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  • Writer's pictureSusan Valproate Victims

DNA Matters

Updated: Feb 1

In my 20 plus years of work on valproate as the mother of a person affected and campaigner I could say that I’ve got the subject just about sewn up, with 28 themes and counting, but imagine my surprise when in recent months I heard from Sanofi via MHRA that valproate is not just teratogenic but genotoxic.

I’d heard stuff about this from other campaigners but for many years I’ve been inundated with conspiracy theories about MHRA and big pharma that make me over-cautious of listening to theories (apologies to all the campaigners I doubted). As this topic also involved gene science, with only an O level general science to my name I didn’t go there. Although I have a folder on it, it’s not been looked at in detail.

But lo and behold, the doubters were right and the drug alters DNA and has been doing this always. A very decisive study came out in 2005. Upon this discovery, what did Sanofi do? Quickly rush to recall a drug that could be harmful for generations to come? No, they found a way to repurpose it for use as an adjunct to cancer treatment. It’s unclear which came first, the repurposing or the side-effect, but as valproate is in a league of its own, with extremely high rates of teratogenicity, you’d think that alarm bells would have rung. It was named a ‘wonder-drug’ when it came out, mainly because it wasn’t known exactly how it worked.

So in December 2022 (note - not December 2005) new guidelines from MHRA, EMA and ChM, advised that men should be warned of the risk to their ‘reproductive health’ - an increase (potentially of 47% if the studies aren’t reevaluated differently) of autism in their offspring. This is huge, yet the great and the good doctors associations seem not so keen to warn their male patients. They set up the Epilepsy Coalition, a group made up mostly of organisations representing prescribers or those interested in preventing seizures, yet all reasonable people with good intentions who I’ve met or worked with along the way.

A quick glance at SUDEP Action - the lead contact in the coalition - explains more. About Us page shows us that all their experts are neurologists, psychiatrists and GPs - prescribers. Their Trustees are sufferers, those who have sadly lost loved ones to epilepsy and woking with Epilepsy Bereaved.

There is no representation on the coalition of the people at the other end of the spectrum, those who had been prescribed a harmful medicine without knowing the impact of the teratogenic effects. The women who would have avoided pregnancy altogether had they known the risks. Now this isn’t some kind of FOMO, we often get pushed out of the room as there’s ‘not enough space’, or because it’s not appropriate and that’s fine.

Ironically their ten-page complaint to MHRA was largely about engagement. Medicines and Healthcare products Regulatory Agency does what it says on the tin - regulates medicines, not doctors and it’s up to doctors organisations to regulate their own members and the way in which they prescribe medicines.

Annex D11 of the Framework Agreement between DHSC and MHRA clarifies their role Framework Agreement between the Department of Health and the Medicines and Healthcare

Healthcare professionals D11 The Agency provides information to different healthcare professional specialties to assist them in the safe use of medicines and medical devices and relies on healthcare professionals to report, and encourage reporting of, suspected reactions to medicines and devices. The Agency consults healthcare professionals’ representative organisations on changes to policies that affect their members

Although MHRA hasn’t got the best track record of monitoring medicines they have been the only organisation to get the victims, including a severely autistic boy, around the table with the heads of these medical organisations. I don’t like to pick apart a powerful coalition expressing heartfelt concerns. But it's been a divisive approach rather than what could easily be a collaborative and inclusive working partnership.

The area of valproate prescribing is messy and complex and restrictions have been 40 years too late. Prescribers need to show that they can act quickly now, in the best interests of patients, especially when there’s a high risk presented by the very organisation producing the drug and could be put at a financial disadvantage. Although I’d agree that the guidelines (to ensure that men are informed of the risks by two medical professionals if starting a first prescription) were rushed, they were announced in December 2022 and it’s now July 2023.

Their justification to stall the information is largely that people may take their lives in their own hands and stop taking their medicines rather than wear a condom. This is fundamentally a paternalistic approach and not transparent and exactly the reason women were shielded from being able to make their own informed choices for 40 years. Every day a child will be born with their fathers having been left uninformed of the risks involved and that’s surely the situation we need to avoid.

Link to the epilepsy coalition statement

Data currently available

2005 Article in ‘Carcinogenesis’

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