Assisted reproductive technology 'in the dark' despite scientific advances
Lawmakers urged to resolve ethical issues
Genetic testing. Cloning. In vitro fertilization. There's no doubt with all the scientific breakthroughs in medicine over the past several years, none tugs the heart strings more than issues dealing with human life. In spite of these advances, there still are unresolved ethical issues involving assisted reproductive technology (ART) that impact not only the physician and patients, but the hospital as well.
In fact, ethical issues involving ART are nowhere near being resolved. That's because more couples today than in the past experience difficulty conceiving their first child - even though there's no increase detected in the prevalence of infertility. In 1995, there were 59,142 cycles of ART carried out in the United States, resulting in 11,315 live-birth deliveries. Of those cycles initiated that year, 70% occurred through in vitro fertilization.1
Recently, problems involving ART were brought to the forefront. The New York State Court of Appeals ruled in May in a landmark case that frozen embryos belonging to a divorced couple should be destroyed.2 In addition, while advances continue to be made in the field of ART, the troubling side effects of multiple births continue, says J. Benjamin Younger, MD, executive director of the American Society for Reproductive Medicine (ASRM) in Birmingham, AL.
The court decision came on the heels of a two-year project from the Albany-based New York State Task Force on Life and the Law. Its Assisted Reproductive Technologies Analysis and Recom men da tions for Public Policy was published in April 1998.3
Although the task force recommendations cover various aspects of the ART process, several areas have created further debate among physicians and professional organizations. Informing children of genetic origins, the use of fertility drugs, and limiting the number of embryos are just a few of the examples of the debate among the groups. (For more information on the recommendations, see story, p. 76.)
"While we agree with the task force that the children resulting from assisted reproductive technologies are an extremely important part of the equation, we as practitioners are equally concerned about the parents of these children and their right to treatment for their disease," adds Younger.
More education, research needed
Perhaps the majority of ethical issues surrounding ART could be alleviated if infertility treatments were covered under insurance plans, he suggests. "Oftentimes, patients choose to take risks with their treatment and desire to implant more embryos than their physician would recommend because they have limited resources and can only afford a single attempt at having a child."
The situation can get complicated, though, when a couple with stored frozen embryos divorces. That's what happened in the New York court case: A divorced man won a battle to stop his ex-wife from having herself implanted with the couple's frozen embryos. The state's highest court agreed with a lower court's decision that the "disposition of these pre-zygotes does not implicate a woman's right of privacy or bodily integrity in the area of reproductive choice; nor are the pre-zygotes recognized as `person' for constitutional purposes." The court defines pre-zygotes as eggs that have been penetrated by sperm but have not yet joined genetic material.
In addition, the court ruled that the marital contract - completed during the marriage - dealing with the couple's fertilized eggs was valid.
But the court did not go far enough, argues Vincent Stempel, attorney for the plaintiff. "We feel, with due respect to the court, that an opportunity to provide clarity and direction was missed. The court didn't provide guidance for the countless number of litigants in the future."
When announcing the decision, the court urged lawmakers to help resolve ethical issues like this by adopting laws outlining how stored embryos should be disposed of. Currently, only Florida, Louisiana, and New Hampshire have laws outlining the disposition of frozen embryos.
But lawmakers in New York are attempting to address the problem. Senate bill 5815, originally introduced in 1997 and reintroduced in 1998, would require couples to specify in writing how embryos are to be disposed of before a facility can accept them for storage. (See insert on what to include in an informed consent form.)
One ART issue the physicians and organizations agree on, however, is the lack of research and education available. A way of reducing the risks associated with multiple births lies in more research into reproduction and embryo development, notes Younger. And the New York task force concluded that risks associated with ART were not fully disclosed to patients seeking fertility assistance.
ASRM has gone a step further, issuing prac tice guidelines to members on the number of embryos to transfer during in vitro fertilization. It suggests the number of embryos should be agreed on by the physician and the couple. (See insert.)
But when individual program data are not available, ASRM suggests the following:
o no more than three embryos for patients with above average prognosis, such as those under age 35;
o no more than four embryos for patients with an average prognosis, such as those ages 35 to 40;
o no more than five embryos for patients with a below-average prognosis, such as women over age 40.
Perhaps one area in which ethics committees can prevent problems similar to those in the New York appeals court case is to clearly specify what should be done to frozen embryos following divorce or death of a spouse.
The task force recommends in its analysis that those with decision-making authority over the embryos should issue instructions regarding their disposition before they are created. The instructions should include the following situations:
o death;
o permanent loss of decision-making capacity;
o divorce;
o termination of the facility's storage period;
o loss of contact with the storage facility.
The recommendations further stipulate that such individuals should have the freedom to revise their disposition instructions, and in such cases, the existing wishes should take precedence over any instructions left in advance.
Additionally, the ASRM ethics committee issued a policy regarding abandoned embryos. (See insert.) The committee concludes it is ethically acceptable for a program to consider embryos to be abandoned if more than five years have passed since contact with a couple, including diligent efforts through telephone and registered mail, and no written instructions exist concerning disposition.
Both the New York task force and ASRM point out, however, that no laws currently provide guidance on disposing of embryos without written directions.
References
1. Centers for Disease Control and Prevention. 1995 Assisted Reproductive Technology Success Rate Report. Atlanta; 1995.
2. Kass v. Kass, 98 NY Int 0049, New York State Court of Appeals (May 7, 1998).
3. The New York State Task Force on Life and the Law. Assisted Reproductive Technologies: Analysis and Recommendations for Public Policy. New York; 1998.
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