Females: The ‘Neglected Variable’ in Medical Studies

Researchers avoided using female animals for fear that their reproductive cycles and hormone fluctuations would confound the results of delicately calibrated experiments.

Holy Hormones Journal:  And there you have it plain and simple – women have been neglected, discarded, ignored and denied – “It’s All in Your Head Honey” Syndrome because the female species has not been  included in lab studies or in clinicof mice and menal medical trials.  Let me reference this study on the timing of breast cancer surgery and survival.

If women were not ‘neglected variables’ this study should have changed guidelines on scheduling surgery with a woman’s menstrual cycle and not with her doctor’s golf schedule:

More specifically, as Hrushesky and Bluming reported in The Lancet in 1989, the rates of recurrence and death due to metastatic disease in this 41-patient group had been more than four times lower for those whose surgery had been done in midcycle — at or around the estimated time of ovulation — than for those who had had their operations well before or after ovulation.

Dr Hrushesky also states in a another para in the Journal of the National Cancer Institute

Of Mice and Women

Hrushesky readily acknowledges that the reproductive cycles of mice and women are by no means identical. “Still,” he said in a recent interview, “proestrus in mice corresponds to ovulation in women, so that the underlying principles are the same… Far-fetched as the idea might have seemed to some people, it seemed plausible to us.”

So why are women the neglect variable? Could it because of our ‘messy menstrual cycle and our fluctuating immunity that makes us too complicated for experiments and studies that are being fast-tracked through the FDA?  How many women have died or suffered severe complications from taking medications, vaccinations (GARDASIL), scheduling surgeries when our immunity is at its lowest – which is during the premenstrual and menstrual phase?

And now, after the fact – we are being included?Is it because we are becoming more vocal about the menstrual process and menstrual management? We are not buying into the drugs an steroids that downplay our normal triphasic cycle?

This is not our reality, obviously.
Off with their heads.

Labs Are Told to Start Including a Neglected Variable: Females

The New York Times
Health
May 14, 2014

For decades, scientists have embarked on the long journey toward a medical breakthrough by first experimenting on laboratory animals. pregnant mouseMice or rats, pigs or dogs, they were usually male: Researchers avoided using female animals for fear that their reproductive cycles and hormone fluctuations would confound the results of delicately calibrated experiments.

That laboratory tradition has had enormous consequences for women. Name a new drug or treatment, and odds are researchers know far more about its effect on men than on women. From sleeping pills to statins, women have been blindsided by side effects and dosage miscalculations that were not discovered until after the product hit the market.

Now the National Institutes of Health says that this routine gender bias in basic research must end.

In a commentary published on Wednesday in the journal Nature, Dr. Francis Collins, director of the N.I.H., and Dr. Janine A. Clayton, director of the institutes’ Office of Research on Women’s Health, warned scientists that they must begin testing their theories in female lab animals and in female tissues and cells.

The N.I.H. has already taken researchers to task for their failure to include adequate numbers of women in clinical trials. The new announcement is an acknowledgment that this gender disparity begins much earlier in the research process.

“Most scientists want to do the most powerful experiment to get the most durable, powerful answers,” Dr. Collins said in an interview. “For most, this has not been on the radar screen as an important issue. What we’re trying to do here is raise consciousness.”

Women now make up more than half the participants in clinical research funded by the institutes, but it has taken years to get to this point, and women still are often underrepresented in clinical trials carried out by drug companies and medical device manufacturers.

Read full article…

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.