- The Octuplet Case—Why More Regulation Is Not Likely
In vitro fertilization and assisted reproductive technologies, or ARTs, have always posed a regulatory conundrum. They’ve been hugely successful (52,000 births from 152,000 IVF cycles in 2005) and are firmly established as the treatment of choice for many kinds of infertility.1 But over the years there has been a steady drip of ethical lapses, from doctors who oversell their success rates to theft of eggs and embryos. A 1992 federal law arranges for accurate reporting of success rates and encourages accreditation of IVF laboratories, but there is no centralized licensing and control authority to enforce it (as exists, for example, in the United Kingdom) and thus few teeth to it.2
The IVF industry argues that there is more regulation in place than meets the eye, citing the many federal and state laws that impinge on IVF practice in some way.3 It also is active in developing ethical and practice guidelines, though it [End Page 26] has little muscle to enforce them. Critics of the industry argue that it’s like the wild west—anything goes if patients can pay, often to that patient’s detriment. Yet these critics are remarkably silent on what specific form more regulation should take. The Bush-appointed President’s Council on Bioethics was concerned enough to spend two years examining the field but found no reason to urge major regulatory intervention.
The octuplet case has peeled back the ART industry’s claim that everything is fine and dandy. In the end, however, it is unlikely to bring major changes to how IVF is conducted and regulated. This is in part due to the case being such an outlier. If the situation had not arisen in real life, it would have been hard to imagine it: an unemployed, thirty-three-year-old single mother of six IVF children with some evidence of personal instability has her IVF doctor implant six frozen embryos in her uterus. She then ends up giving birth to eight children and touching off a media firestorm.
The “octomom” has been widely reviled as an example of irresponsible reproductive behavior, not just because the octuplets, born at thirty-one weeks, are at high risk for cerebral palsy and learning disabilities, but because she doesn’t have the money to pay for their care, nor a husband or partner to help with it. She is partially estranged from her family and depends on the kindness of strangers and Medicaid to pay the enormous medical and rearing costs of an additional eight premature infants.
Nevertheless, the decision to transfer the embryos initially had some defenders. One noted fertility specialist in Los Angeles, Jeffrey Steinberg, was quoted in the Philadelphia Inquirer as saying, “Who am I to say that six is the limit. There are people who love big families.” Jamie Grifo, who is paid approximately $2.3 million annually by New York University medical school for his fertility skills, was similarly quoted in the New York Times: “I don’t think it’s our job to tell them how many babies they are allowed to have. I am not a policeman for reproduction in the United States.”
However, since the first reports, few other doctors have publicly defended Dr. Michael Kamrava’s decision to transfer six embryos. His Web site reportedly proclaimed that he was an “internationally recognized leader in the field of in-vitro fertilization whose work has led to breakthrough technology.” Although no law directly regulates who may have IVF procedures or the number of embryos to transfer, Dr. Kamrava appears to have violated the American Society of Reproductive Medicine’s guideline to transfer only two embryos for healthy women under thirty-five (one if they have already had an IVF birth) and has offered no justification for doing so.4 It is noteworthy that his program—one of many in the Los Angeles area—had a very low success rate.
So what, if anything, should be done about this? Since ART, like most medical procedures, relies heavily on professional self-regulation, let us first examine whether professional self-regulation can prevent such situations...