BioMedical Ethics Topic Paper
J. Timothy Kane
Thomas A. Edison High School Alexandria VA
The Georgetown Day School Washington DC
Part 1: Introduction:
During the past year the issues surrounding BioMedical policies, specifically those dealing with human genetic information (HGI), have come to the forefront of political and social debate. In the summer of 1997, Scottish researcher Dr. Ian Wilmut announced the cloning of a sheep named "Dolly." The furor over this announcement led to thoughts of the impact of the cloning of humans. In August of 1997, President Clinton's National Bioethics Commission recommend that human cloning be banned (Lawrence, 8 August 1997). Undeterred by this announcement, Dr. Richard Seed of Chicago revealed that he was beginning a project to clone human beings (Hendren, 18 March 1998). The issue of human cloning only scrapes the surface of the issues related to the human genome (the complete package of genetic material for a living thing, organized in chromosomes) issues that raise huge public policy questions:
How do we regulate new technologies? How do we try to balance the costs and the benefits they will bring us? I think the regulation of recombinant DNA is perhaps the ideal case study in science and public policy (emphasis added), and for several reasons. First, it offers an unparalleled sweep of new opportunity. Those who practice the technology, let alone the investors, see exciting prospects of new medications, new agricultural crops, new means of remediation environmental problems. It is, in short, the source of stupendous possibilities.
But second, each opportunity affords an array of potential problems: unwanted side effects, unanticipated social costs, unforeseen public health and environmental risks.. But these, not in themselves unusual because they often accompany newly introduced technology, are compounded by a very special kind of drama - the specter of genetic monsters running amuck, and some feel, furthermore, that in undertaking this kind of work we have begun to interfere with a process so fundamental in nature that we may be guilty of the sin of hubris. And that reservation - so deep, that at times in the history of this business, it has seemed almost theological - has been of profound significance in the politics of recombinant DNA regulation. Moreover, this is one of the very few instances in which scientists themselves, the very developers of the technology, were the first to recognize its potential risks and call public attention to the need for evaluating them. Perhaps partly as a result, scientists were given more than the usual amount of responsibility for the early development of regulation in this area. In view of some, that's made the process more sensible, more appropriately suited to the nature of the risk, and in the view of others, it has removed critical issues from public scrutiny and thereby reduced accountability. (Kennedy, 1992)
The issues grow even more complex that those outlined by Dr. Kennedy. Research by the federal government led to an attempt by the National Institutes of Health to patent human gene fragments. The United States Patent and Trademark Office rejected the application but that did not end the debate:
The NIH's decision to abandon its application leaves open the question of whether gene fragments may be patented under United Sates patent law. Private entities have not been dissuaded by the PTO's ruling and have filed applications claiming patents on thousands of gene fragments. Until there is a definitive ruling by a Federal Circuit or by the United States Supreme Court on whether gene fragments are patentable, it is likely that the PTO will receive many more applications. In the meantime, researchers remain uncertain of the patent law governing their research. This comment recommends that Congress promote continued development of the human genome research by clarifying whether certain products of biotechnology are patentable. (McKay, 1994)
Discussions about these applications of biological information magnify the dangers and frequently the benefits are assumed or forgotten. The benefits are great:
The last few years of medical research have been marked by explosive growth in the understanding of the genetic basis for many diseases. Huntington's chorea, cystic fibrosis, Duchenne's muscular dystrophy, retinoblastoma and cleft palate are among the diseases or defects that are now associated with specific genetic abnormalities. Genetic markers have recently been found for Alzheimer's disease and manic depressive illness. To date, such knowledge has been applied primarily to the development of techniques for detecting carriers of genetically transmitted disease. Genetic testing followed by counseling has permitted adult disease bearers to make more informed reproductive decisions, and tests for detecting such diseases in the fetus have made it possible for parents with no moral objection to abortion to ensure that the children they decide to bear are free from genetic disease. Tests have also been developed for identifying disease propensities, such as abnormal susceptibilities to chemical carcinogens. Although the scientific validity of such tests is still open to question, a survey carried out by the OTA in 1982 indicated that they have been used by a number of private corporations to identify high-risk subgroups among perspective employees. Therapeutic developments have lagged behind the advances in genetic diagnosis, but human gene therapy based on insertion of new genes into a patient may be feasible in the forcible future for a limited group of disorders involving enzyme deficiencies. (Jasanoff, "Biology and the Bill of Rights: Can Science Reframe the Constitution." 1989)
Unregulated intervention into the human genome does have far-reaching implications. The ability to read the genetic code of a single individual holds the promise of the ability to cure disease and warn of future risks. That same ability may also result in a world where individuals are defined by their genetic code:
If widely accepted, this essentialist perspective may provide the impetus for the adoption of a wide variety of screening practices, creating a genetic underclass consisting of individuals whose genes have marked them for the "nowhere track." In fact, one health insurer has already attempted to refuse coverage for a child born with birth defects when the mother was warned through prenatal testing, but failed to abort. Other insurance companies may lower premiums for individuals unlikely to suffer from hereditary diseases by incorporating genetic testing into their underwriting methodology. In the workplace, adoption of the essentialist perspective could mean that application procedures will include genetic tests to choose those employees whose biology makes them more likely to stay healthy and perform well. Schools could use genetic screening for tracking so that students who receive expensive educational programs, such as upper-level mathematics courses and musical training, are those most suited to benefit from them. (Dreyfuss, 1992)
Further advances in knowledge of human genetic information hold much promise for the advancement of humanity, however these advancements are fraught with peril. The Federal Government will have to take action in order to regulate this complex issue:
The urgency to pass a cloning ban has been lessened in recent days by the decision of the FDA's declaring jurisdiction over human cloning technologies and planning to inform Dr. Seed and any others of like mind that this technology will not be approved until further animal work is done -- if then. Part of the FDA oversight will also be to make sure that widely accepted standards for the protection of human subjects, including adequate informed consent, are adhered to by those rushing to clone. The appropriate congressional committees need to work with a broad array of scientific societies as they draft legislation that could restrict potentially beneficial technologies, and a continuing public dialogue reflecting the diversity and pluralism of this country also needs to be a part of that process. There is a broad consensus that the technology that brought us Dolly should not be used for at least five years on humans. Such a moratorium will provide society with enough time to begin to debate the momentous issues that cloning technology has thrust upon us in the last year. (Schaffner, 1998).
Part 2: Background:
The study of genes -- units of hereditary information which contain the instructions for the production of proteins, which make up the structure of cells and direct their activities -- has been in full force for over one hundred and twenty years. Gregor Mendel made the first scientific discovery and explanation of genetics, in his research on plants. That understanding of genetics took a great leap forward with the discovery of the double helix structure of the DNA molecule by James Watson and Francis Crick in 1953. Recombinant DNA research was perfected in the 1970s, and the first genetic therapy, the altering of genes to affect their function, occurred in 1990 (Shannon, 1997). As noted above, the first successful cloning of an animal was accomplished by Scottish scientist Ian Wilmut in the summer of 1997.
Understanding of (and a lack thereof) of genetics by scientists and policy makers has been used for both good and bad during the Twentieth Century. The leaders of Nazi Germany used a faulty understanding of genetics, based on racial prejudice to undertake the "Final Solution ". In the United States, early twentieth century laws were on the books that allowed the sterilization of the retarded, in an attempt to remove those genes from the gene pool (Callahan, 1996. In contrast, gene therapy in a young woman has allowed her devastated immune system to recover and today she lives a normal life. Twenty years ago, this woman would most certainly have died (Shannon, 1997). The pace of genetic research, engineering and therapy continues today at a pace unimagined by Watson and Crick as they toiled away in their laboratory at Harvard University.
Much of this research in the United States is concentrated in the Human Genome Project (HGP), sometimes referred to as the Human Genome Initiative. The HGP:
.. is an international research program designed to construct detailed genetic and physical maps of the human genome, to determine the complete nucleotide sequence of human DNA, to localize the estimated 50,000-100,000 genes within the human genome, and to perform similar analyses on the genomes of several other organisms used extensively in research laboratories as model systems. The scientific products of the HGP will compromise a resource of genetic maps and DNA sequence information that will provide detailed information about the structure, organization and characteristics of human DNA, information that constitutes the basic set of inherited instructions for development and functioning of a human being. Successfully accomplishing these ambitious goals will demand the development of a variety of new technologies. It will also necessitate advanced means of making the information widely available to scientists, physicians, and others in order that results may be rapidly used for the public good (NHGRI, 1998).
The HGP was begun by the Department of Energy in 1988 and was soon joined by the National Institutes of Health. The Project is expected to last 15 years and cost three billion dollars (NHGRI, 1998).
In addition, private scientists are forming a company with the goal of realizing the mission of the HGP by the year 2001 and, they claim, at 1/20th the cost of the HGP (Gillis and Weiss, 12 May 1998)
Part 3: Arguments for Regulation of Human Genetic Information:
A - Science and Public Policy
The application of science in public policy has received great attention in the past several years, primarily because science offers so much promise in the elimination of human suffering. Human genetics is a prime example of this promise, as the ability of the science to unravel the very foundation of life holds great promise. This promise also come with a challenge to understand the nature of this new knowledge. Science can not go unchecked in this realm:
In the conventional wisdom of the popular media, genetics is "hard" science with a precise database and clearly defined empirical referents for its concepts, while sociology is "soft" or, perhaps, not science at all. That depends. If one compares the predictions and control in plants or animal genetics with predictions and control in affective social relations, this is unequivocally true. A basic difference, of course, is the availability of far more tightly controlled experiments in plant and animal genetics, unthinkable in human genetics or human behavioral research. However, in the construction of a knowledge base about such matters as the causes of mental illness, crime, intelligence, and alcoholism, the distinction between the explanatory power of genetics and sociology fades completely. In the language of science, the dependent variable is equally complex for those seeking a genetic explanation as for those seeking a social structural account. However, the social scientists have been far more sophisticated in analyzing the contingencies and patterned variations that render a one-dimensional version of these "dependent variables" scientifically meaningless. (Duster, 1990)
Because of the great power of this new understanding of the human genome it is necessary for our governmental and legal institutions to reconceptualize the view of the fundamental nature of the person:
Legal developments necessitated by scientific change ordinarily occurs through a process of gradual evolution. Recent advances in the biological sciences, however, threaten to destabilize relations between the law, particularly constitutional law, and science in an unprecedented fashion. Modern biology has begun to unlock the secrets of some of the basic processes of life. These discoveries may promise to transform our understanding of human heredity and behavior, thereby undermining the basis for conceptual categories that have performed profound cultural and legal significance, including distinctions between public and private, natural and unnatural, health and illness, and determinism and free will. Legal institutions must therefore confront the possibility that the new biology of the past thirty years will render obsolete the concepts of volition and personhood that constitutional jurisprudence currently regards as fundamental. (Jasanoff, "Biology and the Bill of Rights: Can Science Reframe the Constitution." 1989)
Finally, now is the key time for the Federal Government to act, before the new biology reaches a crisis in public policy:
The principal players in biotechnology might find it inconceivable that genetic engineering, with all its promise, could be rejected. Nevertheless, that could easily happen. Recall that nuclear energy, once considered the greatest power source ever developed, has been partly or largely abandoned in many countries, thanks to growing public awareness of its true financial and environmental impact. Society also could choose to accept some uses of genetic engineering and reject others. For example, one could make a solid case for genetic screening - with the appropriate safeguards - to better predict the onslaught of disabling diseases, especially those that can be prevented with early treatment . On the other hand, the use of gene therapy to make corrective changes in human sperm, eggs and embryonic cells, affecting the evolution of future generations, is far more dangerous (Rifkin, Los Angeles Times, 1 June 1998).
B - Cloning
There exists a strong need for the federal government to intervene in the cloning debate and provide significant leadership: "Is there a lot of (pharmaceutical) money there?" Brendan Minogue (clinical bioethicist at Youngstown State University) "Yeah, that's the way Americans do things. Is there anything intrinsically immoral about cloning a human being? No. Are there dangers that may result? Yes. How do we achieve the benefits without the harms? We need to develop guidelines." (Sandstrom, 19 February 1998) In addition to the above concerns there also exists concern about the effect on a child who realizes they are a clone:
The ethical issues of greatest importance in the cloning debate, however, do not involve possible failures of cloning technology, but rather the consequences of its success. Assuming that scientists were able to clone human beings without incurring the risks mentioned above, what concerns might there be about the welfare of the clones? Some opponents of cloning believe that such individuals would be wronged in morally significant ways. Many of these wrongs involve the denial of what Joel Feinberg has called "the right to an open future." For example, a child might be constantly compared to the adult from whom he was cloned, and thereby burdened with oppressive expectations. Even worse, the parents might actually limit the child's opportunities for growth and development: a child cloned from a basketball player, for instance, might be burdened by the thought that he is a copy and not an "original." The child's sense of self-worth or individuality or dignity, so some have argued, would be difficult to sustain. (Wachbroit, Fall 1997)
C - The Human Genome Project
The human genome project is one of the largest public science incentives ever (Macer, 1991). The goal of this multinational project is "obtaining a detailed map and a complete DNA sequence of the human genome" (Macer, 1991). This effort however raises serious questions about who will have access to the information, the intellectual property rights of the individuals involved and whether such massive science efforts should be in the realm of the government.
D - Patents
There is a strong need for the United States federal government to act in the area of biotechnology and patents:
The goal of United States patent law is to encourage the production of socially beneficial inventions. Allowing patents on DNA fragments would only hold up research; therefore, patents should not be issued as a matter of public policy. While there are moral and philosophical reasons for not allowing patents on fully identified genes, awarding such patents would serve the policy goal underlying the patent system because such "discoveries" are truly useful. While the line between a fully identified gene and a partially identified gene may be difficult to draw, it is vital that Congress take action to recognize the distinction between useful and non-useful products of biotechnology research by defining utility, creating a special intellectual property system for biotechnology, changing the obviousness requirement, creating a research exemption, and/or reaching a meaningful international agreement. (Mckay, November 1994)
E - Insurance The use of genetic information by insurance companies is one of the most difficult areas of regulation. However, as Alexandra Glazier points out "Discovering genetic basis for disease is not only of great interest to the medical community; private health insurers are anxiously awaiting the results of genetic linkage studies." (Glazier, 1997). There is a strong need for the United States Federal Government to intervene in this area:
Although this may be an appropriate judicial route, a federal legislative response is also needed to ensure some degree of consistency in court decisions. Judges do not have sufficient medical knowledge to decide whether newly discovered genetic predisposition to genetically linked diseases are illnesses or diseases, or whether treatment is medically necessary. Indeed, most lawyers lack the knowledge necessary to represent their clients effectively in these cutting edge genetic matters. For those who do not possess the perfect pair of genes, a careful legislative response to the issues raised by genetic predisposition in the context of health insurance may better serve justice than do ad hoc court decisions. (Glazier, 1997)
F - Germ Line Therapy
The concept of germ line therapy is one of the most controversial areas of human genetic research and necessitates government intervention:
On March 20, many leading molecular biologists and geneticists met at the University of California at Los Angeles to discuss the prospect of making genetic changes in the human "germ line" -- sperm and eggs -- that would be passed on to future generations. The ability to alter genes before conception raises the possibility that we might be able to re-engineer our genetic blueprints and redirect the course of our biological evolution. (Rifkin, 1998)
There is a great ethical debate as whether germ line therapy should ever be developed and what implications research in this area would have:
Our argument is not that germ-line therapy should never be developed. It is that it should not be developed at this time. As pointed out in the previous paragraph, we have just recently discovered two completely unexpected features of genes. It seems likely that other such novel and bizarre genetic phenomena will be discovered over time. If the incentive structure of science were different than it now is, one would expect that scientists themselves would support a moratorium on the development of germ-line gene therapy in human beings. Indeed, the overwhelming number of scientists with whom we have talked support such a moratorium. However, it takes only a few scientists who have convinced themselves that they know that the risks are only imaginary and that the benefits are real for germ-line therapy to become a field in which scientists compete to be first. It is to prevent those few arrogant scientists motivated often by support from profit conscious venture capitalists, from initiating such a competition that we urge the vast majority of scientists to support a continuing moratorium on the development of germ-line therapy in human beings (Berger, 1996).
G - Eugenics
Perhaps the greatest risk from genetic research and engineering is that of eugenics, not the eugenics of the 1930s but a modern version brought about the new genetic knowledge:
However, although the idea of improving humanity by improving heredity - "positive eugenics" - was generally abandoned, a very different form - "negative eugenics" - developed later. Negative eugenics means merely trying to eliminate genetic diseases and disorders, and appeared in the 1960s, in the context of prenatal testing and genetic screening. (Pence, 1995)
This new version of eugenics is likely to be perceived as a positive force and one that will be driven by market forces. This however does not eliminate the ethical dangers:
But this drive to enhance our worth will soon present us with a fundamental choice: Should we use biotech for human breeding? Genetic science is more likely to come up with a test that tells which embryos are prone to develop cancer prematurely than it is to come up with a cancer cure. Diagnosing an embryo should prove easier and cheaper than reversing disease in a fully-grown adult. Given a choice between fetuses that have perhaps 20 years' difference in their likely life spans, which would you choose? ... Most biotechnologists want to set off their own version of the big one. Biotech startups have an equally naked drive: They want to show enough profit potential to be bought out by the multinational pharmaceuticals. And these big boys simply want to stimulate consumer demand and control markets, whatever the consequences. In the marketplace that we've deified, few moral checks and balances remain. Our great research universities, for example, don't want ethical consideration to limit their own biotech royalties. (Klein, May/June 1998)
Part 4: Arguments against Regulation of Human Genetic Information:
In addition to generic arguments, ample ground exists to debate the specifics of regulations on the use of human genetic information.
Restrictions on research, based on the notion that science and the law can't coexist, are flawed. First, the right to research is a right protected by the First Amendment.
The First Amendment guarantees freedom of speech -- the "full opportunity for expression in all its various forms to convey a desired message." In order to have the opportunity for meaningful expression in the marketplace of ideas, one must have the freedom to pursue knowledge, including research. Without such protection, the government could restrict the free flow of information by regulating its source. This would defeat a major premise of the First Amendment: the protection from government interference. This protection enables the public to gain information for public and private decision-making (Coleman, 1996).
Second, even in the face of legal indeterminacy, science and medicine improves the lives of people:
...Scientific progress generally improves our lives and that knowledge is better than ignorance. It is unlikely that we will ever force people to know their likelihood of developing disease, though perhaps we should educate parents and physicians to be cautious about informing children of their risks. In any case, we all know that we are not at risk of dying, and with or without genetic diagnosis people view the medical history of their parents and relatives as harbingers of things to come. Both knowing and refusing to know one's genetic makeup are empowering choices for competent adults: denying people the option of making this choice does not improve their lives.... Far from making everyone sick, the advance of genetic therapy promises to make everyone well (Hughes, 1996).
Third, the idea of just protecting human genetic information is flawed in the greater context of all medical information:
Is genetic information so different from other clinical data that it deserves special protection? There is, admittedly, precedent for this. Our society traditionally accords a special level of protection to psychiatric records, and we have, to some extent, condoned a higher degree of protection to HIV test results. In essence, the argument that genetic data is different from regular medical information and deserves special protection is two pronged: genetic tests may predict future risks for healthy persons, and they may infer risk about relatives. True enough. But, a decision to treat genetic information with special care depends on the ability to separate it from other clinical information. If, as is almost certainly going to be the case within the next 20 years, genetic testing permeates medical care, it will be exceedingly difficult to implement a law that requires separate treatment of portions of the medical records of many persons. Few bills have confronted this issue. Those that have, define "genetic information" so narrowly that, if enacted, the laws will offer protection about very little information to very few people. Too often lost in the discussion about genetic privacy is that everyone would benefit from enactment of a general medical privacy law that covers access to and use of all health information. (Reilly, "Genetic Privacy Bills Proliferate." The Gene Letter, May 1997)
B - Cloning
Doomsday scenarios about the harms of cloning are over claimed and ignore the benefits:
Most lawmakers are focused on a nightmarish vision in which billionaires and celebrities flood the world with genetic copies of themselves. But scientists say it's unlikely that anyone is going to be churning out limited editions of Michael Jordan or Madeleine Albright. "Oh, it can be done," says Dr. Mark Sauer, chief of reproductive endocrinology at Columbia University's College of Physicians and Surgeons. "It's just that the best people, who could do it, aren't going to be doing it." Cloning individual human cells, however, is another matter. Biologists are already talking about harnessing for medical purposes the technique that produced the sheep called Dolly. They might, for example, obtain healthy cells from a patient with leukemia or a burn victim and then transfer the nucleus of each cell into an unfertilized egg from which the nucleus has been removed. Coddled in culture dishes, these embryonic clones--each genetically identical to the patient from which the nuclei came--would begin to divide. The cells would not have to grow into a fetus, however. The addition of powerful growth factors could ensure that the clones develop only into specialized cells and tissue. For the leukemia patient, for example, the cloned cells could provide an infusion of fresh bone marrow, and for the burn victim, grafts of brand-new skin. Unlike cells from an unrelated donor, these cloned cells would incur no danger of rejection; patients would be spared the need to take powerful drugs to suppress the immune system. "Given its potential benefit," says Dr. Robert Winston, a fertility expert at London's Hammersmith Hospital, "I would argue that it would be unethical not to continue this line of research." (Nash, 9 February 1998)
C - Human Genome Project -
Regulation of the Human Genome Project by outside actors is unnecessary - the Project regulates itself now:
ELSI (ethical, legal and social issues) programs have done a lot to educate the thinkers, and it has produced a higher level of discourse in the country about these issues. DOE is spending a large fraction of its ELSI money on informing special populations who can reach others. Educating judges has been especially well received because they realize the potential impact of DNA technology on the courts (Smith, 1995).
D - Patents
Critics of gene patents misunderstand the benefits:
There is a deep misunderstanding of the patent process, which is designed to make public discoveries of commercial importance so that others may build on that knowledge to open new fields (Weeks, 1998).
There is also a need for the Federal Government to reexamine the implications of its regulations:
Federal patent policy in biomedical research imposes social costs overlooked in the public debate, according to a paper by two professors at the University of Michigan Law School appearing in last week's issue of Science. Profs. Michael A. Heller and Rebecca S. Eisenberg argue that granting too many patent rights in pre-market or "upstream" biomedical research paradoxically may stifle discovery of life-saving "downstream" products. Biomedical research has been shifting from a commons to a privatization model, they note. Under the old model, research was publicly funded and results were made freely available in the public domain. The new model, by encouraging universities and private firms to patent their findings, has increased private investment and spurred the pace of upstream research. However, downstream product developers now face a daunting bargaining challenge. Before they can develop new products and bring them to market, they need to collect licenses from many owners of upstream patents. These owners have conflicting priorities and conflicting assessments of relative value. Heller and Eisenberg use property theory to explain the paradox of more patents and fewer products. Policy-makers often prescribe privatization to cure a "tragedy of the commons" in which people overuse shared resources. But, in solving one tragedy, privatization can go astray and accidentally create a "tragedy of the anticommons" in which people underuse scarce resources because too many owners can block each other. (Science Daily, 6 May 1998)
E - Insurance
There is a great outcry for government regulation to protect individuals from genetic discrimination, particularly in the field of insurance. However there is significant protection in the status quo:
"The Health Insurance Portability and Accountability Act of 1997" (PL104-191), now being called "HIPAA," provides an important new protection to people who want to undergo genetic testing, but are afraid that health insurers may discriminate against them if test results indicate that they are at increased risk for developing a serious disease. Section 101 of HIPAA sharply limits the right of group health insurers to limit coverage of new employees because they have "preexisting conditions," defined therein as conditions that have required medical attention within the six months preceding enrollment into the plan. As of August, 1997, plans providing group health insurance may only impose a preexisting condition exclusion when "medical advice, diagnosis, care or treatment was recommended or received within the 6 month period" before enrollment. HIPAA offers those who have taken or want to undertake predictive genetic testing to a second level of protection. The new law forbids group health plans from applying the preexisting condition rule at all to genetic information unless the person has actually been diagnosed with the illness that the genetic test predicts. For example, a woman who has undergone testing and learns that she carries a mutation that predisposes her to breast or ovarian cancer, but who does not have cancer, may not be denied coverage. (Reilly, "Genetic Privacy Bills Proliferate," May 1997.)
The public outcry that would result from denial of insurance based on genetic test results makes it unlikely that such actions would take place. And, from a purely utilitarian point of view, some may argue that eliminating coverage for some high-risk patients would free up resources, allowing better care for more people.
F - Germ Line Therapy
The ability to manipulate the make-up of the genetic material of humans (germ line therapy) holds the greatest promise for future medical advances and breakthroughs:
One key to Wilmut's success was awakening the de-programmed cell after it was placed inside a sheep's egg. Biologists already knew eggs and early embryos from different species contain gene-regulating molecules that switch genes on and off during different stages of life. If doctors could control those gene-regulating substances, they might stimulate regrowth of nerve cells, which do not regenerate naturally after a spinal cord injury. Or they might deprogram a skin cell and reawaken only genes that create bone marrow to grow cancer victims a customized transplant. Or they could fight sickle cell anemia by switching on a vital blood-producing gene. Developmental biologists already were isolating gene-regulating molecules, but instead of working backward from an adult cell, they cull the substances from human and animal embryos and try growing them up. Ontogeny, based in Cambridge, Mass., has patented 30 molecules that activate genes responsible for, among other things, the embryonic development of brain, sperm and bone cells. These genes become dormant, so Platika's goal is to awaken them to redo their jobs in Parkinson's patients, men with low sperm counts or elderly women with broken hips. But "we have a long way to go," cautioned Harvard University's Dr. Stuart Orkin, who can grow new blood from mouse embryo cells but has found it doesn't work properly when transplanted into animals. Still, Dolly's method did raise the potential of customized treatments that patients' bodies wouldn't reject, by working backwards from a patient's own cells instead of using lab-grown cells, said Millennium Pharmaceuticals President Steve Holtzman. He is a member of the National Bioethics Advisory Commission that will advise President Clinton about cloning. Said Ontogeny's Platika: "To me it's so exciting because it said you can .. unlock the body's capabilities to repair and regenerate." (FOX News, 9 April 1997)
G - Eugenics
In contrast to the those who fear a rebirth of Nazi-type eugenics, genetic research and the knowledge that results from its may "even erode the pseudo-scientific basis on which most eugenics has rested. Presumably the advance of genetic science will tell us whether there is a genetic basis for gender and racial differences in abilities, or not, and how important these are. If there are genetic factors in gender or racial difference, they will most likely be revealed as minor beside the social factors, and the genetic factors will become ameliorable through a technical fix (Hughes, 1996)."
Moreover, restrictions on knowledge and research actually sparks eugenics:
In fact, governmental control over a parent's right to dispose of her own genetic material is more analogous to governmental eugenic decisions and represents a more likely step down that slippery slope (Coleman, 1996).
Part 5: Conclusion
The coming of Dolly has made this the key time to begin the discussion of the regulation of the human genome. It is also vital in this in this discussion for the United States Federal government to act in some way:
There is a tendency to use the law too often as a shield to defend a technology rather than as a sword to promote its beneficial uses. In the early stages of biotechnology, there has been a focus on using the law to defend intellectual property rights, to defend controversial experiments, and to defeat community resistance to specific products. It is time to use the law to guarantee the availability of information domestically and internationally, to provide safeguards against illegal and unethical uses of biotechnology, and to encourage uses of biotechnology that enhance the economic viability of local communities and interests. (Gore, 1991)
Part 6: Important Resolution Criteria:
Timeliness: In the winter of 1998 Dr. Richard Seed announced that he would begin the process of attempting to clone a human being. This announcement follows the success of a Scottish scientist in cloning a sheep. As the technology for genetic manipulation increases our knowledge of the human gene grows exponentially (Macer, 1991). The policy implications of this growth in genetic knowledge are summarized by Sheila Jasanoff "These discoveries may promise to transform our understanding of human heredity and behavior, thereby undermining the basis for conceptual categories that have profound cultural and legal significance, including distinctions between public private, natural and unnatural, health and illness, and determinism and free will." (Jasanoff, Biology and the Bill of Rights, 1989).
Material: There is no shortage of material in both the standard paper library form and quality Internet sites. A search of the Internet reveals that several major universities host WebPages devoted to issues in Bioethics and thousands of other sites devoted to the issue. Further, our initial topic research has revealed more than sufficient high quality resources are available through other means (A Lexis/Nexis search result that can be obtained through the University of Pennsylvania's Web Page has over 200 cites).
Interest: During the 1999-2000 school year and the concurrent election cycle issues surrounding government regulation of human genetic information will be pressed to the forefront of political debate. Some of the issues will include: 1) Government regulations of scientific inquiry and its public and private implications; 2) Pros and cons of a complete ban on cloning of the human genome; 3) The mission and activities of the Human Genome Project (especially in comparison to private efforts toward the same goal); 4) Whether the government should allow patents on human genetic information; 5) The implications of government regulation to protect individuals from discrimination in insurance; 6) The desirability of germ line therapy; 7) What the role of the government should be in regulating both positive and negative eugenics in light of new scientific discoveries.
Balance: The idea that information regarding both the human genome in general and whether specific genetic information should be regulated appears to be balanced. Significant ground for debate exists over the benefits of such regulation, and even among those in favor of regulation, there is disagreement on how such regulation should be structured, what it should cover, etc.
Part 7: Resolutions:
1. Resolved: That the United States Federal government should substantially strengthen the regulation of human genetic information.
2. Resolved: That the United States Federal government should establish a policy regulating human genetic information.
3. Resolved: That the United States Federal government should increase restrictions on the use of human genetic information.
4. Resolved: That the United States Federal government should substantially increase restrictions on the use of and/or research on human genetic information.
Part 8: Definitions of Terms:
(4) GENETIC INFORMATION- The term `genetic information' means the information about genes, gene products or inherited characteristics that may derive from an individual or a family member. (H. R. 341, 105th Congress, 1st Session, 7 January 1997)
(A) GENETIC INFORMATION- The term `genetic information' with respect to an individual means information about the genes of the individual or a member of the individual's family or about any gene products or inherited characteristics that may derive from the individual or a member of the individual's family. (H. R. 2198, 105th Congress, 1st Session, 17 July 1997)
(10) GENETIC INFORMATION- The term `genetic information' means information from a human DNA sample about molecular genotype, information from mutation analysis, or information about nucleotide sequence of a gene. (S. 422, 105th Congress, 1st Session, 11 March 1997)
(A) GENETIC INFORMATION- The term `genetic information' with respect to an individual means information about the genes of the individual or a member of the individual's family or about any gene products or inherited characteristics that may derive from the individual or a member of the individual's family. (H. R. 3299, 105th Congress, 1st Session, 26 February 1998)
Definitions: "Genetic information" is information about genes, gene products, inherited characteristics, or about family history, that is expressed in common language. "Individual" means the source of a human tissue sample from which a DNA sample is extracted and genetic information is characterized. "Research" is scientific investigation that includes systematic development and testing of hypotheses for the purpose of increasing knowledge. (Reilly, "Senator Domenici Redrafts Genetic Privacy Bill", January 1997)
The bill defines "genetic information" as "the information that may derive from an individual or a family member about genes, gene products, or inherited characteristics". The term includes "DNA sequence information including that which is derived from the alteration, mutation, or polymorphism of DNA or the presence or absence of a specific DNA marker or markers." This definition can be read broadly to include information about predisposition discerned from conducting a family history, a routine part of medical care. Another important definition is "insurer" which (unlike most state genetic privacy laws which address only health insurance) includes entities that write any line of insurance. (Reilly, "Broad Genetic Privacy Act Introduced in U.S. Senate," July 1996)
The problem of differentiating genetic tests from non-genetic tests leads to another question: What is "genetic information"? If newborn screening showed that you had phenylketonuria (PKU), the test itself and information directly arising from it (perhaps the particular type of PKU) might be covered under some proposed legislation. But meanwhile you are being treated for PKU, the diagnosis is in your medical record, your insurance company or HMO knows about it because they are paying for your special food (if you are fortunate enough to live in a state that requires insurers to do this), so exactly what "genetic information" would be protected by law? It seems useless to protect information arising from a test when the symptoms are apparent. It might be possible to prevent employers from getting this information, and would also be possible to require that insurers accept everybody, regardless of genetic status. But is this "reverse discrimination" against people whose conditions are not clearly traceable to a gene or set of genes? Is the family history part of "genetic information?" Most insurance companies get all the information they think they need simply from family history, without resorting to genetic testing. The Task Force did not deal with this question. Some proposed laws on genetic privacy would prevent insurers and employers from asking about family history, while other laws would prevent them only from access to molecular DNA tests. New Hampshire has forbidden insurers to ask about family history. The agreed upon trade-off with insurance companies was a state-guaranteed increase in insurance rates, stepped over a period of several years. This approach redistributes inequality, but does not guarantee access to health care for all. (Wertz, "What is a 'Genetic Test'?" March 1998)
The Department of Energy (DOE) - supported working group, "The Social Costs and Medical Benefits of Human Genetic Information," Included 13 students and 8 "seniors" (experts/resource people), each representing a range of international and academic backgrounds, experiences and perspectives. Among the "senior" participants of the working group for, for example, were genetic researchers, genetic counselors, physicians, and ethicists (Fader, 1994).
Martine Rothblatt, a lawyer in Washington, DC, who chairs the IBA's bioethics subcommittee, said: "The human genome project is only about five years old and already there are numerous instances of abuse being reported. Human genome information, such as genetic screening tests, will be available in almost all counties very quickly (Dyer, 1996).
genetic information, A Dictionary of Genetics, 1990 pg. 128- the information contained in a sequence of nucleotide bases in a nucleic acid model
genes, Your Genes, Your Choices, 1996 pg. 74 Units of hereditary information. Genes contain the instructions for the production of proteins, which make up the structure of cells and direct their activities.
genetics, Your Genes, Your Choices, 1996 pg. 75 The field of science that looks at how traits are passed down from one generation to another, through the genes.
Genome, Your Genes, Your Choices, 1996 pg. 75 The complete package of genetic material for a living thing, organized in chromosomes. A copy of the genome is found in most cells.
Human Genome Project, Your Genes, Your Choices, 1996 pg. 75, The scientific mission to "read" the order of bases as they appear in the DNA of human chromosomes. The Human Genome Project actually is not one project, but rather many hundreds of separate research projects being conducted throughout the world. The objective is to create a directory of the genes that can be used to answer questions such as what specific genes do and how they work.
human genetics, International Dictionary of Medicine and Biology, 1986, volume 2, pg. 1191 - The branch of genetics concerned with humans. Included are clinical genetics, medical genetics, and the study of the genetic foundations of human phenotypic variation.
Information, Human Genetic Information: Science, Law and Ethics, pg. 95. the term 'information' has a fourth meaning in relation to the genetic constitution of living things, especially of humans. We speak not only of the 'information' stored in the genome, but also of the 'information' about the specific genetic constitution of particular persons.
Part 9: Bibliography/Works Cited
Bailey, Ronald. "Send in the Clones" Reason. June 1998: n. pg. Online. Biospace. Internet. 2 June 1998.
Baker, Catherine, Your Genes, Your Choices: Exploring the Issues Raised by Genetic Research,, 1996.
Bereano, Phil. "Life Liberty and the Pursuit of Genetic Testing." The Washington Post. 22 March 1998, Late ed.: C5.
Berger, Edward M., "Ethics of Gene Therapy" Morality and the New Genetics, 1996.
Biomedical Ethics in U.S. Public Policy. Office of Technology Assessment Congress of the United States. 1993.
Boyce, Nell. "It's enough to make gene therapist drool" New Scientist. (16 May 1998) n. pag. Online. Biospace. Internet. 2 June 1998.
Brown, David. "Bubonic plague bequeathed gift of survival to Age of Aids." The Washington Post. (7 May 1998): n. pag. Online. Biospace. Internet. 2 June 1998.
Burstein, Rachel. "Regulating the Researchers: Does a ban on public funding means a ban on public knowledge." Mother Jones. (May/June 1998): n. pag. Online. Biospace. Internet. 2 June 1998.
"Can Patents Stifle Innovation In Biomedical Research" Science Daily. (6 May 1998): n. pag. Online. Biospace. Internet. 2 June 1998.
Cloning's Real Promise: Healing Spinal Cords. Fighting Cancer. Fox News, 9 April 1997. Online. Biospace. Internet. 18 February 1998
Coleman, June. "Playing God or Scientist: A Constitutional Analysis of State Laws Banning Embryological Procedures" Pacific Law Journal, 1996.
Dreyfuss, Rochelle Cooper. "Jurisprudence of Genetics." Vanderbilt Law Review. March 1992.
Duster, Troy. Backdoor to Eugenics. 1990.
Dworkin, Ronald. Freedom's Law: The Moral Reading of the American Constitution. 1996.
Dyer, Clare. "Agreement near on use of Human Genetic Information." The British Medical Journal. 16 November 1996.
Fader, Betsy. International Conference Working Group: The Social Costs and Medical Benefits of Human Genetic Information.. 1994
FOX News. Cloning's Real Promise: Healing Spinal Cords, Fighting Cancer. 9 April 1997. Online. Biospace. Internet. 18 February 1998.
Genetic Testing: Predicting Disease or Diagnosis for Disaster? Hearing before the Human Resources and Intergovernmental Relations Subcommittee of the Committee an Government Operations House of Representatives, July 23, 1992.
Gibbs, W. Wayt. "Gene Therapy: Early trails encountered unforeseen complications. A new round of more sophisticated strategies may turn the tide." Scientific American. Online. Biospace Internet. 3 June 1998.
Gillis, Justin. "HGS Brings First Drug To Human Testing Stage." The Washington Post (3 June 1998) Page C17. Online. Biospace Internet. 3 June 1998.
Gillis, Justin and Weiss, Rick. "Private Firm Aims to Beat Government To Gene Map." The Washington Post (12 May 1998): Page A01. Online. WashingtonPost.com. Internet. 13 May 1998.
Glazier, Alexandra, "Genetic Predispositions, Prophylactic Treatments and Private Health Insurance: Nothing is Better Than a Good Pair of Genes" American Journal of Law and Medicine, Vol. XXIII No. 1 1997.
Glusker, Anne. "Fertility Panic: How I Found Myself Caught Between Desire and Destiny." The Washington Post. Sunday 14 December 1997.
Gore, Al. "Planning a New Biotechnology Policy." Harvard Journal of Law and Technology. Fall 1991. Lexis.
Hendren, John. "State Anitcloning Bills Stir Drug-Industry Forces" The Philadelphia Inquirer. 18 March 1998. Online. Biospace. Internet. 15 April 1998.
Hughes, John Ph.D., "Embracing Change With All Four Arms: A Post Humanist Defense of Genetic Engineering" Eubios Journal of Asian and International Bioethics, EJAIB, vol. 6 (4), July 1996
Holdrege, Craig, Genetics and the Manipulation of Life: The Forgotten Factor of Context. 1996.
Hubbard, Ruth & Elijah Wald. Exploding the Gene Myth: How Genetic Information is Produced and Manipulated by Scientists, Physicians, Employers, Insurance Companies, Educators, and Law Enforcers. 1997.
Human Genetic Information: Science, Law and Ethics., 1990.
International Conference Working Group: The Social Costs and Medical Benefits of Human Genetic Information. November 1994, Online, DOE Human Genome Program. Internet. 15 January 1998.
Jasanoff, Sheila, "Biology and The Bill of Rights: Can Science Reframe the Constitution?" American Journal of Law and Medicine, Vol. XIII No. 2-3 1989.---
. Science at the Bar: Law, Science, and Technology in America. 1995.
Jones, Owen D. "Law and Evolutionary Biology: Obstacles and Opportunities" Journal of Contemporary Health Law & Policy.. 1994.
Kennedy, Dr. Donald. Challenges to Public Policy. Winding Your Way through DNA: symposium, 1992, Online. About Biotech. Internet. 15 January 1998
King, Robert & William Stansfield. A Dictionary of Genetics. 1990.
Klein, Jeffrey. "People 2.0" Mother Jones. May/June 1998. Online. Biospace. Internet. 14 May 1998.
Klotzko, Arlene Judith. "Science Fictions: Cloning Is Bad And Sextuplets Are Good" The Washington Post. Sunday 14 December 1997.
Krieger, Lisa M. "Genetic Weapons in the War on Cancer." San Jose Mercury News. (2 June 1998): n. pag. Online. Biospace. Internet. 3 June 1998.
Lau, Edie. "Don't clone people, urges Dolly's 'dad'." The Sacramento Bee. (19 May 1998): n. pag. Online. Biospace. Internet. 2 June 1998.
Lawrence, Jill "Political battlegrounds of the future: The era of big issues - the Cold War, the budget deficit - is giving way to a time of more personal concerns." USA Today, Friday, August 8, 1997, page 6A.
Macer, Darryl R. J. Biotechnology, International Competition, and its Economic, Ethical and Social Implications in Developing Countries. Ch14 in Concepts in Biotechnology, (Universities Press, 1996), Online, DOE Human Genome Program. Internet. 15 January 1998.---
. "Whose Genome Project". Journal: Bioethics 5 (1991), Online, DOE Human Genome Program. Internet. 15 January 1998.
Mckay, Daniel L., "Patent Law and the Human Genome Research at the Crossroads: The Need for Congressional Action" Santa Clara Computer and High Technology Law Journal, November 1994, WestLaw.
Nash, J. Madeleine . "The Case For Cloning: The benefits of this bold technique outweigh the risks, and the danger is not what you think." Time. 9 February 1998. Online. Biospace. Internet. 18 February 1998.
"Next Stop Eternal Youth." ABCNEWS.com. (22 May 1998): n. pag. Online. Biopace. Internet. 2 June 1998.
NHGRI: The Human Genome Project. Online http://www.nhgri.nih.gov/HGP
Pence, Gregory E. Classic Cases in Medical Ethics: Accounts of the Cases That Have Shaped Medical Ethics, with Philosophical, Legal, and Historical Backgrounds. 1995.
Perry, Daniel. Alliance for Aging Statement on Human Cloning Legislation. PRNewswire, 12 February 1998. Online. Biospace. Internet. 18 February 1998.
Reilly, Philip R., MD, JD. "Broad Genetic Privacy Act Introduced in U.S. Senate The Gene Letter. 1: 1 (July 1996) : n pag. Online. 23 March 1998.---
. "Genetic Privacy Bills Proliferate." The Gene Letter. 1: 6 (May 1997) : n pag. Online. 23 March 1998.---
. "Senator Domenici Redrafts Genetic Privacy Bill" The Gene Letter. 1: 4 (January 1997) : n pag. Online. 23 March 1998.
Rifkin, Jeremy. "Consider the Costs of Each Path to the "Biotech Century'." The Los Angeles Times. (1 June 1998): n. pag. Online. Biospace. Internet. 2 June 1998.---
. "Patent Pending: Consumer-driven science and the new eugenics." Mother Jones. (May/June 1998): n. pag. Online. Biospace. Internet. 2 June 1998.---
. "Who Will Decide Between Defect and Perfect?" The Washington Post 19 April 1998, late ed.: C4.
Saletan, William. "Fetal Positions: in the debate over cloning, it's still pro-choice vs. pro-life. It shouldn't be." Mother Jones. (May/June 1998): n. pag. Online. Biospace. Internet. 2 June 1998.
Sandstrom, Eric. "Some Congress Members say they are Concerned Legislation would hinder Biomedical Breakthrough." Akron Beacon Journal. 19 February 1998. Online. Biospace. Internet. 18 February 1998.
Science Daily. "Can Patents Stifle Innovation in Biomedical Research." 6 May 1998. Online. Biospace. Internet. 15 May 1998.
"Scientist who cloned "Dolly" may have erred" CNN Interactive, February 17, 1998. Online. Biospace. Internet. 18 February 1998.
Schaffner, Kenneth F. "Cloning: Congress must take care with legislation" Cloning: Congress must take care with legislation. 2 February 1998. Online. Biospace. Internet. 18 February 1998.
"Senate puts hold on legislation that would ban Human Cloning." Miami Herald. February 12, 1998. Online. Biospace. Internet. 18 February 1998
Shannon, Thomas A. Ed., Bioethics: Basic Writings on the Key Ethical Questions that Surround the Major, Modern Biological Possibilities and Problems. 1993.---
. An Introduction to Bioethics. 1997.
Smith, David "Evolution of a Vision: Genome Project Origins, Present and Future Challenges, and Far-Reaching Benefits" Human Genome News, September-December 1995.
Suzuki, David & Peter Knudtson, Genethics: The Ethics of Engineering Life. 1990.
"To Own the Human Genome" The Washington Post. (15 May 1998) Page A26. Online. Washingtonpost.com. Internet. 2 June 1998.
Tribe, Laurence. "Technology Assessment and the Fourth Discontinuity: The Limits of Instrumental Rationality" Southern California Law Review. 1973.
Wachbroit, Robert. "Genetic Encores: The Ethics of Human Cloning." The Report From the Institute for Philosophy & Public Policy. Fall 1997: n pag. Online. Internet. 15 May 1998.
Weeks, Linton "Mr Green Genes: William Haseltine Sees Future in His Labs", Washington Post, 17 February 1998
Weiss, Rich. "Human Clone Research will be Regulated FDA Asserts it has Statutory Authority to Regulate attempts at Human Cloning." Washington Post, 20 January 1998. Online. Biospace. Internet.
Wertz, Dorothy. "Genetics and 'Germ Warfare.'" The Gene Letter. 2.2 (March 1998): n pag. Online. Internet. 28 April 1998.---
. "Newborn Screening: State Policies on Testing, Informed Consent, and Public Input." The Gene Letter. 2.2 (March 1998): n pag. Online. Internet. 28 April 1998.---
. "Opinion: Can We Overcome Multiculturalism?" The Gene Letter. 2.2 (March 1998): n pag. Online. Internet. 28 April 1998.---
. "UNESCO Declaration on the Human Genome and Human Rights, July 1997" The Gene Letter. 2.2 (March 1998): n pag. Online. Internet. 28 April 1998.---
. "What is a 'Genetic Test"" The Gene Letter. 2.2 (March 1998): n pag. Online. Internet. 28 April 1998.
Woods, Michael. "Gene therapy may turn cells into drug 'factories'." The Toledo Blade. (30 May 1998): n. pag. Online.. Biospace. Internet. 2 June 1998.
Part 10: Study Committee Report Summary, BioMedical Ethics
The majority of debate on this topic would address the role of the federal government in regulating scientific and medical research as well as the application of this research in the public sphere. There are several large case areas: 1) A ban on cloning of the human genome, 2) A change in the mission of the Human Genome Project or an increase in the regulation of its results, 3) Federal action to regulate patents of human genetic sequences, 4) Federal action to regulate insurance companies actions in the realm of the human genome, 5) A federal ban or moratorium on germ line therapy, 6) Federal regulation regarding the privacy implication of an individual's human genetic data, and 7) The regulation of scientific/medical research on the human genome. All these areas offers a great deal of opportunity for affirmative cases.
The negative has a number of strong arguments in all of the above areas. Topic research clearly reveals a great divide in the scientific, medical and ethics community on these issues. Further negative ground exists as well. First, any action by the United States Federal Government to restrict research has significant implications on the First Amendment to the Constitution. Second, any unilateral United States action may not solve the problem as, as Dr. Richard Seed said, "I can just go overseas". Arguments exist that increasing regulation may magnify the harms by driving research and therapy into unregulated environments. Also, the negative may argue that voluntary action by private actors such as scientists and researchers is a better solution than a federal mandate. Finally there are huge political implications for the an expansion of Federal power into such a controversial area especially in light of the fact that this topic would be debated at the beginning of a Presidential election cycle.
There is a huge amount of information available on the topic of BioMedical Ethics both in traditional bound form and accessible through the World Wide Web. Several major universities host web pages specifically devoted to BioMedical issues, Some of the best are the ones hosted by the University of Pennsylvania and Emory University as their holdings include virtual libraries of resources specifically related to the topic. As well as electronic holdings huge amounts of bound material exist related to the topic, as well as many scholarly journals. With the coming of "Dolly" and the public policy debate about cloning, and the private efforts to map the Human Genome Project, a plethora of material is now in the mainstream press related to the issue of government regulation of Biomedical activities.
The BioMedical Ethics topic brings a unique opportunity for young people to learn about and discuss the issue of science in public policy. This issue is at the core of the BioMedical Ethics debate. Doctor and scientists are faced daily with the questions of "not what can they do" but "what should they do", just as lawmakers struggle with the question of "what is in the public's best interest". It will be necessary for our students to increasingly confront these issues as they enter twenty-first century. There are no easy answers to these types of questions and that is the problem. The issue of BioMedical Ethics, specifically the regulation of human genetic information, will bring to our students controversial ideas and necessitate their discussion in an appropriate manner.