute to the increased risk, what the alert fails to mention is that women face the greatest risks when taking these pills.

Last year, a team of researchers from Harvard Medical School and Boston General Hospital in a study  focusing on over 80,000 post-menopausal women, found that among those who had taken PPI pills 3-4 times per week over a two-year period had an increased risk of hip-fracture of 35%.  For current and former smokers, the increase was as high as 50%.[2] A common theory for the cause of this increase is the fact that the pills inhibit the body’s ability to intake calcium, an essential element for maintaining strong bones.

These aren’t the only problems associated with PPI pills, however.  Though the warning labels on nearly all PPI’s, including those sold by major brands like Prilosec®, Nexium®, and Prevacid®, state that the pills should be taken for a maximum of fourteen days annually, many patients continue with daily therapy for years.  These medications,, which treat short-term symptoms of acid reflux by blocking the stomach’s natural production of acid, have serious negative side-effects.  According to the FDA, prolonged dosages of PPI pills can lead to an increase in risk of pneumonia, heart arrhythmia, and Clostridium difficile–associated diarrhea.[3]  Worse, according to a study by Dr. Blair Jobe at the University of Pittsburg, those taking PPI pills regularly to treat mild symptoms were 60% more likely to suffer from Barrett’s Esophagus, which often leads to esophageal cancer.[4]

In response to Health Canada’s warning, Dr. William Dengler, Medical Director of RefluxMD, issued this response: In light of a recent warning by the Canadian federal government,  PPI users and their physicians should carefully consider the long-term side effects when using these drugs.  These same side effects are responsible for the U.S. FDA placing this class of drugs on their "watch list."  With multiple governments warning patients that the side effects for acid reflux medications are troublesome, the media should play a larger role in combatting the over-saturation of television marketing for the drugs.”[5]  More importantly, however, consumers, particularly women, should pay careful attention to the risks associated with PPI pills before starting treatment, as well as consider natural alternatives that could help to treat long-term causes of acid-reflux, rather than short-term symptoms.

Guest Blogger:  Alexander Michael Jakubowski, Northwestern Undergraduate Student

Posted by on March 26, 2013 - 10:42am

Diabetes affects the body in many ways.  Celebrate Diabetes Alert Day (March 26) by learning how diabetes can effect the female body!   Take a few minutes to look at this female anatomy chart to learn more!

 

Posted by on February 18, 2013 - 11:55am

Rheumatoid arthritis (RA) strikes three times more women than men and researchers in Europe may have found a clue.   Scientists at the Arthritis Research UK Epidemiology Unit at the U of Manchester have discovered 14 new genes that can lead to RA, adding to the 32 other genes that have already been identified.  The researchers latest study published in Nature Genetics, has reported genes that are specific to the female X-chromosome.  According to Professor Alan Silman, medical director at the Research Unit, "This is the first time that a genetic association has been established between RA and the X chromosome."

 

Posted by on October 17, 2012 - 1:18pm

Our success as researchers is measured by our ability to translate our findings, according to the often-used phrase, from bench to bedside.  In other words, if we can apply our basic science findings to clinical care, we have the ability to impact countless lives.  This pipeline is a national priority, and in fact, many Academic Medical Centers have established programs to facilitate rapid clinical translation.  However, equally as important, and perhaps less appreciated is the need to translate basic science findings into relevant policies that protect and influence the general public.

Reproductive science and medicine are greatly impacted by the environment. Trends in reproductive health demonstrate that reproductive function has declined since the mid-20th century in certain populations and locations [1].  Coincident with this decline in reproductive function is the large and ever-increasing number of natural and synthetic chemicals to which humans are exposed [2, 3].  Basic, clinical, and epidemiological research has demonstrated that exposure to certain compounds and contaminants, such as Endocrine Disrupting Chemicals (EDC), can have negative impacts on reproductive health. These compounds interfere with the production, transport, activity, and metabolism of natural hormones in the body. As we, as basic scientists and clinical researchers, understand the mechanisms by which these environmental exposures to such compounds affect developmental, reproductive, and neuroendocrine functions, we must also be able to inform and educate the implications of these specific reproductive health findings to the decision makers in Washington, DC.  The question is: How?

In  2010, the Program on Reproductive Health and the Environment at the University of California, San Francisco developed the Reach the Decision Makers Fellowship with the exact intent of providing interested individuals and teams with the resources to advance science-based policy solutions.  Specifically the Reach Program serves to provide individuals with a distinct interest in reproductive health and the environment, with mechanisms to interact with the United States Environmental Protection Agency (US-EPA).  Over the past two years, the Reach program directed by Tracey Woodruff, PhD, MPH, an esteemed leader in the field, has trained over 75 individuals nationwide based on the principles of participatory democracy, social justice, and taking action to prevent harm (for more recent news about the Reach Program, check out the following blog written for the Physicians for Social Responsibility).

Table 1. Our interdisciplinary team

To take advantage of this unique program, we assembled an interdisciplinary team of six individuals committed to reproductive health and the environment (Table 1).  Our team is comprised of professionals from academia, health care, government, and the community, and collectively we have experience in research, policy, advocacy, teaching, and communication (Table 2).   Prior to joining the Reach Program, our team has worked together at Northwestern University and Northwestern Memorial Hospital in various settings including the Women’s Health Research Institute, the laboratory of Teresa K. Woodruff, PhD, the Oncofertility Consortium, the National Physicians Cooperative, the Oncofertility Saturday Academy, and the proposed Northwestern University Superfund Research Center in Reproductive Health Hazards. We joined the Reach Program with the goal of ensuring that the manner in which the US-EPA evaluates reproductive health and toxicity is in line with the current state of scientific knowledge.

Table 2. Team backgrounds

As Reach Program fellows, we have participated in a rigorous training program to define a reasonable “ask” in relation to our goal, to perform research on the topic, and to learn how to identify the key decision makers within the US-EPA who will listen to our request and affect change.   Over the past six months, we have engaged in a first trip to Washington, DC where we attended presentations from policy experts regarding the US-EPA hazard evaluation procedures and how scientists can inform the agency on emerging research regarding the effects of environmental toxins on reproductive health. Meetings at the US-EPA gave the team a greater understanding of the overall institution and current initiatives of the agency. We have also participated in nine webinars covering topics spanning from the effects of environmental toxins on reproductive health to identifying policies and policy makers at the US-EPA.

We also developed our policy project by systematically gaining an understanding of the US-EPA as an agency and the documents and guidelines that inform its staff. Members of the US-EPA helped us identify a principle document in reproductive health and the environment, the Guidelines for Reproductive Toxicity Risk Assessment. This document was written in 1996 and has not been revised since that time so our group decided to focus on some of the significant opportunities to improve upon the guidelines. Since 1996, the state of reproductive research has advanced and we identified three specific areas of research that could be prioritized during the updating of the Guidelines for Reproductive Toxicity Risk Assessment, as follows:

  • While the Guidelines acknowledged the importance of non-reproductive consequences of an impaired reproductive system, such as osteoporosis and increased risk of stroke, they did not include these outcomes as endpoint measures for further research study.
  • Model organisms are necessary for advancing research in reproductive and environmental health. In the Guidelines, the authors state that effects seen in one organism may be assumed to occur in another. While this is meant to be protective for unstudied species, it is also true that certain species are ideal to investigate different aspects of science and health. Thus, we encourage the study of multiple model organisms in reproductive health and the environment.
  • Research advances over the past decade have shown that significant sex differences are seen in the way males and females respond to different drugs and environmental toxins. This warrants the need to include both sexes in reproductive research, a consideration that could strengthen the updated Guidelines.

Our team developed these ideas into a position statement to inform US-EPA staff and interested parties of the need to advance reproductive health and the environment. This project culminates tomorrow, Thursday, October 18, 2012 when the team will fly to Washington, D.C. to meet with Nica Louie (Environmental Health Scientist at the National Center for Environmental Research), Brenda Foos (Director, Regulatory Support and Science Policy Division, Office of Children's Health Protection), and Daniel Axelrad (Environmental Scientist, Office of Policy) at the US-EPA. We hope to gain a greater understanding of the procedures of the agency at these meetings and advocate for the need to update Guidelines for Reproductive Toxicity Risk Assessment.

Virginia Neale, the Associate Director of Government Relations for Northwestern University, will also join the team and bring her expertise in bridging academia and the government to the project. Neale also facilitated a meeting between team members and legislative assistants to the House of Representatives congresswoman Jan Schakowsky (D-IL), who resides over Northwestern University’s Evanston campus. As congressional requests to the US-EPA are often needed to gather teams of experts and update guidelines, we will ask Schakowsky’s office to make such a request to gather the National Academy of Sciences and revise the Guidelines for Reproductive Toxicity Risk Assessment.

The work done this week, and over the past six months, by this interdisciplinary group, will build the foundation for the team to continue communicating evidence-based reproductive health findings to the policy makers in Washington D.C. who have the ability to affect change on a federal level. The relationships we develop this week will be fostered in the coming months and years to ensure that reproductive health is promoted at the highest level within the EPA and advocate that US-EPA guidelines are updated to include the most recent advances in reproductive research

This blog was Contributed by Francesca Elizabeth Duncan, PhD and Kate Waimey Timmerman, PhD    Read more about the team here in a Northwestern University press release.

1.         Woodruff, T.J., J. Schwartz, and L.C. Giudice, Research agenda for environmental reproductive health in the 21st century. Journal of epidemiology and community health, 2010. 64(4): p. 307-10.

2.         Sutton, P., L.C. Giudice, and T.J. Woodruff, Reproductive environmental health. Current opinion in obstetrics & gynecology, 2010. 22(6): p. 517-24.

3.         Woodruff, T.J., et al., Proceedings of the Summit on Environmental Challenges to Reproductive Health and Fertility: executive summary. Fertility and sterility, 2008. 89(2 Suppl): p. e1-e20.

Posted by on September 14, 2012 - 11:42am

In the past, researchers excluded women from many studies and applied information based only on male participants to the experience of both men and women. Researchers did not design research to specifically investigate the differences between males and females because many people did not believe such differences existed. We now know many differences do exist and play a major role in the biological and physiological experiences of women and men.

To learn more about clinical trials and learn if we are making progress in the inclusion of women by reading our latest e-newsletter on the topic by clicking HERE.

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