Dear Editor

JME is to be congratulated for offering the important Olivieri Symposium free of charge on a pre-publication basis. The Olivieri and Healy affairs occurred at one university, in one province. Based on the articles by Arthur Schafer, Gordon DuVal, and Lorraine Ferris and colleagues, non-Canadian readers might underestimate the scope of the crisis confronting research ethics review in Canadian universities and hospitals. I would like to expand on two institutional aspects of that crisis, with primary reference to Ontario (Canada's largest province, the one with which I am most familiar, and the one to which the articles in the symposium refer). I have no reason to believe that the situation elsewhere is either better or worse.

If implemented, Gordon DuVal's proposal that REBs review many aspects of research contracts before they are approved by universities and hospitals would represent a major change for the better. However, his belief that REBs are "independent" bodies misses a crucial point. McDonald [1] has pointed out that 'university REBs generally report to the offices that promote research.' In many universities, the overwhelming majority of REB members are employees of the university or its affiliated hospitals; in one case, at least, they are appointed directly by the president of the university. Remarkably, no systematic published research on this point appears to exist, or to be in progress. Neither does the Tri-Council Statement of Principles, the federal granting councils' non- binding guidelines for REBs, include any requirements that address the independence of REB members. Under these circumstances, it is probably difficult for REBs to take positions, such as asking to scrutinize contractual arrangements for sponsored research, that will seriously impede their institutions' quest for research funding. An REB taking this position would also not be able to find any specific support for such an interpretation of its mandate in the Tri-Council Statement. Given the meagre resources normally available for REB activities, an REB wishing (for instance) to commission a legal opinion on this point would probably have to take up a collection among its members, or hold a bake sale.

Ethical concerns arising from the shift to private research funding in universities as a consequence of (policy-induced) scarcity of public funds are now generally acknowledged. Canadian hospitals confront a similar situation, and the tradeoffs they make in response are even less visible than those made by universities. In Ontario, hospitals can be (and have been) taken over by provincially appointed trustees for failure to balance their budgets,[2] but no comparable mechanism exists for scrutiny either of the ethical short-cuts that may have been taken in the interests of raising revenue, or of what happens to patient care once "business development" becomes a priority. Lorraine Ferris and her colleagues concede that hospital-based researchers may lack even the minimal protections against reprisal that are available in the university setting when ethics collide with institutional (read: financial) priorities. The CEO of Toronto's University Health Network, the hospital complex affiliated with the University of Toronto, recently stated in the context of a shortage of resources for pain care that: 'We decided that patient need, in a broad context, wasn't one of our criteria in deciding priorities.'[3] This is suggestive of a culture in which some patients have become more important than others, based inter alia on their value as clinical trial participants, suppliers of scientifically interesting biological materials, or sources of data that can then be "warehoused" for purposes of subsequent research.

Under these circumstances, it is hard not to be sceptical about proposals for improvements in the governance of research that fail to incorporate genuinely independent oversight, meaningful sanctions for misconduct, and a high level of transparency. On this last point, it should be noted that Ontario's hospitals and universities are both exempt from even the weak public disclosure requirements imposed on other public sector agencies by provincial freedom of information legislation.

References

(1) McDonald M. Canadian governance of health research involving human subjects: is anybody minding the store? Health Law Journal 2001;9:1-22.

(2) Heinz C. Government Taking Back Control of Public Hospitals. Hospital News 2002;15(12),December:12,14.

(3) Papp L. Patients' torment ignored. Toronto Star 2003; June 20.

Dear Editor

As a group of Nephrologists with a lively interest in ethical problems and involved in an educational campaign on dialysis and transplantation, we read with great pleasure the pragmatic and touching editorial of HE Emson;[1] as the senior of the group, I (GBP) had the occasion to watch the moment when the soul departs from the body; without the fear of being “unscientific”, I agree with Dr Emson that wherever the soul goes, the body remains as an empty shell. The sadness of departure is enhanced by the fact that we usually know, often in friendly terms, most of the persons we see in the moment of end of life. At the meantime, we share with our dialysis patients the anxious wait for a renal graft, giving back freedom and a better, and hopefully longer life.

While we agree with the Author that our bodies should be considered as a valuable loan from the biomass, we do not agree with the opinion that the lack of donation is linked to the family attention on a dead body.

In our country, Italy, about one third of the potential donors are “wasted”, going directly under the ground to produce corn or flowers, due to the family opposition to organ donation.[2] The cult for the dead body, the lack of trust in the Health Care System, the misconceptions on brain death were all considered as potential explanations of this pattern. As dr Emson says, the comments and theorizations are often performed by philosophy experts, not directly involved in the care of the patients, nor in running educational programs.

In the last three years, in the context of the activities of the post graduate school of Nephrology, we run an educational campaign in Torino, an industrial northern Italian city with about 900,000 inhabitants, progressively involving all the high schools of the city (last two years of high school: median students’ age 17 and 18 years).

In 2001-2002, 1676 anonymous questionnaires on different aspects of dialysis, transplantation and organ donation were gathered from 14 schools. Students’ opinions were clearly in favour of living kidney donation: 78.2% would donate a kidney to a close relative or partner needing it, witnessing the diffuse knowledge that life with a kidney transplant is highly preferable than life with dialysis. However, the answers on cadaveric donation were sharply different. The question, built as a “collage” of sentences from the newspapers was: “a dear person of your family is in the emergency room; you do not know his/her opinion on organ donation; the doctor says this he/she is brain dead (the heart is still beating with the help of a machine); do you give the consent to organ donation?” the answers were almost evenly divided among yes (35.5%), not (30%), I dont’ know (34.5%). The optional comments, recorded in about half of the questionnaires (blank: 44.4 %) identify in the impossibility of deciding for somebody else (20.5%) and in the fear of causing the “real death” of the beloved person (19.9%) the main reasons for denying consent, followed by the lack of trust in the medical class (3.2%). None of the students mentioned the insult on the dead body nor gave religious motivations; a minority (5.4%) considered organ transplantation an “unnatural” procedure.

From our data, we suggest that, at least in our setting, the focus for increasing organ donation should be on giving exhaustive information on life (and on end of life), clarifying the concept of brain death, the aims and itineraries of transplantation, more then on fighting with prejudices on death.

Our direct involvement, as physicians, in educational campaigns may not only give a valuable occasion to get in touch with the general population, but also, as Dr Emson states, to fill the gap between the large number of people who favour organ donation and the small proportion who do anything about it.

References

(1) Emson HE. It is immoral to require consent for cadaver organ donation. J Med Ethics 2003;29:125-127.

(2)http://www.ministerosalute.it/trapianti

Dear Editor

V. English and A. Sommerville [1] argue for a “limited version” of “presumed consent” for organ donation. They criticize the present law, which they claim presumes most people do not wish to donate, saying that:
“It also seems somewhat bizarre that society assumes that most citizens are more likely to refuse than to help others, when there is no harm or benefit with either choice for the deceased.”
Later, they say that:
“Presumed consent represents a positive endorsement of organ donation as a good thing to do and with this formal acceptance will come a time when donation will come to be seen as the norm, rather than the exception.”
The authors, however, presume (without argumentation) that organ transplantation is a good thing, assuming that removing organs from whom they call “the deceased” does not harm that individual.

Many organs which are “harvested” are taken from patients declared “brain dead,” whether the criterion be “whole brain death” (in the U.S.) or “brainstem death” (in the UK). In either case, the bodies of these patients are warm, their circulatory systems are functioning, their respiratory systems are functioning (in the sense of continued gas exchange in the lungs and throughout the tissues of the body); the ventilator provides oxygenated air. The fact that such patients are dependent on machines to continue to live is morally irrelevant for declaring them dead, for many obviously living people are machine- dependent. Serious doubts have also been expressed about the neurophysiological basis for both the US and UK criteria.[2] It is by no means self-evident that “brain dead” individuals are dead; in fact, the recent evidence suggests that they are very much alive. Writing “brain death” statues into law does not magically alter reality, nor does repeating the word “cadaver” in reference to “brain dead” individuals. It may well be the case that the reason many people are hesitant about organ donation is the legitimate fear that organs are routinely being removed from living human persons. Even if one disagrees with this view and accepts brain death criteria, there is more than enough room for reasonable doubt on this issue. This is not reasonable doubt about a trivial issue; the doubt concerns whether “brain dead” individuals are being killed for their organs. Given the risk that living individuals are being killed for their organs, it is unreasonable to assume that organ donation is a good thing. Instead of a policy of “presumed consent,” potential organ donors should be told clearly and truthfully what actually goes on in organ donation–that “brain dead” donors are not dead in the usual sense of the word, that their hearts continue to beat when the organ donation surgery takes place. The reasonable course of action to take in changing the law is to add more precautions before someone signs an organ donation card, not fewer, and certainly not a policy of “presumed consent.”

References

(1) English V and Sommerville A. Presumed consent for transplantation: a dead issue after Alder Hey? J Med Eth 2003;29:147-52.

(2) Potts M, Byrne PA, and Nilges RG. Beyond brain death: the case against brain-based criteria for human death. Dordrecht, Holland: Kluwer Academic Publishers, 2000.

Dear Editor

I read with great interest the June 2003 issue of the Journal of Medical Ethics on human organs. The taboo on buying them is broken. Even if we use all the available cadavers, there will always be many more sick people in need. Organs save lives and the shortage is chronic, so why not pay for them if that’s what it takes?

Janet Radcliffe-Richards suggests a free-for-all. That is, the freedom of the rich to buy and the freedom of the poor to sell. If both parties benefit from the transaction, she argues, who are we to interfere? John Harris has a tamer proposal – a regulatory scheme whereby a public body is the only legitimate broker and legally sanctioned transactions are limited to national jurisdiction.[1] Leonardo De Castro expands somewhat on global aspects of organ and human trafficking, providing examples from the Phillipines, and suggests safety nets against exploitation through ethics committee approval of monetary compensation depending on the circumstances. But he is not ultimately convinced by the moral arguments about the evils of money and the commodification of human body parts, and seems to conclude with a defeatist message that if we can’t beat the market we might as well join it.

This is a topical subject in Israel. Last week the government approved a legislative bill that is similar to Harris’ proposal. Buying organs will be prohibited except if in accordance with the proposed law: all transactions are to be conducted through a statutory committee; donors will receive compensation in the form of a quasi social security stipend for recuperation and other expenses; and commercial brokerage will be a criminal offence. The next day, on a television talk show there was a woman who wanted to sell an organ to cover a debt of $60,000 she had incurred (as a single parent of five chldren) since she was fired from her job two and a half years ago. She complained that the market price was only $15,000 (and $18,000 if you had a US visa). A representative of the Ministry of Health told her that the government’s proposal was not a solution for persons in need.

The same woman also said she did not understand how family and friends could not give a kidney to someone they cared for. Sitting beside her was a 33 year old woman, also a single parent (of two), who needs a kidney. For the time being, she hooks up to dialysis at home every day before she goes to bed. If her 4 year old wakes her in the middle of the night, she can’t get up. She said that if she had the money – between $60,000 and $180,000 depending on where - she would buy a kidney.

If the current proposal became law, it would not be a criminal offence for these two women to enter a private agreement, if no payment to intermediaries were involved, because both the donor and the donee are protected from prosecution (as under the law of abortion it is the person who performs the illegal operation that is the criminal, and not the pregnant woman). To return to Harris’ model, this means that any such regulatory scheme would legitimise a private market in organs. It would not be expensive to jump the public waiting line. Indeed, the reward of a one-time social security benefit is so meager, compared to the market price for a kidney, that a statutory committee might find itself out of work. The only problem for our two now-hypothetical women-in-need, would be where to find a doctor who would perform the transplantation. If it is illegal in their own country, they could go elsewhere – South Africa, for instance, where there are private for-profit medical institutions which provide quality services – for the rich, of course. The idea of any national containment is naive given the moving forces of globalisation.

Legitimising payment for kidneys has implications for infertility treatment and genetic research, both of which represent significant financial interests in the global health market. If paying for a kidney is okay then perhaps there is no objection to paying for gametes. There is a shortage of eggs for women who need a donation for IVF, and many more are needed for the cloning research that lo and behold promises the world to solve the shortage of human organs and even overcome problems of immunological rejection (again, of course, for the rich).

However, a trade in eggs is one step away from trans-national trafficking in women, as go-betweens import women into the countries that have appropriate medical facilities. People say, why not pay for eggs when we pay for sperm? Why not, indeed, allow poor women such an economic opportunity? But for that matter why should sperm donation not be altruistic? There’s really nothing to it, less even than giving blood. Why not outlaw buying and selling sperm and make it a criminal offence?

Donating eggs is nothing like donating sperm. It involves intensive hormonal treatment and and an invasive egg retrieval procedure, the risks of which are spelled out in any decent IVF informed consent form. As for the medical aspects of kidney donations, the doctors assure us that giving one of our two kidneys does not incur significant medical risks, that organs from living donors are more efficacious for recipients than organs from cadavers (better life expectancy rates), and that the earlier the transplantation the better. However, even if there is no evidence that donating a kidney increases the risk of renal failure (for how long have we actually been collecting and following data?), it is still an invasive procedure. What kind of medical care do donors receive? Who nurses them afterwards? Who makes sure they get proper care for future complications? How do we know that the donor wasn’t robbed of his cash when he walked out of the hospital? How do we know that this particular kidney was not snatched from an unknowing anaesthesized individual undergoing surgery for some other reason?

Nonetheless, the notion persists that nothing can be done to combat market forces, and that there is no moral ground to prevent people from saving their own lives. The ideological problem is that we are committed to the idea of liberty and autonomy, so how can we justify intervening in private agreements between free individuals? What I would like to suggest is that principles of social justice and human dignity provide such justification.

Justice is at stake, because the moral question that the shortage of organs raises is one of fair distribution. Globally, it is clear that the need for organs for all persons suffering renal failure throughout the world will not be satisfied. The rich will benefit from a market in human organs and not the poor. There are many sick persons facing risk of death in the world. Most live in countries that do not have the professional capacity and technological infrastructure for either dialysis or transplantation. Only some are fortunate enough to have access to medical services that can save their lives, and the ability (or insurance) to pay for their costs. In countries that have public medical facilities with transplantation capability, the poor will wait on dialysis for organs from cadavers while rich people will buy transplantation services with living donors.

The argument for human dignity is a moral intuition, which Margaret Radin articulated several years ago. To put it simply, there are certain things that money can’t buy and that are not for sale. Once upon a time medicine was a calling, but now it is becoming a business. Despite the vagueness of the idea of human dignity, it is an intuitive value that resists the notion of a contract for a pound of flesh. Freedom of contract is not an absolute. Many legal systems refuse to recognize the validity of contracts that are illegal, immoral or contrary to public policy.

In 1991 the World Health Organization published guiding principles on organ transplantation. Guiding Principle 5 is crystal clear: “The human body and its parts cannot be the subject of commercial transactions. Accordingly, giving or receiving payment (including any other compensation or reward) for organs should be prohibited.” Nothing has changed since then except for the flourishing of an international black market of profit -seeking private practitioners and institutions pandering to “consumer demand”.

Considerations of distributive justice and of human dignity are sufficient justification to restrict the liberty of individuals. It is true that all we need is an organ, but there are also moral limits on the means that we may employ for the end of saving our own lives. The value of saving life does not give a sick person a right to an organ from a living other at all costs. If saving lives is such an important value, we should be encouraging altruistic donations and an ethic of solidarity, care and compassion.

Reference

(1) Charles A Erin and John Harris An ethical market in human organs. J Med Ethics 2003;29:137-138.