18 January 2010
Former molecular biologist and the founder of the independent watchdog group Human Genetics AlertAppeared in BioNews 541
The HFEA took policy decisions to permit both of these uses of PGD a few years ago, but decided that in order to reassure the public, an HFEA licence committee would look at every family's application. It has been reviewing this policy for the past few months, and at the same time has made an important shift in the regulation of the majority of PGD applications, which are now licensed on a condition-by-condition basis - i.e. the HFEA decides whether it is appropriate for to licence PGD for each condition; once a condition is approved, clinicians in any clinic may then offer PGD to families with that condition. The HFEA is now considering whether to treat tissue typing and late onset conditions in the same way as the majority of PGD applications.
I spoke at a HFEA consultation meeting on this topic on 1 December 2009, which was attended mainly by clinic staff and representatives of genetic disease support groups. This audience was strongly in favour of moving to a condition-by-condition system for both types of case under discussion. The general feeling was that the variation between different families was not significant enough to justify the case-by-case approach, and there were complaints about the time delays that the current HFEA system causes. However, the latter is not an argument for relaxing regulation, but rather for improving the efficiency of the HFEA.
The problem with the way that the clinic staff dealt with regulation was that they approached the question from an overly narrow and technical point of view, which ignores the still-unresolved ethical and social concerns regarding these uses of PGD. It is understandable that once the in principle decision has been taken clinicians do not want to have to deal any more with those issues. But the reason for adopting a case-by-case approach was in order to ensure that when real cases come forward they do not re-arouse those public concerns, and fulfill the predictions that people like me make about slippery slopes. In other words, the ethical issues have not disappeared just because the in principle decision has been taken - they are still alive in the details and variability between individual cases.
In the case of late onset conditions, the concern was that because of the lower penetrance, age of onset and availability of prophylactic treatment in some cases, these conditions are on the borderline of what is considered a 'serious' condition, suitable to be prevented through PGD. It is perfectly possible that the variability between individual cases may provide some instances in which the risk and severity are on the wrong side of the line. For example, contrary to the impression given by the background document for the December meeting of the HFEA's Ethics and Law Advisory Committee (ELAC), risk varies considerably between different families with BRCA1 mutations. Penetrance for BRCA1 is between 60 per cent and 85 per cent, and there is a very considerable degree of variation between different families; risk is also affected by ethnicity. The BRCA genes are large and have hundreds of different mutations in them, each of which will be present in particular families and have its own degree of risk, which will then be modified by the genetic background in that family. The HFEA has so far dealt with only eight cases, of six different conditions, of which the only condition from which more than one (three) families have applied is BRCA1. Clearly, the HFEA does not have enough practical experience to be able to state that inter-family variability is irrelevant to the question of overall seriousness, either with BRCA1, or with other conditions where the severity of symptoms may vary considerably.
In the case of tissue typing, the ethical/social concern is that it is simply wrong to create a child as a means to an end, however good that end may be. That concern has not gone away, and the decision that tissue typing is ethically acceptable simply says that the likely medical benefit outweighs this ethical concern. It is therefore crucial to ensure that tissue typing is really used as a treatment of last resort in really severe cases, and that there is a strong chance that it will work. Again, the inter-case variability may well throw up instances in which it is questionable whether the treatment is really being used as a last resort, and where the symptoms of the sick sibling do not justify creating a child.
Although successful treatment of the sick sibling has been reported in a few cases, the HFEA has admitted that it has failed to collect any information on the success of the treatment for most of the 24 cases it has dealt with since 2001. At the meeting, no-one contradicted the claim made by one participant that the success rate is very low. This may be the reason why the ELAC surprisingly went against the advice of the clinicians and recommended retaining the case-by-case approach for tissue typing. Rather than relaxing regulation, the HFEA should be considering whether it can continue to license the creation of children as tissue donors at all.
This is clearly not the moment to abandon case-by-case regulation. The HFEA has not had enough experience of dealing with these conditions to say that the tricky ethical and social issues raised by them are exhausted. The ELAC made this point in reference tissue typing, and it is equally if not more true for late-onset conditions. It is better for everyone if those judgments are made centrally, in order to ensure consistency over time, and between different clinics, than by clinicians subject to the direct influence of often-desperate parents. The HFEA has often been criticised as being too close to the interests of the IVF industry, and the public will not be reassured that its concerns are taken seriously if the HFEA policy seems to be one of de-regulation for its own sake.