New York Times
22 February 2003

The Other Baby Experiment
By Rebecca L Skloot

also see Skloot's article in Popular Science

There's been a lot of talk from politicians and ethicists about needing to protect children from starting life as medical experiments. It's stunning how much attention is being paid to human cloning, given that most scientists acknowledge it may never be feasible or desirable, let alone commonplace. It's even more amazing when you consider that thousands of children are already being produced each year through potentially dangerous techniques — with scant notice from policymakers.

Since the 1970's, fertility clinics have created almost a million children through experimental technologies. They've used untested and unregulated procedures to inject sperm into eggs, to grow embryos on cells from cows and monkeys, even to combine eggs from two mothers and create children with DNA from three parents. The public, it seems, has remained blissfully unaware. Little wonder, since reproductive medicine has enabled thousands of infertile couples to have babies. Indeed, it's been a blessing for them. But that blessing has also been a powerful distraction from a medical safety issue.

Just within the last year, a stream of studies has found that infertility treatments may carry potentially fatal risks. In March 2002, a study in the New England Journal of Medicine reported that the occurrence of major birth defects more than doubles, from 4 percent to about 9 percent, with common infertility treatments like in vitro fertilization and intercytoplasmic sperm injection — the procedure for injecting sperm directly into an egg. So far in 2003, three more studies produced similar data: one found an increased risk of Beckwith-Wiedemann syndrome, which causes enlarged organs and childhood cancer; another found a five- to seven-fold increased risk of retinoblastoma, a malignant eye tumor. So far, the number of reported cases is small, but they warrant thorough investigation.

Where is Washington in all of this? Since the advent of reproductive medicine more than 30 years ago, the federal government has had almost no role in overseeing the technology or guaranteeing its safety. Despite recent studies, no governmental agency has mandated — or even argued for — further investigation into the risks of assisted reproduction. In addition, most infertility researchers and doctors aren't bound by federal regulations governing research on human subjects. As a result, no one ensures that they inform infertile patients about these safety concerns. Simply put, reproductive technologies have fallen through the regulatory cracks for decades.

The nature of the work has had much to do with this. Because developing safe infertility treatments involves human embryos at some stage — either in devising and testing technologies or in their clinical application — the field is mired in the debate over abortion. As a result, infertility doctors and researchers rarely get federal financing — either because the government refuses or because researchers assume that their grants will be rejected and therefore don't apply. The field is largely kept afloat by the billions of dollars patients spend to conceive.

Consequently, scientists have developed infertility procedures without the government's watchful eye. The Food and Drug Administration recently began examining some extreme procedures, but common treatments like in vitro fertilization remain unregulated. At best, the government appoints powerless advisory panels to look at reproductive issues — but their motivation is often fueled more by politics than science. By contrast, in much of Europe and in Australia, reproductive technology is strictly regulated — from the information that doctors must disclose to their patients, to the number of embryos they can transfer into a woman.

Of course, natural reproduction is hardly risk free. And the decision to take the risks associated with infertility treatments is up to parents. But they have the right to make informed decisions. Many things need to be done to make that possible: Doctors must advise them of all potential problems, and the government and scientists need to follow up on current research to determine long- and short-term risks and then help avoid them.

To truly understand the impact infertility treatments may have on children, scientists would need to study their effects on human embryos. Americans must ask themselves whether protecting children born through such treatments warrants embryonic research. If the answer is no, it means experimenting on infertile women and their offspring instead. If the answer is yes, President Bush will need to revise his ban against government financing of embryo research.

If the far-off prospect of cloning can arouse such heated debate, surely the safety of current infertility treatments can do the same. It took scientists decades to figure out that diethylstilbestrol, or DES, a widely used fertility drug of the 50's and 60's, caused cancer and infertility in children exposed to it in their mothers' wombs. Let's not make that mistake again.

Rebecca L. Skloot, life sciences editor at Popular Science magazine, is the author of the forthcoming "HeLa: The Immortal Cells of Henrietta Lacks.''