Introduction to Bioethics

Transcription

1 Introduction to Bioethics Soraj Hongladarom Department of Philosophy and Center for Ethics of Science and Technology Chulalongkorn University

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 largerscale 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

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 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

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 4

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?