NIH Moves carefully on Sex Equity in Research

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!”

 

New report card on state rankings in women’s health

The Alliance for a Just Society recently released the 2014 Women’s Health Report Card that rates the 50 U.S. states on issues related to health coverage, access to care, and health outcomes.   The Alliance is a group of 14 racial and economic justice organizations around the U.S.    This report uses different methodology than early reports entitled “Making the Grade on Women’s Health” published in 2000, 2004 and 2007 and 2010 by the National Women’s Law Center and the Oregon Health and Science University.

Just two states, Massachusetts and Connecticut, received A’s in all three categories.   Twelve states received D or F in all three categories.   Our WHRI home state of Illinois received an overall B rating.  The entire report is available from the Alliance website.   To just view the table chart for all fifty states, click Here.

Pioneer research often lacked informed consent

The Conversation, an online newsletter originally based in the United Kingdom and Australia, recently launched its US edition.  On Oct. 30 they published an interesting “conversation” about the history behind the “father of modern gynecology” that discusses his early work on surgical repair of obstetrical fistulas.   Like much early experimental medical procedures, it was often the poorest, most vulnerable women who were used as subjects (in this case slaves) so the lack of consent is concerning.  Yet these “experiments” often ended up helping people in the greatest need.   It is an interesting ethical discussion that has value for young researchers and doctors.  Informed consent today is much more regulated and monitored with legal oversight.  The article in its entirety can be accessed HERE.

Birth of the “pill” has profound effect on women’s health

A new book, The Birth of the Pill, by Jonathan Eig tracks the involvement of four individuals who were key crusaders in the advent of readily available contraception that women controlled!   For readers who were not around for the sexual revolution of the late 1960s, here are some factoids that you might find interesting:

  • Four key players are featured in the book:  Margaret Sanger, feminist, and co-founder Planned parenthood;  Gregory Pincus, biologist who was fired by Harvard for his controversial research on in vitro fertilization and is considered the “inventor” of the Pill ;  John Rock, a Catholic,  ran clinical trials on the pill, and served as an intermediary with his Church; and Katherine McCormick, an heiress who funded the research on the pill.
  • Early on, due to Rock’s intervention, the Vatican almost supported the pill as a natural form of “rhythm”…but in the end did not!
  • One of the pre-FDA approval users of the pill was Sue Dixon whose father was Jack Searle the CEO of G.D. Searle and Company–the company that eventually marketed the pill.
  • Early clinical trials for the pill were conducted in Puerto Rico where, at the time, regulations for consent and other ethical issues was far less stringent than they are now.
  • Early versions of the pill were stronger than necessary because scientists wanted to be sure it was 100% effective.  Today, the dosages has been scaled down considerably reducing risks and adverse effects.
  • David Wagner, a product engineer at Illinois Tool Works, Inc.  designed a circular pill dispenser after his wife complained of forgetting to take the pill everyday.  His design was rejected by Searle but picked up by Ortho who was preparing to release their own version on the pill called “dialpak”.  This dispenser design helps distinguish the “pill” in a unique way that still exists today!
  • The pill was initially FDA approved as a treatment for menstrual disorders, giving its manufacturer a  “gentle” release into the market.

 

Missing work when children are sick takes a financial toll on family income

A new data note from the Kaiser Family Foundation reports on the number of working mothers who must take unpaid time off when their children are sick and discusses state and national policies addressing the issue.

Balancing on Shaky Ground: Women, Work and Family Health recounts findings from a recent national Kaiser survey, including:

  • Four in ten working mothers (39 percent) report that they must take time off and stay home when their children are sick, over ten times the share of men (3 percent).
  • Among mothers with no alternative to missing work when a child is sick, 60 percent say they aren’t paid for the time off, up from 45 percent in 2004.
  • Working mothers with lower incomes are particularly affected. More than half report they must miss work to care for sick kids at home, while 36 percent say their jobs offer paid sick leave and 43 percent say they get paid vacation days.

For more information about women’s health policy, visit kff.org.

Prosthesis approved to help women with bladder muscle contraction

The U.S. Food and Drug Administration today allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired detrusor contractility or IDC).

IDC is a condition where patients are unable to spontaneously urinate due to insufficient bladder muscle contraction, which can result from significant neurologic disease or injury such as stroke, multiple sclerosis, spinal cord injury, spina bifida or diabetic neuropathy. IDC is typically managed with various types of catheters, including clean intermittent catheterization (CIC).

“The inFlow device allows women with IDC to urinate, without the need to catheterize daily or be attached to a urine drainage bag,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “This may allow for increased mobility and the ability to be more self-sufficient.”

To read more click HERE.

Still time to comment on Sex Inclusion in Research

Today, NIH released a Guide Notice (NOT-OD-15-012) announcing that the response date for the Request for Information “Consideration of Sex As a Biological Variable in Biomedical Research,” has been extended to October 24th. If you have not had a chance to submit your thoughts, please do so by October 24th.

The issue of including more females in all level of research (cells, animals and human) has been a major national story…and an important one!   This request is part of the usual process for federal implementation and the more people who comment, the more likely the government will move quickly toward changing policies.

Apple and Facebook Announce Egg Freezing Health Coverage

In a groundbreaking announcement today, Apple and Facebook now will offer health coverage for their women employees to freeze their eggs. Egg freezing enables women to protect and preserve their fertility until they are ready to become parents—and with the steep price of $10,000+, this coverage may be seen as a significant investment in women. Climbing the corporate ladder while raising a family can be a significant barrier for many women and the coverage to freeze one’s eggs provides women with the choice and freedom to devote time to work and to one’s family. However, is this potentially pushing women to focus on their careers as primary and family as secondary?

Egg-freezing has reportedly doubled over the past year as women continue to seek this as a solution to longer fertility years. Indeed, the option to freeze one’s eggs has spurred feelings of empowerment in women, Emma Rosenblum even writing, “Not since the birth control pill has a medical technology had such potential to change family and career planning.” This perk may encourage women to stay with their employer longer, devote crucial “fertile years” to their work, and plan to start a family when they are ready–indeed, other companies may be following suit in the near future. Women often report barriers surrounding a seeming choice between work or family. The action of Apple and Facebook is intended to alleviate some stress surrounding career and family planning, while empowering women with the more choices and control in life. While positive in their intentions, some may read Apple’s and Facebook’s new announcement as potentially implying that women should focus on their careers first and family planning second. Whatever the implications, this is certainly an game-changing announcement.

Source: NBC News

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