The American Journal of Bioethics, Volume 11, Issue 11, Page 31-38, November 2011.

Following the widespread occurrence of birth defects from the use of thalidomide to treat nausea during pregnancy in the 1960s and 1970s, the Food and Drug Administration became particularly vigilant about the use of therapeutic agents during pregnancy and in women of childbearing potential. The FDA developed a list that categorizes an agent according to the known risks to a fetus. The drug thalidomide falls into Category X: agents that have demonstrated clear risk of fetal abnormalities and whose risks outweigh (...) the benefits of use during pregnancy.Another Category X drug is isotretinoin, commonly known by its trade name Accutane. Isotretinoin is an oral medication prescribed for severe recalcitrant, nodular acne in patients who are unresponsive to conventional therapy. Isotretinoin has been available since 1982, and it remains the only effective treatment for this condition. (shrink)

The United States Food and Drug Administration , in collaboration with pharmaceutical manufacturers, have recently implemented a heavily revised risk-management program for patients on isotretinoin , a drug with known and pronounced teratogenic effects. This revised risk management plan places significant burdens on both providers and patients in the hopes of achieving its goal of reducing fetal exposure to isotretinoin. The main focus of this paper is to discuss the burdens of various aspects of the program in relationship to potential (...) corresponding benefits. In particular, we evaluate the pregnancy rates of women on isotretinoin therapy compared with that of the general population and the rate changes based on the risk management programs. Additionally, we investigate whether the benefits of the program for women have increased as the benefits have risen. We devote special attention to the ethical implications of the intent of the program and to an analysis of the ethical justification of the restrictions placed on women of childbearing potential as it compares to the risk-benefit relationship of using isotretinoin. (shrink)

In their article in the September-October 2010 issue of IRB: Ethics & Human Research, Chris Kaposy and Françoise Baylis argue that the contraception policy of the University of Nebraska Medical Center’s institutional review board fails to meet an ethically ideal standard in establishing the criteria investigators should follow when including women of childbearing potential in clinical research. In this response, we argue that the UNMC IRB’s policy is evidence-based and pragmatically oriented and that it therefore better safeguards women’s autonomy than (...) an ideal policy could. We also offer some of our experiences with the policy since it was implemented six years ago. (shrink)

The American Journal of Bioethics, Volume 12, Issue 1, Page W1-W2, January 2012.