Ministry Of Health Of The Republic Of Moldovadoc

=== Ministry of Health of the Republic of Moldova ===

Ministry of Health of the Republic of Moldova

Public Institution “Nicolae Testemițanu” State University of Medicine and Pharmacy

Faculty of Medicine II

Department of Philosophy and Bioethics

DIPLOMA THESIS

CLINICAL AND ETHICAL APPROACH OF ORGAN TRANSPLANTATION

(Bibliographic study)

Author:

Yunes Muhammad

6th year

Group 1052

Scientific advisor:

Adriana Paladi

PhD,

Associate Professor

Chisinau 2016

Content

Introduction

1.1 Actuality and level of study of the investigated topic

1.2 Purpose and objectives of the thesis

1.3 Theoretical importance and applied value of the work

Bibliographic analysis of theses

The material and the research methods

Personal results and discussion

Clinical aspects of transplantation

Relevant clinical and historical date about transplantation

Forms of transplantation

Ethical issues in transplantation

The organ shortage

Donor organs

Legal documents in transplantation

Conclusions

Attachment

Bibliography

INTRODUCTION

1.1 Actuality and level of study of the investigated topic

Transplantation of organs, tissues and cells are now effective therapy for the fatal and non-fatal diseases. The high success rate and survival of transplantation such as the kidney, liver and heart have led to increase the levels of demand globally.

Now also through organ transplantation not only the patient survives, but the quality and productivity of his life also improved. In addition, transplantation therapy also decreased the cost of health care for the society.

It is, however, clear that ethical problems occur in transplantation practices. Among them lack of clinical expertise and funds in transplantation; insufficiency in organs and limited access of patient to this procedures; reluctance to donate organs after death; pressure for non-altruistic living donation especially in vulnerable persons; the use of executed prisoners as organ donors; xenotransplantation and potential risks to human health from the transmission of xenogeneic infectious agents through it etc. All of these problems deserve to be carefully examined to increase the level of personal and social awareness which could result in assumption of an appropriate level of responsibility.

1.2 Purpose and objectives of the thesis

The purpose of the thesis is to realize a systematic analysis of the clinical and ethical issues in transplantation.

The objectives of thesis are:

Underlying the most significant medical achievements in transplantology.

Describing clinical types and forms of transplantation.

Identifying the ethical issues in transplantation and ethical/legal solutions

for them.

1.3 Theoretical importance and value of the work

Organ transplantation has become a generally effective and routine treatment for patients with organ failure. It is considered one of the most spectacular medical advances of the 20th century. In the same time it arise a lot of ethical issues. This thesis is an attempt of systematic treatment of the subject and its results could be useful for students and medical professionals.

BIBLIOGRAPHIC ANALYSIS

The thesis resulted from the analysis of the various sources: general medical literature about transplantation, bioethical textbooks, articles on the topic, relevant guides and study cases.

Books:

Arthur Caplan. The Ethics of Organ Transplants: The Current Debate. Prometheus Books, 1999.

Arthur Caplan focuses on how to satisfy the great need for healthy organs still respect personal ethics. Among the questions examined in this book are: Can organs be obtained without turning medical emergencies into free-market enterprise? Should people be permitted to sell their organs? Could cloning be considered as a future source of organs? Should animals be sacrificed to save the lives of humans? Etc.

Robert Veatch. Transplantation Ethics. Georgetown University Press; Reprint edition, 2002.

Robert Veatch devoted his on three major topics: the definition of death, the procurement of organs, and the allocation of organs.

He argues that the United States has the money and resources to eliminate socioeconomic disparities, and if this were done, people could then sell their organs, because it is poverty that requires people to act out in desperation for money and not with an objective and informed mind.

ARTICLES

John Robertson, in a 1999 article, put forth the argument that obtaining organs from condemned prisoners is allowable if the prisoner or their next of kin consents to donation, as long as organ donation is not the means by which the prisoner is killed because that violates the principle that a cadaveric donor be dead prior to donation.

Websites

The United Network for Organ Sharing website has stories of donors and recipients. http://www.transplantliving.org/patientProfile.asp

TransWeb.org is a website “…all about transplantation and donation.” They have recipient and donor stories on their website under the heading “Real People.” www.transweb.org

(www.cnn.com/HEALTH/bioethics/) argues that the imperfections in organ distribution come from the scarcity of donor organs. Kahn says that if Americans wish to support organ transplantation as a medical procedure, then they must be sensitive to the fact that politics and biases will probably factor into any ranking system until there are enough organs to go around: "Policies need to be aimed at both increasing organ donations as well as creating a system that allocates them in the fairest ways possible".

THE MATERIAL AND THE RESEARCH METHODS

This thesis is a result of bibliographic review. To accomplish the objectives of the thesis was analyzed specialized literature recently published on ethically relevant issues associated with transplantation. Relevant articles in English and Romanian languages were identified searching PubMed, Google Scholar, Hinari, SpringerLink .

Studies were identified using combinations of the search terms “ethics and transplantation”, “organ donation or sale”, „history of transplantation”. The references of the selected articles were also evaluated to identify additional relevant publications.

PERSONAL RESULTS AND DISCUSSION

4.1.1 Relevant clinical and historical date about transplantation

An organ / graft transplant is a surgical operation in case of failing or damaged in the human body it is removed and replaced with a new one. The transplantation refers only for the solid organs such as kidney, liver, heart, lungs etc.

The medical practice of organ transplantation has grown by leaps and bounds over the last 50 years. The most important and major transplantation advanced in the medicine through the last century are:

· Successful transplantation of different kinds of organs beginning with the kidney and now expanded to hearts, lungs, livers and other organs.

· Development of cadaveric and living organ donation practices

Deciding who can donate organs has changed, starting with living donors and then moving to include deceased and prisoners or fetuses' dead donors.

· Development of anti rejection drugs that lead to increase the success of organ transplantation.

· Using animal organs for human transplantation – xenotransplantation

· Invention and use of the first artificial organs

· Splitting organs into pieces

The first split liver transplant allowed one cadaveric liver to be used among multiple transplant patients.

· Stem cell research

Stem cell research is examining adult and human embryo cells in an attempt to discover how organs are developed and what stimulates their growth.

Transplantation Ethics by Robert Veatch. Georgetown University Press; Reprint edition, 2002.

Transplantation is not only a medical procedure it is a complex social process performed accordingly to legal and ethical norms.

4.1.2 Forms of transplantation

Autografts: Is the transplant of tissue to the same person.

Allograft and allotransplantation: Is a transplant of an organ or tissue between two genetically non-identical members of the same species. Most human tissue and organ transplants are allograft

Isograft: A subset of allografts in which organs or tissues are transplanted from a donor to a genetically identical recipient (such as an identical twin).

Xenograft and xenotransplantation: A transplant of organs or tissue from one species to another

Split transplants: Sometimes a deceased-donor organ, usually a liver, may be divided between two recipients, especially an adult and a child.

Domino transplants: This term refers to a series of living donor transplants in which one donor donates to the highest recipient on the waiting list and the transplant center utilizes that donation to facilitate multiple transplants.

ABO-incompatible transplants: Receiving organs from incompatible donors.

Transplantation in obese individuals

4.2 Ethical issues in transplantation

Organs Sale for Transplantation

Recently due to the increase of the success therapy of the transplantation lead to increase the demand for it, creating a gap between organ demand and organ supply.

This situation led to trade in human organs, especially in the developing countries where cadaveric organs are not easily available.

As a consequence, many type of medical practice has emerged, where human organs are bought from the poor for transplantation into the wealthy clientele with benefit for agents, private hospitals and financier. It is estimated that since 1980, over 2,000 kidneys are sold annually in India to wealthy recipients from the Middle East, the Far East and Europe.

Therefore, this practice of trading in human organs has alarmed the public and many governments and it has been condemned by all major religions.

Most ethicists believe that organ sale is not acceptable for the following main reasons:

(a) Organ sale promotes duress the poor people.

(b) The poor quality of care to the donor as result of the inadequate donor selection and lead to transmit diseases.

(c) It is against the patient's right for autonomy and the benefits that go to the doctors who care for their egos and financial gain.

Holland S. Contested Commodities at Both Ends of Life: Buying and Selling Gametes, Embryos, and Body Tissues. Kennedy Institute of Ethics. 11(3), 2001 Sep.

justifications for transplantation from Living Donors

Living donation is ethically and medically acceptable. Also, the rate of donor complications after donation is small.

On the side of the donor, there are many psychological and spiritual benefits, most donors express the sense of pride and satisfaction and the joy of giving a gift of life to a relative, a friend or to another fellow human being.

Another justification is that the success rate of living donor transplantation is higher than the cadavers.

The Canadian Standards Association recently arrived to the following

recommendation that considered ethically acceptable:

When there is a rescue of a seriously ill or dying patient

Maximize the medical outcome among potential recipients

The time for waiting list has been prolonged

Spital A. Justification of living-organ donation requires benefit for the donor that balances the risk: Commentary on Ross et al. Transplantation, 2002; 74(3):423424

Acceptable Financial Incentives for Organ Donations

Increasing the demand for organ transplantation and the high death rate of patients waiting for an organ push many transplant professions, ethicists and government organizations to reconsider a number of options which might be morally and ethically acceptable to promote organ donation and save the lives of many patients.

They believes that the families of dying patients who donate their organs should receive payments by the state and the government that will cover the funeral expenses, the cost of travel, and to provide some financial compensation.

A sum of 3,000$ has been suggested by the organizations in most of the regions in the United States.

Also many organizations give for their employees who wish to donate an organ paid leave so they can donate without suffering from any financial loss.

They receive up to 30 days of paid leave when they donate a major organ and up to 7 days when they donate bone marrow.

In a recent article by Emerling, several other suggestions to help organ donation by living donors:

The Federal Government should provide a lifetime tax exemption for every American citizen willing to donate an organ

Some form of life insurance be paid for and offered for the organ donor

Any foreign national who volunteers for donating an organ should be awarded American citizenship.

Veatch RM. Why Liberals Should Accept Financial Incentives for Organ Procurement. Kennedy Institute of Ethics Journal. 13(1), 2003 Mar.

The Use of Stem Cells in Transplantation

The recent developments in transplantation have been the use of stem cells, it can be from blood cord, bone marrow, neural cells, adult and fetal tissue.

These cells have the great potential for differentiation and proliferation into body and thus help many patients with organ failure after their transplantation into the patients.

These stem cells taken from the adult and fetal tissue, after being identified, cultured and stored in many laboratories.

There is considerable moral and ethical debate in many countries regard using stem cells from embryos and fetuses.

In 1950s the use of the fetal tissue helped in the development of the polio and rubella vaccine, while in the 1960s fetal thymus cells were successfully transplanted.

Indeed, the Center for Biomedical Ethics, at the University of Minnesota, has reported that 1,000 patients have received transplanted fetal tissue cells worldwide.

Obtaining these fetal tissues will be only from spontaneous abortion and ectopic pregnancies, but many researchers considered that using fetal tissue from abortion is a way of legalizing abortion and this will increase the number of abortions. As a result of this major concern, the current regulations in the USA do not allow the use of stem cells from aborted fetuses or from embryos created by in vitro fertilization.

Safety of cells, tissues and organs for transplantation: General requirements. Can Standard Assoc Bull Nov 2001;8–64.

The Use of Animal Organs and Xenotransplantations

It is a way of transplantation of organs from animals. ‘xeno’ today, which means foreign, will become ‘familiar’ tomorrow.

We have three ways to use the animals and save patient's life:

(a) Using tissues such as, Neuroendocrine cells, especially from pigs, to treat Parkinson’s disease and their islets to treat patients with insulin-dependent diabetes.

(b) Using animal organs such as the liver

(c) Whole organ transplant. The first was a kidney transplant by Reemetsma in the 1960s, and a liver transplant by Starzl in the 1970s.

The use of animal organs raises important moral, medical, ethical and social issues:

Type of animal species that used. Most societies and animal right organizations will not allow the transplantation of organs from animals.

Transmission of diseases and infection.

To review and check the experiments that uses the animal organs for transplantation by the Ethics Committee institution. So in this way it is expected that using organs from animal will help many patients on waiting lists.

Reiss MJ. The ethics of xenotransplantation. Journal of Applied Philosophy. 17(3):25362, 2000.

4.2.1 THE ORGAN SHORTAGE

The primary ethical mess surrounding organ transplantation arises from the lack of available organs.

The UNOS (United Network Organ Sharing) maintains website that gives the status of people on the waiting list for organ transplantation. The website gives an idea for the extent of organ shortage and proof that the gap between the number of available donor organs and the number of people who need organs grows daily.

83,000 people are waiting an organ in United States.

In 2003 more than 19,000 organ transplants were performed. The organs were taken from approximately 9,800 donors both living and deceased.

On average, 106 people are added to the nation's organ transplant waiting list each day–one every 14 minutes.

On average, 68 people receive transplants every day from either a living or deceased donor.

On average, 17 patients die every day while awaiting an organ (one person every 85 minutes).

By www.unos.org

Distribution of available organs

The concept of distributive justice (how to fairly divide resources) arises around organ transplantation because there are not enough organs available for everyone who needs one. This theory means that there is many ways that could justify a person by giving an organ to him over someone else.

University of Washington School of Medicine website put this list of criteria to distribute the organs fairly:

1. To each person an equal share

2. according to need

3. according to effort

4. according to contribution

5. according to merit

6. according to free-market exchanges

Equal access criteria include:

* Length of time waiting (i.e. first come, first served)

* Age (youngest to oldest)

The equal access theory encourages the distribution for transplantable organs bye the free of biases based on race, sex, income level and geographic distance from the organ and by the free of medical or social worthiness biases.

Medical “worthiness” biases could exclude patients from reaching the top of the transplant waiting list if their lifestyle is unhealthy like smoking and alcohol use that will damage their organs.

A social “worthiness” bias is the patient’s place in society. This would affect, among others, prisoners being punished for offenses against society.

A second type of distributive justice criteria is maximum benefit. The goal for maximum benefit criteria is to maximize the number of successful transplants.

Examples:

* Medical need (the sickest people are given the first opportunity for a transplantable organ)

* Probable success of a transplant (giving organs to the person who will be most likely to live the longest)

People who support the maximum benefit philosophy believe organ transplants are medically valuable procedures and wish to avoid the wasting of organs because they are very scarce. To avoid waste, they support ranking transplant candidates by taking into account how sick the patient is and how likely it is that the patient will live after receiving transplantation.

Successful transplants are measured by the number of life years gained, Life years are the number of years that a person will live with a successful organ.

The Ethics of Organ Transplants: The Current Debate by Arthur Caplan. Prometheus Books, 1999.

Transplantation Ethics by Robert Veatch Georgetown University Press; Reprint edition, 2002

Current organ distribution policy

UNOS in united state relies on the transplant center the following criteria for distributing organs:

1) medical need

2) probability of success

3) time on the waiting list.

4.2.2 DONOR ORGANS

One way to avoid the ethical problems associated with the shortage of transplantable organs is to increase the number of donor organs.

We can find three sources of transplantable organs:

cadaveric donors

living donors and

alternative organ sources.

Cadaveric organ donation

When a person dies, his organs may be donated if the person consented to do so before they passed away. A person’s consent to donate their organs is made while still living and appears on a driver’s license or in an advance directive.

A person is considered dead once either the heart stops beating or brain death. After death, the organs are taken from the deceased person’s body.

If the deceased person’s organ donation wishes are unknown, the hospital, physician, or organ procurement organization will approach a family member to obtain consent to remove the organs.

The family members that have the right to do so are determined by this hierarchy:

Spouse

Adult child

Parent

Adult sibling

Legal guardian

Five strategies to increase cadaveric organ donations

1. Education

To do educational efforts that encourage organ donation before death and educate the families when they are considering giving consent for their deceased patient's organs.

2. Mandated choice

It means that every American would have to indicate their wishes regarding organ transplantation on driver's licenses. The positive side of this strategy is that it enforces the autonomy of the person.

This mandated choice policy requires a high level of trust in the medical system, so people must be able to trust their health care providers to care for them no matter what their organ donation wishes.

3. Presumed consent

This strategy of procuring organs is the policy of many European nations. In these countries, their citizens’ organs are taken after they die, unless the person didn’t requests to donate his organs.

4. Incentives

It takes many forms

Give assistance to families of a donor with funeral costs

Donate to a charity in the deceased person’s name if organs are donated

Offer recognition and gratitude incentives like a plaque or memorial

Provide financial or payment incentives

5. Prisoners

Using organs from prisoners who dead. Some bioethicists believes that it is morally justifiable only if a donation practice was in place and others considered that it is a morally objectionable practice.

Machalinski D, Kijowski J, Marlitz W, Markiewski M, Paczkowski M, Kopkowski A, Majka M, Ostrowski M, Ratajczak MZ: Heparinized cadaveric organ as a potential source for Transplantation 2001; 71:1003–1007.

Living organ donation

Due to the organ shortage, persons started to look for a living donor to donate his organ and bypass the national waiting pool to receive a cadaveric organ.

According to UNOS, there are a number of benefits to living donation, both for the donor and the patient:

· The donation can be pre-arranged, allowing the patient to take antirejection drugs and increase the chances success of the transplantation.

· There are often better matches between donors and recipients with living donation, because many donors are genetically related to the recipient

· Psychological benefits for both the donors and recipients

On the other hand, not everyone encourages the practice of living donation due to drawbacks:

· Health consequences: Pain, discomfort, infection, bleeding and potential future health complications.

· Psychological consequences: Family pressure, guilt or resentment.

· Pressure: Family members may feel pressured to donate when they have a sick family member

· No donor advocate: While the patients have advocates, like the transplant surgeon or medical team who advise them, donors do not have such an advocate and can be faced with an overwhelming and complicated process with no one to turn to for guidance or advice

We can find a few non financial incentives to increase living donation, such as medical leave or special insurance for living donors, it may be a way to entice people to donate their organs. In January of 2004, Wisconsin became the first state to offer a living donation incentive to its citizens by receive an income tax deduction to recoup donation expenses like travel costs and lost wages.

Most experts argue that buying and selling human organs is an immoral practice, because this will lead to socioeconomical disadvantages. People who are poor, uneducated and live in a depressed area will be unfairly pressured to sell their organs for the money. On the other hand, wealthy people would have unfair access to organs due to their financial situations.

In 2002, an article that examined the effects of offering payment for kidneys in India was published in the Journal of the American Medical Association.

The findings uncovered some interesting data:

· 96% of people sold their kidneys to pay off debt

· 74% of people who sold their kidneys still had debt 6 years later

· 86% of people reported deterioration in their health status after donation

· 79% would not recommend to others that they sell their kidneys

Alternative organ sources

Using non-traditional sources of organs such as:

1. ANIMAL ORGANS

2. ARTIFICIAL ORGANS – The ethical issues refers to the cost and effectiveness of artificial organs.

3. STEM CELLS – Stem cells are cells that can specialize into the many different cells found in the human body.

The ethical objections regard stem cells use is their source. Stem cells can be found in the adult human body or from human embryo. Some people find this practice morally objectionable and must stop it because these procedures destroy human embryos.

4. ABORTED FETUSES

Many people believe that this practice is morally objectionable because it can lead to encourage the abortion and increase the organ trade.

Even though, fetal tissue such as pancreas, brain, liver, thymus, bone marrow and adrenal gland have all been used in clinical transplantation despite the concern over the legality and the ethical issues of the procedure.

Abouna GM, Panjwani D, Kumar MS, White AG, Al-Abdulla IH, Silva OS, Samham M: The living unrelated donor: A viable alternative for transplantation. Transplant Proc 1988; 20:802–804.

4.3 LEGAL AND SOCIAL ISSUES

CURRENT LAWS

Organ donation laws at the state and federal levels exist for two primary purposes. The first purpose of organ donation laws is to help ensure a safe and fair organ donation collection and distribution practice.

The second purpose of organ donation laws has been enacted to widen the pool of potential donors in an effort to increase the number of organs available for transplant.

National Organ Transplant Act of 1984

The goal of the National Organ Transplant Act (NOTA) was to address the problems of organ shortage and improve the collection and distribution of organs nationwide. It was passed by the United States Congress in 1984.

· To maintain a nationwide computer registry of all patients who need organs.

· To keep a national registry of patients and organs and matches organs with patients.

· Established the Task Force on Organ Transplantation.

· Banned the purchase or sale of organs or tissues.

Consolidated Omnibus Reconciliation Act of 1986

The Consolidated Omnibus Reconciliation Act (COBRA), passed by the United States Congress in 1986, primarily addressed health benefits and health insurance coverage. The Regulations reforms:

· Requires hospitals to establish a relationship with a federally mandated Organ Procurement Organization. It is also includes the instruction that Organ Procurement Organizations must work with hospitals to coordinate transplants at the local level.

· This act forced all hospitals receiving Medicare or Medicaid funding to enact a “required request” policy. A required request policy ensures that all families of potential donors are told about organ donation and their right to decline donation.

Uniform Anatomical Gift Act

The Uniform Anatomical Gift Act is a set of model regulations and laws concerning organ donation that all 50 states have passed in some measure. There have been many revisions to the Act.

· 1968 – The passage of the Uniform Anatomical Gift Act in the United States Congress allows people to donate their organs.

· 1972 – The Uniform Donor Card is passed as a legal document in all 50 states, allowing anyone over 18 to donate their organs.

Kuczewski MG. The Gift of Life and Starfish on the Beach: The Ethics of Organ Procurement. The American Journal of Bioethics. 2(3), 2002 Summer.

MEDICARE Conditions of Participation

Medicare developed five incentive policies in 1998 to encourage organ donation. They are printed on the International Association for Organ Donation website:

· “The hospital must notify the organ procurement agency of every death occurring in their facility.

· All hospital personnel providing the option of donation to families will be trained by the organ procurement agency.

· The Hospital will have a written agreement to work with organ, tissue and eye banks.

· The hospital will acknowledge that screening for potential donors will be conducted by the appropriate recovery agency.

· The hospital will work in conjunction with recovery agency to conduct record reviews to determine the donation potential of individual facilities.

First Person Consent Laws

In the 1990’s, states began to pass first person consent laws. These laws require hospitals and organ procurement organizations to follow a patient’s organ donation wishes as indicated on their driver’s license or in a health care directive. Where the laws are enacted, the hospital and the organ procurement organization has a legal right to follow a deceased person’s written organ donation wishes and does not require them to approach the deceased person’s family for permission to remove the organs. This laws putt the patient’s decisions above the decisions of their family so this practice and supports and acknowledges autonomy of the person.

Kolata G. In shift, prospects for survival will decide liver transplants. New York Times. :A1, A26, 1996 Nov 15.

Conclusion

Clinical organ transplantation has been recognized worldwide as one of the most gripping medical events of the 20th century.

However, the poor availability of organs supply from cadavers human caused a gap between organ demand and organ supply, which has led to very long waiting times and many deaths among potential transplant recipients. This situation has led to difficulties in organ allocation, to the use of more organs from living donors, and to the abhorrent practice of trading in human organs which have created many ethical dilemmas.

Many physicians and ethicists believe that these problems can be minimized by medically and ethically accepted solutions including the provision of better care and counseling with informed consent to the bereaved family, by showing them respect and compensation for funeral, travel and other expenses.

The use of volunteer living donors, which has many medical advantages, can also be enhanced by appropriate public education with the emphasis of providing a ‘gift of life’ to a fellow human being purely on humanitarian grounds, but not for financial gain.

The current advances in stem cell biology and tissue engineering can bring many benefits for the treatment of common diseases including diabetes, Parkinson’s disease, systemic lupus erythematosus, etc.

However, ethical concerns do arise with regard to the source of such cells and tissues. Most societies, ethicists and clergy will object to take these cells from aborted embryos unless the abortion is done purely for the benefit of mother and fetus and has no relation to willingness to donate.

The use of animal organs does have a definite potential to save the lives of many patients on the transplant waiting list, but before using suitable domestic type animals, the moral and ethical guidelines of society must be respected as well as that there will be minimal risk to the recipient, including transmission of infection.

Finally, for clinical organ and tissue transplantation to be fully beneficial and life-saving, everyone involved in the process, including physicians and medical institutions, must only respect and consider the best interest of the patient and honor the ethical, moral and religious values of society and not be tempted to seek personal fame or financial reward.

Attachment

Table 1.The USA national patient waiting list for organ transplants in March 2002

Table 2. Number of transplants performed in the USA in the year 2000

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http://education.yahoo.com/reference/dictionary/.

The Ethics of Organ Transplants: The Current Debate. By Arthur Caplan. Prometheus Books, 1999.

Transplantation Ethics. By Robert Veatch. Georgetown University Press; Reprint edition, 2002.