2.

6 Genetic Engineering
Marriage as a Vacation Guidelines for Catholics on the Evaluation and Treatment
Resource Allocation of Infertility
Infertile couple
Therapeutic Options

• Should genetic testing be used to identify, or predict diseases 2. Germline Gene Therapy
even when no tx is available? - reproductive or germ cells: sperm cells, egg cells,
• Do carriers of a deadly genetic disease that is likely to be passed cells from early embryos
on to their children have a duty to warn those children of the
risk? - changes in the genetic material would be passed
• Who should control genetic information about a person and what along to the person’s offspring
is a Physician’s duty regarding truth telling & confidentiality? - could result in different genetics in the offspring’s
• Is it playing God to alter someone’s genes to treat diseases or somatic cells
prevent them in future generation?
• Do carriers of a deadly genetic disease that is likely to be passed Techniques of Gene Alteration
on to their children have a duty to warn those children of the
risk?
2 Problems:
• Is it wrong for parents to use preconception genetic testing and • What kind of change to make to the gene?
embryo selection to avoid having a disabled baby? • How to incorporate that change in all other cells to
• Do these practices discriminated against disable people? achieve a desired effect?
• Should genetic technology be used to select a child’s gender or
other attributes – eye and hair color, athletic, musical ability? 1. Homologous replacement
- DNA in the gene could be replaced by another DNA
Genetic Engineering from the outside
• Can be done on any living organism because all 2. Selective reverse mutation
living organisms contain DNA within each cell - gene forced to mutate
nucleus. 3. Addition of gene
• A set of technologies used to change the genetic 4. Using a chemical
makeup of cells, including the transfer of genes - to turn off a gene and prevent it from acting
within and across species boundaries to produce
improved or novel organisms Vectors
• The same techniques used to further medical Viral Method
genetics (such as cloning, gene therapy and splicing, • All viruses bind to their host and introduce their genetic
etc.) material into the host cell as part of their replication
cycle
Therapeutic Genetics • Removing the viral DNA and using the virus as the
Gene Therapy vehicle to deliver therapeutic DNA
• Therapeutic genetic engineering • Retrovirus, adenovirus, lentivirus, herpes simplex
• Negative genetic engineering virus, vaccinia, pox virus, adeno-associated virus
• Alter genes to correct genetic defects and thus
prevent or cure diseases Non-viral Method
• Large-scale production and low host immunogenicity
Genetic Engineering
• Done by:
• Enhancement genetic engineering – Injection of naked DNA
• Positive genetic engineering – Electroporation
• Aims to modify the genes to enhance the capabilities – Gene gun
of the organism beyond what is normal – Sonoporation
Types of Gene Therapy – Magnetofection
1. Somatic Gene Therapy – Use of oligonucleotides
- Somatic cells make up the organs
Arguments in Favor of Gene Therapy
- Therapeutic genes are transferred into the
It offers the potential to cure some diseases or
somatic cells or body of the patient
disorders in those who have the problem and to
- Changing the genetic material in these cells is not
prevent diseases in those whose genes predisposed
passed along to a person’s offspring
them to these problems.
- mainstream line of current basic and clinical
research Arguments Against Gene Therapy
• Therapeutic DNA trans gene (integrated in the • Technically too dangerous
genome or as an external episome or plasmid)
• Discriminates or invites discrimination against PWDs
is used to treat a disease
• May become increasingly irrelevant in some cases
 1. Technically too dangerous
- Tragic deaths
- Specific worries
• The vectors may deliver the DNA to cells other
than the target cells
• Viruses as vectors may not be as innocuous
as assumed and may cause disease
• Adding new genes to a nucleus does not
guarantee they will go where desired
• If changes are not integrated with other DNA
already in the nucleus, the changes may not
carry over to the new cells and the person may
have to undergo more therapy later
2. Discriminates or invites discrimination against
PWDs
- People who are physically, mentally and
emotionally impaired are so as the result of
genetic factors they have inherited
- Result in disablement in the society
- Gene therapy could contribute to removing one of
the sources of discrimination in the society but the
objection sees this as a form of discrimination
against impaired people and persons with
disabilities.
3. May become increasingly irrelevant in some
cases
- In some cases may be superceded by in-vitro
fertilization and selection of embryos
Ethical Issues in Gene Therapy:
• What are good and bad uses of gene therapy?
• Will it only be available to the wealthy?
• Should people be allowed to use gene therapy to
enhance human traits (ht, intelligence or athletic
abilities)
• Because people who would be affected by germline
gen tx are NOT YET BORN, they can’t choose
whether to have the treatmen.
• Could the widespread use of gene therapy make
society less accepting of people who are different?
• Who decides which traints are normal and which
constitute a disability or disorder?
The Human Genome Project
Gene
• Genome < Gene < DNA< A T C G strands
• Each genome contains all of the information needed
to build and maintain an organism.
• In humans, a copy of the entire genome— more than
3 billion DNA base pairs—is contained in all cells that
have a nucleus.
The Human Genome Project
• World’s largest International and collaborative
scientific research project
• Proposed in 1984; Started in 1990; Declared
complete in 2003
• Determined the sequence of the human genome to
create a “map”, which can have a major impact in the
fields of medicine, biotechnology and the life
sciences
Medical Genetics
• Disease classification system:
- Genetic evidence rather than symptoms
- Change clinical practice from a routine of diagnosis
and treatment → prediction & prevention.
- Drugs will be tailored for patients whose individual
responses can be predicted by their genes.
HGP
Goals:
1. To provide a complete and accurate sequence of the
human genome
2. To develop new tools to obtain and analyze the data
and to make this information widely available.
3. To explore the consequences of genomic research
through its Ethical, Legal, and Social Implications
(ELSI) program.
Ethical, Legal, and Social Implications (ELSI) Program
- founded in 1990 as an integral part of the Human
Genome Project
- to identify and address issues raised by genomic
research that would affect individuals, families, and
society
- emphasizes 6 potential ethical problems that should
be solved before medical application
Potential Ethical Problems
1. Privacy of genetic information
- It is unjust for health personnel (physicians,
nurses, etc.) to disclose confidential genetic
information to anyone other than the individual
themselves.
Information about a person’s genes and any
abnormalities they might have.
2. Fairness in its use by the public
- Schools, employers and insurance companies
must be sensitive to genetic information and must
not unfairly judge individuals based on their
genetic status. (Genetic discrimination)
Employers will not accept an individual who has a
parent with a genetic condition they may inherit
(that would affect their work), even if they show no
symptoms of it.
3. Gene Patenting
- Issues surrounding the legal procedure of
claiming "ownership“ of a particular gene or
region of DNA.
“Is it possible to own something that is present in all
humans?”
“Is a gene present in an individual theirs or does it
belong to the person who discovered it?”
4. Genetic testing of adults, children and fetuses
- The different methods of genetic testing for each
type of individual raises different questions.
“Do parents have a right to screen a child for a
disease if the result may affect the child's mental
well-being?"
“Does the child have a right to deny testing even if
the parents want it carried out?"
 5. Human reproductive choices and responsibility
- The uncertain border between enhancements in
gene therapy that are either needed to survive or
improve their life.
”Does improving someone's life include disease
symptom reduction or cosmetic improvement (like
changing skin color)?”
6. Psychological issues
- For those individuals specifically associated with
being diagnosed with a particular gene
“A 20 year old individual who finds out they are
unlikely to live past the age of 30 may cause a
dramatic psychological response, such as anxiety
or depression"
Cloning
• Processes used to create an exact genetic replica of
another cell, tissue or organism
• Clone: the copied material, which has the same genetic
makeup as the original
• The most famous clone was a Scottish sheep named
Dolly.
• Gene cloning
- creates copies of genes or segments of DNA
• Reproductive cloning
- creates copies of whole animals
• Therapeutic cloning
- creates embryonic stem cells
Types:
1. Gene cloning
- aka recombinant DNA technology, molecular
cloning, DNA cloning
- only the DNA of a cell is replicated
- a DNA from an organism is transferred to a self-
replicating genetic element such as a bacterial
plasmid
Cloning: an organism vs. a gene
• Organism: make an exact genetic copy of the
whole organism
• Gene: isolate and make exact copies of just one
of an organism's genes
2. Reproductive cloning
- generate an animal that has the same nuclear
DNA as another currently or previously existing
animal. Human cloning also falls into this
category.
- Dolly: "somatic cell nuclear transfer" (SCNT), the
DNA information from the nucleus of a donor adult
cell is copied into a cell whose nucleus (thus also
its genetic material) has been removed.
Somatic Cell Nuclear Transfer (SCNT)
• Somatic cell: any cell in the body other than
sperm and egg, the two types of reproductive
cells.
• Nuclear: compartment that holds the cell's DNA.
The DNA is divided into packages called
chromosomes, and it contains all the
information needed to form an organism.
• Transfer: Moving an object from one place to
another. To make Dolly, researchers isolated a
somatic cell from an adult female sheep. Next
they removed the nucleus and all of its DNA
from an egg cell. Then they transferred the
nucleus from the somatic cell to the egg cell.
After a couple of chemical tweaks, the egg cell,
with its new nucleus, was behaving just like a
freshly fertilized egg. It developed into an
embryo, which was implanted into a surrogate
mother and carried to term.
• Dolly, was an exact genetic replica of the adult
female sheep that donated the somatic cell. She
was the first-ever mammal to be cloned from an
adult somatic cell.

Prenatal and Genetic Testing and Counseling
3. Therapeutic cloning
• like reproductive cloning, except that the embryos
are not allowed to develop fully.
• The purpose is to extract the stem cells from the
embryos and study them. When the egg has been
cloned and divided for 5 days, the stem cells are
extracted from it. The embryos are destroyed due
to the extraction process, which raises ethical
concerns.
• But why the need for stem cells? Stem cells are
unspecialized cells which can transform into any of
the 220 cell types that are in the human body.
• In November 2001, Advanced Cell Technologies
(ACT)
- cloned the first human embryos for the purpose
of advancing therapeutic research
Pros and Cons of Cloning
Pros of Cloning
• Organ replacement
• Substitute for natural reproduction
• Genetic research
• Obtain specific traits in organisms
Cons of Cloning
• Detrimental to genetic diversity
• Safety Problems
– Risk to the child
– Risk to the egg donor and mother
– Risk to animals
• Invitation to malpractices
• Will this technology reach the common man?
• Man, a Man-made being
Prenatal Testing
- tests performed during a pregnancy to provide
information about the health of a developing fetus
- screen for or diagnose a birth defect, characteristics
of the baby, including size, sex, age, and placement
in the uterus
- science of identifying structural and functional
abnormalities of the developing fetus
Goals:
1. to enable timely medical or surgical treatment of a
condition before or after birth
2. to give the parents the chance to abort a fetus
with the diagnosed condition, and
3. to give parents the chance to "prepare"
psychologically, socially, financially, and medically
for a baby with a health problem or disability, or
for the likelihood of a stillbirth
Non-Invasive
• Ultrasound
Invasive
• Amniocentesis
• Chorionic Villus Sampling (CVS)
• Percutaneous umbilical blood sampling
(Cordocentesis/Funiculocentesis)
1. Ultrasound
- most widely used method of prenatal diagnosis
- in the 2nd trimester of pregnancy
- detects 30% to 50% of all major birth defects,
such as developmental problems in the limbs,
spine and abdomen
- presents no proven risk to the fetus, although it is
not recommended to be used excessively
2. Chorionic Villus Sampling (CVS)
- most common 1st trimester invasive prenatal
diagnostic test for fetal karyotype and molecular
and biochemical abnormalities
- Ultrasound guided sampling of the placental
tissue usually between 10 to 13 ± 6 weeks AOG
3. Amniocentesis
- Diagnose fetal chromosome problems as early as
14-20 weeks AOG (2nd trimester)
- Alpha-fetoprotein (AFP) in the amniotic fluid help
screen for birth defects such as spina bifida,
Down's syndrome, etc.
4. Percutaneous umbilical blood sampling
(Cordocentesis/Funiculocentesis)
• Ultrasound-guided procedure of getting fetal
blood sample through the umbilical cord
• Indicated for:
- Cytogenetic diagnosis of heritable disease
and structural abnormality
- Diagnosis of fetal infection
- Diagnosis of coagulopathies
- Platelet disorder
- Fetal therapy
Is prenatal diagnosis morally licit?
• If prenatal diagnosis respects the life and integrity of
the embryo and the human fetus and is directed
towards its safeguarding or healing as an individual,
then the answer is affirmative.
• "... [Prenatal diagnosis] is permissible...if the methods
employed safeguard the life and integrity of the
embryo and the mother, without subjecting them to
disproportionate risks.
• But this diagnosis is gravely opposed to the moral law
when it is done with the thought of possibly inducing
an abortion depending upon the results...”
- Vatican Congregation for the Doctrine of the
Faith's document Donum Vitae (1987)
• It is “morally licit” to use “prenatal diagnostic
techniques which enable the early detection of
possible anomalies in the unborn child...when they do
not involve disproportionate risks for the child and the
mother, and are meant to make possible early therapy
or even to favor a serene and informed acceptance of
the child not yet born.”
- The Gospel of Life, Pope John Paul II
Are Therapeutic Procedures Carried Out on the Human
Embryo Licit?
• A strictly therapeutic intervention whose explicit
objective is the healing of various maladies such as
those stemming from chromosomal defects will, in
principle, be considered desirable, provided it is
directed to the true promotion of the personal well-
being of the individual without doing harm to his
integrity or worsening his conditions of life. Such an
intervention would indeed fall within the logic of the
Christian moral tradition.”
- Roman Catholic Church (1987)
Genetic Counseling
- originally defined in 1975 by the American Society of
Human Genetics:
“...a communication process which deals with the
human problems associated with the occurrence
or risk of occurrence of a genetic disorder in a
family.
This process involves an attempt by one or more
appropriately trained persons to help the
individual or family to:
• medical facts including the diagnosis, probable
course of the disorder, and the available
management
• appreciate the way heredity contributes to the
disorder and the risk of recurrence in specified
relatives
• understand the alternatives
• course of action
• to make the best possible adjustment
Ethical Principles
• Right to life
• Autonomy
- Voluntariness to submit to prenatal testing
• Free and Informed Consent
• Confidentiality and Disclosure
- Moral responsibility to inform children/relatives at
risk
- Disclosed to employers only with the explicit
consent of the person tested
• Principle of Totality
• Principle of Stewardship
• Principle of Beneficence
• Principle of Non-Maleficence
Genetic Testing
1. Newborn screening
2. Carrier testing
3. Predictive testing
4. Diagnostic testing
5. Prenatal testing
6. Preimplantation genetic diagnosis
 3. Multipotent Stem Cells
Adult and Stem Cell Research Therapy - able to give rise to several different types of
specialized cells constituting a specific tissue or
organ

Stem Cell Therapy

- use of stem cells to treat or prevent a disease or
condition
• Bone marrow transplant is the most widely used
stem cell therapy, but some therapies derived from
Types: umbilical cord blood are also in use.
1. Totipotent Stem Cells
- Each cell can develop into a new embryo and they Ethics
have the potential to generate every cell type in Embryonic Stem Cell Research
the body - Cells are derived in vitro around the fifth day of
the embryo's development
- “Spare” embryos created from artificial
reproductive methods are the usual source of
stem cells used in research.
- Church has consistently opposed research on
embryonic stem cells as these advance through
the suppression of human lives that are of equal
dignity to the life of any other human individual.
2. Pluripotent Stem Cells - “Obtaining stem cells from a living human embryo
- have the potential to generate every cell type in invariably causes the death of the embryo and is
the body, but cannot develop into an embryo on gravely illicit” -Dignitas Personae, 2008
their own Rationale for Opposition
✗ The preparation of embryonic stem cells from a
living embryo requires the destruction of the
embryo, which the Church teaches is a gravely
immoral act.
✗ Some scientists have used cloning to produce
embryos in order to harvest stem cells. The
Church recognizes that they (cloned embryos),
too, are alive, and their destruction is gravely
immoral.
-Declaration on the Production and
the Scientific and Therapeutic Use of Human
Embryonic Stem Cells, 2000
 Non-Embryonic Stem Cell Research
- Uses adult and umbilical cord stem cells
- Harvesting adult stem cells does not involve the
destruction of embryos
- Use of adult stem cells for biomedical purposes
avoids some of the ethical concerns in research
involving the use of embryonic stem cells.
- Catholic Church has publicly supported adult and
umbilical-cord stem-cell research
“ Methods which do not cause harm to the subject
from whom the stem cells are taken are to be
considered licit. Such is generally the case when
tissues are taken from an adult organism, cord
blood taken at the time of birth and fetuses who die
of natural causes.” - Dignitas Personae, 2008
“No end believed to be good, such as the use of stem
cells for the preparation of other differentiated cells
to be used in what look to be promising therapeutic
procedures, can justify an intervention of this kind.
A good end does not make right an action which in
itself is wrong.”
-Declaration on the Production and the
Scientific and Therapeutic Use of Human
Embryonic Stem Cells, 2000
Adult Stem Cell Research and Therapy
Adult Stem Cell
- Undifferentiated cell
- multiply by cell division to replenish dying cells and
regenerate damaged tissues
- also known as somatic stem cell
Defining Properties:
• Self renewal
- ability to go through numerous cycles of cell
division while still maintaining its undifferentiated
state
• Multipotency or multidifferentiative potential
- the ability to generate progeny of several distinct
cell types
Adult Stem Cell Therapy
- The therapeutic potential of adult stem cells is the
focus of much scientific research
- In common with embryonic stem cells, adult stem
cells have the ability to differentiate into more than
one cell type, but unlike the former they are often
restricted to certain types or "lineages".
- transdifferentiation: the ability of a differentiated stem
cell of one lineage to produce cells of a different
lineage.
- Adult stem therapies require a stem cell source of the
specific lineage needed, and harvesting and/or
culturing them up to the numbers required is a
challenge
- successfully treat leukemia and related bone/blood
cancers utilizing bone marrow transplants.
✓ adult stem cells in research and therapy is not
considered as controversial because the production
of adult stem cells does not require the destruction of
an embryo
✗ embryonic stem cells: not morally licit
Basic Ethical Dilemma
• Progress in biomedical research has led to the
development of unique approaches in the treatment of
diseases
• Raises complex ethical questions
• Brings to fore the conflict between two fundamental
ideals:
– Prevention or alleviation of human suffering
– Respect human dignity and the intrinsic value of
human life
• The Catholic Church “appreciates and encourages the
progress of the biomedical sciences which open up
unprecedented therapeutic prospects”
-Address of Pope Benedict XVI (1/21/08)
• Church also reminds us that true service to humanity
begins with respect for each and every human life.
Respect for Human Dignity
• It now seems undeniable that once we cross the
fundamental moral line that prevents us from treating
any fellow human being as a mere object of research,
there is no stopping point. The only moral stance that
affirms the human dignity of all of us is to reject the first
step down this path. We therefore urge Catholics and
all people of good will to join us in reaffirming, precisely
in this context of embryonic stem cell research, that
“the killing of innocent human creatures, even if carried
out to help others, constitutes an absolutely
unacceptable act.
- Pope John Paul II . Evangelium Vitae, 1995
In the Philippines:
RA No. 3720, as amended by RA No. 9711, which
mandates the FDA:
• “to conduct appropriate tests on all applicable health
products prior to the issuance of appropriate
authorizations to ensure safety, efficacy, purity, and
quality” (Section 4h); and
• “to develop and issue standards and appropriate
authorizations that would cover establishments,
facilities and health products” (Section 4m).
Genetic Engineering In The Philippines
Executive Order No. 430 in 1990
• The Philippines is the first ASEAN country to initiate
a biotechnology regulatory which established the
National Committee on Biosafety of the Philippines
(NCBP).
NBCP
• Formulate
• Review
• Amend: national policy on biosafety and formulate
guidelines on the conduct of activities on genetic
engineering
Composition: representatives from Departments of:
• Agriculture (DA)
• Environment and Natural Resources (DENR)
• Health (DOH)
• Science and Technology (DOST), 4 scientists in
biology, environmental science, social science and
physical science; and 2 respected members of the
community.
Informed Consent • These virtues indicate balance, moderation, and
Genetic Exceptionalism clarity of judgment. These are evident in the social
• Whether the consequences of the results of those and political teachings of St. Thomas and it is
tests are substantively different from the important that Catholic physicians should imbibe and
consequences of other "medical" tests, for which practice them.
specific consent is not always obtained.
• They maintain that many medical tests have
consequences for patients that are similar to those of
genetic tests.

Role of Physicians
• Physicians should inform their patients of that fact and
help them to prepare for dealing with their results,
including considering disclosure to their biologic
family.
• If the genetic information could potentially benefit
family members (eg, allow them to improve their own
prognosis), physicians should guide their patients
toward voluntary disclosure while assiduously
guarding their right to confidentiality.
On BRCA+ Individuals:
Principle of Totality and Integrity
1. There must be a question of intervention in the part
of the body that is either afflicted or is the direct
cause of the life-threatening situation
2. There can be no other alternatives for preserving a
life
3. There is a proportionate chance of success in
comparison with drawbacks
4. Patient must give assent to the interventions
CRISPR Ethical Issues
1. the extent to which CRISPR use should be permitted
2. access to CRISPR application
3. whether a regulatory framework(s) for clinical
research involving human subjects might
accommodate all types of human genome editing,
including editing of the germline
4. whether international regulations governing
inappropriate CRISPR utilization should be crafted
and publicized
5. moral decision making should evolve
-CRISPR Ethics: Moral Consideration for
applications for a Powerful Tool. (2019)

Use of Human Embryonic Stem Cells

Ethical Problems
1. Is it morally licit to produce &/or use living human
embryos for the preparation of ES cells?
2. Is it morally licit to engage in therapeutic cloning by
producing cloned human embryos and then destroy
them in order to produce ES cells?
3. Is it morally licit of use ES cells & the differentiated
cells obtained from them, which are supplied by
other researchers or are commercially obtainable?
ADULT STEM CELLS

Virtues of A Catholic Healthcare Provider

Intellectual Moral Theological
• Prudence • Justice • Faith
• Temperance • Hope
• Fortitude • Charity