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Philippa Taylor

Why do Government and fertility organisations show no interest in the health of egg donors?

Philippa Taylor is Head of Public Policy at CMF. She has an MA in Bioethics from St Mary’s University College and a background in policy work on bioethics and family issues.


The views expressed do not necessarily reflect those of CMF.

 

Ostrich

The pressure to harvest women’s eggs is not only increasing, it is also taking different directions. No longer just for reproductive purposes, women’s eggs are urgently needed for research and for treatment, most recently for germline therapies (to create three parent babies).

However it is not easy to obtain large numbers of eggs. The need for more eggs for research drove previous attempts to create animal-human hybrids (‘cybrids’) was but that’s now a dead end of research. So more sources are needed and thus there is a renewed campaign to buy eggs from young healthy women, for £500 a time, for research purposes.

However egg donation, for whatever purpose, carries real health risks to women (see here), yet the Government, despite being warned of risks to women’s health, is taking no responsibility to protect, inform or follow up women:

  • Egg donors are not tracked over their lifetimes, so we have no idea what any of the long-term effects on young women’s health are;
  • No major peer-reviewed studies have been done on the long-term effects of super ovulation on this donor population;
  • The possible link between fertility drugs and uterine cancer (see here also) remains controversial, and needs much more research;
  • The Government, fertility clinics and Human Fertilisation and Embryology Authority (HFEA) have no clear idea of how many women suffer ovarian hyperstimulation syndrome (OHSS), or any other adverse effects, after egg donation.

The Government cannot claim there is no need to sort this out. In 2013 an independent review of the HFEA, The McCracken Review, was presented to the Government. McCracken told the Government that:

‘…where there are well known side effects of ART techniques, such as ovarian hyperstimulation syndrome (OHSS), the HFEA should make sure that appropriate standards in managing them are being adopted across the sector.’ (emphasis added)

McCracken says that responsibility lies with both Government and the HFEA. The HFEA does collect a few statistics. For example, an HFEA report revealed that just under half of 864 reported clinical incidents between 2010-2012 were due to OHSS. And: ‘Each year approximately 60 instances ofsevere OHSS and 150 cases of moderate OHSS are reported to the HFEA.’  This PQin June 2014 states the same.

210 cases per year of ‘moderate’ to ‘severe’ cases of OHSS – approximately – is not an insignificant number, to just be brushed under the carpet. ‘Severe cases of OHSS are treated as incidents. The HFEA expects an incident report from a clinic whenever the clinic is made aware of a severe case of OHSS resulting in prolonged hospitalisation or death.’ (emphasis added).

The problem is, fertility clinics are only required to report instances of OHSS to the HFEA that require a hospital admission with a ‘severe’ grading, although in practice clinics may voluntarily report ‘moderate’ OHSS as well. Yet according to HFEA grading, even ‘moderate’ IVF incidents cover ‘semi-permanent harm’ to an individual, and have potential for litigation. But it seems that the HFEA does not regard any ‘moderate’ OHSS incidents as worthy of reporting to the Medicines and Healthcare products Regulatory Agency (MHRA).

By July 2014, the Government admitted that it actually has no definitive data on the number of women who have been hospitalised for OHSS after egg donation ie. the most severe cases (let alone any data on the less severe cases!).

Again, in February this year, the Government admitted that the HFEA holds no data either:

The HFEA has also advised that it does not hold information on ovarian hyperstimulation syndrome (OHSS) that would allow it to undertake an analysis of the incidence of hospitalisation due to OHSS’

One might hope that this would cause some concern to Ministers and the HFEA.

Yet there are no plans to do anything more:

The [HFEA] strategy does not expressly set out the actions it proposes to take as regards OHSS.’

Instead the HFEA apparently has: ‘an information sharing agreement with the Medicines and Healthcare products Regulatory Agency’ and so ‘any concerns identified by the HFEA are discussed and necessary action is taken by the respective body.’

The same claim was repeated last month by Public Health Minster Jane Ellison MP:

‘… responsibility for reporting adverse reactions in accordance with the Human Medicines Regulations 2012 rests with clinics and the treating clinician. Should the HFEA be made aware of information relevant to the regulatory functions of the Medicines and Healthcare products Regulatory Agency, this information would be shared between the two organisations.

Therefore we would presumably expect information sharing between the two, as claimed.

But Earl Howe admitted last month: ‘The HFEA has advised that it has not reported any adverse incidents due to ovarian hyperstimulation syndrome to the Medicines and Healthcare products Regulatory Agency in any year since 1991’.

This answer is pretty damning. The Government has passed the buck to the HFEA, which in turn has effectively passed the buck to the MHRA, which in turn has denied any knowledge or contact from the HFEA!

So, reporting of OHSS is mainly voluntary, and the data therefore is unreliable. Yet no body in the UK has, or is planning to, do the studies and the research that are needed to inform and protect women.  There is a complete refusal to collect data on (and track) donors, to find out how many women have been affected, and will be in the future.

Yet if we had been recording, monitoring and tracking young women who have donated their eggs (for treatment or research) over the past three decades, we would have a better understanding of what type of risks are most prevalent, and for which kinds of women.

Why such a lack of interest and concern?

An article in the BMJ warned that adverse outcomes from egg donation, such as OHSS, may arise from a reluctance to abandon cycles because of financial payment structures, lack of appropriate cycle monitoring, and competition within the HFEA’s ‘league table.’ In other words: ‘…market pressures can conflict with best and safest practice.’

What should the Government and the HFEA be doing?

  • Collect detailed information on drugs and dosages used in treating each woman;
  • Clinics to report all incidences related to ART and egg donation, from mild to severe;
  • OHSS to become notifiable
  • Publication of all data on egg donation, including numbers and purpose of donation;
  • Long-term tracking of women who provide eggs for fertility treatment or research;
  • Record linkage of women who provide eggs, between HFEA and other health services (IVF associated maternal deaths may be underestimates, because record linkage is not currently allowed);
  • HFEA to report adverse incidents due to OHSS to the MHRA (rather than promising but utterly failing to do so);
  • Review of the long-term effects of super ovulation on egg donors and risk factors for treatment for infertility;
  • The BMJ states that ‘More stringent attention to stimulation regimens, preconceptual care, and pregnancy management is needed’ so that maternal death and severe morbidity do not worsen further.

Fertility expert, Prof Geeta Nargund, has expressed very similar concerns and has issued a strong call to action with useful recommendations to Government.

If women want to know about the research and risks of egg donation before they decide to donate their eggs to others, or for research (ie. for money), but come up with nothing adverse in the research literature, they will believe it is a completely safe procedure.

The producer of Eggsploitation, Jennifer Lahl, simply asks: ‘When will the necessary research be done so that we can know the risks of egg donation, and, more importantly, so young women will know too?’

It’s time some body took some responsibility because (as I say above) they have been warned!

 

Posted by Philippa Taylor
CMF Head of Public Policy

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