Thursday, July 4, 2013

Three-Person IVF Gets UK Government Backing

The UK government has backed three-person IVF, i.e. creating babies using DNA from three people. The UK government said the procedure will probably be available in 2015 after draft regulations have been produced.

Current IVF techniques leave some babies open to potentially disabling and sometimes life-threatening mitochondrial diseases, which are inherited from the mother. Opponents question why couples who are concerned about inherited mitochondrial diseases do not use egg donors instead.

Mitochondria are the powerhouses of cells, organelles that act like a digestive system, taking in nutrients, breaking them down, and creating energy for the cell. Mitochondria are passed on through the egg, from mother to child.

Approximately 1 in every 6,500 babies inherits defective mitochondria from the mother. Without properly functioning mitochondria cells may starve, the baby can become blind, develop serious muscle weakness, become tired easily, there is a risk of heart disease, intestinal disorders, and in extreme cases premature death.

According to previous studies, using mitochondria from a donor egg could be one way of preventing mitochondrial diseases. In the UK alone, approximately ten couples each year would benefit from receiving mitochondria from a donor egg.

Baby would have DNA from three "parents"

Mitochondria have their own DNA, so if mitochondria from a donor egg were used, the baby would have DNA from the mother, father and the donor of the egg.

At the UK government's request, in September 2012 the Human Fertilisation and Embryology Authority launched a public consultation on the ethics of using DNA from three "parents" to prevent the passing on of serious mitochondrial diseases.

In the UK, carrying out mitochondrial replacement in the laboratory is legal, but embryos must not be used in treatment.

In March 2013, HFEA (Human Fertilisation and Embryology Authority) reported that there was no evidence that the three-person IVF procedure was unsafe and that there was "general support" for the idea.

On March 28th, HFEA sent the finalized public dialogue and scientific update reports from public consultation - "Medical frontiers: debating mitochondria replacement" - to the UK Government.

HFEA also gave the following advice regarding the ethics and science of new IVF-based techniques aimed at avoiding mitochondrial diseases:
  • Only clinics licensed by HFEA should be allowed to offer mitochondria replacement

  • Each mitochondria replacement proposal should be approved by HFEA. However, "Regulations should provide the flexibility to modify this in the future".

  • IVF clinics must make sure that follow-up research is done on each child born.

  • Mitochondria donors, like tissue donors have the right to anonymity. The resulting child should not have the right to track down the donor "although information exchange and contact could be arranged locally by mutual consent."

  • "A further assessment of the safety and efficacy should be commissioned by the HFEA once a clinic has submitted an application to carry out one of the techniques. This follows advice from an expert scientific panel that there is no evidence to suggest that mitochondria replacement is unsafe, but that further specific experiments should be conducted."
England's Chief Medical Officer, Prof Dame Sally Davies said "Scientists have developed ground-breaking new procedures which could stop these diseases being passed on, bringing hope to many families seeking to prevent their future children inheriting them. It's only right that we look to introduce this life-saving treatment as soon as we can."

Mitchondrial Replacement in IVF Procedures

Scientists have developed mitochondrial replacement techniques that use mitochondria from donated eggs to prevent mothers passing on mitochondrial diseases to their offspring.

These techniques result in healthy embryos without mitochondrial diseases. They have the DNA of three different people - the father, mother and egg donor. 20,000 genes come from the mother and father and 37 mitochondrial genes from the donor.

Mitochondrial replacement in IVF procedures affects the "germ line" - the donor's mitochondrial DNA will be passed on to future generations of the "three-parent" child. This is a fundamental change to human genetic inheritance.

The BBC quotes Dr. David King, director of Human Genetics Alert, who said "These techniques are unnecessary and unsafe and were in fact rejected by the majority of consultation responses. It is a disaster that the decision to cross the line that will eventually lead to a eugenic designer baby market should be taken on the basis of an utterly biased and inadequate consultation."

HFEA responded to some of Professor King's allegations. With regard to King suggesting that the HFEA consultation process was flawed and the analysis of findings misrepresented in public opinion, HFEA wrote "We strongly refute Dr King's suggestions and think it is important to address his comments. The consultation was made up of many strands. One strand of the consultation showed a small majority against mitochondria replacement and those people tended to have broader concerns about IVF.

In all the other public engagement strands a majority of respondents and participants supported the use of mitochondria replacement. We used a range of methods to explore these complex issues. Our consultation was a more nuanced exercise than simply counting up votes for and against the techniques."

The IVF technique to eliminate mitochondrial disease was pioneered at Newcastle University, England, by Professor Doug Turnbull and Professor Mary Herbert at Newcastle University.

Professor Doug Turnbull said: "I am delighted that the Government is moving forward with publishing draft regulations this year and a final version for debate in Parliament next year. This is excellent news for families with mitochondrial disease. This will give women who carry these diseased genes more reproductive choice and the opportunity to have children free of mitochondrial disease. I am very grateful to all those who have supported this work."

Professor Mary Herbert said "Today's announcement is really encouraging news for families affected by mitochondrial DNA disease. The IVF-based techniques currently under development offer the possibility of greatly reducing the risk to children of affected women. We are in the fortunate position of having substantial Wellcome Trust funding to continue to refine the techniques and to optimise their safety and efficacy.

"We have made good progress in optimising the pronuclear transfer technique and will continue to need a supply of healthy eggs to perform further tests on the safety of the technique. Obviously, the timescale will depend on the outcome of those tests."

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