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Mr. Chairman, I am
a patient advocate. I speak for a
group that is otherwise not represented at this hearing--the infertile
population.
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.”
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. 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. 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.
Thank you. I would be happy to take your questions.
HUMAN CLONING:
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.
What
Cloning Is And How It Is Done.
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.
Where Cloning Technology Is Today (September 1999).
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.
What Cloning Is Not-The "Xerox Copy" Myth.
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.
But even
that's not all.
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.
In other
words, every "clone" is different.
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.
Medical
Uses Of Cloning.
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.
Cloning and the Constitution-The State of the Law.
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.
Constitutional
Rights: Reproductive Freedom.
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.
Now it's time for a second historical
footnote, a legal one this time.
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.
Scientific
Freedom and the First Amendment.
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.
The REAL Question.
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.
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