By Marcia Clemmitt, May 15, 2009
After 33-year-old Nadya Suleman, a mother of six, gave birth to octuplets on Jan. 26, the California fertility specialist who treated her was summoned to appear before the Medical Board of California. The board — which can revoke physicians' licenses for egregious misconduct — is investigating whether Michael Kamrava, head of the West Coast IVF Clinic in Beverly Hills, violated accepted standards of medical practice when he implanted at least six embryos in Suleman during in vitro fertilization (IVF) treatment in 2008, leading to the multiple birth.
Suleman has told reporters that all 14 of her children were conceived using IVF — a high-tech treatment in which eggs are fertilized in the laboratory, then implanted into a woman's uterus for gestation — and that six embryos were implanted in each of her six pregnancies, although she's had only two multiple births: the octuplets and a set of twins.
But professional guidelines from the American Society for Reproductive Medicine recommend implanting only one or two embryos in younger women, such as Suleman, because of the high risk multiple births pose to children and mothers.
Multiple-birth babies, including twins, have a significantly higher risk for developing severe, debilitating disabilities such as chronic lung diseases or cerebral palsy, which occurs six times more often among twins and 20 times more often in triplets than it does in single babies.
The cost to the health-care system of multiple births is enormous. “The cost of caring for the octuplets would probably cover more than a year of providing IVF for everyone in L.A. County who needed it,” says David L. Keefe, professor of obstetrics and gynecology at the University of South Florida, in Tampa. “The likelihood that some of those kids will get cerebral palsy means they'll need a lifetime of care.”
The high-profile Suleman case has spurred calls for government regulation of fertility medicine — sometimes called assisted reproductive technologies, or ART. Like U.S. medicine generally, ART is not regulated by the federal government and only lightly supervised by state agencies. Since 1978 — when the world's first IVF baby, Louise Brown, was born in England — more than 3 million ART babies have been born worldwide, and some experts and ethicists fear the field's rapid expansion leaves too much room for abuses.
Others argue that lack of insurance coverage for IVF is the biggest problem with ART in the United States. Fertility treatments can cost more than $12,000 per cycle, pushing cash-strapped would-be parents to opt for the higher-risk, multiple-embryo implantation to increase their chances of a pregnancy.
By contrast, in most European countries — where IVF procedures are paid for through universal health-care systems — doctors generally implant only one fertilized embryo at a time. In Sweden and Finland, for instance, where the procedure is covered by insurance, doctors perform single-embryo implantations 70 percent and 60 percent of the time, respectively, compared to only 3.3 percent of the time in the United States.
In fact, some European governments prohibit multiple-embryo transfers for women under 36 and limit older women to no more than two embryos per cycle. As a result, “Triplets have virtually disappeared in Europe,” a Danish doctor told European colleagues at a 2006 fertility conference.
Self-regulation of ART in the United States clearly isn't working, said Marcy Darnovsky, associate executive director of the Oakland, Calif.-based Center for Genetics and Society, which advocates for responsible use of genetic technologies. According to the federal Centers for Disease Control and Prevention (CDC), to which ART clinics must report data, 80 percent of programs do not strictly follow American Society for Reproductive Medicine guidelines, making government regulation “long overdue,” she said.
“In reproductive matters, individuals are making decisions [that affect] not just themselves, but . . . others as well,” which makes regulation appropriate, said Johns Hopkins University scholars Franco Furger and Francis Fukuyama. Reproductive medicine is headed toward giving prospective parents “a range of . . . techniques to make specific choices about a baby's health and sex and eventually about other attributes,” said Furger, a research professor, and Fukuyama, a professor of international political economy, both at the Paul H. Nitze School of Advanced International Studies in Washington, D.C. “It would be misguided to take a wait-and-see attitude.”
Industrialized countries that pay for IVF through their universal health-care systems strictly regulate which services may be provided, says Susannah Baruch, director for law and policy at the Genetics & Public Policy Center, a think tank at John Hopkins funded by the Pew Charitable Trusts. The services typically include pre-implantation genetic diagnosis (PGD) — genetic testing of embryos. While PGD to detect serious genetic illnesses is conducted routinely, many countries strictly limit other PGD uses, such as selecting a child's gender, because they aren't considered in the public interest, she says.
However, in the United States — even though U.S. reproductive-medicine experts roundly criticize Kamrava's implantation of multiple embryos in the Suleman case — many ART experts also argue that government regulation of the industry is not necessarily a solution.
Suleman's case is much more of an outlier today than it would have been 15 years ago, when it wasn't unusual to have six embryos transferred, says Josephine Johnston, a research scholar at the Hastings Center for bioethics research in Garrison, N.Y. “I would have bet money that it was not IVF” that led to the octuplet birth, she says, but the use of ovary-stimulating drugs — a much cheaper, far less controllable method of assisted reproductive technology.
Multiple-embryo implantation is being phased out as ART technologies improve, Johnston says, and six-embryo implantation is “so far outside the guidelines it's amazing that a physician would do it.”
Such hair-raising cases are virtually always outliers and shouldn't be used to hastily enact laws, some analysts say.
For example, ever since artificial insemination was introduced sperm banks have promised would-be parents a genetic lineage of intelligence, athleticism and good looks for babies born from donor sperm, says R. Alta Charo, a professor of law and bioethics at the University of Wisconsin Law School. But “it hasn't undermined Western culture as we know it,” she says. “So why do we think that people are very likely to go through much more onerous PGD to choose traits?” Very few will try to use it to enhance their baby's intelligence or appearance, so there would be little point in prohibiting such behavior, she says.
A recent study by New York University's Langone Medical Center supports Charo's view somewhat. Of 999 patients who completed a survey on traits they thought warranted use of PGD screening, solid majorities named potential conditions such as mental retardation, blindness, deafness, heart disease and cancer. Only 10 percent said they might use PGD to choose a child with exceptional athletic ability and 12.6 percent, high intelligence.
“People are after different things” in calling for ART regulation, making legislation difficult, Charo says. Some may want limits on the number of embryos implanted per cycle, but most are calling for rules to enforce “personal morality,” such as whether gay couples should become parents or whether lower-income mothers should be allowed to have very large families, Charo says. “We must then ask why we would regulate these [reproductive] personal choices differently from other personal choices.”
ART-related law would likely be based on the unusual cases that make headlines, “and bad cases make bad policy,” she says.
Opposition to regulation might drop considerably if insurance covered IVF and other artificial reproduction procedures, but today only 12 states require such coverage.
For instance, limitations on multiple-embryo implantations might be acceptable if insurance covered several single-embryo implantations for all patients who have experienced six months of proven infertility, suggests Ronald M. Green, a professor of ethics and human values at Dartmouth College.
Because of the high cost of IVF treatments, the lack of insurance coverage has deprived “the vast majority of the middle class” in America, as well as the poor, from the modern ART “revolution,” says Keefe at the University of South Florida. “Once you have the middle class covered, then I have no trouble saying, 'We're not going to pay' ” for multiple-embryo implantation.
Furthermore, the procedure doesn't have to cost $12,000 per cycle, as evidenced by the lower amounts accepted by IVF clinics when insurance companies that are required to cover the procedure negotiate lower fees, he says. “It's a lot cheaper [for society] to pay for IVF at $3,000 or $4,000 per procedure and deliver only singletons,” thus avoiding the harrowing medical problems and high costs associated with multiple births, he says.
Mandating coverage not only reduces the number of multiple births but also increases access for the middle class. “I practiced in Massachusetts and Rhode Island [which require coverage], where sheet-metal workers and heiresses from Newport” mingled at IVF clinics because insurance picked up the tab, Keefe says.
However, not all fertility doctors would opt into a fully insured system, says Dawn Gannon, director of professional outreach for RESOLVE, the National Infertility Association, which advocates that insurance companies treat infertility like any other medical condition. For example, when New Jersey mandated coverage, in 2001, “some clinics didn't take insurance at all, and some started taking it and then stopped,” she says, because “they got less money per procedure.”
If the United States enacts universal health-care coverage, advocates for the infertile hope ART will be covered as it is in other industrialized countries.
But universal coverage would still leave thorny issues unsettled, such as whether taxpayer subsidies should support ART for unmarried women or women over 40. For older women, the debate centers on whether it is appropriate for health insurance to subsidize an infertility problem that is the result of natural aging and not the result of a medical condition. Also, pregnancy is riskier for both the older mother and the child.
Earlier in IVF's history, many clinicians routinely refused ART to single women, older women, lesbians and, in some cases, poor people. A 1993 survey of Finnish ART clinics found that many doctors “preferred not to treat either lesbian or single women,” arguing that they “wanted to protect children from having inappropriate parents, primarily 'bad mothers,' ” according to Maili Malin, a medical sociologist at Finland's National Institute of Public Health. A single woman's marital status and “wish to have a child” were both “considered indications of . . . questionable mental health.”
Whatever the outcome, the coverage debate will generate intense emotion. “So much of your life feels out of control when you want a child but find that you can't have one,” says Jan Elman Stout, a clinical psychologist in Chicago. “This is often the very first challenge that people encounter in their lives that, no matter how hard they work at it, it may not work out for them.”
- Should fertility medicine be regulated more vigorously?
- Should parents be allowed to choose their babies' characteristics, such as gender?
- Should doctors be able to refuse assisted reproductive technologies (ART) services to gay, older or single people?