"If it ain't broke, don't fix it." Or is it broken?

The Prime Minister, Gordon Brown, called for a national debate on what is called ‘Presumed Consent’ as part of the reform programme to improve the number of transplant procedures carried out in the UK. He made his announcement in the Sunday Telegraph on January 13th, 2008. By calling for the debate the Prime Minister clearly believes that something is 'broke'. But what? And how can it be 'fixed'?

Call me old fashioned but a ‘debate’ usually entails a consideration of a number of options. Not a single, 'take it or leave it' approach.

The issue of presumed consent has to be examined in the broader context of the transplant process as a whole. The root problem for patients on transplant waiting lists is that the demand for donated organs increases in the UK by an estimated 8% every year. Demand for organs outstrips supply. Currently there are about 8,000 patients on the active transplant waiting list with a further 2,000 patients suspended from the list. Many more patients never even get assessed to be placed on a transplant waiting list because they have become too ill, too old or have lifestyle problems that deny them access to a life saving operation. On top of this people experience end stage organ failure and die before they even realise their medical predicament.

So what do we do about this mismatch between the supply and demand for organs?

Playing devil’s advocate, one possibility is to scrap transplants completely. End of problem. Correction - it solves the problem for society as a whole, but not for transplant listed patients and their families. One very cynical surgeon once said to me in a whimsical kind of way - "the cheapest patient is a dead patient." How wrong he was, even though he hadn’t really meant it. I know from my own journey to a heart and kidney transplant that a huge investment in care and NHS resources has been made to keep me alive. What a ridiculous waste of money that investment would have been had I ultimately died waiting for a transplant. Indisputably transplants save lives money and misery.

The view that transplants are not an effective use of NHS resources is usually promoted by people who have had no family experience of end stage organ failure. Medical science and bio-engineering pushes the boundaries of life promoting developments further and further each year. Research progress in stem cell engineering will probably extend the range organ and tissue transplants that can be achieved in the future to enhance the quality of life of very ill, dying patients. Perhaps opponents of transplants might like to reverse this trend for a variety of reasons. They may have political, moral, religious or spiritual reasons why transplants should be banned.

It can be argued that as transplants are very expensive medical procedures and that medical resources are limited, perhaps the public funds could be spent more equitably in other ways. Many opponents of deceased donation do not trust the medical profession to diagnose death accurately enough. Cynics doubt whether health professionals will strive to keep someone alive when death appears imminent if they know that organ retrieval would certainly save the life of another dying person. Comments like the following represent such views:

• “How can I be sure that my organs will not be taken by surgeons before I am absolutely dead?”
• “My body must remain intact for my journey into the afterlife.”
• “Transplants interfere with the natural order of life – if we were meant to have two hearts we would have been designed that way.”
• “Doctors will not fight to keep me alive if they want my organs.”
• “My body belongs to me and God – not the state.”

These are all very valid concerns in the minds of certain people. Society should recognise these views and address them with a level of respect they deserve. These are genuine issues that merit careful consideration in a liberal democracy. However I suspect that sufficient re-assurance could never be delivered to such individuals in order for them to support the transplant process.

Transplant Exploitation

If transplant procedures did not exist the human pursuit for the ‘elixir of life’ would take human ingenuity to procedures that at least postpone death. Medical science inevitably would arrive back at transplantation. To ban transplants now would bring financial paradise to all the middlemen that currently manipulate the unregulated trade in tissue and organ markets that exploit the poorest communities in the world. Kidney sales in south Asia are allegedly at an all time high. ‘Transplant Tourism’ is one of those asinine phrases that trivialises the degradation and suffering experienced by people who are enticed to sell their organs merely to survive. Let’s not disguise the fact that failure to provide sufficient organs through regulated schemes in developed, capitalist economies leads directly to exploitation of vulnerable poor people elsewhere in the world.

Another method of balancing the supply and demand for organs is to lower demand. Long term health strategies to prevent chronic conditions occurring in the first place are having a gradual impact in this respect. Preventive or preventative medicine is showing results in certain areas of health management. This may be one of the explanations for the fall in heart transplant numbers. More effective health screening and earlier therapeutic interventions have reduced the rate of heart transplants in the UK. The recent developments in the UK in relation to obesity and life style management could result in lower levels of diabetes and renal failure.

However effective these preventative programmes are they will always be a demand for tissue and organ transplants. I suspect medical science will never totally eliminate congenital and inherited medical conditions that can only be remediated by transplants. Research in the UK indicates that demand for organs increases by about 8% per year yet the supply from deceased donors has levelled off. That is why more effort is going into living kidney donation programmes. In the period April 2007 to March 2008 over 70% of the transplant waiting list was taken by patients waiting for kidneys. Of the 3,235 transplant procedures that took place in this period 1,453 were kidney transplants (=44.9%). 825 kidney operations were enabled by living donors (=56.7%). In the same period approximately 1,000 died waiting over half of whom needed a kidney transplant.

Transplants are here to stay

So transplants are here to stay and will increase in their frequency and in the range of tissue/organs that can be transplanted.

The Organ Donation Taskforce set up in December 2006 in the UK was given government authority to investigate all barriers to transplantation. It was given an agenda to examine ways of increasing the number of transplants by 50% by 2013 in order to reduce the number of deaths on transplant waiting lists and to reduce highly dangerous waiting times. The government has also announced that it wants to increase the number of people on the Organ Donor Register to 25 million by 2013 from its March 2009 level of 16. 1million. The fourteen recommendations of the Taskforce are outlined elsewhere in the website.

‘Presumed Consent’ was not part of its original remit.

Alan Johnson, the Secretary of State for Health at the time, added this line of enquiry to the Taskforce investigation in September 2007 following on from the views expressed by the UK Chief Medical Officer in his annual report issued in July 2007 - “On the state of public health: Annual Report of the Chief Medical Officer 2006” – ‘Organ Transplants: The Waiting Game’. The conclusions in this section of Sir Liam Donaldson’s report state:

• Proposals to amend legislation should be framed to create an opt-out system for organ donation, with proper safeguards and good public information.
• More opportunities should be taken to secure donation amongst patients who die in hospitals, including in emergency departments.
• Intensive care units should consider the death of any patient in the context of possible organ donation, ensure prompt and accurate testing of brain death and make certain that opportunities for organ transplant are maximised.
• Targeted campaigns should continue to be aimed at increasing organ donation in ethnic minority populations.

It is very interesting that the government sets up an investigative taskforce, then gives it the additional remit of examining the merits of presumed consent and allows various government spokespeople to pre-empt its outcome.

Why does the transplant system need reforming?

Imagine if 1,000 people died from an avoidable illness in short space of time. Imagine a virus that could be easily controlled was neglected and led to the death of hundreds of people in under a year. There would be enormous public outcry. Heads would roll. Ministers for Health would be held to account, vilified and probably dismissed.

Yet every year the promise of a life saving transplant is made to thousands of people and at least one thousand of them die because of the shortage of suitable organs.

By many international yardsticks the UK is not very effective at delivering life saving transplants to its citizens. That is why the Organ Donation Taskforce was set up to examine all barriers to increasing the number of transplant procedures in the UK. The graph below highlights the situation. The figures show the number of organ donations per million population. The graph shows that Belgium and France does about twice the number of organ transplants per head of population, whereas Spain does nearly three times.

Opt-in or Opt-out?

Would the introduction of presumed consent improve the rate of transplants in the UK and reduce the number of deaths of transplant waiting lists?

Would it be more effective than the opt-in voluntary registration scheme currently used in the UK?

The opt-in position is the legal default we currently have. Presumed consent would change the legal default position to the presumption that everyone is willing to be an organ donor at the time of their death UNLESS they opt-out. To opt-out every individual would have to make an official written declaration that they do not want to be an organ donor. This declaration would be kept on a government database. Currently the UK Transplant database in Bristol records the donation wishes for all people that have signed the Organ Donor Register. Presumably a similar process would be devised for the presumed consent opt-out scheme if it were to be implemented.

To attempt an evaluation of this kind we have to keep firmly in mind what we hope to achieve by making this legal and administrative change as a society. The need for change is always framed in the context of wanting to encourage more people to be donors that in turn would enable more transplants to be carried out. We know that there are other actions that could increase the frequency of transplants in the UK e.g.

• making more resources available in intensive care units and operating theatres for organ retrieval
• funding more surgical organ retrieval teams
• accepting organs from groups of donors currently excluded such as drug users or older donors
• allowing greater mismatches in terms of blood and tissue type
• increasing the number of donor transplant coordinators
• compensating families for organ donation
• making sure that all dying hospital patients are given the end of life option to be donors as part of a bereavement support programme
• clarifying the concept of brain stem death
• allowing elective ventilation
• raising educational awareness about transplantation through schools, colleges, universities and hospital courses/training

Some of these ideas are being addressed by the Organ Donation Taskforce with the implementation of their 14 recommendations that will overhaul the transplant process in the UK. The proposed reforms are far-reaching, but not radical enough in the eyes of some critics. There are leading surgeons who advocate the sale of organs. This is a rational, market view that rejects the traditional ethical position that human tissue and organs should only be exchanged on a voluntary and altruistic basis. The sale of organs would be a major departure that would undermine the benevolent 'gifting' ideal incorporated into the Human Tissue Act 2004 which currently regulates donor activity in the UK.

However, the focus here is to examine whether an opt-out system is likely to support the transplant process more effectively than the opt-in system currently used. Would presumed consent deliver more donors and more transplants?

TRANSPLANTS SAVE LIVES, MONEY and MISERY.