Prepared Witness Testimony: Eibert, Mark Donald

Infertility affects about 12 million adult Americans. Medically, infertility is classified as a disease. Legally, the Supreme Court has declared it a disability under the Americans with Disabilities Act.

And psychologically, infertility is a devastating condition. It interferes with one of the most powerful biological drives every human has. Being diagnosed as incurably infertile is like having all your children die, and all your grandchildren too.

Unfortunately, current reproductive medicine can only help less than half of infertility patients to have biologically related children. Among the millions they cannot help are the many patients who cannot produce viable eggs or viable sperm. For many such Americans, cloning will soon provide the only way possible to have their own biological children.

Many people want to outlaw cloning as a treatment for infertility. But the Constitution won’t allow that. The Supreme Court has ruled many times that every American has a constitutional right to have biological children, and to make all kinds of reproductive decisions without government interference. As the Supreme Court has said, “if the [constitutional] right of privacy means anything, it is the right of the individual…to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child.”[1]

Some people argue, “oh, that only applies to sex. Disabled people who need medical help to have children don’t have the same right to reproductive freedom as healthy people.” But that’s not true. Federal courts have struck down state laws that tried to restrict IVF and similar reproductive technologies as violations of the constitutional right to have children.[2] It is not the means of reproduction that is constitutionally protected, it is the end—the right to have children and families. That’s what the opponents of cloning are trying to deny to disabled Americans.

Other cases prohibit discriminatory laws that deny reproductive freedom to some people but not others. For example, Oklahoma once had a law that required the sterilization of convicted criminals, as part of a broader eugenics program designed to prevent the birth of seriously defective children. But the Supreme Court struck that law down, declaring that the right to “have offspring” was a fundamental constitutional right.[3] This case means that anyone who attempts to ban cloning will have to explain to the courts why infertile people should have less of a right to have children and families than convicted criminals do. For infertile people who can’t have biological children any other way, anti-cloning laws are the practical equivalent of forced sterilization.

In short, the federal government simply does not have the constitutional authority to decide which Americans can and cannot have children, or which children are likely to be “perfect” enough to be born.

Today the FDA claims to have statutory authority to regulate reproductive cloning—a pretty radical claim, since America has never before had a Federal Reproductive Police. However, virtually every lawyer on both sides of this debate agrees that the FDA has no such authority under current law. I would be happy to tell you why during the question period.

Should Congress pass a new law giving the FDA control over reproductive cloning? If you do, what message would you be sending? That reproductive cloning is perfectly acceptable once it is safe? Or that chopping up human embryos for stem cell research—what many members of Congress call “clone then kill”—is acceptable, while “clone then love” is not? But either way, Congress cannot delegate to the FDA powers that Congress itself does not have—like the power to control reproduction.

Finally, there is nobody in the world who cares more about having normal, healthy children than infertile patients and their doctors. Safety is what everyone wants above everything else. That is why infertile people are pro-choice on cloning. Cloning will happen very soon. It will either be done legally in fertility clinics that are already licensed and regulated by the states, or it will be done in illegal underground clinics, like the old back alley abortion clinics. If the federal government denies patients all options except underground clinics, the result will be thousands of dead and deformed children.

Mr. Chairman, the infertile population does not want the government to “protect” them from their own doctors. They want to be left alone to make their own private reproductive, medical and family decisions free from government interference, just like healthy people do.

[1] Eisenstadt v. Baird, 405 U.S. 438 (1971).

[2] As one federal court put it, “within the cluster of constitutionally protected choices that includes the right to…contraceptives, there must be included…the right to submit to a medical procedure that may bring about, rather than prevent, pregnancy.” Lifchez v. Hartigan, 735 F.Supp. 1361 (N.D. Ill.), affirmed, 914 F.2D 260 (7^TH Cir. 1990), cert. denied, 111 S.Ct. 787 (1991).

[3] Skinner v. Oklahoma, 316 U.S. 535 (1942).

MYTHS, MEDICAL BENEFITS AND CONSTITUTIONAL RIGHTS

This article is adapted from a speech and multimedia presentation on cloning given by Mark D. Eibert, Esq., at the annual joint meeting of the San Bernardino County Medical Society, the Riverside County Medical Society, and the San Bernardino County Bar Association, on September 23, 1999. It is being reprinted by the permission of the author, who retains all rights in it. Copyright 1999 by Mark D. Eibert.

Tonight I'm going to discuss three topics. The first is what cloning is, how it's done, what is going on in cloning today, and most importantly, what cloning is not. The second is the potential medical benefits of cloning, especially in the treatment of infertility and the prevention of genetic diseases and defects. My third topic is the current state of the law on cloning, and what constitutional questions those laws raise, especially with respect to reproductive and scientific freedom.

Cloning is a method of producing a baby-whether animal or human--that has almost the same genetic makeup as its parent. In very simple terms, it works like this.

You take an egg, and remove the nucleus, thereby removing nearly all of the egg's DNA or genes. You throw that nucleus away, because you don't need it any more.

Then, you take a nucleus from a cell belonging to the adult parent. (Ian Wilmut used a mammary cell-that's why he named his sheep "Dolly" after Dolly Parton.)

You insert this cell nucleus into the egg, either by fusing the adult cell with the enucleated egg, or by a more sophisticated nuclear transfer.

You then stimulate the reconstructed egg, either electrically or chemically, to trick it into behaving like a fertilized egg-into dividing and becoming an embryo. The embryo is then cultured, and when it reaches the appropriate stage, you transfer it to the uterus of a surrogate mother. There it follows the usual course of any embryo. It becomes a fetus, gestates for the usual time, and is then born in the usual way, looking and acting just like any other newborn of its species. That's how Dolly the sheep was created.

Today Dolly is a normal, healthy sheep, who has had four lambs of her own, one single lamb followed by a set of triplets, all the result of ordinary sexual reproduction.

Now you may have heard that Dolly was born already the age of the sheep that she was cloned from-which is six years old. This assertion is based on an experiment that attempted to measure Dolly's "telomeres"--structures within cells that become shorter with each cell division. But that experiment has been widely criticized for technical reasons (it seems that the telomere measurements were within both the margin of error of the study and the normal variation for sheep), and also because on the same day that Ian Wilmut announced the "telomere problem," the company he works for announced that it had found the solution to the problem-a substance called telomerase.

There is a more fundamental reason not to worry about Dolly's telomeres. If Dolly were really born 6 years old, then she was 9 years old when she had her triplets. Since virtually all Poll Dorset sheep are dead by the age of 9, that would make her the "fertile octogenarian" of sheep. I don't think so. Not only does Dolly show no signs of premature aging, she is doing things-like having triplets-that would be impossible if she were prematurely aged. The truth is that Dolly is a healthy young sheep.

Now, I hate to start with badly outdated science, but before I tell you where cloning is today I need to dispel one of the great cloning myths. People seem to almost universally believe that because it took "277 tries" to make Dolly, that means there were 276 miscarriages or deformed or dead lambs along the road to Dolly. The Washington Post reported exactly that shortly after Dolly was born, and we've been reading it in the newspapers ever since. But that's not true. What really happened is this:

Dr. Wilmut started with 277 reconstructed eggs-eggs that had their nucleus removed and were then fused with an adult cell. That's what the number 277 refers to.

The eggs were then cultured in sheep oviducts, and of the 277, only 29 divided and became embryos. All 29 embryos were transferred to the uteruses of 13 sheep-some got one, some got two, and some got three.

When Wilmut later performed an ultrasound, he learned that only one of the 13 sheep had become pregnant. That pregnancy proceeded normally and produced Dolly. There were no dead or deformed lambs, no miscarriages, and no discarded embryos in this particular experiment.

More importantly, let's put this in perspective-the perspective of fertility treatments involving in vitro fertilization (IVF).

IVF doctors and the federal government measure the sucess rate of IVF clinics by the ratio of live births to uterine transfers. IVF with humans began in 1978, but it wasn't until 1990, after 12 years of worldwide human clinical practice, that the average success rate for IVF in humans got to be as good as one live birth out of 13 uterine transfers the Dolly success rate. (Today the average IVF success rate is about one out of four, but it took 20 years of human clinical practice and research to get it there).

And in the year Dolly was conceived, 1995, the largest IVF clinic in my area, the San Francisco Bay Area, was creating thirty human embryos for every one that made it to the delivery room, compared with 29 for the Dolly experiment.

The only part of the Dolly experiment that was out of line with IVF success rates of either today or the recent past was the large number of eggs it took. It was very inefficient.

But the second cloning experiment to be reported in a peer review journal, the cloning of 50 mice in Hawaii, had an efficiency rate (measured by number of eggs per live birth) that was ten times higher than the Dolly experiment.

The third published adult cell cloning experiment, using cows in Japan, was seventeen times more efficient than the Dolly experiment in terms of the number of eggs needed to get each live birth. Furthermore, if you go back to the measurement of success that IVF clinics use-live births per uterine transfer-the Japanese transferred two embryos into each of 5 cows and ended up with 8 calves-all five cows gave birth to at least one calf, which is better than any IVF clinic in the world can do today.

And cloning has continued with a variety of other species, like goats and pigs. There are now literally hundreds of animals in the world who were conceived through adult cell cloning.

Most importantly, scientists are already using cloning technology to create cloned human embryos. The first cloned human embryo was created by a pair of IVF doctors at a fertility clinic in South Korea. They used the egg and body cells of an infertile woman patient. Unfortunately, they only allowed the embryo to reach the two-cell stage before stopping the experiment.

In addition, a biotechnology company on the East Coast is currently mass producing cloned human embryos for medical research on stem cells. According to BBC-TV, they are producing them in batches of 600 at a time. They use cow eggs to hold the human DNA, but the cloned embryos they produce are quite human.

I'm not saying that cloning is sufficiently developed and safe enough for human clinical use right now. It probably isn't-not just yet. Nor do I advocate trying it before there is evidence of reasonable safety from animal studies.

What I am saying is that cloning is not nearly as dangerous as the press makes it out to be-in fact, when compared with early IVF success rates, the current success rates with cloning look very promising indeed. I'm also saying that the process is improving very rapidly. And most of the scientists involved in cloning research that I talk to report that their success rates are steadily increasing, and that they're optimistic that improvements in efficiency and safety will continue with more research, just as you would expect with any new treatment-just as occurred with IVF and heart transplants, for example.

In other words, if "safety" is your main argument against cloning, you'd better have a backup, because if the current trend of research continues, that may not be an issue for very much longer.

If you've been watching television and movies and reading popular fiction for the last 30 years, you've learned a lot about cloning. Unfortunately, almost everything you learned about cloning was scientifically false.

For example, in "The Boys From Brazil," starring Gregory Peck as the evil cloning expert Dr. Joseph Mengele, you learned-or thought you learned-that cloning could be used to "replicate" Adolph Hitler, and the Third Reich along with him-unless the good guys could stop him in time. They did stop him, but it was a real cliffhanger.

In less serious movies like "Multiplicity" with Michael Keaton, you learned-or thought you learned-that "clones" would be "xerox copies" of the original person, born fully grown and with all the memories and feelings of the original-but if you copied one too many times, it was like making a xerox of a xerox of a xerox, and you might end up with a fuzzy copy, like Michael Keaton number four, the gibbering idiot.

But the problem with these and other cloning fiction is that the whole idea of cloning as copying or replicating people is just plain false. Even the National Bioethics Advisory Commission, which is no friend of cloning, admits that the vision of cloning portrayed by popular fiction is "based on gross misunderstandings of human biology and psychology." Let me explain some of the reasons why.

Yes, children conceived with the aid of cloning technology will be genetic twins-or almost genetic twins-of the person who is the cell donor. But we already have 1.5 million genetic twins walking around the United States. We call them "identical twins" but it would be just as accurate to call them naturally occuring clones.

We know a lot about these natural clones. An entire branch of academia is devoted to the study of identical twins. There is a "Twin Studies" department at Cal State Fullerton, another at the University of Minnesota. Physicians, psychologists, sociologists, people who study family relationships, all just love to study twins. And the one thing we know for sure after decades of research is that so-called identical twins are not identical.

Physically, twins have different fingerprints and different organic brain structures, among many other examples.

Intellectually, twins have different IQ's-a recent analysis of 212 separate studies of twins concluded that genes are only responsible for about 48% of a person's IQ.

And of course, twins have different personalities. If you have ever known “identical” twins you that each member of the pair is a separate and different person. That's why the law and society and everyone who knows twins treat them as unique individuals.

And children conceived with the aid of cloning technology will be even more different from their genetic parents than natural twins are.

Most of their genes will come from the adult cell donor. However, a small percentage of the child's genes will come from the mitochondria of the egg donated for the procedure. This mitochondrial DNA primarily affects how cells process energy. Thus, the child will have almost--but not quite--the same genes as the adult cell donor.

The child will grow in a different uterus. Uterine environment has an enormous impact on many different aspects of fetal development. That's why doctors tell you not to smoke and drink during pregnancy, for example.

Most importantly, these children will be born into different families, have different parents and siblings, go to different schools, have different friends, have different experiences from the day they are born, be raised in a diffferent culture-surfing the web rather than watching "Leave it to Beaver" after school, for example. The nurture part of the nature versus nurture equation will be completely different.

I have a beautiful calico cat named Tribble. What if I used cloning technology to give Tribble kittens-what would they look like?

Interestingly, they would not look like Tribble. Like all calicos, Tribble has patches and splotches of different colored fur-black, orange and white. If I cloned Tribble, the kitten would also have patches of different colored fur-but they wouldn't be the same size or shape or location as they are on Tribble. Where Tribble has a mostly black back with a few patches of orange fur, her cloned kitten might have a mostly orange back with patches of black. Instead of a face that was half black and half orange, like Tribble, the cloned kitten's face might be all one color. And so on.

The reason for that is a phenomenon known as "random inactivation of the X chromosome."

Chromosomes are structures that carry genes. The X chromosome of a cat, for example, has about 5,000 genes on it. Male mammals-humans and tomcats--have one X chromosome and one Y chromosome. Female humans and cats have two X chromosomes-they inherited one from their mother and the other from their father, so the genes on the two X chromosomes are all different.

What happens when you have two sets of blueprints for the same 5,000 genetic traits in the same mammal? Which one gets used? Well, nature decides in a very fair way. Randomly. In every cell in Tribble's body, one of the two X chromosomes is switched off. And which of the two is switched off-the one from mom or the one from dad--is completely random.

What genes are on the X chromosome? Well in cats, the genes that determine fur color are among those located on the X chromosome. The reason that the patches and splotches of color on a calico's coat look random is because they are random, thanks to random inactivation of the X chromosome. In other words, you can make a million clones of Tribble, and not one of them will look exactly like Tribble, or exactly like any of the other Tribble clones. Although it wouldn't be as visual and dramatic, the same principle would apply to humans.

A related concept, called gene expression, would also apply equally to male and female "clones." Basically, two identical twins could have the same gene, but they might express that genetic trait differently-or one might not express it at all. That's because whether and how a specific genetic trait or characteristic is expressed depends on very complex interactions both among genes and between genes and the environment. People who have all the same genes can and do turn out differently, even with respect to genetic traits.

My final example is Chang and Eng Bunker. They were the original "Siamese Twins," what we now call conjoined twins. They were joined at the chest, and they shared one liver between them.

Chang and Eng were identical twins, with identical nuclear and mitochondrial DNA. They grew in the same uterine environment. They were born at the same moment. They had the same parents and family. And from the moment they were born, they had as close to the same experiences-as close to the same nurture in the nature versus nurture sense-as any two humans could possibly have. When they got married, they even married sisters.

In spite of all that, Chang and Eng turned out to have radically different personalities.

Chang was an alcoholic, a moody introvert who hated people and was verbally and physically abusive.

Eng was a lifelong teetotaler, an extrovert who loved parties and children and was generally liked by everyone who knew him-everyone who could stand being around Chang long enough to get to know him.

But enough examples. The point I'm trying to make is this: anybody who thinks their child conceived through cloning technology is going to be a little copy of himself is going to be hugely disappointed. You can't copy or replicate a human. That is scientifically impossible, even with cloning.

The truth is this: children conceived with the aid of cloning technology will be ordinary children who will grow up to be unique individuals, just like everyone else.

Once you understand that scientific fact, over 90 percent of the arguments-including most of the "ethical" arguments--against human cloning evaporate like fog when the sun comes up.

Of course you can't replicate Hitler, or an army of Arnold Schwartzeneger soldiers, or a factory full of compliant zombie workers. Cloning by itself has no more potential to do those things than IVF does.

Nor are the children going to be burdened or restricted by how they were conceived. These children will not be freaks leading second-hand lives; they will be unique individuals who have as much of an open future as anyone does. And there is no scientifically valid reason for these children to think of themselves as mere copies, or to be treated like copies by anyone else, or to be psychologically harmed by such an absurd thought.

Now we're ready to answer the next question: who in their right mind would want to be "cloned"?

Now that you understand that cloning has nothing to do with copying people, you can eliminate dictators, narcissists, megalomaniacs, ruthless employers, people who want to bring Hitler or Christ or Elvis back to life, and so on. There's nothing in cloning for them. People like that will find cloning totally useless.

The only thing cloning is really good for is building families, families composed of genetically related but unique individuals-a lot like the families we have now.

And the largest group of people who would be interested in that, once the technology is reasonably safe, is infertile people. About 10 to 15 percent of the population is infertile-physically unable to have children.

Medically, infertility is classified as a disease, according to the American Society for Reproductive Medicine and the American College of Obstetricians and Gynecologists.

Legally, infertility is a disability-the kind that entitles people to protection from discrimination under the Americans with Disabilities Act. That's based on both a recent U.S. Supreme Court case called Bragdon v. Abbott and on a recent decision of the EEOC in New York.

Psychologically, infertility is a devastating condition. It frustrates a basic and very powerful biological drive, one that is an intimate part of the will to survive. One analogy that you hear over and over again from infertile people is that learning that you are incurably infertile is not like having your child die. It's like having all your children die, and all your grandchildren as well. Infertile people are so motivated to find a cure that many of them spend year after year undergoing painful and expensive treatments that are not covered by health insurance and that, for many of them, have a very low chance of success.

Now everybody knows that in vitro fertilization (IVF) is one way that infertility is treated. The first so-called "test tube baby," Louise Brown, was born in 1978. She's a college student now.

But IVF doesn't work for everyone. For a 21 year old woman who's infertile because of blocked fallopian tubes, IVF will probably be a miracle cure. But for a woman who can't produce viable eggs or a man who can't produce viable sperm, IVF isn't much help. To get a good embryo out of the dish, you have to put good ingredients into the dish. There are literally millions of women who can't produce viable eggs no matter how big a dose of fertility drugs you give them-that's why they're infertile.

What makes cloning so revolutionary as an infertility treatment is that it does not require the patient to produce viable eggs or viable sperm. If they can spare a few cells scraped from the inside of their cheek, they can have genetically related children.

Now for a little historical footnote: twenty years ago, when the idea of IVF was first being discussed, most people had a strong visceral reaction against the idea of "manufacturing babies in test tubes." At first they thought it was weird and disgusting and it reminded them of "Frankenstein." And there was a debate about whether so-called "test-tube babies" should be outlawed.

All the same arguments now used against cloning were used against IVF. IVF would be "unsafe," the babies would be born deformed or with birth defects, they would be psychologically harmed when they found out that they were only "test-tube babies" rather than "real" babies, family structures and relationships would be radically altered, and so on. Part of the reason the arguments were the same is that the people making them were the same-some of the current leaders of the anti-cloning movement were also leaders of the movement to outlaw IVF 20 years ago. And before Louise Brown was born, 85 percent of the American public agreed with them and thought that IVF should be outlawed, which is about the same percentage that think cloning should be outlawed today. If you know your history, this cloning debate is just what Yogi Berra called "déjà vu all over again."

But then along came Louise Brown, the world's first "test-tube baby," whose face graced the front pages of almost every newspaper in the world for awhile. People looked at those pictures and said "that just looks like an ordinary baby, ten fingers, ten toes, mom is grinning from ear to ear--what's so terrible about that?" And the movement to outlaw IVF faded away.

Today it's 21 years later. The public has forgotten its horror and now accepts IVF, which so far has brought children, families and happiness to over 150,000 disabled couples. And we now know that all the arguments against IVF were wrong. The same thing will happen with cloning. And it will happen a lot sooner than most people expect.

The second biggest group of people who will be interested in the use of cloning to create children is people who know, from family history or genetic testing or counseling, that they have a high risk of producing children with serious genetic diseases or defects.

As explained by Dr. Lee Silver in his excellent book “Remaking Eden: Cloning and Beyond in a Brave New World”, the vast majority of genetic diseases and defects are caused one of two ways. The first is errors that occur during meiosis, which is part of the process of sexual reproduction. These types of errors cause problems like Down Syndrome.

The second major way to get a serious genetic disease is by inheriting it from a parent who is a carrier. That's how children get born with such serious and often lethal conditions as Tay Sachs disease, sickle cell anemia, cystic fibrosis, hemophilia, and so on-there's a long list of horribles.

Cloning should make all of these kinds of diseases and defects extremely rare, if not impossible. There is no reduction of genetic material in cloning, so there is no opportunity for the kinds of errors that cause Down Syndrome to occur.

And a child conceived with the aid of cloning technology shouldn't get a genetic disease that his genetic parent didn't have-if the parent is a carrier the child will be a carrier too, but he typically won't actually get the disease.

For a lot of people who are at risk of having seriously ill or defective children, cloning technology may soon be a safer way to have children, and a more certain way of having normal, healthy children, than sex is.

So-called "reproductive cloning" isn't the only medical use of the technology. There are also some exciting and important medical uses that don't require the production of whole human beings.

For example, cloning could be used to create embryonic stem cells, which could be used to make tissues, and perhaps even organs, for transplant. Not only would this relieve the serious shortage of tissues and organs for transplant, but if you use cells from the patient who needs the tissue or organ, you could virtually eliminate the danger that the patient's body would reject it. Examples would include creating bone marrow for transplants for leukemia victims, islet cells to return to the pancreas of a diabetic, heart or liver tissue to repair the damage caused by heart attacks or hepatitis, healthy skin for grafts to burn victims, and so on.

Cloning can also be used to create animals that excrete therapeutic human proteins, like insulin, in their milk. You do this by inserting selected human genes into animal embryos during the process of cloning, thereby turning cows into walking drug factories providing an endless supply of cheap and plentiful human medicines. This is already being done.

Cloning may even help to find a cure for cancer by teaching us how to reprogram cells. Cancer cells grow uncontrollably; perhaps they could be reprogrammed.

These are just a few examples of the many exciting medical breakthroughs that should be possible with cloning technology.

Now let's talk about law. What is the current state of the law about human cloning?

First of all, by Executive Order signed by President Clinton, you can't use federal funds for human cloning research. But since there's already a ban on the use of federal funds for embryo research, that doesn't add very much-it was a purely political gesture.

Beyond that, human cloning is currently illegal in three-and only three--states.

California is one of the three, with a moratorium on using cloning to create a child that automatically expires after five years (about 3 years from now). In the meantime, the penalty for using cloning to create a child in California is a fine of up to $1 million for an organization and $250,000 for an individual-it's not at all clear that the fine wouldn't apply to the patient as well as the doctors involved-and the doctor could lose his medical license. Rhode island has a similar law, also with a five year sunset clause. Michigan has an even more radical law, which permanently outlaws not just the conception of children, but also the creation of cloned embryos for laboratory research on, say, curing diseases. The penalty is up to 10 years in prison, and that applies whether you are a laboratory researcher trying to cure cancer, a doctor helping an infertile patient, or an infertile woman who uses cloning to have children.

Human cloning is legal in the other 47 states. It's also legal in most countries, Western Europe being the major exception.

And there is no federal law on cloning. Last year, Congress debated various anti-cloning bills, but they got bogged down in a debate over abortion and couldn't agree on a law. The Republicans wanted a Michigan-style law forbidding the creation of all cloned human embryos. The Democrats filibustered that because it would end almost all cloning research and prevent the technology from being used for all the important non-reproductive medical purposes I mentioned. They proposed a law more like California's, but the Republicans wouldn't go along with it because they thought it was the moral equivalent of abortion-"clone then kill" they called it. Of course, both sides wanted to outlaw "clone then love," but because they couldn't agree on the "clone then kill" issue they fought themselves to a standstill and no law got passed. And now it seems very unlikely that they will be able to agree on a federal law anytime in the forseeable future.

The last piece to the legal puzzle is kind of confusing. When it became clear that Congress couldn't agree on a law, the Food and Drug Administration announced that it had authority to regulate cloning. Not to ban it exactly, but to make researchers go through a lot of hoops to prove to the FDA that cloning is safe and effective before they use it on patients.

What's confusing is that nothing in the Food, Drug and Cosmetics Act or any other piece of relevant legislation gives the FDA jurisdiction over cloning or anything that could even arguably include cloning. As most doctors know, the FDA has no authority to regulate the practice of medicine, and as one of the most vehemently anti-cloning members of Congress (Rep. Ron Ehlers) put it, "it's hard to argue that a cloning procedure is a drug." Moreover, the FDA has for years totally ignored reproductive medicine, including procedures like ICSI and cytoplasm transfer that have a lot in common with cloning.

So far, I have yet to find a lawyer on either side of this debate who thinks the FDA really has statutory authority to regulate cloning, and when I called the FDA myself to find out what statute they were relying on, even they couldn't tell me.

So that's the state of the law. Human cloning is legal in 47 out of 50 states, and in about 175 of 200 countries, and the FDA may or may not be able to enforce safety and efficacy standards. The courts will have to decide that.

What I personally find most interesting about this topic is the profound questions raised by anti-cloning laws.

Can the state really ban cloning? I'm going to suggest that under current constitutional principles, it probably cannot.

Let's start with a few highlights of the legal arguments of infertile people for whom cloning technology, once it's reasonably safe, will be the only way possible to have biologically related children and families.

Reproductive freedom means a lot more than just the right to an abortion. The Supreme Court has said many times that every American has a constitutional right to have children, and to make all sorts of reproductive decisions without government interference. That right stems from the constitutional right to privacy, because reproductive decisions are some of the most private and personal and life-changing decisions an individual can make.

The statement that is quoted over and over again in cases discussing reproductive freedom comes originally from a Supreme Court case about the right to contraception, Eisenstadt v. Baird. There the Supreme Court said that "if the right of privacy means anything, it is the right of the individual, married or single, to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child."

Now, some people argue, "that only applies to sex. People who need high-tech medical help to have children don't have the same right to reproductive freedom that healthy people do." Well there isn't a lot of case law on that yet, but what there is says just the opposite.

In 1990, for example, the state of Illinois tried to outlaw a variety of reproductive technologies and tests, some of which were related to IVF and could be used to treat infertility. In a decision that was later affirmed on appeal, a federal district court struck down that law, explaining that "[i]t take no great leap of logic to see that within the cluster of constitutionally protected choices that includes the right to have access to contraceptives, there must be included within that cluster the right to submit to a medical procedure that may bring about, rather than prevent, pregnancy."

So it looks like you have a constitutional right to high-tech baby-making too, at least if you're infertile. And notice the progression. In 1978, 85 percent of the American people thought "test-tube babies" were terrible and ought to be outlawed. Just 12 years later, in 1990, courts were starting to rule that IVF was a constitutional right. But the right to privacy isn't the only constitutional principle that protects people from government interference with their reproductive decisions. There's also equal protection-the principle that you can't deny basic rights to some people and not to others without a very good reason.

In 1942, for example, the state of Oklahoma had a law requiring the sterilization of convicted criminals. It was a eugenics law, based on the idea that criminal tendencies could be passed down genetically to children.

The Supreme Court analyzed the case under the equal protection clause of the Fourteenth Amendment, and unanimously ruled that "procreation involves one of the fundamental rights of man" and that even a convicted criminal who is sterilized "is forever deprived of a basic liberty."

Because the Oklahoma law affected a fundamental constitutional right-which the Supreme Court described as the "right to have offspring"--the court applied what is known as "strict scrutiny." That means that the Supreme Court placed the burden of proof on Oklahoma to justify its discriminatory law. And strict scrutiny is the highest and toughest burden of proof there is. The state couldn't carry that burden, so the Supreme Court struck the law down. There are a number of other more recent cases that reaffirm that having children is a fundamental right and that laws that interfere with that right are subject to strict scrutiny.

This is my favorite reproductive freedom case because it means that sometime soon-certainly before the current anti-cloning law sunsets-lawyers for the state of California will have to explain to a court, under a strict scrutiny standard, why legally disabled citizens should have less of a right to have children and families than convicted rapists and child molesters do.

The case I just told you about struck down a state "eugenics law." Oklahoma was just one of 36 American states that passed eugenics laws in the early part of this century. Those laws required the sterilization of people who were thought likely to produce seriously defective children. People with leprosy and other dread diseases, mentally retarded people, mentally ill people, habitual criminals and others were sterilized, mostly because the best science of their day said that such people would probably produce children with the same defects.

Supporters of eugenics laws argued that they were necessary to protect the safety and welfare of children. It was said to be in the best interests of children who might be born with defects that they never be born at all. It wasn't until the Vietnam war that our military came up with an accurate characterization of this brand of logic-it's called "destroying the village in order to save it."

The most successful-if you want to call it that--state eugenics law was California's. During the early part of this century, our state government rendered more than 30,000 of its sick and disabled citizens unable to have children. So when the Nazis were drafting their own eugenics law, they modeled it in part on the eugenics law that came out of Sacramento.

But during World War II, Americans got a graphic demonstration of what politicians could do when given the power to decide who was and was not "perfect" enough to be born, and attitudes about eugenics began to change. By the 1960s almost all of our state eugenics laws had either been repealed, struck down as unconstitutional, or fallen into disuse, and states got out of the business of regulating their citizens' reproduction.

Until now. Two years ago, California passed the first anti-cloning law in the nation. Once again, the state of California has singled out a class of disabled Californians and forbidden them by law to have children. Once again, the state has defined a class of children that it says are so likely to be born "imperfect" that the state won't allow them to be born or to live at all. Once again, California has a reproductive police charged with stopping unauthorized breeding by California citizens. Once again, the politicians in Sacramento have a chance to play God. And once again California has a eugenics law.

What our legislature has done is radical all right, but it's not unprecedented. We've been here before.

Reproductive freedom isn't the only constitutional value that anti-cloning laws infringe on.

For instance, there's a lot of Supreme Court dictum to suggest that scientific freedom might have some constitutional protection, and some lower courts and about a million legal scholars have said that scientific freedom does or should have constitutional protection. That protection is based on the First Amendment right to free speech. In science, it's not enough to argue for your theory, or to publish your theory. You and others-including those who disagree with you-have to be able to test your theory through experimentation. That's how science works and how it finds the truth.

Now the Supreme Court hasn't directly addressed that question yet. But cloning may not be such a bad case to try to determine the extent of constitutional protection for science. After all, as one member of the National Bioethics Advisory Commission observed, anti-cloning laws like California's moratorium are the first time in American history that an entire field of medical research has been outlawed. That's a very radical thing to do. And in Michigan today, a scientist who clones cells in a dish to try to find a cure for cancer can get up to 10 years in prison-that's even more radical. In Michigan, the ACLU is considering challenging their anti-cloning law on both scientific freedom and reproductive freedom grounds, and perhaps we will get some new case law on scientific freedom as well.

Now I want to conclude by telling you that I think there is only one question of lasting social significance that cloning presents to us. That question is this: Who Decides?

Who should decide whether and how a particular individual can have children-the individual, or the government?

Who should decide which classes of children are likely to be perfect enough, or happy enough, or socially desirable enough, or politically popular enough, to be born-the prospective parents or the politicians?

Who should decide which treatment is medically best for a particular patient, the physician acting with the informed consent of his patient, or the bureaucrat? Aren't doctors regulated enough already? Do they really need to have the reproductive police looking over their shoulder along with everyone else?

Who should decide how much risk is acceptable for a prospective mother and her unborn child, the mother, with the advice of her physician, or the legislature, making one risk-benefit calculation for all patients at all times, no matter what their personal medical condition is, no matter what their personal religious and moral beliefs may be, and no matter how the technology may have changed during the three or five years since the politicians last debated appropriate treatment protocols? You know, for 200 years American women have been free to make decisions that pose much greater risks to their unborn children than cloning possibly could.

And who should decide what subjects scientists can investigate, or what truths the general public is ready for them to uncover--the scientist or the platform committees at political conventions?

If the word "copy" is the scientific fallacy of the anti-cloning argument, the word "we" is the legal fallacy. The opponents of cloning are always wringing their hands and asking what should "we" do about cloning, and whether "we" should allow it. But “we” don't decide whether John and Mary Smith can have children, they do. That's a private decision, not a political one. And I don't think there is anything so horrible or horrifying about twins that would justify changing that.

This question--"who decides"-is the real heart of the cloning debate. And the Constitution, supported by over 200 years of American tradition and culture, permits only one answer.