Letter from Professor Anne Drapkin Lyerly

March 07, 2006

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-2127-P
P.O. Box 8016
Baltimore, MD 21244-8016


3 May 2002

To Whom It May Concern:

I am writing with regard to the proposal currently being considered that would expand the State Child Health Insurance Program (SCHIP) to include "unborn children" from conception through birth. As an academic obstetrician/gynecologist with a research focus in bioethics, I have published several articles and have been involved in public policy regarding reproductive medicine, most recently with regard to surgical interventions directed at the correction of fetal anatomic abnormalities.

While I agree with the text of the proposed rule change regarding the importance of prenatal care and would generally favor a proposal that would improve the resources available to pregnant woman, I am deeply troubled by the SCHIP proposal and am writing to strongly oppose the proposed rule change. The reason for my opposition is that the framework upon which the proposal is justified (i.e., that in which the fetus is extracted, conceptually, from the woman in whom it necessarily exists) results in an unconscionable disregard for women, and constitutes a serious threat to the well-being of pregnant women and the potential children it purports to protect.

There are numerous examples in the last two decades of why policies claiming to protect fetal well-being have been devastating in the two ways mentioned above. Perhaps none exemplifies the problems of this framework as blatantly as the growing practice of so-called "fetal surgery," i.e., surgery directed at fetal anatomic abnormalities. Interestingly, the proposed rule change references (indeed, lauds) these efforts as uses them as justification for redefining "child" to include unborn fetuses for the purpose of including them in the SCHIP program in the following paragraph:


"Medical care is continually advancing and offers opportunities for services specifically targeted to the care of the unborn child. "Fetal medicine" or "fetology" is emerging as a distinct and important medical specialty which includes: obstetrics, maternal-fetal medicine, neonatology, pediatrics and fetal/neonatal pediatric surgery. Physicians specializing in fetal medicine use the pre-partum period to diagnosis potentially life threatening conditions in utero (e.g. congenital cystic adenomatoid malformation, congenital diaphragmatic hernia, congenital heart disease, gastroschisis, giant neck masses, hydrocephalus, obstructive uropathy omphalocele, spina bifida, sacrococcygeal teratoma). Once detected, such conditions can often be surgically or medically treated in utero, with beneficial consequences which can include: saving the life of the child; elimination of long neo-natal, post-partum medical care for the child; and ultimately lower post-partum medical care costs for the child and therefore the SCHIP plan. The Secretary would like to permit the States the flexibility to pay for the medical expenses related to unborn children because the Secretary has determined that provision of such services before birth should result in healthier infants, better long-term child growth and development and ultimate cost savings to the SCHIP plans (and the federal government through the SCHIP contribution process) through reduced expenditures for high cost neo-natal care."

Contrary to claims in the preceding paragraph, the practices know as "fetal surgery" have been deeply plagued by both clinical and ethical problems. In fact, these practices are an extraordinary example of why it is wrong to conceptualize fetuses or fetal interests as separate or separate from the interests of pregnant women; my comments, therefore use "fetal surgery" as a point of reference in explicating the potential damage the HHS rule change might create.

The recent debate surrounding the evaluation and use of surgery directed fetal spina bifida is particularly relevant. Though generally lauded as "miraculous" by the popular press, widely publicized reports of in utero repair of fetal spina bifida (See Bruner et al, Fetal surgery for myelomeningocele and the incidence of shunt dependent hydrocephalus, JAMA 1999;282:1819-25; Sutton et al, Improvement in hindbrain herniation demonstrated by serial fetal magnetic resonance imaging following fetal surgery for myelomeningocele JAMA 1999;282:1826-31) sparked an intense debate in clinical, ethical and public policy arenas.

The findings in these reports hardly impressed, and have more commonly distressed members of the obstetric community. Modest improvements in the need for neonatal shunting and hindbrain herniation in the neonate were contrasted with severe obstetrical complications (including preterm labor, oligohydramnios, placental abruption, uterine rupture, and maternal small bowel obstruction) and no demonstrable improvement in cognitive, motor or bowel or bladder functioning in the neonate. Responses ranged from skepticism to alarm. In an accompanying editorial, obstetrician Joe Leigh Simpson stated, "the procedure certainly must be considered experimental." (Simpson JL, Fetal surgery for myelomeningocele: Promise, progress, problems JAMA 1999; 282:1873-4.) In a recent survey of the members of the Society for Maternal-Fetal Medicine, 57% of respondents believed that based on the reported outcomes, a moratorium should be imposed on open fetal surgery for nonlethal conditions until a multicenter controlled trial is completed (Lyerly et al, Attitudes of maternal-fetal specialists concerning maternal-fetal surgery, American Journal of Obstetrics and Gynecology 2001;185:1052-8).

Two conferences in the United States were held to address the issues raised, one at Vanderbilt University (March, 2000) and one at the National Institutes of Health (July, 2000). Central to the discussion at the first of the conferences was the fact that in characterizing their work as "fetal surgery," practitioners performing these procedures had neglected the impact of these operations on the pregnant women who consented to them. For instance, one study reported on the following outcome measures: gestational age at delivery, birthweight, leg function in the postnatal period, need for shunt placement, and the severity of the Chiari malformation on MRI; no plans for the measurement of short term or long term maternal outcomes were mentioned. This was the case despite the fact that so-called "fetal surgery," involves at least two operations for pregnant women, including a midtrimester classical uterine incision (a type of incision that places her at greater risk of future uterine rupture and maternal and fetal death) and a cesarean section for delivery of the child weeks after the initial surgery. Based on this devastating oversight, legal scholar Susan Wolf told the participants in Nashville that "fetal surgery" was a mischaracterization of these efforts. "This is maternal surgery and fetal surgery," she said, suggesting that it ought instead to be called "maternal-fetal surgery." The conference convened several months later at the National Institutes of Health adopted this suggestion; the conference was entitled "Current Scientific, Clinical and Ethical Considerations of Maternal-Fetal Surgery."

Discussions following the NIH conference focused not only on nomenclature, but also on the substance of what would be ethically acceptable research on this unproved procedure. A report of the conference made several recommendations, including the following: Women must be considered research subjects in the conduct of trials evaluating MFS. (Lyerly et al, Toward the ethical evaluation and use of maternal-fetal surgery. Obstetrics and Gynecology 2001;98:689-97). Furthermore, it is my understanding that, based on these ethical considerations, plans to perform an NIH-sponsored multicenter randomized controlled trial of maternal-fetal surgery for repair of fetal spina bifida must include short and long-term outcome measures regarding the well-being of women.

Maternal-fetal surgery for fetal spina bifida may ultimately prove to be beneficial; alternatively, it may prove to be no better (or worse) than postnatal repair. Regardless of the outcome of the proposed trial, one lesson should be learned: interventions on the fetus constitute interventions on a pregnant woman, and leaving her out of the picture is a tremendous threat to the well-being of the fetus and pregnant woman alike. The NIH has recognized the importance of keeping womenís interests and well-being central to the evaluation and use of procedures aimed at the improvement of fetal well-being. Those evaluating the proposed rule change should make note of this as well, a hard-learned lesson from the mistakes and problems of decades of work in the field of maternal-fetal surgery.

Ultimately, the practice of "fetal surgery" is not a justification for, but rather a reason to reject any proposal that conceptually extracts the fetus from the pregnant woman. This includes the proposed rule change now under consideration. Again, I believe that there is no justification for expanding the definition of "child" to include the unborn under the SCHIP provisions. It is widely known that the best way to ensure the health of newborns is to take good care of their mothers. A far better plan than the current proposal for increasing prenatal care access would be to grant state waivers across the board that would allow pregnant women of any age to be covered under S-CHIP.

As a physician who cares for pregnant women, I urge the Department of Health and Human Services not to implement this regulation, which, by redefining the term child , reduces women to vessels rather than treating them as the full human beings that they are. I urge you to focus, instead, on addressing the health care needs of the millions of Americans without health care coverage and on health care approaches that respect women's rights, and will ultimately best serve this generation and the next.

Sincerely,

Anne Drapkin Lyerly, MD
Assistant Professor, Department of OB/GYN
Duke University Medical Center