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. Why would anyone choose to take it, and why would it be prescribed? Surely, it's akin to prescribing alcohol.
I later discovered that the risk of birth defects was actually 25 to 50 times higher than the background risk. The women who were informed were told that the risk was 1-2%. Why wouldn't you want to explain that to a patient, whether they are pregnant or planning a pregnancy?
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. What we lacked was the absolute risk, not the relative risk, which is the risk in comparison to the baseline. 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 to their codes of practice. However, doctors' organizations consistently assured them that they would manage the information given to patients, after all they understood their patients needs. It's now become clear that they did not convey the risks in a way that was relatable to 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. 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 of wider health systems.
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 pediatrician recommended switching to a different medication, which I have been using ever since, resulting in only two seizures over 20 years. This harm was completely avoidable.
Despite government reviews and an options paper on 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 attitude continues as doctors argue that men already taking Valproate should not be provided with the full checks that women get.