THE WASHINGTON POST: Lightly regulated in vitro fertilization yields thousands of babies annually
By Michael Ollove
April 13, 2015
If in vitro fertilization still seems to be cutting-edge medicine, you haven’t been paying attention.
The first infant born in the United States as a result of in vitro fertilization entered the world in 1981. In 2012, according to the Centers for Disease Control and Prevention, more than 65,000 U.S. births resulted from assisted reproduction technology. (ART generally refers to fertility treatments in which either eggs or embryos are handled, but it does not include artificial insemination, which experts believe results in far more births than ART does.) The CDC also reports that about 12 percent of women of childbearing age have used infertility services and that 1.5 percent of all American infants are conceived using ART.
So, assisted reproduction is nothing new. And yet regarding regulatory matters, both the federal government and the states have given the multi-billion-dollar industry a wide berth, which makes this country very much an outlier compared with the rest of the developed world. (One exception to minimal federal intervention: President George W. Bush’s ban in 2001 on the use of newly created embryonic stem cell lines in research.)
“The United States is the Wild West of the fertility industry,” said Marcy Darnovsky, executive director of the nonprofit Center for Genetics and Society, echoing a description used by many critics of the regulatory environment surrounding ART.
The federal government requires laboratories engaged in assisted reproduction to be certified by organizations such as the American College of Pathologists and to report certain data to the CDC. States are split about whether surrogacy contracts, usually between prospective parents and an egg donor, are permissible. Other aspects of ART are simply unaddressed. For example, states don’t regulate how many children may be conceived from one donor, what types of medical information or updates must be supplied by donors, which genetic tests may be performed on embryos, how many fertilized eggs may be placed in a woman or how old a donor can be.
Lawmakers are wary of addressing assisted reproduction, Darnovsky said, in part because of the incendiary politics that surround abortion, an issue that also touches on conception and embryos.
Other countries, such as Canada, the United Kingdom, Sweden, Germany and Australia, heavily regulate many aspects of ART.
“I think in the United States we need more regulation of assisted reproductive technologies to protect the rights of children, donors and parents,” said Naomi Cahn, a law professor at George Washington University and co-author of “Finding Our Families: A First-of-Its-Kind Book for Donor-Conceived People and Their Families.”
Cahn believes donor-conceived children should have access at least to full medical information about their biological parents if not also to information about ethnicity and country of origin. Parents, she said, should have the right to know how many times a donor’s sperm or eggs were used to conceive a child. And donors should have the right to know what happens to their sperm or eggs.
The American Society for Reproductive Medicine takes issue with the idea that ART is not adequately regulated.
“I used to call it the ‘myth of un-regulation,’ but it’s actually a malicious and often deliberate falsehood most often conveyed by folks with ideological opposition to reproductive medicine,” Sean Tipton, the chief lobbyist for ASRM, wrote in an e-mail message. “Reproductive medicine is one of the most heavily regulated fields of medicine in the U.S.”
Tipton points out that the federal government regulates all drugs and medical devices, as well as the reproductive tissue used in ART. States, he said, license practitioners (as they do all medical professionals). But the heart of his argument is that “the professional self-regulation is extensive.”
ASRM issues lengthy guidelines to its membership, which consists of fertility clinics and sperm banks. However, critics point out, it does not sanction those who violate the guidelines.
Critics argue that ASRM’s main function is to advance the business interests of its members, unfettered by government regulation. “It’s a field characterized by strong anti-regulatory sentiment because it evolved as a business, not a research enterprise,” said Arthur Caplan, director of the division of medical ethics at New York University’s School of Medicine.
Debra Mathews of the Johns Hopkins Berman Institute of Bioethics agrees that the industry is lightly regulated because “assisted reproduction has grown up as a medical services business not under the auspices of medical research.” The federal government ensured that situation would continue when, in 1996, Congress passed an amendment banning the use of federal funds in research related to the creation of embryos.
“It is unregulated because it touches on two ‘third-rail’ issues,” Caplan said. “It touches on abortion and also the creation of embryos, which politicians run away from because too many people still disagree about the right to use reproductive technologies, particularly who should pay for them and how much.”
The lack of heavy regulation does have some benefits, critics say. For instance, gay couples and single people don’t face any built-in barriers to using ART to produce children.
But others see disadvantages, none of them more loaded than a lack of restrictions on the number of children who can be produced by any single donor. The concern is that two offspring of a frequent donor could inadvertently meet and fall in love, raising the possibility of what is sometimes called “accidental incest.”
Donor-conceived children also argue that donors should be subjected to better medical screenings. Generally, donors are tested only for sexually transmitted diseases. There are no laws requiring testing for genetic diseases or requiring that donors — usually in their 20s at the time of donation — update medical information as they age and inherited diseases may surface.