The Submission by Affinity to the Human Fertilisation and Embryology Authority’s Choices & Boundaries Consultation.

AFFINITY (formerly the British Evangelical Council, which was founded in 1952) is a network of evangelical Christian denominations, church groupings and independent causes. It is probably the largest association of exclusively Bible-centred churches in the United Kingdom, representing approximately 1,200 congregations.

Question 1: We are interested to find out how you feel about using PGD to test for lower penetrance conditions such as inherited breast cancer. To help put your views about this in context, it is important to understand how you feel about PGD for fully penetrant conditions such as cystic fibrosis or haemophilia. Do you agree with the use of PGD in general? For example, for fully penetrant conditions that are present in the child. Please give reasons for your answer.

This is not the place to rehearse the details of our core values. Nevertheless, it is necessary to record that our bioethical stance is based upon sound science plus biblical ethics, both of which insist that human life begins at fertilisation. Moreover, since all human life is “made in the image of God”, it possesses inherent value, dignity and significance, and therefore is to be cherished and protected. Consequently, we are opposed to any practice that deliberately destroys innocent human life, from fertilisation to natural death. Therefore we are opposed to IVF and, inter alia, PGD. We consider that it is only by a selective (and false) understanding of these issues, namely that, “human life commences at some time post-fertilisation”, that, “because embryos are tiny, they are disposable” and that, “disabilities, and therefore the disabled, are intolerable” can PGD be regarded as an acceptable practice. We reject such falsehoods.

Furthermore, we are disturbed not only by the current usage of PGD, but also by its presentation. To state (p. 2) that PGD has resulted in, “…thousands … born free from life-threatening conditions”, is not the whole truth. Such an outcome has been achieved only by procedures that have entailed the sacrificing of many more human embryos. This we deplore.

It is also our conviction that at the heart of all PGD is a sinister eugenic motive – that is, its simple prescription is to kill any genetically-afflicted patients. This is medicine at its worst – no real caring concern, no regard for the dignity of human life, no incentive to search for effective treatments or cures.

In addition, we are alarmed about the negative effect that PGD (and PND) has on those currently disabled by genetic conditions. The underlying messages of disapproval appear to be, “You slipped through the screening net” and, “You are worth less, if not worthless.”

Because we maintain that all embryo screening and selection are invidious procedures, we have consistently opposed the use of PGD for the “search and destroy mission” aimed at embryos with fully-penetrant conditions, as well as for so-called “family balancing”, the production of donor siblings and sex selection for non-medical reasons.

Over the last few years, the HFEA has had an unenviable record of dithering on these issues. This indecision has been caused primarily because the HFEA has sought to devise a strong regulatory framework without any clear and robust bioethical foundation. Its PGD policy has therefore been tossed about more by popular opinion and emotion rather than by the application of objective bioethical criteria.

Now we tremble that the HFEA is seeking to extend the PGD venture. However, we are not surprised by this development – once a foot was placed on the PGD path, the only way was downhill. This latest proposal in the PGD enterprise is a further step towards the testing of all IVF embryos for genetic conditions, both positive and negative. Indeed, the press has recently reported such calls (British Medical Journal, 28 May 2005), as well as the means to achieve them (The Times, 6 January 2006).

Question 2: The HFEA guidance to PGD centres states that PGD should only be available where there is significant risk of a serious genetic condition. Given the lower penetrance, later age of onset and potential treatability of inherited cancer conditions, do you consider them to be serious genetic conditions? Please give reasons for your answer.

And just what is a “serious genetic condition”? A review of bioethics over the last 40 years demonstrates that adjectives such as “serious” and “significant” are, or, at least, rapidly become in practice, virtually meaningless. We are reminded that Humpty Dumpty once asserted, “When I use a word it means just what I choose it to mean.”

And just where and upon what basis will the HFEA decide (and abide by) any future boundaries? Already it has jumped over its recently-drawn PGD hurdles. We despair at such self-inflicted dilemmas. Yet we welcome this (possibly the last) opportunity that the HFEA has to construct sensible and enduring bioethical boundaries rather than mere short-term “fences”.

Question 3: The HFEA guidance to PGD centres states 'that PGD should only be available where there is significant risk of a serious genetic condition'. Does the penetrance of the condition affect whether or not you consider it to confer a significant risk? In your opinion, what would be the lowest penetrance (in percentage terms) that would confer significant risk? Please give reasons for your answer.

The same arguments concerning the problems with feeble semantic definitions, as given in reply to Question 2, apply here.

Question 4: The HFEA guidance to PGD centres states that the views of the people seeking treatment should be taken into account when considering whether to offer PGD. There needs to be a balance between the views of those people who would seek to use PGD to avoid passing on a condition and the views of wider society that may have ethical concerns about them doing so. In your opinion, how much emphasis should be placed on the views of those people seeking treatment? Please give reasons for your answer.

The continued, and the proposed wider, use of PGD is a matter so profound and serious that we would wish it to be the subject of Parliamentary review, decision and legislation.

To take account of the “views of people seeking treatment” may initially appear to be attractive and important – it buzzes with the concepts of democracy, informed consent and patient autonomy. But if the HFEA should learn anything from recent examples, such as the Hasmi and other similar cases, it is that the construction of a sure, wholesome and objective ethical foundation is the first essential. Once constructed, such a foundation will determine the future regulatory framework and hence, clinical practice. To allow so-called “hard cases” to determine medical practice is cart-before-the-horse bioethics. Such subjective decision-making inevitably leads to the practice of substandard medicine, which is then liable to either the whims of populist demand, or a visit to the Courts.

Question 5: The HFEA guidance to PGD centres states that the use of PGD should be consistent with current practice in prenatal diagnosis. Do you agree, with respect to lower-penetrance conditions, that the availability of PGD should be determined by current practice in prenatal diagnosis? Please give reasons for your answer.

Prenatal diagnosis (PND) and preimplantation genetic diagnosis (PGD) have the same intention. To maintain that somehow the destruction of an embryo is preferable to destroying a fetus (or a neonate) is an example of flawed bioethics. To destroy human life deliberately, by whatever method, at whatever stage, for whatever reason, is wrong.

Screening techniques make sense only when a cure or effective treatment is available. Screening for PKU is a worthy example. The major problem with PGD (and PND) screening is that the affected patient is destroyed. So, there is no motivation to research for cures or treatments.

An additional confounding attribute of both PND and PGD screening is that many of the detected medical conditions occur in “degrees”, yet these screening techniques give little or no indication of seriousness. Furthermore, the occurrence of false-positives and false-negatives render these screening procedures less than accurate and appropriate.

Question 6: The HFEA wants to know where you feel the boundaries for the use of PGD lie. Considering penetrance, age of onset and treatability, what type of condition do you think should never be tested for in embryos using PGD? Please give reasons for your answer.

We are not without compassion for those who are predisposed to, or suffer from, genetic diseases – of course, families and individuals from our own constituency are among them. Nor are we against research or progress in medicine, but we would insist that any such advances are practised within a robust bioethical framework. Only this will lead to good and proper medicine. We fear that by allowing the licensing of more PGD, the HFEA will be encouraging the practice of bad medicine.

This Consultation document deals primarily with PGD for low-penetrance conditions. The proposed genetic testing is no longer to be reserved for serious and specific medical conditions affecting a particular embryo, but rather to be extended to include “possible susceptibility” and “predisposition”. Initially, this may apply to inherited breast cancers, but the list will inevitably grow. It would be naïve of the HFEA to think that its latest proposal is anything other than a prelude to opening the floodgates to the use of PGD for all inherited conditions, whenever the relevant tests are available. Our fear is that the HFEA will not be setting “boundaries”, but merely “fences”, or even “gateways”.

Why does the HFEA not come clean and state boldly that it will abandon any pretence at bioethical scrupulosity and consultative niceties, and, that from, say, 1 April 2006, it will license all applications of PGD for any and all conditions? Nevertheless, we hope this will not be the HFEA’s preferred course of action.

It is our considered opinion that any expansion of the use of PGD is a dangerous and unwarranted proposition. We urge the HFEA to think long and hard about these matters and reject any calls for the extension of PGD screening.

Dr John R. Ling
Affinity
PO Box 2119
Reading RG1 7WS.

Email: admin@affinity.org.uk