1. The Ethics of Genomics Are GMOs Bad? Is Genetic Testing Good?
How Should the Public Be Informed of New Discoveries?
Should We Clone Humans?

2. GMOs- Genetically Modified Organisms
Is the modification of genomes intrinsically wrong or enormously beneficial?
Many choose to evaluate this question on a case-by-case basis
Golden Rice
Biological Plastics
Pharmaceutical Produce
Sterile Fruit
Pest-Resistant Plants
Xenotransplants

3. Golden Rice Rice is the staple food for 124 million people
Many of these same people suffer from a vitamin A deficiency- which causes blindness
Vitamin pills are not feasible in countries which lack $ and infrastructure
In Jan 2000, rice was transformed with 3 genes which allow it to make b-carotene
Two of these genes came from daffodil and one came from bacteria
Testing is being performed in the Philippines, Africa, China, India, and Latin America

4. So, What’s the Controversy?
All commercial rights to Golden Rice has been transferred to Syngenta, the world’s largest agribusiness
Syngenta has promised to provide Golden Rice to all subsistence farmers free of charge
Organizations such as Greenpeace believe this is a ploy to introduce more GMOs into developing countries where resistance is limited
Syngenta claims that only strains consumed within the developing country will be bred, not ones which could then be sold in the West

5. Biological Plastics Plastic is usually made from petroleum products
PHA (polyhydroxyalkanoate) is a naturally occurring form of polyester
It was 1st described in 1925
PHA uses renewable resources and is biodegradable
GMOs have been modified to produce PHA
Metabolix is one company working with GMOs in this way

6. Pharmaceutical Produce
Edible plants have been engineered to deliver vaccinations
Arntzen and colleagues produced the 1st prescription potato
Unfortunately, raw potatoes work best to deliver medicine - cooked ones lose 50% of their potency
Increased consumption may make up for this loss
Additional trials are underway with bananas

7. Sterile Fruit
In 1997, a patent was granted for “Terminator” technology
This can render GM seeds sterile so that they cannot be re-planted by farmers
The technology was designed to protect the investments of biotech companies
Monsanto has acquired the rights to this technology
Many farmers, especially subsistence ones, re-plant the seeds from the previous crop
It is feared that companies may monopolize the world’s food supply using this technology

8. Pest-Resistant Plants
Bacillus subtilis toxin (BT) has been incorporated into plants
The use of this natural pesticide should reduce the amount of chemicals used
It is feared that the BT gene could be transferred to other plants via lateral transfer
Initial claims of BT being transferred to milk weed and killing monarch butterflies have been unfounded
Like antibiotic resistance, some insects have become resistant to BT

9. Xenotransplants Organs are taken from one species and put into another
In 1984, a baboon’s heart was transplanted into Baby Fae, who lived 20 days
Pigs are commonly used as sources of adult organs
Nextran is one company which genetically engineers pigs to serve as better donors
The plasma membranes of pig cells have been inserted with human proteins to reduce rejection
Most concerns center on disease transmission

10. Why Pigs?
they grow to be the size of a large human and share certain physiological and anatomical aspects with humans
they are domesticated and are easy to breed
they have large litters and grow rapidly
The first genetically engineered pig was born in 1992
By 1994, hundreds of these pigs had been produced for organ-transplant research
In 2003, it was announced that a pig gene that contributes to human rejection of porcine organs had been knocked-out.

11. Why Not Pigs?
A number of porcine diseases have the potential to infect humans
Pigs are known to have PERVs (porcine endogenous retroviruses)
PERVs have been shown to be able to infect immunodeficient mice and human cells in culture
It is still unknown whether there are diseases which can be passed between pigs and humans
As research continues, thousands wait to receive organ transplants; about 25-30% of patients waiting for heart or lung transplants die before suitable organs became available to them
Could human cloning be an answer to this shortage?

12. Ice-Nucleation Bacteria
The damage caused by frost injury in this country has been estimated to exceed $1 billion/year
In nature, the formation of ice crystals on plants is often triggered by the growth of bacteria on the outside of these plants
Some bacteria have proteins on their surfaces that are particularly effective triggers of ice-nucleation
In the absence of these bacteria, plants can reach an internal temperature of -5oC without freezing

13. How To Keep Plants From Freezing:
warm the air around them or insulate the crops
spray bactericides on the crops to kill the bacteria
spray the crops with bacteria which inhibit the growth of ice-nucleation bacteria
The bacteria responsible for ice-nucleation are P. syringae. These bacteria have been genetically engineered to lack the protein which causes ice-nucleation and are known as ice-minus strains.
In 1983, field tests were approved for the ice-minus bacteria. Jeremy Rifkin complained that ice-nucleation bacteria could play a role in the climate by triggering ice-nucleation events in the atmosphere.
Trials of ice-minus bacteria were blocked for many years, the first test took place in 1987.

14. Insertion of Modified DNA into Cells
Vectorless:
Biolistic delivery uses a particle gun to shoot DNA into an organism. DNA of interest is mixed with particles of metal such as tungsten. Widely used in plants.
Microinjection into the nucleus involves the use of a microscope and a very small needle. This method is used on animal cells (Xenopus oocytes), and ensures that a large proportion of cells take up the DNA.
Electroporation uses a strong electric field which forces the DNA into the cells. Used on plant and fungal cells
Silicon carbide transformation simply mixes DNA with particles which punch small holes in plant cells.

15. Retroviruses
Have been used in attempts to insert a copy of a gene into
bone marrow cells, the desired gene is first made into RNA
and then inserted into the retrovirus
Limitations of this technique are:
Retroviruses can only infect dividing cells, certain body cells (ie. nerves) do not divide
Retroviruses insert themselves at random into human chromosomes- it is not possible to control where they will be inserted
gene may not be effective as normal if inserted into the wrong area
gene may be inserted into tumor-suppressor genes and cause cancer

16. Adenoviruses Agrobacterium
Do not insert their DNA into host chromosomes
Have been used to attempt gene therapy for CF
Descendents of GM cells do not carry the CF gene
The treatment must be repeated every few months, but there is no risk of cancer
Agrobacterium
Causes crown gall in plants, a disease consisting of tumors on the stalk of a plant
The bacterium enters wounds on plants and inserts part of a plasmid (Ti) into the host DNA
Scientists can insert a desired gene into the Ti plasmid and infect plants with this recombinant plasmid

17. History of Biotech: the early years
10,000-9,000 B.C. (Mesopotamia & Canaan) D. of dogs 9,000-8,000 B.C. (Iran & Afghanistan) D. of goats and sheep; (Canaan) D. of emmer wheat and barley
8,000-7,000 B.C. (Peru) D. of potatoes and beans, (Indonesia) rice and (North America) pumpkins
7,000-6,000 B.C. (East Asia & China) D. of pig and water buffalo, (South Asia) chicken, (Turkey) cows, (Syria) einkorn wheat, (Turkey) macaroni, (New Guinea) sugarcane, (Indonesia) yams, bananas and coconuts, (Asia) flax, and (Mexico) maize and peppers; (Egypt) beer first made from yeast
3,000 B.C. (Iran) Breeding records of domesticated donkeys recorded on stone tablets
2,000 B.C. (Sumaria) 19 brands of beer available
300 B.C. Aristotle: concept of speciation

18. History of Biotech: the modern era
1970’s- Restriction enzymes discovered, methods to determine the sequence of DNA
1975- Conference in Asilomar, CA to set guidelines for genetic engineering
1983- PCR developed
1995- H. influenzae 1st organism to have its entire genome sequenced
1996- “Dolly” the sheep becomes first mammal to be cloned by nuclear transfer
1998- Mice and cows cloned
1999- Monkeys cloned, Jesse Gelsinger becomes 1st death attributed to gene therapy
2003- The human genome sequenced; Dolly dies at an early age

19. Traditional Biotech vs. GMOs
species which are crossed in traditional biotechnology are always closely related, this is not so in genetic engineering
the pace of change in traditional biotechnology is much slower than that of genetic engineering, working on a scale of years rather than weeks
traditional biotechnology has been applied on a relatively small number of species, such as crop plants, farm animals and yeast. Genetic engineering is more ambitious in scope and seeks to change these, as well as other, organisms such as those involved in sewage disposal, pollution control and drug production.

20. Is Genetic Testing Good?
Life Insurance
Universal Screening
Genomic Diversity Banks
Who Will Benefit the Most?
At the inception of the HGP in 1990, ELSI was formed to study Ethical Legal and Social Issues of genomics

21. ELSI
Privacy and Fairness in the Use and Interpretation of Genetic Information
Clinical Integration of New Genetic Technologies (examines impact of genetic testing on individuals, families, and society)
Issues Surrounding Genetics Research (the design, conduct, participation in, and reporting of genetics research)
Public and Professional Education

22. Ethics of Genetic Testing
When a new disease-associated gene is discovered, a genetic test may soon follow
Many people in positions of authority believe in genetic determinism, that all human traits are encoded in DNA, this is an oversimplification of the truth
Is genetic testing a new form of eugenics?
Who has the right to know the results of your test?
Who has the right to obtain your DNA for genetic testing?

23. Screening for G6PD Deficiency
In addition to sensitivity to fava beans, deficiency in G6PD puts employees exposed to certain oxidizing agents at higher risk
A simple and inexpensive test can detect G6PD deficiency
A number of companies have screened workers for this deficiency as part of their hiring process when the work entails exposure to oxidizing agents
It could be argued that this practice provides a type of discrimination, but companies argue that they are simply fulfilling their legal and moral obligation to prevent injuries and damage to worker health

24. Life Insurance and Genetic Testing
British life insurance companies can use data from 8 genetic tests, including breast cancer, colon cancer, Alzheimer’s, and (as of 2000) Huntington’s disease
In the latter case, people who test positive can be denied insurance (with the exception of the basic life insurance needed to buy a house in the U.K.)
Shouldn’t those who are free of a disease pay lower rates than those who test positive?

25. U.S. Insurance Providers
Some have recommended legislation be passed that would prevent insurance companies from discriminating on the basis of genetic information. Some of the main stipulations of this proposal are:
IPs should be prohibited from using genetic information to deny or limit any coverage
IPs should be prohibited from establishing differential rates or premium payments based on genetic information
IPs should be prohibited from requesting or requiring collection or disclosure of genetic information
IPs and other holders of genetic information should be prohibited from releasing genetic information without prior consent of the individual

26. Utility of Genetic Tests
A number of factors must be considered to decide whether an individual test is beneficial to the patient

27. Universal Screening for a Disease
Every pregnant woman in America is informed of the availability of a test for Cystic Fibrosis
This is the 1st of nearly 400 genetic tests to be implemented nationally
CF is the most common genetic disease for Caucasians but not other populations
CF occurs in 1 out of 2,500 Caucasian births but only 1 out of 17,000 African American ones
Moreover, the efficiency of detection is 85% in Caucasians but ranges between 30-69% for non-Caucasian populations

28. Screening for Cystic Fibrosis
Most experts agree that a universal test for CF does not make sense
Nevertheless, the HMO Kaiser Permanente conducted a pilot test
They offered the test to all Caucasian patients
1st, both parents were tested- if they were heterozygous- the fetus could be tested
About 18,000 women have been screened to date- 90% of these have terminated their pregnancy if the fetus was homozygous for CF

29. Genomic Diversity Banks
In 1996, Kari Stefansson started a company called deCODE
Their goal is to create genomic fingerprints for the entire population of Iceland- 275,000 people!
Iceland is ideal for such a venture since the majority of the population is descended from a few European explorers and the people have kept detailed family trees
Differences which lead to medical conditions should be easier to find in such a population

30. Icelander’s Right to Privacy?
Iceland has a single medical provider, all records are kept in the same database
deCODE purchased the medical records and has correlated family relationships with medical records
Every citizen will give blood to determine a genetic fingerprint unless they opt out
Some physicians worry that patient-physician trust has been broken and that patients may be less forth-coming with medical information
Estonia has expressed interest in forming similar program

31. How Should the Public Be Informed of New Discoveries?
News media outlets tend to over-simplify findings, but most Americans do not understand the scientific literature
The media has recently reported on the discovery of a: “gay gene”, “smart gene”, “fat gene”, “worry gene”, “Alzheimer’s gene”, “cancer gene”, and “fountain-of-youth” gene
Most of the time, the fact that these are just one of many genes affecting a given condition or that environmental factors exist is buried in the story of left out completely

32. Should We Clone Humans?
In 2001, a number of groups announced that they would clone a human by 2003
However, these groups have little credibility within the scientific community and include the Raelian cult (who believe life was produced by extra-terrestrials)
In Jan. of 2003 it was claimed that a clone had been born but this is now thought to have been a hoax
Despite this, it is likely that some group will attempt to clone a human in the future

33. Arguments Against Human Cloning
In 2001, Rudolf Jaenisch (an epigeneticist) and Ian Wilmut (Dolly’s cloner) published a paper called “Don’t Clone Humans!”
In it they described a number of failed attempted to clone animals and health problems associated with clones
In 2003, Dolly died at half the expected age
Epigenetic factors which may be altered in clones include CpG methylation, chromatin structure, and telomere length
Most have denounced human cloning at this time

34. Ethical Arguments About Biotechnology
Intrinsic: Biotechnology is good/bad in itself
Extrinsic: Biotechnology is good/bad because of:
its consequences
the motivations behind:
advocacy of biotech or
opposition to biotech
Murder is intrinsically bad; we do not have to wait to see its consequences before proclaiming murder bad. Other actions may be morally neutral in themselves, so that any ethical evaluation of the action will depend on the consequences of the action.

35. Intrinsic Arguments Against Biotechnology
Premise: Genetic engineering is unnatural.
Conclusion: Therefore, genetic engineering is intrinsically wrong.
Is this a good argument?
This is a common argument against GMOs. However, it is not clear that it is a good argument. Important questions to ask about this argument are:
Is genetic engineering really unnatural? What does unnatural mean?
Are all unnatural things also unethical? Surely airplanes are “unnatural,” so are they also unethical?

36. Intrinsic Arguments Against Biotechnology
Genetic engineering requires that we take a reductionist view of life that sees only genes, not individuals, as important.
“From the reductionist perspective, life is merely the aggregate representation of the chemicals that give rise to it and therefore they see no ethical problem whatsoever in transferring…even a hundred genes from one species into the heredity blueprint of another species.”
Jeremy Rifkin
This is another prominent argument against GMOs, but one could also question this one. For example, why should we think that genetic engineering requires a reductionist view of life? Don’t scientists value the traits of GMOs, rather than just their genetic structure?

37. Extrinsic Arguments About Biotechnology
Biotechnology is good/bad because of its consequences.
Three ways to evaluate consequences:
Do no harm (avoid bad consequences).
Maximize good consequences and minimize bad ones for all affected.
Justice: Fair distribution of good and bad consequences among all affected.
The three different ways of evaluating consequences are very different. For example, according to the principle that we should cause no harm, very many things would be unethical, including driving our cars (which causes environmental harm by burning fossil fuels and puts ourselves and others at risk of harm from accidents), for example. Maximizing good consequences and minimizing bad ones looks only at the aggregate effects of one’s actions, while the principle of justice requires an analysis of the distribution of consequences--are those who benefit from an action or policy also the ones who pay the costs or bear the risks? If not, it is possible that the policy or action is unjust.

38. Extrinsic Arguments About Biotechnology
Biotechnology is good/bad because of the motivations of its proponents/opponents.

39. Extrinsic Arguments: Motivations
Friends of the Earth: “Golden rice may never help poor farmers, but it could give the beleaguered European biotech industry a new grasp on life.”
Florence Wambugu: “These critics [of biotech], who have never experienced hunger and death on the scale we sadly witness in Africa, are content to keep Africans dependent on food aid from industrialized nations while mass starvation occurs.”
These are quotations from participants in the global debate about biotechnology. These quotations show the deep suspicion that the different sides have regarding the motives of those on the other side.

40. Extrinsic Arguments About Biotechnology
Environmental consequences
Human health consequences
Who benefits?
Who decides?
These are just a few more questions that are relevant to the ethical evaluation of biotechnology, in no particular order.

41. The Precautionary Principle
“When an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.”
Wingspread Statement on the Precautionary Principle, Jan. 1998
“Lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.”
Rio Declaration 1992
The precautionary principle is widely used in environmental ethics. How would it apply to biotechnology? Some argue that it implies that no biotechnology should be used, especially where there is any danger of gene flow, but others argue that it implies that biotechnology should be used to try to alleviate problems with food shortages and malnutrition.