Sunday Times 2
The tangled web of legal, ethical and administrative issues that surround cadaveric organ transplantation
T he Sunday Times is one of the most read Sri Lankan newspapers. The newspaper on February 4, 2018 in its Sunday Punch column titled ‘Medishocker; Brain dead girl’s organs removed whilst still alive’, reveals a gruesome account of a victim of severe road traffic trauma being subjected to the process of organ retrieval for transplantation.
The column’s author, Don Manu, raises ten pertinent questions highlighting the very essence of the ethical and legal complexities that surround the process of organ retrieval from a patient who has died from sudden and accidental circumstances.
Many of these questions are paraphrased allegations of professional misconduct and sadly paint a rather gory and nihilistic image of medical practitioners. As a member of the wider medical fraternity and as an academic in forensic medicine which is the specialty that deals with the legal and ethical dimensions of medicine, I volunteer to answer some of these questions with the caveat that I have not been directly or indirectly involved in the case mentioned above and neither do I have any material evidence to confirm or refute any of the allegations made specifically in relation to this case.
However, there are, I believe, several generalised misconceptions within this article which could be rectified through better understanding of the legal, ethical and administrative guidelines surrounding this important area in medical practice.
Grounds for transfer
Questions one and two are in relation to the necessity and process of transferring patients from one hospital to another. From what was mentioned by the author, the patient had sustained serious injuries to the head which would have necessitated cranial imaging using at least CT scan to properly diagnose and identify the prognosis of the patient; a facility which is not available at a base hospital. This alone would have been sufficient grounds for transfer to the closest tertiary hospital, the National Hospital of Sri Lanka (NHSL).
Given that this patient was young and given that there was an obvious necessity of neurosurgical intervention (surgical operations of the brain), it is inconceivable that any surgeon would not opt to transfer her to NHSL if she had shown some semblance of recovery. Once the extent of the injuries has been properly evaluated, subsequent decisions on the medical management would inevitably be linked to the potential survivability of a patient and would need to be based on judicious resource allocation. What should be deliberated here is whether the transfers were made by appropriate medical personnel after having considered all the available options and whether they were done with the intention of providing this patient with a better quality of care.
Unfortunately, no country is capable of guaranteeing unlimited health care facilities to everyone and in a hospital like the NHSL which is frequently overwhelmed by patients from every corner of the country, doctors have no other option but to focus their limited resources on patients who have a higher chance of survival. This is a basic concept in medicine anywhere in the world referred to as ‘triage’ where, be it on a battle field or a casualty ward, medical attention is prioritised for potentially salvageable injuries rather than severe injuries. It is not improper for the NHSL doctors to decide to manage this patient conservatively if her clinical condition was beyond the stage of successful recovery, ergo the transfers would have had no impact on the final outcome.
End-of-line decision
The third question touches on the highly sensitive and much debated topic of end-of-life decision and withdrawing of life support. At the outset it should be stated that Sri Lanka does not legalise euthanasia (mercy killing) and actively aiding or abetting a person to end his or her life is a crime under the Penal Code. This concept, however, extends into a medico-legal penumbra when it comes to withdrawing or refusing life-sustaining treatment as the doctor plays no active part but merely allows the natural course of events to take over.
The ethical, legal and moral issues are further compounded when another patient with better chances of survival is in need of the life support machine. How does the doctor then pick and choose who lives and who dies? Such are the vicissitudes of life within a hospital, and doctors are required to make such unpleasant decisions on the lives of people day in and day out. It is no wonder then that the author, and no doubt the public, view this transcendent power among doctors with a sense of apprehension; and rightly so. Yet it should be emphasised that doctors are required to wield this power through necessity of ensuring the smooth functioning of the hospital and not with the intention of ‘playing god’!
It is for this very reason that guidelines and standards for treating patients on life support need to be developed in conjunction with the statutory enactments that may vary from country to country. The General Medical Council of the UK, treatment and care toward the end of life (https://www.gmc-uk.org/guidance/ethical_guidance/end_of_life_care.asp), the NICE quality standards (https://www.nice.org.uk/guidance/qs13/resources/end-of-life-care-for-adults-pdf-2098483631557) and the New South Wales guidelines (http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/GL2005_057.pdf) are some examples that could be followed but are not directly comparable to our setting by virtue of these countries having a much higher level of resource allocation for health care.
In this regard the author has clearly exposed a lacuna in Sri Lankan medical practice where there are no established guidelines on how and when life support systems can be withdrawn from a patient. While no specific legal obligation exists to continue life support in a patient that does not show any signs of recovery, the primary governing principle of medicine ab antiquo has been the preservation of life, and no doctor should arbitrarily turn off a ventilator without considering several aspects such as the futility of continuing life support deprivation of the facility to other patients with better chances of survival, due attention to the family’s concerns and wishes and the quality of life of the patient.
What is death?
The author also raises concern on the prolongation of life support purely for the purpose of retrieving organs for transplantation which again touches on a very sensitive topic but can at least be partly addressed through more clearly laid out legal provisions in the Transplantation of Human Tissue Act No. 48 of 1987 referred to hereafter as the THTA48. However, before commenting on that aspect, it is perhaps prudent to digress towards the author’s fourth and fifth questions which together encompass a much debated topic not only in medical circles but also socially, religiously and legally — what is death?
Just as the author’s own example of the Buddha in all supreme sagacity remaining silent on this matter, no doctor too will claim absolute wisdom on how and when death occurs. However, one must realise that doctors, by virtue of being professionals in a scientific field, are disallowed the luxury of making decisions based on philosophical arguments and instead must use pragmatic and evidence-based criteria to justify their actions. Thus the medical community, too, continuously debates and reviews the concept of death at numerous scientific forums in the light of new research findings, advancing life support mechanisms and expansion of cellular regenerative techniques.
One of the first such forums that stipulated a widely accepted medical definition of death was the ad-hoc committee of the Harvard Medical School way back in 1968 and while several other committees revised these criteria regularly, the basic principles for diagnosing death remain unchanged.
There is a consensus among the medical fraternity that when the body has completely lost its natural ability to sustain blood circulation and respiration without the help of artificial means, it is no longer viable. In all vertebrate animals with a central nervous system, the regulation of blood circulation and respiration are ultimately controlled by a tiny center within the brain stem. Accordingly, in Section 15 of the THTA48, death is defined as a state where there is ‘an irreversible cessation of all brain function’ and goes on to say that this state may be determined by the ‘prolonged absence of spontaneous circulatory and respiratory functions’ i.e – loss of brain stem activity. Therefore, to the question of what is death, the answer purely from a medical and legal perspective is, ‘an irreversible, permanent cessation of brainstem activity’ and this is what doctors and courts need to go by.
It is important for the lay person to realise that this does not equate to total cessation of all biological processes in the body. Certain functions that could continue after brain stem death include reflex movement of limbs, secretion of body fluids, cellular healing processes and even continuation of circulation for a varying period of time. Many are the instances when doctors face the awkwardness of explaining to disgruntled family members that the person lying on the bed with twitching fingers or frothing at the mouth is, in fact, dead!
Determining death in respect to persons placed on life support is clearly embodied in sub-section 3 of section 15 of the THTA48 which reads “When the determination of the prolonged absence of spontaneous circulatory and respiratory functions is made impossible by the use of artificial means of support, the irreversible cessation of brain functions shall be determined by any means recognised by the ordinary standards of current medical practice.”
The term ‘ordinary standards of current medical practice’, though seemingly vague, allows for expansion and modification of the methods used to diagnose death according to newer and updated knowledge. Although more recent standard protocols show minute variations, the basic principles remain the same. There should be clear evidence of irremediable brain stem damage. All reversible conditions that could suppress brain stem activity should be excluded or corrected. Clinical tests should prove that the brain stem does not show any activity.
Guidelines on the standard practice for diagnosing brain stem death for the purposes of transplantation in Sri Lanka is communicated to all doctors through government circulars of the Ministry of Health, the most recent being the General Circular No. 01-37/2010 (available at http://www.health.gov.lk/CMS/cmsmoh1/index.php.). Two doctors of sufficient seniority should independently assess the brain stem functions of a person according to these guidelines twice each before declaring brain stem death. This circular also covers the procedure to be adopted when obtaining organs from a person whose death is a result of unnatural circumstances that require an inquest by law and it is this procedure that needs to be applied in the case of this patient as she was a victim of a road traffic accident.
Consent
Coming back to the author’s third question on prolonging ventilation for transplantation, in addition to the mandatory practice of obtaining consent from the next of kin, it would have been necessary for the transplantation team to also obtain written approval from the Inquirer into Sudden Death along with the concurrence of the relevant Judicial Medical Officer prior to the organ retrieval process. Furthermore, these approvals should be clearly documented in the Bed Head ticket and the transplant surgeon would need to furnish a report detailing the condition and appearance of the organs and the surgical procedures. In the current state of functional efficacy within our institutions, obtaining these approvals inevitably encumber early retrieval, hence the need to prolong the brain dead patient’s life support and thereby the family’s grievance. These are definite shortcomings in the system that certainly need discussion at higher administrative forums.
The procedure
Therein lies my approach to questions six, seven and eight which deal with the procedure of removing organs from the deceased person. It should be emphasised that neither of the doctors certifying the death should be members of the transplant team nor should they be connected to the treatment of the recipient of the transplants. Any involvement in the transplant process by the doctor certifying the death is an offence that is punishable by imprisonment (section 16 THTA48). There is no mandatory requirement, as the author queries, for the deceased person to have given consent for organ retrieval during life. There is a clear provision in section 5 of the THTA48 for the next of kin to consent on behalf of the deceased person unless the deceased has, during life, expressed any wishes to the contrary. The hospital where the death occurred is fully within its rights to obtain organs or tissue from the deceased person as long as the criteria stated in the THTA48 and the circular 01-37/2010 have been adhered to.
I reiterate that my intention is not to address any of the specific allegations made by the author but to make the readers appreciate that retrieving tissue and organs from a deceased person is not an arbitrary practice that can be manipulated by few individuals and that it has extensive legal and ethical regulations governing its legitimacy.
On a side note, there is another section in the Act which must be highlighted here and that is the prohibition of disclosure of information in section 18. As are many before, the author of the above article too is in contravention of this section.
The final two questions provoke a negative attitude in the minds of those who are unaware of the potential value of cadaveric organ donation and my fervent appeal is not to demonise this practice by comparing it to the collection of spare parts from an automobile.
While there are many serious implications in the use of cadaveric tissue in the name of scientific advancement, we have over the years witnessed success stories of kidney, liver, lung and, more recently, heart transplants using cadaveric organs and the metamorphosis of fortunes in the recipients of these transplants can never be excluded from this debate.
Where one life ends another prevails… all in the sustenance of humanity, albeit one that must be achieved without detaching oneself from humanity. Indeed, in this respect, the author’s foreboding concerns are not without valid reason. Those of us in the medical profession cannot boast of total acquiescence to the ethical and moral principles that govern our practice.
There are too many who are ready to circumvent rules and regulations in the name of progress. Perhaps it’s a tangled web we weave to which we ourselves fall prey. Nevertheless, the importance of awareness cannot be undermined and it is my sincere hope that the public and perhaps even my colleagues in the medical profession would better appreciate the numerous complexities, rules, regulations and ethical issues that are bound to this expanding practice of cadaveric organ donation.
(The writer is senior lecturer in forensic medicine at the Faculty of Medicine, University of Colombo)