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Tuesday 19 April 2022

Sodium Valproate. The demise of another pharmaceutical drug. 20,000 damaged children? A tragedy worse than Thalidomide?

Pharmaceutical drugs are known to be dangerous. Sometimes even doctors are forced to admit this. There are even times when even the mighty Conventional Medical Establishment can no longer defend the harm their drugs and vaccines do to patients. For the antiepileptic drug, sodium valpoate, this  time appears to be rapidly happening.

Please Note: sodium valproate comes to patients under many different names - rarely sodium valproate. It is vaariously called Absenor, Convulex, Depakene, Depakine, Depalept, Deprakine, Dyzantil, Encorate, Epilim, Epivil, Episenta, Stavzor, Valcote, Valpakine, Orgiril, and no doubt many more (just to confuse us patients! What on earth do these names mean? Why do pharmaceutical companies need so many?)

On Sunday 17th April 2022, the Sunday Times headline blew a whistle (a whistle they use so rarely) on this drug (I will ask "Why?" later). Its front page headline stated "Drug Scandal that damaged 20,000 babies: epilepsy pills are still being given to pregnant women in a travesty that recalls thalidomide". Its editorial announced that "20,000 babies damaged - and still the scandal continues". The main article began:

            " Health experts knew in 1973 that the epilepsy medication sodium valproate posed a risk to unborn children - but mothers-to-be were not told. Almost 50 years and 20,000 disabled children later, it is still being prescribed to pregnant women. Now some are saying 'this scandal is worse than Thalidomide".

Worse than Thalidomide? I have written about the Thalidomide scandal before, briefly outlining the events on this link. It was a tragedy that led to the introduction of our current system of pharmaceutical drug regulation, now used around the world, and intended to ensure that such event would "never happen again". Clearly it has failed. Moreover, as this story shows, the new system of regulation was already failing at the very time it was being set up!

And the problem is almost certainly bigger than the Sunday Times says. If it is thought that 20,000 babies have been damaged that number could be multiplied by 10, even perhaps 100 times, given that regulatory reporting systems are notoriously bad at picking up cases. And, as the Sunday Times outlines, the harm caused by sodium valproate has been going on now for nearly 50 years now - and yet the drug is still being prescribed by doctors, and little of no action has been taken to protect patients from it.


Very few people read the Sunday Times. Its articles are not openly available on the internet, and few people now buy newspapers. So here are some quotations from the article.

        "Sodium valproate, which was given to women with epilepsy for decades without proper warning, has caused autism, learning difficulties, and physical deformities in up to 20,000 babies in Britain".

        "... despite... a 2020 report that criticised the failure over four decades to tell women of the dangers, doctors are still not properly warning women of the risks......."

        "An investigation by the Sunday Times has found that the drug is being handed out to women in plain packets with the information leaflets missing, or with stickers over the warning". (My emphasis).

The article tells us that the problem of birth defects caused by the drug was discussed as early as 1972 and 1973, when "the manufacturers, Sanofi, told the committee that there were signs in animal tests that valproate could potentially be teratogenic - harmful to foetuses" but the committee "concluded that the use of anti-seizure drugs ... was indeed liable to produce abnormalities" but that "the risk appears to be low, and not sufficient to justify stopping the use" of the drug.

        "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". (My emphasis).

The Sunday Times article goes on to outline the subsequent history of the harm caused by the drug over the last 50 years, and the regular warnings that have arisen over time. These range from reports in the Journal of Paediatrics in 1980, the British Medical journal in 1983, debates in the House of Commons, reviews in the Lancet, et al.  

Each time, little or nothing was done to warn or protect patients - indeed the opposite.

            "The CSM (Committee on the Safety of Medicine) finally acted on the concerns, asking Sanofi to write to all GPs and hospital doctors with a new warning sheet, setting out the sodium valproate could lead to birth defects. However, the committee still stopped short of requiring doctors to tell women about the risks, with the danger of spina bifida not being including on patient safety leaflets until 1994. And still no detailed research into the effects of the drug was commissioned".

Warning after warning followed. A study in 2009 confirmed that the use of the drug in pregnancy could damage children's IQ. Yet it was only in 2010 that patient information sheets referred to the risk to cognitive development, including autism.  

So it is quite impossible that the dangers of Sodium valproate could have remained unknown to any doctor, or anyone connected with the conventional medical establishment

But nothing has ever been done, pregnants women are still being prescribed the drug. The thalidomide scandal was supposed to lead to new drug regulation procedures whose primary objective was to protect patients. Yet no action was taken to protect patients from sodium valproate at the time, and for the next 50 years! Drug regulation does not work to protect patients. The system has been taken over, consumed by the drug companies it is supposed to be regulating.

After many years, during which time government, the conventional medical establishment, the NHS, and doctors did not act, patients tried to take action themselves. A lawsuit was brought up against Sanofi; but this collapsed before the trial when legal aid was withdrawn. The government has a vested interest in not wanting such a trial to go forward, so they took action that ensured that patients could not obtain redress!

There comes a time when the CSM realises that it can no longer protect a dangerous pharmaceutical drug, even when this has been its priority for many decades. 

In 2018, Jeremy Hunt, UK's Health Secretary, although refusing to set up a compensation scheme for the families, set up another enquiry. The Cumberlege Report was published two years later, in July 2020. It concluded that the government had an ethical responsibility to provide financial help to families harmed by sodium valproate, to cover the costs of care, and detailed how a 'disjointed, siloed, unresponsive and defensive healthcare system had, for over two decades, failed to fully appreciate or act on the harmful effects of sodium valproate; but (as the Sunday Times article said) the government continue to refuse to compensate the families.

So still nothing has happened. Patients are still not being told of the dangers by doctors; they are still not getting information leaflets with their drugs; and it would seem that even the warnings given on drug boxes are being obscured (intentionally?) by pharmacists. Clearly, we are not supposed to know!


So why has the Sunday Times suddenly decided to publish this information on sodium valproate? The mainstream media does not usually criticise its main source of income - the advertising budgets of the pharmaceutical companies! Perhaps they did so for the same reason Jeremy Hunt agreed to set up the 2018 enquiry - the evidence of patient harm has become so serious it could no longer be ignored!

1. Is Sodium Valproate safe?

The Sunday Times have not been entirely disloyal to its paymasters! Several times the article tells us that sodium valproate is a safe drug, other than for pregnant women, of course.


The horrendous adverse drug reactions caused by sodium valporate are well known to the CME, and is part of their medical literature that everyone can see for themselves. So if anyone believes that this is a safe drug they should go to, for example, the website to read for themselves just how serious its so-called 'side effects' can be - even for people who are not pregnant! This is a very, very long list of very serious adverse drug reactions.

2. Is this really a one-off medical scandal?

Yet there are other issues that have not been tackled by the Sunday Times article, questions that should have been, but were not asked. Sodium valproate is the tip of a very deep iceberg. The mainstream media always likes to present these problems as 'isolated', one-off indiscretions, that are not being repeated anywhere else within pharmaceutical medicine.

Sodium valproate is not an isolated case, there many other drugs in the same situation as sodium valproate. These are drugs that are usually described by doctors as being "entirely safe", but in effect they are drugs waiting to be banned because of the patient harm they are already known to cause. And just as it has taken 50 years to ascertain that sodium valproate is dangerous, the same applies to almost any pharmaceutical drug anyone would like to mention.

And the conventional medical profession has been dishonest, for so long, about this drug, how many other drugs are being 'protected' by doctors, and the CME generally?

3. Patient Choice and Informed Consent.

The experience of women who have taken sodium valproate, as described in the Sunday Times article, clearly shows that a decision was taken NOT to inform them about possible adverse drug reactions. It might alarm them, and the paternalist CME wanted to protect them from such fear! Or perhaps they wanted to use this drug, however dangerous it was known to be, because it was all that they had to offer.

Doctors know best. All patients are expected to do is what they are told to do by the medical experts. Take the 'safe' pills - and take your chances. The danger of being given complete information is that patients might decide for themselves, they might make an"informed choice" and say "No". Patient choice is not good for the business of selling drugs. And it patients refuse, they will then discover that conventional medicine has nothing else to offer.

4. The CME, NHS, honesty and transparency

The NHS is not a transparent organisation, it is not even an honest one! It has sold out totally to pharmaceutical medicine, and conventional medicine has much to hide. We saw it recently over maternity care. Sodium valproate has demonstrated, yet again, that the NHS has clearly been involved in deliberate obfuscation, cover-up, and lies. It is clear that the CME has made a number of calculated decisions over the last 50 years:

  • not to tell women about the dangers of the drug;
  • doctors asked to tell pregnant women about the dangers, have failed to do so; 
  • drugs packaged in plain boxes, without information leaflets;
  • and if there are warnings on a box they have been (intentionally/deliberately ??) covered up with labels.

5. Bankrupting the NHS
It is the use of dangerous, patient harming drugs that is leading to the bankrupting of the NHS, and the growing awareness of the failure of conventional, or pharmaceutical medicine around the world. Sodium valproate demonstrates this as well as any other pharmaceutical drug.

  • There is an illness, in this case epilepsy.
  • Patients are given a drug to treat for the illness.
  • There are serious adverse drug reactions (in this case, at least 20,000 children are damaged, with most requiring medical, social and economic support for the rest of their lives).

This is not a one-off problem affecting just one drug. Most illnesses/diseases can be, and often are caused by pharmaceutical drugs.

Epilepsy itself can be caused by amphetamines and other stimulant drugs, by antipsychotic and antidepressant drugs, by antibiotics and painkillers, by many vaccines, and many other pharmaceutical drugs.

This is why we are sicker now, as a nation, then we have ever been before, why chronic disease, in all its many forms, is now a unprecedented epidemic levels, and rising.