Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies: Volume I, Institute of Medicine (US) Committee on Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies, NCBI PubMed NBK236538, 1994.
Diethylstilbestrol (DES), synthetic estrogen, was first produced in London in 1938. The earliest studies of DES in pregnant women in the United States were conducted at Harvard University in the late 1940s. Although the studies were criticized because they were conducted without the use of controls, the physicians directing the studies concluded that “DES was effective against a variety of pregnancy complications and resulted in a healthier maternal environment“. In 1947 the FDA approved new drug applications (NDAs) to market DES for the purpose of preventing miscarriages.
In the 1950s, however, controlled studies of DES in pregnant women yielded different results. At Tulane University, researchers found that more of the DES-treated women had miscarriages and premature births, while the controls had bigger, healthier babies.
At the University of Chicago, every pregnant woman at the University’s Lying-In Hospital (1,646) was a test subject for a DES experiment without their knowledge or consent, and became part of a clinical trial: one-half were randomized to receive DES and the other half received placebos. None of the women were told they were part of a study, nor were they told what drug they were taking. The study found that twice as many of the DES-treated mothers had miscarriages, premature births, small babies, thereby confirming the finding of a Tulane study that contradicted the original uncontrolled Harvard study which extoled high doses of DES effectiveness against pregnancy complications.
In 1951 the FDA concluded that DES was safe for use during pregnancy and stopped requiring manufacturers to complete NDAs prior to marketing the drug as a preventive against miscarriage.
Despite growing evidence that DES was ineffective and the confirmatory findings of harm, physicians continued prescribing DES for 20 years resulting in numerous birth complications and exposing the unborn daughters and sons of their patients to serious risk of cancers.
- Informed Consent: the women in this study did not know that the study was taking place and did not know about the study.
- Voluntary Participation: these women did not choose to participate in the study.
- Failure to prevent unnecessary harm: the Tulane University study should have been considered before proceeding with this case and ultimately leading to harm.
- Self-determination: the women did not have the choice to participate or decline participation in the study.
Declaration of Helsinki Violations
- The risk and benefits were not weighed in this study.
- The loyalty of the doctor did not lie with the women, but to research and the general population.
- The women did not have self-determination prior to or during the study.
- The University’s Lying-In Hospital experiment should not have been conducted.
- That study violated the Hippocratic Oath, the Nuremberg Code, and the Declaration of Helsinki.
- The data results from this study should have been published and used.