Lacey-Clemens FridayNicole SkrabaczHeather Perez

What is DES?

Synthetic Estrogen

When was it developed?

1938

Where was it developed?

London

Why was it developed? To prevent spontaneous

abortions

Where was DES studied?

Harvard University Tulane University University of Chicago

Common Uses: Prevent miscarriages Treat Pregnancy

Disorders (Preeclampsia)

Diethylstilbesterol

What did the DES studies include and conclude?

Study conducted in 1940 Harvard University Physicians The study was not controlled Concluded: DES was effective against

complications in pregnancy and contributed to a healthier maternal environment.

Study was conducted in 1950 Tulane University The study was controlled Concluded: DES-treated women had more

miscarriages and premature births than those who did not receive DES had healthier babies.

Conducted in the 1950’s. Chicago University Lying-In

Hospital Clinical Trial ½ the women received DES and ½ were given a placebo

University of Chicago DES Case Study Consideration

What was the hypothesis? Women who are treated with DES

will have LESS miscarriages and premature births in comparison to mothers who had not used DES

Who would have benefited from the case results? The population as a whole,

physicians, and women who were being treated with DES or had the potential to be treated with DES

What are the ethical violations in this case?

Ethical Violations Informed ConsentThe women in this study did not know that the study was taking place and did not know about the study. Voluntary ParticipationThese 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-determinationThe women did not have the choice to participate or decline participation in the study.

Ethical Violations Declaration of Helsinki

A statement of ethical principles involving human subjects

Developed by the World Medical Association Physician first researcher second?

DES 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

Should this study have been conducted?

No, this study should not have been conducted…

Sacrificed the health of millions for the potential to do good Irresponsible research conduct The benefits did not outweigh the risk Women were not given the opportunity to exercise their freedom to choose (informed consent,

voluntary participation, self-determination) Violated the Hippocratic Oath, the Nuremberg Code, and the Declaration of Helsinki Risk of harmful health effects (later studies suggested cancer was a result of the babies that were

exposed in utero)

Should the data results from this study be utilized?

Yes, the data can be used with caution.

Results:Adverse pregnancy outcomes were not reduced in women who were given DES= it did not reduce the risk of miscarriage or pregnancy problems.

Why should it be used? No benefit to refraining from publication No further harm can be caused by publishing the data The harm and suffering that took place would have

been caused with no true benefit. Data may have been the same even if the ethical

violations would not have occurred. The data prevents FUTURE harm.

The actions of the researchers are in no way excusable in this case

What are the professional implications? The utilization of ethical codes, principles, and

guidelines in the development of professional research is increased.

Violators are penalized more harshly.Distrust for the medical professionals involved can

impact the professions ability to conduct future research.

The field as a whole is judged by the misconduct of a few individuals who conducted a study in an unethical manner

What are the implications for subjects?

Health Risks for mothers and infants-There are several studies that have been

conducted that determined that exposure to DES in utero caused health risks in the adult exposed children (CANCER) Protections and interventions were established with

the results of this data in reference to the use of DES. Future harm reducedIndividuals have to be active in own care and question

physicians who are prescribing medications and the purpose behind the medication.

Valid reason for mistrust in medical professionals and in research that is done ethically is discredited.

The belief above is passed on in the family.

Study Redesign

Obtain Informed Consent Allow for self-determinationIdentify Risk and BenefitInform participants of potential risk and

benefits Do a literature study prior to conducting

research in any way for this particular study