Select Committee on European Union Written Evidence


Memorandum by David Wainwright Evans, MD, FRCP Emeritus Consultant Cardiologist

  1.  The procurement of organs for transplantation, as currently practised, is unethical on several counts.

  2.  To be capable of continuing function in different bodies, organs must be removed from donors' bodies while they are still alive. So-called "brain stem dead" patients who are designated as organ donors are self-evidently alive. This is obvious to parents who are asked for permission to remove their son's organs while—mechanical ventilation being continued—he remains in that state. Finding him warm, reactive and respiring, still perfused by his naturally beating heart, they find it difficult to accept that he is regarded as already dead by those preparing to operate upon him—to procure the wanted organs—with no change in his condition apart from drug-induced paralysis to facilitate the surgery. It should occasion no surprise that many parents, faced with that request, refuse their permission—particularly those who have been fully and frankly informed about the possibility of remaining brain function which it is beyond the power of the clinical tests routinely used to detect.

  [They may refuse their permission despite their son's name being on the NHS Organ Donor Register in the readily understandable belief that, when he registered, he did not envisage being in that state when used as an organ donor (vide infra).]

  3.  Many doctors (and philosophers) do not accept that patients who meet the UK "brain stem death" criteria—or the various "brain death" criteria in other countries—are dead. They acknowledge that those patients are, indeed, manifestly alive. In terms of the usual concept of death—the absence of all signs of life—such patients cannot reasonably be diagnosed and certified as dead. Most of the world's doctors would not, or could not, certify them dead. The more conservative members of the medical profession are not prepared to certify death until there are not only no remaining signs of life but also positive signs of death.1

  4.  Nevertheless, there are some doctors who continue to be willing to certify those clearly living patients dead as a legally necessary preliminary to removal of their organs for transplantation. They do so on the basis of the simple bedside tests prescribed (in the UK by the Department of Health in its Code of Practice) despite the increasing body of evidence2, 3, 4 that they are inadequate for the purpose. When introduced, over 30 years ago, those tests were claimed to have the power to diagnose death of the brain—it being tacitly assumed that "brain death", as clinically diagnosed, would be a generally acceptable basis for certifying death while the body remained alive—but that claim was clearly spurious, most of the brain not being tested at all (or, indeed, testable) and the prescribed tests lacking the power even to diagnose death of the brain stem as a matter of fact.2 The fallacy of that initial claim was formally recognized in 19955 but the certification of death for transplant purposes has continued on essentially the same clinical assessment, albeit on a novel conceptual basis which, insofar as it has been debated at all, has not found wide philosophical acceptance.

  5.  This new concept of human death is comprised of only two elements—the irreversible loss of the capacity to breathe spontaneously and the irreversible loss of the capacity for consciousness. It was claimed5—without presentation of evidence in support—that death of the brain stem sufficed to ensure those permanent losses and that the prescribed tests sufficed to establish death of the brain stem. There is, in fact, no sound scientific evidence to support those claims. The prescribed test for irreversible loss of ventilatory function (breathing) is dangerous6 but not sufficiently stringent, and there is no means of testing for residual capacity for consciousness. Consciousness is not understood. The notion that its arousal depends crucially and exclusively on elements of the brain stem looks increasingly insecure in light of recent neuroscientific observations. Those elements are, in any case, not specifically testable. They can be said to be permanently functionless only by implication, ie when it is certain that the whole of the brain stem is truly dead—a state which it is beyond the power of the prescribed tests to establish.2

  6.  The most plausible basis for the continuing certification of "death for transplant purposes" on the diagnostic criteria currently in use is that they are widely believed to suffice for the purpose of forecasting death—the final cessation of blood circulation and respiration (plus the passage of a sufficiently long period of time)—within a few hours or days, despite the continuation of mechanical ventilation and other life-support measures. That is of course, in reality, their use as prognostic guidelines. But their confusion with criteria for the actual diagnosis of death is essential to current organ transplantation practice and is backed by the Department of Health in the Code of Practice which governs those procedures. It may be that the doctors involved come to terms with this inappropriate use on the premise that, although the patients they certify dead on that basis are not de facto dead, it doesn't matter because they have no chance of recovery. This is the utilitarian view—that they are "dead enough" for transplant purposes and that it is in some distorted sense "unethical" to await de facto death because to do so would render the wanted organs unviable. But it ignores the inescapable fact that, as the donor is not really dead—whatever his status on paper—he is killed by the operation for removal of his organs.7

  7.  In recent years, concerns about this pragmatically useful confusion have been raised worldwide, and there have been calls, eg by Truog and Robinson,8 to face the facts and provide them to potential organ donors without obfuscation. Only then would it be possible to know the true level of public support for transplantation practice and only on that fully and frankly informed basis would consent to the use of one's body as a source of organs—to be removed while in some clearly defined and frankly described pre-mortal state—be valid. I have welcomed such proposals for full and frank information of the public about such procedures9 as a long overdue precaution against possible misunderstanding of the offer made by registration as a potential organ donor under the system currently in use.

  8.  As things are at present, some 14.6 million people have signified their willingness to be used as organ donors after death by adding their names to the NHS Organ Donor Register. The official leaflet promoting such registration describes the register as "a nationwide confidential list of people, held on a central computer database, who are prepared to be organ donors after their death". The application forms record a request that "after my death" the specified organs "may be used for the treatment of others". The same crucial wording "after my death", without explanation or qualification, appears on Donor Cards and on Driving Licence Application Forms.

  9.  There is, at least, the possibility that some of those signifying their willingness to be used as organ donors by ticking boxes on those forms have a different understanding of the meaning of the term "after my death" from that of the organ procurement team and the two doctors who will certify them "dead" so that the operation can begin, if their offer is ever taken up. It seems to me that the possibility of so serious a misunderstanding must invalidate the offer. It is, therefore, surprising that greater efforts have not been made to clarify that crucial wording so that both parties to the offer have an identical view of its meaning.

  10.  It is, indeed, rather likely that many or even most people who "sign up" by ticking boxes on the simple forms in use, eg on Driving Licence Applications, without actively seeking further information, do so in the belief that they will be dead in the commonly understood sense—pulseless, not breathing, totally unreactive and, perhaps, cooling and stiffening—before surgery to remove their organs will begin. I have heard that belief expressed many times.

  11.  Others, who have taken the trouble to seek more information about the procurement process, have understood that certain tests of brain function must be done by two specially authorized doctors before surgery can begin. They may say they understand that this is to establish "brain stem death" (still too often referred to as "brain death"), that this means that there can be no further hope of useful recovery whatever may be done, and that this justifies (indeed requires) the withdrawal of life-support measures to allow death to occur. [That was, of course, the stated purpose of the criteria when they were introduced in 1976.] However, many of these registered potential donors are under the misapprehension that mechanical ventilation will be permanently discontinued, and the consequent cessation of the heartbeat awaited, before they are subjected to organ procurement surgery.

  12.  Registered donors in the categories described in (10) and (11) above have not understood that they will, in fact, still be very much alive when organ procurement surgery begins and, indeed, during that procedure. They do not realize, because it has not been made clear to them, that mechanical ventilation is continued after the diagnosis of "brain stem death", and kept going while the wanted organs are removed—which may take several hours. In consequence of that continuing provision of oxygen to the lungs, their hearts will be continuing to beat naturally—maintaining the blood circulation throughout the body, including parts of the brain, which are active to an unknown degree. Their bodies will remain so reactive that muscle-paralysing and anaesthetic drugs will be administered to facilitate the surgery—which nevertheless causes inevitable bleeding and other (cardiovascular) reflex responses. The latter are identical to those which, when seen by anaesthetists during everyday therapeutic surgery, prompt the administration of extra anaesthesia to alleviate the patient's thereby expressed pain or distress.

  13.  The registered donors described above have, at the very least, been misled by the unexplained term "after my death". It might well be argued that they have been actively deceived, given the continuing use of that term without qualification or explanation despite many calls for its clarification over the years. Whatever the interpretation of what might seem that legally interesting aspect, it can be said with confidence that at least some of those who have registered under the impression that they will be truly dead—certainly without heartbeat—before their organs are removed would not have done so if the relevant facts pertaining to their offer had been made clear to them when registering. If there is even one such registration on a false premise, it must be a matter of concern—and there may well be millions in that category. There is a case for contacting all those registered to establish the scale of possibly false registrations.

  14.  The above refers to organ procurement from patients pronounced "dead" on the so-called "brain stem death" criteria specified in the current Code of Practice. Possibly because of the low provision of transplantable organs from that source, there is now a move towards procurement from donors whose hearts have been allowed to stop for very brief periods, eg two to five minutes, with or without restoration of the heartbeat and circulation thereafter. This is no more than a sinister charade—aimed at persuading people that death is being certified on the age-old criteria (cessation of breathing and circulation) and conveniently ignoring the fact that those criteria demanded the permanent cessation of the blood circulation and a period of waiting thereafter to ensure that irreversible destruction of the body is certainly under way. Verheijde et al10 have recently exposed the abuse of ethical principles involved in these resource-driven developments.

  15.  If there is to be a truly ethical basis for the procurement of organs for transplantation, there must first be a fully and frankly informed public discussion and debate about the various options capable of providing organs in a viable state for the purpose. In practice—because procurement from living, healthy donors offends against the fundamental "first, do no harm" principle, and organs taken from unequivocally dead people are no good for transplantation—these are limited to the acquisition of organs from the dying. It may be that, when all the relevant facts have been made clearly and universally known, without obfuscation or concealment, some people will be willing to allow removal of their organs for the sake of others when they are, as certainly as can be known in the current state of medical practice, doomed to die soon. Consent to donation on that fully informed basis would seem to constitute an ethically valid offer if the legal difficulties could be overcome.

  16.  Until we can be sure that everybody who might be used as an organ donor has fully understood the nature of that procedure, it cannot be presumed that they have consented to such use merely because they have not registered objection. In the present state of public knowledge about transplant procedures, we are clearly very far from being able to make that assumption of universal comprehension and approval.

References

1  Stuttaford T. Vital signs that ebb to an imperceptible low. The Times 28 February 2007, p 3.

2  Evans DW, Hill DJ. The brain stems of organ donors are not dead. Catholic Med Quarterly. 1989; 40: 113-121.

3  Beyond Brain Death : the case against brain based criteria for human death. Potts M, Byrne PA, Nilges R (Eds), Kluwer Academic Publishers, Dordrecht. 2000.

4  Finis Vitae. Is brain death still life? De Mattei R (Ed) National Research Council of Italy. Rubbettino. 2006.

5  Review by Working Group of the RCP, endorsed by the Conference of Medical Royal Colleges and their Faculties. Criteria for the diagnosis of brain stem death. J Roy Coll Physns (London) 1995; 29: 381-2.

6  Coimbra CG. Implications of ischemic penumbra for the diagnosis of brain death. Braz J Med Biol Res 1997; 32: 1479-87.

7  Potts M, Evans DW. Does it matter that organ donors are not dead? Ethical and policy implications. J Med Ethics 2005; 31: 406-9.

8  Truog RD, Robinson WM, Role of brain death and the dead-donor rule in the ethics of organ transplantation. Crit Care Med 2003; 31: 2391-6.

9  Evans DW. Seeking an ethical and legal way of procuring transplantable organs from the dying without further attempts to redefine human death. Philosophy, Ethics and Humanities in Medicine 2007; 2: 11 (29 June) http://www.peh-med.com/content/2/1/11.

10  Verheijde JL, Rady MY, McGregor J. Recovery of transplantable organs after cardiac or circulatory death : transforming the paradigm for the ethics of organ donation. Philosophy, Ethics & Humanities in Medicine 2007; 2: 8 (22 May) http://www.peh-med.com/content/2/1/8.



 
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