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Apr-Jun2001-9(2)
DISCUSSION: ORGAN
TRANSPLANTS
Organ transplantation: ethical
issues and the Indian scenario
Sanjay
Nagral
There are many who believe that transplantation
represents one of the most spectacular achievements of modern medical science.
Advances from many fields of medicine have contributed to a tremendous
improvement in results over the decades. This has lead to a steep rise in the
numbers of transplants being performed. Transplantation has also raised some of
the fiercest ethical controversies in modern medicine. In a way it is not
surprising that a field which involves the removal of human organs from a living
or dead individual to save the life of another individual should throw up
strange ethical dilemmas. Perhaps no other field of medicine has raised so many
complex and intertwined ethical, moral, legal and social issues. Even from the
Indian perspective the 'kidney bazaar' as it was rather crudely but aptly
termed remains one of the biggest ethical controversies to hit the public domain
in the last decade.
With the increased inflow of personnel and
knowledge from the developed world transplantation of solid organs is being
attempted in increasing numbers in India. Simultaneously with the introduction
of a specific act called the Transplantation of Human Organs Act (HOTA) in 1994,
the way has also been paved for performing 'cadaver' transplants from 'brain
dead' patients. The Act, which was partially a response to the public outcry
about the 'organ trade' in the early 90's, is also meant to monitor organ
trading. Reports from the field indicate that the act has not really succeeded
in achieving its main objectives, namely, to promote cadaver transplantation and
to curb trading in organs.
As a journal trying to raise discussion relating to
the ethical practice of medicine in India we have in the past carried articles
on various aspects of transplantation ethics . We thought that this was an
opportune time to revisit some of the ethical controversies in this collection
of articles.
Historical
evolution
Mythology is not medical history but many religious
texts are replete with stories and figures where human organs are replaced by
animal ones. The 'miracle' of Saint Cosmos and Saint Damien from Christian
mythology as described in the 'Lives of the Saints' needs mention at least for
the bizarre similarity it has to modern transplantation in more than one
ways. Saint Cosmos and Damien were called upon to treat a priest
afflicted by a cancer of his leg and the two saints went to the nearest
graveyard where an 'Ethiopian' had just been buried , took off his leg and used
it to replace the priest's leg.
The British surgeon John Hunter in the late 18th
century successfully transplanted a human tooth on to a hen's comb and thus made
some of the first scientific attempts at animal transplantation. However it was
really in the 20th century that transplantation caught the fancy of the medical
fraternity and became a reality. The first attempt at human solid organ
transplantation was made by a Russian surgeon, Voronoy, who unsuccessfully
transplanted a kidney from a cadaver into the thigh of a patient suffering from
renal failure. In 1946, surgeons in Boston first successfully transplanted the
human kidney, between two identical twins. This was followed by the liver in
1963 and the heart in 1967. Today, many other organs including the lung,
pancreas and intestines are also being transplanted with varying degrees of
success. Transplantation of organs like the kidney, liver, and heart is no
longer regarded as experimental but an established therapy by the WHO (1) and
around 50,000 such transplants are being annually performed.
The kidney, being a paired organ can be removed
from a living person, whereas the heart and the liver have to be removed from
dead individuals. In the initial stages, removing organs from an individual who
was 'dead' as per our classic understanding of death, that is, when the heart
had stopped, was attempted. This was largely unsuccessful, since for an organ to
be viable it had to be removed within minutes of cessation of heartbeat, which
was an impractical proposition. This is unlike the 'cornea' or the eye, which
remains viable for a few hours and hence can be removed after some time has
elapsed after death. In the last three decades, the concept of 'brain
death', a state where the brain is irreversibly damaged but the heart is
beating, came into being in the Western world. 'Death' as we understood it over
the years was redefined. 'Brain death' represents a state of irreversible damage
to the brain which over a period of time (12 to 36 hours) inevitably leads to
stoppage of the heart (cardiac arrest). This is typically seen in patients with
severe head injury, massive stroke, brain tumors, brain hypoxia, and as a
complication of neurosurgery. Such brain dead individuals or 'heart beating
donors' are in intensive care units (ICUs) on artificial respiration, and
removal of organs from them is performed as an operative procedure. Almost all
transplants in the developed world are now done in this fashion.
French physicians first described the concept of
brain death in 1959, before the era of organ transplantation. However it was
then legalised and popularised due to its implications for organ
transplantation. Till recently, 47 countries in the world had accepted 'brain
death' as a legal concept and 39 countries had enacted specific laws on organ
transplantation (2). The form and method of obtaining consent for removal of
organs from brain dead individuals has varied. Generally, two forms of consent
have been practised. The commonest form of consent is 'informed consent' in
which close family members agree to donate organs of the deceased after 'brain
death'. This involves the treating doctor motivating the family for organ
donation after 'brain death' has been certified. Even in the West, doctors have
been observed to be reluctant to do so for the fear of inviting the wrath of
family members in an emotionally charged situation and only about 30 to 40 per
cent of families actually give consent. The other form of consent is called
'presumed consent'. This grants authority to doctors to remove organs from brain
dead individuals whenever usable organs are available, in the absence of
objection from the deceased in his or her lifetime, or his family members.
Presumed consent places the burden of opting out of organ donation on those who
object to this procedure. This system has been legalised in European countries
like Austria, Belgium, Denmark, Finland and France. Vijay Rajput in an article
in this issue (3) examines presumed consent in detail.
In spite of many measures to promote organ
donation, the discrepancy between 'demand' and 'supply' of organs continues to
grow. In 1994, around 3,000 patients waiting for an organ died in the USA. As
more and more patients are put on transplant waiting lists the desperation to
look for methods to increase the 'supply' of organs has increased.
Transplant surgeons have resorted to the use of organs from animal species in a
process called xenotransplanatation. So far kidneys, livers and hearts have been
transplanted from non-human primates commonly the baboon to man. Besides raising
animal rights issues, there have been ethical objections to the purely
'experimental' nature of such procedures where the patients were made 'guinea
pigs'. These issues are discussed in detail by Vijay Rajput (3).
Once consent for removal of organs has been
obtained from relatives of brain dead patients, intimation is given to networks,
which coordinate transplant programmes between various centres. The organs are
distributed based on a 'waiting list' where recipients are prioritised. With
organs being in short supply there is a scope for considerations like money,
influence, race and nationality creeping into the distribution system. In
choosing the recipient, another debate that has raged for a long time is whether
to transplant the sickest patients since they need the organ most but also have
the poorest chance of survival, or to transplant relatively healthy patients in
whom the result is better and hence the organ is utilised better. In patients
with diseases resulting from addictions, such as liver disease due to
alcoholism, it has been debated whether a transplant should be performed at all
since the disease has been brought on by an addiction and there is a chance that
the patient could go back to the same addiction. In general, the question has
been raised whether given the shortage of organs the medical profession should
sit on moral judgment about diseases that are preventable or should it purely go
by the medical merit of the case.
Transplantation and religious beliefs
Transplantation has thrown up peculiar and
complicated religious and moral questions. For example if a heart is removed
from a cadaver, does it mean that it is now devoid of a 'soul'? Also, will
removal of organs in any way affect the process of 'rebirth'? Both Roman
Catholics and Protestants tend to support organ donation, believing that God's
power to resurrect the body will not be thwarted by prior disposal of its parts.
Jewish law prohibits deriving benefit from mutilating or delaying the burial of
a corpse but this prohibition can be overridden to save a life. The Islamic
Organization of Medical Sciences passed a resolution many years back recognising
brain death (2) and many Islamic countries are now performing cadaver
transplants. The only big religious group, which till recently opposed the idea
of brain death, is the Shintos in Japan. Thus Japan, a country otherwise
extremely advanced medically was unable to start cadaveric transplantation of
organs till recently when the Japanese Parliament gave a go ahead. Swami
Lokeshwarananda of the Ramkrishna Mission is reported to have said in a seminar
in 1988 that Hindu and Vedic scholars accept the concept of brain death (2). The
concept of 'giving' or 'daan' is ingrained in Hindu thought and therefore
there seems to be no major religious objection to the act of organ
donation. Activists of organisations involved in mobilising people for
organ donation report that they have received hundreds of inquiries from
citizens desiring to donate their body/organs after death. The eye donation
movement in India has never faced any significant religious resistance. A survey
by the Tata Institute of Social Sciences in Bombay revealed that the majority of
respondents irrespective of religious and economic status were in favor of organ
donation (2).
The Indian scenario
In India a majority of patients with end stage
disease of potentially transplantable organs presently die of their disease. In
the case of kidney failure some are on long-term dialysis an alternative
inferior to transplantation. Till the passage of the Transplantation of Human
Organs Act there was no comprehensive legislation regulating the removal of
human organs. In 1991, the Central government constituted a committee to prepare
a report, which could form a basis for all-India legislation. Although the main
terms of reference of the committee were concerned with 'brain death', it also
recommended that trading in human organs be made a punishable offense. The
Transplantation of Human Organs Act was thus passed by Parliament in 1994. The
act legalises 'brain death' making removal of organs permissible after proper
consent. The first few hundred such cadaver transplants have been performed
mainly in the metros in the last two to three years but the activity in the
field is well below what was expected or what is needed. On the other hand, the
Act also seeks to regulate non-related live donation of organs and makes
commercial trading an offense. It makes it mandatory for institutions
conducting transplants to register with an authority appointed by the
state government. This authority will also enforce standards, investigate
complaints and inspect the hospitals regularly to monitor quality. All persons
associated in any way with hospitals conducting transplants without the proper
registration are liable for punishment. Thus, it is probably for the first time
that an external body has been given legal powers to scrutinise and monitor the
activities of medical institutions. The Act also lays down criteria for
determining brain death. Many safeguards against misuse have been built in the
rules. The brain death tests must be performed by four individuals together,
none of whom has anything to do with the transplant, and this must be done
twice, with a minimum gap of six hours. Such brain death can be declared only in
institutions recognised by state appropriate authority. The written
consent can be obtained only from a close relative. There are problems peculiar
to the Indian situation that have already come up in the practice of cadaveric
transplantation. Firstly the Act links 'brain death' and 'transplantation',
which as Sunil Pandya and Harsha Deshmukh state in their articles (4,5) is a
fundamental flaw. The diagnosis of brain death is made in ICUs where the
facilities for keeping a brain dead patient's organs working with mechanical
ventilation, cardiac support and intensive monitoring exist. Such ICUs are few
and are a part only of big hospitals in major cities. They are usually
overloaded, understaffed and lack a central command structure. Given this
situation, brain dead patients have traditionally been given low priority and
treated with 'benign neglect'. When such patients become donors, they would
require the attention like any other patient to keep the organs viable till they
are removed. This would require a major attitudinal change and could be resented
by an already overburdened staff. When other, salvageable patients often lack
the required medical attention, is it ethical to lavish such care on the dead?
Harsha Deshmukh, a transplant coordinator involved in the early cadaver
transplants in Mumbai in a view from the field puts forth some of the practical
problems (5) that are being already experienced.
'Rewarded gifting': the unrelated
donor
The 'Indian kidney bazaar' has been a subject of
much discussion and three of the articles in this issue focus on this
controversy. For a long time an organised network of doctors and middlemen lured
people in desperate need of money into 'donating' their kidneys, which were
transplanted into the wealthy, including a large number of Arab patients. These
operations were often performed in sleazy nursing homes with little respect for
basic transplant principles. With the passage of the Transplantation of Human
Organs Act much of this activity died down. The discovery of an organised
racket in NOIDA on the outskirts of Delhi a few years back showed that the
racket has probably moved from the metros to smaller places. In what many
believe is a major loophole the HOTA allows for donation from a non-related
person as long as the intentions of such a donation are scrutinised by committee
in every state. It is now common knowledge that the number of such 'altruistic'
donations forms a significant percentage of transplants. As Dr MK Mani from
Chennai puts it in a recent article, "Dozens of slum dwellers from Chennai have
this great and transcending love for millionaires from Kanpur or Calcutta, whom
they could not have met more than a few weeks earlier. Truly this is love at
first sight."(6) A certain new line of argument from western philosophers in
favor of 'organ selling' supported by some from the international transplant
community has appeared in the last few years. We carry two pieces (7,8) which
more than adequately convey the gist of this argument, and a response from India
(9). The question that is likely to be asked time and again however is: what are
the options for a patient who desperately requires an organ transplant for
survival but does not have a close relative to donate the same, or does not get
a cadaver organ? Finally, transplantation is a costly affair and this poses an
ethical dilemma in itself. In addition to the cost of the procedure which
runs into lakhs of rupees the patient has to bear a life-long recurring cost of
Rs.7,000 to Rs 8,000 per month for immunosuppressive medication. The idea of
equity in health care, which now rightfully occupies an important place in
ethics, assumes a rather stark dimension in the field of transplantation. For
the common man who is caught in the pincer of an ill-equipped and crumbling
public sector and a costly private sector transplantation is in reality a very
distant dream.
Conclusions
This review has attempted to discuss some of the
historical aspects as well as the areas of debate in the field of organ
transplantation and some of these areas are detailed in the accompanying
articles. An effort has been made to emphasise the Indian scenario. With the
passage of time and advances in the field many more areas for ethical debate are
likely to emerge. Given the events of the last few decades it is a sad reality
that at least in this country organ transplantation has come to be associated
more with commerce than science and healing. For those who desire to
provide the benefits of this advance in medical science to people at large in an
ethical and equitable fashion, it is indeed going to be a daunting challenge to
try and change this state of affairs
References
1. Human Organ Transplantation. Report by the
Director General, EB 79/8. World Health Organisation, Geneva. 1986. 2. Pande GK,
Patnaik PK, Gupta S, Sahni P: Brain death and organ transplantation in India.
The National Medical Journal of India, New Delhi. Pages 70. 1990. 3. Rajput V:
Addressing the organ shortage. Issues in Medical Ethics 2001; 9: 54-55. 4.
Pandya SK: 'Brain death' and our transplant law. Issues in Medical Ethics 2001;
9: 51-52. 5. Deshmukh H: Problems in cadaver transplantation. Issues in Medical
Ethics 2001; 9: 53 6. Mani MK. Making an Ass of the Law. Letter from
Chennai. Natl Med J India 1997; 10: 242-3. 7. Kyriazi H: The ethics of
organ-selling: a liberatarian perspective. Issues in Medical Ethics 2001; 9:
44-46. 8. Radclife Ricahrds J: Organs for sale. Issues in Medical Ethics 2001;
9: 47-48. 9. George T: The case against kidney sales. Issues in Medical Ethics
2001; 9: 49-50.
Dr Sanjay Nagral,Surgeon, Jaslok Hospital and Research Centre, Mumbai 400 026. Email:nagral@vsnl.com.