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


We now have plants that are insect resistant, ... de ciency Public Oversight of Human Gene Transfer Research Early concerns about genetic engineering ... – PowerPoint PPT presentation

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

Ethical problems of genetic engineering
technologies. Genetically modified food and.
Human gene transfer research
  • Human gene transfer research (HGTR) involves the
    deliberate transfer of genetic material
    (naturally-occurring, genetically-modi?ed, or
    synthetic DNA or RNA) into human subjects.
  • Clinical success has come more slowly than was
    ?rst 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 speci?c

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
  • 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.

Ornithine transcarbamylase (OTC) de?ciency
  • Gelsinger was affected by ornithine
    transcarbamylase (OTC) de?ciency. Patients with
    OTC de?ciency 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 Gelsingers symptoms were
    manageable so that, unlike subjects in other gene
    transfer trials, he approximated a healthy
  • The viral vector used in this protocol was an
    adenovirusa virus that usually causes the common
    cold. Although used in many protocols prior to
    Gelsingers 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.

Early concerns about genetic engineering
  • 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
    Presidents 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 justi?ed.

Ethical issues in human gene transfer research
  • Early ethical and social concerns surrounding
    HGTR were outlined in 1985 in the NIHs Points
    to Consider.
  • Since then, broader public and commercial
    contexts of HGTR have raised additional concerns,
    especially involving subject recruitment and
    economic con?icts 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
  • 1. Concern for the well-being of
    genetically-modified animals should be
  • 2. The effects on the offspring and possible
    repercussions for the environment should be
  • 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
  • Almost 20 years since the first gene-transfer
    trial was carried out in humans, the field has
    made significant advances towards clinical
  • 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.
  • .

Arguments in Favor of Gene Transfer Research
  • 1) germ-line gene transfer offers a true cure,
    and not simply palliative or symptomatic
  • 2) germ-line gene transfer may be the only
    effective way of addressing some genetic
  • 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

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

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.

Potential conflict of interest problems
  • Others have pointed to potential conflict of
    interest problemspitting an individual's
    reproductive liberties and privacy interests, on
    the one hand.
  • Against the interests of insurance companies, or
    society on the othernot 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

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.

Medical Prospects
  • 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, Alzheimers 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

Scientific Prospects
  • One of the ideals of science is freedom for
    self-understanding. The influence of Human Genome
    Project on human self-understanding 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.

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.