It is ironic that while the cultivation of genetically modified (GM) crops remains banned in the UK, we are just a step away from creating GM babies. Creating GM babies was declared safe (enough) last week, but growing commercially-produced GM crops is still not.
This blog is not about GM crops, however, but about the news that a report has declared it is now safe enough genetically to modify a human baby with genes from three parents, using research techniques mainly trialed on monkeys and mice. The HFEA is the regulatory body for embryo research and fertility treatment.
Actually, the report did not declare this new research to definitely be safe for humans. It used this double negative wording to suggest as much: ‘The evidence [the Human Fertilisation and Embryology Authority 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 HFEA panel] has seen does suggest that these techniques are safe.’
So why do the HFEA not actually say this directly?
Because they know that there are still far too many safety concerns and unknowns remaining to justify an unqualified ‘yes’ to creating reconstituted human babies, the purpose for which to avoid passing on debilitating and life-threatening mitochondrial disorders.
From a safety perspective alone, we surely need to wait longer to see if it is safe before using with humans? As with the (GM) food we eat. But, while important, this is not just a narrow issue of safety.
- to enable safe and effective treatment for severe 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 the 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. 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 that instead mice, or humans themselves, should be used for trials!
It seems to me, as a layman, that if a 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 an admission that it might well not even work. Are false hopes being offered here?
The report details other complexities with mixing haplogroups, unmatched donors, interaction of nuclear and mitochondrial genes, carryover of abnormal mitochondria, etc. This New Scientist article covers these concerns in more detail.
Now of course it could be – and indeed is – argued that no research is 100 per cent 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 (correctly or incorrectly) 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 these 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!
So, what about the argument that it gives reproductive choice?
This is about offering more choices not one choice. Women with severe mitochondrial diseases who (understandably) want a healthy child, already have the choice of adoption, or IVF using donor eggs. 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, embryo screening is an alternative for many.
But first, a quick reality check here: the offer of extra reproductive choice would actually apply to very few women, as a Government ‘estimate’ admits. Maybe 10-20 women a year in the UK would be candidates for even considering these new techniques – hardly a large unmet clinical need. Again, are false hopes being raised here?
So, if solid evidence for safety is still lacking and if the 10-20 women who may benefit from this risky research already have other choices, that leaves another motive for changing the law: putting the UK at the frontier of scientific research on mitochondrial disease. How much 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)? And how much is about kudos, ambition and money?
Those are questions for my next post, which will also highlight a concern that never receives the full attention that it deserves, but which should be paramount, especially for women.