Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Wednesday, December 24, 2014

Where Are They Now? - Dr Alastair Benbow

Alastair Benbow was once GlaxoSmithKline's mouthpiece when it came to defending the safety (and efficacy) of Seroxat (known as Paxil in the US) - but where is he now?

Benbow is now Chief Medical Officer and Head of Operational Services at Kinapse, an expert advisory, capability building and operational services to the world’s leading life sciences organisations.

Benbow's role, according to his profile page on the Kinapse website, is to be accountable to the CEO and Board of Kinapse for the integrity and effectiveness of Kinapse’s system for medical governance. His role as Head of Operational Services covers Kinapse Regulatory, Medical Writing and Information, Clinical Trial Disclosure and Pharmacovigilance functions.

Have you finished laughing yet?

Apologies if you have choked on your cornflakes.

Responsible for  Clinical Trial Disclosure, Pharmacovigilance and Medical Writing?

Other employees of Kinapse include:

Head of Strategy - Suzanne Budsworth
Senior Pharmacovigilance Scientist - James Whitehead
Regulatory Associate - Kapil Pal
Senior Manager, Regulatory Affairs - Stuart Goodall

All are previous employees of GlaxoSmithKline.

Former Management Consultant at Kinapse, Stephen Mayhew, is now Head, R&D Strategy Development and Programme Management Office at GlaxoSmithKline.

Revolving door anyone?

Benbow is infamous (whether he likes it or not) for defending Seroxat and playing down the suicide link and other side effects associated with it.

He also took umbrage to a video slide-show I created about him back in 2008 [Seroxat Secrets]

Here's part of a transcript featuring Benbow and BBC investigative journalist, Shelley Jofre. Much of what is transcribed here never went to air.


Q = Jofre
A = Benbow

Transcript GSK Tape - Panorama Interview - Dr Alastair Benbow 9 October 2002

Q. Let us move on. What has the company done about the Wyoming verdict?

A. As I told you before, in this matter because of a confidentiality agreement between the family and GSK I am not able to specifically comment on the mitigation, but what I can say is that there is no reliable clinical evidence that Seroxat causes violence, aggression or homicide. This tragic, tragic case is something that does occur from time to time in patients who are depressed...

Q. This man had no history of suicidal thoughts or tendencies. The jurors sat and listened to all the evidence and decided that there were four deaths that were mainly caused by Seroxat. Your company was found guilty of negligence. You cannot ignore that.

A. No, and nor would we want to ignore it. This was a tragic case but we remain firmly convinced that Seroxat did not cause the tragic events in this case.

Q. So the jurors got it wrong!

A. No, I am not saying that. What I am saying - as I have said before - is that there is a confidentiality agreement between the family and GSK in this matter and I cannot comment on the specifics of this but we remain firmly convinced that Seroxat did not cause the tragic events in this case.

Q. It was pretty clear-cut. There was nothing else to explain his behaviour. He had only been on the drug two days and he clearly had a reaction that threw him into mental turmoil and made him behave in this way.

A. Yes, but there is a lot of speculation in the question you asked there but as I said I cannot comment specifically on this case because of a confidentiality agreement between the family and GSK. What I can say is that looking at all the data and the clinical trials there is no reliable evidence that Seroxat causes violence, aggression or homicide.

Q. All the evidence was produced in the trial. I am sure your company more or less produced the best evidence that was available. The jurors decided Seroxat was responsible for those four deaths and that is pretty serious.

A. As I have said before, I cannot comment on the specifics of the case...

Q. You cannot tell me that the clinical trials support Seroxat as not being linked to aggression or suicide?

A. Yes, I can say that. The clinical trial data and spontaneous adverse event data for reporting over the last ten years since Seroxat was made available in the UK do not support the finding that Seroxat causes aggression, violence or homicide.

Q. All of this data was presented to the jurors so they had ample opportunity to hear arguments on both sides and they felt Seroxat was responsible for the deaths.

A. As I say I cannot comment on the legal situation because of a confidentiality...

Q. I am not asking you to comment on the legal situation. I am asking you to comment on the fact that your company's drug was found responsible for four deaths.

A. As I said, I cannot comment on the specific situation but what I can say, quite clearly, is that when you look at the data from clinical trials and from the data in use in tens of millions of patients in 1999 that there is no reliable evidence that Seroxat causes violence, homicide or aggression.

Q. Is your company just going to ignore this verdict as if it never happened?

A. No we take very seriously any event that occurs when patients are taken off...

Q. What have you done to make sure that this does not happen again?

A. We have looked very, very carefully at the data, and as I say the data clearly shows that there is no reliable evidence that Seroxat causes violence, aggression or homicide.

Q. What does the warning in the patient leaflet mean then?

A. What do you mean?

Q. The warning about self-harm and suicide that is on the Seroxat leaflet, what does it mean?

A. As you will know, in patients who are depressed there is a significant risk of suicide and self-harm. That risk of suicide is at its worst when people have their worst depression, and that is often when people go to the doctor...

Q. Why would the risk of suicide increase once they start taking Seroxat?

A. No, I am not saying it increases when they start to take Seroxat; I am saying people are at risk of suicide early in treatment because it takes a while for an anti-depressant to work.

Q. The suggestion in the warning is that there is an increased risk in the first few weeks of being on Seroxat, but you say it is nothing to do with your drug?

A. What I am saying is that there is an increased risk of suicide early in the treatment of depression. Whatever the treatment, or indeed if there is no treatment there is an increased risk of suicide, and this is a very...

Q. So it is just a co-incidence that the increased risk of suicide starts when they start taking Seroxat?

A. No, what I am saying is that there is an increased risk of suicide even if patients receive no therapy. This is a fact of people who have depression. The reality is that many people with a severe depression have a very low mood and loss of energy. As people start to recover their energy and mood encourages...

Q. But they are not recovering, you say, until a few weeks after they start the Seroxat.

A. Early on in treatment the major affects of anti-depressants take a week or two to start, but the reality is that energy levels are one of the first things that start to improve, but mood comes later.

Q. Is it not that they get agitated?

A. Not at all. Not at all.

Q. It sounds to me here as though you are trying to have it both ways. You are trying to say the risk increases when you start taking the drug but it is nothing to do with the drug. It is meaningless warning.

A. No the warning is there, and has been agreed with the regulatory authorities, and it is basically to tell doctors, 'Look, you have a patient who is depressed. They are at risk of suicide. Don't just think just because you have started them on anti-depressants that they are not going to remain at risk of suicide immediately. The fact is that antidepressants take a while to work. If you look at the data what does the data show? The data shows that Seroxat reduces suicidal ?hydration and thought. Over the past ten years - or the ten years between 1990 and 2000 - with the increasing use of antidepressants, suicide rates in England and Wales have fallen by 15%...

Q. Are you taking credit for that?

A. I am saying that the increased used of anti-depressants, the better diagnosis of depression and the better treatment that is available - yes, that has contributed to the fall in suicide rates.

Q. Perhaps over the long term drugs like Seroxat are useful for avoiding suicide and reducing suicide rates but what we are talking about is a window in the first few weeks where there is quite a lot of evidence that people can become agitated, restless and anxious. It seems to correspond exactly with the period that you are saying there might be an increased risk of suicide but you are saying it is nothing to do with your drug.

A. No, I must disagree with the comments you made. There is not a lot of evidence to suggest that patients are getting agitated and restless and anxious. The reality is that anti-depressants do take a short while to work, and during that first few weeks, when patients are taking therapy, doctors should be aware that patients are at risk of suicide, because of their underlying depression.

Q. So it is not an increased risk. I do not understand what you are saying. If you are saying, 'Until the anti-depressant starts working they are at the same risk of suicide as they have always been' then that is one thing. However, your warning says there is an increased risk of suicide...

A. What I am saying is the greatest risk to patients of committing suicide is in those who are severely depressed.

Q. But in those first few weeks of... [talking simultaneously] start Seroxat?

A. No, the most severely depressed patients are those that have just presented their doctor and just started on therapy.

Q. Of course not everyone take Seroxat for depression and we have spoken to someone who took Seroxat for panic attacks and he began to self-harm in the first few weeks of taking it, something he had never even dreamed of doing before.

A. Seroxat is indeed available for a range of depression and anxiety related disorders, all have clear criteria for laying down exactly what the conditions are. There is a range of different conditions - panic disorder, obsessive-compulsive disorder, social anxiety disorder etc. Many of them are associated with depression and the same patients will be at risk of suicide and...

Q. Again is it just a coincidence this behaviour would start a few weeks after taking Seroxat?

A. No I am not saying it is a coincidence. I am saying it is a reality of depression and other related disorders...

Q. Panic attacks?

A. Yes, panic attacks and...

Q. I thought that is a link to self-harm.

A. Panic attacks are linked to depression, which is linked to self-harm.

**At this point Jofre pushes home the point about Seroxat withdrawal - She then continues with...

Q. Well, let us move on. Here is a drug that is linked to suicide and self-harm, a drug that thousands of people say they are addicted to; do you seriously think it should be given to children?

A. Let me just correct something in your question. There are a number of allegations you made there none of which are correct. In terms of whether we think Seroxat should be made available to children, absolutely. Two percent of children, 4% of adolescents, will develop depression. The adolescents are at particular risk of suicide.

Q. You think this is safe for children?

A. I think we need to do the trials to determine this. We have an obligation to make our medicines available to those patients at need. Adolescents are some of the patients who are most at need of anti-depressants. Suicide in adolescents is the third leading cause of death. Do not trivialise depression for those patients. We have a strong obligation to study our medicine in these patients to see if we can help them.

Q. In a recent study that Glaxo funded more than 10% of children developed psychiatric problems within eight weeks of taking Seroxat.

A. I think you will have to tell me a little more about the specific study so that I can understand your question.

Q. It was funded by Glaxo and carried out in America - the biggest ever study of Paxil in depressed children and more than 10% of children developed psychiatric problems within a few weeks of taking Seroxat.

A. I think in any study a proportion of patients (as in this particular study) where patients were either taking Seroxat, or Imipramine, or a placebo, a proportion of patients will develop adverse effects in the course of the study.

Q. There were far more children on Seroxat than on the other drug, or on sugar pills who developed these psychiatric problems.

A. There are a number of different elements that you lump together in psychiatric disorders.

Q. I will run through the list of problems if you like. Five of the children suffered suicidal thoughts and gestures. There was aggressiveness. There were behavioural problems at school. None of this sounds very safe; it all sounds quite worrying for the children who are on Seroxat.

A. Actually not because some of those symptoms were also seen on the patients taking Imipramine and placebos.

Q. Not as frequently.

A. Maybe not as frequently, but they still suffered. This is typical of the sort of symptoms that occur in this population of patients. This is a difficult population to treat and you will be aware that for many medicines there is no licensed implication for use in children so much of prescribing in children is done off-label. We firmly believe that we have an obligation to study our medicine to treat population to examine the safety and the efficacy of that medicine.

Q. I appreciate that but there were many problems on Seroxat than on the other drug or the sugar pills.

A. Actually the majority of those side effects were relatively minor.

Q. No, a lot of these children were hospitalised it was so serious.

A. If you look at the proportion of patients who withdrew from therapy - and you can see less than 10% had to withdraw from Seroxat - more than 30% withdrew from the other active therapy and just under 10% withdrew from the dummy.

Q. It is heart complaints with the other drug, and I understand that, but-

A. But that is the sort of therapy that is the alternative, which is why it is very important that we study Seroxat in this group of children who are most at risk from suicide.

Q. What we are talking about here though are psychiatric side effects, the sorts of side effects that can lead to suicide and there were far more children on Seroxat suffering these problems than on the other drug or sugar pills.

A. What you are trying to do is make a link here with the adult data. The adult data clearly shows that there is no reliable scientific evidence that Seroxat causes suicide.

Q. But why should it be that so many more children should suffer these side effects on Seroxat than the other drug or sugar pills.

A. Actually, if you look at the more serious of those side effects the number difference was very small, and the sort that you would expect to see in clinical trials. On one trial there may be more than on another, in another it will go the other way.

Q. And for the 10% of the children on Seroxat who had these side effects you are not worried that it was caused by the drug?

A. The vast majority of these patients did not have side effects significantly enough to withdraw from the treatment. The reality is that in this population depression is an extremely serious condition and in many cases leads to suicide.

Q. I appreciate that.

A. Are we worried by the side effect profile? We take the safety of our medicines extremely seriously and we will look very carefully at this, and the combination of other data, to decide whether this medicine is suitable for children. My belief is that it will be but because there is a lack of treatment for this serious condition that this medicine will be suitable for a range of children as well as adults.

Q. You cannot be sure that the 10% of children on Seroxat who suffered these problems did not suffer them because of Seroxat can you? You cannot be sure about that.

A. One can never be sure of anything in medicine, but just because you take a medicine and you get an effect does not mean to say cause and effect because the same sort of symptoms occur with the dummy pills.

Q. That is why if you compare it to another drug and the sugar pills, in that comparison Seroxat was much worse.

A. In that comparison the proportion of patients withdrawing from the study due to adverse events was much lower on Seroxat than one of the other potential treatments available.

Q. There are 60 psychiatric side effects - the sorts of side effects that are linked with suicide and self-harm.

A. Let us look at the totality of the adverse event profile because it is the total risk and input that is important.

Q. We are considering the link with suicide, and this evidence points very strongly to the fact that more children are suicidal and had suicidal gestures in fact on Seroxat than the other drug.

A. With respect the totality of the data is important. What you are talking about are five patients out of the 275 on Seroxat, three patients on Imipramine. That difference is not significant and one patient had a placebo.

Q. No, I am talking about five children. The figures are-

A. I have given you the figures. Five on Seroxat, three on Imipramine and one on placebo.

Q. There were children out of 93 children on Seroxat who had suicidal thoughts and gestures, another five out that 93 had serious psychiatric side effects. Do you not think parents would be worried about that if their child were to be given this drug?

A. I believe that what parents would be more worried about is the risk that their children had of committing suicide and other symptoms of severe depression if no treatment was available. In my opinion parents want treatments to be properly evaluated during clinical trials before their children are given any medicine.

Q. But the evidence here suggests that their children might be at more risk of suicide if they go on Seroxat.

A. No, the evidence is not there. There is no statistical difference between the groups. The reality of the situation is that in this trial Seroxat was generally well tolerated by this difficult to treat population.

Q. You are not concerned about this and you do not think parents should be concerned about this?

A. What I am saying is that we are attempting to study Seroxat in this difficult to treat population. If, and when, we demonstrate the efficacy and the safety of the product, then the data will be submitted to the regulatory authorities with a view to getting a licence so that these patients and their doctors have another treatment available to them to treat this difficult disease.

Q. You would like it to be licensed for children?

A. Of course it must be driven by the data. There are many times we do clinical trials where you find that the balance of risk and benefit is not capable, in which case you do not try and get a license. The reality in this situation is the data we have generated so far is favourable. There is more benefit than risk in this population but until we have developed all the clinical trials, and done a full package of information, and adequately studied this drug in this population we cannot say that.

Q. Are you satisfied then that your company, generally, has done everything it can to keep patients properly informed about the negative side of the drug?

A. Absolutely, and it is not something we just sit and watch. Our summary of product characteristics is a living document. You start with a very limited number of healthy volunteers. Then you develop the clinical trials in thousands of patients. Then you make it available to tens of millions of patients around the world. As time moves on you collect more information and more data becomes available, and as a result we regularly change the information, which we provide to prescribers and patients for all our medicines, and of course for Seroxat as well. We will continue to do that. We will continue to monitor the safety of our medicines. We will make changes to the information to prescribers and patients, driven by facts and data not by anecdote.

Interview ends.

Here's some brief segments of Benbow in action. The other 'Alasdair' in this short video is Alasdair Breckenridge. Both Breckenridge and Benbow are seen here defending Seroxat.

Breckenridge was the former Chairman of the British drug regulator, the MHRA. Before joining them he worked at GlaxoSmithKline.

Bob Fiddaman.

Saturday, December 20, 2014

Andrew Witty: The Acceptable Face of Big Pharma?

Dr David Healy has a belter of a post over at his website. The post, entitled, "Persecution: He Who Would Do A Great Evil", throws out much for debate and readers have been forthcoming with comments.

Many of the comments mention the AllTrials Campain, spearheaded by Dr Ben Goldacre. He and I have never really seen eye to eye, he thinks I'm one of those "angry smeary conspiracy theorists", (Fig 1) which is a shame. I'm really just a patient seeking answers from a big corporate company who lied about one of their prescription drugs that I took.

Fig 1

Three days ago All Trials published a letter from Ben Goldacre on their website, the crux of which sees the announcement that Goldacre, along with Síle Lane (Director of Campaigns at Sense About Science) are going to be banging on the doors of individual pharma companies to ask them what they’re doing to fix the problem of future clinical trials reporting.

At present pharmaceutical companies carry out clinical trials for their drugs and hand over the successful trial results to medicine regulators in efforts to get a licence to sell their wares to the public. Any failed trials (that shows the drug didn't work or caused serious adverse events) are kept away from the regulators, doctors and the public.

I'm almost certain that Ben Goldacre didn't wake one morning and think to himself, "I know what needs to be done, I'll start a campaign calling for transparency and enter into a partnership with GSK on their terms."

He probably (and this is just an assumption) was delighted when the UK's biggest pharmaceutical company jumped on board the AllTrials train. His measure of elation overriding what lay beneath GSK's reasons.

It looks great for GSK, even more so for AllTrials - what a coup!

One of the most abhorrent pharmaceutical companies in the history of medicine agreeing to open their doors to "the privileged" so "the privileged" can just see how GSK are trying, oh so desperately, to make it look as though they have nothing to hide.

Do you think for one minute that GSK would have jumped on board any campaign spearheaded by any of their fiercest critics?

The Seroxat User Group, back in 2011, asked for a meeting with GSK's Andrew Witty. The meeting was an attempt to ask Witty for help on behalf of the thousands of patients suffering severe withdrawal problems at the hands of his company's antidepressant Seroxat (known as Paxil in the US)

Witty declined, even though Janice Simmons, who operates the Seroxat User Group, had amassed over 60,000 emails from Seroxat patients, most of them are struggling to get off Seroxat.

GSK’s UK medical director Dr Pim Kon wrote back to Janice informing her that they (GSK) was not allowed to discuss personal matters with patients and that they should 'talk to their doctor'. [See - **Exclusive - GSK's Andrew Witty in Patient Aftercare Snub]

It's a perfect escape route for GSK. 60,000 emails from patients complaining about one of their products and 60,000 patients being told "Um, we can't talk about your experience or offer you any guidance regarding withdrawing from our product... but you can talk to your doctor."

AllTrials, however, have had red carpet rolled out for them by GSK because their campaign would actually make GSK look good. I mean whose idea was it to forget the 60,000 or so patients wanting help from GSK and, instead, focus on how to make GSK look like a great, caring company.

Put the two together - what's more important?

GSK had nothing to gain by meeting Janice Simmons but they have everything to gain by teaming up with AllTrials. It's all about image. Not the image of AllTrials. Not the image of Dr Ben Goldacre. The image of GSK.

Dr David Healy has given evidence against GSK in US Courts. Would they have been so obliging to him had they had been approached by him regarding a campaign to open their doors to show their clinical trials?

I think we know the answer.

So, why have they teamed up with Ben Goldacre who has, in the past, been slightly critical of them?

Well, Ben, as mentioned above, seems like the sort of chap who can be beneficial to GSK. Labelling me an "angry smeary conspiracy theorist" would have, no doubt, given the likes of former Glaxo spokesperson Alistair Benbow and Andrew Witty a jolly good laugh - "Way to go Benny boy, that Fiddaman guy is just a blogger and knows nothing about our medicines and how they have helped millions of people all over the world."

By turning against the patient, be they disgruntled or be they advocates pushing for answers, Ben Goldacre has created a divide. He, himself, is a physician and any patient with questions about prescription medication should not be turned away and be labelled in such a way to make them feel they are wrong.

I think the concept of AllTrials is a good one. I think the terms under which pharmaceutical companies are agreeing to open their doors is a recipe for disaster. Goldacre, for what its worth, seems like a decent enough guy, I wouldn't like him if he were my doctor though, especially if he could dismiss my concerns over a drug with a brush of the hand and a slur of conspiracy theorist.

If the likes of GSK wish to be transparent then they should be so with absolutely no restrictions.

Joining forces with AllTrials is pretty on the eye yet deceiving.

GSK, in this instance, are your street magician. They are showing the public the delights of magic and the public applaud.

Always bear in mind that magicians often use secret helpers to accomplish their magic. They also use sleight of hand to make things just disappear... Think Paxil 329.

Bob Fiddaman.

Friday, December 19, 2014

Lundbeck: Possibly, Probably or Certain about Celexa Birth Defects?

Possible or probable, so what is the difference?

I've struggled with these two definitions, really tried to get my head around them both.

First off I used

1. that may or can be, exist, happen, be done, be used, etc
2. that may be true or may be the case, as something concerning which one has no knowledge to the contrary

1. likely to occur or prove true
2. having more evidence for than against, or evidence that inclines the mind to belief but leaves some room for doubt.
3. affording ground for belief.

When it comes to prescription medications causing adverse events, the World Health Organisation (WHO) use "causality categories" and define possible and probable as thus...

• Event or laboratory test abnormality, with reasonable time relationship to drug intake
• Could also be explained by disease or other drugs
• Information on drug withdrawal may be lacking or unclear

• Event or laboratory test abnormality, with reasonable time relationship to drug intake
• Unlikely to be attributed to disease or other drugs
• Response to withdrawal clinically reasonable
• Rechallenge not required

In essence both words have two possible outcomes yet both have different meanings.

I am going to focus on the case of Cheryl Buchanan here and her correspondence with citalopram makers Lundbeck. Citalopram is better known as Cipramil in the UK and Celexa in the US. ( Forest Laboratories)

Cheryl has been at loggerheads with Lundbeck regarding the death of her baby girl. Cheryl made the heart wrenching decision to abort her fetus at 23 weeks because she had been told that scans had detected a series of anomalies in her unborn child, namely...

  • Diaphragmatic hernia or eventration
  • Long bone immobility
  • Cystic hygroma 
  • Unilateral cleft hand
  • Microgynathia

Cheryl had been taking Lundbeck's citalopram prior and during her pregnancy. She wrote a guest post for my blog back in 2013 and has since been trying to get answers from the Danish pharmaceutical giant Lundbeck.

Lundbeck carried out an assessment of Cheryl's claims and forwarded their findings to the MHRA.

Lundbeck, as far as I am aware, also use the World Health Organisation "causality categories".

Here's what they found.

(Foetal death in utero) - drug related - possible
(Pulmonary hypoplasia) - drug related - possible
(Diaphragmatic hernia) - drug related - possible
(Hand deformity) - drug related - possible
(Skin laxity) - drug related - possible
(Skin swelling) - drug related - possible
(Drug exposure in utero) - drug related - possible

Fig 1.

Fig 2. **Initial reporting from Lundbeck to the MHRA did not give any indication for Cheryl's fetus developing Pulmonary hypoplasia**

Fig 3. **Updated assessment by Lundbeck sent to the MHRA regarding a possible connection between citalopram related Pulmonary hypoplasia**

Sometime later Cheryl wrote to Lundbeck and asked if citalopram could cause birth defects?

Here's the reply from Lundbeck's Dr Andrew Jones, Medical Director, Medical Department.

"...there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). " 
It was at this point that I wrote to Dr Jones to ask him if this was a personal opinion or an opinion of Lundbeck. He replied...

Dear Mr Fiddaman,
I confirm that this is the position of Lundbeck.
What I am struggling with here takes me back to the definitions of possible and probable.

Lundbeck assess Cheryl's case and write to the MHRA with their findings. They tell the MHRA that the birth defects (listed above) are possibly drug related. Using the WHO criteria this means that...

The defects could just be coincidental to Cheryl's "drug intake" or

The defects may possibly have been caused by "disease or other drugs" or

The Information Cheryl provided Lundbeck "may be lacking or unclear" 

Let's now take a look at the position of Lundbeck regarding citalopram use and birth defects. Remember, it was their own Dr Jones that told me that the following was the position of Lundbeck...

"...there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). " 

So, how do we categorize the position of Lundbeck. Are they suggesting that it's possible that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Are they saying it's probable that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Or are they saying they are certain that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Back to the WHO criteria again.

• Event or laboratory test abnormality, with plausible time relationship to drug intake
• Cannot be explained by disease or other drugs
• Response to withdrawal plausible (pharmacologically, pathologically)
• Event definitive pharmacologically or phenomenologically (i.e. an objective and specific medical disorder or a recognised pharmacological phenomenon)
• Rechallenge satisfactory, if necessary

Lundbeck have done nothing more than open the door for debate when sending information back to the MHRA.

Where the mother is concerned they have quite literally slammed the door on her face by telling her that their position is there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population.

Why would they (technically) tell the MHRA otherwise?

Why would Lundbeck tell the MHRA that it was possible that citalopram caused the birth defects in a mother's fetus but tell that same mother something completely different?

I'm confused by it all. Is the WHO criteria merely a set of probabilities with at least two possible outcomes? If so, it doesn't really tell us much does it?

Is the WHO criteria not as stringent as they think and each category open for debate?

What we basically have is two opposing statements of reality intertwined.

The third statement of 'certainty' by Lundbeck to Cheryl Buchannan being an ultimatum, in essence, "our drug does not cause birth defects", forgetting or purposely failing to add that they told the MHRA otherwise.

It's certain that Cheryl Buchanan aborted her fetus at the age of 23 weeks because, she was told, the chances of survival were minimal due to a series of internal defects.

My money is on citalopram being the cause of those defects.

Any good lawyers in the UK?

Bob Fiddaman.

Back Stories

Citalopram Birth Defects (Guest Post)

Are Lundbeck Luring Pregnant Mothers With a Red Apple?

Tuesday, December 16, 2014

New Study Uncovers Paxil's Hidden Toxicity

As if we didn't know already (as if Glaxo didn't know all those years ago)

A new study carried out by the University of Utah has revealed what Glaxo have been hiding from the public for many years. The only people that really know the truth are the US Courts where information has been suppressed as part of settlement agreements made between Glaxo and Plaintiff lawyers.

In a nutshell, GSK attorneys come to a compromise when their case defending Paxil goes pear-shaped. They, of course, use all the tools at their disposal - the statute of limitations, whether or not a fetus is viable, ie, whether or not it can be regarded as a human at the time it was aborted - they also use many other points of law to defend their toxic blockbuster drug.

According to Neurotoxicology and Teratology, Volume 47, January–February 2015, mice exposed during development experienced a multitude of problems: males weighed less, had fewer offspring, dominated fewer territories and died at a higher rate. Females took longer to produce their first litters, had fewer pups and pups that were underweight.

The Paxil doses were relatively close to those prescribed for people.

In the study, researchers gave food laced with Paxil to 20 breeding pairs of mice for several weeks, until all had produced up to four litters. The offspring also ate Paxil-laced chow until they reached breeding age.

This from Newswise...

Researchers then released the exposed offspring into the competitive arena with the offspring of a control group of mice never exposed to Paxil. Groups consisted of eight males and 14 to 16 females, creating population densities comparable to those seen in the wild. The researchers started five such populations and kept them going for six months.
Males exposed to Paxil were about half as likely to control a territory. They also lagged behind control males in body weight throughout the weeks of competition and were more likely to die. Exposed males produced 44 percent fewer offspring. Exposed females showed no significant weight or mortality differences, but they produced half as many offspring as control females at the initial assessment. Their fecundity rebounded at later time points.

Are we surprised anymore?

Question is... Why has it taken so long for such a study to be carried out? In truth, it hasn't.

Here's a bit of history...

3-year-old Lyam Kilker was born with serious heart defects. While pregnant, Kilker's mother took the antidepressant paroxetine [Paxil]. The Jury's decision in this case was that Paxil was the causation of Lyam Kilker being born with heart defects. In other words, Paxil was deemed responsible as the agent that disturbed the development of an embryo or fetus.

The following was taken from the court transcript in the Kilker v GlaxoSmithKline trial. [Verbatim]

"In May of this year, 2009, a study was published by Doctor Sloot. The study said this.
"What Doctor Sloot did is, he took Paxil and all the other reuptake inhibitors and he exposed rat fetuses to these 12 different drugs, including Paxil. And what Shearing Plough was trying to figure out, what they were trying to do was figure out whether one of the drugs that they were going to put on the market to compete with GSK's drug was capable of causing birth defects. And so they took the drug they were going to take to market, and before they took it to market, they did this test. And they compared it to all the other SSRIs. Because, as you will learn, GSK never did this test.
"What Doctor Sloot discovered in May of this year is that out of all the teratogen, out of all the SSRIs, the 12, only one was a clear teratogen, Paxil. He discovered that Paxil in May of this year was actually more powerful a teratogen than cocaine.
"It would be safer, according to Doctor Sloot's study, to take cocaine than it would be to take Paxil while you were pregnant.
"Now, Shearing Plough, quite rightly, took their drug that they were thinking about taking to market to compete with Paxil, and even though it was just a possible teratogen, they scrapped their plans to take it to market and decided the risk was not worth the benefit."

Upon this revelation I emailed both Glaxo and the British drug regulator, the MHRA. All of that correspondence is featured in my book, The evidence, however, is clear, the Seroxat scandal. For those of you that don't have a copy there's an extract featuring that correspondence here.

No doubt medicine regulators around the globe will raise an eyebrow at the latest study by the University of Utah, they may shuffle uncomfortably... then ignore the findings. That's my experience of regulators. Quite why they are called regulators baffles me.

Paxil is just one example of a pill causing birth defects, there are many more, much of which are dished out to women because they have some form of dangerous depression during their pregnancy, a depression, that we are told, if left untreated can be passed on to the fetus.

Genius marketing folks...with the sole aim of making money...and lots of it.

Bob Fiddaman.


Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

Wednesday, December 10, 2014

FDA Shake-Up New Pregnancy Drug Guidelines

I'm all for a shake-up for a more simplistic approach to drug safety drug guidelines for pregnant mothers, so a recent article filled me with hope with the headline 'New Pregnancy Drug Guidelines A Mixed Bag For Consumers'.

Alas, it's not all it's cracked up to be.

The FDA have, for many years, categorized a number of prescription drugs, particularly for use in expectant mothers.

Here's how it currently stands.

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Simple enough but, in my opinion, very vague. Let's take a look at Category C.

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
In essence the FDA are telling pregnant mothers that the drug they have in their possession has had an adverse effect on the fetus of animals...they go on to say that there have been "no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks."

It's more or less telling the mother that they should take the drug at their own peril.

So, a shake-up to make these guidelines more crystal clear is welcoming.

Are the FDA going to consolidate all the cases of birth defects that have been settled by pharmaceutical companies throughout US courts and then apply them to the new guidelines?


Are the FDA going to read the countless stories on the internet and in the media about mothers giving birth to children with defects after taking a specific prescription drug?


Are the FDA going to contact pediatricians to ask if they have ever come across instances where children [fetuses] have had to be aborted due to prescription drug medication causing birth defects?


Here's what they plan to do.

They are, it seems, going to ask the drug companies to write the warnings.

So, the likes of Paxil, a drug marketed and manufactured by GlaxoSmithKline, a drug that has, on countless occasions, been implicated in hundreds, possibly thousands of birth defects, will now get a new lease of life. Glaxo, who have settled many of these birth defect cases out of court, will now be asked by the FDA to come up with a warning for pregnant mothers to read.

Are we expected to believe that Glaxo are going to have the consumer in mind when writing a warning about ingesting Paxil while you are pregnant?

To my knowledge GlaxoSmithKline have defended the majority of Paxil birth defect lawsuits. Those they win are usually down to absurd state laws [see Ryan, Glaxo's Non-Viable Fetus - Part I and Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists.]

Do we really believe that the likes of Wyeth are going to be anything but truthful when they write a warning for Effexor? [see - Two Hours With Matthew - The Story of "Effexor Baby", Matthew Schultz and Effexor Baby's Grieving Mother Protests Potential MOTHERS Act, Warns Others]

Perhaps Lundbeck will cease the opportunity to cover their drug, citalopram [Celexa] in garlands when there are cases suggesting that it can cause all sorts of problems to the fetus. [see Citalopram Birth Defects and The Lundbeck Emails [Citalopram Birth Defects]

The FDA plan to remove the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling, they are recommending that the labeling include a summary of the risks of using a drug during pregnancy and lactation.. and they are leaving this to the manufacturers of the said drugs, the same manufacturers who have suppressed information surrounding their drugs and birth defects.

On one hand the FDA are looking as if they really do care about the dangers of these drugs in pregnant mothers, on the other hand they are passing the buck back to the pharmaceutical industry whose main priority is to make bucket loads of money out of the supply of these drugs.

It's just like allowing the cannibalistic witch to provide information on candy and food to Hansel and Gretel.

Don't get me started on the British drug regulator, the MHRA, they still insist that Paxil is not a teratogen...despite the fact that it has been proven to be one in US Courts.

There will be many who read this who will claim that they took antidepressants during pregnancy and their babies turned out just fine. To those I ask just one simple thing...please spare a thought for those mothers who, through no fault of their own, don't have the luxury of holding their babies or ever having the chance to hold their babies babies.

Bob Fiddaman.

Please contact me if you would like a guest post considered for publication on my blog.