Influential Panel Urges Big Changes in Regulation of Infertility

The following article appeared on the front cover of the Wednesday, April 29 1998 edition of the New York Times.

April 29, 1998

Influential Panel Urges Big Changes in Regulation of Fertility

By Lawrence K. Altman

NEW YORK -- An influential panel of the New York State Health Department is urging sweeping changes in the regulation of new fertility technologies, including more steps to reduce the incidence of multiple births.

In a report being issued on Wednesday, the panel said doctors providing infertility treatments must think more about the babies born as a result and avoid treatments that are more likely to produce so-called high-order multiple births -- pregnancies of three, four or more babies who are far more prone to devastating problems like retardation and blindness.

Doctors should talk with patients in advance about the possible need to abort one or more fetuses in a high-order multiple pregnancy, the panel said. If an abortion is not an option for the patient, doctor and patient should consider other treatments, even if the chances of pregnancy are reduced.

The panel, the New York State Task Force on Life and the Law, said that many women are inadequately informed about the risks of fertility treatments and couples are often not told enough in advance about the costs of such therapies and their generally low chances of success.

The therapies include drugs to induce the ovaries to produce eggs, the transfer of embryos fertilized in the laboratory directly into the womb and artificial insemination. With such techniques, a child can be born with three biological parents -- a man who provides sperm, a woman who provides an egg and a woman who carries and delivers the child.

The panel rejected calls for legislation mandating health insurance to cover such therapies because it found "no persuasive reason for giving" them special legal priority, given that the United States does not pay for everyone's health care.

Independent experts who have followed the drafting of the report praised it, particularly its emphasis on the well-being of children born through the new techniques. They predicted it would be a model for regulation around the country.

The panel, made up of doctors, lawyers, ethicists, members of the clergy and others, has had unusual influence since its creation in 1985. Its recommendations are not binding, even in New York, but its earlier recommendations have become part of state laws and U.S. Supreme Court decisions on defining death, on the withholding and withdrawal of life support, on organ transplantation and on other complicated issues of medical ethics.

Dr. Barbara DeBuono, the New York state health commissioner, said in an interview that she would immediately take steps toward implementing the recommended regulations, starting with reviewing the processes used to inform patients of all risks of the reproductive technologies.

"The technology is advancing faster than government officials, religious leaders and medical ethicists can keep up with," Dr. DeBuono said, "and therefore many of the thorny ethical issues are being played out in the courts."

The panel said its main focus was to recommend "laws that promote clarity about parental rights and responsibilities that protect the stability of the parent-child relationship."

Among the recommendations that the panel made in addressing an array of issues were:

-- Establishing the woman who gives birth as the child's legal mother, even if it was conceived from an egg donated by another woman.

-- Monitoring programs to determine whether they meet guidelines on multiple births and other issues.

-- Strengthening procedures for obtaining informed consent regarding risk and other issues.

-- Requiring doctors to tell women if procedures are experimental.

-- Giving prospective parents more information about the generally low chance of pregnancy.

-- Determining whether prospective participants have any serious medical conditions, such as infection with the AIDS virus, that could pose serious dangers to children.

-- Not making embryos from donor sperm and eggs without the explicit permission of the individuals who intend the embryos for their own use.

-- Obtaining informed consent from egg donors.

-- Conducting research to determine the odds of consanguinity.

-- Not discriminating against unmarried couples, including lesbians.

-- Considering carefully whether to use the new technologies in women 50 years and older.

The panel said physicians offering fertility treatment are not ethically obliged to treat everyone who seeks help. But it said doctors who use psychological screening of potential patients should recognize that such testing is often prone to mistake and abuse and should insure that similar standards for such screening are applied to all patients.

Dr. DeBuono said that if a dispute arose between a birth mother and the woman who donated the egg from which the child was conceived, "the burden would be on the genetic mother to prove in courts why an exception should be made."

Other significant changes include amending the law to make the husband of a married woman the legal father of any child conceived with donor sperm, if the procedure was performed by a licensed physician with the husband's consent. At present, the law applies to artificial insemination but does not cover all assisted reproductive techniques.

Also, New York law should allow donors of semen and eggs, which scientists call gametes, to relinquish their parental rights and responsibilities at the time of donation. Current law covers only artificial insemination with a husband's consent.

Panel members said they held differing views on the ethics of bearing children outside of marriage. But they unanimously agreed that if unmarried women were denied donations from semen banks, they would likely turn to other sources and use semen that had not been screened for infectious diseases, creating serious personal and public health problems.

The report being issued on Wednesday is not the panel's first on issues involving reproduction. In the late 1980s, it recommended against allowing surrogate motherhood for pay. Later, it recommended legislation to repair deficiencies in the testing of donor sperm. The state legislature approved both.

In 1995, shortly after she became commissioner, Dr. DeBuono expanded the panel's mandate, saying she had become concerned about the rapid pace of advances in the fertility field. The panel became the first public body in this country to comprehensively address the individual and societal interests involved in treatments for infertility. The study was financed in part by the Ford Foundation.

Independent experts hailed the new report.

George Annas of Boston University School of Public Health, a prominent medical ethicist, said the panel "has produced a landmark report on a subject that no other state has been willing to tackle." It is the first study to lay a basis for legislation, Annas said, and "that is what makes it so powerful -- it sets the standard for further discussion of the issues in this country."

"The panel's decision to make the child the primary focus was courageous and correct because up to now all of the focus in the United States has been on infertile adults and their physicians," Annas said.

The panel received information from a broad range of people and organizations, including advocacy groups for infertile couples. The panel expressed hope that its report would stimulate widespread discussion about infertility, which affects 7.1 percent of married couples with wives of childbearing age. An additional 5.8 percent of married couples have problems in conceiving or carrying a pregnancy to term.

As important as assisted reproductive therapies are to those seeking them, Arthur Levin, who heads the Center for Medical Consumers, a nonprofit consumer advocacy group in New York City, said in an interview that he agreed with the panel's decision not to mandate health insurance coverage for them.

In reviewing the information women receive before agreeing to therapy, the panel collected consent forms, advertisements and other material from each of the 21 programs in New York state that used in-vitro fertilization, in which eggs fertilized in a laboratory dish are transferred to the womb. The programs were found to vary widely in explaining the known or suspected short- and long-term effects of IVF, and often provided a rosier picture than warranted in reporting rates of pregnancy and the risks of the procedures.

Occasionally, the panel found, a clinic has charged patients for untested reproductive therapies. The panel urged that such procedures be introduced through a formal research plan.

Fertility clinics also have been criticized for using various methods to inflate their success rates. To help guide patients, the panel said clinics should be legally bound to offer statistics about their latest successes and provide written material about the nature of the reproductive procedures.

Federal law requires fertility clinics to report their success rates each year to the Centers for Disease Control and Prevention in Atlanta, and the statistics are made public. State health officials should monitor the information, the panel said.

Another pressing issue, the panel said, was the need to reduce the incidence of multiple births, which make up at least one in three deliveries resulting from newer reproductive techniques. These babies are at increased risk of prematurity, low birth weight, lifelong disability and death. At least one professional group, the American Society for Reproductive Medicine, has warned about the problem, but the panel's recommendations are not binding and the proportion of multiple births is climbing, the panel said, in part because competing fertility clinics strive to have the highest birth rate possible.

From the time infertility patients seek therapy, they and their doctors need to discuss the poorly appreciated hazards of multiple births, the panel said. Doctors should specifically discuss the possibility of abortion to reduce the number of fetuses with patients prior to beginning therapy, and if patients consider that unacceptable, doctor and patient should strive to use alternative therapies, the panel said.

Carl Coleman, the panel's executive director, said in an interview that many prospective parents did not know that they might face such an agonizing decision. "Had they known going into it, they may have acted very differently in terms of accepting the risk of a multiple gestation," he said.

Still, the panel opposed legislation limiting the number of embryos that doctors can transfer from the laboratory to a woman. Instead, the panel urged medical groups to set strict limits and compliance.

The panel said children born through the new techniques have a right to information about the medical and genetic past of the gamete donors, but do not have a right to know who they are, Coleman said. The panel said that doctors should ask gamete donors about their family histories and require genetic testing before using their gametes. The aim is to identify any deleterious medical condition that might be passed on. Individuals who refuse testing should not be used as donors.

Informing children born from assisted reproductive therapies of their genetic origins would also help prevent inadvertent future matings between siblings and other close blood relatives. The risk of transmitting many genetic diseases rises if parents are closely related.

But the extent of the prospective problem is unknown. The panel said there is an urgent need for research to establish the number of times an individual or couple can donate gametes or embryos without creating a substantial risk of inadvertent consanguinity.

The panel called for gamete banks to keep medical records for 60 years.

The panel said that steps were needed to ensure that potential donors of eggs received sufficient information to make an informed decision about donation and that payments to egg donors should not be based on the number or quality of eggs retrieved. Payment should be limited to compensation for time and inconvenience.

The panel also recommended that New York enact legislation prohibiting the retrieval of gametes from the dead or from people incapable of providing informed consent. It recommended making it a crime to steal or transfer gametes without the donor's permission.

With respect to the disposition of frozen embryos, the panel said that no embryo should be transferred for implantation, destroyed, or used for research without the consent of the individuals with decision-making authority over the embryo. And if one of two people who have joint decision-making authority objects to transferring, destroying or using an embryo for research, the the wishes of the objector should take precedence over the other partner.

Gamete donors have the right to withdraw their consent to the donation of frozen gametes until a specific individual has begun therapy that depends on the availability of gametes from that donor, the panel said.

?

?

?

Related Article: Guidelines for High-Tech Fertility

?

Guidelines for High-Tech Fertility

Here are some of the recommendations of the Task Force on Life and the Law, a panel of the New York State Health Department, which is issuing a report on new technologies of medically assisted reproduction:

-- Laws should specify that the woman who gives birth to a child is its mother, even if the child was not conceived with the woman's egg.

-- Steps must be taken to reduce the number of triplet, quadruplet and higher-order multiple births.

-- Doctors must inform patients if treatments are still in the experimental stage.

-- Doctors must inform prospective parents about the low odds of success in fertility treatments.

-- Doctors must not make embryos from donor sperm and donor eggs without the express permission of specific patients who intend the embryos for their own use.

-- Doctors are not obliged to treat everyone who seeks help, but should not necessarily refuse to treat unmarried couples, including lesbians.

Return to RESOLVE NYC Media Articles