Just recently,
I came upon an article telling the story of Sarah Mancoll, who was pregnant
with her first child and contracted a cold. She was very hesitant to take any
medications to treat her cold symptoms, even as small as a cough drop, thinking
that it would affect her baby. Now, she is a supporter of pregnant women to
take part in clinical studies that assess the safety of taking prescription and
supplemental medications.
In most
cases, when we think of research on pregnant women, we are quick to say that it
is unethical on the baby’s behalf. We classify these pregnant women as a vulnerable
population and largely exclude them from clinical research. A review was
conducted to prove this fact. Out of 558 clinical trials, 95% of those trials
excluded pregnant women (Graham, 2018).
Many supporters
are now advocating for expanding clinical research to include more pregnant women,
especially for those who need evidence-base information on the risk medications
imposes on their babies. Take Sarah, for example, who developed an autoimmune
disease five years after her pregnancy and was now prescribed stronger
medication than just a cough drop she was once worried about. What if she
developed this disease just prior to her pregnancy or while pregnant and needed
to take her medication? How would her medication affect her baby?
About 90%
of pregnant American women are currently taking at least one medication and 70%
take at least one prescription medication while they are pregnant (Graham,
2018). Within 33 years, from 1976 to 2009, there has been a 60% increase in prescription
medication consumption in the first trimester of pregnancy (Graham, 2018). So
why should we exclude these women from trials when they are a targeted population
that need to be researched the most?
Graham, J. (2018, October
19). Pregnant women are largely left out of drug research. Should this change? Deseret
News. Retrieved December 3, 2018, from
https://www.deseretnews.com/article/900037801/pregnant-women-are-largely-left-out-of-drug-research-should-this-change.html
This is a really interesting way of thinking about this topic. One of the first rules in IRB approval is that you are not allowed to perform research on pregnant women, but this might also be one of the biggest physiological changes that a woman can go through. You are literally growing a human inside of you. I understand that both the woman and the baby are in vulnerable states during this time period and how testing medications or procedures may cause horrible effects to both the mother and the baby. On the other hand, doing research on this population and during this developmental time frame may lead to possible breakthroughs in pre-birth care. I found an article that stated a the major hurdles that need to be crossed on the path to increasing pregnant woman in research is "the need for effective treatment for women during pregnancy, fetal safety, harm from the reticence to prescribe potentially beneficial medication, and the broader issues of justice and access to benefits of research participation"(Lyerly, Little, & Faden, 2008). The article continues on with how there are multiple benefits that way come about from by doing research but these hurdles must be first to protect the mothers to the fullest extend. My personal opinion is that research need to be done on the research techniques so ensure that the safety of both the mother and the baby are taken in the highest priority prior to any type of testing be done. Once that has been accomplished, and the autonomy of the research has been clearly stated to the mother, research may show a lot of possible breakthroughs in the treatment of pregnant woman.
ReplyDeleteLyerly, A. D., Little, M. O., & Faden, R. (2008). The second wave: Toward responsible inclusion of pregnant women in research. International Journal of Feminist Approaches to Bioethics, 1(2), 5–22. https://doi.org/10.1353/ijf.0.0047
Auna, This is such a different stance that most people don't ever consider and brings up a lot ethics. As Kyle said, I don't think that people even consider trying to include pregnant women in their studies because of the guidelines laid out by the IRB. Most studies are trying to get funding and approval to even make clinical drug trials possible for them. So, why hinder their study by adding in the complication of pregnant women? You bring up an excellent point about women who need to be on medications during their pregnancy for prior conditions. When you stated that in your post, I was just thinking "That's so true! How do we know what the effect is of these drugs during pregnancy? We should probably study that, so we can be providing equal care for mother and baby". I think there is a big distinction that needs to be made with this post. There is a difference in studying brand new drugs that are still in clinical trials on pregnant women vs. drugs that have already been approved by the FDA. We shouldn't be studying the effects of drugs on pregnant women when we don't even fully understand everything about the drug. That being said, I think it is important to start new studies on drug effects during pregnancy because we need to be able to provide just care to everyone. We need to have beneficence to the mother and no malfeasance to the fetus, which is definitely a fine line of balance. As with any ethical discussion, we could go on all day! This is not really an ethical topic that I would have ever thought about before, so I am glad that you brought it to the attention of everyone in this blog to really getting our brains working!
ReplyDelete