Genetic Cloning, Testing,
use of living organisms, cells, or substances from living organisms
to make products, improve plants or animals, or develop microorganisms.
Chromosome The structure
in the nucleus of a cell, composed of DNA, that contains genes.
Clone An exact genetic
copy of an organism.
Deoxyribonucleic acid (DNA)
A chemical, found in the nucleus of a cell, that carries
genetic informationthat is, the instructions for making all
the structures and materials the body needs to function.
Embryo The prefetal
product of conception from implantation through the eighth week
of development. An embryo conceived through sexual reproduction
receives half its genes from each sexual parent; that is, half from
the sperm and half from the egg. A cloned embryo receives all its
genes from one parentthe DNA donor.
Gene A component
passed from one generation to the next that occupies a specific
location on a chromosome and helps determine a particular characteristic
in an organism.
Genetic marker A
known DNA sequence associated with a particular gene or trait; some
are associated with certain diseases and conditions.
Genetic profile The
record of a person's genetic makeup.
Genome The complete
collection of an organism's chromosomes. Except for red blood cells,
all human cells contain a complete genome.
Genome sequencing Determining
the order of the chemical bases that make up DNA; that is, reading
the genetic makeup of an organism. This order spells out the exact
instructions required to create a particular organism with its own
unique genetic traits.
Stem cell A cell
that has the ability to divide for indefinite periods in culture
and to give rise to specialized cells such as skin or heart cells;
embryonic stem cells are undifferentiated and thus more capable
of being nurtured into various types of tissue than are non-embryonic
Stem cell line The
continuing division of a particular stem cell; as cell lines age,
they lose their capacity to differentiate into various kinds of
[APRIL 1, 2002] Recent advances in the field of genetics have expanded
with dazzling speed, bringing with them the challenge of wide-ranging
and often unknown consequences. Over the years, genetic manipulation
has been used for purposes such as improving crop yields and accelerating
animal growth. Cloning an animal from embryonic cells and, more
recently, from adult cells, vaulted genetics into the daily headlines,
then, in 2001, there came the announcement that a very early human
embryo had been produced.
The birth of Dolly, the sheep cloned in 1997, generated
both anticipation and fear that human cloning would not be far behind.
At the federal level, an executive order immediately banned the
use of federal funds for human cloning. Extensive discussion ensued
in Congress about the ethics of cloning, and numerous bills were
introduced in an effort to prohibit human cloning without restricting
promising research. Cloning began to be discussed in terms of therapeutic
cloning (to create an embryo for a supply of stem cells for
research or therapy, thus destroying the embryo) and reproductive
cloning (to produce a human being). Currently, Congress is considering
legislation to ban all cloning, including therapeutic cloning, and
alternatively, legislation to ban only reproductive cloning.
Michigan enacted laws in 1998 making human cloning
a felony, setting penalties for cloning, and prohibiting state funds
from being used for it. California, Louisiana, and Rhode Island
also have such a ban, and other states have similar legislation
Related controversy surrounds research using embryonic
stem cells, which are believed to hold potential for leading to
treatment for diseases such as Alzheimer's, Parkinson's, diabetes,
and heart disease. The president announced in August 2001 that he
would allow the award of government funds for research that uses
embryonic stem cells being cultured in laboratories around the world
but would prohibit funding to develop new lines that involve creating
and destroying additional embryos.
In early 2002 two biotechnology companies announced
that they had cloned pigs that do not have a specific gene that
appears to cause the human body to reject pig organ transplants;
the breakthrough is thought to be an important step in the field
of xenotransplantationanimal-to-human transplants.
In addition, human embryonic stem cells have been developed into
tiny blood vessels, a crucial step in someday using such cells to
repair blocked arteries.
Genetic Testing and Profiling
Genetic testing is the process of examining human
chromosomes for genetic markers that may indicate the presence or
likelihood of diseases or conditions that sometimes can be treated.
Hundreds of genetic tests are available, and seven are required
of newborns in Michigan. Similarly, genetic profiling records an
individual's DNA makeup and can be used to identify a person with
In 1999 the report of the Michigan Commission on Genetic
Privacy and Progress recommended ways to protect genetic data, prevent
discrimination, and maximize the beneficial uses of new genetic
medical knowledge. Legislation followed in 2000 that
- prohibits health insurance companies from requiring
genetic information before issuing coverage,
- requires a person's informed consent before undergoing
genetic testing, and
- prohibits the use of genetic tests as a condition
for obtaining employment.
Pending Michigan legislation (HB 4936) would require
separate written consent from the patient for disclosure of genetic
information to another party, except as allowed by law or Medicaid
policy. Another bill (SB 1214) would set conditions under which
DNA test results may be considered as the basis for a new trial
of someone convicted of a felony.
Effective January 2002, Michigan law expanded DNA
profiling to the entire felon population, including those convicted
of specific sex-related misdemeanors.
Although considerable federal legislation has been
introduced regarding genetic testing, none has been enacted to date.
In 2000 the president issued an executive order prohibiting federal
agencies from using genetic information in making employment or
promotion decisions and declaring genetic information subject to
the same privacy protections as other medical information. The president
has urged Congress to pass legislation extending these protections
to all citizens.
Biotechnology is the practice of using living organisms,
cells, or substances from living organisms to make products, improve
plants or animals, or develop microorganisms other than human cloning.
Nearly 300 biotech businesses in Michigan generate
$2 billion in annual revenue and employ more than 16,000 workers.
In July 1999 the state agreed to invest $1 billion
over 20 years in a life sciences corridor designed
to make Michigan a leading state in developing biotechnology applications.
The lead Michigan research institutionsMichigan State University,
the University of Michigan, Wayne State University, and the Van
Andel Institutehave been joined in proposing biotech projects
by other institutions and universities. The initial investment was
$100 million, which, along with all future monies awarded under
the program, is allocated in three areas: 40 percent on basic research;
50 percent on collaborative research, with emphasis on developing
emerging discoveries; and 10 percent on commercializing developments
through start-up companies. The proposals are awarded competitively
after peer review by a third party, most recently the American Association
for the Advancement of Science.
The awards, administered by the Michigan Economic
Development Corporation, are intended as a catalyst for bringing
health-related products to the consumer while also building companies
that create high-technology jobs. The funds are augmented by substantial
private money, and 21 new life-science companies were formed in
or attracted to Michigan in 2001. Interest from public and private
researchers generated nearly 300 project proposals for $45 million
to be awarded in 2002. While some proposals are in the field of
genetics/genomics, 40 focus on bio-defense.
At the international level, the massive, ongoing Human
Genome Project is designed to identify and sequence the genes in
human DNA and develop tools for analyzing the resulting data. A
feature of the U.S. government's part in the project is transferring
technology to the private sector through licensing and awards for
innovative research. In 2000 the government and a private company
announced that a first draft of the entire human genome had been
sequenced, and, more recently, three chromosomes of the total 24
in the human genome have been decoded to a high scientific standard.
Stem cell research and cloning pit doubts about the
morality of embryo experiments against the promise of treating disease.
Some people believe that harvesting stem cells from human embryos
is tantamount to homicide and any benefits derived from such research
are morally tainted. Others counter that stem cells offer staggering
potential to treat disease, and research should not be limited,
as the president has decreed, to existing stem cell lines.
The National Academy of Sciences and the Institute
of Medicine assert that public funding of research on human stem
cells derived from both adults and embryos will provide the most
efficient and responsible means to fulfill the promise of stem cells
for achieving medical breakthroughs. The academy notes that new
stem cell lines will be needed in the future to replace existing
lines compromised by age and to address concerns about cultures
using animal cells and serum that could result in health risks for
humans. The academy report continues,
Although stem cell research is on the cutting edge
of science today, it is still in its infancy, and an enormous amount
of basic research remains to be done before it can result in medical
treatments . . . Public sponsorship of basic research would help
ensure that many more scientists could pursue a variety of research
questions and that their results are made widely accessible . .
. In addition, public funding offers greater opportunities for regulatory
oversight and scrutiny of research . . . [However] Human reproductive
cloning should not now be practiced. It is dangerous and likely
Opposition to cloning a human being is nearly universal.
Advanced Cell Technology, the private company that produced a very
early, six-cell human embryo, denies interest in cloning a human;
its stated goal is to produce stem cells for research. While a very
few scientists have expressed interest in cloning a human, most
believe that apart from moral or ethical issues, it is simply too
dangerous at the current level of knowledge.
In 2001 the U.S. House of Representatives passed a
measure to prohibit human cloning. A few months later, during consideration
of an unrelated bill, the Senate defeated an amendment that would
have placed a six-month moratorium on all cloning, but it has not
acted on the cloning-prohibition bill itself. The Council of Catholic
Bishops condemns this inaction as morally irresponsible,
and asserts that the successful early-stage cloning of human embryos
has dangerous implications of playing God and devaluing human life.
Right to Life of Michigan also deplores the Senate's inaction. At
this writing, debate continues on the prohibition bill and on a
second Senate bill that would ban reproductive cloning but allow
continued cloning for medical research. The president has affirmed
his intention to sign a bill banning human cloning if it comes to
Current policy of the American Medical Association
directs its member physicians not to participate in human cloning
at this time because further investigation and discussion
regarding the harms and benefits of human cloning are required.
The final report of the National Bioethics Advisory
Commission (its charter expired in October 2001) concludes that
the federal oversight system should protect the rights and welfare
of human research participants, regardless of whether the research
is publicly or privately sponsored. Since no current entity has
the authority to develop federal policy for all research involving
human participants, the commission called for legislation creating
a single federal office.
Three to five percent of the U.S. Human Genome Project
budget is devoted to studying the ethical, legal, and social issues
surrounding the availability of genetic information; this is the
largest bioethics program in the world. Among the issues under study
are the following:
- Fairness in the use of genetic information by insurers,
courts, schools, adoption agencies, and the military: Who should
have access and how will it be used?
- Privacy and confidentiality of genetic information:
Who owns and controls it?
- Stigmatization due to an individual's genetic differences:
How does personal genetic information affect society's perceptions
of that person?
- Reproductive issues such as adequate informed consent
for complex procedures and reproductive rights: How reliable is
fetal genetic testing? What larger issues are raised by new reproductive
- Clinical issues, including the education of professionals
and the public, and the implementation of standards in testing
procedures: How will genetic tests be evaluated and regulated
for accuracy? How do we balance limitations and social risk with
- Uncertainties associated with gene tests for susceptibilities
and complex conditions: Should testing be performed when no treatment
- Philosophical implications regarding human responsibility,
free will versus genetic determinism, and concepts of health and
disease: Do people's genes make them behave in a particular way?
Where is the line between medical treatment and enhancement?
- Health and environmental issues concerning genetically
modified foods and microbes: Are such foods safe to humans and
- Commercialization of products, including property
rights such as patents and copyrights and accessibility of products:
Who owns genes and other pieces of DNA? Will patenting DNA sequences
limit their accessibility and development into useful products?
The questions surrounding genetic cloning, testing,
and research are controversial and growing more complicated with
every announcement from genetic science and biotechnology, and they
can be expected to be present on the political agenda, in scientific
research, and in public debate for some time.
See also Abortion; Crime and Corrections; Privacy.
FOR ADDITIONAL INFORMATION
American Medical Association
515 North State Street
Chicago, IL 60610
(312) 464-4184 FAX
Human Genome Project Information
Oak Ridge National Laboratory
1060 Commerce Park, MS 6480
Oak Ridge, TN 37830
(865) 574-9888 FAX
(312) 464-4184 FAX
Michigan Economic Development Corporation
300 North Washington Square
Lansing, MI 48913
(517) 335-0198 FAX
(312) 464-4184 FAX
National Academy of Sciences
2001 Wisconsin Avenue, N.W.
Washington, DC 20007
(312) 464-4184 FAX
CONTENT CURRENT AS OF APRIL 1,
© 2002 Public
Sector Consultants, Inc.
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