IVF babies: life chances

‘I’ve been a communist all my life. But at times like this I say thank God for American capitalism.’ This comment, made by an 80-year-old woman at a talk I once gave about the ethics of embryo research, came to mind when I heard the news of Jamie Whitaker’s birth.

For once again, the much-maligned American private sector, and a specific Chicago clinic in particular, has stepped in where others in the UK either could not or would not.

Jamie’s older brother, Charlie, is four years old. He suffers from a rare blood disorder called Diamond Blackfan anaemia. Currently he has to undergo regular blood transfusions and painful injections. His life expectancy is much reduced. A very promising treatment is a transfusion of blood stem cells from the umbilical cord, which is rich in them. But for that to work it is also necessary that the cord be from a baby born with a closely matched tissue type.

Jamie was conceived in such a way that there is a very good chance – 98 percent, in fact – that he will provide such a match for his ill brother. This was achieved through fertilisation, genetic testing and selection of the embryos prior to the beginning of pregnancy. This is a combination of several techniques and issues guaranteed to lead to headlines about ‘designer babies’. But for the boys’ mother, what they have done is very simple: ‘We have always wanted four children, so we just combined having more with helping Charlie.’ (1)

The Whitakers’ rapid success, less than one year after the UK Human Fertilisation and Embryology Authority (HFEA) turned them down, has brought into sharp focus the way in which the UK regulatory regime has judged this and another closely related case: that of the Hashmi family.

Both cases raise important questions about the existing UK law regulating fertility treatment, and the role played by the HFEA. As science opens up new possibilities to infertile couples and parents of sick children, the precautionary approach taken by the law and the regulators is restricting the progress of these developments, and their use by people who could benefit immeasurably from them.

In the UK there are legal restrictions on who has access to fertility services and for what purposes. Whereas anyone can (try to) conceive naturally, if medical assistance and genetic diagnosis is involved, so is an external regulatory regime. As far as the HFEA was and is concerned, the Whitakers’ application was a step too far.

Ever since it was formed, following the passage into law of the 1990 Human Fertilisation and Embryology (HFE) Act, the HFEA has licensed clinics to carry out genetic tests on embryos to determine whether they carry a gene linked to a serious genetic disorder. After much internal discussion, the HFEA decided more recently that if an embryo was being tested for a genetic disorder, its tissue type could also be determined in order to help an existing sibling suffering from the condition. But it decided that it would not allow the testing of embryos simply to select a tissue match, in the absence of any need to test for the presence of a mutated gene.

Accordingly, the HFEA gave permission for the Hashmi family to use IVF and genetic testing in an attempt to conceive a child who could be a stem cell donor for their son, who suffers from beta thalassaemia major. However, it refused permission to the Whitakers, as their son’s condition is not thought to be significantly influenced by genetic factors; and in any case, even if his particular case is influenced in this way, the gene(s) are not known and so cannot be tested for.

Following Jamie Whitaker’s birth, Suzi Leather, chair of the HFEA, reiterated the regulatory body’s view that the long-term risks of preimplantation genetic diagnosis were unknown and it was therefore only appropriate to limit its use: ‘If there are benefits for the child to be created from the [tested] embryo, for instance, to avoid a significant risk of a serious disease, then I think the balance of potential harm and potential good falls in a different place than if you are simply [testing] an embryo for the benefit of another person.’

Leather expressed concern not only about long-term physical harms that might result from the process of testing, but also potential emotional harms: ‘We don’t know what the social and emotional consequences of being a so-called “saviour sibling” will be. It seems to me that in this area of considerable uncertainty, where there is a possibility of theoretical risk, that we should adopt a precautionary approach.’ (2)

While I have not seen any opinion polls, I do get the feeling that many people would side with the Whitakers, and families in their situation, against the regulators. We are told, after all, that the Daily Mail newspaper has its finger on the pulse of at least part of the nation, and it covered the story in a very sympathetic manner.

The British Medical Association (BMA) was uncharacteristically forthright in its support of the family. Vivienne Nathanson, head of ethics and science, said: ‘As doctors, we believe that where technology exists that could help a dying or seriously ill child, without involving major risks for others, then it can only be right that it is used for this purpose. The welfare of the child born as a result of the treatment is of crucial importance, but in our view this is not incompatible with allowing the selection of embryos on the basis of tissue type.’ (3)

Those more sympathetic to the HFEA have certainly been on the back foot. Leader of the House Peter Hain gave us a grown-up treatment of the issues on BBC Question Time. He backed the HFEA but said that as a parent he would have gone to America. He then said he wouldn’t want to change the law, but conceded that maybe it does need modernising…. He trailed off at this point in that way he does so well.

And well might those sympathetic to the HFEA’s decision be defensive. Setting aside what, admittedly, can become something of an angels-on-a-pinhead discussion about whether it is legitimate to raise the issue of the harm to the second child, since he would not have been born unless he was selected in the way he was, this is still a pretty breathtaking balancing act in which the regulators want us to take their side.

If we take it as given that the treatment has a good chance of saving a life (this is the view of many experts, and is borne out by limited experience so far, although it is questioned by others, such as fertility expert Robert Winston), we are supposed to forget about this because of possible harm to the new child. And make no mistake: it is a possible harm, for that is why the cowardly precautionary approach is invoked rather than clear data or theory.

So what is to be done? Some of those sympathetic to the Whitakers have added their voices to those calling for parliament to reconsider the whole area, such as the ProLife campaigner Josephine Quintavalle and Ian Gibson, chair of the House of Commons Science and Technology Committee. Evan Harris, Liberal Democrat health spokesman and constituency MP for the Whitakers before their recent move to Derbyshire, said that the law prohibited new treatments, such as that used to create Jamie, and needs changing: ‘The [HFE] Act is 13 years old and is no longer up-to-date with clinical developments.’ (4)

Perhaps feeling somewhat buffeted by the response to this case, I sense that the HFEA is beginning to think that this solution might not be such a bad idea. It is also a solution that I am sympathetic to. However, things are not as straightforward as they might appear. The immediate barrier is in fact not the law but the policy of the HFEA, which in turn is buttressed by recent judicial interpretations of the HFE Act.

Josie Appleton has told the story on spiked about the way in which the HFEA rejected the view of its own ethics committee, which was of the opinion that both the Hashmis and the Whitakers should have been able to receive treatment in the UK (see Life and death decisions). It seems clear that the HFEA as a whole formulated policy with an eye to what it thought the courts would tolerate – and, perhaps more to the point, its own desire to manage a process of development – rather than the merits of either case, viewed both from the point of view of current law and ethics (5).

The positive decision in the Hashmi case was then challenged, successfully, by Quintavalle’s campaign group Comment on Reproductive Ethics, in the High Court at the end of 2002. However, in what appears to be a final judgement, given in spring 2003, the Court of Appeal overturned this decision and the Hashmis are now trying again in the UK.

Ironically, and significantly for the current discussion, the main judge in the Court of Appeal hearing, Lord Justice Schiemann (6), presented more liberal arguments than did the HFEA, leaving little doubt that the HFEA was free to licence a wider set of treatments – including that required by the Whitakers and others in a similar position. But what the judges also made plain, and herein lies the rub, was that the HFEA was also free to exercise its judgement and refuse treatment in such cases.

The arguments presented by the HFEA in court, and those made by judges in deciding in favour of the HFEA, contained a number of inconsistencies and arbitrary judgements. As a side-effect of this, the nature of regulations and the meaning given to the HFE Act are developing in an instrumental and ad hoc way. What is more, in squeezing new developments such as ‘saviour’ babies into the existing categories enshrined in law, the real nature of them is denied. This provides one good reason to revisit the issues in Parliament.

But in the meantime, it is important to note that the HFEA’s legal success in the most recent Court of Appeal case fits a pattern: following trouble in the lower courts, judges in the higher courts have in general looked more favourably upon the Authority, especially in relation to its core functions of regulating research and clinical practice.

It is not just ProLife critics who have seen their challenges founder. Mohamed Taranissi, the Whitakers’ UK-based clinician, lost a challenge in the Court of Appeal in 2001 in which his clinical freedom to judge whether an individual woman was best served by implanting a greater number of fertilised eggs than regulations permitted was rejected.

Once again, and this time explicitly in response to the notion that the 1998 Human Rights Act might limit the discretion of the HFEA, the judge reaffirmed that this was not the case: ‘It is not the function of the court to enter the scientific debate, nor is it the function of the court to adjudicate on the merits of the Board’s decisions or any advice it gives. Like any public authority, the Board is open to challenge by way of judicial review, but only if it exceeds or abuses the powers and responsibilities given to it by Parliament.’

The natural inclination of supporters of IVF treatment and embryo research has been to welcome the court victories of the HFEA against its ProLife critics. But these have come at a price. The Authority is engaged in a dance with the courts, its critics and what it thinks, or claims to think, public opinion will tolerate. This is causing delays and restrictions where progress ought to be quicker.

Furthermore, the higher courts, in seeking to provide some general guidance beyond the merits of each particular case, have emphasised that the Authority should have a wide discretion to make decisions in its area of competence. This can be viewed as both reinforcing the discretionary powers of the Authority, and throwing the problem back into its hands to deal with. This may imply further defeats for the closely related ProLife organisations should they try again. It is also likely to lead to frustration for some patients and researchers, keen to push the boundaries of what is possible.

If and when the issues do return to Parliament, a focus of activity must be to change the basis on which research is conducted. Presently, the law, for all its appearance of being permissive, is founded on a restrictive logic: research and treatments are forbidden unless they fall within certain categories. A more progressive starting point should be that research and treatments are permitted unless good reason can be shown for them to be forbidden.

John Gillott works at Genetic Interest Group.

Read on:

Life and death decisions, by Josie Appleton

(1) ‘Designer baby’ gives hope to his ill brother, Daily Telegraph, 20 June 2003

(2) Blood brothers: how newly born Jamie offers hope to Charlie, Independent, 20 June 2003

(3) Blood brothers: how newly born Jamie offers hope to Charlie, Independent, 20 June 2003

(4) ‘Birth of “saviour sibling” stirs call for debate on fertility law’, Mark Henderson, The Times, 20 June 2003

(5) Life and death decisions, by Josie Appleton

(6) Paragraph 50