Any sub-heading to this blog post could ask a further question: ‘why should we be concerned about this issue anyway? After all, what’s not to like about new techniques that could stop a horrible disease, that seem to be safe (enough), that only involve manipulating a tiny bit of DNA on a tiny embryo and that could bring in direct investment to the UK?
To answer my last question first, yesterday the Human Fertilisation and Embryology Authority (HFEA) released their third review of the safety and efficiency of controversial new research that could potentially help women to avoid passing abnormal mitochondrial genes down generations. It would work by creating re-combined embryos with normal mitochondria taken from a donor, to replace abnormal mitochondria. This CMF File explains more.
The answer to my other questions I hope will become apparent through this blog.
The new HFEA report says that it is safe enough to create one baby from three parents assuming, that is, that one considers their double negative wording to say as much: ‘The evidence [the panel] has seen does not suggest that these techniques are unsafe.’ If we remove the double negatives we are left with the words: ‘The evidence [the panel] has seen does suggest that these techniques are safe.’
So why do they not actually say this directly?
Because the HFEA panel knows that there are still too many safety concerns and unknowns remaining to justify a green light to creating reconstituted human embryos in order to avoid passing on debilitating and life-threatening mitochondrial disorders. But at the same time they cannot bring themselves to say ‘no’ to it.
It’s effectively like giving an orange light which everyone just assumes will turn green shortly, and so are preparing legislation and human trials to that end.
From a purely safety perspective, we need to wait to see if the light indeed turns green…or red. But, while important, this is not just a narrow issue of safety.
- to enable safe and effective treatment for mitochondrial disease;
- to give women and families reproductive choice;
- to put the UK at the cutting edge of medical techniques and attract outside investment.
So first, are these two new techniques now safe and effective to use in humans?
The new report is full of the unknown risks and complexities with this experimental research, with most of the (limited) available data showing it is safe on the basis of research on mice and monkeys. But one of the techniques (PNT) was so unsuccessful with monkeys (causing increased abnormalities) that the HFEA suggests that monkeys are not a good model for humans and instead mice, or humans themselves, should be used for trials.
It seems to me, as a layman, that if it one technique doesn’t work with primates, that should sound a warning, rather than a reason to simply use another animal instead (especially one that has even less in common with humans) in order to get the desired results.
The results from mice and invertebrates also suggest that many deleterious effects would not be revealed until adulthood. The HFEA seems to take this concern seriously. The panel warns that if a woman has a daughter born using these new techniques, her daughter will have to use embryo screening to avoid the risk of passing on mitochondrial disorders, because there is such a risk her daughter will have abnormal mitochondria!
In other words, a mother can choose to use this technique instead of embryo screening but her daughter will have to use screening. ‘Reproductive choice’ only works for some.
Not only that, this is surely a clear admission that it may well not even work. Are false hopes being offered here?
The report also details many of the complexities with mixing haplogroups, unmatched donors, interaction of nuclear and mitochondrial genes, carryover of abnormal mitochondria, etc. This New Scientist article covers safety concerns in a little more detail.
Now of course it could be – and indeed is – argued that no research is 100% guaranteed to be safe, which is why we need human clinical trials.
That is certainly true to some extent, but these techniques are different to any other others ever tried or permitted before. Indeed, they would be prohibited in most other countries in the world. This is because they would change the germline so any good and bad effects will not just affect that one person but would be inherited by their descendants. This is unprecedented and is why the term GM babies is bandied around.
The HFEA understand this concern, so they suggest putting in place follow-up studies of children born of these new techniques. However this would not be legally required and follow-up studies are notoriously difficult to carry out over the long-term, especially if descendants also need follow up. Families cannot be contained in a lab, or in one place, like animals!
Second, what about the argument that it gives reproductive choice?
This is about offering more choices not one choice. Women with mitochondrial diseases who (understandably) want a healthy child, already have the choice of adoption or IVF with the use of a donor’s egg. Of course their child would not be genetically related but neither would he/she be put at grave risk by an extreme procedure!
For women who want (note, ‘want’ not ‘need’) to have a healthy genetically related child, pre-implantation genetic diagnosis is an alternative for many (albeit with some ethical concerns).
At this point I should note that the offer of extra reproductive choice would apply to very few women, as a Government ‘estimate’ admits. Maybe only 10 or so women a year would be candidates for even considering these new techniques – hardly a large unmet clinical need. Again, are false hopes being raised here?
So, third, if the evidence for safety is still lacking and if the ten or so women who may benefit from this risky research already have other choices, that leaves one other primary motive for changing the law: putting the UK at the frontier of scientific research on mitochondrial disease. Is this research about the concern for ten women a year who may be helped by this (if we ignore the risks of it for themselves and their daughters) or is it also about academics’ ambition and money?
There is a revealing statement in Wired by one vocal advocate of this research, scientist Robin Lovell-Badge, who says he would not rule out taking the technology well beyond mitochondrial genes: ‘I do not argue that germline genetic modification of nuclear genes should never be considered, for example, parents might accept modifications that would protect their child against diseases such as AIDS. However, we do not yet have the technology or knowledge to guarantee that any such genetic alteration would be safe.’
No wonder Lord Winston spoke recently of his fears of a eugenic future driven by the desperation of childless couples and the pace of scientific developments in the booming embryo industry.
From a global health perspective, there seems little justification for the investment of resources (time, talent and money) into research on avoiding the transmission of mitochondrial disorders for so few women when there are much greater reproductive health needs experienced by women in both developed and developing countries.
I cannot finish this blog post without mention of another concern that never receives the attention that it deserves, especially in the media, but which I believe should be paramount.
The need for eggs from women for this research is generally passed over as an issue, although the HFEA report briefly mentions that it raises ethical and practical issues.
Yet the truth is, this research will require women to donate hundreds of eggs!
Egg donation has significant health and ethical implications, including the health risk to the donor from powerful hormonal treatments, injections, invasive surgery, and it is not for her own benefit. How do researchers get hold of enough eggs for research and ‘treatment’? By inducing women to incur these risks, ie paying them through cut-price fertility treatment or direct monetary ‘compensation’. Through eggsploitation of women.
It is telling that wealthy women rarely donate their eggs. It is those who are disadvantaged, economically needy and/or infertile and vulnerable.
Egg donation on the scale needed cannot be justified for experimental research that is unsafe, unpredictable, unnecessary, may not work and is unethical, however much kudos and money it may bring to the UK as it positions itself, alone, at the frontier of mitochondrial research.
Posted by Philippa Taylor
CMF Head of Public Policy