Transcript Ethical problems of genetic engineering technologies. Genetically modified food and. products.

Ethical problems of genetic
engineering technologies.
Genetically modified food and.
products.
Human gene transfer research
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Human gene transfer research (HGTR) involves the
deliberate transfer of genetic material (naturallyoccurring, genetically-modified, or synthetic DNA or
RNA) into human subjects.
Clinical success has come more slowly than was first
predicted, but HGTR remains a fundamentally novel
approach to medical practice. It may one day enable
clinicians to cure genetic disorders at their source, as
well as provide oncologists with tools designed to
disable or cure specific cancers.
Clinical Successes and Setbacks
In March 2000 Katherine A. High and Mark A. Kay
reported that subjects with hemophilia B
experienced an increase in factor IX protein
activity for at least six months after the gene
transfer.
 Yet this long awaited clinical progress has been
tempered by setbacks. In December 2002 a
subject in the hemophilia-B study developed signs
of liver injury, halting the trial.
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Ornithine transcarbamylase (OTC)
deficiency
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Gelsinger was affected by ornithine transcarbamylase
(OTC) deficiency. Patients with OTC deficiency lack an
enzyme needed for processing nitrogen with the result that
toxic levels of ammonia accumulate in their bloodstreams,
leading to severe mental impairment and even death. But
Gelsinger’s symptoms were manageable so that, unlike
subjects in other gene transfer trials, he approximated a
healthy volunteer.
The viral vector used in this protocol was an adenovirus—a
virus that usually causes the common cold. Although used
in many protocols prior to Gelsinger’s death, in his case the
vector triggered a deadly immune response.
Public Oversight of Human Gene
Transfer Research
HGTR is overseen in the United States by two
agencies within the Department of Health and
Human Services: the NIH and the Food and
Drug Administration (FDA).
 While FDA review is “public” insofar as it
involves federal oversight, NIH review through
the Recombinant DNA Advisory Committee
(RAC) is truly a forum open to the public.
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Early concerns about “genetic
engineering
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Serious debate about human gene transfer began in the 1960s,
when scientists, theologians, and philosophers raised many
concerns about genetic engineering, or genetic manipulation.
Theoretical concerns evolved into real possibilities in 1972
when scientists discovered how to combine genetic material
from different organisms.
One of the most important outcomes of these events was the
1982 publication of Splicing Life, a report on human gene
transfer issued by the President’s Commission for the Study
of Ethical Problems in Medicine and Biomedical and Behavioral
Research. The commission argued that only transfer into
somatic tissues to prevent or treat disease could be justified.
Ethical issues in human gene
transfer research
Early ethical and social concerns surrounding
HGTR were outlined in 1985 in the NIH’s “Points
to Consider.”
 Since then, broader public and commercial
contexts of HGTR have raised additional
concerns, especially involving subject recruitment
and economic conflicts of interest. These issues
become increasingly important as HGTR moves
toward new applications and methods.
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Fundamental ethical conditions which must be respected
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1. Concern for the well-being of genetically-modified animals
should be guaranteed;
2. The effects on the offspring and possible repercussions
for the environment should be considered;
3. Such animals should be kept under tight control and
should not be released into the general environment;
4. The number of animals used in experiments should be
kept to a bare minimum;
5. The removal of organs and/or tissues must take place
during a single surgical opera-tion;
6. Every experimental protocol on animals must be
evaluated by a competent ethics committee.
History of gene-transfer
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Almost 20 years since the first gene-transfer trial was carried out
in humans, the field has made significant advances towards
clinical application.
Nevertheless, it continues to face numerous unresolved ethical
challenges — among them are the question of when to initiate
human testing, the acceptability of germline modification and
whether the technique should be applied to the enhancement of
traits.
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Arguments in Favor of Gene Transfer Research
1) germ-line gene transfer offers a true cure, and not simply
palliative or symptomatic treatment;
2) germ-line gene transfer may be the only effective way of
addressing some genetic diseases;
3) by preventing the transmission of disease genes, the
expense and risk of somatic cell transfer for multiple
generations is avoided;
4) medicine should respond to the reproductive health
needs of prospective parents at risk for transmitting serious
genetic diseases;
5) the scientific community has a right to free inquiry, within
the bounds of acceptable human research.
Arguments Against Gene Transfer Research
1) germ-line gene transfer research would involve too much
scientific uncertainty and clinical risks, and the long term effects
of such research are unknown;
2) such gene transfer research would open the door to attempts
at altering human traits not associated with disease, which could
exacerbate problems of social discrimination;
3) as germ-line gene transfer involves research on early
embryos and effects their offspring, such research essentially
creates generations of unconsenting research subjects;
4) gene transfer is very expensive, and would never be
costeffective enough to merit high social priority; and
5) germ-line gene transfer would violate the rights of subsequent
generations to inherit a genetic endowment that has not been
intentionally modified
The difficulty of following up with patients in
long-term clinical research
Other commentators have pointed to the
difficulty of following up with patients in
long-term clinical research (III. Ledley
1993).
 Some are troubled that many gene
transfer candidates are children too young
to understand the ramifications of gene
transfer research.
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Potential conflict of interest
problems
Others have pointed to potential conflict of
interest problems—pitting an individual's
reproductive liberties and privacy interests,
on the one hand.
 Against the interests of insurance companies,
or society on the other—not to bear the
financial burden of caring for a child with
serious genetic defect. Issues of justice and
resource allocation have also been raised: in
a time of strain on our health care system,
can we afford such expensive research?
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Human genome project
Progress in molecular biology has enabled us
to better understand human genetic disease,
and has helped enhance the quality of life.
This has been possible with technical
developments to detect genetic disease
presymptomatically.
 Presymptomatic testing would not yield
information about the carrier status of an
individual but also about other family
members. Such information may lead to
unreasonable beliefs and could alter social
relationships.
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Medical Prospects
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The sequencing of the entire genome has already
had a profound impact on the wider spectrum of
clinical research, as it opens a new horizons for
not only treatment of diseases but looking at the
most fundamental causes of diseases. Already the
genes for many diseases including for example,
various cancers, Alzheimer’s disease, and
polycystic kidney disease, have been identified.
Genomic sequencing allows rapid and accurate
diagnosis for individuals. Initially the sequencing of
human genome has led to a shift towards
preventive medicine rather than curative, because
further research is needed to develop therapies.
Scientific Prospects
One of the ideals of science is freedom for
self-understanding. The influence of Human
Genome Project on human selfunderstanding has been heralded as
revolutionary. The sequencing of the genome
will provide new clues on how we evolved.
 It would help us to understand what it means
to be a human from different historical
perspectives of bioarchealogy, anthropology,
evolution, and human migration.
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Agricultural Prospects
Genetically-Modified Organisms (GMOs) are
already a hot topic in agriculture and livestock
breeding. GMOs are organisms with genes
modified for one or the other trait. We now
have plants that are insect resistant, disease
resistant, drought and cold resistant.
 We have farm animals that are healthier,
more productive and disease resistant. Other
plants and animals that are genetically
modified include ones that incorporate
vaccines in an edible form, or deliver
hormones.
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