Baby-Making Industry: Gone Too Far?

WASHINGTON — Some might say, “You've come a long way, baby.”

President Bush's Council on Bioethics seems to be saying, “The baby-making business has come too far.”

Louise Brown, the world's first test-tube baby, celebrated her 25th birthday July 25. She has grown up in a world in which scientists are now seriously talking about crossbreeding humans and animals, impregnating men and bioengineering children.

The president's council has reported just how bad it can be: Unregulated and unrestrained practitioners give desperate patients risky treatments. Mothers and children pay the price in serious injury, illness and birth defects.

But the council is caught in a quandary over what, if anything, can be done about it.

Appointed in January 2002, the panel of 17 scientists, doctors, ethicists and attorneys are debating where and how to draw the line between a medical community tradition of self-regulation and public safety. They also have to weigh the desires of infertile couples against responsible reproductive medicine. They are due to issue a report by the end of November.

As the council took up the question of human cloning in January 2002, the underlying issues of reproductive science ultimately led them back to the practice of in vitro fertilization.

The council is working from a 72-page staff paper that offers a succession of grim statistics, starting with the fact that only a quarter of those who submit to painful, dangerous and expensive procedures can expect to have a baby after the first try, and many will never succeed.

According to the report, as many as 1 in 20 prospective mothers suffer from enlarged or burst ovaries, cysts, cancer, cardiac disorders and sudden death as part of the ovarian stimulation process. Surgical procedures to harvest the eggs can result in puncture of adjacent organs, infection or reaction to general anesthetic.

The common practice of implanting multiple embryos to improve the chance of pregnancy, as well as injury to the embryo during the growth and implantation process, results in multiple births one-third of the time, with associated risks of preeclampsia, high blood pressure or anemia.

There is a 17% chance of miscarriage and a 25% chance of premature birth. One in 10 of the premature children will die within a year. Many of the rest will suffer from blindness, chronic respiratory disorders or mental retardation.

A third of the children conceived through in vitro fertilization are reported to have low birth weight and a 1 in 10 chance of being diagnosed with often rare and exotic birth defects within the first year of life. Both events are twice the level as natural conception.

Newer techniques include direct injection of sperm into the egg to aid the 39% of in vitro fertilization client couples with male infertility, called intracytoplasmic sperm injection. This process is very likely to pass along genes for cystic fibrosis, since the cystic fibrosis gene also can cause male infertility. The now-banned practice of ooplasm injections, to overcome deficiencies in embryo mitochondria, resulted in children born with the genes of three parents.

Pre-implantation genetic diagnosis is incorrect as much as 10% of the time and subsequent genetic screening that reveals defects usually results in an abortion. Meanwhile, more than 400,000 embryos languish in cryo-storage with little or no chance of ever being implanted.

‘Patchwork’ Regulation

The council's report called the regulatory landscape “a patchwork, with authority divided among numerous sources of oversight.” Most professional practices are monitored only by the American Society of Reproductive Medicine, which has no enforcement authority.

In reviewing the report, council member Mary Ann Glendon, who teaches law at Harvard University, said, “I think the background assumption for a lot of these people is, ‘Somewhere, someone is looking out for me.' Somewhere, there are government agencies that do keep an eye on things.”

But that's not the case, she said. “It's very important just to do what our mandate tells us we're supposed to be doing, and that is raise the level of public awareness and deliberation,” Glendon said. The result should lead to improved monitoring and, possibly, regulation, she added.

Opposing in vitro fertilization and the other scientific and medical practices that have grown from it doesn't mean being against regulation of the industry, said Austin Ruse, president for the Culture of Life Foundation. “We're faithful Catholics, but we are not critics of the President's bioethics council,” he said.

Through the council's investigation, “members on the left and right have discovered there's a problem,” Ruse said. “At the very least, they are recommending regulation of an industry that is totally unregulated.”

Ruse, who is also president of the Catholic Family & Human Rights Institute, a pro-life lobbying group at the United Nations, sees regulation as an essential first step in a process that will ultimately lead to a ban on in vitro fertilization. “People are awakening to the facts,” he said, “and it is fairly good news that there is now a healthy debate about the efficacy and [health] of IVF.”

He is especially pleased that the council has recognized “there is a problem with excess embryos.” He would like to see a recommendation from the council that would force the medical profession to disclose the fact that there are 20 leftover fertilized embryos for each in vitro fertilization. This action alone could save lives, he said.

“We would like to snap our fingers and see that it would end, but it won't happen,” Ruse said. “It will take a while to convince enough people that you can't mess in this way with the conception of children. For now, we can accept a law that limits it.”

Regulation that bans intracytoplasmic sperm injection and limits super-ovulation would be a good first step, said Richard Doerflinger, deputy director of the Secretariat for Pro-Life Activities for the U.S. Conference of Catholic Bishops. These two rules alone would reduce the risk to mothers, curtail birth defects in children and arrest the growing number of surplus embryos.

Doerflinger, who testified before the bioethics council June 12, said the bishops would support “any regulation that would rein in [assisted-reproduction therapy] providers.” However, he cautioned that support for regulation does not mean approval for any regulatory scheme that includes government support for any aspect of assisted reproduction.

In council discussion, he said, some members have noted that government funding is the traditional means for extending federal authority.

“We totally disagree,” Doer-flinger said. “You don't rein in an out-of-control industry by giving it money. No federal support should be given to IVF or any other assisted-reproduction therapies, even if it is presented as a lever for regulating the practice.”

Although he praises the council and its consideration of the issues surrounding assisted reproduction and bioengineering, Msgr. William Smith said any proposal for federal regulation presents “ethical traps for Catholics.”

Msgr. Smith, a moral theologian at St. Joseph Seminary of the Archdiocese of New York, said, “The first trap is accepting the fallacy that couples have a right to a child — because they don't.”

“Married couples have the right to engage in activities that may lead to children, but we don't ever have a right to another human being,” he said.

This leads to the second ethical trap — accepting procedures that put unborn children in jeopardy in order to meet a supposed right to a child. “This brings in its own level of ethical concerns,” Msgr. Smith said, “and who's controlling the shots? Technicians.”

Pointing to Canadian attempts to regulate, he said support for laws “that are better than nothing” can lead to conclusions inconsistent with authentic Catholic teaching. “When you say 90% survival is better than 50%, you are canonizing the destruction of 10%.”

“Unless we know enough about what we are supporting,” Msgr. Smith said, “we are likely to wind up accepting something we'll be very unhappy with five years from now.”

Philip Moore is based in Vancouver, Washington.

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