Bioethics

Dr. Vignesh Muthuvijayan

Department of Biotechnology

Ethics vs. Regulations

Do you know the difference?
Ethics
Moral guidelines based on individual values

Regulation
Rules imposed by an external agency
Examples of such agency relevant to Biotech?

What Will Not Talk About

Agencies involved in policy making
Regulations governing ethical debates
These vary with countries and states

What is Bioethics?
Study of ethical issues related to advances in
biology and medicine

Factors in Ethics/Bioethics
Legal factors
Rules can guide what is right and wrong

Organizational factors
Ethics of the leader
Values imbibed through policies, publications, and speeches

Individual factors

Moral development
Personal values and personality
Religious influences
Family and peer influences
Life experience
Situational factors
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Bioethical Issues
Can you think of some major issues grappling bioethics?

Todays Topics
Medical care
Abortion
Physician-assisted
suicide
Prenatal genetic
screening

Biotech products
GM food

Biological research

Informed consent
Animal testing
Embryonic stem cells
Human reproductive
cloning
Human genetic
enhancement

Ethical issues in medical care

ABORTION

Abortion
Why is abortion a major ethical debate?

Abortion
Pro-choice

Pro-life

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Abortion Where People Stand?

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Death of Savita Halappanavar

Denied an abortion as the

miscarried fetus had a heartbeat
Died of bacterial infection, which
likely caused miscarriage
Became a major controversy
Arulkumaran report
inadequate assessment and
monitoring
failure to offer all management
options to a patient
non adherence to clinical
guidelines related to the prompt
and effective management of
sepsis
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Arguments
What are your pro-choice arguments?
What are your pro-life arguments?

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Arguments
Pro-choice
No scientific consensus on
when life starts
Women have the right to
control their body
Government shouldnt
make medical decisions

Pro-life
Murder of a human being
A womans right to control
her body doesnt include
right to kill another being
Govt should protect the
rights of the baby

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Ethical issues in medical care

PHYSICIAN ASSISTED SUICIDE

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Euthanasia vs. Physician-Assisted Suicide

Euthanasia
Physician takes an active role in carrying out patients
request
Usually involves intravenous delivery of a lethal
substance

Physician-assisted suicide
Making lethal means available to the patient to be
used at a time of the patients own choosing
Easier emotionally for the physician as he or she does
not have to directly cause a death
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Hippocratic oath
Expression of ideal conduct of a
physician
refrain from doing harm
give no deadly medicine to any
one if asked, nor suggest any such
counsel
Some version of this is
undertaken by many medical
students
Used as an argument against
euthanasia
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Physician-Assisted Suicide
Is it a violation of refrain from doing harm if PAS is for a
terminally ill patient?
Death could be a welcome relief

Should PAS be sanctioned despite give no deadly

medicine to any one if asked, nor suggest any such
counsel?
Is the Hippocratic oath even valid today?
Isnt a medical oath; you pledge allegiance to pagan Gods and
Goddesses
Was formulated by a group (in late 5th century BCE) that was
opposed to PAS
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Physician-Assisted Suicide

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Karen Ann Quinlan

Consumed diazepam,
dextropropoxyphene and
alcohol during a crash diet
Slipped into coma followed
by persistent vegetative state
Parents requested to
disconnect Karens respirator
Request was denied by
doctors
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Karen Ann Quinlan

Parents filed a case in 1975
New Jersey Superior Court
denied
Parents appealed
New Jersey Supreme Court
granted in 1976
Respirator was disconnected
Karen continued to breathe
Survived for 9 more years
Died in 1985 of respiratory failure
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Dr. Jack Kevorkian: Visionary or Villain?

Pathologist who (allegedly) assisted suicides of
over 130 patients with devices that he built

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Dr. Jack Kevorkian: Visionary or Villain?

Monickered as Dr. Death
My aim was not to cause death,
thats crazy. My aim was to end
suffering (2008)
Assisted suicide of Janet Adkins in
1990 using Thanatron
Administered lethal injection to
Thomas Youk on September 17, 1998
Taped this and later broadcast it on
national TV

Convicted for 2nd degree murder

Served over 8 years in prison
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PAS Arguments
What are your arguments supporting PAS?
What are your arguments opposing PAS?

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PAS Arguments
Supporting
Dying with dignity should be
a fundamental freedom
Pain and suffering can be
minimized for patients,
family and friends
Healthcare costs reduced

Opposing
Request for assisted suicide
could just be a cry for help
Suicidal intent is transient
Pain is controllable
Terminally ill patients could
be depressed, and
depression is treatable
Legalizing PAS for terminal
illness will spread nonvoluntary euthanasia
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Ethical issues in medical care

PRENATAL GENETIC SCREENING

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Prenatal Diagnosis
Ultrasounds are commonly performed to
monitor development of a fetus

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Prenatal Genetic Screening

Combined test
10-14 weeks pregnant women
Blood test and an ultrasound
Screens for Downs, Edwards, and Pataus
syndromes
Doesnt tell you if the fetus has any of these
syndromes
Tells if there is a higher or lower risk

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Prenatal Genetic Screening

Low risk doesnt mean no
chance
Higher risk Amniocentesis
or chorionic villus sampling
1% risk of miscarriage during
diagnostic testing

If diagnosed with a syndrome,

choice between continuation
vs. termination
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Prenatal Genetic Screening

Should prospective parents be allowed to
acquire whatever genetic information they
want about their fetus?
Success of human genome project makes it urgent
to understand the ethics behind genetic testing

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Prenatal Genetic Screening

Where do we stop?
Is it okay to test for chance of heart disease?
How about chance of getting cancer?
How about chance of diabetes?
How about potential IQ?

Although some of these questions are not

applicable in todays technology, with the pace
of scientific advancements, you might actually
face these dilemmas in your lifetime
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Ethical issues in biotech products

GENETICALLY MODIFIED FOOD

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Genetically Modified Foods

Answer True or False*
All plants contain genes
Only genetically modified plants contain genes
Plants can be modified to contain animal genes
A tomato containing a jellyfish gene would taste
like squid
Genetically modified foods are available at a store
near you
I have never eaten a genetically modified food
*From Markkula Center for Applied Ethics

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Genetically Modified Foods

What GM foods have I eaten?

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Genetically Modified Food

Before modern biotechnology
Modifying crops through selection, breading and
crossing

After advancements in molecular biology

Deletion and insertion of gene(s)
Novel traits

Increased yield
Disease resistance
Longer shelf-life
Enhanced nutrient content

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Arguments
What are your arguments supporting GM
food?
What are your arguments opposing GM food?

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Ethical Concerns
Is genetic engineering meddling with nature?
Yes, we cant predict potential ramifications
No, it is an evolution of traditional selective
breeding

What are possible future effects of GM foods?

Positive: Can lead to a sustainable future
Negative: May pose serious environmental, socioeconomic, and health problems for future
generations
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Ethical Concerns
Will this help the developing world?
Yes, GM crops can increase food supply to
malnourished people
No, Africa and other under-developed parts of the
world could be used as dumping grounds

Is patenting of these GM crops ethical?

Patenting will help in revenue, which is an
incentive for innovation
Patenting removes the possibility of a sustainable
future
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Ethical issues in biological research

INFORMED CONSENT

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What is Informed Consent?

Providing sufficiently detailed information to

participants before they consent to participate
Includes:
Purpose of the study
Expected duration
Procedures of the study
Information on their right to decline or
withdraw
Foreseeable consequences of withdrawing
or declining
Potential risk, discomfort, or adverse effects
Prospective research benefits
Incentives
Whom to contact for questions
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Henrietta Lacks
1951 31-year old Henrietta Lacks died
of cervical cancer in Johns Hopkins
University
Dr. George Gey
Worked on culturing human cells
Received Lacks cells

Lacks cells obtained without informed

consent
Survived and reproduced an entire
generation every 24 h
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Henrietta Lacks
First time human cells grew and
reproduced outside human body
First immortal cell line (HeLa) was created
More than 50 million tonnes of HeLa cells
have been grown since she died
Over 60,000 papers have used her cells
Millions of dollars
Thousands of scientific careers
Hundreds of millions of patients
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Violation of Privacy
Genetic characteristics of HeLa cell
Paper published by McKusick et al. in 1976
Breached many confidentiality rules that are
very serious today

A Conspiracy of Cells: One Womans

Immortal Legacy and the Medical Scandal
it Caused
Book published by Michael Gold
Described her autopsy
He was given access to medical records
without family consent
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Violation of Privacy
In 2013, genome was published
without permission
NIH and Lacks family have come to an
agreement
Family gets some control over access to cells
DNA code
Acknowledgement in scientific papers
Two family members join the six member
committee which will regulate access to the
code

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Tuskegee Syphilis Experiment

1932-72 by US Public Health Service
Study of natural progression of untreated
syphilis in rural African-American men in
Alabama

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Tuskegee Syphilis Experiment

Participants were not informed about their
disease
Participants were not treated
Although penicillin was identified as an effective
antibiotic against syphilis

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Ethical issues in biological research

ANIMAL TESTING

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Animal Testing
Used to develop new
medicines
Test safety of
experimental medical
procedures
E.g. Monkeys in polio
research, Cats in antihypertensive drug
research
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Animal Testing
What are your thoughts?

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A Scientists Perspective

Medical progress depends on animal research

Human testing will become riskier
In vitro studies are performed ahead
In vitro systems wont provide comprehensive understanding
Care is taken to make the process as humane as possible
3Rs replacement, reduction, and refinement

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A Philosophers Perspective
Supporting Animal Testing
Animals are not morally equal to humans
Lesser cognitive capabilities
Lesser autonomy

Animals dont have the same rights as humans

Does this mean infants and mentally challenged
humans are also not morally equal to other fully
developed humans?
But these humans come really close, so cant be
considered the same as animals
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A Philosophers Perspective
Opposing Animal Testing
Animals have some moral
status
Wrong to abuse/hurt pets
and other animals

Strongest supporter for

animal rights
Humans and animals are
equal
Otherwise it is speciesism

Deserve fundamental rights

and freedoms
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An Animal Activists Perspective

Animals are exposed to too much
suffering
Better alternatives than animal
research
We dont have the right to exploit
natures beings

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Ethical issues in biological research

EMBRYONIC STEM CELLS

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Embryonic Stem Cells

What are stem cells?

What are embryonic stem cells?
What are the other types of stem cells?
Why embryonic stem cells?

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Embryonic Stem Cells

How are embryonic stem cells obtained?

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Ethical Questions
Similar to abortion: when does life start?
Is it okay to create embryos purely for
destroying it?

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Ethical issues in biological research

HUMAN REPRODUCTIVE CLONING

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What is Cloning?
Creating a genetic copy of a sequence of DNA
or a whole genome

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What is Reproductive Cloning?

Somatic cell nuclear transfer
Different from IVF

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Dolly The Most Popular Sheep

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Should We Clone Humans?

Why should we clone humans?
Why shouldnt we clone humans?

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Reasons for Wanting Human

Reproductive Cloning
May be the only way to have a genetically
related child
Avoid sharing of DNA in the child
Replacement child
Cloning of replacement pets

Control over childs genome

Creating an ideal donor
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Reasons Against Human Reproductive

Cloning
Cloning is unnatural and wrong
Clones identity and individuality are
threatened
Clones could be created purely as donors
Clones could be discriminated against
Could be an evolutionary disadvantage

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Ethical issues in biological research

HUMAN GENETIC ENHANCEMENT

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Debate on Creating a Super Hero

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