A call for federal oversight of fertility clinics
Medical ethicists see need for regulation of clinics that create and store embryos.
WASHINGTON — This could be the moment medical ethicists have hoped for.
With all the attention on stem-cell research, they say, now is the time for a harder look at the hundreds of in vitro fertilization clinics where those cells originate.
Largely unregulated, the clinics are an exception in medicine. In them, scientific application goes directly from animal testing to widespread human use - skipping the human trial and oversight phases. This not only raises questions of medical risk, but also profound ethical issues - such as what happens to "surplus" human embryos that are never implanted in a woman.
The lack of oversight is "unprecedented anywhere else in medicine," says Jeffrey Kahn of the Center for Bioethics at the University of Minnesota in Minneapolis. "Why do we have 200,000 spare embryos frozen in clinics all over the world? Partly, it's because no one's paying attention."
Bioethicists such as Laurie Zoloth, president of the American Society of Bioethics and Humanities, point with admiration to the way the British oversee IVF clinics and human-embryo research. A decade ago, Parliament established the Human Fertilization and Embryology Authority, which licenses clinics and all research on human embryos.
The authority has settled some tricky questions, such as how many embryos can be implanted in a woman and the issue of gender choice. (Couples may choose the baby's sex only if there's a medical reason for it.) Surplus embryos, meanwhile, may be frozen for up to five years.
In the United States, some clinics advertise sex choice to prospective patients. There are no standards for what happens to frozen embryos. Cases such as one in California in which a surrogate mother is carrying twins - one of which the designated couple requested to abort - end up in lawsuits. (A new couple has since been found that wants the twins.)
"The British have developed a very thoughtful regulatory process that far exceeds that which we've been offered in this country," says Ms. Zoloth. "This is going to take some rethinking ... because there is generation and fabrication of hundreds, perhaps thousands, perhaps tens of thousands of embryos every year that are then used or discarded with scant mechanisms to regulate their creation, their use, and their discard."
White House Chief of Staff Andrew Card said recently, on ABC's "This Week," that "the president and Congress will take a look at" regulating IVF clinics. But "right now," he added, "we don't ... see the need for further regulation."
The politics of regulating fertility clinics may be more daunting than those surrounding Mr. Bush's recent stem-cell decision.
"There are two places we [as a society] don't like government involved. One is the physician's office, and one is the bedroom," says Sean Tipton, spokesman for the American Society for Reproductive Medicine.
Additionally, Mr. Tipton and others say, the anti-abortion movement - which could arguably rise in protest over thousands of embryos headed for the dustbin - won't touch this issue. They recognize the popularity of IVF clinics among infertile couples, and the fact that more than 150,000 babies have been born as a result of in vitro fertilization. Indeed, the National Right to Life Committee declined to comment for this story.
Tipton also argues that the reproductive industry is sufficiently regulated. Its physicians are state licensed, and the federal government requires clinics to report their pregnancy success rates.
Meanwhile, the Food and Drug Administration is moving into oversight of fetal tissue. But FDA itself describes its new requirements as "baseline" and knows they do not address the ethical questions that arise in IVF clinics.
Joe McIlhaney, a founder of St. David's IVF clinic in Austin who has consulted with the White House on reproductive issues, wishes other clinics would use the standards he helped establish at St. David's.
St. David's, for example,
fertilizes only the number of eggs a woman wants to have implanted. In many clinics, by contrast, all eggs produced in the IVF process are fertilized, the best are chosen, and the rest are discarded. St. David's approach results in fewer embryos, and interestingly, in high rates of success for pregnancy and birth.
But many things stand in the way of additional regulation. For one, Mr. Kahn says, none of the stakeholders in IVF is inclined to push for it. Patients who desperately desire babies don't want to restrict any possible avenue. Doctors naturally resist oversight. Insurance companies don't usually cover IVF, so they are absent from the usual lobbying mix.
Still, there's some stirring in the hinterland. Wisconsin Assemblyman Steve Freese is devising a bill that not only bans human-embryo research but that also studies IVF clinics. "The purpose of our legislation is to start a dialogue that has not occurred to date - about stem-cell research, cloning, and what happens at fertility clinics," he says.