FDA: Where are the Women?

By Rachel Ross, NOW Government Relations Intern

First publicized over thirty years ago, the lack of women in clinical trial research of drugs and devices is still a serious problem.  As CBS’s Sixty Minutes reported on May 25, we now know that women sometimes respond very differently to prescription drugs than men.  Sixty Minutes correspondent Lesley Stahl reported on the problem of Ambien, a popular sleep aid, which produced excessive sleepiness the next day.  Many women who had taken the drug were still under its effects while driving to work in the morning.  Because no one had carefully analyzed the effect this drug had on women before it hit the market, women taking Ambien were unknowingly driving under the influence.

Several car accidents were attributed to the drug, including a famous case involving Kerry Kennedy. Kennedy, the daughter of the late Sen.  Robert F. Kennedy, was charged with and tried for impaired driving but later acquitted.

As was eventually determined by researchers, women metabolize Ambien (Zolpidem) more slowly than men and were being prescribed twice the dosage that they should have received.  It took 20 years for the Federal Drug Administration (FDA) to change the dosage recommendation for women.

Dr. Larry Cahill, a neuroscientist at the University of California at Irvine interviewed on the Sixty Minutes program, suggested that all FDA-approved drugs and devices should be re-tested with a representative sample to analyze their effects on women.

Since the midcentury thalidomide scare — a drug that was given to pregnant women for morning sickness and caused massive birth defects — researchers have been reluctant to use women of childbearing age in clinical trials. Clinical trial groups are overwhelmingly composed of white men under the age of 55. In addition, when women and minorities are included in trials, there are rarely separate analyses about how a drug affects those subgroups.  This has resulted in a dearth of knowledge about how female bodies react to drugs.  Though researchers have known about this problem for decades, there has been little improvement in the levels of representation of women and communities of color in clinical trials; this is largely because it is easier to recruit white men under 55 for clinical trials. Until adequate representation is made mandatory by the FDA, the companies who conduct the majority of clinical trials for new drugs and devices will have no incentive to close the diversity gap.

There is growing evidence that this representational gap has negatively affected women’s healthcare, as Ambien is not the only drug that works differently in women. In 1989 a study reported that the popular pain-reliever Aspirin reduced heart disease.  It wasn’t until 15 years later, when researchers looked at the effects on women, that it was discovered that Aspirin only reduces heart disease in men. So for 15 years women with heart conditions hoped to avert a heart attack by taking Aspirin were essentially taking a placebo.  We also know that women experience heart attacks very differently from men and that women have died when doctors failed to diagnose a heart attack.

Furthermore, there is a known difference in how elderly persons and children respond to prescription drugs. Thus the need to have representative samples by age in clinical trials, as well.

This problem extends past human trials. There is a lack of representation of female animals and female cells at every level of research. Every cell has a sex, and this leads to profound differences across organ systems.  Differences not found in initial trials due to a lack of female cells and female animals could create serious problems.   Interestingly, research with stem cells has found that men’s stem cells do not exhibit the same effect in cultures that women’s cells do:  women’s stem cells have the growth stimulating effects that researchers have been using with amazing results. That observation alone is a strong testament to the need for gender-balanced research.

(The National Institutes of Health announced on May 20 that they are ordering that animal and cell research dealing with drug effects be done on both genders.)

The National Organization for Women recently submitted comments to the FDA that urged the agency to absolutely require all companies conducting clinical trials for new drugs and devices to include representative samples of women as well as racial and age groups and to adequately analyze the effects for each group.  To allow physicians to continue prescribing without this critical information puts many patients at needless risk.

4 Responses to “FDA: Where are the Women?”

  1. Pam Leighton-Burwell

    It is totally irresponsible for the FDA to allow incomplete drug trials that affect over HALF the population to be standard procedure in approving medicine for market. Stop the blatant discrimination and intentional adverse outcomes by testing ALL drugs on males AND FEMALES, now.

    Reply
  2. Dawn Conti-Jordan

    What we need is more women in research.
    Those who DESIGN the meds in the first place.
    Leave it to MEN not to consider the affects of ANY medication on women
    THEY don`t even consider US.
    WE do not matter on the grand scale. So, why would we matter on the medical scale.
    Dr.s have been prejudiced against women all throughout history.
    EVERYTHING was always “”All in our mind””
    I hate the medical profession, even though I worked in the field for years.
    NEVER AGAIN !!!

    Reply
  3. Theresa Kaplan

    I have a chronic medical disorder and have seen firsthand the differences in sympthoms and treatment results between male and female sufferers. More research must be done to include understanding how gender impacts treatment options.

    Reply
  4. Winona M. Moeller

    As a mastered prepared nurse clinician and educator I have directly observed and assessed the relationship of drug dosing vis-à-vis age and gender. I have taken it upon myself to work in a major pharmacy chain, and an international research company to observe the practices therein. It is appalling to witness the lackadaisical attitudes and practices in these environments and the epidemic of polypharmacy. It is despicable to evidence the lack of professional ethics and practice relative to pharmacology at all levels: research, marketing, application and evaluation. Quality control is often non-existent. In order to accomplish its mission, Elderly and children, female and male, and racial differences are essential elements of research in drugs if outcomes are to be reliable. FDA needs to be fully funded to enable employment of duly qualified and competent individuals in adequate numbers. Oversite and constant review can provide the desired health and well being of our population as well as cost containment in health care.

    Reply

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