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A team of Northwestern University scientists including a member of our Institute team met October 18, with Environmental Protection Agency (EPA)in Washington, D.C., to advocate for important changes in the agency’s guidelines for reproductive health research.

“The problem is current research assessing the risk of toxins on reproductive health is not being uniformly investigated in both sexes and across the lifespan,” said Kate Timmerman, program director of the Oncofertility Consortium at Northwestern University. The reproductive health guidelines have not been updated since 1996 and need to be revised to reflect new research findings.

The Northwestern team asked the EPA to expand the definition of reproductive health beyond pregnancy to include the lifespan of an individual.

“Reproductive health is important across the entire lifespan because your endocrine system affects your bone health, cardiovascular health, and other systems in the body,” Timmerman said. Endocrine disrupters, sometimes triggered by environmental factors, can lead to increased risk for stroke and heart attack as well as osteoporosis.

The Northwestern scientists also requested that all EPA-sponsored research require appropriate testing in both sexes. Currently many toxicity studies are only conducted in male animal models with the assumption that females are affected the same way, but that isn’t necessarily true.

“What happens now is if researchers don’t see an effect in males, they won’t look in females,” Timmerman said. “But we know certain toxins in the environment can have a significant effect on females and not males and vice versa.”

Timmerman and colleagues  presented a white paper to the EPA on how to improve and update the guidelines.  See our previous blog for more details.

In addition to Timmerman, other Northwestern scientists meeting with the EPA include Kimberly Gray, professor of civil and environmental engineering at Northwestern's  McCormick School of Engineering and Applied Science; Mary Ellen Pavone, MD, assistant professor of obstetrics and gynecology at Northwestern University Feinberg School of Medicine and a physician at Northwestern Memorial Hospital; and Francesca Duncan, reproductive scientist/research associate in the lab of Teresa Woodruff, PhD, chief of fertility preservation at Feinberg and director of the Oncofertility Consortium. Woodruff is also the founder and director of the Women's Health Research Institute at Northwestern who host this blog site.

Author:  Marla Paul , Northwestern NewsCenter

Oral medication for treating a type of incontinence in women is roughly as effective as Botox injections to the bladder, reported researchers who conducted a National Institutes of Health clinical trials network study, with each form of treatment having benefits and limitations.

After six months, women in both treatment groups said that the average number of daily episodes had declined from about five per day to about 1-2 per day.

In the study, the researchers compared the effectiveness of Botox injections to oral anticholinergic medications for treating urge urinary incontinence in women in nearly 250 women, average age 58.  Anticholinergic medications reduce bladder contractions by targeting the bladder muscle through the nervous system. Many women who take anticholinergic medications relate having unpleasant side effects, including constipation, dry mouth and dry eyes.

The proportion of women receiving Botox whose urinary leakage completely went away six months after starting treatment (27 percent) was twice that of the group taking oral medication (13 percent). Women in the Botox group were more likely to experience incomplete bladder emptying or bladder infections, while the women taking the medication were a little more likely to report that they had dry mouth — a common side effect of the medication.

The study focused on treatment for urge urinary incontinence — the unpredictable release of urine shortly after feeling the urge to urinate. Information on urge incontinence as well as other kinds of incontinence is available from the National Institute of Diabetes and Digestive and Kidney Diseases

Women are twice as likely as men to experience urinary incontinence, and older women are more likely to experience it than are younger women. An estimated 15.7 percent of U.S. women experience urinary incontinence. Pregnancy and childbirth, menopause, and the structure of the female urinary tract account for this difference.

The findings appear online in the New England Journal of Medicine.

Urge incontinence results from unpredictable activity of the bladder muscles, the cause of which is often unknown. Botox injections work by relaxing the overactive muscles. In August 2011, the U.S. Food and Drug Administration approved Botox, or onabotulinumtoxinA, for the treatment of urge urinary incontinence when the cause of the overactive bladder is known, and due to spinal cord injury, multiple sclerosis or other nervous system disorders.

OnabotulinumtoxinA is not FDA-approved to treat an overactive bladder without a neurologic cause, even when other therapies have been found to be ineffective.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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-20^th 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.