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Voluntary isn’t working

Recent events show need for regulation of assisted reproduction


By Marcy Darnovsky
Posted: April 13, 2009 - 12:01 am ET
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Each year, assisted reproduction quietly helps thousands of people in their quest for children biologically related to them. But the fertility field has been far from quiet of late. In recent weeks, two scandals burst into the headlines

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The first stories about the Southern California octuplets, in late January, focused on the novelty and details of their birth. But shock and then outrage quickly followed as news of the mother’s circumstances and the fertility doctor’s recklessness emerged. Entertainment news has yet to tire of the story; a more sober conversation about the need for additional policy and oversight is also simmering.

A few weeks later, the Wall Street Journal reported that another Los Angeles-area fertility clinic had begun advertising the “pending availability” of embryo screening to select for hair color, eye color and even skin tone. As that story bubbled into network and cable news, it elicited a reaction similar to the one surrounding the octuplets: What’s going on here? How can irresponsible fertility doctors get away with this sort of thing?

These questions are not being asked only by bloggers, tabloid editors and talk-radio hosts. Many bioethicists and fertility-sector insiders say the two events highlight the inadequacy of fertility industry oversight.

The multibillion-dollar American-assisted reproduction industry has long argued that self-regulation and the rules that apply to general medical practice are sufficient. Fertility treatment, however, differs from most other medical practices in important ways.

First, infertility is not a disease in the traditional sense: Its diagnosis depends on social factors as well as on biology. Of three biologically identical people, one might be happy without children, one might want to adopt, and another might strongly desire genetically related offspring. Only the last would seek a diagnosis of infertility for which medical treatment is invasive and success rates are low.

Second, the U.S. assisted-reproduction sector faces more and different commercial pressure than other medical fields, largely because most patients pay for fertility treatment. Like practices offering cosmetic procedures, fertility programs rely on advertising and marketing to compete for customers. Indeed, Jeffrey Steinberg, the fertility doctor who advertised pre-implantation genetic diagnosis, or PGD, for hair, eye and skin color, defended his offer as “cosmetic medicine.” Most importantly, assisted reproduction is unlike other medical fields—and unlike adoption—because it creates new children. Yet these children are not the fertility doctor’s patients. The clinic’s responsibility ends with a successful pregnancy.

What about the claim that self-regulation is effective and makes additional public oversight unnecessary? The field’s professional organization, the American Society for Reproductive Medicine, or ASRM, sets guidelines for its member programs. But many fertility programs routinely violate them.

Let’s start with the octuplets. Medical professionals know that even twins pose significant risks to mothers and babies, and that most patients can achieve pregnancy as well with one or two embryos as with higher numbers. ASRM therefore recommends transferring no more than two embryos per cycle for women under 35. Its educational efforts have helped reduce the rate of in vitro fertilization multiples in recent years.

Data from the Centers for Disease Control and Prevention, however, show that 80% of fertility programs fail to comply with the ASRM’s guidelines. In California, the noncompliance rate is 92%. Fertility doctors say that patients often press them to transfer greater numbers of embryos. Might regulations with more teeth than ASRM’s voluntary guidelines, as well as better insurance coverage, help the fertility field practice good medicine?

What about PGD for nonmedical traits? The Steinberg program to preselect a child’s appearance was both technically dubious and highly provocative. Though it was suspended after public hostility built, Steinberg’s offer made the seemingly cliched phrase “designer babies” seem remarkably appropriate, along with concerns about new forms of discrimination and inequality that the prospect raises.

Steinberg is not alone in offering PGD for nonmedical traits. Although ASRM guidelines discourage using PGD for sex selection (except in the rare cases of sex-linked disease), many fertility programs advertise it openly.

Dozens of countries have established rules for assisted reproduction, with notable success from the perspectives of both patients and practitioners. Typically, these policies prohibit extreme reproductive procedures—inheritable genetic modification, reproductive cloning and PGD for clearly nonmedical purposes.

Public policy for the U.S. assisted-reproduction field is overdue. Baseline federal policies will be important to prevent an unviable state-by-state patchwork; some rules can be set by state-level legislation.

The U.S. situation is complicated by challenges to abortion rights; opponents are already seeking to use concern about in vitro fertilization abuses to advance their own agenda. We will need to take special care to regulate assisted reproduction without policing women’s bodies, but we are better off doing that proactively than defensively.

Most American fertility practitioners are caring and conscientious professionals. Many will welcome clear rules and a level playing field. Responsible regulation and oversight will protect fertility patients and bolster public trust in the enterprise of assisted reproduction.


Marcy Darnovsky is associate executive director of the Center for Genetics and Society, Oakland, Calif.

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