HFEA

U.K. Approves Fertilization Treatment Using DNA From Multiple People to Make Babies

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IN BRIEF
  • Clinics in the UK can now offer patients mitochondrial donation, a treatment that uses DNA from a third person to help women with mitochondrial diseases give birth to healthy babies.
  • Despite criticism that mitochondrial donation will one day lead to “designer babies,” the only certainty is that it can help patients right now overcome a problem with no other solution.

ONE BABY, THREE PARENTS

The United Kingdom’s fertility regulator will now begin accepting applications from clinics seeking to offer patients mitochondrial donation. The treatment has been proven to help women with mitochondrial DNA mutations give birth to healthy babies, and the Human Fertilisation and Embryology Authority’s (HFEA) approval for the technique has been deemed a historic step forward in this field.

The process involves the removal of the nucleus DNA from the egg of the mother carrying the mitochondrial disease and transferring it to a donor egg. The egg is fertilized with the father’s sperm, and the embryo is then implanted in the mother. That embryo will therefore have nucleus DNA from its parents, but mictochondrial DNA from a donor, though the third-party DNA will account for less than one percent of the embryo’s genes.

“Today’s historic decision means that parents at very high risk of having a child with a life-threatening mitochondrial disease may soon have the chance of a healthy, genetically related child. This is life-changing for those families,” says HFEA Chair Sally Cheshire in a statement.

A mitochondrial donation at a Mexican clinic resulted in the successful birth of a three-parent baby earlier this year, and the team behind that case recently announced plans to treat as many as 20 new patients in the first half of 2017.

Micrograph showing ragged red fibers, a finding seen in various types of mitochondrial diseases. Image Credit: Nephron/Wikimedia

LIFE-CHANGING TREATMENT

Women with mitochondrial disorders have a high risk of passing on the mutated DNA to their offspring. In most cases, the affected child will die early due to the lack of available treatment options or suffer debilitating condition such as muscular dystrophy, organ failure, and muscle weakness.

Prior to the availability of mitochondrial donation, women with faulty mitochondria who wanted to have children were limited to adoption or undergoing in vitro fertilization (IVF) using healthy donor eggs. If they wanted to push for genetically related offspring, they would have to risk natural birth or undergo a screening procedure that could potentially help doctors find embryos with the fewest mutations.

Despite being a viable and better alternative to existing options, the procedure is not universally embraced. Critics have asserted that the DNA manipulation the technique requires could eventually lead to the creation of “designer babies.” However, as it provides a solution to a condition for which there is currently no better option, the value of this breakthrough is enormous.

Receiving the green light from regulatory bodies proves that advancements that could save lives and have positive life-changing implications right now will garner support despite any hypothetical future scenarios. “After a lot of hard work and invaluable advice from the expert panel, who reviewed the development, safety, and efficacy of these techniques over five years and four reports, we feel now is the right time to carefully introduce this new treatment in the limited circumstances recommended by the panel,” says Cheshire.

‘Let me keep my dead husband’s sperm’

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Beth and her husband Warren

Beth and her husband Warren

  • A woman has begun a legal bid to prevent her dead husband’s frozen sperm from being destroyed.

Beth Warren, 28, has been told by the Human Fertilisation and Embryology Authority (HFEA) that the sperm cannot be stored beyond April 2015.

Her husband, Warren Brewer, a ski instructor, died of a brain tumour at the age of 32 in February 2012.

His sperm was stored before treatment, and he made it clear his wife should be allowed to use it posthumously.

“Start Quote

I do not know what will happen in the future and I would like to have the choice left open to be able to have my husband’s child as I know he would have wanted.”

Beth Warren

The couple, who were together for eight years, married in a hospice six weeks before his death. She subsequently changed her surname to Warren.

“I understand that it’s a huge decision to have a child who will never meet their father, ” said Mrs Warren, who lives in Birmingham.

“I cannot make that choice now and need more time to build my life back. I may never go ahead with treatment but I want to have the freedom to decide once I am no longer grieving.

“My brother died in a car accident just weeks before my husband’s death, so there has been a huge amount to cope with.”

Mrs Warren was initially told that her husband’s last consent form lapsed in April 2013, but has subsequently been granted two brief extensions amounting to two years. The frozen sperm is stored at the CARE fertility clinic in Northampton.

Her lawyer, James Lawford Davies said the 2009 regulations created injustice.

“Common-sense dictates that she should be allowed time to recover from the loss of her husband and brother and not be forced into making such an important reproductive choice at this point in her life.”

Mr Lawford Davies, whose firm is not charging Mrs Warren to represent her, said there were a number of inconsistencies about the regulations.

The sperm has to be used by April 2015, but if it was thawed and used to create embryos, these could be stored for a further seven years.

The time limit also means that Mrs Warren could use the sperm to create one child but not a second.

There is also no restriction on the sperm being exported, which would mean Mrs Warren could be treated abroad in the future, but not in the UK.

The case will be heard next year by a judge from the Family Division of the High Court.

Beth Warren: “I really just need more time to make a decision”

Options open

In her legal submission Mrs Warren said: “I am aware that I may decide not to use the stored samples in the event that I meet someone in the future and choose to have a family with him.

Regulations for storage of sperm and eggs in the UK

Patients about to undergo radiotherapy often have sperm or eggs (gametes) removed as the treatment can cause infertility.

Regulations which came into force in 2009 allow for gametes to be stored for up to 55 years provided that the person who provided the sperm or eggs renews their consent every ten years.

But patients who die are unable to renew their consent, setting a shorter time limit on storage.

“I do not know what will happen in the future, and I would like to have the choice left open to be able to have my husband’s child – as I know he would have wanted.”

In a statement the fertility regulator said: “The HFEA has every sympathy with Mrs Warren and the tragic circumstance in which she finds herself.

“We have been in discussions with Mrs Warren’s solicitors for some time and each time new information has been presented to us, we have reconsidered the legal situation in as responsive a way as possible.

“However, the law on the storage of gametes is clear and the HFEA has no discretion to extend the storage period beyond that to which her husband gave written consent.”

The case will renew the debate over the ethics of posthumous conception.

In 1997 Diane Blood won the right to conceive a child using sperm from her dead husband.

The Court of Appeal ruled against the HFEA and said that Mrs Blood should be allowed to seek treatment abroad.

But in that case the sperm had been removed when he was in a coma and without his written consent. Mrs Blood went on to have two sons after treatment in Belgium.

In this case Mr Brewer had his sperm stored prior to radiotherapy treatment in 2005, and in subsequent years signed several forms stating that his wife could use the samples.

Three-person IVF moves closer in UK.

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The UK has moved closer to becoming the first country to allow the creation of babies from three people.

The Human Fertilisation and Embryology Authority (HFEA) has advised the government that there is no evidence the advanced forms of IVF were unsafe.

The fertility regulator’s public consultation also showed “general support” for the idea as the benefits outweighed the risks.

A final decision on whether to press ahead rests with ministers.

If the techniques were approved it could help a handful of families each year. Around one in 6,500 children develop serious “mitochondrial disorders” which are debilitating and fatal.

Research suggests that using mitochondria from a donor egg can prevent the diseases.

However, it would result in babies having DNA from two parents and a tiny amount from a third donor.

Concerns have been raised both about the safety and the ethics of creating such babies.

The results of a public consultation at the end of 2012 showed there was support for the idea.

Prof Neva Haites, who was on the expert panel supervising the consultation, said: “Broadly speaking the public was in favour of these novel techniques being translated into treatments.

“They felt that any ethical concerns were outweighed by potential benefits.”

One of the main issues raised was of a “slippery slope” which could lead to other forms of genetic modification.

‘Power stations’

Mitochondria are the tiny biological power stations that give energy to nearly every cell of the body.

Defects can leave the body starved of energy, resulting in muscle weakness, blindness, heart failure and death in the most extreme cases.

The cigar-shaped mitochondria are passed only from mother to child. A father does not pass on his mitochondria through his sperm.

Scientists have devised two techniques that allow them to take the genetic information from the mother and place it into the egg of a donor with healthy mitochondria. It is like taking two fried eggs and switching the yolks.

The result is a baby with genetic information from three people, as mitochondria have their own genes in their own DNA.

The implications are not just for the couple and the child. If the therapy was performed it would have ramifications through the generations as scientists would be altering human genetic inheritance.

‘Recommendations’

The HFEA has advised that any changes to the law should be only for the modification of mitochondria to overcome serious diseases and that there should still be a ban on changes to the main nuclear DNA, which contains the vast majority of a person’s genetic code.

It also recommended continuing research and that any children born through these techniques, and possible the children’s children, be monitored closely.

Any time soon?

These therapies using sperm and eggs from three people are not yet ready to be performed in the clinic. However, it is thought that scientists in the UK and the US are getting close to the point where it will be possible.

Prof Robin Lovell-Badge, part of the expert panel analysing the science, said there was “still no evidence to suggest the techniques are unsafe,” but he said further experiments were needed for reassurance.

“Safety is absolutely not a black and white issue. In reproductive medicine in particular it is not possible to be absolutely certain about the consequences of any new treatment until children are born.

“Someone at some point is going to have to take the brave decision to go ahead with it.”

Some of the researchers involved believe they may be ready to make the leap in three to five years – if everything goes to plan, something which is by no means certain.

There was vigorous discussion at the HFEA Open Meeting, where the advice to ministers was agreed, around issues of identification. In sperm and egg donation the donor is identified.

The meeting agreed to advise ministers that there should be no right for the child to know the identity of the donor, however, the HFEA will tell ministers that public opinion was mixed.

Mr Hossam Abdalla, clinical director of the Lister Fertility Clinic in London, told the meeting: “If a child wants to know about that, why are we so restrictive… why are we telling them we they can’t have this access?”

‘Astounded’

Prof Lisa Jardine, chairwoman of the HFEA, said the UK was in one of the most advanced positions in the world.

“Other countries are astounded that we’re this far on in the discussions,” she said.

However, she pointed out the techniques would be used only for mitochondrial disorders: “This is not a Rubicon or a slippery slope.”

One of the pioneers of the field, Prof Doug Turnbull, from Newcastle University, said: “The techniques we are working on could help hundreds of women have healthy children.”

He said more research was required, but it was now “crucial” that the government approved the techniques in the UK.

The Department of Health said mitochondrial diseases could have a “devastating impact” on families and it would consider the HFEA’s advice.

Making three-person IVF legal would not require a new act of Parliament, but would require a vote in both the Commons and the Lords.

Speaking after the meeting Dr David King, the director of Human Genetics Alert, said: “Historians of the future will point to this as the moment when technocrats crossed the crucial line, the decision that led inexorably to the disaster of genetically engineered babies and consumer eugenics.

“This was the moment at which they casually tossed the bioethical consensus of the last 30 years into the trash. And for what?

“Not so mothers could avoid having sick babies, because they could do that already, through egg donation. It was so that a few dozen mothers who insisted they must be genetically related to their child could be satisfied.”

Source:BBC