Putting your fetus to the test

Should pregnant women undergo biomedical research? Ethical guidelines say yes, but personal ethics often say no. Researchers must consider the hazards of both their inclusion and exclusion. Clinical trials pose risks to woman and unborn child, but research leads to the establishment of treatments that can help alleviate the illnesses affecting them. Because fetal development faces potential harm, minimized risk clinical trials should only include pregnant women with preexisting conditions.

Francoise Baylis of Nature Magazine feels that pregnant women’s involvement in biomedical research is a necessity, and their exclusion is both unethical and unscientific. While she acknowledges that researchers must take extra safety precautions when studying pregnant women, she ignorantly dismisses the possible fetal damage that could result from their inclusion. In Baylis’ opinion, trial organizers should convince pregnant women that these trials are safer than taking prescribed medication, luring them into participating. However, her claims about said trial safety are weak; and she uses terms such as “often” and “generally” that demonstrate her inability to completely support her opinion. Baylis raises an issue that needs addressing, but ignores some key information when developing an appropriate solution.

Clinical trials do prove themselves beneficial. They offer information that researchers can utilize to develop safe and effective treatments. When pregnant women are excluded from these trials, their access to much-deserved treatments is destroyed. This is because they do not have the same drug reactions that non-pregnant women have, and therefore require specific medical aid research (“The Second Wave: Towards the Responsible Inclusion of Pregnant Women in Medical Research”). Doctors are currently unable to recommend evidence-based treatments and must instead rely on partial information and guesstimates when developing treatments (Baylis). Biomedical research eliminates fragmented-data dependence by providing doctors with the necessary information to make educated recommendations.

Unfortunately, the women and unborn children partaking in such research cannot have their safety guaranteed. The unforeseen dangers of untested medications are just that, unforeseen; doctors cannot fully predict the way the treatment will affect trial participants. Nearly a quarter of all clinical trials receive no federal oversight. Even some FDA-approved trials fail to follow guidelines and are full of deficiencies (Lemonick and Goldstein). Dangers like these make biomedical research seem like a pretty risky gamble with your own life, and an insane chance to take with both yourself and your offspring.

Pregnant women have much more at stake than regular participants, creating a warranted hesitation to volunteer. It isn’t even the mother who is being studied and subjected to exposures, but rather the fetus; and while pregnant women can freely give their consent to being guinea pigs, the children they are carrying cannot (Brody). Few women are willing to make this decision for their unborn children and subject them to research that could turn out developmentally detrimental. So, although no laws actively prevent pregnant women from participating in clinical trials, they aren’t exactly lining up to offer their bodies and their children to science.

Some expecting mothers make better candidates for research participants than others. There are rare cases where taking a pregnant woman off of medication that she is already taking would be worse for the baby than the drugs are. Women with diabetes and depression are prime examples of this need for treatment continuation (Smith). In these cases, doctors would continue to administer the woman’s current medications as long as there were no known lethal fetal effects. In the case of a drug being known to harm unborn children, the mother may have to switch medications, but still remain under the same type of treatment she was already being given. This allows women to receive the drugs they need, babies to develop properly, and doctors to conduct research. The researchers can then monitor the medications’ effects without subjecting both mother and fetus to new, potentially harmful, and frequently unnecessary treatments.


Image: Oregon Health and Science University http://www.google.com/imgres?imgurl=http://www.ohsu.edu/xd/health/services/women/clinical-trials/images/midwifery-research.jpg&imgrefurl=http://www.ohsu.edu/xd/health/services/women/clinical-trials/current-clinical-trials.cfm&usg=__uhbxqD-WYgfcKTxgcle0wUTL8Zk=&h=250&w=544&sz=48&hl=en&start=106&zoom=1&tbnid=XOELalekcZlwtM:&tbnh=60&tbnw=130&prev=/images%3Fq%3Dpregnant%2Bwomen%2Bclinical%2Btrials%26hl%3Den%26biw%3D975%26bih%3D598%26gbv%3D2%26tbs%3Disch:10%2C3507&itbs=1&iact=rc&dur=493&ei=dyaiTPjbAoT78Aai-L2DBA&oei=aSaiTNLgM8T58Aacq731Aw&esq=8&page=8&ndsp=15&ved=1t:429,r:6,s:106&tx=40&ty=20&biw=975&bih=598

Sources:
Baylis, Francoise. “Pregnant women deserve better”. Nature Magazine. 9 June 2010. http://www.nature.com/nature/journal/v465/n7299/full/465689a.html

Brody, Baruch A. “The ethics of biomedical research: an international perspective”. Oxford University Press. 1998. http://books.google.com/books?id=merfunmvv_oc&pg=pa101&lpg=pa101&dq=risks+of+biomedical+research+on+fetuses&source=bl&ots=cmkthbuybq&sig=dz5p3uei6kiw7iezktyq6mcep28&hl=en&ei=csoatjwad4oclae_omhjcq&sa=x&oi=book_result&ct=result&resnum=8&ved=0cdkq6aewbw#v=onepage&q&f=false

Lemonick, Michael and Goldstein, Andrew. “Human Guinea Pigs”. TIME Magazine. 14 April 2002. http://www.time.com/time/covers/1101020422/story.html

“The Second Wave: Towards the Responsible Inclusion of Pregnant Women in Medical Research”. Johns Hopkins University

http://www.bioethicsinstitute.org/web/page/901/sectionid/379/pagelevel/2/interior.asp

Smith, Stephanie. “Should pregnant women be medical test subjects?”. CNN Health. 17 June 2010.

http://pagingdrgupta.blogs.cnn.com/2010/06/17/should-pregnant-women-be-medical-test-subjects