ASRM Report Denies Regulatory Reality
The American Society for Reproductive Medicine (ASRM) issued a report this past May responding to widely voiced concerns about the fertility industry's lack of oversight. The industry organization's conclusion: Regulation is unnecessary, since assisted reproduction "is already one of the most highly regulated of all medical practices in the United States."
Were it not for its source, such a claim would surely surprise many observers of the field. This is especially true since it was revealed that U.S. fertility clinics routinely flout the ASRM's own guidelines in the aftermath of the so-called "Octomom" controversy of early 2009.
In their announcement of the report, ASRM suggests that its conclusions were drawn from its December 2009 meeting of "professionals, patient advocates, government representatives and legal experts." But neither the announcement nor the report itself give any names, positions, or organizational affiliations of the participants - making it impossible to know what kind of qualifications were prioritized, and whether there was a meaningful diversity of perspective and expertise, for example in public health, medical sociology or women's health.
The report asserts that existing federal and state legislation affecting the fertility industry is exhaustive. It notes that state licensing requirements ensure that practicing physicians have completed medical school and postgraduate training, and passed a medical examination. It details federal reporting mandates.
But ASRM's assumption is that reporting requirements are synonymous with regulation. Even the centerpiece of existing legislation - the 1992 Fertility Clinic Success Rate and Certification Act, which mandates that fertility clinics report certain data to the Centers for Disease Control - lacks any means of enforcement. Clinics can and do fail to report, with no direct consequences.
Another example: The FDA does require that sperm and egg donations are free of disease. But the agency is remarkably absent in the other aspects of the fertility industry. The standard ovulation-stimulation drug Lupron, for example, was approved by the FDA for use in advanced prostate cancer, but is used "off-label" for assisted reproduction in spite of thousands of reports of severe side effects in women.
Furthermore, new fertility procedures are not, as bioethicist Rebecca Dresser puts it, subject to "the FDA approval process that governs drugs and other medical products." This means that ART procedures "need not meet FDA safety and efficacy standards before entering the clinical arena."
ASRM allows some realism to creep in when it recommends that assisted reproduction "be performed only at clinics that are subject to SART standards." The obvious implication is that presently, assisted reproductive technology is underway at clinics that operate outside the purview of SART, a sister organization of ASRM.
As Debora Spar argues in The Baby Business, one important explanation for the inadequate regulation of the fertility industry is the reluctance of many people to see it as an industry. Furthermore, it is an industry defined by an atypical set of characteristics. In economic terms, it is notable for the unusual nature of its demand and for its limited "supply." For many people, there are not acceptable substitutes for a biologically related child. Some will end their treatment (or perhaps transfer treatment to less expensive and even less regulated countries in Eastern Europe or India). Those who are left either have the money, or are willing to mortgage their house, use their savings, or borrow.
Another feature also distinguishes reproductive technology from other medical practices. Unlike any other field of medicine, the fertility industry doesn't just treat people - it helps to create new ones. That alone makes a strong case for unique governance structures and oversight mechanisms.
Update 7/15/10: "Octomom" doctor, Dr. Michael Kamrava, accused in new allegation of implanting too many embryo's in a patient, leading to death of fetus.
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