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legal aid funding has been withdrawn just weeks before trial in a case where families are suing a pharmaceutical company after babies were born with birth defects that were caused by sodium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Horrible that the sodding legal aid commission has withdrawn funding weeks before trial.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.

edam - yes but all the examples given on here it appears to be the prescribers that have let their patients down, not that the drug company knew the drug was not safe & witheld that information? - which is surely what any case against the drug company would have to prove to be successful? (They may potentially have a case against the prescribers for negligence though?)

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.

but surely if the trial was due to start in a few weeks, the preparatory work is all but complete already, funded via legal aid already? IF the lawyers involved think they have made a strong case then there is little risk involved. (and if they haven't made a strong enough case, and therefore they aren't prepared to go NWNF, then that's probably why the legal aid was pulled in the first place...)

HERE is the cached version of the PIL from the 26/03/10 change (can't find any older cached versions) so they definitely haven't just added that information in last week, but obviously doesn't show how long before that it was added in.

for whatever reason the link straight to the cached version doesn't work... it was straight from a google search though - followed the "cached" link instead of the usual one

it was a "snapshot of the page as it appeared on 22 Aug 2010 17:40:04 GMT"

Betsy - if you find the Sanofi PIL you'll see the last amendment was made on 3.11.10. Seems you are looking at an older version (August?).

I think the idea that trial costs are not prohibitive without legal aid funding would cause some amusement at any legal gathering.

I don't know whether the drug company is at fault. That's what the trial would have decided. We need the trial to establish the facts. Now we will never know whether information was withheld from patients over the past decade or more. It may well be available now. But was it available when these children in this case were conceived?

I'd be delighted if it was the case that every single health professional is well-informed and communicates risk fully to gain truly informed consent from women of childbearing age who are taking anti-epileptics. Sadly I doubt that is true. The woman I happen to know was stuck on epilim by her GP as a first line treatment. That GP clearly didn't realise it was completely inappropriate for a woman of childbearing age unless there are very good reasons. And the patient didn't get to see a neurologist for 18 months.

the cached version was the 26th March version

this contains the 2007 version

In 2003 Professor Gordon Duff, who was the head of the Committee on Safety of Medicines said that "warnings to prescribers about the possible effects of valproate in pregnancy have been available since 1983 and were reinforced in 1993 in Current Problems in Pharmacovigilance"

This is totally crap for the families & children concerned but everything I've read before, seen on this thread & seen in the past couple of days says that the risks were published, so I can't see how a case against the drug company would succeed?

And thatb is why the legal funding ahs been withdrawn.

The rules of legal funding are very clear. The tax payer will only bankroll cases that are likely to succeed...in this case the evidence seems to be on the side of the defendants.

Now that is not to say where the truth lies. But the court's job is to weigh up the evidence put before it.
And on the current evidence, the claimants will almost certainly fail.

And that is why the LC have withdrawn funding and why the claimants' soliciotrs won't take the case on a no win no fee basis.
They just don't think they can win.

By that reasoning legal aid can virtually never fu.d a pharmacy claim. No matter where the truth lies, the companies have the resources, understand tactics and political backing to make winning against them an everest.

quite, Appletrees. Which is why Glaxo would have got away with peddling a drug they knew increased the risk of suicide quite happily had it been left to the UK legal establishment.

And let's stop dragging no win no fee into this as if it somehow justifies dropping the case. No lawyer is going to take on a multi-billion pound multinational company on a no win no fee basis. Doesn't mean those companies never break the law. It means no win no fee is not capable of holding them to account.

So what evidence is there in this case that the drugs company were hiding the facts when the head of the Committee on Safety of Medicines says it was a known and published back as long ago as 1983?

It would appear to me that the families concerned have a stronger case against the prescribers for negligence than against the drugs company.

just putting myself on the thread to come back to it tomorrow.

Betsy - that's what the court case would have established. Now we will not be given the chance to find out. Sanofi had a responsibility to ensure patients were aware as well as prescribers. What information have they given to patients since 1983? What did the various issues of patient information leaflets say over the past 30 years?

And they haven't done a very good job with prescribers, either, as my friend's experience with her GP shows. It would be interesting to see how many women of childbearing age are on Epilim and how many have a record of a full consultation with a neurologist or specialist nurse covering pre-conception planning and pregnancy. My guess is there are far too many women who are on Epilim and not all of them will have had such a conversation.

It may be entirely appropriate, on the balance of risks, for some women to be on Epilim if that offers the best chance of seizure control. But not as first line treatment unless there's a very good reason due to the individual's medical history. And only where being of childbearing age has been taken into account, other drugs have been tried and not worked satisfactorily or should not be attempted due to that patient's individual circumstances AND where the patient is fully informed of the risks and has given genuinely informed consent.

I was on Epilim between the ages of 14 and 30. I went to see my GP before ttc the first time to find out whether it was ok. Was told fine as long as I take extra folic acid. Was told the same by various different medical professionals over the years.

I had one miscarriage at 7 weeks, obviously no way of knowing why. Then got pregnant again. At about 13/14 weeks I read a scary story in the Standard about a woman who had been on Epilim and had a disabled son, so I ran to my GP in a panic. I was told it would be fine, it was nothing to worry about. He even did that 'look at my steady hand' thing, to prove just how confident he was I had nothing to worry about. At 20 week scan (actually 21+5 weeks) baby was diagnosed with very severe spina bifida, I was advised he was unlikely to survive the pregnancy and would die during or shortly after birth if he did, so had a termination.

I have no doubt the Epilim was responsible, and 10 minutes of angry googling led without much difficulty to clear evidence that I should never have been on Epilim in the first place, and certainly should have been advised to come off it before conceiving as the risks were much much greater than I had been advised.

I changed on to Lamotrigine and had two lovely DSs. I didn't know anything about this legal case until it was on the news about funding being withdrawn, and tbh it's not something I've wanted to explore, as it's too painful. It's horrible the feeling you have done something to your child through putting something in your mouth. I know it's not my fault but I was the one whose physical actions and personal 'defect' caused it.

I do blame the medical professionals more than the pharmaceutical company though. It was really really easy for me to access guidance for medical professionals about pregnant women with epilepsy, all of which clearly indicated women of childbearing age should not be on Epilim.

Flowery, I'm so dreadfully sorry. The way you were treated was appalling. And you are right that it is the doctors who are responsible for informing patients and ensuring patients are on the appropriate drugs.

I know how lucky I was to live next door to a specialist neurology centre when I developed epilepsy - they went for lamotrigine straight away. Wish everyone else had the same level of treatment - it's not asking for the moon on a stick, is it? Just doctors looking at the patient and going 'ah yes, that person in front of me is an adult female, guess Epilim is not the best idea'.

BUT I wish this case had gone ahead so we could see what action the pharmaceutical company has taken to ensure the drug they produce is used correctly and to inform patients as well as doctors.

Well exactly. Not hard to put in guidance for doctors along the lines of 'adult female = avoid Epilim', and you would certainly hope that even if GPs wouldn't be aware, or wouldn't think, that neurologists doing the diagnosing and initial prescribing would exercise their brain.

But yes better information from the pharmaceutical company as well, and it looks like their liability won't now be explored.

flowery - I'm really sorry to hear what you went through - particularly shocking that when you queried your situation with your GP that they didn't bother to check the guidance & still said "all ok" when it clearly wasn't.

I would agree that it appears to be the prescribers that bear the brunt of the blame here - as a warning to prescribers was first published as long ago as 1983

There is clear guidance in the BNF (the prescriber's bible), which was in the paper copy I have from 1995 (and most probably in earlier verions than this too) so there is no excuse for doctors not knowing. It is their responsibility to check that what they prescribe for individual patients is safe considering their medical history/allergies/likely circumstances (including getting pregnant...) Like you said, a quick internet search revealed all the information so it was hardly a secret...

edam - the contents of PILs is heavily regulated so I would suspect (although the earliest version on the web I could find was from 2007) that there have always been warnings in there, the argument would be around whether they were strong enough. (I would imagine before any problems were known with epilim the PIL would have contained the standard get-out "if you are pregnant or considering becoming pregnant please consult your doctor before taking this medicine" anyway... )

The problem with PILs is that you get very sad people like me who read every word in there (and read up on the drug in the BNF & search the web for issues...), but I suspect I'm in a small minority. I would guess a significant proportion of people bin them unread and/or rely on the fact that a DOCTOR prescribed the drugs so they must be okay for them...

Yes, quite, Betsy. It's quite reasonable of people to believe that their doctor knows what he or she is doing. Sadly some of us have had experiences that prove you really do have to check. And a generic warning saying 'if you are pregnant consult your doctor' isn't actually helpful at all. Doesn't alert the patient that there may actually be a very serious problem here indeed or indicate this medicine is any different to any other. And even if you do, you may be unlucky enough to consult a fuckwit doctor who doesn't know his BNF from his BFP. Like the one flowery met or the GP who put my friend on Epilim.

What is it, 50 or 60 years since GPs were merrily handing out Thalidomide? Yet somehow medicine and pharma are still merrily killing and harming babies. That's appalling. And not why anyone went into medicine in the first place, surely.

When I was put on Epilim, it wasn't by a NEurologist - it was by a urologist with a 'special interest' in Neurology. (I wasn't told that at the time!). Because my PCT had no Neuro. Still doesn't 7 years later. My PCT has no epilepsy nurses either. I get one annual visit a year to a Neuro 60 miles away, that's all my PCT will pay for.

At the time of me being prescribed epilim, all that was on the PIL was 'if you are pregnant then please consult yor doctor before taking this medicine'. But on the same PIL it also said 'do not discontinue use of this medication without a doctor's advice'. This was 2003.

Thankfully by the time of my last pregnancy, I was off epilim and onto Gabapentin - but even my Neuro at Queens had no idea of how tetarogenic it was - I had to do a LOT of research myself that included phonecalls to America as Gabapentin is more widely used there. That was 2 years ago, and unfortunately, I lost that baby (for a different reason). I am currently 30 weeks pregnant again, wih a healthy baby.

And that's exactly why Sanofi should be held to account. Thank you for posting that, Loudlass. (AND the NHS for failing to train and employ enough neurologists. How many babies have been killed in utero or horribly damaged because their mothers only saw GPs?)

Utterly utterly depressing. Thankyou edam for the vital work that you do.

Epilim in the first line epilepsy drug for childhood epilepsy so a lot of people go straight on to it. I think the info about pregnancy has been around a lot. I suspect a lot of the problems have been caused by GPs and othe medical professionals who 'think' they know a lot about epilepsy and the drugs but either have not kept up to date or do not know the finer details. Also anyone with epilepsy under 16 doesn't even get to see a neuro, only a paediatrician. Ds1 is lucky as I think his paed is good but when I read online about other parents of children with epilepsy and the experiences they've had, some people have had shockingly poor care, especially those who don't get much further than a gP appointment.

I think the bottom line is that if you or a child have a condition, don't trust anyone. Do as much research as you can and don't accept anyone's word as gospel.

I've been on Epilim since 14. We went to neurologist before starting family and were told of cleft palate and spina bifida risk - that was all. When our baby was born with MANY problems, we then discovered the whole Fetal Valproate Syndrome existance and I asked to look at my medical records. Strangely, the GP had even put "fetal drug damage" down !!!! Hate Sanofi more than it is possible to hate anything. The fact that the public funding was suddenly withdrawn is as good as condoning the deliberately harming of unborn babies without conscience; treating us like guinea pigs or lab rats in in an experiment.

Ive just looked up the 2006 copy of the BNF and its got all the negative side effects on the foetus down there.
took me about three minutes to find it, and thats just because i am not that familiar with the book. I find it horrific that the gp's didnt check. Thats precisely their job!