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?

2

What Will Not Talk About

• Agencies involved in policy making

• Regulations governing ethical debates

• These vary with countries and states

3

What is Bioethics?

• Study of ethical issues related to advances in biology and medicine

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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?

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Today’s 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

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ABORTIONEthical issues in medical care

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Abortion

• Why is abortion a major ethical debate?

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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 shouldn’t make medical decisions

Pro-life

• Murder of a human being

• A woman’s right to control her body doesn’t include right to kill another being

• Govt should protect the rights of the baby

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PHYSICIAN ASSISTED SUICIDEEthical issues in medical care

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Euthanasia vs. Physician-Assisted Suicide

• Euthanasia– Physician takes an active role in carrying out patient’s

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 patient’s 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?

– Isn’t 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 Karen’s 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, that’s 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 non-voluntary euthanasia

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PRENATAL GENETIC SCREENINGEthical issues in medical care

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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 Down’s, Edwards’, and Patau’ssyndromes

• Doesn’t 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 doesn’t 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 today’s technology, with the pace of scientific advancements, you might actually face these dilemmas in your lifetime

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GENETICALLY MODIFIED FOODEthical issues in biotech products

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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

33*From Markkula Center for Applied Ethics

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 can’t 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, socio-economic, 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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INFORMED CONSENTEthical issues in biological research

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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 Woman’s 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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ANIMAL TESTINGEthical issues in biological research

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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 anti-hypertensive drug research

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Animal Testing

• What are your thoughts?

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A Scientist’s Perspective

• Medical progress depends on animal research

• Human testing will become riskier

• In vitro studies are performed ahead

• In vitro systems won’t provide comprehensive understanding

• Care is taken to make the process as humane as possible

• 3Rs – replacement, reduction, and refinement

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A Philosopher’s Perspective –Supporting Animal Testing

• Animals are not morally equal to humans

– Lesser cognitive capabilities

– Lesser autonomy

• Animals don’t 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 can’t be considered the same as animals

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A Philosopher’s 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 Activist’s Perspective

• Animals are exposed to too much suffering

• Better alternatives than animal research

• We don’t have the right to exploit nature’s beings

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EMBRYONIC STEM CELLSEthical issues in biological research

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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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HUMAN REPRODUCTIVE CLONINGEthical issues in biological research

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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 shouldn’t 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 child’s genome

• Creating an ideal donor

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Reasons Against Human Reproductive Cloning

• Cloning is unnatural and wrong

• Clone’s 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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HUMAN GENETIC ENHANCEMENTEthical issues in biological research

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Debate on Creating a Super Hero

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