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Does ART Need More Regulation?

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by Laurie C. Gordon, Dec. 23, 2009

It was a year in which some high profile “cases” put the fertility industry in national headlines. You can name them: Octomom and her doctor, Kamrava, Jon & Kate’s eight combustion, embryo “mix-ups,” PGD for sex selection, a 65-year old mother, a doctor replacing donor sperm with his own sperm.

Last week FertilityAuthority attended a conference in Washington, D.C. on “The Adequacy of ART Oversight,” hosted by the American Society for Reproductive Medicine (ASRM). The conference brought together the various parties facing the issue of ART regulation: the federal government (the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)), state agencies (Federation of State Medical Boards), the ASRM, ethics and legal experts, RESOLVE, professors, and, of course, clinics and doctors.

By and large, those present seemed to agree that it wasn’t more regulation of fertility treatment that was needed. The sentiment amongst both speakers and audience members was that continued adherence to the regulations already in place and ASRM guidelines was critical.

In fact, slightly more than one percent of all American infants are born with the help of ART. The few-and-far between high profile cases are rarities, the cases of “outliers,” seized upon and sensationalized by the media.

But that doesn’t mean there aren’t legitimate issues. Here are just a few of the conference highlights.

Multiple Embryo Transfer

One area in which the fertility industry needs to focus and self-regulate is single embryo transfer. Though the practice of ART has changed dramatically over the past decade, doctors and clinics are still, on average, transferring too many embryos, stated Maurizio Macaluso, M.D., Ph.D., of the CDC.

Here are Macaluso's facts: The average number of embryos transferred during an IVF cycle has declined from four in 1996 to two today. Across the board, the number of triplets has declined dramatically. But the number of twins has not gone down. An increase in single embryo transfer hasn’t happened. (That said, according to Macaluso, only 18 percent of all infants born in multiples deliveries were ART babies).

Speakers called for fertility doctors to educate their patients about the risks of multiples and to encourage single embryo transfer whenever it is in the patient’s best interest.

PGD for Sex Selection

The availability of preimplantation genetic diagnosis (PGD) as a tool for selecting a baby's sex also raised red flags. “More than 40% of the clinics offering PGD performed PGD,” stated Susan Baruch, quoting a survey conducted by Generations Ahead, an Oakland, California advocacy agency concerned with genetic technologies that protect human rights. Baruch, the agency's head, said Generations Ahead and ASRM are focusing on discouraging PGD for sex selection.

Baruch admitted that once the technology is readily available, it will be difficult for clinics to make the decision not to offer sex selection. Right now, however, only a handful of clinics advertise for sex selection. (In case you were wondering, Baruch says there’s as much sex selection in the U.S. for girls as for boys. Surprised?)

MICROSORT, a new sperm sorting technology designed to increase the likelihood of conceiving a child of a particular gender is currently being reviewed by the FDA. Baruch said the FDA will call for public comment soon and all interested parties should weigh in on the issue.

Though she didn't claim to know how sex selection should be overseen, Baruch said the answer didn’t lie in government regulation.

Older Mothers

Linda MacDonald Glenn, J.D., L.L.M., of the Women’s Bioethics project, talked about how “moral panic” has occurred as people focus on “outlier” cases, which are less than one percent of all ART cases. Some of these cases have dealt with woman in their 50s and 60s becoming mothers.

According to MacDonald Glenn, the “flipside of pro-Choice is a woman’s right to have a child, regardless of her advanced age.” She believes that when an older patient looks to them to conceive, doctors and clinics should investigate whether there is “social support” for the child.

Patient Care

Barbara Collura, President of RESOLVE: The National Infertility Association spoke on behalf of patients. With regards to patient care, her concerns were how more regulation would affect patients’ access to care. She stressed that “regulation, to date, hasn’t been about patient care,” so more regulation is probably not the answer.

Collura also spoke about the issue of multiple births. “Doctors need to say “No” more often when a patient asks for multiple embryo transfers,” she stated. “By saying “No” doctors would let patients know they care about them and their future offspring.”

Where Does That Leave Us?

Winding up the conference, Mark Hornstein, M.D., a member of SART’s Executive Committee, and William Gibbons, M.D., of the Baylor College of Medcine and a past president of ASRM, called for voluntary programs to reduce multiple births which will continue to allow for physician and patient autonomy. Such programs, they suggested, could include an in-office meeting between physician and clinician about risks, as well as a follow-up letter to patients from the doctor before transfer. Gibbons emphasized, however, that bringing down the rate of twins “required buy in from both patients and physicians.”

But perhaps it wasMacDonald Glenn who summed the day up best. “First,” she stated, “There are no quick and easy answers here” and second, “Hard cases make bad laws so we should do whatever we can to keep the outlier cases out of court.”

Doctors need to do the best job possible for each of their individual patients and regulation shouldn’t interfere with that goal. As Susan Crockin, a lawyer with Crockin Law & Policy Group, LLC and an Adjunct Professor at Eastern Virginia Medical School, put it, “To treat baby-making as widget-making is problematic.”

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