Sector insiders fear a return to the early days of IVF, when clinics made vastly inflated claims of success.
BY RON SHINKMAN
The Centers for Disease Control has disbanded its Assisted Reproductive Technology Surveillance (ARTS) team, alarming fertility sector experts about the potential loss of accurate data on the operations of fertility clinics across the United States.
The loss of the six-member team was first reported by NBC News andt confirmed through interviews with industry observers
“A Bloodbath for Public Health”
The cuts were part of a massive wave of firings at the U.S. Department of Health and Human Services carried out in late March and early April, with as many as 10,000 employees let go.
“This is a bloodbath for public health,” Sean Tipton, chief advocacy and policy officer for the American Society for Reproductive Medicine told Inside Reproductive Health. “And it certainly appears that anybody who had anything to do with women’s or reproductive health was a particular focus of these cuts.”
Tipton did note that under federal law, fertility clinics still must submit data on the success of IVF procedures to the CDC, and the platform for submitting such data remains operational. But whether that data will be preserved or disseminated to the public remains to be seen. Tipton noted that voluminous databases regarding maternal mortality and pediatric illnesses maintained by the CDC have already been eliminated.
Tipton also noted that ASRM affiliate the Society for Assisted Reproductive Technology would continue to publish numbers on IVF success rates, but whether it will have the same reach and impact on the public than data issued by a well-known institution such as the CDC remains a mystery.
The data vacuum surrounding the moves at the CDC have alarmed those working directly at or with fertility clinics, who fear a return of the “wild west” before the federal Fertility Clinic Success Rate and Certification Act was signed into law in 1992 and mandated reporting of both IVF success rates and errors to the CDC. The CDC began reporting out IVF data in 1996, according to Tipton.
>80% Success Rates: Fears of False Advertising in Private Equity Medicine
“It’s quite alarming,” Eva Schenkman, a fertility clinic consultant and laboratory director based in North Carolina, told Inside Reproductive Health.
Schenkman recalled a period prior to the federal reporting law being implemented when it was commonplace for clinics to advertise IVF success rates of greater than 80%, even though “no one in the 1990s has a success rate close to that.” The current IVF success rate for women age 35 and younger is around 50% in the U.S., and it declines significantly for women over the age of 35.
“This shift may open the door to the spread of misleading or inaccurate information, heavily skewed to boost marketing tactics and financial gain rather than upholding ethical practices and prioritizing patient welfare,” Brian Levine, M.D., founding partner and practice director of CCRM Fertility of New York, told Inside Reproductive Health.
Levine added that this could also increase the risk that patients “may deplete their resources at subpar clinics, unable to assess their likelihood of success or the quality of care provided.”
Schenkman is also concerned that the rapid growth of private equity firms in the fertility space could exacerbate such a trend.
“If you have bankers running these clinics, they’re also running the ethics of these programs. Can we trust the bankers to do the right thing when they're beholden not to the patients, but to their shareholders?” Schenkman said.
85% Membership, SART Oversight without CDC Involvement
Meanwhile, reporting and publicizing clinic data will fall more heavily on ASRM and SART, Levine noted.
SART releases outcome data of its own, typically a year ahead of the CDC. SART membership includes about 85% of the fertility clinics in the U.S. that perform about 92% of all IVF procedures, according to Tipton.
But a more active SART may not be a panacea for the end of the ARTS surveillance team.
“While (the involvement of ASRM and SART) will enhance oversight and patient safety, it may also introduce additional demands for monitoring and reporting that exceed their current scope and resources,” Levine cautioned.
Tipton is also concerned that without the CDC involvement, what SART publicizes will not connect as readily with the public.
“We like to think that our recommendations are influential, and they are. But when you put the reputation and prestige and power of the CDC behind it, it has a much bigger impact,” he said. “That has been a tremendous public health success story. And now it’s one that is going to be a challenge to replicate.”
