Triple DNA fears dismissed as MP’s vote to allow new IVF technique

By The Press Association3rd February 2015News EnglandChildren, News England, Pregnancy

Suggestions that Britain will allow “genetic modification” by permitting the creation of IVF babies with DNA from three different people, have been dismissed by the Public Health Minister.

Mitochondrial donation techniques aimed at preventing serious inherited diseases will be legalised should MPs back a controversial amendment to the 2008 Human Fertilisation and Embryology Act.

Tory front-bencher Jane Ellison (pictured) told MPs the techniques provided in the regulations offered the “only hope” for some women who carry the disease to have “healthy, genetically-related children” who will not suffer from the “devastating and often fatal consequences” of mitochondrial disease.

She said mitochondrial DNA is 0.054% of a person’s overall DNA and none of the nuclear DNA which determines personal characteristics and traits.

Mitochondrial donation would not alter the nuclear DNA, Ms Ellison said.

Ms Ellison said mitochondrial donation had been subject to “extensive scrutiny” throughout the Parliament, adding it was believed it was right for the current cohort of MPs to have a say on the next step.

Tory backbencher David Burrowes (Enfield, Southgate), intervening, told Ms Ellison: “Will you accept, as scientists I understand do broadly accept, that the procedures are cell nuclear transfer.

“That’s what regulations four and seven do and make clear. By that they very implicitly do explicitly alter the nuclear DNA in the egg and therefore one has to agree an honest clear definition is what we’re dealing with is genetic modification.”

Ms Ellison replied: “No, I can’t accept that description. I recognise you have objections to the procedure but I don’t recognise your description and no nuclear DNA is affected by this. Mitochondrial DNA is different.”

Ms Ellison assured MPs that “all rigorous steps” had been taken in order to get to the stage where Parliament can make an informed decision.

The Public Health Minister also insisted that there is no indication that the two techniques for mitochondrial donation are unsafe.

She was responding to Tory Richard Fuller (Bedford), who is part of a group of MPs who want the process paused so more tests and research can take place.

Intervening, Mr Fuller said: “This is in some ways for us an ethical gateway for the framework for the scientists and medical experts to move forward.

“Could you advise the House why it appears that there are a number of people who for ethical reasons and religious reasons are quite close to agreeing with the Government but haven’t quite yet agreed and have asked for more time?”

Ms Ellison replied: “What I seek to demonstrate in my remarks and which the Government, and there have been three expert panel reviews, what we’re seeking to show is that we have taken all rigorous steps to reach a point where Parliament can make an informed decision.

“And I think what’s important to distinguish is between those things that are knowable, in order that Parliament can make that informed decision.

“And those things that can only be known when we go to the next step, which involves making the regulations.”

On safety, Ms Ellison said an expert panel convened by fertility regulator the HFEA had written three reports on the technique.

She said: “On each occasion the expert panel has concluded that there is nothing to indicate that the two donation techniques are unsafe.

“Although the expert panel has recommended that further experiments should take place, the panel expects its research to support the conclusions it has reached so far.”

If Parliament passes the regulations in front of it then a “robust” set of safeguards would be put in place for the development of the treatment, Ms Ellison said.

She went on: “These regulations would also bring in to place important safeguards through the HFEA’s own licencing procedures.

“For a licence to be issued to a provider of mitochondrial donation, they would first have to demonstrate that they could carry out the procedure safely and effectively.

“Each provider would need to be licensed and treatment for each patient would be approved on a case-by-case basis.

“Such decisions would be based on the scientific evidence and advice submitted to the licensing committee.

“The HFEA are highly respected across the globe as a model for the regulation of fertility and embryology treatments and research.

“Many other countries do not have this framework in place.”

Ms Ellison concluded: “This is a bold step for Parliament to take but it is a considered and informed step. This is world-leading science within a highly-regulated regime.”

Shadow public health minister Luciana Berger said the techniques could break a “chain of misery” that would otherwise affect multiple generations.

She told MPs:”We have within our reach the possibility of eradicating mitochondrial disease and families who have been blighted by it for generations, families who have endured a disease for which there is no cure.

“They have suffered daily battles with painfully debilitating symptoms and have sadly lost their children prematurely.

“Families who have had to face up to the risk and perhaps the certainty that to be a parent must come at the expense of a difficult and, in too many cases, painful life for their children.

“Not only would children born through such techniques be free of these conditions, but so would their children and grandchildren, breaking a chain of misery that would have otherwise ruined generations of lives.”

She dismissed the idea the process was being rushed, saying the scientists who had been working on their research for 15 years would disagree.

She also said both the science and the ethics had been debated extensively and that there was no evidence the techniques were unsafe.

Ms Berger also argued that despite the “unprecedented scrutiny” there would always be a leap of faith when testing a new technology on humans for the first time.

Labour’s Angela Smith said the risk in this instance was “very, very low” and “completely justified” the leap of faith Ms Berger described.

She added: “It is, in effect, a further advance of the use of IVF technology which itself was pioneered as a leap of faith in 1978.”

Conservative MP Fiona Bruce (Congleton) said the issue was a “red line” MPs should not cross, highlighting her opposition both on principle and on safety grounds.

She said: “I believe the regulations before us today fail on both counts, ethics and safety, and they are inextricably interlinked.

“One of these procedures we are asked to approve today, pronuclear transfer, involves the deliberate creation and destruction of at least two human embryos, and probably in practice many more, in order to create a third embryo which it is hoped will be free from human mitochondrial disease.

“Are we happy to sacrifice two early human lives to make a third?”

The MP added: “This is about the principle of genetically altering, indeed genetically creating, a human being and no matter how well meaning the motives – and my heart goes out to the families with mitochondrial disease – this technique will not cure it.

“This technique will involve the permanent alteration of the human genetic code… this is something, this alteration, will be cast down generations, the implications of this simply cannot be predicted, but one thing is for sure: once this alteration has taken place, once the genie is out of the bottle, once the procedures we are being asked to authorise go ahead, there will be no going back for society, and certainly not for the individuals.”

Ms Bruce said it was “profoundly concerning” studies into the procedure were not finished and peer-reviewed.

She said not only had there been no clinical trial, there could not be any under European law.

“If we pass these regulations today, the technique will be applied to the creation of children without clinical trials,” she said.

“In other words that we will be approving uncontrolled – because there will be no controls – uncontrolled experimentation on children.”

Andrew Miller, Labour chairman of the science and technology committee, urged MPs to set aside their general beliefs in the “overwhelming interest” of those families who have suffered enormously from mitochondrial disease.

He backed the measures, explaining scientists had judged the risks to be small but the benefits enormous.

Mr Miller said: “In all cases where there are risks one needs to look at the risks versus the benefits.

“And I put it to this House that the benefits to those – about 2,500 families – affected by mitochondrial disease up and down this nation, they deserve the support of this House because of the potential benefits.

“Yes, of course, we’ve got to assess the risks as we do with all risks but they’ve got to be done in a rational and balanced way.”

Conservative Richard Drax (South Dorset) intervened to tell the Commons: “Everyone in this House wants the best for these families. There’s no doubt about that.

“It’s just the speed that I think most are concerned with and today I heard apparently as far as the experimentation is concerned, no trials have been carried out on primates – which are as near to us as possibly can be.

“Mice it’s proved successful but on primates, which is a standard part apparently of this procedure, it’s not been carried out on.”

Mr Miller said there were plenty of occasions where this procedure had not been followed, including tests on Ebola vaccines.

Addressing research work undertaken in China 10 years ago, Mr Miller said: “I would put it to (MPs) that the ethical and scientific rigour applied to experimentation in the UK far exceeds anything in China 10 years ago and indeed the technologies themselves have moved on to a very, very high degree since that time.”

Conservative Steve Baker (Wycombe) said science proceeded through trial and error, adding that there would always be uncertainty in any scientific procedure.

The question before MPs, he added, was whether there was a reason to withhold the techniques from people.

He said: “If there is a reason it’s because they may do harm to (a) person’s future and that is why I will not support the measure today because it is inherently uncertain, that uncertainty is an inherent part of science, and it is no good whatever appealing to authority to try and resolve the question because different authorities will disagree, and that there is no way to resolve those disagreements apart from empirical evidence which we can only obtain by experimenting on humans.”

Mr Baker added: “If the “germline” is to be modified, then to me this is genetic modification.”

He concluded: “We each of us have our own particular DNA identity, this procedure may change only a tiny part of it, but change it it certainly does.

“I’ve already discussed the uncertainty and having changed it we just cannot know what the future consequences will be and I think with great sorrow, knowing the families will be affected, with great sorrow I say that when it comes to human beings this degree of uncertainty cannot be borne by my conscience and I shall be voting against the regulations.”

Labour’s Liz McInnes (Heywood and Middleton), an NHS biochemist, dismissed concerns about “three parent children” and “designer babies”.

She said: “Referring to this donor as a third parent as some people have is something of a misnomer.

“There are 37 genes in mitochondrial DNA which is less than 0.01% of our total DNA.

“Altering the mitochondria will not alter a child’s characteristics inherited from its biological parents, but it may provide a way to prevent a debilitating and sometimes fatal disease.

“The spectre of designer babies can be dismissed here – there is no possibility using this technique of being able to select certain characteristics.

“It will simply allow mitochondria to function normally and for the child to be free of mitochondrial disease.”

Ms McInnes also rejected suggestions a case of mitochondrial transfer in China where a woman became pregnant with triplets could be used as a test.

One of the babies was aborted and the other two were born prematurely and died.

She said: “Importantly the clinician attributed to the outcome entirely to multiple pregnancy and obstetric complications – not to the method of conception.

“I do not accept that that one case represents a proper clinical trial.”

Former health secretary Frank Dobson said scientists had been trying without success to come up with a treatment and were continuing to do so.

But he added: “They think it would be better to prevent it arising because prevention is better than cure.”

He also told MPs it was a “credit” to the nation and the House that the HFEA had been established as a “middle way between the free-for-all which a few nutters want and a total ban”.

The Labour MP insisted there was “no sign of a slippery slope” and pointed out there had been no scandal since the regulator was set up.

He went on: “If it doesn’t work there will be people gloating even in this chamber … They (the scientists) are willing to take these risks and the parents are willing to take these risks.”

But Liberal Democrat John Hemming (Birmingham, Yardley) said he could not see the difference between mitochondrial DNA and nuclear DNA.

“Both are inherited, both can prevent inherited diseases,” he added, warning society was moving away from one where people are valued as people.

Labour’s Robert Flello (Stoke-on-Trent South) said he was concerned families pinning their hopes on this would be let down and rejected the idea the transfer technique was akin to a blood transfusion.

He added: “If it isn’t genetic modification we don’t need this legislation … The HFEA could get on with it.

“If this was GM crops we would be up in arms.

“This is not about whether we should quite rightly be helping families … this is about saying we should get this right.”

Conservative David Willetts (Havant) said he understood that the existence of potential benefits did not automatically overcome the ethical issues.

But he stressed this was not crossing a red line as mitochondria do not form part of “core DNA” and therefore do not affect character.

He also said there was no evidence the technique was unsafe and suggested some people were using health and safety concerns as a “cover” for an underlying objection on principle.

Tory veteran Sir Edward Leigh (Gainsborough), a prominent Catholic, claimed that approving mitochondrial transfer could pave the way for further “modifications” to babies and said he opposed the technique.

Sir Edward said: “It is a new step, it will affect the germ line, mitochondria is inherited, it is not just another organ of the body.

“It is a fatal and important step. As my colleague said earlier – where do we stop?

“If we believe that sadly given the nature of the human condition there are these appalling diseases, where does it stop? What further modifications will we make?”

Sir Edward said he also opposed the move on safety grounds.

He said: “I believe that we should have whatever there is in European conventions and regulations, we should have full clinical trials and the scientific community should be united on aspects of safety, which it is not.

“Unfortunately we will be the first state to authorise this in the world and in that sense by ethical terms we will be in a unique position.”

Paul Burstow, a Liberal Democrat former coalition health minister, said world class research had offered potential innovation to IVF which could make a real difference for thousands of families.

He backed the measures, telling MPs: “The minister was right. This is about light at the end of the tunnel for thousands of families in this country. It’s about the opportunity and prospect of life lived, life realised and the prospect of having the potential opportunity to live.”

Tory Mr Burrowes reiterated his opposition to the measures, saying: “The Government said in its consultation response that what this is about is to provide a greater understanding of the ways in which mitochondrial DNA mutations are passed down from mother to child.

“That’s what they want to do. It is, in many ways, an experiment, a wider trial, a trial I would say to the House that should not go ahead.

“It’s unprecedented in the world. Some may say it’s leading the pack, others may say it’s leaving us out on a limb, ethically breaking international norms, legally we’ve heard in terms of the directive and also in terms of safety when the tests have not been completed.

“You may think not yet, you may think no, either way please vote against the motion.”

Concluding the debate for the Government, Ms Ellison said it was not right to say Britain stands alone nor that it was going down a “slippery slope”.

She said: “The department has recently received quite a lot of correspondence from researchers and scientists in Germany, France, the Netherlands, Sweden, Japan, Hong Kong, two states in Australia, all indicating support for UK advances on mitochondrial donation.”

She added she had spoken to the Bishop of Carlisle, who speaks for the Church of England (CoE) on ethical matters in the Lords, and spoken to the CoE’s national adviser on medical ethics.

Ms Ellison said: “They have told me that I can confirm the church is not opposed in principle to mitochondrial donation.”