drug company gets away with harming babies

[edam]

legal aid funding has been withdrawn just weeks before trial in a case where families are suing a pharmaceutical company after babies were born with birth defects that were caused by sodium valproate (Epilim).

The comparison with thalidomide is obvious. Women of childbearing age should NOT be on epilim unless no other drug controls their seizures and women should be in a position to give informed consent - not just stuck on this drug without being warned of the effects on the foetus.

Horrible that the sodding legal aid commission has withdrawn funding weeks before trial. Unlikely to succeed my arse - if it was that unlikely, why have they spent two years funding the case? The very point of the courts is to judge which side succeeds - the legal aid commission shouldn't be second-guessing them weeks before trial in a case of such huge significance.

Still, it's just women and children on one side (who have in many cases been plunged into poverty by the economic and social impact of caring for a disabled child) and a multi-billion pound pharmaceutical company on the other. So guess which side the authorities come down on.

Let's not forget the thalidomide scandal only came to light and the manufacturers were only held to account because of campaigning journalists. The authorities did fuck all. Looks like nothing has changed in the past 50 years.

bump - surely on a board full of mothers this is relevant?

Plus to warn anyone unfortunate enough to be prescribed epilim - I know women of childbearing age who have been put on it without any warning or any attempt to find another drug that suits them without damaging the foetus.

I was on Epilim while being of childbearing age, knew nothing of the Dangers at the time, I thank my lucky stars that I was single at the time! I'm now on Gabapentin which has no major known tetarogenic effects. I think this is shocking, but because Epilepsy is a condition that not many people are very talkative about, it just isn't getting the press that something lke thalidomide got, because it affects such a small percentage of the population.

Unlike thalidomide where links were completely denied, there is a recognised link between this drug and foetal abnormality. The women whose children were affected - as I understand it - are claiming that they weren't told about the side-effects by whoever prescribed the drug and/or weren't advised not to get pregnant whilst taking it. So if there is insufficient evidence to support that, even after 2 years of investigation, they need to make the case stronger. Spending millions of public money on a case that's going to fail is not an efficient use of funds, however strongly anyone feels.

Chil - sadly it is all too likely that they weren't told. I know of women who weren't told. I am ruddy lucky that when I developed epilepsy as an adult, I happened to be living practically next door to a major teaching hospital with a neurology department where, as a matter of course, because I was 28 they did not reach for the epilim. Other people are far less fortunate. Friend of mine waited 18 months to see a neurologist, with her GP dumping her on epilim. Sheer luck that she didn't become pregnant. (Given there's no 100% perfect contraceptive and she's a married woman with three kids.)

GPs are not specialists in epilepsy and unless the patient sees a neurologist, warnings such as these are sometimes unlikely to be noticed. Yet in many areas there are no local neurologists - it's a specialist service. That's why my friend had to wait so long.

Warning on netdoctor says the following. One of the women in the action says she DID plan her pregnancy carefully, she followed all the advice, her doctors took her off other drugs so she was taking epilim alone - yet no-one told her epilim itself could cause birth defects. From this warning, I think the impression created is that the only issue with epilim is taking folic acid. That is very far from the full picture.

Warning:

It is vital that women with epilepsy receive specialist advice before getting pregnant, so they are well informed of potential risks and benefits of continuing antiepileptic treatment. Pregnant women taking antiepileptic medicine have a higher risk of carrying a baby with developmental problems and malformations. However, if a woman with epilepsy stops treatment because she is pregnant, there is a risk of seizures that can harm both mother and baby.

Women who decide to try for a baby while taking valproate should start taking folic acid daily as soon as contraception is stopped, as this may reduce the risk of neural tube defects such as spina bifida in the baby. Ask your doctor for advice on the dose to take - it may be recommended that you take 5mg daily.

Women who continue to take valproate during a pregnancy should, wherever possible, be prescribed valproate on its own, in the lowest effective dose, in doses that are split over the day, and if possible as a prolonged release brand. These measures can help minimise the risk to the baby. Specialist medical advice must be sought.

Valproate passes into breast milk in small amounts, but there have been no reports of harmful effects from this on nursing infants. Seek further medical advice from your doctor.

Heard this on the radio this morning.
Utterly disgusting.
Dreadful decision by the legal aid comission, but I expect nothing less from a pharmaceutical company. They truly are fuckers

Edam - my understanding is that the public funding was given for investigative purposes.

Thisb often happens. Cetificates almost never cover the entire case. You get a certificate for the first bit. Then you repply and get it for the next bit etc.
On each reapplication the lawyers ahve to certify that there is still a good case to argue and provide evidence of that.

In this instance the certificates have been renewed periodically, until this point, where it is belived that the case is now unlikely to succeed so the public funding will not be recouped. ( Public funding in these cases is a loan not a gift iyswim).

Agian, this often happens, the lawyers think they have a great case until something new comes up - an expert report etc.

What I would say, is that if these cases do have a good chance of success, there are lots of PI lawyers prepared to act on a no win no fee basis.

My point btw is not that these claimants dont have a good case...just that you cannot say the legal aid commission wouldn't have funded it so far if they hadn't.

Evidentially, it is often very difficult to say whether a case will succeed or not until all the reports etc are in.

I've just looked at the patient information leaflet online. And whaddya know, the information on pregnancy and breastfeeding was changed last Wednesday. That information was previously updated in 2007 and 2004. So it's entirely possible that someone who became pregnant in 2004 on the old product information leaflet may not have had the full picture. Or someone who became pregnant in 2004 - 2007. You'd have to be able to access the old wording to check - and of course, with the legal case halted, I doubt very much Sanofi-Aventis is going to make that available for anyone to check.

the legal case isn't halted Edam, just funding has been withdrawn.

If the case is very strong, I'm be sure the lawyers already involved would take it on a no win no fee. Why wouldn't they? When they win or get a settlement their costs will be recouped. And as you say, it's only weeks away.

Litchick - I was one of the journalists who broke the Seroxat story in the UK. I'm afraid there were plenty of 'experts' - including most of the Royal College of Physicians - who were only too happy to ignore the facts and pretend that there was no link between Seroxat and suicide. Even though it was there in the paperwork Glaxo had hidden and one very dogged and brave psychiatrist had uncovered.

The RCP also argued that patients who reported difficulty in withdrawing from Seroxat were just imagining it. Because there couldn't possibly be any problems if a doctor hadn't decided there were problems - mere patients couldn't possibly know whether they were experiencing symptoms or not.

So I'm afraid I'm not impressed by a legal system that says 'ooh, one expert opinion, that's enough to throw out am important case where patients have been harmed'. Rubbish. That's not how science works. (Particularly as pharmaceutical companies control what is published to a large extent, and fund researchers and organisations like the RCP). Just as shit as the treatment of 'experts' like Roy Meadows as the fount of all knowledge with no scrutiny of his claims.

Oops, sorry, Royal College of Psychiatrists, not physicians! The RCP were entirely blameless and not directly involved. It was the RCPysch who were refusing to admit that the papers showed a link with suicides and that patients were reporting problems with withdrawal.

Edam, FYI the information that you are so adamant that Sanofi are withholding seems to be freely available on the internet.
Still, why stop to look for the facts when you've got a high horse you can climb onto, eh?

www.medicines.org.uk/EMC/history/6781/SPC/Epilim+500+Enteric+Coated

Edam, I spoke to soon and apologise to you - the full details are not there although Sanofi will have this information on file and of course would have been publically available when it was current.

I'm now going to slink off from my own high horse before I get myself into more trouble

I, too, was put on epilim at a young age. I also miscarried a baby (unknown until miscarriage happened - no medical attention sought) whilst I was on epilim (went from 300mg to 900mg over the course of a week then stopped cold turkey).

When my seizures restarted again a few years later I was put on phenytoin but soon taken off after I nearly lost my teeth (phen. can cause receding gums). Luckily my Ep. nurse put me on lamotrigine then and I have had 3 healthy babies on it (well they all have atopic illnesses and reflux but no hare lip/cleft palate).

This was in 2002 and they were very reluctant to continue with phen. or try epilim again as I was a 'young lady' who may have children in the future.

I can't believe I had the only Ep. nurse in the country who knew about this

Am bumping this, no time to yeas right now but I saw it in the paper. Will read later, well done edam.

Bump again
Something is seriously up with the legal aid people, this feels political

Thanks ultimate, appreciate that correction. Easy to post in haste, I know, I've done it...

Truth, you and I are lucky. Sadly it's sheer chance whether you get a well-informed health professional or not. Access to neurologists and specialist nurses is far from universal - see my post about the friend who waited 18 months to see a neurologist and was put on epilim in the meantime by her GP, despite being a mother of three of childbearing age. (No neurologists at her local hospital - she had to go to a specialist centre run by a different PCT, hence the delay.) See one of the case studies in the Guardian today, where the mother DID ask for advice before conceiving and wasn't told about the risks.

I've just dug out the paper copy of an old BNF (#29 from 1995), which is the prescriber's bible

This is an extract from the pregnancy advice
"In view of the increased risk of neural tube and other defects associated, in particular, with carbamazepine and valproate,the CSM has advised that women taking antiepileptic drugs who may become pregnant should be informed of the possible consequences. Those who wish to become pregnant should be referred to an appropriate specialist for advice."

So this has been known about since at least 1995 & Doctors should have discussing with/advising their patients.

(The current BNF version (#60) has similar wording, but with more drugs on the list)

As has already been said, if the case is that strong there will be plenty of lawyers willing to take it on a no-win-no-fee basis.

I don't think so. Pharmaceuticals devote vast resources and employ bullying tactics. No win no fee in a case like this is a fantasy. It is too political.

Betsy - yes doctors should have been advising patients BUT A. that is not always the case, sadly and B. warnings should have been VERY clear in patient information leaflets.

The case study I saw on the BBC website was of a woman who DID discuss this with her doctors and follow their advice - which was to stay on Epilim, bizarrely. She feels she was not fully informed of the risks. (Epilim may have been the best bet for seizure control in her case, but she should have been able to give fully informed consent, having a clear explanation of all the risks.)

And agree re. no win, no fee, it's a fantasy in cases like this. Cases against big pharma are very complex and take years of preparation. While the multi-billion pound multinational has the very best lawyers at their disposal using every delaying tactic in the book. A lawyer would have to be mad to take that on with the risk of not being paid for years of work.

The case against Glaxo wrt Seroxat happened in the States. It would never have been funded over here in our legal system. Had it not been for lawyers in the US, Glaxo and the Royal College of Psychiatrists would still be denying any link with an increased risk of suicide especially in young people. And people would still be dying as a result.

(Btw, there is plenty to criticise in the US legal system, but at least unlike ours it is possible to attempt to hold pharmaceutical companies to account for their actions.)

Agree edam. And rather than be ruled against they settle at the last stage. I still can't forget merck sending those threats that mmr claimants would lose their homes and the legal aid decision there was deeply fishy. You're job is deeply worthwhile.

Ahem your

(dullard)

They will only have to pay costs if they lose the case and since the effects are well documented how can they lose, they can't.