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Suleman Case Shines Public Spotlight on Reproductive Technologies

In the late 1970s, a popular television show led us to believe that "Eight is Enough." Fast forward to 2009, and the resulting furor over the "octomom" seems to indicate that eight is actually way too many.

To put it mildly, professional leaders in the field of assisted reproductive technology (ART) and fertility are extremely frustrated by this latest development.

"There is a set of guidelines as to how many embryos should be transferred, and clearly the physician did not follow the guidelines with Ms. Suleman," stated Michael A. Thomas, MD, the incoming board chair for the Association of Reproductive Health Professionals. He added this is an outlier case that sheds a bad light on an important technology that has successfully helped thousands of people achieve the dream of having children in a medically safe manner.

Based on Suleman's age, continued Thomas, director of the Division of Reproductive Endocrinology and Infertility at the University of Cincinnati College of Medicine, no more than two embryos should have been transferred in the attempt to achieve pregnancy and live birth. Double board certified in his specialty and in obstetrics/gynecology, Thomas said his field has progressed greatly since the first successful in vitro fertilization (IVF) in 1978.

Success rates realized by transferring one or two embryos generally make it unnecessary to go outside the evidence-based guidelines created by the American Society for Reproductive Medicine (ASRM). Doing so also greatly increases the risk of complications for the mother and long-term medical issues for multiples, who are often born prematurely.

"When the story broke, I told reporters not to cover this as a medical miracle. It's a medical failure," said Sean Tipton, director of public affairs for ASRM. "The fact that eight children were born at one time indicates a medical problem."

He continued, "Controversy in the field of reproductive medicine is nothing new, particularly in the United States. Frankly, we have a shameful history in the U.S. of not treating reproductive medicine as seriously as we should."

Tipton added there is a "completely false" perception by some that fertility is an unregulated industry. "Reproductive medicine is regulated in the same way that every other field of medicine is in the United States so it's this complicated patchwork of federal, state and professional self regulations." He added that as with other fields, the state licenses physicians but specialty credentialing is left to the professional associations.

"At the federal level," he continued, "obviously all the drugs and devices used in reproductive medicine have to be approved by the FDA. One significant difference," Tipton continued, "is that it is illegal to perform an IVF cycle in the United States and not report that cycle and its outcome to the federal government. That is not true for any other medical procedure in this country. Now what's not regulated in this country are decisions about who gets to become a parent, how and why."

Thomas said, "Ideally, you'd like to have these decisions made between a patient and a physician. You'd hate to have the government decide." Again, he added, "If doctors just follow the guidelines put forth by ASRM and the Society for Assisted Reproductive Technology (SART – the ASRM affiliate that has oversight of fertility clinics), you wouldn't have these problems."

Tipton noted the guidelines, which have been updated and revised several times, have been in place for a decade and have resulted in a statistically significant decrease in the number of high order multiple births.

"Fewer than 2 percent of IVF live births now result in triplets or more," he said. "We think it's quite clear that these guidelines work."

As for the specifics of the Nadya Sulleman IVF procedure, Tipton said that his association is looking into the matter. "We're not prepared to take the word of the patient appearing on the Today show as to how her treatment occurred," he said. "I will say, it's extremely difficult to imagine a scenario where the guidelines were followed that would lead to the birth of octuplets."

Tipton said Suleman's physician is a member of SART and that clinics have been removed from membership for a failure to meet the organization's criteria. "We do not have the ability to put anybody in jail or take away anyone's license so our efforts are focused on education," he said of working with clinicians who go outside the guidelines.

"It's very clear that infertility therapy such as IVF is helping hundreds of thousands of American build their families, and one bad outcome isn't going to change that," he continued.

Thomas wasn't quite as optimistic. "I think this situation has set us back many years when we discuss the possibility of insurance coverage for in vitro fertilization," he stated.

If there is a silver lining in the current cloud hanging over ART, both industry leaders said it is the dialogue it has started regarding how the industry moves forward.

Despite the recent issues swirling around their field, neither professional believes more government oversight is the panacea. Tipton called it "an incredibly bad idea" when states try to legislate the number of embryos that can be transferred or draw hard lines as to who is qualified to become a parent. However, there are areas where he would welcome some government interference.

"First, you could make sure insurance companies are no longer allowed to discriminate against the infertile by not paying for their treatments," he said, adding that having insurers involved brings another layer of quality control. Second, Tipton continued, "The federal government could start funding research that would help improve treatments."

Despite the recent setback, Thomas believes some of the answer to ultimately winning over insurance companies lies with physicians. One way of getting insurers to take the idea of ART coverage more seriously, he said, is if "they think physicians are doing all they can to follow the guidelines and reduce the number of multiple births. Their biggest fear is to have six or eight babies in the ICU."

For more information about practice guidelines and ethics committee reports, Tipton urged healthcare professionals to visit www.asrm.org.

Tags:

American Society for Reproductive Medicine, Assisted Reproductive Technology, Association of Reproductive Health Professionals, high order multiple births, in vitro fertilization, Michael Thomas, Nadya Suleman, octomom, SART, Sean Tipton

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