Reproductive Research Far Outpaces Public Policy

Dr. Gary Hodgen stands at the place where science and politics collide. As America’s lawmakers grapple with the cloning of a sheep named Dolly, he would like to contribute a little history to the debate.

Hodgen is a fertility pioneer. In 1980, while at the National Institutes of Health in Bethesda, Md., he proposed an experiment that, he believed, held the promise of someday eradicating Tay-Sachs disease, a genetic affliction that kills children by the time they become toddlers.

Hodgen wanted to screen embryos--while in the test tube--for Tay-Sachs. The experiment would be performed soon after the union of egg and sperm, when the embryo was a microscopic bundle of just eight cells. Embryos that carried the deadly gene would be discarded. Those that did not would be implanted in the mother’s uterus.

The goal was to help Tay-Sachs carriers have healthy babies. But Hodgen’s plan ran smack into a ban on government funding for human embryo research, and his bosses vetoed it. So he packed his bags and headed south, to this sunny port city, home to a renowned private fertility clinic with its own research labs.

Here, at the Jones Institute for Reproductive Medicine, Hodgen’s experiment has come to fruition. In 1994--the same year that President Clinton declared that human embryo research “raises profound ethical and moral questions”--Hodgen engineered the birth of a healthy girl to a Louisiana couple whose first child had died of Tay-Sachs at age 3.

Hodgen’s experience illustrates the paradox of America’s approach to the brave new world of reproductive biology: While the United States has some of the tightest restrictions of any industrial nation on what can be done with government funds, it has no limits on what private money can buy--and little appetite to interfere with the private practice of medicine.

In the 19 years since the birth of the world’s first test-tube baby, at least a dozen nations have engaged in far-reaching ethical discussion about--and regulation of--the new biology of life, including cloning, reproductive medicine’s outermost frontier. Six countries have banned human cloning outright.

The United States government, by contrast, has been strangely silent, choosing instead to address reproductive medicine’s thorny ethical questions by simply eliminating taxpayer-financed research. The nation most adventuresome in the pursuit of science may be politically the most afraid of it.

“We don’t have a clear way of figuring out what our collective social values are,” said Lori Andrews, who teaches law and genetics at Chicago-Kent College of Law. “In the United States, our dominant cultural value is ‘Show me the money.’ ”

A Congress Awash in Hearings

Now, America is taking on the issue of human cloning.

It has been two months since Scottish scientists shocked the world with the disclosure that they had, for the first time, cloned an adult mammal, with techniques that could someday be refined for use in humans.

In Washington, lawmakers are struggling with whether--or how--to prevent this from occurring. Congress is awash in public hearings. Ian Wilmut, Dolly’s creator, has been paraded around Capitol Hill as though he were Exhibit A. Clinton has weighed in with a 90-day moratorium on federal funding for human cloning research--a largely symbolic act, given that there are no such studies going on or planned. He has asked that the private sector voluntarily hold off as well.

At Clinton’s request, a new National Bioethics Advisory Commission is examining cloning’s moral and legal implications. Measures to ban or severely limit cloning-related research are pending in both the House and Senate and in several state legislatures from Sacramento to Albany.

To Hodgen, this is a sorely misguided approach.

“You cannot have government simply say you can’t go and learn that, don’t be curious about that. . . ,” said the 53-year-old scientist, now president of the Jones Institute. “It has always failed.”

Certainly, it failed in Hodgen’s case.

The embryo research ban was intended by abortion foes to keep their tax dollars from funding what they viewed as immoral science. Instead, in the spirit of the American free market, the fertility industry simply grew up around the research ban--albeit at a slower pace than it would have otherwise. And with federal authorities out of the picture, there are no government-funded studies to determine what procedures are safe and little guidance from policymakers about what society considers ethical.

“In the absence of public funding, and public regulation, the private sector is left rudderless,” said R. Alta Charo, a medical ethicist at the University of Wisconsin and member of the president’s bioethics panel.

‘Energy, Ambition’ and ‘the Will to Succeed’

There is a sign hanging over the door to Hodgen’s office. It says “Spizzerinctum.” It is not a word one can find in the dictionary; Hodgen invented it. He defines it as “energy, ambition, the will to succeed.”

Spizzerinctum, it might be said, took a young Gary Hodgen, fresh out of medical school, to the National Institutes of Health in 1969. He arrived with an ambitious, if politically delicate, agenda. He wanted to study the origin of human life.

How, he wanted to know, are eggs fertilized? How do embryos grow? Can science intervene in the creation of new life, not only to benefit the infertile but to treat and prevent illnesses at the beginning of life, rather than the end?

Hodgen expected a free hand in pursuing these interests. America has a long tradition of protecting academic freedom; nowhere is this tradition more ingrained than at the NIH, one of the country’s premier scientific institutions.

“We believe very strongly as a nation that if you free science to do its job, that it will rebound to human good,” said Lawrence Gostin, professor of law and public health at Georgetown University. “It is part of the pioneering spirit of the United States. We are much more likely to take risks, to be adventurous.”

But as Hodgen quickly discovered, that pioneering spirit tends to wither in the face of the politics of abortion.

In the mid-1970s, shortly after the U.S. Supreme Court handed down its landmark Roe vs. Wade decision, abortion foes began pressing the government to put an end to research involving fetal tissue and early embryos.

“We believe that life begins at the beginning, not in the middle, and that even a single-cell child has the dignity of all the children of God,” said John Cavanaugh-O’Keefe, director of the bioethics arm of the Virginia-based American Life League.

In 1975, the Department of Health, Education and Welfare, sensing the sensitivity of such research, ruled that it would not fund in vitro fertilization research until its ethics advisory board had reviewed the proposal.

But there was a catch: There was no ethics advisory board.

It took two years for HEW to create one. In 1979--one year after the birth of Louise Brown, the world’s first test-tube baby--the board issued an extensive report that recommended the government fund studies to determine the safety of in vitro fertilization.

But the recommendations were never adopted, and the board’s report “has gathered dust for 18 years,” lamented Georgetown University ethics expert LeRoy Walters, who helped write it.

From time to time, government has tried to revisit these issues--with little success. The only congressional panel that might have dipped into the new biology of life dissolved in 1989, the victim of a fight between abortion rights advocates and opponents over who would fill its last seat.

Then, in 1994, the NIH convened an ethics panel specifically to reopen the question of human embryo research. The group recommended that, in certain limited instances, government scientists be permitted to create human embryos for research or use “spare embryos” obtained from fertility clinics.

The furor was instantaneous.

Within 24 hours, Clinton had stepped in to declare that the government would not fund scientists who created embryos for research. Congress later used its appropriations authority to effectively ban all embryo studies.

Now, Clinton has turned to the bioethics community yet again for advice on another hot-button issue: cloning. And the question raging in ethics circles is whether the president will listen to them or whether politics will once again intervene.

The debate over whether to ban the cloning of humans will be the easy part; public sentiment is lined up fairly solidly against it. Much trickier will be the discussion over whether to permit studies involving the cloning of adult human cells for purposes other than creating babies.

At a recent Senate hearing, Dr. Harold Varmus, the director of the National Institutes of Health, told lawmakers that the cloning technique pioneered by Wilmut--”nuclear transfer technology”--could be used to cure disease. For instance, it might be helpful in generating bone marrow for transplantation.

“My own view,” Varmus said, “is that legislation and science frequently don’t mix very well. . . . The matters are complex. If there were to be legislation--which I hope will not be necessary--it will be very important to be specific about what would be excluded.”

Burdens, Frustrations Come With Progress

The issues in embryo research are complex as well. It was the government’s inability to sort them out that drove Gary Hodgen to the private sector.

By the late 1970s, Hodgen had climbed the ladder to become the chief of the pregnancy research lab at the National Institute on Child Health and Human Development. But he had become increasingly frustrated.

Four times, Hodgen submitted his Tay-Sachs proposal. Four times, it was rejected. “The government’s heavy hand was getting in the way of following the natural course of medical inquiry,” he complains. “It became clear that I had to leave.”

The ensuing decade was a remarkable time for reproductive medicine--a time when laboratory advances were quickly translated into medical practice. America’s first test-tube baby, Elizabeth Carr, was born in 1981 at the Jones Institute. In vitro fertilization, once a novelty, became a mainstay of American fertility treatment; in 1994 alone, 6,000 test-tube babies were born in North America.

In a pretty brick courtyard at the Jones Institute, one can see the fruits of these successes. Brick after brick is engraved with the names of happy parents and their babies--often twins and triplets. “Our Dream Come True,” one brick reads. “A Double Joy!” reads another. It is hard to stand there and not be moved.

But there are burdens to scientific progress--pressing ethical questions from surrogate motherhood to the ownership of frozen embryos. Around the globe, in the late 1980s and early 1990s, nations began to confront these concerns, and much of the industrialized world now has regulatory policies on the issue.

A notable exception is the United States.

In part, this difference comes about because our health care system does not require a policy. Unlike the European model, American health care is private, and thus lawmakers do not have to determine what the government will and will not pay for. The result is that private doctors and their patients are constantly pushing the edge of what society considers acceptable.

Conflicts often wind up in the courts, where decisions are not always consistent. In 1993, a Tennessee judge was asked to award custody of frozen embryos belonging to a divorcing couple; he sided with the man. In 1995, a New York judge heard a similar case and sided with the woman.

“In the United States, our policies develop from the individual cases up,” says Charo, the Wisconsin ethicist. “The European system tries to design the dog and let it wag its tail. We have 50 or 100 or 150 wagging tails from which we then try to reconstruct the dog. It’s no wonder that our dog looks a little bit like a Picasso.”

‘A Simple Set of Rules’

Hodgen has developed his own ethical standards--”a simple set of rules” that he calls his “double-based litmus test.”

The test consists of two questions that Hodgen asks himself before every experiment: Will it meet an unmet need of patients or their families? And will it help--or harm--society?

The test came in handy four years ago, when Hodgen and his colleagues at the Jones Institute learned how to determine the sex of test-tube embryos. The procedure was developed to identify so-called X-linked genetic diseases--such as hemophilia--that affect only boys.

Hodgen’s dilemma was whether to allow doctors at the Jones Institute clinic to employ the test for patients who wanted to pick the sex of their children.

He decided not to.

“It fails the second question,” he explains. “If I value being a man and a woman as equal, then I cannot use the precious resources of medical science for the sole purpose of helping a couple have a boy or a girl.”

He is aware that others might reach a different conclusion--and indeed, others already have.

Great Britain, for instance, has a ban on test-tube sex selection. But a British doctor named Paul Rainsbury recently set up a clinic in Saudi Arabia to avoid that ban--announcing that his British patients could evade their country’s laws and choose the sex of their child for the extra price of an airplane ticket. Rainsbury said he expected 80% of his clients would seek boys.

To Hodgen, this is simply a casualty of doing business in a free world. Scientists, he says, must be free to let their consciences guide them; if society objects to their ethical choices, he says, let society mete out the punishment. “Each person,” he says, “must search their own soul for what they spend their time doing.”

At its heart, this is what the cloning debate in Washington is about. How much is society willing to let scientists search their own souls in the pursuit of knowledge? Will lawmakers simply cut off federal funding, allowing the private sector to press forward unhindered? Will they permit the cloning of human cells but ban the creation of babies by cloning? Will they make human cloning a crime, like bank robbery or murder?

And regardless of what they decide, can lawmakers make their rulings stick, or will ambitious scientists and wealthy clients simply cross national boundaries to find permissive jurisdictions?

Some say the notion of human replicas separated by time is so abhorrent that politicians the world over must join hands to ban it outright. Wilmut, Dolly’s creator, subscribes to this view; he recently asked a panel of U.S. senators to launch an international drive to ban cloning in humans. Gostin, the Georgetown ethicist, senses that Americans would favor such a move.

“Cloning,” Gostin says, “was a defining moment in our perception of science. . . . I think that this might be a spur, where we would draw the line.”

Others say that society will eventually get used to the idea of human cloning, just as it has gotten used to artificial insemination and in vitro fertilization.

Already, some commentators are wondering if Americans might support cloning in certain instances, such as the case of a family that loses a child. And human cloning has its defenders, among them U.S. Sen. Tom Harkin (D-Iowa), who recently offered an impassioned defense of science’s right to pursue cloning research, wherever it may lead.

“Some would make us believe Dolly is a wolf in sheep’s clothing,” Harkin said, “but I don’t think so. . . . I don’t think it’s legitimate for us to try to stop this.”

If humans were to be cloned, the logical place for it would be in private fertility clinics like the Jones Institute. Hodgen says that is not about to happen on his watch; cloning fails both criteria of his litmus test. Still, he speaks vociferously against a government ban.

“I join with the massive plurality of Americans and other people around the world who say, ‘Let’s not have human cloning.’ ” Hodgen says. “We don’t have a reason to do it and we have many reasons not to do it. But let’s come to that decision as free individuals, not by the heavy hand of government.”

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Question

Would society be better off not knowing how to clone humans?

Steven H. Holtzman, chief business officer, Milennium Pharmaceuticals Inc., member of the National Bioethics Advisory Commission:

“We’re better off knowing how to do certain of the procedures that can lead to the cloning of a human being because of their benefits. And then the question becomes: Are we socially mature enough to limit the use of the technology to those good ends? . . . Our energies should be focused on not unknowing this stuff, but on becoming a society who knows how to deal with the kinds of knowledge we’re acquiring.”

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Pat King, professor of law at Georgetown University Law Center:

“I can’t come up with any reason why society would be advanced in being able to clone humans, but that’s a pretty qualified answer. I can’t say not for ever and always, because information changes and there may be in the future reasons for doing it that we might agree with.”

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Glenn McGee, author of The Perfect Baby: A Pragmatic Approach to Genetics:

“We’re not better off without the understanding of how to clone, but we’d be much better off if the scientists who brought us cloning had an understanding of society. . . . Fault has to be laid at the footstep of Dr. Wilmut and other scientists who created a media tornado before they had pursued any debate about what to say a about their discovery and how it should be used . . .

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Ellen Moskowitz, associate for law, the Hastings Center:

“I think on the whole society would be better off not knowing how to clone humans. I think that, for some individuals caught in the throes of infertility, cloning does hold a remarkable possiblity open for them to be able to reproduce, and I don’t want to minimize that. On the other hand, I think for society as a whole this is a door that I’d just as soon be left closed. This is a technology that encourages our unfortunate tendency to overvalue particular traits or characteristics. . . . There are other ways to become a parent.”

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George Annas, professor of health law, Boston University:

“I think we’re going to know how to do it. The question is, is society better off not doing it, whether they know how to do it or not. The answer is yes, we should not clone a human being. We should be able to draw a line here and say that it is much more likely that there will be many more harms to society than benefits to cloning humans. We should therefore not do it.”

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Art Caplan, director, Center for Bioethics, University of Pennsylvania:

“Ironically, knowing how to clone humans is our best defense against cloning them because we will see how hard it is, how dangeorus it is. We will understand the risks that might be posed by taking genetic information from adults and using it to try to replicate people. We will understand that what might work great for the production of lamb chops and fur coats will not be acceptable for the production of personalities and behavior in human beings.”

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James L. Nelson, professor of philisophy at the University of Tennessee:

“It wouldn’t be a good idea for us to find out now, because there’s a whole bunch of other things we need to sort out first, such as who gets to determine the social meaning of the new biological relationships that human cloning would saddle us with. How do we determine: Am I your mother or am I your sister? . . . Right now we are not ready to know. Will be always be unready to know? That, I can’t say.”

Compiled by SHERYL STOLBERG / Los Angeles Times

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The Legal Landscape

In the wake of the announcement that a Scottish researcher had succeeded in cloning a sheep, numerous state legislatures have begun considering laws to ban cloning or restrict related research. These states already have laws banning or restricting embryo research:

Louisiana

Maine

Massachusetts

Michigan

Minnesota

New Hampshire

North Dakota

Pennsylvania

Rhode Island

Utah

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Restrictions around the world

* Category I, bans all embryo-related research: Norway

* Category II, allows research but subjects private research to government regulation: Australia, Canada, Denmark, France, Germany, Spain, Sweden, United Kingdom

* Category III, allows research without government regulation: United States

Source: National Institute of Health

Compiled by CARY SCHNEIDER / Los Angeles Times

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About This Series

The cloning of a sheep named Dolly sent shockwaves throughout the world this year. But that is only one of a host of advances in biotechnology. The revolution is touching virtually all corners existence, from conception to nutrition to disease control. The genetic engineering advances also raise basic questions about how society will deal with these newfound abilities, who should control their use and how far research should be allowed to proceed.

Sunday: The biotechnology revolution--the future has arrived.

Monday: What is the “self” and can it be cloned?

Today: The U.S. government’s reluctance to regulate reproductive technology raises some thorny issues.

Wednesday: The quest to map the human genome leads down some unusual roads.

Thursday: Barnyard biotech--of cows with medicinal milk and pigs with human-like organs.

ON THE WEB: Graphics, photos and stories from “In Our Own Image” are available on the Los Angeles Times World Wide Web site at: https://www.latimes.com/cloning/