Med Ethics Cases

Medical Ethics CASE SCENARIOS

April 18th : Propaedeutics (4hrs) & Part 1 "The idea of man" (1 hr) April 19th: Part 2 "The idea of man" (1 hr) & The Bochum Protocol/ Medical Cases (4hrs) April 20th: Case studies (5hrs) A) B) Propaedeutics and Repetition of basics (4 hrs) a. Discussion rules and working techniques of the course b. What is ethics, moral, morality and their function in a societal context? c. Why does medicine need ethics? Who is responsible for it? d. Main approaches to medical ethics C) The idea of man in Medicine / self-understanding of the medical profession (2 hrs) a. The body-soul problem b. The role of the Health professionals in Western and other traditions D) Case studies (Approx. 9 hrs) a. The “Bochum Protocol for Ethical Medical Practice for the scientific and ethical analysis and assessment of medical cases” as an example of a structured ethical analysis b. Case scenarios Course evaluation Oral analysis of one of the case scenarios (groups up to 3, depending on the total number of participants)

Bochumer Protocol for Ethical Medical Practice

Bochumer Protocol for Ethical Medical Practice Scientific and Ethical Analysis and Assessment of Medical Cases Medical-Scientific Diagnosis Source: http://www.ruhr-uni-bochum.de/zme/Arbeitsbogen.htm#e

The evaluation of the medical-scientific diagnosis follows traditional patterns. General considerations: What is the patient's diagnosis and prognosis? What type of treatment is recommended regarding the diagnosis and prognosis? What alternative treatments could be offered? What are the anticipated outcomes of these various treatment options? If the recommended treatment is neither offered to nor accepted by the patient, what is the prognosis? Special considerations: Will the preferred medical treatment be helpful to the patient? Will the treatment selected lead to a positive prognosis in the particular case? If so, to what degree? Could the selected treatment harm or injure the patient? To what degree? How can benefits, harms, and risks be evaluated? Medical practice: Are any other medical treatments equally adequate? What consideration should be given to (1) the most recent medical advances due to biomedical research as well as (2) the physician's extensive clinical experience? What relevant facts are unknown or unavailable? Are the terms employed correctly, are they precise? Summary: What is the optimal treatment after considering all the available scientific-medical knowledge? 1

Bochumer Protocol for Ethical Medical Practice

Medical-Ethical Analysis The analysis of medical-ethical considerations applies to the following three principles: Health and well-being of the patient: What harm or injury may arise as a result of selecting a single method of treatment? Will the treatment compromise the patient's well-being, cause extensive pain, or even shorten his/her life? Will it cause physical or mental deterioration? Will it tend to produce fear or grave anxiety in the patient? Self-determination and the patient's autonomy: What is known about the patient's cherished values? What is the patient's level of understanding of intensive or palliative treatment as well as resuscitation criteria? Is the patient well informed about the diagnosis, prognosis, and the various treatment options available for him/her? Is it possible to satisfy the patient's preferences in formulating the treatment plan? To what degree should the physician permit the patient to determine the treatment plan? Who else, if anyone, should make decisions on behalf of a patient and his/her best interests? Must the patient agree with the chosen therapy? Medical responsibility: Have any conflicts surfaced between the physician, the patient, the staff, or the patient's family? Is it possible to eliminate or resolve such conflicts by selecting a particular treatment option or plan? How can one work to assure that the following values will be reaffirmed: (1) the establishment of mutual trust between patient and physician; (2) honoring the principle of truth-telling in all discussions; and (3) respecting the patient's privacy and protecting his/her confidentiality? What relevant facts are unknown or unavailable?

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Bochumer Protocol for Ethical Medical Practice

Have the salient ethical issues been adequately formulated, clarified, and addressed within the physician-patient relationship? Summary: What kind of treatment is optimal given thorough attention to the salient and relevant medical-ethical issues?

Treatment of the Case What options (alternative possible solutions) are available in the face of potential conflict between the medical-scientific and the medicalethical aspects? Which of the aforementioned scientific and ethical criteria are most affected by these alternative options? Which options are most appropriate given the particular value profile of the patient? Who, if anyone, should be consulted to serve as an advisor to the physician? Is referral of the patient necessary for either medical or ethical reasons? What are the moral (in contrast to the legal) obligations of the physician with regard to the chosen treatment? What are the moral obligations of the patient, staff, family, health care institution and system? What, if any, are the arguments for rejecting the selected treatment? How should the physician respond to these arguments? Does the treatment decision require achieving an ethical consensus? By whom? Why? Was the decision taken with respect to treatment choice adequately discussed with the patient? Did he/she agree? Should the decision process be reassessed and the decision actually revised? Summary: What decision was made after assessing the scientific and ethical aspects of the case?

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Bochumer Protocol for Ethical Medical Practice

How can the physician most accurately represent the medical-ethical issues and the process of evaluating the medical and ethical benefits, risks, and harms?

Additional Questions for Moral Assessment 1. In cases of long-term treatment: Will the chosen medical treatment and its ethical acceptability periodically be reconsidered? Is the treatment capable of being brought into line with the appearance of newly-derived medical-scientific and/or medical-ethical information? What factors must be rethought given the unforeseen appearance of new medical-scientific knowledge or medical-ethical insight during ongoing treatment? How do patients react to alterations in treatment strategy? In case where the prognosis is dim, how should the physician decide whether the patient should receive intensive or palliative treatment? It is possible to appropriately satisfy the patient's explicit wishes, demands, as well as his/her tacit intentions, and to be reassured that they have been seriously considered? 2. In cases of considerable social impact: What are the anticipated costs, personal and material, to the patient, the family, the health care institution, and society? Are the patient, relatives, and community able to bear these costs? Will the costs of the social reintegration of the patient, his/her life style, personal development, and recuperation be adequately met? How do the answers to these questions of cost bear on the medical-scientific and medical-ethical considerations? 3. In cases of therapeutic and non-therapeutic research: Has the research protocol and design taken the medical-ethical aspects under full consideration? Is the research necessary? Did the patient provide a truly informed consent in order to be entered into the protocol?

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Bochumer Protocol for Ethical Medical Practice

Who is responsible for providing adequate and thorough information to the patient subject and to assure that it is adequately understood? What reasons might explain why a patient subject did not give a fully informed, competent, and voluntary consent? What procedures were initiated to avoid discriminating against a patient subject when requesting his/her participation in a research protocol? What mechanisms are in place to respect and act on a patient's right to withdraw from participating in a aresearch protocol at any time? Was the experiment fully explained to the patient subject in clear and fully comprehensive language?

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MAN AS AN INDUSTRIAL PALACE

Your personal “secret code”: House-Number |__|__| day of birth |__|__| first name of mother |__|__| first name of father: |__|__| only the last 2 digits, e.g. 144=44

only the day of birth e.g. 21.1.80 = 21

In each case the first and second letter of first name

Dr. Paul’s Problem At the beginning of her internship, Dr. Paul didn’t need to be told that it was illegal to remove organs or tissues from a dead person without permission from the family. As a Catholic it would also violate her faith. However, she soon learned that there was a great shortage of transplant tissues for persons suffering from third degree burns. Their life can only be saved if their skin is replaced by skin from cadavers.

One day her boss tells her that they have again run out of suitable skin for grafts and they were in immediate need because there was an emergency operation scheduled for that same day. He told her to go to the morgue and quietly collect skin to be used for grafts in the surgery later that day. She should not talk to anyone about this. She did as he said.

If you were in this situation, how difficult would you find it to make a decision? I feel a decision would be ... (Circle one answer) very easy

0 1 2 3 4

5 6

very difficult

If you had to make a quick judgement about Dr. Paul’s decision, do you feel that it was right or that is was rather wrong? Mark your answer by circling one of the following numbers on a scale from “completely wrong” to “completely right:” I feel that Dr. Paul decision was... (Circle one answer) completely wrong

-4 -3 -2 -1 0 +1 +2 +3 +4

completely right

What are the reasons for your judgement about Dr. Paul’s decision? Give as many as you like in short sentences (use back of page for further comments):

d-dr-paul-engl.wpd Copyright (c) by Georg Lind, University of Konstanz. This dilemma can be freely copied by public institutions of education. All others have to obtain written permission by the author.

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Artificial Wombs Return to Main Menu Over the years, the development of human babies in artificial wombs has been a significant element in much science fiction, going back at least as far as Aldous Huxley’s Brave New World, published in 1932, and explored more recently in the Vorkosigan Saga authored by Lois McMaster Bujold. When Miles Vorkosigan, the main protagonist of the series, makes his first appearance, he is a tiny newborn being removed from an artificial womb and presented to his anxious parents. Miles spent the last four months of his development in the artificial womb in order to receive experimental treatment for exposure to a teratogen (a substance that disrupts fetal growth). As readers of the series know, Miles did not escape all the detrimental effects of the teratogen, but artificial womb technology saved his life. Although Bujold’s Vorkosigan Saga takes place in a futuristic setting with advanced reproductive technology, the artificial womb appears to be emerging from the realm of fiction into reality. It is likely that it will first be used to treat premature infants. The earlier such a baby is born, the slimmer are his or her odds of survival. Many premature infants who do survive require an extended period of life support, including an incubator to maintain body temperature, a ventilator to assist breathing, intravenous feeding, and so on. Some of these life-sustaining treatments damage the infants’ fragile bodies and can result in lifelong medical problems. An artificial womb would provide such infants with a more favorable environment in which to complete their development. In recent years, much progress has been made in developing artificial wombs. In 1997, Yoshinori Kuwabara of Juntendo University in Japan and his research team made headlines with their artificial womb, which was able to sustain fetal goats for several days. Kuwabara’s womb was a clear plastic tank filled with synthetic amniotic fluid, with a component that acted as a placenta for the delivery of oxygen and nutrients and the removal of wastes. At the time, Kuwabara expressed hope that it would soon be possible to support a human fetus in such a device. Kuwabara has since passed away, but other researchers are continuing his work. More recently, Hung-Ching Liu of Cornell University has been successful with a different approach. She and her team grew cells from human endometrium (the inner lining of the uterus) on a biodegradable scaffold. When growth was complete, the scaffold broke down, leaving an artificially grown uterus. Liu took human embryos remaining from in vitro fertilization (IVF) and got them to attach to the inside of the artificial womb, where they survived for several days. Liu was not able to determine how much longer the embryos would have survived because the experiment was stopped to comply with regulations that place time constraints on human embryo studies. Media reports of research like Kuwabara’s and Liu’s have generated a great deal of controversy. Some hail artificial wombs as a great medical advance—one that could save the lives of many babies who would otherwise die or suffer lasting harm as a result of premature birth. Others point to issues that may arise should it become possible for babies to develop entirely in artificial wombs. On one hand, women would be free of the discomfort and danger associated with pregnancy and childbirth, without the legal and emotional entanglements of using surrogate mothers. However, some people are concerned that artificial wombs might be misused, and that women could even suffer diminished reproductive rights as a result of the new technology. Questions 1. In order to develop artificial womb technology for use on humans, human embryos and fetuses would at some point have to be used as experimental subjects. Under what circumstances do you think this should be permissible, or should it? Explain your response. 2. What impact do you think artificial womb technology will have on the abortion issue? Why? 3. If artificial wombs for humans become a reality, they are likely to be quite expensive, at least at first. What concerns does this raise about who should pay? 4. Do you think people should be able to choose to grow their babies entirely in artificial wombs? If so, should this choice be available to everyone? Explain your response. 5. Would you consider using an artificial womb to have your own children? If so, under what circumstances? If not, why not? 6. What is your prediction regarding how advances in artificial womb technology will affect women in our society? Explain. Copyright ©2000 The McGraw-Hill Companies. All rights reserved. Any use is subject to the Terms of Use and Privacy Policy. McGraw-Hill Higher Education is one of the many fine businesses of The McGraw-Hill Companies. If you have a question or a problem about a specific book or product, please fill out our Product Feedback Form. For further information about this site contact [email protected]

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28.10.2006 18:47

Ethics Updates - Ethics Case Study Detail

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ETHICS UPDATES

ETHICS CASE STUDY DETAIL Case # 84:

CREATING A LIFE TO SAVE A LIFE Category: Bioethics

In England, the Whitaker family faced a terrible situation: their son, Charlie, suffered from a rare disorder that prevented his body from producing red blood cells. Without daily medications and frequent transfusions, Charlie would simply die. With them, he continues to live, but under close medical care. For a while, it looks as though Charlie’s parents had figured out an answer to this dilemma. They proposed to use in vitro fertilization to have another child, but with an added twist. They would, as is usual in this procedure, have the eggs fertilized outside the womb in a laboratory dish, but they would then include an additional step. Using new screening techniques, they would screen the embryos to see which would be most able to donate blood-making cells to Charlie. That would be the one that they would choose to implant and bring to term. In contrast to the United States and many other countries, in England someone proposing such a procedure must obtain government permission –in this case, from the Human Fertilization and Embryology Authority. The Authority rejected the request by the Whitaker family, saying that it was not right to create a human life with the express intent of saving another life. This case raises two kinds of questions. First, do you agree with the Authority’s decision? Why or why not? What are the significant moral considerations in this case? What consideration is decisive for you? Second, who should make these decisions? The United States does not currently have such a board, nor do most other countries. However, something similar is currently under consideration in several countries. Leaving aside financial considerations about who should bear the cost for the moment, who should have the right to make the final decision in such cases? Who should make the decision if the procedure is being paid for by federal health insurance? Private health insurance? The individual patient or family?

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Ethics Updates - Ethics Case Study Detail

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Notes: Source: Aaron Zitner, “COLUMN ONE. A Matter of Life, Ethics.” Los Angeles Times, October 29, 2002, p. 1..

Author Information Name: Lawrence M. Hinman E-mail: [email protected] Homepage: http://ethics.sandiego.edu/About/editor/index.asp Institution: University of San Diego Web site: http://ethics.sandiego.edu/ Copyright: Lawrence M. Hinman 2002

Suggestions or contributions ? Send email to [email protected] Page Cite: Ethics Updates - Ethics Case Study DetailEthics Updates - Ethics Case Study Detail http://ethics.sandiego.edu/resources/cases/Detail.asp - 2/27/2006

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ETHICS UPDATES

ETHICS CASE STUDY DETAIL Case # 75:

INTER-SEXED CHILDREN Category: Bioethics

According to rough estimates, 1 in every 1000-2000 infants born each year has ambiguous genitalia. These inter-sexed infants display various combinations of both female and male genitalia (e.g., an enlarged clitoris without a vaginal opening and with undescended testes). According to the American Academy of Pediatrics (AAP), "The birth of a child with ambiguous genitalia constitutes a social emergency." Parents, understandably, are distraught, and the AAP notes that both the ambiguity of the child's sex and the parents' reactions to that ambiguity carry significant implications for the child's long term well-being. The most acute quandary is to determine whether the child will be raised as a girl or boy; in fact, parents are typically advised not to name the child or register the birth until the child can be assigned a sex. Typically, genetic evaluations are undertaken to determine the infant's genetic sex (i.e., whether the child's chromosomal pattern is XX of XY) and the cause of the sexual ambiguity. Additional pediatric, urological, endocrinological and gynecological evaluations determine how best to assign potential fertility capacity for normal sexual function, endocrine function, potential for malignant degeneration, and intrauterine testosterone imprinting. Following sex assignment, surgical interventions are undertaken to revise the genitalia to conform to the selected sex. While surgical reconstruction is not urgently required for medical reasons in most cases, the majority of pediatricians believe that sex selection should be completed as quickly as possible. Since parents and other family members, as well as members of society, interact differently with boys and girls; until the child's sex is established, say the pediatricians who favor immediate sex selection, interactions are likely to be stilted, stunted, aberrant, confusing, or discomfited. In addition to the distress of the parents and others, say the majority of pediatricians, the child whose sex is undefined may experience ostracism and suffer from confused self-identity and self-understanding. This assumption, and accordingly, the propriety of early surgical correction, has come under increasing challenge. Medical ethicists have recently argued that, as intersexuality is seldom threatening to life or health, the surgery should be postponed until the person who will be most affected -- the intersexed individual -- can give autonomous consent. Moreover, autonomous consent requires a full explanation of burdens and benefits, the nature of which have yet to be determined. In opposition to the assumption that early treatment is always in the child's best interests, intersexed adults have begun to come forward to report various harmful effects of early surgical intervention. For example, first-person accounts testify to the pain and loss of trust that arise upon learning that one's parents and physicians have deceived them about the nature of one's gender. This loss of trust is often accompanied by a perception that the deceit stems from embarrassment or from seeing the intersexed person as a "freak." Further, surgery that involves reducing the size of a penis or clitoris often results in loss of sensation and of orgasmic capacity. Notes: Eighth Intercollegiate Ethics Bowl at The Annual Meeting of the Association for Practical And Professional Ethics in Cincinnati, Ohio on February 28, 2002

Author Information Name: Robert F. Ladenson

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Ethics Updates - Ethics Case Study Detail

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E-mail: [email protected] Homepage: http://www.iit.edu/departments/humanities/ Institution: Department of Philosophy Illinois Institute of Technology (IIT), and Illinois Institute of Technology (IIT), and Faculty Associate, Center for the Study of Ethics in the Professions (IIT) Web site: http://ethics.iit.edu/ Copyright: Association for Practical and professional Ethics

Suggestions or contributions ? Send email to [email protected] Page Cite: Ethics Updates - Ethics Case Study DetailEthics Updates - Ethics Case Study Detail http://ethics.sandiego.edu/resources/cases/Detail.asp 2/27/2006

28.10.2006 18:38

Ethics Updates - Ethics Case Study Detail

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ETHICS UPDATES

ETHICS CASE STUDY DETAIL Case # 59:

WHOSE LIMB IS IT ANYWAY? Category: Bioethics

Kevin Wright came to Dr. Robert Smith, a general surgeon at Falkirk and District Infirmary in Scotland, with an unusual request. He wanted one of his legs to be amputated below the knee. Dr. Smith referred Mr. Wright, a teaching assistant from Essex, to the senior psychiatrist at Falkirk and District Royal Infirmary, Dr. George Dodds, for a psychiatric consultation. After meeting with Mr. Wright, Dr. Dodds said that he could not support the surgery and so advised Dr. Smith, the surgeon. Despite Dr. Dodd's negative recommendation, and without further consultation, Dr. Smith amputated Mr. Wright's leg below the knee, as requested. Earlier in the year, Dr. Smith had carried out an amputation on a German citizen, Hans Schaub. In both cases there was no medical reason for amputating the limbs. The limbs were physically healthy and not diseased or deformed in any way. According to a report by Dr. Smith, Mr. Wright subsequently e-mailed him and said that he was very happy after having been in misery for thirty years. Dr. Smith admits that he does not understand the motivation of these patients: "It is a concept I still have difficulty in understanding," he said. Although the operations were performed in National Health Service hospitals, the patients were private patients who paid the cost of the operation personally. Dr. Smith received no fee for the surgery. When Dr. Smith revealed that he intended to perform a third amputation, this time on an American psychoanalyst (Greg Furth, a Jungian analyst in New York) who also wanted a healthy limb removed, the hospital board learned of his plans and refused him permission to perform the operation. At a news conference, Ian Mullen, a spokesperson for the hospital board said: "I don't believe it's appropriate for this type of operation to go ahead without consideration being given to the potential implications for the local reputation of the hospital and the concerns that might arise among the local population. Notes: Case #11 Ethics Bowl 2001

Author Information Name: Robert F. Ladenson E-mail: [email protected] Homepage: http://www.iit.edu/departments/humanities/ Institution: Department of Philosophy Illinois Institute of Technology (IIT), and Illinois Institute of Technology (IIT), and Faculty Associate, Center for the Study of Ethics in the Professions (IIT) Web site: http://ethics.iit.edu/ Copyright: 2001

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ETHICS UPDATES

ETHICS CASE STUDY DETAIL Case # 77:

POST-MORTEM SPERM COLLECTION Category: Bioethics

Mr. Jamison suffered a severe head injury in an accident and died without regaining consciousness soon after being brought to the emergency room. Upon his death, his wife requested postmortem sperm procurement, telling doctors that the couple had been trying desperately to conceive a child. Mr. Jamison had no advance directive stating, or implying, his wish to father a child, or specifying his agreement to this procedure in case of his death. The hospital ethics committee noted that, under State law, the spouse of the deceased is the surrogate decision maker, and concluded, for this reason, that the decision rested with Mrs. Jamison. Mr. Jamison's parents argued that their son would never have wished to father a child who would be raised with only one parent. Mrs. Jamison's physician expressed the opinion that the Jamison's efforts to conceive a child demonstrated Mr. Jamison's desire that his wife have his child. The hospital's social worker suggested that it would be unfair to bring a child into the world with only one parent. The hospital chaplain pointed out, however, that many children live in stable, loving single parent homes. The hospital has the equipment to do the procedure and offers services for sperm collection and storage for various reasons, including posthumous fatherhood. However, it has no policy for this situation, where the father is not a competent participant in the consent process. The medical staff is divided. Some feel that allowing the procedure respects Mr. Jamison's wishes to father a child with his wife. Others believe it is wrong to be an agent of conception without the explicit consent of both parents. Notes: Eighth Intercollegiate Ethics Bowl at The Annual Meeting of the Association for Practical And Professional Ethics in Cincinnati, Ohio on February 28, 2002

Author Information Name: Robert F. Ladenson E-mail: [email protected] Homepage: http://www.iit.edu/departments/humanities/ Institution: Department of Philosophy Illinois Institute of Technology (IIT), and Illinois Institute of Technology (IIT), and Faculty Associate, Center for the Study of Ethics in the Professions (IIT) Web site: http://ethics.iit.edu/ Copyright: Association for Practical and professional Ethics

28.10.2006 18:36

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Heart Transplant Return to Main Menu The hospital ethics committee was discussing an important and urgent case. A donor heart had become available, but an extremely rare thing had happened. Two heart-transplant candidates in the hospital were both matches for the donor heart. One patient was known to the committee as Mr. X, the other as Ms. Y. For someone with heart failure, Mr. X had been on the transplant waiting list a long time. He had been waiting one year and was near death. Ms. Y had just been placed on the list and could be sustained with medication for quite some time, possibly until another heart became available. The answer seemed obvious-give the heart to Mr. X. A number of the members of the committee did not agree with this answer. They argued that time on the transplant list should be only one factor considered. They saw a problem in Mr. X's medical record. Mr. X was 64 years old and had suffered from a heart condition for years. He had had two angioplasties and two bypass operations to correct a blockage of the heart's blood vessels. The problem seen by some committee members was that Mr. X still smoked, ate fatty foods, and was very overweight. After each procedure, doctors had warned Mr. X that he must change his life-style, and that if he didn't, his condition would worsen. He never stopped smoking, however, and never changed his diet. He said it was too hard. Research has proven that smoking and high cholesterol are risk factors for heart problems. Blockage of the coronary arteries is directly attributed to these two factors. Treatments such as angioplasty (opening the blood vessels by passing a tube into the arteries) and bypass surgery (connecting new blood vessels that go around the clogged ones) can correct the problem, but they are not a total cure. To avoid further problems, patients must control their diet, stop smoking, and alleviate stress. This, of course, is not easy. Mr. X appeared not even to try. The heart was about to be airlifted to the hospital. The committee had to make their decision very soon. Questions 1. What should the committee do? 2. How would you vote if you were on the committee? 3. In some cases, transplant operations are not successful, and a second operation is needed. Should someone be allowed two transplant procedures? Three? Why or why not? 4. In some hospitals, alcoholics are not allowed to receive liver transplants. In other hospitals, they are. Those who see alcoholism as a genetically determined condition argue that these people cannot help their addiction. Others feel that these people are responsible and should just stop. Should hospitals deny transplant livers to alcoholics? 5. What other factors should go into choosing who should get an organ when two people are eligible? List three. Copyright ©2000 The McGraw-Hill Companies. All rights reserved. Any use is subject to the Terms of Use and Privacy Policy. McGraw-Hill Higher Education is one of the many fine businesses of The McGraw-Hill Companies. If you have a question or a problem about a specific book or product, please fill out our Product Feedback Form. For further information about this site contact [email protected] or let us know what you think by filling out our Site Survey.

28.10.2006 18:44

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The Quest for an AIDS Vaccine Return to Main Menu 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. 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.) Questions 2. Why do you think a person would volunteer to test an AIDS vaccine? 1. 3. 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? 4. 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? 5. Since the antibodies produced in AIDSVAX recipients were insufficient to protect them against infection, what might scientists try next? 6. 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? Assignment Research how HIV differs from other viruses for which there are effective vaccines. Then hypothesize why it has been so difficult to develop a vaccine against AIDS. References http://www.vaxgen.com http://www.cdc.gov Copyright ©2000 The McGraw-Hill Companies. All rights reserved. Any use is subject to the Terms of Use and Privacy Policy. McGraw-Hill Higher Education is one of the many fine businesses of The McGraw-Hill Companies. If you have a question or a problem about a specific book or product, please fill out our Product Feedback Form. For further information about this site contact [email protected] or let us know what you think by filling out our Site Survey.

28.10.2006 18:45