Last week, a team of pediatric surgeons reported the landmark finding that prenatal spinal cord surgery of fetuses with incipient spina bifida led to substantially better long-term outcomes than deferring surgery until just after the child was born. (My news organization’s coverage.)
A foll0w-up analysis in the New York Times by Pam Belluck detailed some of the tricky ethics that surrounded this practice-changing trial. Despite promising early results with fetal surgery to correct the early stage of spina bifida, no definitive evidence existed that the outcomes would surpass waiting to perform the surgery following delivery. As Belluck notes, the trialists added this unusual footnote to their published background narrative of their study: “All other fetal-intervention centers in the United States agreed not to perform prenatal surgery for myelomeningocele while the trial was ongoing.” Her article fleshes out what this meant in ethical terms, and in the human terms of mothers forced to decide whether to enroll in a study that gave them a 50/50 chance of assignment to the control arm, which would delay their child’s surgery to the postnatal period.
While the cynic might say they had no real choice, given the researchers’ foresight to funnel all willing U.S. families into the study, I’m sure it nevertheless took courage and conviction on the part of the parents to agree to participate in the randomization roll of the dice. The Times article includes a touching comment from a mom whose son, part of the control, post-natal surgery group, bears many of the scars of spina bifida. While her son never got direct benefit from prenatal surgery, “he benefited from the research that has happened about his disability.” Benefited how? By suffering the consequences that helped prove the advantages of the prenatal surgery that new generations of affected fetuses will now be able to undergo.
So here’s to control patients (and in this case to their parents too), usually an unsung group. The Belluck article has one other very telling line, this one from a medical ethicist who critiqued the decision to shut down prenatal surgery everywhere to best serve this trial. “For physicians who believe in it, why should they be pressured into stopping,” she quotes Baruch A. Brody, director of medical ethics at Baylor College of Medicine. Physician belief! Medical history is full of surgeries, procedures, and treatments that some or even many physicians believed in but turned out to actually harm. When no one really knows, the cooperation of physicians, and patients (and parents) to work together to find out for sure , and to have the answer advance medicine so profoundly, is a notable event.
—Mitchel Zoler (on Twitter @mitchelzoler)