Fifty Times

Since my daughter's diagnosis of fetal Valproate syndrome, I've been determined to understand how a harmful congenital syndrome could be caused by a drug, especially when the drug's name is clearly associated with the condition. As a word enthusiast, this contradiction is striking. It seems inconsistent with the medical principle of "first, do no harm," and the idea of medicine as beneficial, not associated with harm. Why would anyone choose to take it and why would it be prescribed?

I later discovered that the risk of spina bifida was actually 25 to 50 times higher than the background risk which was 0.04% in the 1980s. The women who were informed were told that the risk was 1-2%. Why wouldn't you want to explain that to women, particularly with the knowledge that around 50% of pregnancies are unplanned? Particularly when considering that the discovery of a serious skeletal defect may result in a termination which in itself could case serious harm to the mother?

In scientific research, risks are typically conveyed using a standard protocol—when the figures are below 1%, they are expressed as X in 10,000. We were given the absolute risk - 1-2%, not the relative risk. I think this is where issues arose and communication became unclear.

The First Do No Harm Report indicates that after the drug's release, the pharmaceutical company and medicine regulators shared information through standard channels, adhering, in the main, to their codes of practice. However the early historical evidence shows that doctors' organisations consistently assured them that they would manage the information given to patients, as they understood their patients needs when prescribing. It was understandable that in these complex areas, risks and benefits to each individual needed to be weighed up by consultants.

It's now become clear that they did not convey the risks in a way that was understood by women; they merely reiterated the basic statistics found in the leaflets and other information provided by the regulators without any context or comparisons. This does not mean to say that industry and regulators should not have done more, this is the pattern that can be seen in the IMMDS Review evidence. Neurologists were normally those who led prescriptions for epilepsy and bipolar, as it needs the training of a specialist and medical bodies took the lead in guidance to their members and their guidance was crucial.  They regularly hold conferences and discuss research on medicines and that's a necessary part the wider public health processes.

None of my members with an affected child or pregnancy has claimed it was worth the risk, and none would have taken the risk if they had fully understood its true extent. I am among those women. Right after the diagnosis, my daughter's paediatrician recommended switching to a different medication, which I have been using ever since, resulting in only two seizures over 20 years. The harm was completely avoidable.

Despite government reviews and the Hughes Report on Options for Redress, the narrative has been that it's not really anyone's fault.  It's complicated.  “We didn't know” is the classic response.  Well I argue that everyone who has a medical degree knew the seriousness of the figures and the women affected were not told in plain English what the risks were because they didn't want to worry them and they'd stop taking their meds and have a seizure.  That paternalistic and potentially sexist and disablist attitude continues as doctors argue that men already taking Valproate should not be provided with the full checks that women get.

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