Date: Wed, 12 Aug 1998 10:02:16 -0400 (EDT)
From: "John L. Niedfeldt-Thomas" <jthomas@essential.org>
To: Multiple recipients of list CX-L <cx-l@debate.net>
Subject: BioEthics Topic Paper
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Here is the BioEthics topic paper authored by Tim Kane and myself. Please
contact us with any questions.
John Niedfeldt-Thomas
BioMedical Ethics
A Topic Proposal Presented to the High School Topic
Selection Committee
J. Timothy Kane - Thomas A. Edison High School
Alexandria VA
John Niedfeldt-Thomas - The Georgetown Day School
Washington DC
August 1998
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.
A. Science
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: Application of the National Federation 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).
Range: Most high school biology curriculum includes a discussion of the
human genome and the possibilities of genetic manipulation. High school
students in 1999/2000 will be forced to confront, in their lives, through
parenthood, genetic screening or disease, issues of BioMedical Ethics,
particularly as it applies to the regulation of human genetic information.
It is, therefore, crucially important for today's high school students to
examine the intersection of science and public policy and its potential
application to their lives.
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. Note: We chose not to
establish the usefulness of the Lexis/Nexis database for this topic as only
a very few high school students have legal access. 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.
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Part 10: Study Committee Report Summary, BioMedical Ethics
Cases:
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.
Negative Arguments:
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.
Resources:
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.
Debatability:
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.
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.
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