Posted by on April 24, 2015 - 9:39am

The Women's Health Research Institute has teamed up with North American leaders to advocate for sex inclusion in basic research.   Teresa K Woodruff, PhD, director of WHRI, and Melina R Kibbe, MD, WHRI Leadership Council member and vascular surgeon have joined nine other academic leaders in sex based medicine on an opinion piece entitled Sex inclusion in basic research drives discovery.  Published in the April 2015 edition of PNAS the article reinforces why sex inclusion is one of "most underappeciated differences in biomedical research".   It addresses the objections that have been made against inclusion of females in preclinical research by naysayers who are resisting a more equitable policy.  

While most of the discussion on this topic has revolved around biological sex differences, this article begins the discussion of the complex interdependency of sex and gender in animal research.

This article emerged from a workshop held at Stanford University in September 2014.  Besides Northwestern Feinberg School of Medicine, the other authors represent John Hopkins, Stanford U, U of California Irvine, U of Toronto, Georgia State, U of Maryland, McGill U, U of California Berkeley.

Posted by on April 8, 2015 - 10:37am

As we learn more about sex differences, it is  easy to understand why both men and women need to be included in clinical research.  But why does the sex of a cell used in basic research matter?    Cell lines and primary cells are often used by basic scientists in proof-of-concept experiments and when trying to figure out how biological mechanisms work.  These early findings help provide valuable clues for developing new drugs, treatments and diagnostic models that eventually can be applied to humans. 

Recently, researchers in Korea have reported that the sex of cell lines and stem cells (the start of the science pipeline)  is often ignored.  Furthermore, most scientific journals still do not require authors to include the sex of the cells used in an experiment. 

A similar problem exists when using animals like mice and rats---though that is starting to change due to outcries from advocates of sex inclusion in ALL research.

Many researchers use commercially available cells so this problem is not just one for the scientific community to solve.   It also behooves commercial enterprises to help change the paradigm of "sexless" experimentation by clearly defining (and providing) the sex of their biological products. This would help researchers to evaluate sex as a variable and ensure the sex distribution of cells is more balanced.  These changes will help advance science that is more accurate and unbiased.

In the end, to truly advance sex based research, we must ensure that changes are made in partnership with all members of the scientific pipeline:  the cell and animal suppliers, the bench scientist, the clinical scientist, the Institutional Review Boards who approve human study designs, the funding agencies, and the Journals who publish scientific outcomes.

With the new focus on "precision medicine", advocates must continue to make sure that sex differences are part of the equation.

Source:  AJP-Cell Physiolo.doi:10.1152/ajpcell.00369.2014


Posted by on November 25, 2014 - 4:16pm

In response to the call for more sex inclusion data in drug studies, the FDA has developed  Drug Trials Snapshot a pilot project to provide information about the sex, age, race and ethnicity of clinical trial participants for a small group of recently approved drugs. In addition to information about who participates in the trial, each Snapshot also includes information on how the study was designed, results of the efficacy and safety studies and, if known, differences in efficacy and side effects among sex, race and age (referred to as subgroups).

While this is certainly an important step toward inclusion, the recently posted six examples reinforce the lack of racial minorities in all studies and the lack of women in many studies.   These drugs were approved over a two month period in 2014.  In summary, of the six examples provided:

  • All studies, except one, had more males than females in the clinical pool
  • All studies except one, reported that the drug achieved the desired response (efficacy) in both in men and women (one study showed the the drug trended in favor of females though only 23% of the study subjects were female)
  • Four studies indicated the side effect (safety) profile was similar in both sexes; one study did not evaluate safety; and one study found increased risk for women even though only 24% of the study subjects were female).
  • All studies showed a considerable lack of minority race/ethnic participants .

"‘This new report provides a clarion call to action for the scientific, medical and regulatory communities to ensure representational science, medicine and the approval process. By taking strong, decisive action today, we can be assured a healthier tomorrow for all people." says Teresa K. Woodruff, PhD, director, Women's Health Research Institute and a national leader in the movement toward sex equity in science.


Posted by on November 4, 2014 - 4:49pm

The recent announcement by the NIH that it would change its funding decisions to address the lack of female animals and cells in early bench research, was indeed good news.  Yet, to date, no funding rules have changed.  To be fair, the NIH did issue a request for information from the research community so they could better understand the barriers to inclusion.  They are now reviewing those comments.

According to an Oct. 28 article in the Scientific American,  "once in place and codified, the requirement would be a major shift for the nations' biomedical labs, many of which study mostly or exclusively male animals.   One estimate found that pharmacology studies include five times as many male animals as female ones..."

The announcement did shake up the scientific community and has generated plenty of  excuses ---too costly to include both sexes, not all conditions will have sex differences, etc.   It behooves the NIH to carefully consider all public comments and come up with thoughtful guidelines to insure inclusion but not hamper scientific progress.   We also need to remember that sex differences are not just about females. A drug may not work well in women but it could be a lifesaver for  men---and this alone would justify the importance of good science that includes and analyzes outcomes reported by sex!

Those of us who have been advocating to include more females in research are impatient (it's been over 20 years since the NIH required the inclusion of women in clinical trials!!!--a goal not quite reached!!)...however, it is important that we define  rules that are fair, enforceable, manageable and result in the best science  "our tax dollars  can buy!"


Posted by on September 3, 2014 - 11:58am

The Women’s Health Research Institute at Northwestern University applauds the recent release of a new Action Plan developed the Food in Drug Administration in response to a Congressional directive to look closer at the inclusion and analysis of demographic subgroups including women and minorities in applications for new drugs and devices.

The Action Plan to Enhance the Collection and Availability of Subgroup Data, released August 18,  includes 27 action steps that address the quality of data collection,  reporting and analysis; barriers to subgroup inclusion in clinical trials; and availability and transparency of sub group data in new drug/device applications.    Members of the WHRI Leadership Council, composed of researchers, educators and clinicians at Northwestern Medicine committed to women health and the study of sex differences will be reviewing and commenting on the plan.   In addition, several Council members will be participating in workgroups helping the National Institute of Health develop guidelines to increase the inclusion of female subjects in all basic science, translational and clinical research.


Posted by on May 20, 2014 - 2:48pm

Stephen Colbert's show  featured clips from the Women's Health Research Institute's recent 60 Minutes segment on sex inclusion in research. More than ever, it is essential to include male and female animals at the research level to ensure that sex is examined as a variable that can lead to different treatments and medications for different genders. The Institute has be advocating for full inclusion in human, animal and cell research!

Watch The Colbert Report clip now!