Reply

Abstract

We thank Dr Lyerly for taking the time to consider and respond to our article, which provided a comprehensive ethical framework for maternal-fetal surgery. She claims that current clinical research on spina bifida would not be ethically justifiable in an ethical framework that treats the fetus and pregnant women as separable patients. Happily for us, and unfortunately for Dr Lyerly, we have never proposed or defended such a framework. Her criticisms, although they may apply to a possible position on the ethics of maternal-fetal surgical research, cannot reasonably be considered applicable to our own. Indeed, to claim that our approach to ethics in obstetrics commits us to the view that the fetus and the pregnant woman are separable patients involves an egregious misrepresentation of our work. We have argued explicitly and repeatedly that the moral status of the fetus as a patient does not involve independent moral status, which is the only ground for claiming that the fetus is a patient separable from the pregnant woman.1McCullough LB Chervenak FA. Ethics in obstetrics and gynecology. Oxford University Press, New York1994Google Scholar We have also emphasized in all of our work that the physician's obligations to the fetal patient can never be determined in isolation from obligations to the pregnant woman; beneficence-based obligations to both the fetal and pregnant patients and autonomy-based obligations to the pregnant woman must all be taken account of in reaching any ethically reliable judgment about the physician's obligations to both and the balance of obligations in the case of conflict. Moreover, we have emphasized that the pregnant woman is obligated only to take reasonable risks to her own life and health to protect the fetus1McCullough LB Chervenak FA. Ethics in obstetrics and gynecology. Oxford University Press, New York1994Google Scholar; any implication that our ethical framework would run roughshod over the woman's health interests and autonomy in the name of obligations to the fetal patient is therefore groundless. In contrast to our approach, which treats beneficence and respect for autonomy as prima facie principles that must be carefully balanced with each other, Dr Lyerly treats respect for autonomy as an absolute principle and simply shunts aside as irrelevant direct obligations to the fetal patient. As a consequence, Dr Lyerly's approach does not require explicit, comprehensive analysis of component obligations, resulting in a clinically incomplete and therefore inadequate approach. Consistent with our ethical framework, our account of equipoise takes account of both the fetal patient's and the pregnant woman's health-related interests. The third of our three criteria for equipoise requires that mortality and morbidity risks to the pregnant woman be low or manageable, not nonexistent. Dr Lyerly may wish to argue that our third criterion is somehow unreasonable, but simply asserting that maternal-fetal surgical research is, on balance, risky to the pregnant woman (and the to fetus, we would add) states a different criterion, not an argument against the one we proposed. That such research might involve risk to the pregnant woman is not enough to eliminate equipoise because (as required by our ethical framework) that risk must be balanced against potential benefit for the fetus to determine the “merits of the intervention to be tested.”2Brody BA. The ethics of biomedical research: an international perspective. Oxford University Press, New York1998Google Scholar The view that any research that on balance involves health-related risks violates equipoise would make virtually all clinical research ethically unjustifiable. Our beneficence-based reasoning about equipoise is directly parallel to clinical judgment about cesarean delivery based on reliable fetal indications. To be sure, cesarean delivery is, on balance, more risky to the pregnant woman than vaginal delivery, but this is not the whole of the story; benefit to the fetal patient needs also to be considered for clinical ethical judgment to be comprehensive and reliable. Dr Lyerly appears to hold that mortality and morbidity risks to the pregnant woman are the whole of story, thus invoking a framework for obstetric ethics that is inconsistent with ours. Finally, Dr Lyerly invokes psychosocial benefit to justify a claim that equipoise exists concerning maternal-fetal surgical research. This introduces an autonomy-based component into the concept of equipoise, which will allow equipoise to vary widely from patient to patient. Moreover, physicians are not in a position to identify the psychosocial benefits and risks of whether to have children with handicapping conditions; this judgment can only be reached from the patient's perspective. For these two reasons alone, an autonomy-based concept of equipoise is, at the very least, controversial. As such, its use must be supported with argument, not simply asserted as somehow a viable alternative. Another advantage of our comprehensive approach is that it balances obligations to the fetal patient and the pregnant woman without invoking such a controversial concept of equipoise.