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There's a bank in central Boston that offers its customers a unique investment opportunity. For an initial outlay of $2,500 and yearly fees of $95, investors can realize returns of incalculable value--or, more often, no returns at all. Unlike most business deals, this one involves the extraction of blood. But participants in the Boston scheme give up the blood willingly, because blood is the very substance of their investment.
The institution in question is Viacord, the nation's largest commercial banker of blood from fetal umbilical cords. In recent years cord blood has become something of a hot commodity, as medical research has demonstrated its potential for treating leukemia and certain immune disorders. A few tablespoons of the blood can be drawn quickly and painlessly from a baby's umbilical cord right after delivery and frozen for future use. Because it is rich in the so-called stem cells that give rise to all other blood cells, cord blood can be used to reconstitute immune systems damaged by disease or radiation treatments. Although nonprofit centers have begun banking donated cord blood, private bankers like Viacord can guarantee customers--that is, expectant parents--future access to their own baby's blood, thereby increasing the likelihood of a match should the child or a relative someday need to restore a crippled immune system.
Viacord takes custody of the samples at Hoxworth Blood Center, a part of the University of Cincinnati Medical Center that has been contracted to process and store the cord blood. Small plastic packets of whole blood in refrigerated containers arrive by courier from hospitals all over the country 24 hours a day, seven days a week. More than 1,400 samples of cord blood are stowed in cylindrical liquid-nitrogen freezers set at -320.8 degrees. The frozen blood could represent roughly $3.5 million in revenue for Viacord. But no one knows what cord blood will be worth to the families who have paid to keep it. Viacord's president and founder, Cynthia Fisher, calls cord-blood banking a kind of insurance. Critics say that it is an attempt to capitalize on parents' worst fears.
Cord-blood banking is just one of many enterprises that make up the late-twentieth-century trade in body parts and products. Advances in medical technology have created a marketplace for everything from organs and tissues to genes and sex cells. Prices vary: $300 for a pint of plasma (the fluid in which blood cells are suspended), $50 for a sample of sperm, $10,000 for a nine-month lease on a surrogate mother's womb. In this country, organs cannot be sold for transplant, but the charges surrounding a donated organ can turn into tens of thousands of dollars. It costs about $20,000, for example, to remove and transport a donor kidney. This commerce is conspicuous and unapologetic. But other companies--such as those that sell parts of aborted fetuses to medical researchers--prefer to keep the nature of their trade and the size of their profits to themselves.
Blood was the first commodity on the market, and it is still the most commonly sold body product. Its economic journey began with the discovery of blood groups earlier this century, and by the 1950s, blood transfusions were a staple of medical care in the United States. As blood banks were established across the country, two competing models soon emerged: commercial suppliers, which pay blood donors, and nonprofit collection centers, which depend on volunteers to donate blood. The two ended up splitting the market. Today the vast majority of transfusions are done with donated blood, while commercial centers provide almost all of the blood used by the pharmaceutical industry in developing vaccines, diagnostics, and drugs. International trade in plasma products from paid blood donors--antibodies, clotting factors, and other blood components--is a multimillion-dollar industry in which the United States is a leading exporter.
Paid blood donors typically earn from $50 to $500 per pint; those with rare blood types or components may get more. With plasmapheresis, a procedure in which red blood cells are separated out from extracted blood and returned to the body, most healthy donors can safely part with two pints a week. For people in extreme circumstances, that kind of cash can mean making the rent or car payment or both--and therein, some say, lies the problem. The League of Red Cross Societies and other international organizations have expressed concern that the financial incentives offered by the blood trade constitute a subtle form of coercion for impoverished or otherwise disadvantaged groups.
But concerns about donor exploitation have not succeeded in halting blood buying and selling in several countries, including the United States. Part of the reason may be that, in legal terms as well as popular perception, blood is more a body "product" than a body "part." The U.S. National Organ Transplant Act (NOTA), which in 1984 banned interstate commerce in organs for transplant, specifically excluded "replenishable tissues such as blood or sperm" from its prohibitions. That blood is a renewable resource seems to set it apart from the more finite entities that the transplant act was designed to regulate. But that may be reading more into the statute than lawmakers intended.
"There's no coherent legal, ethical, or political theory of the body in the United States," says George Annas, professor of health law at the Boston University School of Public Health. "The regulations have come about in a patchwork fashion, because they've come in response to certain things that were perceived as abuses." Historically, says Annas, the states have had authority over the body, and states have proved reluctant to interfere with trade in pieces of their citizens. "There's no uniform act even proposed about body parts."
NOTA itself was passed in response to the transplant successes of the late 1970s. From the beginning, organ-transplant programs have been beset by a supply-and-demand crisis. Each time doctors add another organ type to their tally of interchangeable parts, waiting lists for that organ proliferate wildly. Before the transplant act, there were cases of would-be donors advertising for potential buyers, and of organ brokers offering to match the two in exchange for a piece of the action. Though kidneys were--and still are--the item living donors were most likely to part with, they could also contribute lungs, eyes, and skin. Sales of less expendable items, such as hearts and livers, were also proposed. The idea was to make the arrangements in advance of death, sort of like life insurance.
The extent of these transactions isn't well documented. But the market interest in organ sales made lawmakers queasy--much as does the business interest in cloning today. One of the inciting events in the passage of NOTA, in fact, was a proposed scheme to bring impoverished people to the United States and let them swap organs for money. Al Gore, then a senator, got wind of this proposal and, horrified, prodded Congress to ban payment for organs.
Doctors who tracked the development of transplantation techniques anticipated the organ shortage and took steps to relieve it. In 1968, prompted by the first transplant of a human heart the year before, a committee at Harvard Medical School recommended revising the definition of death so that hearts could be "harvested" from people whose brains had ceased to function but whose breathing was sustained via artificial respirators. Today the concept of brain death has won widespread acceptance. But organs are still in desperately short supply, and thousands of people die each year waiting for transplants. Hence while NOTA has shut down organ brokers here, unregulated--and poorly documented markets for organs are believed to flourish elsewhere, mostly in India and Brazil. Cases have been reported in both India and Egypt of living donors selling kidneys--sometimes to pay for a business or education but most often just to make money to get by.
Some ethicists have argued that body parts constitute a natural asset and that individuals should be free to make contracts regarding their disposal. But most reports about the organ trade concern the exploitation of groups that are anything but free. Several years ago, staffers of a state mental hospital in Argentina were accused of murdering patients to sell their organs. More recently, two Chinese men were arrested in New York for trying to arrange the sale of body parts from prisoners executed in China. And earlier this year, a state representative in Missouri floated the idea of permitting prisoners on death row to donate organs in exchange for a life sentence.
Meanwhile, organs and Ussues are still being bought and sold--legally--in this country. While NOTA prohibits traffic in organs for transplantation, it allows such commerce if the body parts in question are to be used in research or product development and testing. When profits are made on these sales, everyone benefits--except for the original source of the biological material. In 1984 businessman John Moore sued his doctor, the University of California, and several pharmaceutical companies for using, without his consent, tissue from his cancerous spleen--as well as blood, sperm, and bone samples--to create a commercial cell line now valued by some at $3 billion in potential profits. Moore lost. In 1990 the California Supreme Court ruled that patients do not have property rights to their tissues, since granting such rights would "destroy the economic incentive to conduct important medical research."
In issuing its ruling, however, the court also noted that doctors like Moore's might have a conflict of interest that could compromise the validity of informed consent and the quality of medical care. Since the Moore ruling, some observers say, that conflict has only become more pronounced. And the problem is not helped by regulations on informed consent that vary from state to state and institution to institution.
"I'm amazed by the scope of the market here, you know, the fact that hospitals with existing tissue banks are getting large financial rewards in joint ventures with biotech companies that want to have access to them," says Lori Andrews, a professor at Chicago-Kent College of Law. "Right now the code of federal regulations says that if there is existing tissue on the shelf, and it is used in an anonymous way in research, you do not have to get informed consent from the individual. But I don't think there's any tissue `on the shelf' anymore. I see it all in a pipeline to commercialization."
Oddly enough, you and your relatives may have more to say about what happens to your body parts after you're dead than you do premortem. There are laws protecting the inviolability of cadavers but almost none to protect what happens to tissues and organs removed from a patient who's still alive. "The next or kin nave a lot more authority over your dead body than you have over your live body," says Annas.
One of the most complicated issues in body-shop policy is the traffic in fetal parts, which are gleaned almost exclusively from fetuses that have been electively aborted (rather than from miscarried or stillborn fetuses, which tend to have defects and are harder to harvest). Fetal tissue--once, like cord blood, a medical waste--has been a prized medical resource ever since research demonstrated its potential for treating Parkinson's disease, diabetes, and Alzheimer's, as well as spinal-cord injuries and hemophilia. Combined markets for cures of these diseases have been estimated at more than $6 billion. But when a company began in the mid-1980s to develop a treatment involving transplanted fetal cells, right-to-life protests erupted, and in 1988 Congress passed an amendment to NOTA--the only amendment to NOTA--extending the act's restrictions to include fetal organs and tissues.
Of course, fetal body parts are still being collected for use in research. A lab at the University of Washington in Seattle can supply "tissue from normal or abnormal embryos and fetuses of desired gestational ages between 40 days and term" by overnight express, and at least a half-dozen brokers of fetal parts harvest tissue from abortion clinics and hospitals across the country. The women who donate the tissue are supposed to sign a consent form, and they cannot legally receive payment for the fetal tissue. The brokers, however, pay a small fee to clinics for collecting the tissue, and charge, in turn, a handling fee of between $50 and $150 per specimen to their customers in the private research community. The transplantation of fetal cells and tissues into human patients is still allowed, if the procedure is done in the name of approved clinical research
Another segment of the body-parts market prices the goods and services for assisted reproduction. At present, money can buy sperm ($50 to $100), eggs (starting at $2,000), embryos (market value varies), and a place to put them (gestational surrogates start at $10,000, not including brokers' fees).
These arrangements have bred some formidable contract disputes, as the courts struggle to spell out what belongs to, whom--or more precisely, what exactly is being purchased in such transactions. In one memorable case, contractual parents told their surrogate just two weeks before her due date that they would not accept any male children. When the surrogate delivered a twin brother and sister, the boy was put up for adoption and the couple left the hospital with the girl. The surrogate and her husband then decided to keep the boy and threatened legal action to regain custody of the girl. Though the other couple agreed to give back the girl, it's not clear that they would have been legally compelled to do so.
In the notorious Baby M decision, the New Jersey Supreme Court ultimately voided Mary Beth Whitehead's surrogacy contract, upholding her status as a mother and granting her visitation rights (but not custody). In cases involving gestational surrogates, who bring to term a genetically unrelated baby created from other people's gar metes, the California courts tend to favor the rights of genetic mothers over those of gestational mothers. But when an infertile woman buys someone else's eggs in an attempt to conceive, it is commonly assumed that the egg donor has no legal claim over the resulting embryos or children. That assumption has yet to be tested in court.
Advances in medical industry are stirring up other, more far-reaching questions about ownership. At the heart of the controversy are conflicting perceptions of genetic material. "Genes are an abstract entity to most people," says sociologist Dorothy Nelkin of New York University, who shares a National Science Foundation grant with Lori Andrews to study legal disputes over uses of body tissues in biotechnology. "They're not seen as body parts." Yet, says Nelkin, when it comes to an individual's DNA, genes are perceived as essentialist" entities--that is, they are seen as embodying the very essence of a person's identity. The more than 1,900 claims for patents on human DNA that have so far been registered create an image of genes as commodities, and observers like Nelkin fear that commodification could ultimately infringe on individual rights. A patent on the gene for Huntington's disease may seem abstract, for example, until it turns out to be one of your genes and employers or insurers discriminate against you based on results from a test developed by the patent holder.
Researchers and economic analysts also disagree on whether gene patents will speed medical progress or impede it. Proponents of the practice claim that patents provide financial incentive for investment in DNA research, a lure for venture capital, and protection for privately funded scientists who wish to disclose their findings to the public. John Doll, director of Biotechnology Examination at the U.S. Patent and Trademark Office, has likened the role of DNA and gene patents in the growth of the biomedical industry to the role of patented polymer components in the plastics industry. But other experts insist that the patenting of human DNA will present obstacles to research if too many different owners hold rights to materials and procedures that are necessary for new discoveries. They fear that the simplest experiment could get hung up in a snare of licensing agreements.
The story of cord-blood banking may present an object lesson in commercialization, though the moral of the story is not quite clear. Some ten years ago, when techniques for transplanting cord blood were still being worked out, a number of scientists formed a company called Biocyte to commercialize the technology. Investors put up money for the new venture, and Biocyte developed the clinical procedures, informed consent practices, patient counseling and education, and storage protocols for cordblood banking. And then, with more than 200 cord-blood samples stored in a freezer in a Pittsburgh blood center, investors decided they could not continue the service.
The company is still trying--so far unsuccessfully--to recoup its investment through patents on its cord-blood retrieval and storage procedures. And Biocyte's 200 patrons can still gain access to their banked blood. But they probably never will. Even now, the only proven use for fetal cord blood is as a substitute for bone-marrow transplants, and at least one expert has predicted that the average person's chance of ever needing to use the blood banked is 1 in 200,000. Nevertheless, the idea of cordblood banking seems to be taking off. More than a dozen companies, in addition to Viacord, now offer banking services.
And people are buying. At first, Viacord's customers were mostly families who had a present or foreseeable need for stem-cell transplants: parents, for example, whose children had leukemia or immune disorders and who hoped that their new baby's blood would be compatible with the sick sibling's. Now more than half of Viacord's families have no apparent need for the blood at all.
Champions of cordblood banking maintain that they have turned a medical waste product into a valuable resource. But critics of the trafficking in human anatomy claim that no matter how many lives are saved (or created), any such commerce inevitably violates the sanctity of the human body. To demonstrate this point, biotech gadfly Jeremy Rifkin, president of the Foundation on Economic Trends, and cell biologist Stuart Newman of New York Medical College in Valhalla revealed earlier this year that they had applied for a patent for creating human-animal chimeras, organisms consisting of human cells mixed with the cells of (at least) one other animal. It was a publicity stunt: the two explained in press accounts that they have never actually made their chimera--for these days it is necessary to clarify such things--and don't want to. Their intention instead was to provoke discussion about the patenting of life-forms in general and the definition of human life in particular. Rather than a radical departure, they contend, the chimera patent is a next logical step in proprietary claims on the human body.
In the United States, animals engineered with human genes and tissues have already been patented, and the European Patent Office has reportedly received applications for chimeric animals that could also include women engineered to secrete certain proteins in their breast milk, should such women ever be engineered. The Thirteenth Amendment to the Constitution, which outlawed slavery, would seem to prohibit the patenting of a human being. But when does a human part, or a part-human, become a full-fledged person? The ever-expanding scope of biomedical commerce is forcing answers to such improbable questions. As the market races forward, issues that were once the province of the very ill or the very thoughtful may soon become every body's business.
by, Karen Wright
The institution in question is Viacord, the nation's largest commercial banker of blood from fetal umbilical cords. In recent years cord blood has become something of a hot commodity, as medical research has demonstrated its potential for treating leukemia and certain immune disorders. A few tablespoons of the blood can be drawn quickly and painlessly from a baby's umbilical cord right after delivery and frozen for future use. Because it is rich in the so-called stem cells that give rise to all other blood cells, cord blood can be used to reconstitute immune systems damaged by disease or radiation treatments. Although nonprofit centers have begun banking donated cord blood, private bankers like Viacord can guarantee customers--that is, expectant parents--future access to their own baby's blood, thereby increasing the likelihood of a match should the child or a relative someday need to restore a crippled immune system.
Viacord takes custody of the samples at Hoxworth Blood Center, a part of the University of Cincinnati Medical Center that has been contracted to process and store the cord blood. Small plastic packets of whole blood in refrigerated containers arrive by courier from hospitals all over the country 24 hours a day, seven days a week. More than 1,400 samples of cord blood are stowed in cylindrical liquid-nitrogen freezers set at -320.8 degrees. The frozen blood could represent roughly $3.5 million in revenue for Viacord. But no one knows what cord blood will be worth to the families who have paid to keep it. Viacord's president and founder, Cynthia Fisher, calls cord-blood banking a kind of insurance. Critics say that it is an attempt to capitalize on parents' worst fears.
Cord-blood banking is just one of many enterprises that make up the late-twentieth-century trade in body parts and products. Advances in medical technology have created a marketplace for everything from organs and tissues to genes and sex cells. Prices vary: $300 for a pint of plasma (the fluid in which blood cells are suspended), $50 for a sample of sperm, $10,000 for a nine-month lease on a surrogate mother's womb. In this country, organs cannot be sold for transplant, but the charges surrounding a donated organ can turn into tens of thousands of dollars. It costs about $20,000, for example, to remove and transport a donor kidney. This commerce is conspicuous and unapologetic. But other companies--such as those that sell parts of aborted fetuses to medical researchers--prefer to keep the nature of their trade and the size of their profits to themselves.
Blood was the first commodity on the market, and it is still the most commonly sold body product. Its economic journey began with the discovery of blood groups earlier this century, and by the 1950s, blood transfusions were a staple of medical care in the United States. As blood banks were established across the country, two competing models soon emerged: commercial suppliers, which pay blood donors, and nonprofit collection centers, which depend on volunteers to donate blood. The two ended up splitting the market. Today the vast majority of transfusions are done with donated blood, while commercial centers provide almost all of the blood used by the pharmaceutical industry in developing vaccines, diagnostics, and drugs. International trade in plasma products from paid blood donors--antibodies, clotting factors, and other blood components--is a multimillion-dollar industry in which the United States is a leading exporter.
Paid blood donors typically earn from $50 to $500 per pint; those with rare blood types or components may get more. With plasmapheresis, a procedure in which red blood cells are separated out from extracted blood and returned to the body, most healthy donors can safely part with two pints a week. For people in extreme circumstances, that kind of cash can mean making the rent or car payment or both--and therein, some say, lies the problem. The League of Red Cross Societies and other international organizations have expressed concern that the financial incentives offered by the blood trade constitute a subtle form of coercion for impoverished or otherwise disadvantaged groups.
But concerns about donor exploitation have not succeeded in halting blood buying and selling in several countries, including the United States. Part of the reason may be that, in legal terms as well as popular perception, blood is more a body "product" than a body "part." The U.S. National Organ Transplant Act (NOTA), which in 1984 banned interstate commerce in organs for transplant, specifically excluded "replenishable tissues such as blood or sperm" from its prohibitions. That blood is a renewable resource seems to set it apart from the more finite entities that the transplant act was designed to regulate. But that may be reading more into the statute than lawmakers intended.
"There's no coherent legal, ethical, or political theory of the body in the United States," says George Annas, professor of health law at the Boston University School of Public Health. "The regulations have come about in a patchwork fashion, because they've come in response to certain things that were perceived as abuses." Historically, says Annas, the states have had authority over the body, and states have proved reluctant to interfere with trade in pieces of their citizens. "There's no uniform act even proposed about body parts."
NOTA itself was passed in response to the transplant successes of the late 1970s. From the beginning, organ-transplant programs have been beset by a supply-and-demand crisis. Each time doctors add another organ type to their tally of interchangeable parts, waiting lists for that organ proliferate wildly. Before the transplant act, there were cases of would-be donors advertising for potential buyers, and of organ brokers offering to match the two in exchange for a piece of the action. Though kidneys were--and still are--the item living donors were most likely to part with, they could also contribute lungs, eyes, and skin. Sales of less expendable items, such as hearts and livers, were also proposed. The idea was to make the arrangements in advance of death, sort of like life insurance.
The extent of these transactions isn't well documented. But the market interest in organ sales made lawmakers queasy--much as does the business interest in cloning today. One of the inciting events in the passage of NOTA, in fact, was a proposed scheme to bring impoverished people to the United States and let them swap organs for money. Al Gore, then a senator, got wind of this proposal and, horrified, prodded Congress to ban payment for organs.
Doctors who tracked the development of transplantation techniques anticipated the organ shortage and took steps to relieve it. In 1968, prompted by the first transplant of a human heart the year before, a committee at Harvard Medical School recommended revising the definition of death so that hearts could be "harvested" from people whose brains had ceased to function but whose breathing was sustained via artificial respirators. Today the concept of brain death has won widespread acceptance. But organs are still in desperately short supply, and thousands of people die each year waiting for transplants. Hence while NOTA has shut down organ brokers here, unregulated--and poorly documented markets for organs are believed to flourish elsewhere, mostly in India and Brazil. Cases have been reported in both India and Egypt of living donors selling kidneys--sometimes to pay for a business or education but most often just to make money to get by.
Some ethicists have argued that body parts constitute a natural asset and that individuals should be free to make contracts regarding their disposal. But most reports about the organ trade concern the exploitation of groups that are anything but free. Several years ago, staffers of a state mental hospital in Argentina were accused of murdering patients to sell their organs. More recently, two Chinese men were arrested in New York for trying to arrange the sale of body parts from prisoners executed in China. And earlier this year, a state representative in Missouri floated the idea of permitting prisoners on death row to donate organs in exchange for a life sentence.
Meanwhile, organs and Ussues are still being bought and sold--legally--in this country. While NOTA prohibits traffic in organs for transplantation, it allows such commerce if the body parts in question are to be used in research or product development and testing. When profits are made on these sales, everyone benefits--except for the original source of the biological material. In 1984 businessman John Moore sued his doctor, the University of California, and several pharmaceutical companies for using, without his consent, tissue from his cancerous spleen--as well as blood, sperm, and bone samples--to create a commercial cell line now valued by some at $3 billion in potential profits. Moore lost. In 1990 the California Supreme Court ruled that patients do not have property rights to their tissues, since granting such rights would "destroy the economic incentive to conduct important medical research."
In issuing its ruling, however, the court also noted that doctors like Moore's might have a conflict of interest that could compromise the validity of informed consent and the quality of medical care. Since the Moore ruling, some observers say, that conflict has only become more pronounced. And the problem is not helped by regulations on informed consent that vary from state to state and institution to institution.
"I'm amazed by the scope of the market here, you know, the fact that hospitals with existing tissue banks are getting large financial rewards in joint ventures with biotech companies that want to have access to them," says Lori Andrews, a professor at Chicago-Kent College of Law. "Right now the code of federal regulations says that if there is existing tissue on the shelf, and it is used in an anonymous way in research, you do not have to get informed consent from the individual. But I don't think there's any tissue `on the shelf' anymore. I see it all in a pipeline to commercialization."
Oddly enough, you and your relatives may have more to say about what happens to your body parts after you're dead than you do premortem. There are laws protecting the inviolability of cadavers but almost none to protect what happens to tissues and organs removed from a patient who's still alive. "The next or kin nave a lot more authority over your dead body than you have over your live body," says Annas.
One of the most complicated issues in body-shop policy is the traffic in fetal parts, which are gleaned almost exclusively from fetuses that have been electively aborted (rather than from miscarried or stillborn fetuses, which tend to have defects and are harder to harvest). Fetal tissue--once, like cord blood, a medical waste--has been a prized medical resource ever since research demonstrated its potential for treating Parkinson's disease, diabetes, and Alzheimer's, as well as spinal-cord injuries and hemophilia. Combined markets for cures of these diseases have been estimated at more than $6 billion. But when a company began in the mid-1980s to develop a treatment involving transplanted fetal cells, right-to-life protests erupted, and in 1988 Congress passed an amendment to NOTA--the only amendment to NOTA--extending the act's restrictions to include fetal organs and tissues.
Of course, fetal body parts are still being collected for use in research. A lab at the University of Washington in Seattle can supply "tissue from normal or abnormal embryos and fetuses of desired gestational ages between 40 days and term" by overnight express, and at least a half-dozen brokers of fetal parts harvest tissue from abortion clinics and hospitals across the country. The women who donate the tissue are supposed to sign a consent form, and they cannot legally receive payment for the fetal tissue. The brokers, however, pay a small fee to clinics for collecting the tissue, and charge, in turn, a handling fee of between $50 and $150 per specimen to their customers in the private research community. The transplantation of fetal cells and tissues into human patients is still allowed, if the procedure is done in the name of approved clinical research
Another segment of the body-parts market prices the goods and services for assisted reproduction. At present, money can buy sperm ($50 to $100), eggs (starting at $2,000), embryos (market value varies), and a place to put them (gestational surrogates start at $10,000, not including brokers' fees).
These arrangements have bred some formidable contract disputes, as the courts struggle to spell out what belongs to, whom--or more precisely, what exactly is being purchased in such transactions. In one memorable case, contractual parents told their surrogate just two weeks before her due date that they would not accept any male children. When the surrogate delivered a twin brother and sister, the boy was put up for adoption and the couple left the hospital with the girl. The surrogate and her husband then decided to keep the boy and threatened legal action to regain custody of the girl. Though the other couple agreed to give back the girl, it's not clear that they would have been legally compelled to do so.
In the notorious Baby M decision, the New Jersey Supreme Court ultimately voided Mary Beth Whitehead's surrogacy contract, upholding her status as a mother and granting her visitation rights (but not custody). In cases involving gestational surrogates, who bring to term a genetically unrelated baby created from other people's gar metes, the California courts tend to favor the rights of genetic mothers over those of gestational mothers. But when an infertile woman buys someone else's eggs in an attempt to conceive, it is commonly assumed that the egg donor has no legal claim over the resulting embryos or children. That assumption has yet to be tested in court.
Advances in medical industry are stirring up other, more far-reaching questions about ownership. At the heart of the controversy are conflicting perceptions of genetic material. "Genes are an abstract entity to most people," says sociologist Dorothy Nelkin of New York University, who shares a National Science Foundation grant with Lori Andrews to study legal disputes over uses of body tissues in biotechnology. "They're not seen as body parts." Yet, says Nelkin, when it comes to an individual's DNA, genes are perceived as essentialist" entities--that is, they are seen as embodying the very essence of a person's identity. The more than 1,900 claims for patents on human DNA that have so far been registered create an image of genes as commodities, and observers like Nelkin fear that commodification could ultimately infringe on individual rights. A patent on the gene for Huntington's disease may seem abstract, for example, until it turns out to be one of your genes and employers or insurers discriminate against you based on results from a test developed by the patent holder.
Researchers and economic analysts also disagree on whether gene patents will speed medical progress or impede it. Proponents of the practice claim that patents provide financial incentive for investment in DNA research, a lure for venture capital, and protection for privately funded scientists who wish to disclose their findings to the public. John Doll, director of Biotechnology Examination at the U.S. Patent and Trademark Office, has likened the role of DNA and gene patents in the growth of the biomedical industry to the role of patented polymer components in the plastics industry. But other experts insist that the patenting of human DNA will present obstacles to research if too many different owners hold rights to materials and procedures that are necessary for new discoveries. They fear that the simplest experiment could get hung up in a snare of licensing agreements.
The story of cord-blood banking may present an object lesson in commercialization, though the moral of the story is not quite clear. Some ten years ago, when techniques for transplanting cord blood were still being worked out, a number of scientists formed a company called Biocyte to commercialize the technology. Investors put up money for the new venture, and Biocyte developed the clinical procedures, informed consent practices, patient counseling and education, and storage protocols for cordblood banking. And then, with more than 200 cord-blood samples stored in a freezer in a Pittsburgh blood center, investors decided they could not continue the service.
The company is still trying--so far unsuccessfully--to recoup its investment through patents on its cord-blood retrieval and storage procedures. And Biocyte's 200 patrons can still gain access to their banked blood. But they probably never will. Even now, the only proven use for fetal cord blood is as a substitute for bone-marrow transplants, and at least one expert has predicted that the average person's chance of ever needing to use the blood banked is 1 in 200,000. Nevertheless, the idea of cordblood banking seems to be taking off. More than a dozen companies, in addition to Viacord, now offer banking services.
And people are buying. At first, Viacord's customers were mostly families who had a present or foreseeable need for stem-cell transplants: parents, for example, whose children had leukemia or immune disorders and who hoped that their new baby's blood would be compatible with the sick sibling's. Now more than half of Viacord's families have no apparent need for the blood at all.
Champions of cordblood banking maintain that they have turned a medical waste product into a valuable resource. But critics of the trafficking in human anatomy claim that no matter how many lives are saved (or created), any such commerce inevitably violates the sanctity of the human body. To demonstrate this point, biotech gadfly Jeremy Rifkin, president of the Foundation on Economic Trends, and cell biologist Stuart Newman of New York Medical College in Valhalla revealed earlier this year that they had applied for a patent for creating human-animal chimeras, organisms consisting of human cells mixed with the cells of (at least) one other animal. It was a publicity stunt: the two explained in press accounts that they have never actually made their chimera--for these days it is necessary to clarify such things--and don't want to. Their intention instead was to provoke discussion about the patenting of life-forms in general and the definition of human life in particular. Rather than a radical departure, they contend, the chimera patent is a next logical step in proprietary claims on the human body.
In the United States, animals engineered with human genes and tissues have already been patented, and the European Patent Office has reportedly received applications for chimeric animals that could also include women engineered to secrete certain proteins in their breast milk, should such women ever be engineered. The Thirteenth Amendment to the Constitution, which outlawed slavery, would seem to prohibit the patenting of a human being. But when does a human part, or a part-human, become a full-fledged person? The ever-expanding scope of biomedical commerce is forcing answers to such improbable questions. As the market races forward, issues that were once the province of the very ill or the very thoughtful may soon become every body's business.
by, Karen Wright
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