NIH Request for Information: Consideration of Sex as a Variable in Research

Help Advocate!! Send a comment…Keep the pressure on!!!

In a May 14, 2014, Nature commentary (see Nature. 2014 May 15;509(7500):282-3.), NIH leadership stated an intention to develop and implement policies requiring applicants to consider sex as a biological variable in the design and analysis of NIH-funded research involving animals and cells.    Animal studies have typically focused on males, and investigators studying cell models have often not reported the sex of the individual from which the cells were obtained.  Even if both sexes are included in a study design, resulting data may not be analyzed or disaggregated by sex. The failure to consider sex as a variable may leave critical knowledge gaps and undermine the quality and  reproducibility of research findings (see Nature. 2014 Jan 30;505 (7485):612-3).  Consideration of sex is a critical component of rigorous experimental design, just like randomization, blinding, sample-size calculations, or other basic design elements.  By developing a policy to ensure that sex is considered in NIH-funded studies, NIH will ensure that sex and sex differences are examined in all aspects of biomedical research. This will lead to a stronger foundation upon which to build clinical research and clinical trials.

Request for Information

The NIH has formed a trans-NIH working group to inform the development of these policies. This Request for Information (RFI) seeks input from the research community and other interested stakeholders on the following topics regarding the consideration of sex as a biological variable in biomedical research. Public comment is sought for but not limited to the following:

  • Whether consideration of sex as a biological variable is an issue affecting the reproducibility, rigor, and/or generalizability of research findings.
  • Areas of science (e.g., cancer, neuroscience) or phases of research (e.g., basic, translational) conducted with animals that have the greatest opportunity or need for considering sex as a biological variable.
  • Areas of science or phases of research conducted with cells and/or tissues that have the greatest opportunity or need for considering sex as a biological variable.
  • Main impediments (e.g. scientific, technical, and other) to considering sex as a biological variable in research.
  • Ways in which NIH can facilitate the consideration of sex as a biological variable in NIH-supported research.
  • Any additional comments you would like to offer to NIH about the development of policies for considering sex as a biological variable in research involving animals, tissues, or cells.

Responses

Responses to this RFI must be submitted electronically using the web-based form at: http://grants.nih.gov/grants/rfi/rfi.cfm?ID=37.  Please do not submit comments by other mechanisms, such as fax or email.

Responses will be accepted through October 13, 2014.Notice Number: NOT-OD-14-128

National Institutes of Health (NIH)  IT-OD-14-128

 

Experts recommend change in labeling for low-dose vaginal estrogen

As more post menopausal women change to a low dose local vaginal estrogen to control vaginal atrophy, a group of experts have recommended that the FDA modify the package Black Box Warning label  on the product packaging.  The current warning is based on research done mainly on oral estrogen which is a systemic rather than local therapy.   The local low-dose therapy, in fact, was designed to reduce estrogen exposure to the woman while still providing localized (vaginal) relief from vaginal atrophy.   The panel of experts who wrote the editorial published in the journal Menopause, believe that the current warning is not based on this form of the estrogen and is harming women by discouraging their use of this very effective product that could improve their quality of life and prevent some serious health problems.

Vulvovaginal atrophy (VVA) is a common and progressive condition that is due to the lack of estrogen during and after the menopause.  This results in  the  thinning, drying and inflammation of the vaginal walls that can lead to painful sex and urinary disorders.   Localized estrogen is an approved treatment for this disorder.   To read more about menopause and the latest evidence based treatment options, visit MenopauseNU.org. a site developed by the Women’s Health Research Institute at Northwestern University.

 

 

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Selfies and Self-Reflection: The Endocrine Society Meeting

By Katie Cobian

In 2009, I was one of twelve participants in the San Diego Oncofertility Saturday Academy.  Entering the program as a rising high school sophomore, I had no idea what to expect from the program; in fact, I barely knew what the word ‘oncofertility’ meant.  Little did I know the impact this one summer would have on the rest of my life.  This one summer gave me an unexpected sense of belonging in the scientific community.  This one summer taught me lessons far beyond the confines of the lab.  This one summer introduced me to many of the most inspirational people I have ever met.  This one summer changed my life forever.  It’s not everyday that a fourteen-year-old comes across such a life-directing experience; I am so lucky it happened to me.

Fast-forward five years.  I’m currently a rising junior at the University of Notre Dame.  Because of my involvement with the Oncofertility Academy, I had the wonderful opportunity to attend the Endocrine Society Meeting in Chicago earlier this summer.  I was assigned many mentors during the conference—scientists from all over the U.S., including members of the Woodruff Lab.  My first day at the conference was overwhelming.  I was made aware that there were 10,000 attendees at the meeting this year—a number difficult to comprehend.  The intellectual energy was high in every room at the conference center.  As clinical practitioners and basic scientists sat in the same rooms together, there was dynamic sense of collaboration.  More impressive to me, however, was Dr. Teresa Woodruff, President of the Endocrine Society.  It was Dr. Woodruff who led the masses every morning and made appearances at all the major events.  And though she was clearly the busiest and most demanded person at the conference, she still took the time to meet and interact with eager undergraduates dying to shake the hand of a true inspiration.

One afternoon after visiting lectures on the challenge of preserving the fertility of cancer patients, I visited a poster session that contained the work of thousands of labs from all over the world.  As I walked through the reproductive endocrinology section, I was shocked to run into a very familiar face: that of Dr. Chang from our very own San Diego Oncofertility Academy.  In conversation with Dr. Chang, I couldn’t help but think about how much we have discovered about the world, but simultaneously, how many new questions arise with every new discovery.  It is this reason, precisely, that I have always been drawn to biological sciences—the sheer magnitude of the field is enough to fuel my interest in the life sciences.   At the conference, I was able to visit posters from the Woodruff Lab and was utterly amazed at the advances that are occurring in the field of oncofertility, including the growth of ovaries in vitro–yet another reminder of the power and innovation that oncofertility represents.

In addition to attending the conference’s daily scheduled events, I was given the opportunity to attend the Women in Endocrinology dinner during my time at the conference.  The women that surrounded me at the dinner were inspiring—a true testament to the power and strength of women in science.  They were brilliant, and their stories were powerful.  Leaders in their field, they support each other and celebrate the accomplishments of peers working alongside them.  The room full of glamorously dressed, influential women was an uplifting look into the force that women have become in STEM fields.

After a weekend of high-powered, intellectually stimulating events, I found myself at a more intimate event in Dr. Woodruff’s suite with current and past members of her lab.  Dr. Teresa Woodruff has been my idol since my first introduction to Oncofertility.  Her vision to create a new field of science has always astounded me.  I met Dr. Teresa in person for the first time four years ago on a visit to Northwestern to tour the campus.  She opened the doors of her lab to me and welcomed me with a bright smile and encouraging words.  During this first visit to the Woodruff Lab, I took a series of photos that I still cherish.   While chatting with Dr. Teresa this summer, she shared with me that she still keeps one of those photos on her desk in her office.  At once, I was humbled and filled with pride.

At the event, I was fortunate to rub elbows with the founders and grant-writers vital to oncofertility’s establishment.  Dr. Teresa made her way through the crowd like a superstar—followed by cameras and people anxiously awaiting their chance to chat with her.  But unlike a pop-sensation, Dr. Teresa was down-to-earth and obviously respected by everyone in the room.  Just that morning, I had the honor of witnessing her star power as she spoke to a crowd of six thousand people.  And here she was a few hours later with a heart-warming smile and joyous embraces for the children of her current lab members.  As I left Dr. Teresa’s event that night, she asked me to take a selfie with her so she could place it next the picture on her desk from four years ago.  I was thrilled to take that selfie with one of the most inspirational women in my life.

Dr. Teresa Woodruff has been and will continue to be that source of inspiration as I continue my education in life sciences.  It’s her work and her character that motivate me to work toward my own goal of pursuing a career in science.  I see my life coming full-circle, fulfilling an even greater role in the field that had the power to change the life of a fourteen-year-old, sitting wide-eyed and eager on a summer Saturday morning in San Diego.

Tattoos and Permanent Make-up

Some women get tattoos for beauty, self-expression, or cultural events.  Whatever your reason, know the facts before and after you get a tattoo.

Types of Tattoos
  • Permanent Tattoo: A needle inserts colored ink into your skin. Permanent tattoos last a lifetime.
  • Permanent Make-Up: A needle inserts colored ink into your skin to look like eyeliner, lip liner, eyebrows or other make-up.
  • Henna: Plant dye called henna or mehndi is used to stain your skin.
  • Black Henna: Developed from henna, may contain hair dye or other dye to darken the stain and make it last longer.
  • ‘Sticker’ Temporary Tattoo: A tattoo design is on a coated paper. It is put on your skin with water. Temporary tattoos may last up to 3-4 weeks. Sticker tattoos last hours to days.
Tattoo Risks

Problems can happen.

  • Infections and serious illness, like HIV or hepatitis, from unclean tattoo tools, practices, or products
  • Allergic reactions to the inks or stains can cause skin problems, such as rashes
  • Other skin problems like increased chance of sunburn, bumps, redness, or scarring
  • Swelling and burning of the tattoo when you get an MRI test
  • Pain and high costs if you want to remove a permanent tattoo

Contact your state or local health department for tattoo safety information to reduce your risk. Tell your doctor about any tattoos you have before any medical procedure.

FDA’s Role

FDA–

  • has not approved any inks for injecting into your skin.
  • has not approved henna or hair dye for use on your skin.  Some people have reported serious skin problems after using henna or black henna.
  • does not regulate tattoo parlours.
  • does monitor problems from tattoos and permanent make-up.

Report problems online to FDA or call 1-800-332-1088

Removing Your Tattoo

Permanent tattoos can be hard and painful to remove. It may take several treatments that cost a lot of money. Talk to your doctor about your options. Remember:

  • You may not be able to completely remove your tattoo.
  • You could get a scar when you remove your tattoo.
Laser Removal

The FDA approves certain laser devices to remove tattoos. Lighter colors such as yellow, green, and red are more difficult to remove than darker colors such as dark blue and black. It may take 6-10 treatments to remove a tattoo. Some side effects may include bleeding, redness or soreness.

Surgery

Tattoos can sometimes be removed by cutting out the tattooed skin then sewing the skin back together.  Other times, the skin can be sanded down to remove the tattoo.

Ointments and Creams

The FDA does not approve tattoo removal ointments and creams or do-it-yourself tattoo removal kits. These products may cause skin rashes, burns or scars.

Sex inclusion study cited in ‘Atlantic’

The lack of females in basic research was highlighted by the Atlantic today.  Melina R. Kibbe, MD and Teresa K Woodruff, PhD, two of the co-authors of a study published in Surgery this month, reported that 22% of the publications in five high-impact surgical journals between 2011 and 2012 did not specify  the sex of their animal subjects, and of those that did, 80% only used male animals.

According to Kibbe, a surgeon and professor at Northwestern University Feinberg School of Medicine,  “The obvious issue is, if you’re only studying males, you don’t know if that therapy is going to work in females.”   Kibbe along with Dr. Woodruff, the director of the Women’s Health Research Institute at Northwestern University and a professor of OB/Gyn have been advocating for sex inclusion in all research– cells, animals and humans.   Other members of the WHRI Leadership Council are looking at sex inclusion in their respective fields that are not typically consider to be impacted by sex:  dermatology, anesthesiology, and neuroscience.

Last May, NIH Director Francis Collins acknowledged the lack of females in animal and cell research and is planning to development new guidelines for researchers.   “It’s really an exciting for all of us who have been advocating for sex inclusion science,” Woodruff stated in the Atlantic article.  “If we can fundamentally study the way sex influences biology, I think we’re going to learn a great deal…that’s going to change, frankly, our health.”

 

FDA to address diversity in new drug and device studies

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.

 

Should competition adjust for size?

Last night I watched American Ninja Warrior because Internet sensation Kacy Catanzaro, a 5 ft, 100 lb athlete, was the only women competing in the American Ninja Warrior Finals. Despite 2 years of training, she simply could not complete the “jumping spider” obstacle part of the course last night.   In the replays, you could see that her legs connected well with  the walls, but her arms could not span the gap adequately.   Evidently she worked hard on this task and likely made it during practice but men (or women) with wider arm spans have a greater likelihood of connecting with a wall with ‘all fours’.

This raises an interesting point when discussing sex equity in health and in sports. Should size matter,  especially in events where both men and women compete against each other?   Should obstacle courses be adjusted for body size?   Both sexes train equally, but if an arm span is 6 feet verses 8 feet, the likelihood of success is less consistent for the smaller competitor.    The same question holds for a 5’6″  male competing against  a 5’10″ woman!

As we ponder this question, we congratulate Kacy for an amazing effort and hope to see her on the circuit again soon.!!!

 

Five major journals to include sex in studies!

Melina Kibbe, MD  reported in a new study that surgical researchers rarely use female animals or cells in the published studies—despite a huge body of evidence showing that sex differences can play a critical role in medical research.  “Women make up half the population, but in surgical literature, 80 percent of the studies only include males,” said Kibbe.  Published Aug. 28 in the journal Surgery, the study follows a “60 Minutes” segment aired in February that featured Dr. Kibbe and raised concerns that overlooking sex differences in biomedical research could lead to serious adverse effects.

 

As a result of Kibbe’s article, editors of the five major surgical journals reviewed in Kibbe’s publication will now require authors to state the sex of animals and cells used in their studies, and if both sexes are not included give the reasons why.

Dr. Kibbe, Professor of Surgical Research at Northwestern University Feinberg School of Medicine is member of the Women’s Health Research Institute which is actively working on sex equity in research at the national level.   To read more:   CLICK HERE

Mediterranean diet has lots going for it!

Reasons to try the Mediterranean Diet:

  • Includes most food groups including fats, carbs, etc.
  • Can swap out bad fats for healthy ones (e.g., olive oil instead of butter, fish/poultry instead of red meat)
  • Lots of fresh veggies
  • Includes bread
  • Wide range of ethnic foods to keep it interesting (Italian, Greek, Turkish, Moroccan, Spanish, etc)
  • Lots of spices so you can lower salt
  • Includes wine
  • Good for the heart, brain

To learn more, view the WebMD slide show

Illinois Medicaid to Provide Increased Access to Contraception.

Medicaid patients in Illinois (our home state!) could gain increased access to contraception under policy changes proposed August 18 by the Department of Healthcare and Family Services, according to the Chicago Tribune.  Health care providers would receive more money for providing vasectomies to men and birth control to women under the proposal, which also includes a possible new referral requirement for Roman Catholic providers and others that object to contraception.

The department expects to implement most of the proposed changes this fall, but department Director Julie Hamos said Medicaid will immediately start paying more toward the cost of long-term contraception at walk-in providers such as Planned Parenthood clinics.

Hamos said her department proposed the changes in part to address the recent Supreme Court decision that allowed some companies to exclude contraceptives from their employees’ insurance coverage on religious grounds. Oklahoma-based arts-and-crafts retailer Hobby Lobby, owned by evangelical Christians, sued over a requirement under the Affordable Care Act to cover contraceptives.

The court’s decision was of “extreme concern” to Gov. Pat Quinn and state health officials, Hamos said. The new proposal affects residents covered under Medicaid, not by employers, but Hamos said the court’s decision brought new focus to the issue, spurring the department to announce the proposal quickly.

“It is an opportune time when women across the country are paying attention … that’s a time that we can really use that attention to focus on what’s available to them through Medicaid,” Hamos said. She noted that the change could help low-income women who shift between Medicaid and employer coverage as their employment situations change. Unplanned pregnancies constitute a major cost among the approximately 1 million women of childbearing age enrolled in Medicaid in Illinois, Hamos said. About 3 million Illinoisans in all are enrolled, and the number is set to expand under the Affordable Care Act, commonly known as Obamacare.

Expanded family planning has succeeded at saving money in other states, Hamos said, citing a Colorado initiative that she said cut teen birthrates by 40 percent from 2009 through 2013, reduced abortions and saved the state $42.5 million in 2010.

The Illinois proposal aims to coax more health care providers into expanding family planning services by increasing their reimbursement rates starting Oct. 1. Payments for vasectomies and intrauterine devices would be doubled. Hamos said the department is working with companies that manufacture IUDs to ensure they’re on health care providers’ shelves when needed.

This Chicago Tribune story was produced in partnership with Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.