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The case of the frozen embryos.

THE CASE OF THE FROZEN EMBRYOS

Increased use of cryopreservation, a technique for freezing human embryos for later implantation, has generated a host of new ethical and legal problems.

In 1981 Elsa and Mario Rios, a wealthy California couple who wanted to have a child, sought the services of the Queen Victoria Medical Center fertility clinic, in Melbourne, Australia. Each had had a child from a previous marriage, though Elsa's 10-year-old daughter had recently been killed while playing with a gun. Elsa, 37, was treated with fertility drugs, and three developing eggs, or oocytes, were surgically extracted from her ovaries. The eggs were combined in a petri dish with sperm from an anonymous donor (her 54-year-old husband was infertile). One resulting embryo was placed in her uterus. The others underwent cryopreservation, a process of freezing in liquid nitrogen. After ten days Elsa spontaneously aborted. Distraught, she decided against becoming pregnant again soon. The Rioses were killed in a plane crash in 1983. They died without wills,

leaving an estate of $8 million. Among the "survivors" were the two frozen embryos.

New ways of creating and defining life captivate modern societies much as intricate and bizarre murders once did. Like Baby M, and the Parpalaix case in France (in which a widow successfully sued to become inseminated with sperm collected before her husband's death), the Rios embryos became the subject of an international soap opera and debate. Did they have a stake in the estate? Were they part of it? Did they have a right to be gestated? Women from Australia and abroad volunteered to be impregnated.

The State of Victoria empaneled a blue-ribbon committee, headed by Louis Waller, a law professor, which concluded that the embryos should be destroyed. The Australian right-to-life movement and the Catholic Church insisted that the issue of the "orphan embryos" be brought before Victoria's legislature, which subsequently passed a law preserving the cells in case another couple in the Melbourne infertility program wanted them.

Because cryopreservation, or cryo, techniques were not well-developed in 1981, the embryos' chances of surviving a thaw are believed by medical researchers to be less than 5 percent. And the California courts disqualified them from making any claims on the Rioses' estate under a state law requiring that a child beneficiary be born or in utero at the time of the parental death. In 1989 the Rios embryos, still tanked in liquid nitrogen, remain controversial.

With the increasingly sophisticated use of programmable freezers; of such cryoprotectants as dimethylsulfoxide and propylene glycol, which cross cell walls and act like antifreeze to prevent crystallization; and of the synchronization of cooling to the optimal stages in embryonic development, cryopreservation has become a fact of life.

Freezing is on its way to becoming a common adjunct to in vitro fertilization, or IVF. Of the hospitals and clinics reporting to the American Fertility Society's IVF Registry, 9 used freezing in 1985, 15 in 1986, and 39 in 1987.

When a woman undergoes IVF, she receives fertility drugs, which stimulate simultaneous development of a number of oocytes (ordinarily only one at a time will develop). Upward of 40 eggs, or ova, have been removed at one time from women taking fertility drugs, though 5 to 10 is the usual range. Then these ova are drawn out of the ovarian follicles with a hollow needle inserted through the abdomen or the cervix. Performed under local or general anesthesia, the procedure entails a slight risk of tubal or ovarian damage. Fertility drugs cause mood swings and irritate the uterine lining, probably making it less than normally receptive to implantation by an embryo. But using them makes it possible to implant more than one embryo at once, which, studies have shown, makes impregnation more likely.

Without cryo, a woman must take drugs and go through an egg extraction every time she undergoes IVF. If a clinic uses cryo, perhaps two or three "fresh" embryos will be implanted and the rest will be stored. If the woman does not conceive, she can return for an implantation of thawed embryos at a favorable time in her menstrual cycle without taking the fertility drugs again, experiencing their side effects, and then going through another egg extraction. A full IVF cycle costs $6,000 to $7,000; thawing embryos and implanting them costs about $1,000.

Moral Questions

For all its flexibility, cryopreservation presents profound moral questions. The 1987 Vatican edict on reproduction saw freezing as showing insufficient respect for human life--a curious position, considering that the procedure will allow more children to be born.

American clinics froze 289 embryos in 1985, 824 in 1986, and 3,715 in 1987, and the numbers continue to climb. Some couples banking embryos will not use them all, because of success with "fresh" IVF cycles. Other would-be parents will die, divorce, adopt, become disabled, or simply grow weary of the financial and psychological costs of continued rounds of thawing and implantation. Not surprisingly, questions stemming from the Rios case remain current: Should spare embryos be donated for adoption, or should they be destroyed or even used in experiments? And who should decide: the woman, the couple, the clinic, the state?

Neither the debate between the pro-choice and the pro-life factions nor its jurisprudence furnishes answers. Under Roe v. Wade a woman has the right to an abortion on demand during the first trimester of pregnancy because her control of bodily privacy, according to the Supreme Court, outweighs the value of the early fetus. But a frozen embryo is outside the womb, so physical privacy is not an issue. And the continued existence of such an embryo does not depend on the woman's body. Formed in a petri dish, it is no more a part of the woman's body than of the man's.

Those who would apply a pro-choice framework suggest that concerns about privacy, albeit not physical privacy, should give progenitors the right to decide the fate of the embryos, which, as the Planned Parenthood Bioethics Advisory Panel has noted, "could be brought into life under circumstances and at times unenvisioned by their creators."

The pro-life position is no more useful, because frozen embryos, unlike those in a uterus or a laboratory culture, are not fully alive. Nothing can live in liquid nitrogen. Nor are they exactly dead, because more than half can return to life when thawed. "We have a real category problem," says Dr. Kathleen Nolan, of the Hastings Center, a bioethics think tank in Briarcliff Manor, New York. Some suggest that frozen embryos be viewed as property. As Kenneth Alpern, a professor of philosophy at DePaul University, puts it, "The question may be whether you have the right to determine if there is a piece of yourself in the world." Under American law a person owns his organs and may choose to donate them through his estate and in certain other limited situations. But no consensus exists about whether embryos, which are not organs of the body but potentially complete persons, can be possessed.

In Del Zio v. Presbyterian Hospital, in 1978, a New York jury heard a case involving an embryo formed in vitro by a physician lacking institutional authority. Without the consent of the couple who provided the sperm and the ovum, a hospital `official destroyed the embryo. The jury awarded the wife $50,000 for emotional distress but did not recognize her ownership of the embryo. Of course, a single trial is not binding as precedent. To Nolan, "the real issue is who is responsible for the frozen embryos, not who owns them."

The problem is being worked out in various ways publicly and privately. In 1986 Louisiana enacted legislation defining any "in vitro fertilized ovum [as a juridical person]...which shall not be intentionally destroyed." The state recognizes no ownership interests in the embryos but makes physicians responsible for them. Though not as clear as Louisiana's, the laws of certain other states could be read to forbid the destruction of any in vitro embryos, fresh or frozen. In 1983 the Boston district attorney issued an opinion that the Massachusetts fetal-research law did not forbid in vitro fertilization, provided that all viable embryos were implanted in women. The same year, an Illinois federal court let stand a similar opinion by that state's attorney general.

Infertility specialists and pro-choice advocates say that such laws infringe procreational freedom. John Robertson, a law professor at the University of Texas and a member of the ethics panel of the American Fertility Society, deplores the legislation but concedes that it could be found constitutional, because Roe v. Wade specifically permits destruction only of fetuses physically connected to their mothers. Strangely, the coexistence of Roe's pro-choice options and state laws protecting embryos means that a woman intent on destroying extra embryos legally might need to have them implanted and then aborted.

Because of the Rios imbroglio, most clinics present couples with a simple choice about extra frozen embryos: donation or destruction. At Albert Einstein Hospital, in Philadelphia, couples are given the usual two options plus a controversial third--experimentation--if allowed by law. At present, however, Pennsylvania is among at least a dozen states that forbid nontherapeutic procedures on embryos and fetuses.

Benefits of Embryo Experimentation

Frozen cattle embryos are selected or rejected for implantation according to the sex, the presence of adequate amounts of growth hormone, and the absence of blood disorders. Theoretically, human embryos could be chosen for desirable traits or even enhanced genetically.

The specter of genetic engineering, including cloning and hybridization with other species, probably shocks most people. But some experiments that have already been performed on embryos and fetuses have been beneficial. For example, in 1963 the immersion of 15 fetuses in a salt solution to test their ability to absorb oxygen through the skin led to the design of life-support systems for premature infants.

Today, some researchers believe, experiments with IVF embryos in various culture media could yield a closer approximation of the natural uterine environment and enable more embryos to live after thawing. And the development, on embryos, of microbiopsy techniques for DNA analysis would provide a better understanding of such hereditary diseases as sickle cell anemia, Down's syndrome, and Tay-Sachs disease, and might ultimately result in "gene therapies" that would erase these conditions--by re-sequencing the nucleotides (the building blocks of DNA), for example.

Currently, little if any experimentation is performed on embryos in America, because of state laws and the absence of federal support. In 1978 the U.S. Department of Health and Human Services convened an ethics advisory board to review all grant proposals in the area, and was prepared to fund research on in vitro embryos that had not reached the 14th day of development, which is when the embryo acquires a distinct symmetrical shape and also when implantation would normally occur.

In 1980 Washington allowed the ethics advisory board, which had become a political hot potato, to pass out of existence. Last September the Department of Health and Human Services announced that it was taking steps to reconstitute the board. Eventually, guidelines for research on embryos, and funding as well, may flow from Washington. Dr. Zev Rosenwaks, who heads the IVF program at New York Hospital-Cornell Medical Center, says that the profession would prefer that the government not try to direct couples' decisions about donating or discarding extra embryos, but would welcome federal clarification, of the limits on experimentation.

When the freezing protocols began in the United States, most couples were expected to choose to donate rather than to discard, and they seem to have done so. At the Cleveland Clinic the donation rate exceeded 80 percent. Some embryos have sat in liquid-nitrogen canisters, which look like portable picnic coolers, for more than three years. "We don't know why couples don't come back to use them," says a cryobiologist at the Cleveland Clinic. About the possibility of eventually having to dispose of embryos she had formed and frozen, she adds, "I feel very odd about it. It's a very awkward situation."

The American Fertility Society takes the position that cryo programs should not preserve embryos "for longer than the reproductive life of the female donor." Some programs specify that embryos are to be discarded within a set number of years, usually two to ten, after the female donor's menopause, if no one has adopted them.

David Ozar, a philosopher writing in the Hastings Center Report, spoke for other IVF critics as well when he objected to "reasons of economy and efficiency" as a basis for "a policy of disposal," since embryos have "a potential for full human life. Indeed it is precisely because of that potential that they were frozen in the first place."

Properly stored, frozen embryos are quite stable. They could be thawed for use in 10 days or 10,000 years. Some experts have suggested, not altogether whimsically, that frozen embryos would be ideal long-distance space travelers, provided that an artificial womb (whose technology has been under discussion since the 1920s) could be developed, along with a means of caring for the children who emerge from that artificial womb. A more daunting problem might be to build eternal-care facilities on this planet.

Cryopreservation of Ova

In the 1990s some of the women who have participated in cryo programs will begin to enter menopause, and some leftover embryos will have to be discarded. Judging from the uproar over the Rios case and the impassioned back-and-forth in scholarly journals, one of the most wrenching new moral controversies since the abortion debate began could erupt in this country.

The frozen-embryo issue, unlike the abortion issue, may have a resolution. While many people value or even revere life from the moment of conception, few have strong feelings about gametes--unfertilized oocytes and sperm cells. Over the course of a life an average male sheds trillions of sperm. A woman's ovaries contain about 300,000 eggs, only a few of which will be fertilized. Partial rather than complete packets of genetic material, gametes are for the most part wasted, and almost no one mourns the loss. If gametes, rather than embryos, were frozen, couples in infertility therapy would have the flexibility that embryo storage provides without the ethical problems. In other words, the eggs and sperm could be thawed and combined into embryos for implantation as needed.

Scientists have been successfully cryopreserving human sperm since the 1950s. But ova are far more delicate. One reason is that an ovum contains a great deal more cytoplasm, or cellular fluid, than a sperm, which is basically just a strand of DNA with a whipping tail. The more cytoplasm in a cell, the greater the likelihood that it will undergo crystallization, which will destroy it.

Unfertilized oocytes are also more delicate than embryos, because they contain structures called meiotic spindles, which hold their chromosomes in place. The spindles are easily damaged by freezing and thawing, which can result in a condition called aneuploidy--an abnormal number of chromosomes--which can stop further cell division or cause birth defects.

During the Rios affair, the Australian Waller Committee "warmly encouraged" the development of freezing techniques for human ova, adding that if the research is successful, the "whole subject" of embryo cryopreservation should be reviewed. In recent years experimenters have begun to focus on the cryopreservation of eggs. The most striking, and, I think, an unprecedented, aspect of the studies now appearing in print is that the researchers make plain that ethical, rather than medical or physiological, questions impel their work.

Work on human oocytes has been done in France, West Germany, the Netherlands, and Australia. The first human births--of twins, both normal--resulting from such work took place in 1986 in Australia. At least three other successful births from frozen ova have been reported since.

Though encouraging, the existing studies are too small to generalize from, and worries about chromosome damage remain. Dr. Martin Quigley, who heads the Cleveland Clinic's IVF program, feels that with proper research frozen ova could be used clinically in the United States in three to five years. No state or federal laws prohibit experimenting on gametes, provided that they have not been joined by fertilization. The major source of medical research grants is the federal government, which has been loath to fund research involving in vitro reproduction.

"The private sources of funding are tapped out," says Richard Marrs, who was the first in this country to successfully freeze, thaw, and implant human embryos but now favors cryopreservation of eggs. "Two or three major competitive grants definitely could speed things along," he says. A good sign that the federal government might be receptive to underwriting the work came last fall, when the National Institutes of Health requested grant proposals for improved methods of freezing sperm.

The world's largest consumer of in vitro procedures, the United States, has about as many frozen embryos in storage as all nine other nations that use the procedures combined. This country should do what it can to hasten the development of gamete freezing, not only in order to head off an ethical and political storm but also because it would bring a new kind of equality to women.

If a man must undergo radiation or chemotherapy that might genetically alter his sperm or render him sterile, or if he decides to have a vasectomy, he can freeze his sperm to preserve his reproductive options. A woman, however, needs the cooperation of a man to make future use of her eggs, which cannot now be stored unless they are fertilized. And because aging oocytes produce the highest incidence of chromosomal abnormalities, a woman might wish at 25 to freeze some of her eggs for fertilization and implantation later. Until the time of menopause she could be confident about delivering a healthy baby. Freezing eggs could add more than a few ticks to her biological clock.

PHOTO : Preserving human embryos in liquid nitrogen is established procedure in fertility clinics

PHOTO : around the world. Some leading clinics abroad now implant only frozen embryos, in the

PHOTO : belief that those that survive freezing and thawing are the hardiest and the most likely

PHOTO : to survive a pregnancy.

PHOTO : In August the estranged husband of Mary Sue Davis filed to stop her from having an embryo

PHOTO : implanted. It was America's first highly publicized embryo custody case.

PHOTO : An egg fertilized in vitro can be frozen and preserved for later implantation.
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Author:Lieber, James
Publication:Saturday Evening Post
Date:Oct 1, 1989
Words:3066
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