A Matter of Life, Ethics

Freshly changed into pajamas, Charlie Whitaker sucks on a pacifier and tries to ignore the needle in his father’s hand. He focuses on the television while the needle goes into his belly, then winces as his father tapes it in place. The needle will stay there overnight so that the drug Desferal can filter into Charlie’s body.

“Why do we give you Desi?” his father asks in a comforting ritual.

“To get rid of iron in my blood,” answers the 4-year-old boy.

“And what does Billy Blood do?” his father asks.

“It keeps you alive,” says the boy.

Charlie needs this nightly ritual, along with frequent blood transfusions, because his body cannot produce red blood cells. The disorder threatens his life. But illuminating one of the most gripping moral quandaries of modern genetics, a British government panel has barred the Whitakers from trying a promising new cure.

The reason: The cure depends on creating another person -- specifically to help Charlie. Charlie’s parents would mix their eggs and sperm to produce embryos, a common fertility technique. But to select which embryo to grow into a baby, they would use a new screening test to find the one that could best donate blood-making cells to their ailing son.

Is it proper to create one child to help another? In the U.S., no government agency even considers the question. But for the British government panel, it is only the latest concern in a decade-long effort to determine what is proper -- and what is immoral -- as scientists put the human embryo to new uses.

The panel is called the Human Fertilization and Embryology Authority, and it is quickly becoming a major force in the worldwide debate over embryo science. Human cloning? The embryo authority barred it in 1998. Testing embryos to pick a child’s sex? The panel sharply curtailed that in 1993.

Whether for research or high-tech reproduction, anyone in Britain who wants to create or use embryos needs the panel’s permission. Even the most emotional plea is rejected if the 21 panel members decide, as they did in the Whitakers’ case, that it violates the public interest.

Now, many other nations are turning to the British model as they grapple with the boom in fertility clinics and embryo stem-cell research. Canada is poised to approve a similar body. Officials from Taiwan, Japan and Ireland, among others, have consulted with the British panel.

There is even growing interest from the U.S., where there is relatively meager regulation of fertility techniques and private-sector embryo research.

Earlier this month, embryo authority chairwoman Suzi Leather consulted with President Bush’s Council on Bioethics, an advisory group that is deciding whether to propose its own plan for regulating embryos. A report due soon from the Hastings Center, a well-known New York bioethics think tank, will recommend that U.S. officials copy the British model.

“I think we need a similar kind of body in the United States,” said Francis Fukuyama, a political scientist at Johns Hopkins University and a member of Bush’s bioethics council. Irving L. Weissman, a Stanford University stem-cell researcher and businessman, said adopting the British model “makes sense to me, if it has knowledgeable members.”

Adopting something like the British authority would be a political challenge in the United States, where each side in the abortion debate fears that new embryo regulations could weaken its position.

And the Whitakers warn that regulation comes with a price: an intrusion on the traditional privacy of reproductive decisions and on the independence of doctors and patients to decide the course of their own treatment.

“The worst part of this is that medical science is dangled in our face as a potential cure, and then it is pulled away,” said Jayson Whitaker, Charlie’s father. “At the end of the day, this should be our decision for our children and our family.”

Still, a growing number of critics say society should have a larger role in regulating techniques that touch on the earliest stages of human life.

The reason, they say, is that fertility doctors are increasingly treating patients who want to screen the genes of their embryos to guarantee that their next child will be a boy, or a girl, or free of serious familial diseases. Next, some people fear, could be the “designer baby” -- a child whose traits are ordered up as if they were features on a new car.

The debate goes beyond traditional fertility issues, thanks to the discovery of embryonic stem cells. Scientists want to study these cells for their potential to cure disease. But embryos must be destroyed to obtain the cells, drawing protest from people who see life as beginning at the moment of conception.

Only a small portion of the work using embryos falls under federal supervision in the United States.

The Food and Drug Administration regulates drugs and medical devices, but not medical procedures, such as reproductive techniques.

In the research world, the National Institutes of Health enforces a strict ban on experiments that harm embryos -- but that applies only to government-funded research.

Privately funded researchers can work in secrecy. They can create embryos or dissect them for stem cells. When a Massachusetts company merged two species to create a human-cow embryo, the work became public only because the company chose to reveal it.

Critics say U.S. regulation is full of gaps and morally inconsistent.

“If you think embryos are special and deserve protection,” said Lori Knowles of the Hastings Center, “then they deserve it whether or not it’s the government that’s funding the research.”

Oversight in Britain

Britain, by contrast, brings all embryo work under the Human Fertilization and Embryology Authority -- whether funded publicly or privately, in fertility clinics or research labs.

Created by Parliament in 1990, the panel learns precisely what will be done with embryos before deciding whether it is proper. Can the research be done through other means? Does it involve a truly serious disease? Is there evidence that a reproductive technique might harm a patient or, most important, injure the child to be born?

“There is a fear of science being out of control, that what’s being created is abhorrent to the human race,” said Dr. Maureen Dalziel, the panel’s top staff official. “We show that you can consider all the issues, and that gives people a degree of comfort.” The result, she said, is greater public support for the research and treatments that are permitted.

Some limits have been laid down by Parliament. Embryos may be dissected for stem cells, but no one may experiment with an embryo more than 14 days old. Cloning is banned to produce a baby, but not as a tool of disease research. Fertility procedures should be barred if they harm the welfare of the child.

But generally, the embryo panel is left to its own judgment. Panelists are appointed by a government health ministry, and more than half must come from outside the medical and scientific professions. The current lineup includes a social worker, a philosopher, an Anglican bishop and a newspaper columnist.

The result is a system in which the freedom to work with embryos is broad, but also far more supervised than in the United States.

Fertility services are booming in both countries, but only Britain can say how many embryos are created at clinics: 925,747 between 1991 and 1999. The British authority also can say how many have been destroyed, donated for research and created by scientists specifically for experiments.

In the United States, no one tracks that information.

Fertility patients in both countries can use eggs and sperm produced by donors. But the British sharply cap payments to donors, even laying out how much they may be compensated for each mile traveled to a clinic by car, bus and bicycle. In the United States, where faith in the free market is stronger, women with the right looks and college credentials have been offered as much as $80,000 for their eggs.

“The U.K. has struck a very sensible balance in this whole domain that we’re just still struggling for and has eluded us,” said Michael J. Sandel, a professor of government at Harvard University and a member of Bush’s bioethics council.

“I think we should have regulation of fertility clinics and embryo research -- not to stop the activities but to permit it with the confidence that it will be done ethically and won’t give rise to abuses,” said Sandel, who believes abuses include high payments to induce women to donate eggs.

Many fertility doctors, however, are suspicious of putting more government in the medical office.

“What you’re talking about is the government regulating how people have children, and we have a much stronger tradition of avoiding that in this country than they do,” said Sean Tipton, spokesman for the American Society for Reproductive Medicine, which represents fertility doctors.

Only Cure for Boy

When it rules on an application, the British panel often inspires a spirited public debate. But few decisions have been as contentious as its rejection of the Whitakers’ effort to help their son.

From birth, Charlie Whitaker was pale and sleepy, and at 12 weeks, his doctors discovered why: His body was not manufacturing red blood cells. Charlie had been getting by on the few cells that had slipped in from his mother, Michelle, while he was in the womb.

The diagnosis was Diamond-Blackfan Anemia Syndrome, which affects fewer than 700 people worldwide. The average life expectancy is 31.

To survive, Charlie needs a blood transfusion every three weeks, along with Desferal to draw out the excess iron that builds up after the transfusions. The only cure is to transplant new blood-making cells, which can be found in bone marrow or in a newborn’s umbilical cord blood.

The trick is to find cells that Charlie’s body will not reject. His doctors said he needs a donor whose biology closely matches his own -- so closely that the cells could come only from a sibling. And not just any sibling. Brothers or sisters have only a 25% chance of being the right match.

The Whitakers, who live in Bicester, a town of modest homes near Oxford, say they always wanted a large family. Last year, they had a daughter, Emily. She is healthy, but not able to help Charlie.

But another development in the United States was giving the Whitakers hope. In October 2000, doctors announced the birth of Adam Nash of Colorado. Adam had been conceived in a laboratory dish along with other embryos, then singled out by a genetic test as the only one who could donate cells to his sister, Molly, who suffered from a deadly blood disease called Fanconi anemia.

Adam’s birth suggested that the Whitakers could also create a baby to help their sick child. “We went to our consultant right away,” Michelle recalled, referring to Charlie’s doctor, “but she said, ‘You must be joking. That will never happen in this country.’ ”

Then late last year, the British embryo authority had its own Nash case. A couple from the northern city of Leeds, Shahana and Raj Hashmi, sought permission to create a child who could donate cells to their son, Zain, who suffered from the blood disorder beta thalassemia.

The embryo panel had several concerns.

To study an embryo’s genes, doctors grow it for three days, until it has about eight cells, and then remove one cell for testing. The panel feared the cell removal might expose the embryo to lasting physical harm.

And there might be emotional risks to a child whose identity was forged in relation to a sibling. “One of the most important characteristics of parenthood is the unconditionality of parental love,” said Leather, the embryo authority chairwoman. “If you start out by saying, ‘Well, we really only want one that comes in blue or one that comes in pink,’ it undermines that unconditionality.”

Finally, the panel considered whether selecting a child as a cell donor was a step toward the widely feared “designer baby.”

“How far would it go?” asked the Right Rev. Michael James Nazir-Ali, the bishop of Rochester and a panel member. “Could parents get characteristics that are not life-threatening medical issues? What about colorblindness?” Or musical ability? Or blue eyes?

In the end, the panel decided that embryo selection should be used only when the unborn child had something substantial to gain. And because the Hashmis’ next child ran a risk of inheriting beta thalassemia, the child could in fact benefit from embryo screening. When they chose an embryo that could help Zain, the Hashmis would be choosing an embryo free of the disease.

In the Whitaker home, the decision was great news. Like the Hashmis, they had a son with a blood disorder. Like the Hashmis, they saw a way to boost their odds of gaining a cell donor.

But the embryo authority saw a key difference. Zain inherited his illness. Charlie, so far as doctors could tell, was ill because of a one-time genetic fluke. When the Hashmis created a dish of embryos, some would carry Zain’s illness and some would not. If the Whitakers created embryos, none would have a substantial chance of carrying Charlie’s disease.

“So, you would be creating a child to serve somebody else’s ends, albeit a sibling’s,” Leather said. “You would expose it to potential risk for which it wasn’t getting any benefit. And that to us felt like it was breaking an ethical principle, and tipping the benefit scale away from the individual” to be born.

To the Whitakers, the rejection made no sense. People have children for all sorts of reasons, Jayson said, “to look after them in old age, for passing on the family fortune.”

“Teenagers have babies in this country to get a subsidized flat,” he added. “Why would they think we wouldn’t love this child as much as any other?”

“I’m just so angry,” said Michelle. “Abortion is legal in the United Kingdom. They’re protecting a 3-day-old embryo, but we could terminate an 18-week-old fetus.”

In Britain, some people criticized the embryo panel’s decision. But some also had been angry when the panel allowed the Hashmis to proceed.

“Whichever way we take it, we’re going to get lambasted,” said Sara Nathan, a broadcast journalist on the panel. “They’ll either say you’re on the slippery slope toward having designer babies, or you’re going to be seen as a rigid moralist who says no.”

But generally, the British panel’s decisions are accepted by the public, said Nathan, several scientists and the country’s main advocacy group for infertile patients.

Some think that no U.S. embryo panel would win similar acceptance, because the debate over abortion, and over legal protections offered to embryos, is far more contentious than in Britain.

“It won’t work in the U.S.,” said Tipton of the fertility doctors’ group. “The climate around abortion politics in this country precludes rational discussion.”

Abortion politics, in fact, have stalled past efforts to regulate embryo science.

Congress has never laid out rules for stem-cell research, leaving it to Bush. And it has not banned cloning to produce babies, even though lawmakers from both parties, and with opposing views on abortion, have said creating a cloned baby would be immoral.

Some people believe the nation needs a new approach. They include several members of Bush’s bioethics advisory council, said Dr. Leon Kass, the physician and ethicist who leads the council.

On Oct. 18, just after hearing from the leader of the British authority, the bioethics council voted to draft a proposal on how to regulate embryo screening, embryo research and other technologies that involve early forms of human life.

The Whitakers are urging caution. They now have plans to visit the United States, where doctors perform embryo screening about 15 times each month to produce cell-donor matches for sick children. If U.S. doctors were stripped of freedom to use the technique, the chance to cure Charlie might also disappear.

Michelle Whitaker said she’s “really glad” that the United States has not followed Britain.

“I don’t agree with people wanting blond-haired, blue-eyed children or deciding what sex it is,” she said. “But it’s another thing to help a sick child.”