- The Washington Times - Sunday, March 8, 2009

Like most observers all over the country and indeed the world, I was disturbed by the news of the octuplet birth in Southern California. The problem was compounded by the unsettled situation of the mother and the number of children she already had. Regardless, a pregnancy with eight human babies is a medical failure, even when it ends with all eight infants surviving. It is difficult to discuss some aspects of this case because we don’t know the facts. We can’t even say the regulatory system failed because the incident is still under investigation and we don’t know what the final sanctions will be. But I can offer some perspective on the medical issues raised by this case.

The most important medical fact to consider is that the occurrence of any multiple pregnancy after an IVF cycle is undesirable. High-order multiple pregnancies are particularly problematic because they bring with them high risk of prematurity, birth defects and long-term disabilities. Thanks to surveillance data first collected by the Society for Assisted Reproductive Technology (SART) in 1988 and by the Centers for Disease Control and Prevention (CDC) since 1995, we can track the number of births resulting from assisted reproductive technology (ART) treatments.

Until 1996, we were seeing an increase in the number of high-order multiple births. Recognizing that increase and understanding the consequences, SART and its parent group, the American Society for Reproductive Medicine, moved to address the problem.

Starting in 1998, we issued guidelines on the number of embryos to transfer in ART procedures. In the subsequent 10 years, we have revised those guidelines downward four times to the point where current guidelines for women under 35 with a good prognosis encourage single embryo transfer and only allow the transfer of more than two embryos in less than favorable circumstances.

It is very clear that these guidelines have worked. Articles have been published in prestigious medical journals that attest to their effectiveness. In addition, everyone can go to the SART Web site (www.sart.org) and see that the triplet rate has dropped from more than 6 percent of all IVF cycles in 2003 to only 1.8 percent in 2007. We are pleased the data allowed us to issue and revise these guidelines, gratified our members complied with them and proud of the resulting drop in triplet and higher births.

Looking at these outcomes, it is evident that the vast majority of U.S. physicians performing IVF have acted with the best interests of their patients and babies in mind seeking to maximize the chance of success while reducing risks associated with multiple pregnancy. The determination of the precise number of embryos to be transferred is a highly personalized decision made between patients and their physicians. When making a recommendation, the physician takes into account the diagnosis of the patient, her age, her prior experiences with medical treatment and the quality and quantity of embryos available.

As you can imagine, this is a very complex decision that must be individualized for each patient each time she seeks treatment. It simply does not lend itself to blanket regulations for all patients in all circumstances. A government mandate dictating the same treatment for all women in all circumstances would be bad medicine and an unprecedented intrusion into the patient-physician relationship.

There are, of course, those who contend that professional self-regulation is insufficient and who, in complete ignorance or disregard of the truth, claim that assisted reproduction is not regulated. Like all forms of medicine, reproductive medicine is regulated through a complex patchwork of federal, state and professional self-regulation. Professional societies set standards and credential individual physicians, and physicians who cannot meet those standards or do not abide by established guidelines are subject to disciplinary procedures.

At the state level, clinicians involved are licensed to practice by the state, and those licenses can be limited or removed. At the federal level, the Food and Drug Administration regulates the drugs and devices used and promulgates regulation of all the tissues involved in ART treatments where donors are used. Laboratory procedures are also subject to federal regulation. Indeed, reproductive medicine is subject to more rigorous federal regulations than any other kind of medicine. Here is a notable example:

It is illegal in the United States to perform an IVF cycle and not report that cycle and its results to the federal government. It is hard to reconcile that fact with claims of the field being unregulated. Since the passage of the Fertility Clinic Success Rate and Certification act in 1992, all ART clinics are required to report their procedures and outcomes to the CDC. As was noted above, SART was collecting this information from its members prior to passage of this law and indeed is still collecting and publicly reporting these results.

What has not generally been regulated in this country are decisions about who gets to become a parent and, how, when or why. In the United States, we consider these to be private decisions. Those of us who care for patients with infertility believe this is as it should be. We believe patients suffering from the disease of infertility are already burdened enough, and they should not face additional hurdles to building their families just because they must seek the help of a physician.

It is understandable that so many people would be concerned with this infamous case. There are, in fact, actions the government should take to improve treatments for infertility patients and to help ensure nothing like this happens again. We would encourage governments to be proactive and get involved on the front end of the problem rather than attempting to regulate based on one exceptional case.

If the federal government wishes to address the problem, perhaps it should consider lifting the ban on federal funding for embryo research, research that would allow us to better improve our embryology and move us toward successful single embryo transfer for every patient.

If state governments wish to address the problem, perhaps they should ask themselves why they allow insurance companies to discriminate against the infertile by not covering treatments for their disease. If patients knew they could try again, they would be much more willing to have fewer embryos transferred.

Working together, all of us, patients, physicians, concerned citizens and our government, can move toward the goal of providing medical assistance to everyone who needs it to build their families, and to do so in a safe and effective manner.

Dr. R. Dale McClure is president of the American Society for Reproductive Medicine.

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