In 2014, Kelsey Taylor of Norwood, Massachusetts, was 19 years old, ill with severe sickle cell disease, and about to be treated at the Clinical Center, the research hospital at the National Institutes of Health (NIH). But the toxic drugs and radiation used in her treatment were likely to injure her ovaries and leave her infertile.
Even at 19, Taylor knew she wanted the chance to have biological children someday. “For me that was huge,” she says. She was fortunate: NIH was just starting to freeze patients’ eggs before fertility-damaging therapies, so that women might start a pregnancy after their medical odyssey. But the next year, the National Institute of Child Health and Human Development (NICHD), which launched the egg-freezing program, suspended it, dismaying infertility experts.
The program originated with OB-GYN Erin Wolff, then a scientist in training at NICHD. Several months earlier, Wolff had proposed to NICHD’s scientific director, pediatrician Constantine Stratakis, that she provide egg freezing to patients like Taylor. Several young women had decided not to enter potentially lifesaving research studies when they learned they were likely to lose their fertility, Wolff says.
The American Society for Reproductive Medicine had declared in 2012 that egg freezing was no longer experimental, and major hospitals across the country were offering it. But Stratakis and his clinical director, paediatrician Forbes Porter, told Wolff she would need to offer the egg freezing as a research study, she says. (NICHD declined to make Stratakis or Porter available for comment.)
Wolff launched the study in August 2014, and Taylor was her first patient. Wolff retrieved and froze the eggs of 20 more women and teens over the coming 16 months. But in December 2015, NICHD’s Institutional Review Board, an ethics committee, suspended the study because of protocol deviations. Wolff says the lapses, such as adjusting pregnancy test timing by a few days to accommodate patients’ schedules, were well within the standard of clinical care. She failed to win a permanent job at NICHD and left.
After Wolff’s protocol was suspended, “I was upset,” says Barbara Collura, president and CEO of Resolve: the National Infertility Association. She served on NICHD’s external advisory council from 2015 to 2019. “This was standard of care; it was not experimental. This is supposed to be our nation’s preeminent research facility.”
Before leaving, Wolff wrote to NIH Director Francis Collins in February 2016, asking him to protect the egg-freezing program. She noted that in the 6 weeks since the trial’s suspension, four women had already undergone therapies toxic to their ovaries without being offered egg freezing. She told him that the patients she had treated were mostly poor, with many uninsured. Virtually all had told her they could not pay the procedure’s $16,000 price tag at private fertility clinics. “We at NIH are failing to do what is well within our means to protect [patients’] ability to bear children,” she wrote.
Collins passed the letter to Michael Gottesman, NIH’s deputy director for intramural research, who wrote to Wolff in March 2016 that he had concluded that egg freezing was “both appropriate and feasible” for Clinical Center patients. He added: “I can assure you that all patients whose fertility might be affected by these treatments will be offered the option of egg freezing.”
More than 3 years passed before NIH resumed offering egg freezing to Clinical Center patients in July 2019. By late January of this year, 10 patients had taken advantage of it. NIH declined to explain the delay, saying only that in the interim the agency had “counseled” patients about getting egg freezing done outside NIH.
The lapse was “really unethical,” says Joyce Reinecke, executive director of the nonprofit Alliance for Fertility Preservation. “You are potentially sterilizing people.”
Infertility physician Kenan Omurtag of Washington University in St. Louis says his institution began to offer egg freezing as a service in 2012, “the minute” the experimental label was lifted. He calls the 3.5-year delay outrageous and says, “The right response is: ‘What happened? Why did it happen? And how can we make sure it doesn’t happen again?’”
This story was supported by the Science Fund for Investigative Reporting.