Money, morals and medical risks: conflicting notions underlying the recruitment of egg donors

K.K. Ahuja1,3, E.G. Simons1 and R.G. Edwards2

1 IVF and Fertility Centre, Cromwell Hospital, London SW5 0TU, and 2 Churchill College, University of Cambridge, Cambridge, UK

We suggest that the policy recommended for adoption by the Human Fertilisation and Embryology Authority (HFEA) on altruistic donation is flawed. Many of the considerations involved are complex matters and wrong decisions could precipitate harmful effects that could have significant repercussions, not the least of which is litigious.

In a recent consultation paper, the HFEA (1998a), the government appointed panel which regulates the practice of assisted reproduction in the UK, concludes that: (i) gamete donations should be a gift, freely and voluntarily given after informed consent and that direct payments should be phased out; and (ii) that an arrangement involving benefits in kind, such as an egg sharing scheme in which a couple receive treatment at a reduced charge in exchange for donating surplus eggs should also be phased out. Accordingly, if the conclusions of this consultation paper are accepted, egg donation in the UK will in future depend wholly upon altruistic, non-patient, volunteer donors.

The Biblical injunction `to give and not to seek any reward' is perhaps the model for the HFEA policy, but to apply it in this context seems misguided and potentially detrimental to both donors and recipients. The validity of the HFEA consultation paper is questionable: it contains information on egg donation, which is misleading, inaccurate and unfair. We give below the reasons as to why it should not form the basis of implementing any new policies.

Evidence of clinical risk to donors of oocytes is ignored in the HFEA consultation paper

Retrospective studies and case reports concerning the association between ovulation inducing agents and a variety of malignant tumours have begun to appear with regularity which is worrying (Ahuja et al., 1997Go; Ahuja and Simons, 1998Go). This is a major concern to practitioners engaged in in-vitro fertilization (IVF) programmes because women are exposed during IVF to high doses of ovulation stimulating agents that leads to the production of a large number of eggs (Edwards et al., 1996Go). The process occasionally presents a serious iatrogenic condition called ovarian hyperstimulation syndrome (OHSS). A global study has revealed that OHSS raises the chances of deep vein thrombosis (Stewart et al., 1997Go), itself thought to increase the risk of malignant disease (Rance et al., 1997Go; Buller and Cate, 1998Go). Whilst accepting that prospective long-term confirmation of an association requires much further work, the American Society for Reproductive Medicine (1998) recently recommended that `it is necessary that the physician cautions the woman that the use of exogenous gonadotrophins may increase her lifetime risk of malignant ovarian tumours'. Fully informed consent, free from any inducement and pressure is fundamental to gamete donation (HFEA, 1998b). The clinician has a duty to explain the risks to any potential donor, yet the word `risk' is largely excluded from the HFEA's document except for a casual mention amongst the arguments against egg sharing. Lockwood (1997) questions, rightly in our opinion, whether we should even allow, let alone encourage, non-patient volunteers to donate eggs in the name of altruism.

The HFEA's reasoning is flawed with regard to the policy contained in their consultation paper that non-patient volunteer egg donation is a natural progression of the Human Fertilisation and Embryology (HFE) Act (1990). The HFEA were granted discretion to issue directions, so that future policies would be consistent with emerging medical evidence. The Act was based on the Warnock Report (1984) when the policy makers had no knowledge of the evidence, which has since emerged regarding risks associated with fertility drugs. We find it extraordinary that the HFEA consultation paper should have excluded the unwelcome, but recent evidence published in this medical field. This would seem to be negligent. On the other hand, Israel, Denmark and Canada, having kept abreast of published evidence, either disallow non-patient volunteer egg donors or discourage them (Ahuja and Simons, 1998Go).

Failure to warn a donor properly of medical risks may lead to litigation

The law is clear: the nature of any risk of developing serious complications following egg donation, whether they be `paid' egg sharers or volunteer donors, should be fully and candidly explained. In the case of volunteer donors, where there is no therapeutic benefit associated with donation, the position is exceedingly complex. In warning potential donors of the risks associated with egg donation, clinicians have an obligation to donors, in keeping with the judgements of Sidaway v Board of Governors of the Bethlehem Royal Hospital and the Maudsley Hospital [1984] (QB493) and Bolitho v City and Hackney Health Authority, (Lloyds Law Reports, Medical Part I [1998] Lloyds Rep Med, February [1998], p. 26) which may be summarized as follows. Firstly, there is no doctrine of `informed consent' in England and Wales, as there is in some North American jurisdictions. For the most part what is said in warning patients or advising them before obtaining consent to treatment fails to be judged by the test of Bolam v Friern Hospital Management Committee [1957] (2 A11 ER 118, (1957) 1 WLR 582): what is good practice? The Courts recognize that the warnings given have clinical implications: if every possible risk were described every time, far too many patients would decline suitable treatment. Secondly, doctors must answer fully and truthfully if a patient asks directly about risks or side-effects. At the risk of discouraging a potential egg donor, the facts must be provided before the donor gives her `informed consent'. Thirdly, if there is a common risk or side-effect, even if minor, then good practice normally will mean that the patient should be warned of that side-effect or risk. A balance needs to be struck between the desirability of the treatment and the risk of frightening the patient through the need to warn. If the treatment is essential for the patient's health then it may be acceptable clinically not to warn of minor side effects. If the treatment is entirely elective then good practice will normally expect full warning before consent to surgery is taken. Finally, if there is even a very slight risk of very serious consequence, then a warning is required save in special therapeutic circumstances.

To illustrate this principle we draw attention to recent court findings in regard to clinical application of human growth hormone (Dyer, 1998Go). In 1977, when human growth hormone extracted from human pituitary glands and given to children, it was known to carry a small risk of death due to Creutzfeldt—Jakob Disease (CJD). This possibility, remote though it was, should have been communicated to the practitioners responsible for the treatment, but it was not, and some deaths followed. In 1997, the High Court found the Department of Health responsible for failing to acknowledge and notify the risk involved and awarded damages to the families of the victims. In the following year the court ordered compensation to those who feared that they might contract CJD as a result of treatment with the hormone. The Australian government adopted a similar course of action to compensate families that were exposed to growth hormone extracts from cadaveric pituitries (Tattam, 1998Go). Who can say with certainty that women who develop severe OHSS will not lead to more complicated conditions say in 25 years time?

Clearly, there is no doubt of our obligation as practitioners to advise patients of any known risk which fits this matrix. This applies particularly to non-patient donors who receive no therapeutic benefit. Whilst cancer or other reported complication of IVF remain epidemiologically unproven there seems no basis in therapeutic privilege for risk taking. This is not only because of the nature of the risk being run, but also due to the difficulties in applying suitable statistical methods in chronic disease epidemiology and the relatively recent use of the ovulation enhancing drugs in therapeutic IVF. The weight of the observational evidence produced by medical case reports and retrospective short-term studies, thus becomes the primary instrument for policy decisions in these circumstances.

The precautionary principle espoused by Horton (1998) appears particularly pertinent to non-patient donors for whom donation is not incidental but rather the primary reason for undergoing IVF surgery. When the risk to the health of a person could be high and the cost of the corrective action potentially great, then prevention should take precedence over everything else. The principle requires the HFEA to approve only those policies that protect the non-patient donors from the possible threat of irreversible harm even in the absence of clear evidence of harm. If so radical a cultural shift is needed that the UK doctors by law must only accept the unpaid healthy donor for treatment using drugs with no knowledge of their long-term effects, then we think the issues go beyond the HFEA and must involve a wider professional and lay audience.

Studies show that donors clearly distinguish between cash rewards and subsidized fertility treatment

Women attend fertility clinics to receive IVF treatment, not to make money (Ahuja et al., 1997Go). After careful consideration, medical screening and counselling some then choose to participate in egg sharing to save some money and to help others: they receive no encashable benefit. Indeed many disapprove of cash rewards. They should not have been begrudged in the consultation paper and equated with mercenary donors who are already disallowed in the UK. Self seeking, evident amongst `paid' egg share donors, is not a repugnant subversive act which destroys altruism. Legitimate self interest is part of being human. To achieve a balance between concern for yourself and concern for others is at the root of the progress inherent in human society. To equate self interest with greed is just as wrong as believing that subsidized IVF treatment is equal to giving money to women.

Parliament also considered the issue of payments; in Section 12(e) of the HFE Act 1990, they contemplated that `payments' would be made and regulated by the HFEA. Egg sharing was unheard of, both at the time of the Warnock report in 1984, and in 1990, when the HFE Act was passed by parliament. In deciding the ban must include treatment benefits, the Authority appears to be over reaching its function and possibly subverting the worthy intentions of the Act. If parliament had intended that there should be no payment or payment in kind, it could have said quite simply in place of Section 12(e) that any and all payments would be unlawful. Published studies, excluded from the HFEA paper, show that the egg share donors are typically well educated, responsible women, to whom the denial of access to a well considered choice at HFEA licensed centres is unacceptably paternalistic.

The legacy of The Gift Relationship by Richard Titmuss (1970) leads to the principle of non-payment to blood donors and set the modern scene for the evaluation of ethical responsibility in society. The HFEA consultation paper misleads when it suggests that this principle is compromised by `benefit in kind' egg donation. Neither the current debate on the effects of fertility drugs nor the introduction of market changes in the NHS could have been foreseen in 1970. Indeed, according to Julian Le Grand (1997), the present Richard Titmuss Professor of Health Policy, Titmuss himself would now agree that a quasi-market system is a good way to channel self interest, which we believe would embrace egg share donors, and make it work towards the public good. The present government clearly accepts this pragmatic approach to applying ethical principles in modern medicine; consider the recent decision of the Health Secretary to replace the entire stock of UK-sourced and non-payment based blood plasma suspected of running a theoretical risk of contamination with the new variant CJD with stocks purchased from those sources where donors would normally have received payments (Department of Health, London, 13 May 1998).

There is also no evidence to support the HFEA's contention that children born to recipients may later in life suffer knowing their parents paid a donor. Patients already pay large sums for IVF treatment. Indeed, studies by Golombok have shown children born following IVF and donor insemination (DI) treatment (typically self funded) are often happier and better adjusted than their `normal' counterparts (Golombok et al., 1995Go). Families resulting from `paid' donor egg treatment also show greater psychological well being then those where donor gametes are not involved (Golombok et al., 1998Go). It is not difficult to see how the consultation paper allows the moral imagination to run wild without focusing on the facts. In our opinion, the expression of altruism can not be reduced to a choice between payment and non-payment or economics and ethics, as though they were mutually exclusive; they are not.

Equating egg and blood or organ donors is not justifiable

Blood donation is virtually non-invasive and entails minimal risk in medical terms, while organ donation typically takes place after the death of the donor. To raise issues of culture preferences in such circumstances, as the consultation document suggests, shows a measure of callousness and certainly inadequate appreciation of the nature of egg donation which is invasive and relatively unpleasant; it necessitates many visits to the clinic, requires complicated surgery and the ingestion of, perhaps, dangerous drugs.

Expensive publicity campaigns in the UK have failed to recruit sperm and egg donors without compensation (Anonymous, 1998Go; McLaughlin, 1998). In some other countries (e.g. France, Canada) such campaigns are disallowed. The HFEA's declared policy to encourage these unworkable campaigns to recruit egg donors is morally questionable and socially naïve. Such publicity is immoral also because it can exert social pressure on non-patient donors and can mislead women into thinking there are no risks attached to donating eggs. The immorality continues when the Authority turns a blind eye to the fact that licensed centres, private or NHS, command disproportionately large sums of money (£3000—5000 per treatment) from the use of eggs that have been donated free of charge. Often donor eggs are allocated amongst two or more recipients all of whom pay full fees for the treatment. Surely this amounts to sequestering altruism from a policy that is intending to promote a culture of altruism in gamete donation? Blood transfusion services would suffer irreparably if this approach were used to recruit blood donors (Ministerio de Sanidad y Consumo, 1989; Howden-Chapman et al., 1996Go).

The HFEA consultation paper does not comment on what it may perceive as recipient motivation

The attitude of the recipients can have a significant bearing on the risk and benefit balance. Under the projected HFEA policy, oocytes available at a clinic could be disposed of in a number of ways, and a decision could be influenced by market forces. For example, should a woman who is amenable to IVF treatment with her own eggs be offered donor eggs because she personally wishes to avoid the risk of IVF and can afford any expense to attain her aim? Could she not persuade a less wealthy member of her family to become a donor perhaps, as Lockwood (1997) has described, in settlement of a debt? Her actions would be consistent with the HFEA's proposed definition of payment yet the consequences of donation for the family and the growing child will have been ignored. With the loss of the donor's anonymity and possibly her autonomy any chance remark in the family will undermine the relationship between the child and the carrying mother. We believe that few clinics in present circumstances would subscribe to such a philosophy. In the event of a change in legislation that probably make eggs scarcer than they already are, a different philosophy would emerge.

The converse situation is equally traumatic. For example, what are the options for a menopausal woman seeking donor eggs who is reluctant to expose her close relatives, or even unknown non patient donors, to the involuntary risks of IVF? In the USA, where payments to donors are accepted on grounds of the risks involved (Lindheim et al., 1998Go), medical insurance packages can also partially indemnify the recipient against the claims of injury by a donor, but this is not so in the UK.

The document ignores the proven advantages and benefits of shared egg treatment

There cannot have been a more speculative basis for an important HFEA policy than the current paper dealing with the question of payments to egg donors. Many of the difficulties of volunteer egg donation are largely overcome by shared egg donation (Ahuja et al., 1998aGo,bGo), which has the following benefits:

(i)There are no associated risks for any third party because the act of donation is incidental to the act of receiving treatment; healthy women are not turned into patients which leaves the recipient without a long-term anxiety for the donor.
(ii)Medical risks faced by IVF patients do not increase with the act of sharing eggs, as the surgical procedures and ovarian stimulation protocols remain the same; indeed in the event of concurrent success in donors and recipients (not an uncommon event) the protective effects of the pregnancies against the cancer of the ovary are doubled.
(iii)It provides treatment for some who cannot afford IVF, though the selection is not based on a patient's resources, rather her medical suitability.
(iv)It provides treatment for the recipient in a dignified way, without the need for offensive advertising appeals or applying pressure to friends and relations over which the HFEA have no control; `awareness' appeals can be socially coercive, often unproductive and expensive and by omission of reference to risk, brutally misleading.
(v)It is an opportunity to express altruism in a pragmatic way, because the donor, the recipient and the IVF centre all contribute to the success of the exchange. By accepting only the single fee from the recipient, the centre facilitates the exchange in a meaningful way.
(vi)It is easily regulated because the licensed centres are responsible for matching the donors with anonymous recipients; the risk of losing a licence is a powerful deterrent against unauthorized practices, such as the fear of the coercion of the donors.
(vii)It encourages compassion and warmth between donors and their unknown recipients, regardless of the outcome of the donor's own treatment. Egg share donors are five times more likely than non-patient volunteers to leave a pen portrait of themselves for the benefit of future children of the recipients.
(viii)Unless altered by further legislation, anonymity inherent in shared egg donation provides protection against possible malevolent influences on the growing child.
(ix)It obviates the need to trade eggs for cash awards for the donor which is already disallowed in the UK; egg sharing removes the confusion in defining and implementing the boundaries between expenses, which are currently acceptable to the HFEA, and payments, which are not acceptable. Egg share donors, being themselves patients, do not expect to receive money as reward or to recoup the expenses; indeed for many who are suitable subjects, payments are usually not a consideration.
(x)The donor in egg sharing usually donates only to one family so reducing her possible anxiety about numerous unknown recipients; this removes inadvertent consanguinity as a major concern.
(xi)It does not compromise the success rate of the donors and the recipients; indeed with egg sharing overall success is enhanced because surplus eggs which are destined for disposal or storage, neither option being universally acceptable, are carefully used to result in additional successes.
(xii)Unlike non-patient volunteers, egg sharing gives women from ethnic minorities easy access to IVF treatment using eggs from their own communities; a recent unpublished survey of IVF centres showed an almost total absence of Asian non-patient donors.
(xiii)There is a therapeutic balance between the risk and benefit for the donor; from the moral point of view, this is more acceptable than the sum of risks and benefits.

Shared egg donation presents a unique situation from the point of view of informed consent. While the risks involved in donation must still be fully explained to the donor, the fact that the donor has a clear potential for therapeutic benefit increases the likelihood of achieving a balance of risk and benefit. This is the best solution to the decision-making process, which is also sufficient to encourage donation. Since both patients have a potential benefit from `paid' shared egg donation, justice is done in the distribution of risk and benefit. Ethics committees, regulatory bodies and the courts can be equally satisfied that a proper balance is attained by the process of `paid' egg sharing.

In conclusion we submit that the HFEA is in danger of placing itself and the profession it regulates at risk by ignoring evidence that contradicts its own viewpoint in regard to payment of egg donors. In adopting this position, it patently denies two key entitlements offered to patients in its `Code of Practice', namely `providing best possible protection from harm' (section 3.1), and, `fair and unprejudiced assessment of their situations and needs' (section 3.16). The government has recently stated that it supports the formulation of policies and practices which reduce the escalating cost of medical litigation (Department of Health, London, 26 April 1998). We have pointed out here that the document under review is likely to undermine this desirable aim. We suggest further that to persist with the policy this document espouses is likely to have a detrimental effect on the supply of donor eggs in this country and thus militate against offering a service to thousands of couples desperately searching for an ethical solution to the absence of children in their homes.

Looked at in terms of the HFEA's objectives, the evidence presented here indicates that its consultation paper of 1998 is counterproductive. Arbitrarily banning new concepts which help patients is an inappropriate use of the powers which parliament has bestowed upon the HFEA.

ADDENDUM

Decision on withdrawal of payment to donors: HFEA statement 9.12.98
Remarkably on 9 December 1998, a week after the current paper was displayed on the Human Reproduction web track, the HFEA announced that it would be wrong to ban paid egg sharing in the United Kingdom. Egg sharing will continue to be allowed as a treatment option for the infertile in a controlled and regulated manner.

The campaign to dissuade the HFEA from carrying out its previous pronouncement would have included many factors most notably the concerns expressed by patients, professional bodies and informed individuals. Policies of those countries (i.e. Denmark, Israel and Canada) where egg sharing is the only or preferred form of egg donation would have undoubtedly influenced the UK policy makers. However it is our view that the fast track channels of Human Reproduction played a vital role in the debate on donor gametes.

In a fast moving field conflicting arguments surrounding key proposals must be publicly presented and analysed without delay. Conventional printing is unavoidably slow and in those areas of public policy where the pace of debate is rapid it loses some of its appeal. With electronic printing, traditional qualities of the written word, i.e. peer review, verifiable references and argued debate, can be preserved and presented to the readership with appreciable speed. This enhances debate and reduces anxieties, which can result from the feelings of exclusion from the debate. In our opinion the current paper and previous peer reviewed publications from others which were put on the fast track channels of the journal have made an important contribution in the debate.

The full text of the letter from the Chairman of the HFEA is as follows:-

Dear Colleague,

I am writing to thank those of you who contributed to the recent consultation on payments to donors, and to let you know of some recent decisions made by the HFEA regarding payments and egg sharing.

Payments for egg and sperm donors
The HFEA believes that the donation of sperm or eggs to create new life should be a gift, freely and voluntarily given. As we have said before, we would like to see a culture of altruism where donors come forward voluntarily, and we will continue to look at ways in which that might be achieved. Our recent consultation document raised the possibility of a National Donor Service, and we look forward to seeing the progress of the National Gamete Donation Trust in its efforts to raise awareness of the need for donors.

Nevertheless, it has become clear from the responses to the recent consultation that the removal of payments in the present climate would seriously jeopardise the supply of sperm donors. We are aware that social attitudes and prevailing cultures may change over time, and we will continue to monitor developments. We have a responsibility to patients as well as the wider community. We know also that sperm donors are advertised on the Internet, and there is an emerging international trade in gametes. We therefore feel it is important that the supply of safe, screened sperm in the UK remains adequate, and do not feel that £15 payment is so wrong that we are prepared to threaten the entire service.

We also recognise that it would be unfair not to grant equity to those clinics set up since 1991 who have not been allowed to pay up to £15 plus expenses to donors. I attach copies of new General Directions Ref. D.1998/1, allowing these clinics to pay the same as others.

Egg sharing
We have debated the complex issue of egg sharing at length. Whilst no-one can have a problem with a woman who is undergoing IVF freely and voluntarily choosing to share surplus eggs with someone else, we recognise the concerns arising when subsidised IVF treatment is offered for such eggs. However, the overwhelming view of the HFEA was that it would not be right to ban `compensated' egg sharing, which can be enormously beneficial to both sharer and receiver. It is clear, however, that such egg sharing needs to be closely controlled and regulated, and we will be working on producing specific guidelines on this for our Code of Practice. This will look at, amongst other things, consent, the information that is given to potential sharers, and the choices they are presented with when a limited numbers of eggs have been collected.

I hope this is helpful.

Ruth Deech

Chairman

Notes

3 To whom correspondence should be addressed Back

This Opinion was previously published as Webtrack 23 on December 2, 1998 Back

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Submitted on September 24, 1998; accepted on November 23, 1998.