Urgent: 48 hours left to respond to the HFEA consultation on mitochondrial disease

In The Geek Manifesto, I point out that it’s important for those of us who care about and appreciate science to respond to public consultations, so that our views can be heard and taken into account.

There are just 48 hours left to respond to rather a significant one.

The Human Fertilisation and Embryology Authority is currently consulting over whether new IVF techniques for preventing a group of severe disorders known as mitochondrial diseases should be permitted for clinical use. These involve replacing defective mitochondria — the “power plants” of the cell — in eggs or embryos, so that any children born as a result are free from the disease.

Here’s a great feature explaining the work, the diseases, and their impact on families.

I think it’s important that this should be permitted (disclosure: I work for the Wellcome Trust, which funds this research).

My response to the consultation is here. Please submit yours — the consultation closes on Friday.

HFEA Consultation: Medical Frontiers

HFEA

Name of participant: Mr Mark Henderson
These are the recorded submissions for Session 1. Only sections to which responses have been recorded are listed below.

Permissibility of new techniques

Q1: Having read the information on this website about the two mitochondria replacement techniques – maternal spindle transfer and pro-nuclear transfer, what are your views on offering (one or both of) these techniques to people at risk of passing on mitochondrial disease to their child? You may wish to address the two techniques separately.
Your response:
Both techniques are ethical and should be approved for clinical use, subject to award of relevant licences. As we do not currently know which of the two techniques is likely to be safer or more effective, it would be foolish to favour one over the other at this point. Comparisons between the two techniques can be expected to yield useful scientific and clinical information that could ultimately benefit patients. It is also possible that one technique may be suitable for some patients, and the other for others. It would thus be very unwise to throw one out.

The Nuffield Council on Bioethics noted that there were no good ethical reasons for preferring one technique over the other. I concur with this view.
Changing the germ line

Q2: Do you think there are social and ethical implications to changing the germ line in the way the techniques do? If so, what are they?
Your response:
I do not consider that altering the germline in this way raises significant ethical or social concerns. Indeed, altering the germline so that disease is not passed to future generations is a positive benefit of these technologies, and makes them more ethically acceptable, not less.

It is worth remembering that these techniques alter only the mitochondrial genome, and not the nuclear genome. Approval would thus set no precedent for manipulation of the nuclear genome in germline fashion, which may raise different ethical questions.

The benefits of this technology clearly outweigh any risks that are posed by germline manipulation. This is because the alternative is the near-certainty that abnormal mitochondrial DNA that causes severe disease will be passed on through the germline.

There need be no slippery slope here. It is perfectly possible for society to decide that a germline manipulation may be appropriate for one purpose, such as preventing mitochondrial disease, and not for another, such as altering characteristics such as eye colour.
Implications for identity

Q3: Considering the possible impact of mitochondria replacement on a person’s sense of identity, do you think there are social and ethical implications? If so, what are they?
Your response:
I think it highly unlikely that mitochondrial replacement will significantly impact anybody’s sense of identity. It is already established that many people can contribute to a child’s genetic, gestational or social parentage, through techniques such as gamete donation, surrogacy and adoption. In many of these instances, a third party to the social parents makes a much greater biological contribution to that individual than would be the case with mitochondrial donation.

If we think it acceptable that a person can be conceived using donated eggs or sperm that contribute half of their DNA, we should also accept donations of the tiny proportion of DNA contained in the mitochondria.
The status of the mitochondria donor

Q4 (a) In your view how does the donation of mitochondria compare to existing types of donation? Please specify what you think this means for the status of a mitochondria donor.
Your response:
Please see my response to question 3. I think this technique raises fewer issues than gamete donation, which I consider wholly acceptable.

Q4 (b): Thinking about your response to 4 (a), what information about the mitochondria donor do you think a child should have? (Choose one response only)
Your response:
Option3
Please explain your choice
Your response:
I do not have a strong view. I think it likely that in practice, most mitochondrial donors are likely to be known to patient families.
Regulation of mitochondria replacement

Q5: If the law changed to allow mitochondria replacement to take place in a specialist clinic regulated by the HFEA, how should decisions be made on who can access this treatment? (Choose one response only)
Your response:
Option1
Please explain your choice
Your response:
The most appropriate people to decide whether these techniques are ethically appropriate for individual families are those families themselves: they are the ones who are best placed to understand the impact of mitochondrial disease. They should he advised by clinicians, who can judge whether these techniques are technically appropriate in particular cases.

The role of parliament is to set the general direction of travel, then it is for the regulator to decide whether the techniques are safe and effective enough to be tried in patients. Clinical decisions should then be taken by patients and doctors.
Should the law be changed?

Q6: In Question 1, we asked for your views on the mitochondria replacement techniques MST and PNT. Please could you now tell us if you think the law should be changed to allow (one or both of) these techniques to be made available to people who are at risk of passing on mitochondrial disease to their child?
Your response:
The 2008 HFE Act provides for regulations to be passed to permit clinical use of these techniques. These regulations should be passed without delay to enable clinical use, subject to licensing by the HFEA or its successor.

It is important that the law is changed before research shows safety and effectiveness, so that this research can proceed in parallel with the legal processes required. Waiting for this evidence to be available would lead to significant delays before patient can be treated. The law should permit clinical use in principle, and leave the HFEA to decide whether there is sufficient safety and effectiveness data to warrant awarding licences.

About markgfh

Mark Henderson is Head of Communications at the Wellcome Trust, a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health by supporting the brightest minds in biomedical research and the medical humanities. The Geek Manifesto contains his personal views, not those of the Wellcome Trust. Before joining the Trust in January 2012, Mark was Science Editor of The Times, where he built a reputation as one of Britain's foremost science journalists and commentators. Mark's first book, 50 Genetics Ideas You Really Need to Know, was published in 2009 by Quercus
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