The Mixed Legacy of the UK’s Departing Fertility Regulator
Posted by Jessica Cussins November 20, 2013
Biopolitical Times
Lisa Jardine, the chair of the Human Fertilisation and Embryology Authority (HFEA), has announced that she will be stepping down from her position as head of the United Kingdom’s regulatory agency for assisted reproduction in January 2014. Since the announcement, she has been vocal about a number of important points.
In an interview with The Independent, Jardine argued that some IVF clinics have been over-using intracytoplasmic sperm injection (ICSI), a technique involving the insertion of sperm into eggs with micro-manipulation devices. She points out that although ICSI makes in vitro fertilization procedurally easier, it has limited utility and carries documented risks to resulting children.
In a commentary she wrote for the BBC, Jardine also warned that IVF still has a very high failure rate. “The world of IVF is a market, a market in hope,” she said. “Those who enter it deserve to be fully informed of its potential to deliver grief and a sense of failure, as well as success.”
However, for some reason, Jardine seems to be actively propagating highly dubious hope around extremely controversial and unverified mitochondrial replacement techniques. These would create an embryo through a biologically radical process that would combine genetic material from three people. The procedure has received extensive regulatory guidance from the HFEA. If the UK decides to carve out an exception to an existing law in order to allow clinical trials of mitochondrial replacement, it would become the first approved form of inheritable human genetic modification anywhere in the world.
While many people are alarmed and disturbed by that prospect, Jardine seems proud of her personal involvement with the issue. In a short press statement on her departure, she noted,
The trouble is that there are many reasons to believe that mitochondria replacement poses profound safety, social and ethical concerns, and there are a growing number of people, from scientists, to activists, to politicians, who have spoken up about them. But for some reason, Jardine has been extremely reluctant to accept these varied and widespread critiques. In an article she wrote for the BBC, she stated,
We weren’t the only ones who noticed the discrepancy between the consultation’s data and what the HFEA reported to the public. But the HFEA responded defensively to the claim that they misrepresented their data, saying, “Our consultation was a more nuanced exercise than simply counting up votes for and against the techniques.”
I’m not sure what “nuanced” could mean other than that they seem to have considered the voices that agreed with them and disregarded the rest. I truly don’t understand why Jardine is comfortable saying that “the public supported the new technique.” At best, this is an over-simplification of an extremely socially and historically important moment. At worst, it is an example of exactly what she has decried: pandering to the market of hope, at the expense of desperate patients.
Previously on Biopolitical Times:
In an interview with The Independent, Jardine argued that some IVF clinics have been over-using intracytoplasmic sperm injection (ICSI), a technique involving the insertion of sperm into eggs with micro-manipulation devices. She points out that although ICSI makes in vitro fertilization procedurally easier, it has limited utility and carries documented risks to resulting children.
In a commentary she wrote for the BBC, Jardine also warned that IVF still has a very high failure rate. “The world of IVF is a market, a market in hope,” she said. “Those who enter it deserve to be fully informed of its potential to deliver grief and a sense of failure, as well as success.”
However, for some reason, Jardine seems to be actively propagating highly dubious hope around extremely controversial and unverified mitochondrial replacement techniques. These would create an embryo through a biologically radical process that would combine genetic material from three people. The procedure has received extensive regulatory guidance from the HFEA. If the UK decides to carve out an exception to an existing law in order to allow clinical trials of mitochondrial replacement, it would become the first approved form of inheritable human genetic modification anywhere in the world.
While many people are alarmed and disturbed by that prospect, Jardine seems proud of her personal involvement with the issue. In a short press statement on her departure, she noted,
I am particularly honoured to have overseen the ‘Medical Frontiers: debating mitochondria replacement’ public consultation. It clearly demonstrated the specialised ability the HFEA has to engage, educate and communicate complex science and public opinion.And, according to The Independent,
Jardine is disappointed she will not be able to see through the HFEA’s consultation on mitochondrial replacement – the so-called “three-parent” IVF babies who will receive their mitochondrial DNA from a donor egg.Jardine apparently sees her work on this technique as a high point of her six years at the HFEA. Under her guidance, the HFEA certainly has played a critical role in advancing the potential change to UK law that could allow scientists to attempt human clinical trials as early as next year.
The trouble is that there are many reasons to believe that mitochondria replacement poses profound safety, social and ethical concerns, and there are a growing number of people, from scientists, to activists, to politicians, who have spoken up about them. But for some reason, Jardine has been extremely reluctant to accept these varied and widespread critiques. In an article she wrote for the BBC, she stated,
Over the past two years, the HFEA has carried out a consultation process with clinicians, scientists and the public in order to advise the present government on whether this technique - which has up to now only been allowed in the research laboratory - should be introduced into clinical practice. Perhaps surprisingly, the public supported the new technique, if it could prevent serious illness. They had little objection to its being approved for clinical use, as long as it was scrupulously overseen by an appropriate regulatory body.Pete Shanks and I wrote a blog about the HFEA’s claim of "public support" shortly after its report came out. We were surprised to read – in the agency’s own report –that in what was by far the largest strand of the public consultation, and the only one open to everyone, the majority of people were against the introduction of any form of this technique, for a broad array of reasons.
We weren’t the only ones who noticed the discrepancy between the consultation’s data and what the HFEA reported to the public. But the HFEA responded defensively to the claim that they misrepresented their data, saying, “Our consultation was a more nuanced exercise than simply counting up votes for and against the techniques.”
I’m not sure what “nuanced” could mean other than that they seem to have considered the voices that agreed with them and disregarded the rest. I truly don’t understand why Jardine is comfortable saying that “the public supported the new technique.” At best, this is an over-simplification of an extremely socially and historically important moment. At worst, it is an example of exactly what she has decried: pandering to the market of hope, at the expense of desperate patients.
Previously on Biopolitical Times:
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