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again concluded that there was still nothing to indicate that
the techniques were unsafe. The group also recommended
long-term follow-up monitoring of any children born as a
result of the use of these techniques in treatment.
The panel of experts’ report concluded that there was
no evidence that mitochondria replacement therapy was
unsafe. It stopped short of expressing certainty that the
new procedures were safe, as we might expect from a
group of responsible scientists. Although in the short
run this allowed the tabloid press to exaggerate the risks
associated with the therapy, in the long run the scrupulous
care with which the panel assessed a wide range of data
and evidence helped build trust in the community at
large. This was helped by the fact that the panel Chairs
(Professor Neva Haites and Dr Andy Greenfield) were
extremely effective communicators.
In its own statement, the HFEA said:
“The panel of experts convened by the HFEA to
examine the safety and efficacy of mitochondria
replacement carefully considered the interaction between
nuclear and mitochondrial DNA and concluded that
the evidence did not show cause for concern … As in
every area of medicine, moving from research into clinical
practice always involves a degree of uncertainty. Experts
should be satisfied that the results of further safety checks
are reassuring and long term follow-up studies are crucial.
Even then patients will need to carefully weigh up the risk
and benefits for them.”
Here, once again, the HFEA scrupulously underlined
the uncertainty that is part and parcel of scientific inquiry,
while capturing the overall confidence, based on substantial
amounts of data, that the panel expressed in the safety of
mitochondria replacement, subject to regular checks and
follow-up studies.
Dr Andy Greenfield, chair of the final reconvening of
the panel of experts, said: “The scientific questions that
we examined and the research that we examined — and
it was voluminous — will never answer all of the critical
questions. And, of course it won’t answer the fundamental
question, which is are these techniques safe and efficacious
in humans.”
Building a solid platform
Meanwhile, in January 2012, the Secretary of State for
Health and the Secretary of State for Business, Innovation
and Skills asked the HFEA, with the support of the
Sciencewise Expert Resource Centre, to carry out public
dialogue work on the ethics and public attitudes towards
mitochondria replacement. This work was conducted
between July and December 2012. It involved multiple
strategies and modes of analysis, in order to include as
wide a range of respondents as possible.
The public consultation consisted of five strands:
1. Deliberative workshops (held in Newcastle, Cardiff and
London). These met twice in each location. Participants
were recruited to represent a broad spectrum of age,
gender, socio-economic status and family circumstances.
Taken together, the expert
and public consultations
provided a solid platform
on which to build
the HFEA’s advice to
ministers.
Thirty people were recruited for each location. The
aim of this strand of the consultation was to explore
public attitudes in-depth, and to understand participant
viewpoints as they become increasingly engaged with,
and knowledgeable about, mitochondrial disease and
mitochondria replacement techniques.
2. Public representative survey. Just under 1,000 face-toface
interviews were carried out with members of the
public across 175 random locations. For each location,
demographic quotas were set to ensure the sample was
representative. The aim of the survey was to benchmark
public opinion on: general attitudes towards medical
research and genetic treatments; awareness of IVF and
mitochondrial disease; views on the genetic treatment of
mitochondrial disease; and attitudes to the regulation of
genetic treatments.
3. Open consultation meetings. Two public meetings
were held in November 2012, the first in London (53
attendees) and the second in Manchester (39 attendees).
The meetings were open to anyone wishing to attend
and were advertised on the HFEA consultation website,
through HFEA networks, and promoted to stakeholders
and the public in a number of ways. At each meeting, a
panel of speakers shared their knowledge and views with
audience members. Panellists were selected to reflect a
range of different perspectives and areas of expertise, and
to provoke discussion amongst participants.
4. Patient focus group. One focus group was held with six
participants. The aim of the focus group was to create a
forum where people effected by mitochondrial disease,
either directly or indirectly, could give their in-depth views
on mitochondria replacement techniques.
5. Open consultation questionnaire. A public consultation
was held between September and December 2012.
Respondents were invited to consider a range of
information presented on the consultation website,
and to respond to seven questions using the online
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