Lectured at Faculty of Medicine, Khon Kaen University

1. Introduction to Bioethics
Soraj Hongladarom
Department of Philosophy and
Center for Ethics of Science and Technology
Chulalongkorn University
hsoraj@chula.ac.th

2. Outline
• What is bioethics?
• Discussion of cases
• Is there a way to find a definite solution to
bioethical cases?
• Complexity of the problems

3. What is Bioethics?
• Study of the normative judgments related to
problems of how to decide or how to find the best
course of action in a variety of issues related to
biomedical science.
• Difference between descriptive and normative
studies.
• Bioethics is naturally an interdisciplinary field of
study.
 Philosophy, sociology, law, management, literature,
medical and scientific disciplines.

4. What is Ethics?
• Ethics is a branch of philosophy dealing a
series of questions dealing with values:
 What makes an action a good one?
 How is one to choose a course of action so that
it is a good one?
 What is the 'good life'?
 What is the meaning of 'good'?
 Is there a universal standard of ethical value?
Or are all values relative to different cultures?

5. Ethics and Medicine
• Since medicine deals with the life and death
of people, ethical problems naturally arise.
• Doctors face ethical problems everyday.
• But how well equipped are they to deal with
the issues?
• Basic principles:
 Do No Harm. (Non-maleficence)
 Do Good (Beneficence)
 Be Fair (Justice)

6. Case I: AIDS Vaccine
AIDS (acquired immunodeficiency syndrome) afflicts 38 million people
worldwide. Almost 3 million people died from AIDs in 2003 alone, and over 20
million have died since the epidemic began. A vaccine that could prevent or
slow down the spread of this deadly disease would be a boon to the world.
However, since 1981 when the first cases of AIDS were diagnosed,
researchers have been unsuccessful in their attempts to develop such a
vaccine. The efforts of a company called VaxGen illustrate the complexity of
this task.
VaxGen, which is located in Brisbane, California, developed a vaccine called
AIDSVAX. The vaccine contained synthetic proteins of recombinant gp120, a
protein normally found on the surface of HIV, the virus that causes AIDS. The
vaccine was designed to induce the immune system to respond to this
noninfectious protein and to produce antibodies that could protect the
recipient from an actual HIV infection. In phase I clinical trials, the vaccine
was tested for safety. Phase II clinical trials included a larger-scale test for
safety as well as a test for the production of antibodies against gp120. As a
result of these trials, AIDSVAX was shown to be safe, and patients receiving
the vaccine did develop antibodies against gp120.From http://www.mhhe.com/biosci/genbio/olc_linkedcontent/bioethics_cases/

7. Case I
Phase III clinical trials involved large-scale, placebo-controlled, double-blind tests of
the vaccine’s effectiveness. The first trial began in June of 1998 and involved 5,100
gay men and 300 women, all volunteers, from the United States, Puerto Rico,
Canada, and the Netherlands. The second trial began in March of 1999 and involved
2,500 IV drug abusers from Bangkok, Thailand. Both trials were completed in 2003.
Unfortunately, these trials revealed no difference in the overall rate of HIV infection
between the vaccinated and the unvaccinated participants. The data indicate that
recipients of the vaccine did produce antibodies against gp120, but that those
antibodies were not adequate to protect against HIV infection. (It did appear that
certain subgroups—ethnic minorities other than Hispanic—exhibited a small but
statistically significant lowering of the infection rate, but these results are still being
examined.)

8. Questions
• Why do you think a person would volunteer
to test an AIDS vaccine?
• In the AIDSVAX trials, some people were
given a placebo instead of the vaccine. All
the recipients had been told of this
possibility ahead of time, but they did not
know which substance they were receiving.
Is it ethical to give some of the trial
participants only a placebo?

9. Questions
• If a vaccine being tested works for some
ethnic minorities but not others, do you think
it should be given to just those races or to
everyone?
• Since the antibodies produced in AIDSVAX
recipients were insufficient to protect them
against infection, what might scientists try
next?

10. Questions
• If a private company develops an AIDS
vaccine, it will spend a large amount of
money on development and testing. Should
it offer the vaccine free of charge to people
who cannot afford it, especially those in
very poor countries? How can private
companies afford to develop vaccines if
they do not charge for them?

11. Case II: Critically Ill Newborn Baby
Art and Julia Inskeep's new baby, Joshua, was born premature at 24 weeks of
pregnancy. When they went to see him in the neonatal intensive care unit, they
were not allowed to touch him. He was so small. His feet weren't even as big as a
fingertip.
The doctors don't know what caused Julia to go into premature labor. But when
Joshua was born, they told the Inskeeps that there had been successes in saving
24-week-old babies. With the newest machinery and techniques, the doctors said,
the baby had a good chance of surviving.
Neonatologists, who study newborns, are concerned with outcomes. The more
premature a baby, the worse its outcomes. A normal pregnancy length is 36 weeks,
but babies have survived after being born as early as 23 weeks. The biggest
problem is the lack of a substance called surfactant. This fatty substance coats the
inner surface of the lungs and keeps them from collapsing. During its time in the
uterus, the baby breathes fluid, and its oxygen comes from the mother's blood.
From http://www.mhhe.com/biosci/genbio/olc_linkedcontent/bioethics_cases/

12. Case II
A number of advances are helping younger and younger babies survive. One is the
development of a surfactant taken from calf fetuses. Another is a respirator called
an oscillator. Instead of delivering the normal respiration rate of 30 breaths per
minute, the oscillator gives 900 tiny puffs per minute. This keeps the baby's lungs
constantly inflated, and oxygen seems to enter the bloodstream more efficiently.
The procedure, however, can be dangerous. The technology is usually used with
babies who are at least 25 weeks developed; the less developed the baby, the
more likely the occurrence of a brain bleed, which would cause brain damage and
have other serious consequences.
The doctors have asked the Inskeeps to decide whether or not to have Joshua
connected to the oscillator. Art and Julia have never had a more difficult decision.

13. Questions
• What should the Inskeeps do?
• What information do the Inskeeps need to
make the decision? List four things.
• A number of years ago, doctors would make
this decision without consulting the parents.
Give two reasons this might be wrong. Give
two reasons this might be best.

14. Questions
• If the doctors connect Joshua to the oscillator and he
then dies, are there grounds for a malpractice suit?
Why or why not?
• If the doctors don't connect Joshua to the oscillator
and he dies, are there grounds for a malpractice suit?
Why or why not?
• Sometimes next of kin must sign an informed consent
form, by which they acknowledge that the doctor has
told them certain information and that they agree to a
certain procedure or medical plan. Whom does this
protect?

15. Case III: Brain Death
• On October 5, 1992, an 18-year-old
German woman had a fatal road accident
that severely damaged her brain and was in
a comatose condition. However, nobody
knew that she was already about 13 weeks
pregnant, so the doctors told the parents
that they were able to keep the body
functioning for 5 more months until it was
safe to deliver the baby. The doctors asked
for the parents' consent for this.

16. Case III
• The parents at first gave their consent (the
doctors said that they would lose their daughter
if they did not do so), but three days later the
daughter was declared brain dead. The
parents changed their minds and tried to
withdraw the consent, but the doctors said that
letting the body go would kill the baby inside.
• The parents leaked the news to the media and
the story became very popular in Germany.

17. Case III:
• There was a series of national debates on
the issue - “corpse incubators” “gymnastic
for corpses”, etc.
• On November 16, 1992, there was
spontaneous miscarriage. The reason was
unknown because the girl's parents refused
consent for autopsy.
Source: Peter Singer, Rethinking Life and Death: The Collapse of our Traditional
Ethics. New York: St. Martin's, 1994.

18. Questions
• Is a 'brain dead' person actually alive or dead?
• If a brain dead woman happens to carry a fetus
inside, should the doctors keep the body
functioning in order to protect the fetus?
• Who has the authority here? The parents? The
doctors? The state?
• Whose interests come first? The fetus'? The
parents'? The doctors? (or can we talk about the
“interest” of the brain dead person?)

19. Compulsory Licensing
• Article in the New England Journal of
Medicine: “Thailand and the Compulsory
Licensing of Elfavirenz”
 http://content.nejm
.org/cgi/content/full/356/6/544

20. Questions
• The Ministry of Public Health made the decision
on compulsory licensing and then they informed
the cabinet. Do you think this is a serious issue?
• Do you think the MoPH should issue CL on other
drugs? Why? Why not?
• Drugs for AIDS patients are clearly very
necessary for them, but what about other kinds of
drugs? There are many other expensive drugs
out there.

21. Questions
• Is it right for the MoPH to issue CL without
consulting the relevant pharma companies who
own the patents?
• Suppose there is an administrative change in
MoPH and there are benefits to be gained from
issuing CL (such as benefits to local drug
manufacturing company), and it then happens
that next batches of CL provide benefits to these
companies. What do you think of this scenario?

22. Questions
• What message does this CL send to local
drug producing companies?
• What are the global implications?
• Where can we find the right balance
between the need for effective public health
measure and the need for protection of
patents and intellectual property rights?