The chase to be at the forefront of the biotech industry’s genetic therapies could be the key reason the UK government is seeking to rush through proposals that would allow therapies using DNA from three parents.
The UK government is the only government on the verge of accepting this controversial technique. While traditionally conservative Britain is pushing for immediate approval of this controversial technique, a role reversal has taken place with dynamic USA, whose head of food safety urging caution. Prof Evan Snyder has written to the Human Fertilisation and Embryology Authority (HFEA) warning them not proceed.
The aim is elimination not cure
Women carrying faulty mitochondrial DNA are between 1 in 500 (Turnbull 2014) with 1 in 6500 children being born with mitochondrial diseases each year (CARE 2014) in the UK population. The effects of these diseases vary, but can be expected to be noticed from childhood & early adolescence. Whilst some treatment of symptoms such as epilepsy is possible, the actual condition is currently untreatable, and can lead to premature death.
But what is being proposed is not a cure for Mitochondrial diseases, but rather a risky IVF procedure which could mean a carrying mother might be able to carry a child with reduced chances of having the disease. This seems to offer great promise to those women effected, that they could have healthy babies, but no-one knows the impact of these genetic changes as the three groups of DNA interact.
What is being proposed is pronuclear transfer; to take a donor egg, remove the nucleus, and replace it with the nucleus from the mothers egg. Then the father’s sperm would fertilize this blended cell.
Worldwide ban – Safety
The significant ethical and safety concerns have meant that this technique has been specifically banned by the Council of Europe, and the European Union, by stating that no germline alteration should take place in clinical trials. The UK government’s proposed solution is not to do trials at all. In answer to parliamentary questions the department of health were not explicit about whether any such trials had already taken place. This is deeply concerning, given that MPs are uninformed and yet being asked to endorse the crossing of a major bioethical boundary.
One trial on human embryos in China in 2003 resulted in two babies who died before birth, at 24 and 29 weeks, prompting indignation from the scientific community (http://www.nature.com/news/2003/031014/full/news031013-4.html)
Proponents have downplayed the risk of not having all the faulty mitochondria removed from the mother’s egg, thus still having a baby with mitochondrial disease. They also dismissed the evidence that mitochondria play a more important role in the overall function of the cell through interaction with the other DNA, rather than the simple ‘change of batteries’ metaphor the biotech lobby peddle. Their conclusion that this procedure, in their opinion ‘should not be unsafe’, should assure no-one.
The only assurance the HFEA propose is that children born of this technique would be closely monitored, and their children too. But this is a worthless safeguard, as by then it is too late. The people born from this technique could not be ‘recalled’ if found ‘faulty’, nor could they be forced to not reproduce because the risks were too high. Approval would be tantamount to giving the green light to Eugenics.
It is clear that licensing this procedure would not only contradict the spirit and letter of global medical law, but it is not what the public want. In a poll commissioned by Christian charity CARE, only 20% of respondents approved of this legislation, with 41% against.
CARE’s Director of Parliamentary Affairs Dr Dan Boucher said:
“From the outset we have been arguing that the regulations should not be put to the Parliament until all of the advised pre-clinical safety tests have been concluded.
“The Department of Health has not listened and these figures clearly reveal the majority of people think they are wrong to try to push the regulations through without waiting for the conclusion of the preclinical safety tests.”
45 members of the European parliament have voiced their strong opposition to the health secretary Jeremy Hunt, in an open letter sent today. Miroslav Mikolášik, chairman of the European People´s Party Working Group on Bioethics and Human Dignity warned that approval of this technique would be in contradiction with European clinical trials directive explicitly stating that “no gene therapy trials may be carried out which result in modifications to the subject´s germ line genetic identity”. Therefore, infringment procedure against UK could be brought in case this law passes, concludes the letter
No-one questions the difficulty for families with children affected by this disease. But licensing a dangerous, unethical and untested procedure which does not cure, should never be brought before parliament.