Thursday, February 18, 2016

Equality for Women in Clinical Research

If there is one thing most of the population of this planet can agree on, its that there are definitely some differences between male and female anatomy, both on a physiological and endocrine level.  Why is it then, that for so many years and even up to the present day, that the impact of sex on illnesses and their treatments was often overlooked or flat out ignored?  For decades, most research has been conducted using male subjects, the predominant rationalization for this being that since males lack a menstrual cycle, their hormones don’t fluctuate over time, making them a “more homogenous study population” (Moyer).
 This would be completely fine, if not for the fact that those pesky little hormones that researchers want to avoid can have a huge impact on how susceptible women are to certain illnesses, much as autoimmune diseases and depression, and on how they metabolize medication (Harreys).  Women of childbearing age were even completely banned from early-stage clinical trials in 1977, including those who used contraception or were gay (NIH).  In 1993, the NIH Revitalization Act updated their guidelines for the inclusion of women and minorities in clinical research in an attempt to make their health a priority, the gap between the number of men used for research compared to women is still quite large (Moyer).
A study published in Neuroscience and Biobehavioral Reviews in 2009 found that was a bias for male animals in eight out of ten disciplines, including neuroscience, pharmacology, and physiology (Harreys). Another study published in the Journal of Women’s Health found that in a sample of 69 papers, women comprised on average 37% of each sample group and 87% of the papers did not publish any outcomes by sex, showing an inadequate adherence to the NIH guidelines these studies were required to abide by (Geller).  The only drug on the market for which the FDA recommends different doses for men and women is Ambien, after research clearly showed that women metabolize the drug in a way that allows it to remain in the bloodstream much longer.

Change must occur in order for us to fully understand the interactions between sex and disease. Federal agencies must be held accountable for the research they fund, efforts must be made to examine correlations between results and the sex of the experiment’s participants, and new training curricula must be implemented to ensure that the next generation of researchers does not make the same mistakes as the last if we hope to properly cater to women’s health concerns.  Even if we don't want to risk the health of women who could become pregnant or deal with possible complications arising from the use of female subjects, that doesn't change the fact that these women will at some point be taking medication and seeking treatment for disease.  If we don't find potential issues in the clinical stage, then the entire female population has their health left up to chance. A report for women’s health from Brigham and Women’s Hospital goes in depth into how cardiovascular disease, lung cancer, depression, and Alzheimer’s affects women differently than men and outlines a full list of actions and policies that should be taken and created improve current sex-related problems in research, and you should read it fully if you have the time. If you are a woman who cares about her health, a person who has cares about the health of the women in their life, or just someone who thinks that all people deserve to receive adequate and equal medical care regardless of gender, then this issue is one you cannot ignore.


Bibliography 

Harreys, Alexandra. "Women's Health Summit Policy Report." Brigham and Women's Hospital.
Brigham and Women's Hospital, 4 Dec. 2014. Web. 18 Feb. 2016.

Moyer, Melinda Wenner. "Drug Problem." Slate. The Slate Group, 29 July 2010. Web. 18 Feb. 2016.

NIH. "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research."
National Institutes of Health. NIH, 1 Oct. 2001. Web. 18 Feb. 2016.


Stacie E. Geller, Marci Goldstein Adams, and Molly Carnes. Journal of Women's Health. January
2007, 15(10): 1123-1131. doi:10.1089/jwh.2006.15.1123.


Westervelt, Amy. "The Medical Research Gender Gap: How excluding Women from Clinical Trials Is
Hurting Our Health." The Guardian. Guardian News and Media, 30 Apr. 2015. Web. 18 Feb. 2016.



7 comments:

  1. I was truly unaware that these sort of regulations were put on the patients of clinical trials. It blows my mind that women are left out due to hormone changes, when those could easily be measured and known ahead of time to help in consistency. I went to a presentation last week about a study which is now looking into the differences between male and female mice that are MDR2 knock out. I has been observed so far, that the male are more negatively affected by this knock out. However, many points were raised about the effects of estrogen on many treatments, as well as the fact that many mice foods contain hormones in them, that the researches may be completely unaware of. It was suggested to test repressing the estrogen in the females to judge their effects, but males also have estrogen in some levels in their body so they would have to be tested as well. I found both the presentation and this post very interesting!

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  2. This is an incredible post. I had always known that only males were used in research and trials to maintain stability but I never thought about the changes that women would have for whatever they were researching. It's crazy that women will be using these medications, procedures, etc. when they have only been researched and tested on males subjects. Hopefully more people look into these issue and find resolution.

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  3. I'm not one to get involved in certain issues when gender or identity are involved, due to the sensitivity of our world, but I completely agree with what you have presented. Everyone in the clinical environment must be treated equally for tests and trials of products and practices that, in the post-clinical phases of those trials and tests, will be used for both men and women alike. With the exception of drugs and practices that will be targeted towards women ONLY, such as birth control, etc., all drugs should be gender equal. Hopefully regulations are placed to advance towards clinical practices of equality. Awesome blog, and thanks for bringing this to attention.

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  4. It was interesting to read your post, since it had never really occurred to me that mainly males are the only ones used as test subjects. I would like to find out how many of the results of research experiments would changed if a better female to male ratio was used. Thanks for bringing this issue to my attention.

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  5. This is a great post! I was not aware of this issue and I'm so glad you brought it up. It's crazy to think that researchers favor men over women simply because they think it will be easier to form conclusions. Science isn't about taking the easy way out. Research should be equal in order to be deemed accurate. We have come pretty far in the fight for gender equality, but it looks like the fight isn't over yet.

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  6. As research is progressing, it is very true that studies need to be done on different genders, races, and ethnic groups. Medicine and treatments will of course vary from person to person and it is important to try to tailor this as much as possible to the patient's sex and race. Studying the difference in male and female responses would be a important step to more individually tailored medical treatment.

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  7. I may be going out on a limb here but if the medicines are tested on male subjects and it's a known fact that women can react differently than men to certain medications, then should it even be legal/ethical for doctors to prescribe women medicines that weren't tested on women. What if the rate at which a woman metabolizes something is much slower than a males and a multitude of doses if required each day. Could the women potentially overdose? What would happen then and who would be responsible? I know this is an extreme but it's something that I thought of while reading this.

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