MPR: Limits on Embryo Research Affect Treatments for the Infertile

Limits on Embryo Research
Affect Treatments for the Infertile
By Stephen Smith
February 5, 1998

When the Iowa septuplets were born last November, many experts in reproductive medicine reacted with mixed feelings. The mother, Bobbi McCaughey, got pregnant using a powerful fertility drug that stimulated her ovaries so much that she produced seven babies. Some infertility specialists say that the chance of multiple births - and other risks with infertility medicine - might be lower if not for a long-standing ban on federal support for human embryo research.

An embryo is the first stage of human development, when sperm fertilizes an egg. In 1974, anti-abortion forces in Congress won a temporary ban on federal funding of human embryo research. With a few brief exceptions, that ban has stayed in effect ever since. Michigan Republican Congressman Vernon Ehlers, a Christian conservative, wants to make sure the ban on embryo research is permanent.

Ehlers: There's a great body of belief in this country that the creation of a human being occurs at the time of fertilization of the egg. And that you are dealing with something special, something sacred, and there should not be experimentation.

Embryo research is not against the law. The congressional ban means that the largest government source of money and scientific research standards, the National Institutes of Health (NIH), can neither fund nor control embryo studies. Bioethicists who support embryo research, like University of Minnesota Law Professor Susan Wolf, say human embryos deserve special respect, but the age of the embryo is the key.

Wolf: I think the bulk of opinion around the world, those who have looked at this question have said, within the first 14 days after conception you're talking about a different kind of embryo. Some people use the word pre-embryo. It's certainly entitled to heightened respect, but it's not at all even a unique individual, it could become two individuals, so there is this zone where we tolerate a certain amount of research.

The main organization representing infertility specialists, the American Society for Reproductive Medicine, wants the NIH to fund embryo research and generally welcomes the intense scientific scrutiny for which the NIH is famous. Sean Tipton is the medical groups' lobbyist. He says the 24-year ban has harmed infertile people by slowing the advance of reproductive science. Treatments used today are imperfect. For instance, doctors can't control how many babies some procedures will produce. Fertility drugs and in vitro fertilization often result in expensive, dangerous, multiple births. And while high-tech treatments do help people get pregnant who otherwise couldn't, Tipton notes that 60 percent of those pregnancies never result in a live birth.

Tipton: Infertility treatments are more expensive than they need to be, they're probably not as efficient as they need to be. There's a lot about the fundamental, underlying dynamics of infertility as a disease that we need to know more about. It's very difficult to do that kind of research when you have the kind of prohibitions that exist now.

Human embryo research is happening in the US, just not in the universities and publicly funded labs where much of medical research is typically conducted. The long-range goal is to keep more embryos alive and help more couples get pregnant. Most studies take place at private infertility clinics and medical centers. They are usually paid for from clinical profits and donations from patients. Critics of the congressional ban, such as the University of Minnesota's Susan Wolf, say it's wrong to drive such a vital and sensitive area of medical research out of the public sector.

Wolf: The whole regulatory mechanism we have for protecting human subjects in federally funded research doesn't apply. It applies to research in practically every other area of medicine. But this area, because it was always politically too hot to handle, fetuses and embryos and all this controversial stuff, has been an area of laissez faire.

The worry is that profit motives could pressure infertility specialists to market new techniques before they've been fully tested. For example, the announcement last fall of the first pregnancies in the United States achieved with frozen eggs came from a private infertility clinic in Atlanta called Reproductive Biology Associates. Frozen eggs from a 29-year-old woman were thawed, fertilized, and implanted in a 39-year-old woman whose premature menopause meant she had no eggs of her own. Dr. Hilton Kort, co-director of the Atlanta Center, says the study was funded from clinic profits and was performed professionally.

Kort: The basic principles of good research apply to whether you're in an academic institution or whether you're in private practice. Basically, we adhere to the same principles.

The egg-freezing procedure is still so experimental that it's not publicly available - not the least because it is so difficult to do. A major question is whether the process can cause genetic damage or birth defects in the child. Health policy expert Nancy Reame of the University of Michigan argues that such unanswered questions highlight the need for federal oversight.

Reame: Well it certainly puts the infertility specialist in a bind. It's hard to be a patient advocate as well as a researcher if, at the same time, you're an entrepreneur interested in the bottom line.

In a slightly different approach, a Saint Paul infertility clinic, Reproductive Health Associates (RHA), is paying for a study at the University of Minnesota that may eventually uncover the secret to freezing human eggs. A number of the doctors at RHA also serve on the University faculty. Clinic administrator Chuck Gooder says if egg freezing proves safe, it would be a valuable new choice for some patients. And in the increasingly competitive infertility industry, he says, a cutting-edge image is critical.

Gooder: We think it's important in terms of marketing, in terms or getting patients in, in terms of the financial viability of the practice. We've made the conscious decision to be cutting-edge technology, high visibility, and a quality program.

At New York University, infertility specialist Dr. Jamie Grifo says that even if the NIH did fund embryo research, the vast lengths of red tape accompanying NIH grants make government funding more trouble than it's worth. Grifo argues that private research allows patients to get access to valuable new treatments more quickly than the government would allow. Still, Grifo worries that studies on the safety of new fertilization techniques may rely too much on a relatively limited number of clinical pregnancies.

Grifo: Ultimately, the true test is to actually do this with humans. And you can't always do the experiments in as scientific a way when you're dealing with human embryos because that would imply that you were going to make large numbers of embryos for research and you just can't do that.

While it is not illegal to produce embryos solely for research, most programs shy away from doing it because the bad publicity could hurt their reputations. Instead, they use damaged or leftover embryos donated by their infertility patients. In 1994, an NIH advisory panel called for a limited national program of embryo research, a controversial suggestion which President Clinton promptly quashed. Fertility specialists concede that lifting the embryo research ban now would be virtually impossible, because it's become entwined with congressional efforts to ban human cloning.

For more on the subject of infertility, see
The Fertility Race
An extensive site covering social, scientific, and medical aspects of the topic.

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