The Many Faces of Human Cloning
Lori B. Andrews
J.D.
Professor, Chicago-Kent College of Law
Chairman, Institute on Biotechnology
and the Human Future
First, let me thank you for the great honor of inviting me to speak at this incredible institution, one of the true birthplaces of knowledge. I am humbled to be at this spectacular library at Alexandria because of the thousands of years of Egyptian knowledge that it represents. Since the dawn of recorded history, Egyptian scholars have played a pivotal role in the development of all the disciplines from mathematics to art, from astronomy to medicine. And today Egyptian religious leaders are playing a major role in the international discussion that is occurring over the prospect of human cloning. (I've represented this by the photo of the library on one part of the slide and a photo of a human embryo on the other.)
In the course of your extensive tribute to the half century of genetics since the discovery of the chemical makeup of DNA, you have listened to notable speakers describing the scientific aspects of genetics and the social implications of such technologies as genetic testing to predict future disease. Here, for example, next to the library at night are human embryos being genetically tested for certain chromosomal abnormalities. Just like the ancient maps , we now have a genetic map of the entire set of 30,000 genes that make up the human body. But it will be up to people like those of us in this room to think about where we want that genetic map to lead -- and whether certain applications of genetics should be forbidden, such as human reproductive cloning or genetically engineering human babies to have enhancements, such as greater intelligence or the running speed of a cheetah. Top of Page
A few years ago, a store opened in a shopping area in California. The store, called Gene Genies Worldwide, said it offered “the key to the biotech revolution's ultimate consumer playground.” It sold new genetic traits to people who wanted to modify their personalities and other characteristics.
The boutique was filled with the vestiges of biotechnology -- petri dishes and a ten-foot model of the ladder-like structure of DNA. Brochures highlighted traits that studies had purportedly shown to be genetic: creativity, conformity, extroversion, introversion, novelty-seeking, addiction, criminality, and dozens more.
Shoppers initially requested one particular trait they wanted changed, but once they got into it, their shopping lists grew. Since Gene Genies offered people not only human genes, but ones from animals and plants, one man surprised everyone by asking for the survivability of a cockroach.
The co-owners were thrilled at the success of their endeavor, particularly since none of the products they were advertising were actually yet available. Despite their lab coats, they were not scientists, but artists attempting to make a point, striving to serve as our moral conscience. “We're generating the future now in our art and giving people the chance to make decisions before the services actually become available,” said one of them.
So it's not just scientists or lawyers or bioethicists who are thinking about these issues, but artists as well. Artist Daniel Lee does digital photos to indicate what men would look like if merged with animals , but that is nothing new here.
Today, I am going to talk about the coming applications of genetics in a variety of realms, from cloning to germline interventions. Egypt cares greatly about its pharmaceutical and biotechnology industries and, like many nations around the world, is struggling with questions about how to encourage appropriate new technologies that can benefit its population and the economy, while, at the same time, not creating serious risks to individuals and to cultural values. As I prepared for this presentation, I learned that many of laws of Egypt are better than those of the United States in achieving the necessary balance between encouraging innovation in health care and yet fostering the public health. Top of Page
Cloning—
It's amazing that we are here today, in part, because of the birth, in a small town in Scotland, of a sheep named Dolly. She was cloned through a technique called somatic cell nuclear transfer. Researchers isolated a cell from breast tissue from an adult female sheep. Next, they transferred the nucleus from that cell to an egg cell from which the nucleus had been removed. After a couple of chemical tweaks, the egg cell, with its new nucleus, was behaving just like a freshly fertilized zygote. It developed into an embryo, which was implanted into a surrogate mother and carried to term.
More recently, researchers announced another potential use of cloning, therapeutic cloning. In South Korea , scientists cloned human embryos so that they could produce embryonic stem cells from the embryos. Such stem cells are valuable because they can potentially be used to grow any sort of cell in the body. They can be manipulated into growing into nerve cells, heart cells, lung cells, and other regenerative materials. But the process destroys the embryo, which otherwise could have been implanted to create a child.
Both reproductive cloning and therapeutic cloning start out with the creation of a human embryo out of the genetic material of an existing person. With reproductive cloning, that embryo is put in a woman's womb for the creation of a child.
With therapeutic cloning the embryo is not brought to term. After a short period of time, the stem cells are removed for research, with the hope of progress that could help those suffering from diabetes, Alzheimer's, and other ailments.
Now, countries around the world, including Egypt, are debating whether either reproductive cloning or therapeutic cloning should be allowed. This has become a matter of international importance. In the United States, one of the raging debates that will determine the outcome of our presidential election next November concerns the fact that President Bush opposes therapeutic cloning and widespread embryo stem cell research and his opponent, presidential candidate Senator John Kerry would allow those techniques. At the United Nations last year, the delegates were asked to vote on whether or not to ban cloning. A group led by Germany and France suggested banning only reproductive cloning. A group led by Costa Rica and the United States recommended banning both reproductive and therapeutic cloning.
However, it was a fatwa from the Eygptian religious authority Ahmad al-Tayyib, written while he was in the Ministry of Justice in Cairo , that influenced the international debate. He argued in that fatwa that reproductive cloning should be prohibited but therapeutic cloning should be allowed under Islamic law. He analogized to organ transplantation, which was permissible to save or greatly improve the quality of a life.
As a result of his opinion and the related discussion of it among Muslim authorities, the representative of the Organization of the Islamic Conference (OIC) in the United Nations suggested postponing the U.N. vote -- and a majority of delegates agreed. Thus, international deliberations are still underway to determine what to do with these new technologies. Top of Page
The first week in October the African member States of the WHO Regional Office for the Eastern Mediterranean will meet in Cairo to deliberate on cloning.
Currently, countries differ in whether their own national laws forbid cloning. You can look on our website www.thehumanfuture.org to get the latest data. Here is how the countries break down currently.
If a ban on creating human beings through cloning is appropriate, then an international treaty would be needed. Otherwise, a person desiring to be cloned could just fly to another country to use the technology.
That is what happens with surrogate motherhood, in which an infertile couple pay a woman to gestate the couple's embryo. This is banned in many countries, but not the United States. So the United States has become a site of “reproductive tourism” where people from other nations fly to the U.S. to contract with surrogate mothers or to use paid egg donors or sperm donors. In fact, there are ads in newspapers in the US offering as much as $100,000 to smart, athletic women for the donation of eggs.
I got involved in this issue shortly after the birth of Dolly the sheep, when President Clinton's newly-formed National Bioethics Advisory Commission called me for a legal opinion on human cloning. In its human application, cloning would be a means to create later-born twins of an individual who is living or has already lived.
What are the situations in which individuals might decide to create a child through cloning? If both members of a couple are infertile, they may wish to clone one or the other of themselves. If one member of the couple has a genetic disorder that the couple does not wish to pass on to a child, they could clone the unaffected member of the couple. In addition, if both husband and wife are carriers of a debilitating recessive genetic disease and are unwilling to run the 25% risk of bearing a child with the disorder, they may seek to clone one or the other of them. This may be the only way in which the couple will be willing to have a child that will carry on their genetic line.
Even people who could reproduce naturally may desire to clone for a variety of reasons. People may want to clone themselves, deceased or living loved ones, or individuals with favored traits. A wealthy childless individual may wish to clone himself or herself to have an heir or to continue to control a family business. Parents who are unable to have another child may want to clone their dying child. This is not unlike the current situation in which a couple whose daughter died is making arrangements to have her cryoperserved in vitro embryo implanted in a surrogate mother. Top of Page
Additionally, a person with favored traits could be cloned. Respected world figures and celebrities have been suggested as candidates for cloning. Less well-known individuals could also be cloned for specific traits. For example, people with a high pain threshold or resistance to radiation could be cloned. People who can perform a particular job well such as soldiers, might be cloned. One biologist suggested cloning legless men for the low gravitational field and cramped quarters of a space ship.
When I was asking to give a legal opinion on reproductive cloning to the U.S. government, I rapidly began to think of human reproductive cloning as the Bill Gates problem. If a wealthy individual like billionaire Bill Gates, the head of Microsoft, wanted to clone himself -- perhaps creating Bill Gates 5.0, 5.1, and 6.0 -- would any existing law stop him?
I called embryologist Don Wolf at the Oregon Primate Center who had just cloned two rhesus monkeys using embryonic cells, rather than the adult cells used for Dolly. In addition to his research with chimps, he worked with patients in a human IVF clinic. I asked Wolf how much he thought it would cost for the equipment and personnel necessary to clone a human. “About a million U.S. dollars,” Wolf said – about 6 million Egyptian pounds.
As I reviewed existing laws, I saw that there was nothing in the United States law to stop the truly rich from cloning, themselves, their departed loved ones, or celebrities. The United States has over 300 in vitro fertilization clinics, and at least half of the clinics have the equipment and personnel necessary to undertake human cloning.
There are over 40 IVF clinics here in Egypt as well that would be capable of human cloning. Many IVF clinics offer a procedure known as “intracytoplasmic sperm injection,” or ICSI, in which an embryologist uses a microscopic pipette to inject a single sperm into a woman's egg. Clinics use ICSI to treat infertile couples when the man has a low sperm count. But clinics could easily adapt ICSI to clone humans by injecting nucleic DNA from an adult's cell into an egg from which the nucleus has been removed -- the method used to create Dolly and the cloned mice.
Nor are there any clear laws to prevent Bill Gates from being cloned against his will. What if Gates' barber used DNA from hair follicles to create a Gates clone -- and then sued Gates for child support? Under current law, people have little right to their body tissue and genes once these materials leave their body. In Moore v. Regents of the University of California , a patient's doctor, allegedly without his knowledge or consent, used the patient's unique tissue to develop a cell line worth an estimated $3 billion dollars. The court found that the patient had no right to a share of the proceeds, which could lead to a snip-and-run industry of cloning from stolen bits of celebrity hair. (Already, Nobel Laureate Kary Mullis is marketing jewelry with celebrity DNA in it -- why not a human replica?) Top of Page
Even if Gates intended to clone himself, to hold power in his company or create a worthy heir, he might not be recognized by law as the legal parent. In some states in the United States, the legal parents would be Gates' parents and the clone would be his brother. In two other states -- North Dakota, and Utah -- if the twin were gestated by a surrogate mother, the child would be considered the legal offspring of the surrogate and her husband, even though she had no genetic connection. Gates would be a legal stranger to the child.
How Should Cloning Be Assessed?
Any nation that is considering regulating human cloning must find a way to assess its potential benefits and harms in relation to its own values. The methods that each country uses to make that assessment vary. In Canada, for example, a Royal Commission was chartered to recommend policies governing genetic and reproductive technologies as a whole. The commission used a variety of innovative methods to address these issues. They instituted a free phone line so that citizens could detail their own experiences with these technologies and express general opinions. In order to assess the values that defined Canadian life, they sought research and analysis from representatives of 70 disciplines on such topics as the psychological and social impacts of infertility, assisted reproduction, human zygote research, genetic testing, and the use of fetal tissue. The Commission determined that Canadian social values stressed non-commodification and non-objectification, as well as protection of the vulnerable. This led to the recommendation of bans on paid surrogate motherhood, genetic enhancement, sex selection for non-medical purposes -- and human cloning. In recent months, the Canadian Parliament enacted bans on both reproductive and therapeutic cloning.
In the United Kingdom, the Human Fertilization and Embryology Authority, through a licensing system, determines which types of reproductive technologies are permissible and which clinics should be allowed to perform these technologies. Therapeutic cloning is allowed in Great Britain.
Many of you at the conference may be helpful in determining what Egypt's position on cloning will be. I am timid about even attempting to predict how Islamic values will be brought to the question of cloning. From what I understand, A the pursuit of knowledge, including scientific inquiry receives a divine warrant in Islamic thought. @ I understand that the Islamic Code of Medical Ethics A portrays the pursuit of knowledge as worship of God. @ Science A can reveal the intimacies of God = s creation and will to humanity. @
Islamic values also focus on preserving spousal, procreative, and parenting relationships, and object to use of third party gametes by infertile couples. This would suggest that a different analysis might be necessary if a couple clone the husband or wife versus if the couple use somatic material from another individual, such as another relative or celebrity. Top of Page
Some Islamic leaders express concern about how reproductive cloning could A jeopardize the very foundation of human community, namely a religiously and morally regulated spousal and parent-child relationship under the laws of God. @
Cloning is not the only biotechnology that raises complicated issues. Consequently, I would like to advocate a way of assessing each new technology. I would ask the following questions:
- What are the risks of the technology and how will it be regulated?
- What are the individual impacts of the technology?
- How will social institutions use the technology?
- How will the technology be distributed?
- How is the technology being funded?
- Who benefits, and who loses, from applications of the technology?
- What are the cultural implications of the new technologies?
I'll address each of those questions, and give some examples.
What are the risks of the technology and how will it be regulated?
Human reproductive cloning – 1/3 of animals die shortly before or after birth. Some of the mother animals die, too.
Let's just explore the risks of another technology -- germline genetic interventions. Princeton . “Doogie Howser” mice which seemed to move more quickly through mazes than the mice that had not been altered. Immediately, the question arose about whether such interventions should be undertaken on humans. Yet subsequent research, by other scientists, learned the genetic intervention had a downside. The Doogie Howser mice were more susceptible to long-term pain.
Animal studies indicate that g ermline genetic intervention on people may increase cancer risks, sterility, or other problems in the next generation. Proponents of genetic engineering of animals and humans suggest that it is no different than selective breeding. But geneticist Jon Gordon points out there are enormous differences when only a single gene is being introduced in a complex organism. Gordon notes that unlike selective breeding, where favorable alleles at all loci can be selected at one time, gene transfer selects only one locus and tries to improve the trait in isolation. Gordon notes that this single-gene approach has, “despite more than 10 years of effort, failed to yield even one unequivocal success.” Instead it has produced disastrous results. When a gene shown to induce muscle hypertrophy in mice was inserted into a calf, the animal did exhibit the desired trait initially, but later exhibited muscle deterioration. The animal had to be shot. Top of Page
What are the individual impacts of the technology ?
Genetic testing can change self concept. Breast cancer tests. Time bomb ticking away inside of me.
How will social institutions use the technology?
Genetic testing -- insurers and employers have used. Discrimination of African-Americans with sickle cell carrier status and men in Sardinia
How will the technology be distributed?
Therapeutic cloning and human gene therapy have been proposed for a variety of disorders, including even enhancement of humans. But these technologies would cost over 600,000 Egyptian pounds to use. Who would be able to pay for that? In the United States, there is no way that most people would have access to those technologies or that insurers would fund them.
How is the technology being funded? Who benefits, and who loses, from applications of the technology?
There are major ethical, legal and social issues, warranting public attention and journalistic coverage related to the intellectual property issues with respect to new biomedical technologies. One arises from the fact that the “bio” in biomedical engineering comes from living organisms, such as plants and people, bacteria and animals. And, in many instances, it seems odd for someone to be able to patent an existing biological organism or biological process.
The framers of the U.S. Constitution realized two centuries ago that it was important to create incentives for technological innovation. This is very similar to the privileged status of scientific inquiry in the Muslim world.
There are now international patent law rules under treaties which Egypt has signed. Under those rules, we reward inventors with a 20 year monopoly that forbids anyone else from making, using or selling their invention in order to make sure that novel , non-obvious and useful technologies get developed that otherwise might not have been created.
Scientific principles -- such as E=mc 2 -- are not patentable so everyone will have access to them. At the same time, patents are allowed on particular inventions, nuts-and-bolts applications of those ideas. When Samuel Morse convinced the Patent Office to grant him a patent on all uses of electromagnetic waves, the Supreme Court said no, he could not patent every conceivable use of electromagnetic waves. He could only patent his invention -- the telegraph. Top of Page
We also do not allow patents on products of nature because the public would not be gaining anything new if an individual was allowed to, say, patent air and charge us each a license fee whenever we breathed. You're not supposed to be able to patent a product of nature or a formula, yet genes, the arrangement of the chemical letters C A T and G seem to be both. In fact, the useful properties of a gene -- such as its ability to bind to another complementary strand of DNA for diagnosis or its ability to code for a particular protein -- are not ones that the scientist has invented, but rather are natural, inherent properties of genes themselves.
Nonetheless, countries around the world, including the United States, have begun to grant patents on human genes. And this has had disastrous results. It has increased the cost of genetic testing and has begun to impede medical research. It has also hampered health care.
For 20 years, a gene patent holder controls any use of “its” gene. The breast cancer patent holder can prevent my doctor from looking in my body to see if I have a mutation in that gene.
The patent holder can charge whatever it wants for the test. Myriad, which holds the patent on the BRCA1 gene, charges 18,000 Egyptian Pounds. Canadian Provinces. There are access issues. One in four laboratories has stopped performing certain genetic tests because of patent restrictions or excessive royalty costs. Half had not developed a test for fear of running afoul of patent law.
You've probably heard about the benefits that pharmacogenetics will bring. Most drugs only work on a percentage of patients who use them. Genetic testing can help distinguish those patients for whom a drug will work from those for whom it will not.
But such tests will also limit the market for drugs. For example, one pharmaceutical company has filed for a patent on a genetic test to determine the effectiveness of its asthma drug Flovent. But the company says it will not develop the test – or let anyone else develop it. That would diminish the market. (Should company lose patent?) In trademark law, you can lose the trademark if you don't use it for 3 years and in Europe, you must “work” the patent.
Companies now sequence disease-causing bacteria and virus genes. In fact, in one instance, a company wants to introduce inexpensive, quick public health testing for a common infectious disease -- but the company holding the patent on the infectious disease has forbidden it.
Quality issues. Various mutations in the same gene can cause a particular disease. But companies that do not let anyone else test for “their” gene make it more difficult to find mutations than if a lot of pathologists were testing. In countries where the Alzheimer's gene and hemachromatosis gene were not patented, researchers found previously unknown mutations. These mutations can be used to diagnose people who would not otherwise be diagnosed. Top of Page
Moreover, there are fewer downsides to granting a patent on a drug or a medical device than granting a patent on a gene or a biological process. Other researchers can create alternatives to drugs and devices. There are no alternatives to the patented human genes in genetic diagnosis and gene therapy.
Gene patents also impede applications of the scientific method of hypothesis generation, discovery and replication. 28% of researchers say they have had trouble getting access to genetic materials to duplicate published results. When geneticists were asked why they intentionally withheld data, more than 20% listed the need to protect the commercial value of their results.
Egypt has a much better patent law than does the United States. Book One, Part 1, article 2 of the Egyptian patent law says that patents shall not be granted for: diagnostic or therapeutic methods for humans or for “organs tissues, live cells, natural biological substances, nucleic acid or genome. In addition, in Egypt, patents shall not be granted on inventions whose exploitation are contrary to human health. Thus, the Egyptian law apparently provides that patent shall not be granted on human genetic sequences. It is important to make sure that genes are not patentable in Egypt -- or, if they are, that such patents are not enforced.
What are the cultural implications of the new technologies?
I'm fascinated by the cultural implications of technologies, how institutions respond to them, and how technologies shape cultural values. Within law, technologies have three eras. Genetics. Are the tests good enough to use? If good enough, are there reasons we wouldn't want to use them? Will use of them change a cultural value? Criminal justice as a choosing system, punishing people who choose to be bad, but what if people are born bad, and their genes made them do it, do we need to change ideas of criminal responsibility.
Photosynthesis gene. ½ Human?
Biomedical engineering encourages a view of people as products. For example, because genes are owned by companies, there is an incentive to encourage more profits by more use of the genes in diagnostic tests. Not only are adults tested for a genetic propensity to breast cancer, but so are children. There is likely to be a push for genetic enhancements, like those advertised by the Pasadena store.
The current Alice in Wonderland world of biotechnology that is unregulated, is available to anyone. At various websites, I can order up genetic tests to see if I have genes associated with breast cancer or Alzheimer's disease, among others. A handheld genetic sequencer is available that would allow me -- a la the movie GATTACA -- to test the DNA of my friends or co-workers. From various biotechnology companies, I can buy the building blocks of life to design human genes. Top of Page
As technology evolves, parents-to-be will have even more control over the traits of their offspring. In a Louis Harris poll sponsored by the March of Dimes, 42% of potential parents surveyed said they would use genetic engineering on their children to make them smarter; 43%, to upgrade them physically. Another survey found that over a third of people wanted to tweak their children genetically to make sure they had an appropriate sexual orientation. With around 4 million births per year in the U.S., that's a very large market.
The very boundaries of what is human are being changed by genetic technology. Yet hardly anyone in the public or the legislatures is paying attention. We might notice if the government decided to inoculate all its citizens with the photosynthesis gene. But the change, the designing of children, is occurring much more subtly, as a result of individual choices through an open market. A man seeking to sell his sperm for $4000 a vial established a Web site with his family tree claiming to trace his genes back to six Catholic saints and several European royal families. Thousands of couples turn to the Internet to find genetic parents for their future children. They view pictures of sperm and egg donors, listen to tapes of their voices, and review pages of descriptions of their physical features, their hobbies, their intelligence test scores, their philosophies of life. At the Repository for Germinal Choice, they purchased sperm from Nobel Laureates. Can purchasing single genes -- rather than a person's whole packet -- be far behind?
How is society going to judge such desires? Should certain genetic and other biomedical manipulations be allowed and others not? Should parents be able to buy height-enhancing genes for their embryos? Will that be viewed more like cheating in sports or more like signing your child up for private tennis lessons? Olympic Is giving a child a gene protective against a deadly disease appropriate but manipulating genes to create a blue triangular head not? What about cases that fall in the middle -- genes to prevent baldness or assure taller stature? And should we really exercise dominion over other species, changing their features at will?
And remember, these powerful biomedical technologies are being privatized and owned by just a few companies. The market is good for some things, but should it govern the type of people we create? Lee Silver, Princeton biologist, GenRich and Naturals. (2 species)
Creating a baby is beginning to resemble buying a car, with consumer choices about which features and extras to request. Yet children don't come with the same guarantees as do cars or toasters. The child of an attractive model could be downright homely. And Nobel Prizes tend to be awarded to people in the same laboratories rather than in the same families. William Shockley, a Nobel laureate sperm donor, once said that his own children were a “regrettable regression to the mean.”
How will parents feel if they pay for “smart” sperm, and E=mc 2 isn't the first thing out of their child's mouth? Already, one couple sued a sperm bank when the babies weren't as handsome as they had wanted.
Conclusion
At the Institute on Biotechnology and the Human Future, where I chair the board, I view my own work in law as akin to writing science fiction. The challenge is to try to determine what society would look like if we chose one path as opposed to another. I often think of Dame Mary Warnock's admonition when her biotech committee was making recommendations about reproductive technologies: that we try to create a society that we can praise and admire, even if in individual detail we may wish it were different.
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