Times Investigation: for 40 years it's been known one drug causes disabilities when given to pregnant women

[PurgatoryOfPotholes]

www.thetimes.co.uk/article/5fcdfb18-bd72-11ec-b03a-035ba70491ca?shareToken=25fdb16d7cd8a8182562f2b6f9b01cb4

A scandal worse than thalidomide

Doctors knew in 1973 that the epilepsy drug sodium valproate posed a risk to unborn children — and ordered that warnings be removed from packets. Almost 50 years and 20,000 disabled babies later, it is still being prescribed to pregnant women

When sodium valproate was introduced as a new epilepsy drug in the 1970s, the British medical community was still reeling from that very scandal — in which hundreds of babies were born severely deformed after pregnant women were given thalidomide.

The UK’s newly formed Committee on Safety of Medicines had been designated as the key decision-making body on new medicines.

This committee — whose membership comprised some of the UK’s leading medics and was chaired by Sir Eric Scowen, professor of medicine at St Bartholomew’s Hospital in London — met to discuss sodium valproate on multiple occasions in 1972 and 1973.

They noted that the drug had shown enormous promise in controlling the terrible seizures suffered by patients, even for those whose epilepsy had proven resistant to other treatments.

Sodium valproate is still a safe and effective drug for sufferers of epilepsy, who should not stop taking it without first discussing this with their doctor.

However, the notes of the meeting show that the manufacturers, Sanofi, had raised to the committee that there were signs in animal tests that valproate could potentially be teratogenic — harmful to foetuses.

The committee concluded that the use of anti-seizure drugs such as sodium valproate was indeed “liable to produce” abnormalities. But they stated that “the risk appears to be low, and not sufficient to justify stopping the use” of the drug.

In a decision that would have disastrous consequences for thousands of families, the committee chose not to alert the public to the concerns that the drug could harm babies — concluding that since the evidence was not clear, doing so would risk causing “fruitless anxiety” to patients.

They specified that warnings should be provided to doctors, “but not on package inserts, so that there would be no danger of patients themselves seeing it”.

The committee’s decision not to warn women of the risks was probably “influenced by the paternalistic nature of society at the time”, believes Dr Rebecca Bromley, a paediatric neuropsychologist at the University of Manchester.

She believes the committee did not appear to consider the need for “women to have an informed say in their treatment”. Instead, the effect of the decision was to “leave patients fully in the dark about the risk that their medicine might carry”.

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As a result, about six babies every month are being born in the UK having been exposed to the drug.

An investigation by The Sunday Times has found that the drug is still being handed out to women in plain packets with the information leaflets missing, or with stickers over the warnings.

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www.thetimes.co.uk/article/5fcdfb18-bd72-11ec-b03a-035ba70491ca?shareToken=25fdb16d7cd8a8182562f2b6f9b01cb4

You need to read the full thing to fully grasp the scale of this.

Charmatt Thank you for explaining the failures so clearly. It is outrageous that they have not made financial redress. They could do it with the stroke of a pen and you deserve the peace of mind that it would give you.

The guidance has changed but only in the last few years. I had my first seizure at 14 (it's common for women to develop epilepsy in puberty) and it was the first and only drug they prescribed at the time. It's incredibly effective at controlling seizures and as a mood stabilizer and compared to most neurological medications, it's very cheap so it became the drug of choice. Once on it, consultants seem very reluctant to take people off it. We had a real fight to transition my son to another drug and it wouldn't have happened without my GP fighting with us.

Women who medication through to the foetus will pass it through to every child they carry, so that's why they changed my medication. I tried 2 others which weren't suitable before I was successful with my current medication, which costs a lot more than Sodium Valproate.

The side effects are significant - hair loss, weight gain, PCOS, immense tiredness (I didn't realise that I had been so tired until I came off it) and liver damage. The newer drugs tend to have fewer side effects so the cost justifies that because ultimately, the NHS doesn't end up paying for problems caused.

I am so proud of what he has managed to achieve and he is a lovely person - old ladies love him - but the damage done and the lost potential will affect him forever and he, and the other children affected, don't deserve that!

It truely is a scandal!

Thank you to all of you who understand the implications of this on the children and families affected. If we were donors to the Tory party, or had friends in high places, etc, the redress would have been agreed and the cheques written.

This is not about the ability to buy cars or have holidays - this is about making up for the loss of potential for each child to ensure they can live safely and protected for the rest of their lives.

I see the difference every day in my children - my daughter's achievements are fabulous, but they are a constant reminder of what my son will never be able to do. We have to put that aside and celebrate her while celebrating what my son can do.

Relationships have broken up over this (not mine, fortunately) - some fathers have not been able to reconcile that the cause was because the mother took the medication, but despite judgement from people who are ill-informed, I would never have had a child knowing I was putting him at risk.

The dreadful irony is that my life has still been made better by having him in it, despite the fact that it was me being his mother (and my treatment) that have caused all his problems.

Here's the thing; if a discover is made that a drug or procedure causes harm, and it's been given to many, many people and garners lots and lots of income for pharmaceutical companies (through original harm and subsequent related harm, things you can treat for a lifetime afterwards), the average person may think ‘that drug/procedure would get pulled immediately and every doctor would right away cease its use’

It's not that simple. It's politicised and when there is a lot of money and a lot of harm involved it will be covered up.

This is a conspiracy, but conspiracies happen; conspiracy to murder, conspiracy to deal drugs…. They happen more often and are much better done among the people with access to all the world’s media and all the world’s money.

There is not one place that conspiracies such as this occur than in the pharmaceutical industry.

Thankfully in the age of information anyone with critical thinking skills, the ability to assimilate and interpret information, knowledge of what a primary source is, can find out what is going on themselves and implement the knowledge within their own circle.

This is far from an isolated incident.

The only safe thing to do is look into things yourself, especially when it comes to medical decisions. To delegate medical decisions to an industry known for endemic corruption is a risk to say the least. You leave yourself and your family at the mercy of criminals.

So who do you ask in a situation like this? Not everyone has the benefit of a good education or the confidence or knowledge to research themselves. People with epilepsy, in many cases, don't have a high level of education. I was lucky that I did. I asked questions and was pushy, but still was not given an informed choice.

When we asked lots of questions in the late 90s, we didn't have the benefit of the detail on the internet of today. Consultants were the point of knowledge and all roads we went down led back to them.

The patients are not to blame, so please don't blame them! The system needs to be safe to use.

I had my DC in the mid 90s when DH was taking sodium valproate, and asked my doctor if it was OK because I knew about the problems with women taking it. DH was recently diagnosed and no internet then, I had no medical background so I assume it was on the pack insert then?

There has been at least one panorama-style documentary on TV about the lack of publicity about this, can’t recall exactly when but I think early 2000s. Can’t believe it’s still happening.

Cross post with Charmatt - no criticism intended

@SoManyTshirts I the mid to late 90s the PIL said 'if you wish to become pregnant, speak to your doctor first'

In 2001, after I had my son it said that occasionally, children born to mothers who had taken Valproate, developed more slowly.

Later it gave more information, but the Cumberlege Review found that PILs weren't routinely enclosed in medication boxes and the government accepted that to be the case.

Omg

i take this drug. Different country. Perimenopause and vasectomy for DH, but still menstruating. No one said anything.

It never will be, it's endemically corrupt.

@Charmatt I'm so sorry you have been so let down. I was started on carbamazepine over 18 years ago and have always been told sodium valproate was not safe for pregnancy. I'm sorry you were not given the right information and care.

I hope you are able to get the justice and compensation for your son.

Thank you @CurbsideProphet

Over 20 000 children have been affected - all those mothers who didn't have the information they needed to make an informed choice. All those lives affected....and it's not over - children are still being born with Fetal Valproate Syndrome.