An article was released in the June 10, 2010 edition of the well-respected journal, Nature, that raises the question of doing research studies on pregnant women.    Women  get colds, the flu, infections and other diseases during their pregnancies that have nothing to do with their mom-to-be status.   Many women simply "toughen it out" hoping their condition is just a virus that will run its course.   Other times, they rely on their obstetrician's experience with other patients who may have been prescribed an antedote that the physician has used successfully in her/his practice, but has not actually been studied in well-designed research studies that included pregnant women.

Are these women being shortchanged?   Are they simply not supposed to get sick through their pregnancy?     Here's a bit of history:   It wasn't until 1994, that the Food and Drug Administration (the regulatory agency that approves drugs for safety and effectiveness)  lifted the ban on inclusion of women with childbearing potential from the early clinical trials.    This ban had been in place since 1977 and not only excluded pregnant women, but "women who had childbearing potential" and certainly impacted the number of women participating in clinical studies.   No wonder our knowledge of sex differences in disease remains inadequate!

An important and legitimate concern, of course, is the safety of a potential fetus.    Anyone over age 50 recalls the thalidomide (a drug prescribed for morning sickness)  tragedy of the late 50s/early 60s that resulted in far too many babies, especially in Europe, being born with deformities.   While this tragedy alerted us to potential in-utero harm, it also slowed the progress we need to be sure tragedies of this nature never happen again while collecting important data on drug use in women.    The author of the Nature article  provides a logical strategy that should be considered and supported by all women's health activists. Click  Pregnant Women Deserve Better to view article.

Biological differences between the sexes could be a significant predictor of responses to vaccines, according to researchers at the Johns Hopkins Bloomberg School of Public Health. They examined published data from numerous adult and child vaccine trials and found that sex is a fundamental, but often overlooked predictor of vaccine response that could help predict the efficacy of combating infectious disease. The review is featured in the May 2010 issue of The Lancet Infectious Diseases.

“Sex can affect the frequency and severity of adverse effects of vaccination, including fever, pain and inflammation,” said Sabra Klein, PhD, lead author of the review and an assistant professor at the Bloomberg School’s W. Harry Feinstone Department of Molecular Microbiology and Immunology. “This is likely due to the fact that women typically mount stronger immune responses to vaccinations compared to men. In some cases, women need substantially less of a vaccine to mount the same response as men. Pregnancy is also a factor that can alter immune responses to vaccines.”

Researchers conducted a review of existing literature on several vaccines including yellow fever, influenza, measles, mumps and rubella, hepatitis and herpes simplex to obtain evidence of the difference in responses between women and men. They also examined the effect hormonal changes that occur during pregnancy have on vaccine efficacy. Researchers found that despite data supporting a role for sex in the response to vaccines, most studies did not document sex-specific effects in vaccine efficacy or induced immune responses.

“Understanding the biological differences between men and women to vaccines could have led to better distribution of the 2010 H1N1 vaccine during the early months. Our review of the literature found that healthy women often generated a more robust protective immune response to vaccination when compared to men,” said Andrew Pekosz, PhD, associate professor at the Bloomberg School’s W. Harry Feinstone Department of Molecular Microbiology and Immunology. “An understanding and appreciation of the effect of sex and pregnancy on immune responses might change the strategies used by public health officials to start efficient vaccination programs, optimizing the timing and dose of vaccines so that the maximum number of people are immunized.” added Klein.
“The Xs and Y of Immune Responses to Viral Vaccines” was written by Sabra L. Klein, Anne Jedlicka and Andrew Pekosz.

Source:   Johns Hopkins Newscenter

Yesterday, I started writing a blog explaining why sex and gender research was important.  I got bogged down in historical background, mandates, and the usual boring facts and justifications.   While doing this, my desktop binged and one of several daily notices from federal agencies popped up on my computer.   Since I was having writer's block, I decided to check these new emails....and BINGO....there is was!     A news release from the National Institute on Drug Abuse (NIDA), one the Institutes at the  National Institutes of Health (NIH).   The title of the press release was "Common Mechanisms of Drug Abuse and Obesity".   It summarized a study funded by NIDA  that will appear in a prestigious journal in May.   The study found that some of the same brain mechanisms that fuel drug addictions in humans accompany the emergence of compulsive eating behaviors and the development of obesity in animals.  The investigators found that when they gave rats access to varying levels of high-fat foods, they found unrestricted availability alone can trigger addiction-like responses in the brain, leading to compulsive eating behaviors  and the onset of obesity.  According to one of the study authors, "The results of this study could provide insight into a mechanism for obesity".

This was all very interesting but what popped out at me was a sentence in the fifth paragraph:   Researchers conducted this study in three groups of male rats over a 40-day period. What about female rats!  Do they behave the same?    Will this study translate to a human study before these findings are tested in female rats?   What we do know is that obesity rates are higher in women.   How many women reading this have experienced a change of eating urges during their periods? Do hormones play a role here?

Why am I upset?    It took decades of advocacy from women to create mandates at the NIH, the major funder of health research, that requires the inclusion of women in federally funded research studies.  Recently, there has been a growing debate on whether or not researchers are adequately meeting this mandate.   While there are more women's cancer studies (that may be inflating the % of women who are in studies), diseases like heart disease still do not have equal representations of men and women in clinical trials.    This mandate does not trickle down to animal studies, allowing researchers to continue to do basic science work in male animals that are, after all, "easier" (Translated:   they don't have complicated hormone cycles).   Too many studies have been conducted in males (animal and human) over the last few decades and the results applied to the whole population--sometimes with detrimental effects.  The Adverse Reporting system at the FDA has many more reports of adverse effects of drugs in women than in men......has anyone asked if these drugs have been adequately tested in women???

So, what needs to be done?    The inclusionary mandates for research studies requiring both sexes, need to include animal studies.   After all, isn't it much cheaper to do preliminary studies in animal models BEFORE they are applied to humans?  Researchers also need to report findings by sex....even if the answer is "they are the same".   Is anyone else asking these questions? Have women really come 'a long way'?

We realize that Thursday nights are jam packed with all sorts of great TV shows, but hopefully you were able to set the DVR for the WTTW series Health Secrets:  What Every Woman Should Know.  The 4-part TV series was hosted by Paula Zahn and sponsored by Northwestern Memorial Hospital and Alberto Culver.  Each one-hour program was aimed at addressing women's health needs at all stages of life. Topics ranged from vaccinating young girls (and boys) against HPV to Oncofertility to the importance of clinical research participation to the serious risk of heart disease and stroke in women.  No doubt each show was full of important and useful health information!  If you missed the series or do not get WTTW, you can watch segments from all the shows and obtain any information you need online at http://www.wttw.com/main.taf?p=1,57.

Over the past 4 weeks, an underlying theme was made pretty apparent - we just don't know enough.  In order to achieve the goal of personalized medicine, we must first better understand the differences in health and illness in men and women.  As we continue to conduct research that will bring about the next medical breakthroughs we need to focus on the necessity of educating the population about the clinical research process and why participation is key.  The Illinois Women’s Health Registry (https://whr.northwestern.edu), highlighted in show #3, serves as a resource for research and education that advances scientific knowledge of sex- and gender-based differences in health and disease.  If you want to observe what a powerful tool this Registry is becoming, please view the video below.

[video http://www.wttw.com/main.taf?p=72,9,2&pid=Fan7kByLCJDnJJaChFFiamvET7d_zFi9 here]

Both Drs Woodruff and Bristol-Gould are featured, in addition to a Registry participant who was interviewed about her experiences while enrolled in a knee osteoarthritis study.

If you haven't already enrolled, please get involved today.  https://whr.northwestern.edu