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To Be, or Not to Be: The Ethics of Biotechnology
By Joan Indiana Rigdon

Why we still lack a definitive national policy on cloning and assisted reproductive technologies.

Maybe you are legally prepared for death. You have some combination of life insurance, a will, a living trust, and a living will. You have provided for everyone who counts and left explicit instructions on organ donation, when to discontinue life support, and how to dispose of your remains.

But you forgot to say something about your gametes. Suppose you get hit by a bus tomorrow. Your fiancée, your wife, maybe even your parents, could ask your doctors to harvest your sperm. They might tell the doctors that you wanted an heir, or a sibling for your first child, or a child for your second wife. (In a few years, when egg preservation is more reliable, a husband can have his dead wife’s eggs harvested, too.)

No matter what your loved ones tell your doctors, you won’t be around to object. Some hospitals grant these requests. And why not? In most states there is no law against it. At least one baby girl has already been born to American parents this way: Brandalyn Vernoff of Los Angeles, California.

Because of lack of legislation, lots of things are legal in the brave new world of biotechnology. In various states you can buy and sell eggs and sperm, or advertise your gametes for sale at a high price based on your claims that you are descended from royalty, or that you aced your SATs (though there is no scientific proof that anyone’s gametes, even Bill Gates’s, will result in a “better” baby). You can pay fertility clinics to genetically test and weed out embryos that are prone to developing fatal diseases, or simply annoying diseases, or even the wrong gender or hair color. In some states you can agree to serve as a surrogate mother and then legally keep the baby.

As long as you don’t use federal funds, you can legally clone humans in 41 states, according to the National Conference of State Legislatures. “We’ve had this crazy quilt of legislation,” says Lori Andrews, a lawyer and bioethicist who has advised the U.S. Congress, numerous state legislatures, and foreign governments on the issue of biotechnology regulation.

“It would seem to me that if the prospect exists, as it now does, for having a baby made with both parents dead, from frozen sperm and a frozen egg, we’re overdue for someone to say whether it’s a good idea,” says Arthur Caplan, chair of the Department of Medical Ethics at the University of Pennsylvania. “We really should not be this far along in the reproductive revolution without some kind of guiding legislation.”

Genetic testing is problematic, too. If you want to see if you have a gene that is related to breast cancer or another disease, beware of who can access your test results. In many states insurance companies can legally use them to cancel your coverage or raise your premiums. In more than half the states employers can use them to fire you.

One Million Plus
Of course, some biotechnology is too new to regulate. However, much of it, especially assisted reproductive technologies, has been widely practiced for decades. So in some respects, we are facing not just a brave new world, but a brave old one, which has already produced more than a million children.

In 2001 these technologies produced 1 percent of all U.S. births, according to the Centers for Disease Control and Prevention (CDC). Many were born using in vitro fertilization (IVF), in which a sperm and an egg are combined in a laboratory before being implanted. Some IVF babies were born through intracytoplasmic sperm injection, or ICSI, in which doctors inject a single sperm into an egg before implanting. Some were born using preimplantation genetic diagnosis, in which embryos are genetically screened before they are transferred to the womb. At least a few babies, including the three children of Bill and Susan McNamara of New Jersey, spent their early gestational days on tissue from a cow uterus before being implanted in their mother.

Scientists have conducted many studies of assisted reproductive technologies. There are statistics on success rates (40 percent as of 2001, according to a CDC report published in April) and the risk of multiples (53 percent, according to the CDC). There are many studies showing that multiples and their mothers are at much higher risk for health problems. Other studies show that IVF and ICSI children are at higher risk for birth defects.

But a lot remains unknown. For instance, it is unclear how many women and their children contracted HIV or other sexually transmitted diseases from donor sperm in past decades. (Now sperm is routinely frozen so the health of the donor can be tracked before use.) It is unclear whether IVF and ICSI pose long-term health risks to the children they produce. And no one knows whether children like the McNamaras are at risk of developing animal viruses, based on their early gestational contact with animal cells.

Ironically, the United States has higher standards for using untested technologies on animals than it does on humans. “It’s very interesting to see the way in which high-tech fertility procedures have proceeded without sufficient prior animal experimentation or randomized clinical trials,” says Andrews. “Women served as the model for nonhuman primates.”

National Policies
Many European countries, along with Australia and Canada, have passed comprehensive legislation to regulate reproductive technologies. On the conservative end of the spectrum, Italy’s new law, passed in February, requires every embryo to be implanted. None may be abandoned or used for research. It also bans egg and sperm donation, any form of surrogacy, and any assisted reproduction treatment for homosexuals, unmarried people, and elderly women.

Canada’s new law, the Assisted Human Reproduction Act, which became effective in March, is much more moderate. It allows unpaid surrogacy and egg and sperm donation, but does not allow the buying and selling of eggs, sperm, or embryos. It allows stem cell and other research on leftover embryos—ones that were created through IVF but never used. It does not allow any cloning, including cloning for research purposes.

At the more permissive end of the spectrum is England, which produced the world’s first test tube baby, Louise Brown, in 1978. In addition to allowing regulated use of many reproductive technologies, England also allows its scientists to clone human embryos for research purposes—with government approval.

The United States has tried several times to pass biotechnology legislation, but those bills focused exclusively on cloning and stem cell research. Of the three bills that were introduced in the 108th Congress, two would have banned all cloning (and therefore the creation of embryos for stem cell research) and the other, a bipartisan bill sponsored by self-proclaimed right-to-life senator Orrin Hatch (R-Utah) and pro-abortion senator Diane Feinstein (D-Calif.), would have banned reproductive cloning but not therapeutic cloning. All three bills remain bottled up in Congress, and are expected to die. The sponsors’ spokespersons say the bills will probably be reintroduced in the next Congress.

In the meantime, more than a quarter of a century after Louise Brown’s birth, the United States has only shreds of a national biotechnology policy. We have a law that requires fertility clinics to disclose their success rates; a rule that forbids the use of federal funds for stem cell research (or any research) on human embryos that were destroyed after August 9, 2001; a Food and Drug Administration (FDA) rule that prohibits making inheritable changes to the human genome; and, as of May, an FDA rule that requires all tissue donors, including stem cell donors and sperm donors, to be screened for diseases including AIDS. This last rule is hugely controversial because it also forbids sperm donations from men who say they have had sex with other men in the last five years, but it does not forbid sperm donations from promiscuous heterosexuals.

There are a lot of holes between these rules. In the void states and private institutions are making up their own. So far two states, California and New Jersey, have legalized stem cell research, and several more are set to follow suit. At the same time, private universities, including Harvard and Stanford, are setting up their own stem cell research labs. For supporters of stem cell research, this is good news, but even some supporters say it would be better to proceed with some guiding legislation than without.

Caplan supports stem cell research with regulation. “I would like to see proposals reviewed by institutional review boards, some guidelines about who can be an egg donor, informed consent and what’s reasonable compensation for serving as an egg donor, and some policy about how to handle unwanted embryos,” he says. “If embryos are not viable for research, are they to be cooked in an incinerator, given a funeral, or what?”

Europeans have found it easier to regulate in this area because they “tend to have a much shorter distance between their cultural, social, and ethical senses,” says Nigel de S. Cameron, the British-born president of the Institute on Biotechnology and the Human Future. “Here in the States you can have very strong convictions and you end up with an appropriations bill instead of a major law.”

Embryo Politics
There are plenty of incentives not to regulate biotechnology. In 2001, after President Bush announced a ban on the use of federal funds for most stem cell research, some American scientists packed up their labs and moved overseas. Now South Korean scientists have become the first to clone a mature human embryo. Some lawmakers fear that any new rules will chase away more scientists and put American biotechnology industry at a disadvantage in the global marketplace. They are also afraid of losing jobs. Economists are looking to the biotechnology industry to help provide jobs.

There are distinctly American reasons for our lack of legislation, too. The idea of regulating reproduction, cloning or otherwise, violates our sense of individual rights and privacy.

The biotechnology industry does not hesitate to point this out. The American Society for Reproductive Medicine’s director of public affairs, Sean Tipton, says his industry is already well regulated by the Food and Drug Administration and by self-policing. Anything more would be intrusive, he argues. “It is true that what we have not done in the United States is pass legislation to allow the government to control the reproductive decisions of its citizens. Thus couples or individuals are free to make their own decisions about whether to have children and, if so, when, with whom, and how.”

Of course, the biggest roadblock to federal regulation of biotechnology is abortion. In the United States any regulation that has anything to do with sex, eggs, sperm, embryos, or fetal tissue is held hostage to the abortion debate.

Thomas Murray, president of the Hastings Center, a bioethics center in Garrison, New York, likes to call this “embryo politics.” “There’s no question that embryo politics has made it extremely difficult to deal with a broad range of issues, including things like stem cell research and reproductive technology,” he says.

Cameron, an outspoken abortion opponent who was present when President Bush signed the ban on partial-birth abortion into law, agrees. “The cultural significance of the abortion debate has distorted every other discussion that is vaguely related to human life,” he says.

So for the last several decades, while the anti-abortion and pro-abortion factions continued to march, debate, and occasionally take up arms, biotechnologies have been allowed to evolve unchecked.

Andrews is hoping to do what may be impossible: speed up the possibility of a national biotechnology policy by taking abortion off the table. About four years ago she began discussing this goal with Cameron. She is the chair of the Institute on Biotechnology and the Human Future and describes herself as having “fought for the reproductive rights of women”; Cameron is the institute’s anti-abortion president. Andrews and Cameron have invited people with opposing views on abortion to discuss bioethics. They brought together people as diverse as feminists and Catholics, and at first they did it behind closed doors. “The feeling is that it’s in everybody’s interest to know what actually can be done without the public relations hype,” says Andrews.

When Andrews addressed the President’s Council on Bioethics last July, she stressed the importance of sidelining the abortion issue. “People who have previously identified themselves as pro-life and pro-choice . . . are waking up and saying . . . let’s put abortion off the table, because we’re going to lose a lot of ground with human dignity and human life if we just let the people who are commercially benefiting make all the laws, while we’re busy . . . shooting across the barricades on this other issue,” she said.

Andrews knows the people for and against abortion will never agree on the moral status of a human embryo. However, she says they are starting to agree that some biotechnology regulation is better than none.

Call for Self-Regulation
Some people think self-regulation is not a bad idea, since biotechnologists know more about these technologies than anyone else. One of these people is Bruce Wilder, a Pittsburgher who practices neurosurgery and law and chairs the American Bar Association (ABA) Section of Family Law’s Reproductive and Genetic Technologies Committee. The committee is drafting proposed model legislation, which it intends to present to the ABA for approval.

Biotechnology’s self-regulation comes through its professional societies, including the American Society for Reproductive Medicine (ASRM) and the Society of Reproductive Technology. Both already publish numerous guidelines for their members. As of this writing, for example, ASRM recommended that doctors transfer no more than two to five embryos to IVF patients, with the higher number for older patients. (ASRM said it expects to decrease the limits by one embryo this summer.) The trouble is, these guidelines are voluntary.

But they don’t have to be. Wilder’s recommendation: instead of enacting biotechnology laws that are too specific—he thinks the English and Canadian laws fall in this category—governments should enact enabling legislation that would give the force of law to guidelines proposed by professional societies. Wilder says this enabling legislation can be briefly stated, but enduring, like the Sherman Act.

“We want to try to make the legislation flexible, more like the Constitution than a whole bunch of regulations with nitty-gritty details,” says Wilder. “If you write [something] into legislation, it’s pretty hard to change it. The way I think this should be done—and I know there’s going to be some controversy—is to have a state agency that asks certain societies” for guidelines every two years, so as to keep pace with changing technology. Those proposed guidelines should be opened to public comment, he adds.

“Some say that’s the fox watching the henhouse,” Wilder acknowledges. “But where the best regulation is going to come from is self-regulation. . . . The people who are most qualified to establish these guidelines are the people who actually do it. . . . They really do a pretty good job. And I think with some enforcement from the state it would be better.”

If societies failed to propose guidelines in certain areas, the overseeing state agency could say, “If you don’t do it, we’re going to make up our own [regulations],” says Wilder.

Wilder’s committee is in the third draft of its proposal, and hopes to submit it for approval to the ABA Section of Family Law this summer. If it is approved, the proposal will be submitted to other ABA sections, and from there it might eventually be submitted to the ABA membership. If finally approved by the ABA, it could be used as a model act for state governments.

Wilder isn’t hopeful. “It might never happen, quite frankly, getting something like this through any large body, because you have people that have all kinds of different views on religious issues,” he says. “It may be difficult, if not impossible.”

Prompting Action
Bioethicists worry that we are not likely to see much legislation in this area until we suffer through enough scandals to prompt action. “You need one of three things,” says Arthur Caplan: “A whopping scandal like Tuskegee [in which 400 black men suffering from syphilis were denied effective treatment in the interest of scientific study]. Or you need some fight about money. Where money is at stake you can get laws. And then sometimes you bumble around for a while, with cases popping up, and finally some state legislature says, all right, we’ll write a law.”

Dozens of bioethical institutes have been thinking over these issues for decades. Every year they hold conferences and produce papers pointing out the actual or potential impacts of various technologies. So far their efforts have not resulted in much concrete legislation, although they have helped precipitate a shift in mainstream thinking.

Thirty years ago, for instance, doctors routinely concealed news of bad health, or even imminent death, from their patients. “Now there’s an overwhelming consensus that doctors cannot deceive patients,” says Murray. “We give patients much more of a say at the end of things. It didn’t happen overnight. It took a decade or two to really become the consensus.”

Murray expects that bioethical issues will follow the same course. “I don’t expect them to bear fruit instantly,” he says. “You’ve got to put it on the public agenda. You’ve got to get people thinking and talking about it. You’ve got to see some kind of moral consensus about it, and that takes time.”

But we have already been discussing a lot of these issues since at least 1978, when Louise Brown was born. If those decades of public debate have not led to significant biotechnology legislation in this country, that is because, as Murray points out, “we live in this inconveniently messy system called democracy.”

President’s Council on Bioethics
Given the history of think tanks’ impact on legislation, it is hard to expect much to result from the efforts of the country’s most senior think tank on biotechnology, the President’s Council on Bioethics.

The council has a lot going against it. For starters, its own general counsel, O. Carter Snead, cannot recall any time in American history when an American think tank’s recommendations have completed the long journey from white paper to law.

Second, the council itself is the butt of much criticism, mostly because of its membership. It was named by President Bush, who opposes cloning and any research that involves embryo destruction. It is headed by Leon Kass, a University of Chicago ethicist who is against cloning and is uneasy with the idea of embryo destruction. The council has 18 members, including doctors and lawyers; most are conservative, but still, they hold varying views on abortion, stem cell research, and cloning.

The council came under heavy fire in February when the White House replaced two members who were both advocates of embryo research and filled a vacant seat. Scientists accused the Bush administration of trying to stack the council with conservatives. Kass responded that the council was merely reconstituting itself to better reflect its upcoming work on neuroscience.

Those wounds are fresh and the arguments are ongoing. However they turn out, one thing is sure: the debate over who should be on the council has dwarfed the importance of the council’s latest report, which includes recommendations on how the United States should regulate cloning and assisted reproductive technologies. The report, Reproduction and Responsibility: The Regulation of New Biotechnologies, was published in March.

Critics say it lacks a lot, and in many respects they are right. For instance, it concentrates on odd possibilities, like the crossing of animals with humans, but does not address here-and-now problems such as the lack of a legal limit for the number of embryos that may be transferred into an IVF patient. “They’re wrestling with Star Trek stuff,” says Caplan.

Still, it is a start. Among other measures, the council’s report calls for bans on reproductive cloning (cloning a human for the purposes of creating a new human); performing research on embryos that are more than 10 to 14 days old; the buying and selling of eggs and sperm; efforts to cross humans with nonhumans; and attempts to patent human embryos.

The council did discuss issues like sex selection and limits on embryo transfer, but did not make recommendations in these areas because they could not unanimously agree, says Snead. However, they did agree to call for long-term studies on how assisted reproductive technologies impact the health of women and their resulting children. If such a study showed that any aspect of in vitro is typically unsafe, the council could recommend banning or limiting those practices.

Unanimity Qualified
Because any issue involving embryos is hugely controversial, the President’s Council on Bioethics made only unanimous recommendations. Nonetheless, the council’s unanimity was diminished by the fact that its members, sometimes as individuals, sometimes as voting blocs, issued a total of 10 “personal statements”—the judicial equivalent of separate opinions—as an appendix to the report, emphasizing their own interpretations of what the recommendations mean.

Some members say the report opens the door for therapeutic cloning—cloning a human embryo for research purposes, such as harvesting stem cells. (Because embryonic stem cells have the capability to grow into any type of tissue, scientists believe they can be used to cure a wide range of diseases.)

Snead disagrees. Readers of the report who think it opens the door to therapeutic cloning are taking “sort of an aspirational perspective,” he contends. He points out that the report specifically says it does not repudiate any of the council’s previous pronouncements. That would include its 2002 recommendations for a ban on reproductive cloning and a ban for at least four years on therapeutic cloning.

Wherever the council’s debates on cloning and stem cell research lead, it is still notable for now that 15 members (one seat was empty and two council members were not involved in final deliberations) with varying beliefs on abortion managed to reach unanimous recommendations on any issues involving embryos.

As in any legislative effort, the consensus was achieved by careful attention to language. For instance, although the members remain at odds on the issue of therapeutic cloning, they want to ban reproductive cloning, which has already been banned in most of Europe.

England banned reproductive cloning by prohibiting the transfer of a cloned embryo into a woman’s uterus. But that rule would be problematic here, because under the current state of technology, if you don’t transfer an embryo into a woman’s uterus, it will die. So if you prevent the transfer of a cloned embryo into a woman, you are in effect ordering its destruction. Anti-abortion advocates would not support that.

The council got around all these concerns with a careful turn of phrase: it suggests a ban on any “attempts to conceive a child by any means other than the union of egg and sperm.” Thus the matter has centered on preventing the creation of certain clones, instead of requiring that they be destroyed. If enacted, this recommendation would ban reproductive cloning, but not therapeutic cloning.

In other words, the council has successfully separated the issues of reproductive and therapeutic cloning. Whatever it may ultimately decide on cloning, the President’s Council on Bioethics has given Congress a tool to consider the issues apart.

That could make it easier for Congress to act, says Caplan. “But it won’t before the election. They’re not going to risk alienating anyone before November.”

Canada’s 15-Year Odyssey
As it turns out, the absence of embryo politics does not necessarily speed up legislation. The Canadians have no laws against abortion. Yet it took them 15 years to regulate this area. Canada’s new Assisted Human Reproduction Act became law this past March.

Ironically, although President Bush’s Council on Bioethics has a conservative bent, its recommendations closely mirror Canada’s new law, which was shepherded by a left-leaning advisory committee. Abby Lippman, who was closely involved with Canada’s legislation for most of the time it was under consideration, was a member of the committee “until I resigned in despair two years ago,” she says. She describes it as “an extraordinary group of people, mostly women, not scientists, not biomedical researchers, [including] a good group of feminists.”

Lippman, who cochairs the Canadian Women’s Health Network, says people have reacted negatively to the council’s recommendations, but she likes what the council has recommended.

We can only hope our process does not take after Canada’s, which got its official start in 1989, when the government formed a royal commission to investigate the issues. The commission heard from experts, patient advocate groups, doctors, and, through a toll-free number, the public at large. After four years it produced a 1,300-page report with 293 recommendations.

At first the report seemed as if it could change Canadian law. A year after it was published, the government announced a temporary, voluntary moratorium on nine reproductive practices. The following year the government introduced legislation to make the bans permanent (by this point the number of banned practices had expanded to 13).

Although the legislation was never voted down, it died several deaths on its way to becoming law, usually because it was still under discussion when Parliament adjourned (when Canada’s parliament adjourns, any bills that have not been decided on are swept aside), or was likewise in limbo during a change of government. Along the way, the bill was rewritten to establish a regulatory agency, and to specify what should be allowed as well as what should be banned. Except for those changes, the thrust of the bill did not substantially change.

Now that the Canadians have ended their 15-year odyssey (until new technology requires new rules), some of them look south and see a lawless nation of “repro cowboys,” as Lippman calls them (though she is quick to add that said cowboys exist worldwide). “Get moving” on passing reproductive technology legislation, Lippman advises the United States. “If you don’t move now, it’s not going to be any easier. It’s only going to get worse.”

The bioethicists interviewed for this article were reluctant to say when the United States might pass its own legislation. No one expects anything to happen before the election. Many guessed it might take five years, but none were willing to bet on it. “I hope we do it more quickly than Canada did,” says Andrews.

Unnatural Selection?
In the early days, the goal of reproductive technology was to produce a baby. Increasingly, genetic engineering is giving intended parents a new goal: producing particular kinds of babies.

With preimplantation genetic diagnosis, or PGD, doctors can test an embryo in a laboratory to learn its gender, and to see if it is likely to develop any one of more than 100 diseases, ranging from those that are apparent at birth, like Down Syndrome, to early-onset Alzheimer’s. In the next five to seven years, the National Human Genome Research Institute expects that scientists will be able to identify the genetic markers for some of our most troubling diseases, including heart disease, stroke, diabetes, and mental illness.

There are nonmedical possibilities, too. If scientists identify genetic markers for traits like intelligence, athletic stature, and musical ability, doctors could also use PGD to evaluate embryos for those traits as well. Ditto for homosexuality.

This undertaking presents many medical, political, and social dilemmas. No one knows the long-term health effects of performing PGD, which requires the removal of one to two cells from an embryo’s six to eight cells. Who gets to decide which traits are desirable? What happens to unconditional love when parents can design their children to order? Will the parents be disappointed if the children don’t live up to the promise of their engineering? How will children feel about themselves if they know they have been engineered?

The resulting legal issues are mind-boggling. Should doctors be liable if PGD test results are wrong? What if the child did not want to be engineered to be an athlete, or a heterosexual, or a homosexual? What if parents decide not to use PGD and give birth to a child with cystic fibrosis? Could they be liable for child abuse? Who will have access to the test results, and will they be used against the child?

Preimplantation genetic diagnosis has an error rate of 1 to 10 percent, depending on the test. But even if it were always accurate, there is no guarantee that selecting for or against certain genes will have the desired outcome. If a child is engineered to be an athlete, he might rather be an actor. Or he might be more likely to suffer injury in a violent sport. What about the fact that some desirable traits, like intelligence, are linked to mental illness? Or suppose we agree that it is generally not a good idea to implant an embryo that will eventually develop deafness and depression. Anti-abortionists like to remind us that if we could have made that decision in Germany in 1770, Beethoven would not have been born.

These technologies pave the way for eugenics. If the child you want to have stands a 50–50 chance of being born with an abnormality, should that child not be born? If individuals with one identifiable gene are statistically prone to deviant behavior, should we deny them the right to life?

Final Frontier
Other biotechnologies that don’t get much press pose additional legal questions. Arthur Caplan points out that we already have the capability to do rudimentary “brain mapping,” which works along the principles of a lie detector. If you show a murder suspect a photo of the murder scene, his brain may produce an involuntary impulse, which can be detected by a machine. Should that be allowed in court?

Enhancement poses other issues. If a law student takes Ritalin to boost her focus before sitting for her bar exam, is she gaining an unfair advantage that results in economic damage to others? “It’s essentially competitive, where you are looking for an advantage over another person whose abilities are otherwise comparable,” says Thomas Murray. “Would we have to institute drug or urine testing at bar exams? Sadly, this is not a fantastical scenario.”

Or suppose there is a new drug with no side effects that could steady a surgeon’s hand. “Most of us would be reassured to know that our surgeon was in fact on that drug, in the same way we’d want to know the surgeon had the best training and the best tools,” says Murray. But then, would surgeons be pushed to take that drug? If they did not, could they be sued for not using the best tools available?

As biotechnology evolves, these questions will multiply. “The longer we delay, the harder it will be to get any type of uniform policies in place and the more we’re going to see idiosyncratic rules or no rules prevail,” says Caplan. If we don’t pass comprehensive legislation, we are “going to find people basically pushing the frontier when they can raise the money to do it,” he adds. “Some people will be doing experiments that the vast majority of the scientific and the policy community would all agree are repugnant.”

Freelance writer Joan Indiana Rigdon is a frequent contributor to Washington Lawyer.
 
 

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