Infertility treatments: New report
The treatment of infertility with drugs and high-tech procedures, called assisted reproductive technologies (ART), comes at a high price that is often not covered by health insurance. Infertility treatment has become a $2 billion a year industry, despite its high-risk and low success rate. Over the last few years, there has been a trend toward lobbying for mandated coverage in some state legislatures. In anticipation of just such a move, New York State asked a special task force to examine the ethical, medical, religious, legal, and policy questions surrounding ART. The Task Force on Life and the Law just released its comprehensive report.
ART, in the words of the Task Force, seek to establish pregnancies without correcting the underlying cause of the patients infertility. Drugs to stimulate ovarian function are crucial to the ART arsenal. These drugs made headlines in 1994 when a follow-up study of infertile Seattle women given Clomid between 1974 and 1985 found they had an increased rate of ovarian cancer. Worse, the investigators found that there was widespread inappropriate use of Clomid. For example, there is no scientific evidence to show that this drug can benefit women without ovulatory dysfunction, yet medical records show that 52% of the infertile women who took Clomid in the Seattle study had normally functioning ovaries. Twelve earlier studies also showed an increased ovarian cancer rate among the women given the infertility drug, but only among those who didnt get pregnant.
Since these studies were conducted, many more powerful drugs have been introduced. The New York State Task Force found that in 1996, ART practitioners from three countries told colleagues of their growing concern about the safety of ovarian stimulation drug regimens. Over the last two decades, these regimens have gradually evolved to include a greater number of drugs, at higher doses, over longer periods of time. Long-term safety is yet to be established. High-dose ovarian stimulation drugs are standard protocol for a procedure known as in vitro fertilization (IVF). They stimulate the release of multiple eggs which are retrieved from the woman and fertilized in a petri dish. Several days later, the resulting embryo is implanted in the womans uterus.
Informed consent was a major concern for the Task Force, which found wide variation in what couples were told prior to treatment. One woman interviewed said of the process: You have to sign a big long consent concerning the [egg] retrieval, but there is a lack of any discussion about the use of the drugs. Pumping yourself with hormones has a tremendous impact on your body and emotions. Plus I was concerned about the studies on ovarian cancer and I really wanted to put into my calculus the risk of using the drugs. Some doctors were angry even discussing the risk of the drugs, saying it was just the press, but I just think a more deliberate discussion would have put it in context.
Quoting the fertility treatment centers that reported outcomes of nearly 27,000 IVF cycles in 1994, the Task Force found an overall success rate of 18%. But there were wide variations among programs and patients. One program reported a live birth rate of 50% for women under age 40, while other programs had a success rate of less than 5% in women over age 40. The overall success rate of 18% isnt much higher than the spontaneous pregnancy rate of 14% observed in a 1995 study of infertile Canadian couples who remained untreated for one year (Fertility and Sterility; 64:22).
Once a pregnancy is established, the risks can escalate. At least one in three deliveries of ART-generated pregnancies involves a multiple birth, which is associated with increased rate of prematurity, low birth weight, infant death, and lifelong disability.
The report also addresses the range of treatment possibilities for men. Though they receive much less medical attention, male problems are the primary cause of infertility in an estimated one-third of infertile couples and in another third, a male problem is a contributory factor.
On the pressing issue of insurance coverage, the Task Force report concluded, The question is whether New York should mandate coverage for assisted reproduction when insurance policies routinely exclude coverage of basic health care services and when many New Yorkers have no health coverage at all. While the Task Force is sympathetic to the need for broader access to insurance coverage for assisted reproduction, it can find no persuasive reason for giving assisted reproduction special priority as a matter of state law.
The Task Force has provided numerous other recommendations. While some countries have laws that limit the possibilities for multiple gestation and use of medications, the Task Force chose to put the onus on physicians to limit the number of embryos transferred in ART. But the Task Force recommends that the outcome data be monitored by New York State to determine whether ART programs are meeting the goal of reducing multiple gestations. Noting that the risks of ART extend beyond the patient undergoing the procedure to include any offspring, the Task Force recommended that New York State enact informed consent legislation. It would require physicians to provide their patients with the programs outcome statistics, as well as written information about the nature of the procedure, the likelihood of a pregnancy, anticipated price, risks, and alternatives to the procedure, including non-treatment.
The Task Force supports the relatively new Federally mandated system that requires all infertility programs to report their outcome data annually to the Centers for Disease Control and Prevention (CDC) to develop a system for validating reported outcome data on a national level. The benefits of providing more reliable information to prospective patients outweigh the slight increase in costs that such a system might entail, wrote the Task Force. The first such report, produced in collaboration with SART, the CDC, and Resolve, a national advocacy organization, was published in December 1997. For a free copy of the CDC report, write to Resolve, Department ART, 1310 Broadway, Somerville, MA 02144-1779. (Allow three weeks for delivery.) To learn the price of the New York State Task Force report on Assisted Reproductive Technologies, contact Health Education Services, P.O. Box 7126, Albany, NY 12224 (518) 439-7286.
By Maryann Napoli