The Human Fertilisation and Embryology Authority (HFEA) was set up to monitor and regulate the UK's £500million IVF industry. The HFE Act enjoins the HFEA to take into account the welfare of children before providing IVF treatment, but not specifically the welfare of women undergoing treatment.
As a result no-one is monitoring the drugs (type or dosage) given to women during IVF treatment or the effects of the same despite the fact that one of the main health risks to women is OHSS (Ovarian Hyperstimulation Syndrome) a condition which can lead to emergency hospital admission and which is linked to the use of stimulatory drugs given during treatment. Despite OHSS being a potentially life threatening condition, clinics only need report cases on a voluntary basis, meaning we have little indication of how many women develop this serious complication.
This glaring omission in the HFE Act is one that Siobhain McDonagh MP (Mitcham and Morden), last week took to the Health Minister in a Parliamentary debate on the need to consider the safety of women in IVF. In raising this issue with Parliament, Siobhain made four key calls to action:
•An explicit commitment to the protection of the welfare of women being added to the HFE Act 1990,
•A request for the HFEA to start collecting information about all drugs, dosages and off-label drugs administered to women during IVF treatment and early pregnancy
•That the HFEA should introduce licence condition expressly focused on reducing the incidence of OHSS
•Finally, the HFE Act should be amended to link the HFEA registry with hospital, cancer and death registries, to enable accurate recording and publication of the links between IVF treatment and incidence of severe OHSS, cancer and mortality among women.
Such measures are by no means radical and indeed exist already across Europe, the United States and Australia and have the potential to save lives and reduce the strain on the NHS by ensuring that each and every clinic holds a clear and direct responsibility to protect the health and welfare of women undergoing IVF treatment. Following Siobhain's speech, the Health Minister responded. Unfortunately, most of her rebuttals were incorrect and do not conform with advances in practice.
Separating fact from fiction
One of the most striking inaccuracies was her response that OHSS cannot be predicted, and is not in fact determined by drug dosage levels. There are ultrasound (Antral Follicle Count) and hormonal (Anti Mullerian Hormone) markers that can be performed prior to IVF treatment to identify those who are at the highest risk of over-response and OHSS and allow the adjustment of the stimulating dose. The Minister's claim that "that drug dosage levels do not determine the risk to individual women of OHSS" is also incorrect as most women undergoing IVF treatment, and nearly all women undergoing NHS-funded treatment, have either normal or high egg reserve. In these women the stimulating drug dosage can be adjusted to reduce the risk of OHSS. It is only in minority of women who are either older or have low egg reserve where high dosage does not lead to OHSS.
The Minister noted that "only" 0.33% of cycles out of 60,000 annually carried out in the UK result in serious incidents - suggesting that such figures are not worthy of action. Yet I would argue that up to 200 women suffering serious clinical incidents cannot be regarded as negligible. Severe OHSS can be prevented with a short-acting analogue trigger during treatment in modern IVF practice. Siobhain also highlighted the gross under-reporting of moderate to severe OHSS, which meant that the figure given by the Minister is highly unreliable. Evidence for this can be calculated from HFEA's own database by the number of women who had more than 20 eggs collected which is a strong predictor of the risk of severe OHSS and admission to hospital. For example, over the first half of 2013 there were 1764 IVF cycles where there were more than twenty eggs collected but only forty-six cases of severe OHSS were reported which is an unrealistically low figure. Therefore currently, it is impossible to know the true incidence, and only a linkage to hospital registries would provide the true picture.
A number of additional concerns raised by Siobhain as yet remain unanswered. These include the use of "off label" intravenous immunology drugs, which are potentially harmful and of no proven benefit, and also come with a health warning from the Royal College of Obstetricians and Gynaecologists. There was also no response from the Minister to either the call for collection of information regarding drugs given to women during IVF treatment and early pregnancy, or for the establishment of linkages between the HFEA database and NHS registries for hospital admission, cancer and mortality.
What next?
The HFE Act has to be updated to protect the safety and welfare of women. Currently the HFEA lacks the legal framework to undertake its role fully. As the Health Minister rightly notes "within its statutory and regulatory remit, the HFEA is taking proportionate action". The point is, its statutory and regulatory remit must be broadened.
I remain hopeful that the Health Minister will listen to Siobhain's compelling argument. Otherwise the Government is ultimately condoning a system in which the health of women is put at risk. For too long the IVF industry has escaped proper monitoring and regulation when it comes to drug administration to women during IVF treatment. If nothing is done, it could be construed as putting profit before the safety of women. It is time for us all to speak up to support Siobhain in her campaign.