SEROXAT SUFFERERS - STAND UP AND BE COUNTED

Guest Post: Life ‘at’ and Escape ‘from’ Paroxetine Island

2013-05-18T10:36:00.002+12:00

The hell of Aropax withdrawal

Following on from Part I [Like a Lamb to the Slaughter] of Mark's trilogy of guest posts.

This post sees Mark describe the frustrations and hardships of withdrawing from GlaxoSmithKline's Aropax, known in the UK as Seroxat and in the US and Canada as Paxil.

Life ‘at’ and Escape ‘from’ Paroxetine Island [PI]

Life at Paroxetine Island(PI) can only really be described in hindsight and with insight once one has spent time back on the mainland and drug-free. Here are some observations:

On arrival at PI one has all motivation, passion, spontaneity and confidence taken away and one is given yawning, fatigue and indecisiveness 24/7 in exchange.
On my 1st night at PI I experienced the most real, horrific and terrifying dream of my life. It involved my death. At the time I was clueless as to what caused this.
Like creeping mold is to the internal walls of a house in winter so too was paroxetine to my brain. It was a slow, insidious takeover of not just my brain but also my soul. Dulling my emotions and senses, and even when the wallpaper started falling off I was clueless as to the cause.
My quality of life grew worse and worse, as I became more and more removed from reality.
Life was sucked out of me and I was no longer living I was simply existing.
I became a loner and yet I wasn't lonely.
Much time and effort was spent fighting back evil intrusive thoughts, thoughts that did not belong to me, thoughts that were extraordinarily immoral, offensive and almost audible in my mind beckoning me towards self-destructive behaviour. Thoughts that were demonic in nature.
Personality and behavioural changes occur on PI perhaps best described as a severing of the conscience.
Loss of feelings and caring occurred, a total disconnect from reality. The mantra of PI was:
‘So what, who cares’! And I was soon singing it.
An early attempt to break free and swim to the mainland resulted in such psychological, emotional horror and panic I rushed back to my doctor and asked to go back to PI. I was sent back no questions asked.
Despite promising to never swim away again several more failed attempts to escape left me in a state of learned helplessness, a massive major paradigm shift now occurred in my being. I now believed that I needed to be on Paroxetine Island!
One day I learned of a person who had escaped from PI and swum back to the mainland. I became very envious, jealous even!
I was now determined that I too would get back to the mainland. Little did I know that I was about to start a 3-year traumatizing nightmare, a journey through ‘Hell,’ that was going to require every ounce of strength to survive, fighting for my life, daily.

My Escape from Paroxetine Island (PI)

I would like to start by just saying that my escape from PI was the most difficult thing I've ever done in my life. No non-poisoned-by-an-SSRI-brain can conceive, imagine, or understand the traumatising nature of this ordeal.

I presented to my doctor in January 10, after 10 years use, wanting to get off paroxetine. His reply “okay come off slowly”, and sent me on my way. (Absolutely criminal!)
I had no idea what slowly was. But decided to start to alternate doses 20 mg one day and 10 mg the next.
After 6 months I was on 10 mg and in a distraught state.
The distress drove me to seek counselling, yet it offered no relief. Except lighten my wallet.
At 9 months and on 5 mg feeling death would be a welcome relief I reluctantly presented to my Doctor (Dr W), only to be told I had an underlying depression and I needed to up dose. At this point I realised Dr W was clueless. I replied, ‘that is not right’. He referred me to a psychiatrist Dr S.B.
Confused, distraught, frustrated, and in a very dark place, somehow knowing deep down something was not right here but what could it be, I confided in the neighbouring pharmacist. He leaned over and quietly whispered, “Mark I’m not supposed to tell you this but it’s not you it’s the drug”.
It was like a light switch was flicked, the light bulb went on, I came to my senses. Of course it’s not me, it’s the drug! It was the damn drug! How could I have been so stupid! Words cannot describe the humiliation that started to flood my being followed by anger and disbelief.
I immediately started digging, and stumbled upon an SSRI addict’s and survivors support group. I realised I had found a place ‘sought by millions but found by few’. I owe my life to them.
On asking the psychiatrist Dr S.B. if he was aware of any problems with people getting off Paroxetine he replied, “Well if there were problems with people getting off paroxetine people would be suing the drug companies” [I was later to realize this was a Dr who clearly had his initials around the wrong way].
He also okay’d a Healtheries supplement I wanted to take to try to get some relief. I was sent on my way. I now realised I was on my own.
I broke free of PI on 28 September 2010.
The 9 month taper down and the next 2 years drug free was hell. The nightmare I had to suffer (believe me to call it a nightmare is an understatement) coming off this drug had nothing to do with me and everything to do with this drug!
I wouldn't want my worst enemy to go through this. I was unable to function experiencing daily uncontrollable restless anxiety, endless crying and drug induced suicidal ideations starting from 6 a.m. lasting throughout the day and receding somewhat in the evening. I felt as if I was being psychologically and emotionally raped daily. This withdrawal horror went on for almost 3 years, with the drug induced withdrawal hell pushing me for months to cut my wrists, then for months it tried to get me to hang myself, then it wanted me to shoot myself, and if that wasn't enough drive my car into oncoming traffic. I still remember the day I fought off an overwhelming desire to jump off a bridge.
These drugs are not given to patients under 18 because they cause suicide …well if my experience is anything to go by they should extend the relabeling ban to those under 50!
In order to get through this hell alive I dragged several family members so far into emotional overdraft I will never be able to repay them. You can forget being able to hold down a job during this ordeal it’s a battle to just survive each day.
I so much wanted to reinstate to take the horror away, yet I was driven by a sense of unbelievable anger and humiliation to not do so. Often chanting back ‘it’s not me it’s the drug’ when waves of hell flooded me.
All I wanted was an opinion on my sore arm, I never consented to this.
At about 18 months drug free I felt the shark infested waters start to recede, a few months later I washed ashore onto the mainland, exhausted, traumatized and in total disbelief that I was still alive.
I felt like Rip Van Winkle coming to after being placed in a living coma becoming acutely aware of the damage done to me, waking up in shock and disbelief.
Let there be no mistake about it, if I was an enemy combatant and the NZ army did this to me, someone would have been dragged to the Hague and jailed for this!
Hippocratic Oath…..Yeah Right!
I was determined to get an explanation for this insult to my humanity an answer for something no human should have to endure.

Mark Carter NZ

Coming soon Part III

Bob Fiddaman

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Reporting Adverse Events to Pharmaceutical Companies

2013-05-16T15:41:00.000+12:00

Roche NZ, lengthy response to consumer query

So, you feel suicidal, maybe you've self-harmed, maybe your child has been born with a heart defect or brain abnormality - you could be a parent who has lost a child to suicide or a wife/husband who is mourning the loss of a partner.

If you fall into any of the above categories and antidepressants have been involved, chances are you'll accept that Joe killed himself because he was depressed or Lucy self-harmed because she has a psychiatric disorder and that's what people do when they are mentally ill. Maybe it was just God's will that young Daniel was born with a serious heart defect or Kate was born with defects to her skull... then again, maybe not.

I recently emailed 6 of the major pharmaceutical companies and asked about the protocol in place to respond to consumers who report an adverse reaction to them. Only two of the six replied. I'm grateful to Roche and Merck for their feedback.

I'll focus on the response that I got from Roche as it was refreshingly long and not just some cut and paste job from a compliance manual.

I asked two questions:

1. What are your obligations if you receive an adverse event from a consumer?

and

2. Are you obliged to give feedback to the reporting consumer?

I was more interested in answers to question 2 as this seems to be a grey area for many. More often than not pharmaceutical companies tend not to write what they can say and don't say what they can whisper.

Managing Director at Roche Products (NZ) Limited, Stuart Knight, was very helpful.

Dear Mr Fiddaman

Thank you for your enquiry which has been passed onto us at Roche New Zealand. And I am assuming your question relates to medicines, rather than medical devices.

1. What are our obligations if we receive an adverse event from a consumer?

The ongoing monitoring and reporting of adverse events is a priority for all pharmaceutical companies & government medicine regulators. It is actively encouraged and it helps build over time, a stronger evidence for any medicine, thereby helping to ensure its safe and appropriate use by both prescribers and consumers.

As with all companies, Roche have to follow applicable global regulations such as European Union Pharmacovigilance legislation and ICH Good Clinical Practice (GCP) guidelines, which dictate what our legal responsibilities are. Individual countries also follow their local regulations if stricter than global requirements.

All adverse events Roche receives (regardless of who has reported them), get entered into our global Safety database (and therefore contribute to signal detection), also ensuring we comply with data privacy requirements. Roche then submit reports to individual country Regulatory Authorities (who are independent Government agencies tasked with ensuring medicine quality, safety and efficacy), who then generate local safety overview documents (datasheets and consumer medical information leaflets) to assist prescribers and consumers.

In NZ, we report adverse events for 'approved' marketed medicines to the Centre for Adverse Reactions Monitoring (CARM), if the case meets CARM’s reporting requirements.

The requirements can be found on the Medsafe website http://www.medsafe.govt.nz/regulatory/pharmacovigilance.asp

Essentially, any report has to be rated/graded and assessed according to ICH seriousness assessment guidelines. Further information on this is available on the Medsafe website.

2. Are Roche obliged to give feedback to the reporting consumer.

I wasn't sure what you meant here, so have tried to answer it broadly. If it doesn't meet your needs then please let me know.

If a consumer or patient has a question relating to a possible adverse event, then they can phone or contact our Roche NZ Medical Information service and the enquiry will be answered. However we do often need to involve the consumers Healthcare Professional - HCP (e.g. their doctor/prescriber). We need to do this because we are not aware of the wider medical context and therefore it is sometimes difficult to answer questions without having further information. Permission to provide information to the patients/consumers HCP will always be requested.

If a consumer reports an adverse event to us, in order to fufill our legal obligations we will need to get medical confirmation of the event from their HCP. In order to do this we request written consent from the patient to contact their HCP. If we do not receive written consent, we do not contact their HCP.

Regarding the adverse event itself, once it has been reported to us, further contact with the reporter (irrespective of who it is) is not made. But consumers and HCPs can read summary documents of reported adverse events of the medicine(s) on the Medsafe website.

If you have any further questions then please do not hesitate to contact me.

Yours sincerely

Stuart Knight

Quite a response from a major pharmaceutical company I'm sure you'll agree.

I was, however, quite baffled with Mr Knight's response to question 2 - "Are Roche obliged to give feedback to the reporting consumer."

Mr Knight's answer didn't really make much sense to me and, it seemed, to make a mockery out of the current legislation here in New Zealand. With this in mind I wrote back the following...

Many thanks for this response.

On answer two you gave me I'm slightly confused as this would, as far as I know, contravene s22(f) of the Health Act 1956 and rule 6 of the New Zealand’s Health Privacy Code 1994 which you will be aware covers health information held by pharmaceutical companies.

Can you clarify this for me please?

Bob

I didn't have to wait long for a reply...

Dear Bob,

Thank you for your follow-up email question.

In my email to you on Friday 26 April I said:

“Regarding the adverse event itself, once it has been reported to us, further contact with the reporter (irrespective of who it is) is not made. But consumers and HCPs can read summary documents of reported adverse events of the medicine(s) on the Medsafe website.“

Your email expresses the view that:

“This would, as far as I know, contravene s22(f) of the Health Act 1956 and rule 6 of the New Zealand’s Health Privacy Code 1994 which you will be aware covers health information held by pharmaceutical companies.”

It looks like you might have taken a meaning from my email that was not intended. Roche is fully aware of its obligations under the Health Act and the Health Information Privacy Code and Roche’s policy and practise is to comply with those obligations.

What I was intending to convey is that as a general matter of policy, Roche will not initiate follow up contact with people that have reported an adverse event. Those people are still free to make contact with Roche and Roche will respond as appropriate. If an inquiry concerns a person’s own personal health information then Roche will:

provide that person with confirmation as to whether or not Roche holds the Information, if the Information can be readily retrieved (subrule 6(1)(a) of the HIPC);

provide that person with access to the Information, if the Information can be readily retrieved (subrule 6(1)(b) of the HIPC); and

provide that person with the right to correct the Information (subrule 6(2) of the HIPC),

unless Roche has appropriate lawful justification for refusing to disclose or provide access to the Information.

If, for example, we withhold Information for reasons in sections 27 to 29 of the Privacy Act 1993, we will inform that person of:

the reason for the refusal;

the supporting grounds; and

that person’s right to make a complaint to the Privacy Commissioner and to seek an investigation and review of the refusal.

I hope this addresses your concerns.

With kind regards

Stuart Knight
General Manager
Roche Products (NZ) Limited

So, there you have it folks. You send in an adverse reaction report to a pharmaceutical company and they don't have to reply. Pursue the matter and they have to give some sort of response.

It's seems a tad silly that one would have to follow-up their own report but at least we have it in black and white now, from Roche at least.

So if you fall into the category of my opening paragraph you may just want to get in touch with the pharmaceutical company that you wish to query.

Force their hand. Don't be an anecdote.

"Get busy living, or get busy dying" - Andy Dufresne

Bob Fiddaman

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SSRi Withdrawal - A Lesson For Doctors

2013-05-10T15:17:00.002+12:00

Far be it from me, a blogger, to give doctors a lesson in managing antidepressant withdrawal... but I'm going to anyway.

I've been writing this blog for 8 years now and, over this period of time, have been inundated with emails from patients struggling with withdrawal issues from their medication. Most popular question is along the lines of "How long does it take before these terrible side-effects go away?"

A good 90% of the emails start off by telling me the side effects, crying, sweating, electric-like zaps in the head, shaking, most of these conditions, if not all, appear when the patient starts to taper off the drug on the advice given by their healthcare 'professional'.

When I have told those who have contacted me about their medication being available in a liquid form they are flabbergasted. Why didn't my doctor tell me this? is the normal reply.

The liquid formulation for SSRi type medication came about as a result of pharmaceutical companies being able to persuade doctors [via their reps] that patients who had difficulty in swallowing their medication could always use the liquid. These 'patients' were the elderly and children. The liquid was never intended to be used as an aid to help people wean off the medication.

Wait a minute, these medicines aren't meant for children. Correct, but that has never stopped the pharmaceutical industry reps in their quest to boost company sales in return for that big bonus at the end of each month or quarter.

So, what about adults who have no trouble swallowing tablets? Well, the gist I'm getting from the emails I've received is that doctors tend to read the company spin on withdrawal.

Pharmaceutical companies never liked the word 'withdrawal' as it implied giving the patient a hard time so they changed it to 'discontinuation'. Doctor's when reading the product monograph for any of the SSRi's will read that 'discontinuation syndrome should only occur for around two weeks'. There is no information given to the doctor or patient about how much he/she should reduce their dosage by.

Contact the manufacturer of your particular SSRi and you are taken on a frustrating journey.

Pharmaceutical companies will tell you that they are not allowed to discuss individual patient cases and will refer you back to your healthcare professional, who remember has at his disposal the product monograph that claims 'discontinuation should only last around two weeks'.

Truth of the matter is, discontinuation/withdrawal can last months even years. Your healthcare professional won't acknowledge this because all he has to go on is what the pharmaceutical company have provided him [product monograph]

Some of the advice given by doctors that I've seen personally has ranged from the ridiculous to the sublime. Here's some:

Cut your tablet in half
Take 20mg Monday, 10mg Tuesday, 5mg Wednesday then stop.
Try stopping altogether at the weekend as there will be less stress in your life, ie; work, dropping the kids to school. If you still feel bad then start again on Monday.

One patient, a 17 year old, was told by his trainee psychiatrist, to stop taking his Prozac at weekends so he could enjoy up to six bottles of beer then restart again after the weekend. That patient, Toran Henry, killed himself shortly after being prescribed a generic form of Prozac [Fluox]

So, where can doctor's go for their information on antidepressant reduction?

Product Monograph [Written by the manufacturers of the drug]
Patient Information Leaflet [Written by the manufacturers of the drug]
Medicines Regulator [A body fully funded by the pharmaceutical industry]

Where do patients go?

Well, they go to the one person they can trust, their doctor. It may take a while for the patient to realise that the doctor is as clueless as they are when it comes to withdrawal help, it's then that they turn to either friends or, more commonly these days, Google.

Many patients find themselves using search terms such as 'Escitalopram aggression', 'Seroxat Brain Zaps', 'Cipramil Agitation'. The hits, when I first started this blog, were few and far between. That's when I learned that Seroxat isn't called Seroxat in the USA, it's called Paxil. Back then I Googled the words 'Paxil + Withdrawal' - I hit the jackpot. Website after website, forum after forum appeared. Stories about brain-like zaps, aggression, suicidal thinking, self-harming. The same can be said today for Cipramil and Escitalopram [both brand names for drugs known in the US as 'Celexa' and 'Lexapro' - Try a Google search yourself and you will see much more can be learned by typing in the US brand names opposed to the British/European brand names.

Even if you do find evidence that you are not alone in this withdrawal hell don't expect your healthcare professional to thank you for bringing the evidence to his/her attention. More than likely you'll be told that it was he/she who went through med school, if he/she does tell you this then ask him/her how long he spent covering SSRi withdrawal.

He/she may also tell you not to do your own research as you are either not qualified in such matters or the information on the internet about SSRi's is just conspiracy theories.

What you, as a patient, must do is TELL your doctor that you need a liquid version of your antidepressant so you can taper safely and effectively. Remember, this is YOUR body.

Tapering by using the liquid is a very slow process but it is much safer than skipping doses or drastic reductions in dosage.

You may find the taste somewhat off-putting, Glaxo's Seroxat liquid is orange flavoured and tastes like 5 cups of sugar has been added. If you can get through the bad taste then it's better than having to endure mind-bending electric jolts through your head.

Apparently the liquid formulations of SSRi's cost more, probably one of the main reasons doctors won't write scripts for them.

Remember that SSRi withdrawal is your own experience, it does not belong to your doctor or anyone else for that matter. Don't frustrate yourself because the manufacturers of your medication won't help you - that's just their way of avoiding litigation. If they acknowledge you are having a bad time on their drug then they'd have to acknowledge that other people are too - that would just open the door and they'd be flooded with personal injury lawsuits.

So, how slow do you taper once you have the liquid? As slow as you need to is the answer. I came down 0.5mg per week. [20mg dose of Seroxat = 10ml of Seroxat liquid] It took me over a year to drop from 40mg per day to 22mg per day. I then quit cold turkey - not recommended.

So, if you are a healthcare professional using Google and you have stumbled on this post then I suggest you put your BNF to one side, disregard all the pharmaceutical propaganda you have at hand, take off your God hat and start listening to patients.

The pharmaceutical industry will get richer from you, the patient, snapping up their sickly, foul-tasting liquid but at least you will be reducing the money going in their pocket. What's it to be, a slow taper or a life-time hooked on SSRi's?

At the time of writing this I'm only aware of four SSRi's that are available in liquid. Namely, Fluoxetine, Sertraline, Paroxetine and Citalopram .

Bob Fiddaman

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ROLL UP, ROLL UP - PHARMED-OUT CONFERENCE IS IN TOWN

2013-05-09T10:34:00.000+12:00

This year's 4th annual PharmedOut conference is hitting town and, judging by the speaker list, looks like it's going to be the best yet.

Highlight of this year's conference, for me at least, is the 'surprise guest' from a major pharmaceutical company who is going to be talking about ethical conflicts inside the industry.

PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.

Some of their goals are:

Document and disseminate information about how pharmaceutical companies influence prescribing
Foster access to unbiased information about drugs
Encourage physicians to choose pharma-free CME

Sadly, the conference is too far for me to attend but I'm sure it will be much talked about in the future.

So, if you are a lawyer, state government official, FDA official, or work for the pharmaceutical industry then you may just want to go and listen to what these speakers have to say... however uncomfortable it may be for you. Speakers include:

Marcia Angell MD, author of The Truth About Drug Companies: How They Deceive Us and What to Do About It; former editor-in-chief, NEJM
Virginia Barbour MD, chief editor, PLoS Medicine
Elizabeth Loder MD, editor, BMJ
Carl Elliott MD PhD, author of White Coat, Black Hat: Adventures on the Dark Side of Medicine and Better Than Well
Charles Ornstein, Senior Editor, ProPublica
Diana Zuckerman PhD, president of the National Research Center for Women and Families
A ghostwriter describing how he helped sell Low Testosterone Syndrome (“Low-T”)

You can register for the conference here.

Event start date: June 6, 2013 8:00 AM
Event end date: June 7, 2013 5:00 PM
Location: Georgetown University
Questions? Call: 202-687-1191

Email: nzd2@georgetown.edu

Bob Fiddaman

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Sara Carlin - 6 Years On

2013-05-06T11:45:00.001+12:00

18 year old Sara Carlin

Today [May 6] marks the 6 year anniversary of the death of Oakville teen, Sara Carlin.

Sara tragically took her life back in 2007 and her much publicized 2010 inquest saw her parents, Neil and Rhonda, face teams of lawyers representing doctors and GlaxoSmithKline.

Sara had, around a year or so prior to her death, been prescribed Glaxo's Paxil [paroxetine], a drug that is infamous for inducing suicide, particularly in children and adolescents.

Sara was just 18.

The inquest, that I labelled the Glaxo & Friends Vs The Carlin Family, rolled out apparent SSRi experts who made various claims that 'suicide is much more strongly related to cases of untreated depression' and in any event Paxil induced suicide is more common when first starting the drug.

Oh really?

Sara had missed her dose for three to four days leading up to her suicide. This was disregarded by the experts because "the information provided did not suggest that Ms Carlin suffered from the usual triad of symptoms seen with withdrawal" - Oh really?

Completed suicide is a symptom of withdrawal. There is no greater suffering than death Mr Expert Man!

Anyway, Sara's story went global and many, myself included, believe that her suicide was brought on by Paxil. Yes there were other factors, all of which were used by lawyers representing both Glaxo and doctors during the inquest. I've mentioned before how Glaxo like to blame everything but their product, Sara's inquest is a classic example of this.

We see this played out all the time in coroners courts. I don't envy anyone who has to sit through so called experts blaming the victim but softening the blow with terminology such as 'troubled youngster' or 'mentally ill'.

Coroners courts put the victim on trial and offer opportunity for people that didn't even know the victim to say how bad they was, be it through drinking, illegal drug-taking or being an uppity teen. We've seen victims of suicide bad mouthed before and after Sara's inquest, Toran Henry and Shane Clancy are two that spring to mind.

A whole heap of recommendations were made at the end of Sara's inquest. I have wrote about the word 'recommendation' before. It means nothing.

None of the recommendations made back in 2010 have been implemented.

Today my thoughts are with Neil and Rhonda

Here's a video I did for Sara back in 2010, a video that has been viewed over 13,000 times.

Nessun dorma Sara

Related Sara Carlin articles

Sara Carlin Inquest – Latest

Sara Carlin Inquest – Failure of Oakville Medical Profession

Sara Carlin – ‘Death by Paxil’ Inquest – The ‘Expert’

Sara Carlin Inquest – Coroner’s Witness In U-Turn… And That Man Shaffer!

Coroner’s Inquest – Glaxo & Friends Vs The Carlin Family

Sara Carlin Inquest – Local MP Slams GlaxoSmithKline

SARA CARLIN INQUEST - What The Jury Should Know

Sara Carlin Inquest - "Paxil likely played important role in teen's suicide"

Sara Carlin Inquest - The Eli Lilly 'Links' & Today's Recommendations.

**Exclusive - Sara Carlin Inquest: The Bias Of Coroner's Counsel, Michael Blain & Coroner, Bert Lauwers?

The Inquest of Sara Carlin and the Moderation of Yahoo Groups

Bob Fiddaman

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Guest Post: Like A Lamb to the Slaughter

2013-05-04T19:04:00.000+12:00

As this blog grows I get more and more requests from readers asking if they can write a guest post. This has proved very popular and gives a chance for people, patients to vent... none more so than the author of this post, Mark Carter.

As you will learn, Mark is yet another victim of the over prescribing of psychiatric medication, another victim of off-label prescribing.

Mark's story... and this is just part 1 of 3, is nothing new. Thousands, if not millions, of unsuspecting patients are, within minutes, walking out of consultation rooms with pills that are nothing more than loaded bullets. They are being diagnosed with ailments, in Mark's case sore wrists and arms, and then prescribed drugs that have no indication to treat the diagnosis.

This is, sadly, on-going globally.

Mark is from Auckland, New Zealand.

Here's part I of his story.

Like A Lamb To The Slaughter - Part I

I have decided to do a posting for Bobs blog for the following reasons:

1. It’s not acceptable to me, for SSRi’s especially paroxetine [Seroxat, Paxil, Aropax] and including venlafaxine [Effexor] to continue to be on the market.

2. It is my wish that these drugs be exposed for what they truly are; toxins that disrupt and chemically damage the brain and body.

3. I feel morally obligated to communicate to the general public the dangers of these poisons , as I have been grievously injured by taking and subsequently discontinuing them,

4. A dangerous, negligent and appalling level of ignorance from doctors who have thoroughly hoodwinked patients into believing black is white, and from whom no one has a chance of being informed of the truth.

5. I have nothing to hide only devastation to human life to expose

6. If I can stop one person from taking an SSRI or its evil cousins then its been worth it.

It all began in the summer of 2000. In December I presented to an Occupational Specialist Doctor D. with sore wrists and arms from keyboard overuse at my work site.

I was a 37 year old single, cheerful, happy, sports loving, opera chorus singing male. I had never smoked, drunk alcohol, or taken any drugs prior. I also had never had any psychological issues.

I was diagnosed with chronic pain syndrome and given what I now know to be a smorgasbord of poisons.

At the time I was like a lamb to the slaughter, naive, trusting and oblivious to oncoming danger.

I asked the right questions as anyone would, are these addictive, are there any side-effects?

I left assured they were not addictive but may find they give me a dry mouth.

I was also assured they would heal my arm.

Arrived home that day with canisters of amitriptyline, nortriptyline, venlafaxine, and paroxetine . I was told nothing regarding tapering down or not stopping abruptly.

I never felt comfortable with the diagnosis of chronic pain syndrome. The term at the time was repetitive strain injury or occupational overuse syndrome.

I also was filled with dread at being sent back to a job that I clearly could not do any longer. I clearly had an injury in my hand in which pain and an inability to type was amplified when using a keyboard and receded when not using the keyboard.

I was told to take a course of each drug and if no benefit move onto the next one.

I was totally unaware that I was about to expose myself to some of the most dangerous addictive mind-numbing soul destroying potent body damaging chemicals ever manufactured for human consumption.

I was totally unaware of the nature or the toxic effects of venlafaxine and paroxetine.

In hindsight I felt pressured to take these drugs, I mean not taking anything was never a tabled option.

I worked my way through the drugs, on starting the venlafaxine I immediately started getting floaters in my eyes. I was clueless. I also recall being incredibly fatigued, my walking became labored. I rang Dr D at the time from my former work site regarding the struggle to cope and was told to double the dose. Not long after this, my employer, as I could no longer use a keyboard, fired me.

As I no longer had to bare a workload and didn't really want to take drugs I quit cold turkey the venlafaxine, as one would with a so-called non-addictive drug that was doing nothing except fatigue me.

What I didn't know at the time, but I do now, is Dr D had persuaded me to take a sequence of drugs not authorized for use for my injury. He had in fact persuaded me to participate in the off-label use of the drugs and did it by obtaining my uninformed consent.

Shortly after this I started to manifest an uncontrollable anxiety, a kind of psychological panic, a distressed tearful state. There was something clearly wrong with me and something I had never experienced before.

I was clueless as to the cause of this, and thought it may be due to some external stresses at that time.

Concerned I now presented tearful agitated and confused to my family Doctor W of 20 years,… like a lamb to the slaughter. I can still remember my exact words at the time.

“There is something wrong with me, I don’t know what it is, you know me I’m so against the taking of drugs, but do you think I need something for this.”

Without any hesitation, enquiry or diagnostic checklist I was presented with a prescription for paroxetine 20 mg per day and sent on my way assured it was not addictive, safe and may cause a little weight gain.

And that was to be the start of a 10 year drug addiction with a sore arm somehow morphing into a drug induced 'mental illness'.

Stuck on paroxetine-Island only to be met by psychological and emotional shark infested waters every time I tried to leave.

And in addition totally unaware that I was now exposing myself to a slow chemical castration.

Mark Carter - New Zealand

Part II Coming Soon

If you would like to write a guest post then I can be contacted via the 'Contact' tab at the top of this blog.

Bob Fiddaman

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Patient Information or Litigation Disclaimer?

2013-05-02T11:24:00.002+12:00

I was browsing through some SSRi patient information leaflets [PILs] earlier and have come to the conclusion that the manufacturers warnings about this, that and the other are merely coded messages to the consumer.

Years ago, when SSRi's first hit the market, there were few warnings of side-effects. Sure, back then we had dizziness, nausea, sweating etc but that's standard for most, if not all, prescription medicines.

Today, after US litigation, patient reporting and, it has to be said, internet activism, the PILs take on a completely different look. They [the manufacturer] are telling us we can't sue because we were told.

It's almost as if pharmaceutical compliance departments had a eureka moment and turned really bad news into something that could be productive in the future. "Hey if we stick broad but vague warning labels on our drugs then we cover ourselves from future litigation... quick, get the number for that medical ghostwriting team we used back in 1998"

Let's take a look at Seroxat for example. [NHS Information]

Motion to dismiss

1. Some people who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment.

Very vague statement but one that would certainly be used by GlaxoSmithKline attorneys if they were ever faced with a lawsuit. "There is no case for your client as my client clearly stated in the patient information leaflet that Seroxat wasn't for everyone."

2. "If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide.

"If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible."

Again, Glaxo attorneys could have a field day, "Your honour, we have reason to believe that the deceased did not contact their prescriber, yet my client clearly stated in the patient information leaflet for them to do so if they were feeling suicidal, therefore we argue that there is no merit in this case"

3. Seroxat is not suitable for everyone and some people should never use it.

"Your honour, if the deceased had killed themselves by touching an electrical fence despite there being a warning not to do so would my learned friends still be representing him in court?"

4. Over time it is possible that Seroxat can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately.

"Your honour, the plaintiff may have become, over time, unsuitable for our client's product, he may also have had an adverse reaction to my client's product. At no time, leading up to his attempted suicide, did he contact his prescriber despite the fact that my client had advised this in the patient information leaflet."

5. You should only take this medicine during pregnancy if your doctor thinks that you need it

"Your honour, whilst my client has every sympathy for the birth defects the child in this case was born with, it was not my client's fault. My client never prescribed Seroxat to this young mother, it was her doctor."

6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth

"Your honour, how many warnings did this mother need, was she illiterate, could she not read? My client refutes any responsibly with regard to the plaintiff's son being born with septal heart defects. In fact, my client believes that it should be the plaintiff who should be facing prosecution for acting irresponsibly."

7. This medicine may decrease fertility in men.

"Your honour, he was warned."

8. Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.

"Your honour, my client blames the plaintiff and both the doctor and midwife, they should have read the patient information leaflet."

Judge's summation - Sadly, it is with great regret that I am granting GlaxoSmithKline motion to dismiss on the grounds that they covered all bases for any future litigation by applying warnings to their patient information leaflet. I am, however, recommending that in future Glaxo elaborate on the warnings. My recommendations are underlined:

1. Some people, particularly those who are poor metabolizers, who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment. GlaxoSmithKline nor your prescriber cannot tell you if you are a poor metabolizer so, in essence, by administering Seroxat you are playing solo Russian roulette.

2. If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide. Changes such as an increase in depression, anxiety, an inability to sit still, a lack of empathy toward others, excruciating electric-like zaps in your head, horrific nightmares where the subject matter is death, homicide, suicide. Outbursts of anger, for no apparent reason, aimed at those you love. If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible. NHS Direct et al should then telephone a 24 hour hotline, manned by an independent body who have no financial ties to GlaxoSmithKline, and request a safe withdrawal protocol. The patient should be hospitalized, at GlaxoSmithKline's expense, and monitored at regular intervals. Any item of clothing that could be used as an instrument for suicide must also be removed. GlaxoSmithKline's CEO, Sir Andrew Witty, should be contacted, no matter what time of day or night it is. Sir Witty may then realise that bad things didn't just happen to patients under JP Garnier's watch, they are still happening and are not part of "an era". Sir Witty can sit with the patient while he/she experiences thoughts of self-harm and/or suicide. Because of the logistics and vast number of people who suffer these kind of adverse reactions to Seroxat it is recommended that Sir Witty handpicks a team of GlaxoSmithKline executives to be on emergency call to tend to the needs of Seroxat induced suicide victims.

3. Seroxat is not suitable for everyone and some people should never use it. Some people cannot excrete Seroxat from their system quicker than others. This means that they build up toxic levels of the drug, in fact these people are overdosing on Seroxat without actually knowing it. This simple fact should be made crystal clear in future patient information leaflets. Sir Witty and his handpicked team of executives should disseminate this information to the public by word of mouth. Alternatively a full page advertisement can be used in popular mainstream newspapers to warn this vulnerable patient population. "Toxic levels of Seroxat may lead to self harm and suicidal thoughts" should also be added to the patient information leaflet.

4. Over time it is possible that Seroxat can become unsuitable for some people, particularly those who are poor metabolizers, or they may become unsuitable for it, particularly those who are poor metabolizers, If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately. The Prescriber should then contact GlaxoSmithKline to file an adverse reaction report. In turn GlaxoSmithKline should investigate the adverse reaction and report back to the prescriber with a causality assessment. This will then help the prescriber decide, in future consultations with patients, if Seroxat is the drug for them.

5. You should only take this medicine during pregnancy if your doctor thinks that you need it - This whole sentence needs drastic change. A doctor does not have access to the rat pup studies that GlaxoSmithKline has and kept from the public. Expectant mothers should be made aware of the Sloot study whereby Seroxat and other SSRi's were exposed to rat fetuses. Out of all the SSRi's used in this study only one came out as a clear teratogen - Seroxat. Another example of a teratogen, in case consumers are not aware of the word, is the anti-nausea and sedative drug, Thalidomide.

6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth. The sort of 'problems' are:

Persistent Pulmonary Hypertension of the Newborn (PPHN) – 6 times increased risk
Anencephaly (fatal neural tube defect) – 2.5 times increased risk
Clubfoot – 5 times increased risk
Craniosynostosis (craniofacial defect) – 2.5 times increased risk
Omphalocele (abdominal wall defect) – nearly tripled risk
Gastroschisis (abdominal wall defect) – 30 percent increased risk
Pulmonary Atresia – 3 times increased risk
Spina Bifida – 60 percent increased risk
Diaphragmatic Hernia – 80 percent increased risk
Anal and Esophagal Atresia – 30 percent increased risk
Heart Defects – nearly doubled risk
Septal Defects, including Atrial and Ventricular (also known as “hole in the heart” defects)
Hypoplastic Left/Right Heart Syndromes
Malformed or blocked heart valves that will not close
Transposition of the Great Arteries
Tetralogy of Fallot
Mitral Valve
Heart murmur

Like packets of cigarettes I make the recommendation that GlaxoSmithKline add a photograph to the packaging of Seroxat. An example is below.

Spina Bifida – 60 percent increased risk when taking Seroxat [1]

7. This medicine may decrease fertility in men. Given recommendation 6 this may not be such a bad thing, particularly if the female partner is also digesting Seroxat. Sir Witty and his team of handpicked executives may wish to visit any male patient who has decreased fertility as a result of taking Seroxat and, if requested, help to fill out some adoption forms for the wannabe father. GlaxoSmithKline shall foot the bill for the whole adoption procedure, including lawyers fees and expenses for the child up to the age of 19.

8. Before you have your baby you should discuss breast-feeding with your doctor or midwife as Seroxat can find a way into your baby when he/she breast feeds. This can cause serious implications for the newborn child and may result in Seroxat overdose, addiction, agitation and in some instances death. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. They will also offer you the court transcripts from the Kilker Vs GlaxoSmithKline birth defect trial where GlaxoSmithKline were found guilty for manufacturing a drug [Seroxat] that caused Lyam Kilker to be born with heart defects. This will help expectant mothers to make a fully informed decision and may deter them from breast feeding given that Seroxat can harm a baby whilst it is still in the womb so chances are the baby can be harmed if ingesting breast milk that is still in the mother's system. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife and with the knowledge that your doctor or midwife actually know what they are talking about.

I make these recommendations with the knowledge that healthcare professionals and GlaxoSmithKline have the right to ignore them as do global medicine regulators and coroners. In fact, the word 'recommendation' means nothing. It just makes people like me seem as if I really care when in actual fact I'm just recommending what I think should be done but I know that the likelihood of any recommendations made simply means that nothing has to be adhered to. I'm a Judge and I have to be seen to be doing something. I use war as an example. World leaders got together to fight the might of Hitler. At some point it was only recommended that they intervene. They didn't have to but because they did they stopped Hitler, some would suggest that those recommendations to intervene should have been carried out earlier, maybe more lives would have been saved. Thing is, those recommendations were listened to, they were put into place and we are a better world for it.

I would urge for GlaxoSmithKline's CEO and handpicked executives to search their consciences but past litigation [in the US] has shown that these individuals blame everyone and everything but their product.

I would like to recommend that Seroxat is removed from the shelves but know I would face tough opposition from those who have been duped into believing that the benefits of this particular antidepressant outweigh the risks. The risks, all of them, should be printed out in clear laypersons terms, again, I can only recommend this. I do know that, after reviewing all the court documents in cases such as Seroxat induced suicide, Seroxat birth defects, Seroxat withdrawal/addiction, that I will never allow any family member of mine to take this drug. That's my privilege as I am a Judge.

Glaxo's motion to dismiss - Granted.

Rt Hon Judge I.M Pointless

**Footnote**

Later that year the Rt Hon Judge I.M Pointless granted the same motions to Eli Lilly, Wyeth, Pfizer, Forest Labs, Lundbeck and other SSRi manufacturers, including those manufacturers that make generic versions of SSRi medication.

He also made similar recommendations.

[1] Birth Defects Cased By Seroxat [Birth Defect Resource]

Bob Fiddaman

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An American Psychiatrist in New Zealand

2013-04-30T07:02:00.000+12:00

"Beware the moon" - An American Werewolf In London [PolyGram Pictures 1981]

I wish this were parody. It's not.

A reader from NZ sent me the following audio . His GP was unable to explain the sexual dysfunction after exiting from 10 years of ssri use, given to him to cure repetitive strain injury from keyboard overuse, so he was referred to a psychiatrist to get some answers . He asked the psychiatrist what was the future prognosis. The psychiatrist, having just claimed he'd never heard of pssd (post ssri sexual dysfunftion), then went on to explain the reasons for the sexual dysfunction.

The audio is now available on youtube [video below] - For those who, like me, find some of the audio difficult to listen to, there's a transcript for you perusal.

The patient, Mark Carter, will be writing a series of guest posts for my blog soon. In the meantime, please listen to this remarkable audio.

Before you listen it may be useful to know what PSSD is.

I won't go into the mechanics of it all, in a nutshell PSSD is a sexual dysfunction believed to be caused by SSRi use, an SSRi being the group of drugs we more commonly know as, Celexa, Lexapro, Prozac, Paxil, Zoloft and the SSRNi, Effexor. These are all US brand names and may be called something else depending on what part of the world you live in.

Pharmaceutical companies know there is a problem but, as usual, play it down. They claim that "psychiatric disorders" can cause sexual dysfunction thus enabling them to say that untreated depression can be dangerous. They say the same about suicide - whilst acknowledging that SSRi's can induce suicide they claim that depression causes suicide.

Ironically, another SSRi, GlaxoSmithKline's Wellbutrin, has been deemed as a treatment for PSSD. Treatment with Wellbutrin comes on the back of studies that show it's one of the SSRi's that doesn't cause PSSD. Amazing huh, if a pill doesn't cause an adverse event then it must be able to treat it!

The psychiatrist featured in the audio recording explains PSSD as something completely different than an SSRi induced problem, in fact, after listening I'm not sure the psychiatrist exactly knows what causes PSSD.

Transcript.

Mark - “Is it going to improve because it seems to me like it's been two years and it seems to be diminishing you know… I just want to know if it’s coming back or its going to be permanent?”

Psychiatrist - “Well I think the other factor that has to be considered here is age, now I have the advantage or disadvantage of being older than you are and I know that...er... desires tend to diminish with age, so there’s that, and then there is also … circumstances.

"I have to tell you that one thing I appreciate about New Zealand culture and on the other hand I have to say is quite different from the States. There is very little sexual provocation around here, women tend not to dress sexually whereas in the States, if you are on the sidewalks of New York, probably every 10th woman you would be looking at because she is dressed provocatively and have…. so the demure in which you are has a lot to do with it and one of the ways we know this is that er... because...er... stories about Catholic priests and sexual abuse aside, when people dedicate themselves to the monastic life...er... their testosterone levels go down measured in this more accurate way as I've described um… so…. so the prognosis here in part depends on whether or not you are reacting to age whether or not you are getting sexual stimulation apart from manual and um… and then there’s the whole question of what role sex plays for you psychologically...er... and... um... to what degree is that bound up in intimacy and that gets to be very complicated.

"There are some people who don’t have sex unless they are feeling really close to another person, and there are other people for whom being close to another person is in fact somewhat of a turn off that’s why there are all these people who are married and have mistresses, so it can get very complicated and I can’t give you a prognosis."

----

Er...um... thanks for clearing that up doc. Only thing I learned after listening to this explanation of PSSD is that more women in New York dress provocatively than they do here in New Zealand. I don't know if that's a compliment to New York women or a compliment to women of New Zealand.

Coming Soon: A trilogy of guest posts from Mark Carter in which you will learn how Paxil and Effexor were prescribed for repetitive strain syndrome and how this started a series of chain reactions.

Bob Fiddaman

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Celexa/Lexapro... Or Your Money Back

2013-04-27T07:47:00.002+12:00

Not for use in children and adolescents

Celexa [citalopram] and Lexapro [escitalopram] are two antidepressants in the family of SSRi's. Some would argue [I'm one of them] that both antidepressants are pretty much the same. Let's face it, Lexapro only ever came to market because the patent was running out on Celexa.

Forest Labs, the manufacturer, have argued that the two drugs differ, maybe so but the end result is the same particularly when it's been down to the marketing team of Forest Labs.

Once again, kids have been targeted despite these group of drugs bearing warnings that they were not recommended for pediatrics.

How do we know this for sure?

Well, in 2010 Forest Labs settled with the US government. Forest Labs were accused of illegally promoting Celexa for use in children and adolescents despite the fact it had not been approved for marketing in the United States.

In other words, they were promoting the use of Celexa in kids to doctors through "off-label" marketing.

We know how that works, right?

Kickbacks, holding back negative study results, ghostwritten papers, in general bending the law to suit their needs.

Forest Pharmaceuticals, a subsidiary of Forest Labs, also pled guilty to a whole range of underhand practices including misbranding Celexa by marketing it for use in children from 1998 to 2002.

With these two settlements Forest Labs and Forest Pharmaceuticals have paid out a wad of cash, moved on and now, it seems, it's business as usual.

But there's one final twist in the Forest saga.

Both Forest Labs and Forest Pharmaceuticals, because of their illegal promotion, now may have to reimburse the families of those who paid for prescriptions of Celexa and Lexapro. Rightly so too.

A consumer fraud class action is underway, meaning that if you as a parent of a child who took Celexa or Lexapro can claw back what you paid. Quite a hefty amount if your child was on either drug for a long time.

These types of consumer fraud cases need a lead plaintiff, someone that not only represents their child or children but one who represents the whole class action. It's like a lead case. Classic example here being the Kilker V GlaxoSmithKline case. Lyam Kilker was born with heart defects as were 800 other kids. Kilker et al represented the class action, they won the case against Glaxo which meant Glaxo settled the majority of other cases.

The Forest lawsuit is looking for additional class representatives. There are already some lead cases in places for many of the US states but more are needed. I'm pretty sure those that represent a group action are compensated handsomely, and why not - putting yourself out front deserves to be rewarded.

I think it's important to keep the pressure on Forest. Settling with the government is one thing, now it's time to settle with the people they duped - the public.

A cynic would suggest that this is just about the dollar, they'd be wrong. This is about getting your teeth into a pharmaceutical company and biting them so hard that they think twice about doing any dirty deeds again.

If I had my way I'd put those responsible behind bars, to promote something that is harmful to any human is wrong, to promote it for children is despicable and abhorrent. Sadly, the only way to hurt big bad pharma is in the pocket and media.

Forest have made two settlements, they should now cough up to those who matter, the parents who forked out money for weekly prescriptions of Celexa and Lexapro.

The fact that some kids never experienced any adverse reaction is irrelevant here. The fact is both Forest Labs and Forest Pharmaceuticals played Russian roulette with children and for that two things should happen.

1. They should be held accountable.

2. They should compensate those they played Russian roulette with.

Both Forest Labs and Forest Pharmaceuticals made huge profit from Celexa and Lexapro, they did so by basically using children as guinea pigs, they did so by wining and dining doctors so they would prescribe more Celexa and Lexapro to children, they did so by withholding negative data about both drugs, data that showed that Celexa was no more effective than placebo for pediatric use.

Why should any company, be they pharmaceutical or a fizzy soda drinks company benefit from putting children's lives at danger?

So, did you or do you know anyone that paid for prescriptions for their children and/or adolescents for Celexa and Lexapro between 2001 and the present day? If so, then you may want to represent a class action in your state.

You can find out more information by calling 800-827-0087 or by filling in an online form HERE.

Forest Labs and Forest Pharmaceuticals should not benefit from your purse, particularly when the products they promoted for children and adolescents were actually dangerous for this vulnerable population. Their shareholders should not benefit from your purse either, namely, Wellington Management Company, LLP, Icahn Associates Corp and many more.

The full complaint can be read, in PDF form, HERE.

Bob Fiddaman

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Global Medical (Mis) Information

2013-04-24T22:43:00.001+12:00

I was sent a private email on Twitter a few days ago from Global Medical Education, known on Twitter as @GlobalMedEd. The blurb on their Twitter page reads, "GME is an online medical education resource that provides evidence-based medical education from faculty at Columbia, Duke, Harvard, Oxford, Stanford and more."

The content of the email was baffling considering I've been blogging about the dangers of antidepressants for over 7 years.

We're offering FREE access to 700 unbiased, evidence-based psychiatric videos Code: GMETwitter http://bit.ly/Pzvkhs Limited time offer.

So, I checked out the GME website and watched a few of the videos on offer. Ones about ADHD, bipolar, depression and many other box-ticking illnesses.

I publicly tweeted GME and asked the following:

@globalmeded Do you have any educational videos on SSRi induced suicide?
— BOB FIDDAMAN (@Fiddaman) April 22, 2013

A day later they replied with...

@fiddaman you may be interested in this video here: ow.ly/kk8aT I hope that helps.
— Global Med Education (@GlobalMedEd) April 23, 2013

So, I checked out the video.

I watched it... then I watched it again... and to be sure I wasn't hearing things I watched it for a third time.

The video features Manpreet K. Singh an Assistant Professor, Department of Psychiatry and Behavioral Sciences and Associate Director, Pediatric Bipolar Disorders Clinic. She's also a Pediatric/Adolescent Psychiatrist practicing from the Stanford University School of Medicine

I'll dissect Singh later in this post, first I want to highlight the video GME entitled, Can Antidepressants Cause Suicidality in Children and Adolescents?

There's even a slide show a separate audio commentary if watching videos isn't your thing.

Singh starts off by telling us that suicidal thoughts and behaviours are more common in adolescence than at any other time, but completion is more common among adults. Not in NZ where the highest suicide rates are in the 15-19 age group. She goes on to tell us that untreated depression increases the risk of suicide.

One can assume here that Singh is setting her stall.

She juxtaposes the FDA decision to add a black box warning to antidepressants with the following...

There were no cases of suicide in the cases they [FDA] studied. Autopsies of teenagers who have committed suicide show that very few of them had traces of an antidepressant, making the link between antidepressant use and suicide even weaker.

She then tells us...

Between 1992 and 2001, there was a large increase in the number of adolescents being prescribed antidepressants.

Adding...

But during that time the rate of suicide among American youth ages 10-19 dropped by more than 25%. This was the first time in nearly 50 years that the suicide rate declined in young people.

She makes no reference to the study, one can only assume she is refering to the [now debunked] studies of Robert Gibbons. His paper regarding suicide rates was described in the BMJ as “astonishing,” “misleading,” and “reckless.” Even one of his own researchers, Ron Herings, claimed, findings are “not right” and that it “ doesn't follow from the data, it is not true and serves just to scare people. It is hard to admit this, as I am one of the authors of the article and I attached my name to it …” [1]

Bob Whittaker, an award winning journalist and author, takes up the story of Gibbons here. Retired psychiatrist, Mickey Nardo, also highlights the flaws of Gibbons here.

Anyway, back to the video... or rather the star of the video, Manpreet K. Singh [Fig 1]

Fig 1

Her CV, at first glance, is impressive...if the field of psychiatry impresses you, that is. However, Singh fails to mention on her CV or the video message on GME that she has links to the pharmaceutical industry. She has, however, disclosed relevant financial relationships in various psychiatric journals. In 2007, for example, she disclosed she had relevant financial relationships with AstraZeneca, Otsuka, and Pfizer [2]. Also in 2007 she disclosed that she serves as a subinvestigator for Eli Lilly, AstraZeneca, Bristol-Myers Squibb, Janssen, Pfizer, Abbott, and Shire Pharmaceuticals. [3]

Jump to 2010 and she declares that she has no financial ties or conflicts of interest to disclose. [4] Yet Pro Publica have her down as receiving $1,209 from Pfizer in 2010. [5]

As for the claims she makes in the video, let's just take a look at them once again.

There were no cases of suicide in the cases they [FDA] studied. Autopsies of teenagers who have committed suicide show that very few of them had traces of an antidepressant, making the link between antidepressant use and suicide even weaker.

What Singh fails to mention is the FDA were powerless to track down a large number of subjects in the clinical trials that were lost to follow up [IE; dropped out of the studies as a result of adverse reactions] These subjects were never followed up to see if they killed themselves. She also blatantly misses the point that when patients are prescribed antidepressants they are still part of a clinical trial, it's called the post-marketing phase.

Singh also fails to mention that the autopsies was just one method the FDA used to determine the risk factor of antidepressant use in adolescents. The FDA actually looked at data obtained from their British counterpart, the MHRA, who, after analyzing studies done by GlaxoSmithKline, found that “These data do not demonstrate efficacy in depressive illness in this age group and show an increase in the risk of harmful outcomes including episodes of self-harm and potentially suicidal behaviour in the Seroxat group compared to placebo. Various analyses suggest that the risk of these outcomes is between 1.5 and 3.2 times greater with Seroxat [Paxil] compared to placebo.” [6]

Once the Paxil danger had hit the streets Wyeth soon announced via a letter warning physicians that venlafaxine (Effexor and Effexor XR) was associated with an increased rate of hostility and suicidal ideation in pediatric clinical trials.

To what length did the FDA go to see if there were traces of antidepressants? What tests were carried out and how stringent were they?

An independent report by Janne Larsson, analyzed the 2007 suicide data documented by the Swedish National Board of Health and Welfare (NBHW) and from the regional departments of the National Board of Forensic Medicine. The data, not readily available to the public, was obtained under Freedom of Information requests. [7]

In 2007, there were 1,126 suicides in Sweden (325 women and 801 men). Autopsy reports were made for 1,109 of the suicides, which is 98%.

The majority of persons who died by suicide in Sweden in 2007 had received extensive treatment with psychiatric drugs within a year of death by suicide.

Janne Larrson, a Swedish investigative journalist, had requested the records under the Freedom of Information Act. He learned that , "In the forensic toxicological analyses traces of psychiatric drugs were found in 575 persons (52%) of the 1109 analyses done. Traces of antidepressant drugs were found in 132 (41%) of the women investigated."

None of the documented 1,126 suicides were reported to the agency that maintains adverse drug reaction data.

These were adults.

If questioning the methods of the FDA analyzing teenage autopsies one need look no further than the case of 17 year old Toran Henry. Toran had been prescribed the generic form of Prozac [Fluox]. A change in mood, abnormal behaviour culminating in suicide - this just 15 days after he had first ingested Fluox.

During the inquest of Toran, his mother, Maria, called for a toxicology report. The first, taken on the 28th March 2008 found only alcohol in Toran's system. Knowing her son was taking Fluox at the time of his death Maria requested a further toxicology report. In the 14th April 2008 a second test was carried out. Here's a direct quote from the inquest transcript:

"No fluoxetine was detected in the blood, this analytical technique will detect therapeutic use of this antidepressant drug."

Once again Maria knew this was wrong. She pushed for a third toxicology report.

On 23rd July 2008 a third test was carried out. This from the inquest transcript:

"Blood was analyzed for the detection of fluoxetine - fluoxetine detected - 3rd test was carried out as requested by Ms Bradshaw, Toran's mom"

Three blood tests, the second apparently being so robust that "this analytical technique will detect therapeutic use of this antidepressant drug."

Truth is, it didn't.

The truth was outed but it took a grieving mother to out that truth.

For the purpose of this argument let's assume that 17 year old Toran Henry was a black box retrieved at the site of an airline crash. Let's assume that investigators found nothing within the black box that suggested any malfunction in the plane. Let's assume that after a second investigation of the black box, a more robust one, that, once again, nothing was found. Now, let's assume that after a third investigation something was found, that something was the cause of the airline crash. Would we, as members of the public, have faith in investigators one and two?

Five years down the line and both the New Zealand government and Mylan, the pharmaceutical company that manufacture Fluox, have admitted that the probable cause of Toran's suicide was down to the Fluox he ingested. [8] [9]

One would have to question then the methods used by the FDA in determining whether or not antidepressants were found in the autopsies they studied.

There are many tests carried out for toxicology, we've seen what happened in the case of Toran Henry. Were the FDA relying on autopsies that carried out toxicology tests just like the first two methods in the case of Toran Henry? I'm surprised nobody has asked them this.

There are a number of tests that can be carried out. Here's some for just one of the SSRi's, Prozac. Which ones did the autopsies the FDA studies use? Could it be argued that there were few adolescents with antidepressants in their system because the wrong type of toxicology test was carried out? It's a fair enough question, right?

Moving on the Singh's other claim in her 4 minute video...

Between 1992 and 2001, there was a large increase in the number of adolescents being prescribed antidepressants. But during that time the rate of suicide among American youth ages 10-19 dropped by more than 25%. This was the first time in nearly 50 years that the suicide rate declined in young people.

I'll use simple tit-for-tat here.

SSRi's were introduced to New Zealand in 1989. The table [Fig 2] shows a general increase in suicides since their introduction.

Fig 2

To take this one step further, let's now take a look at 2008 onwards.

Here's the prescription rates for antidepressants in NZ - 2008/2012 [Fig 3]

Fig 3

And now let's look at the NZ suicide statistics.

2008 - 540
2009 - 531
2010 - 541
2011 - 558
2012 - 547

So many antidepressant prescriptions, so many suicides.

On top of this myself and Maria Bradshaw [CASPER] are in the middle of writing up a cohort study. We have, under the freedom of information act, obtained suicide data from the same district health boards [DHB's] seen in Fig 3. Initial findings see 90% of those who died under the care of DHB services were on or were recently on psychiatric medication at the time of their suicide. The figures we have will be made public once we have completed our study.

As for Global Medical Education and Manpreet K. Singh, I believe the information they provide with regard to suicidality in adolescents on antidepressants is very misleading, very one-sided and extremely dangerous.

Watching the performance of Singh left a terrible feeling of helplessness in the pit of my stomach. For a professional to go against the regulators and manufacturers of these dangerous medications means that less internet savvy members of the public may find themselves one day Googling whether or not antidepressants are safe in children and adolescents. Her biased [read from an auto-cue] performance may convince parents that antidepressants are safe when used by this vulnerable population. She may also have convinced healthcare professionals.

Here's the video

Global Medical Education carry the disclaimer at the foot of their website, "All material on this website is protected by copyright, Copyright © 2013 by GME Inc. This website also contains material copyrighted by 3rd parties."

If they feel I have infringed their copyright by posting their video on my blog then I request that they email me, they can do so by using the 'Contact' tab at the top of this blog.

Worryingly, Global Medical Education have over 5,000 followers on Twitter. If all of those 5,000 + received a private message from them, as I did, then it would appear that they are pushing the promotion of their website to all and sundry... even to those who vehemently believe that antidepressants can cause suicide.

Bob Fiddaman

[1] Coincidence a fine thing - David Healy [Link]
[2] Pharmacotherapy for Child and Adolescent Mood Disorders
Manpreet K. Singh, MD, MS; Jonathan C. Pfeifer, MD, MS; Drew Barzman, MD; Robert A. Kowatch, MD, PhD; Melissa P. DelBello, MD, MS [Link]
[3] Journal of the American Academy of Child & Adolescent Psychiatry Volume 46, Issue 3 , Pages 306-307, March 2007 [Link]
[4] Neural Correlates of Response Inhibition in Pediatric Bipolar Disorder
Manpreet K. Singh, M.D., M.S, Kiki D. Chang, M.D. Paul Mazaika, Ph.D., Amy Garrett, Ph.D., Nancy Adleman, Ph.D., Ryan Kelley, B.S., Meghan Howe, M.S.W., and Allan Reiss, M.D. [Link]
[5] Payment Disclosure - Singh, Manpreet, Kaur [Link]
[6] WHO Drug Information Vol. 17, No. 2, 2003 [Link]
[7] Psychiatric drugs & suicide in Sweden 2007 - Larsson [Link]
[8] Mylan's Fluox Can Probably Induce Suicide, admit Mylan [Link]
[9] CARM Assessment of Toran Henry's suicide [Link]

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Canadian Network Report on Big Bad Pharma

2013-04-22T09:46:00.001+12:00

Well worth watching.

As usual the pharmaceutical companies mentioned (Eli Lilly, Pfizer and GlaxoSmithKline) in the 16×9 investigation failed to appear in front of camera, opting instead for the tired old "Our drugs are safe and effective" kind of statement.

The regulators come under fire too. Footage includes Pete Breggin and David Healy.

Good to see Canadian TV highlighting the flaws of antidepressants... only wish their limp-wristed regulator, Health Canada, were the same.

**If you can't get the video player to load you can watch it via the TV network [HERE]
Bob Fiddaman

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Glaxo Add to Their List of Misdemeanours

2013-04-20T14:06:00.002+12:00

GSK's addictive antidepressant, Seroxat

One would have thought that British pharmaceutical giant would still be licking their wounds after the record fine of $3billion they dished out a couple of months ago.

No sooner had that particular scab healed Glaxo find themselves [once again] in hot water.

And it's Seroxat that rears its ugly head [once again]

This time Glaxo haven't been accused of pushing it on kids via ghostwritten articles or Madonna tickets for doctors... they've been accused of not allowing other companies to get in on their act.

How did they do this?

I'll explain.

When Seroxat first hit Britain it did so for only a limited time. When pharmaceutical companies bring a drug to market they have the sole rights to that drug until their patent expires. Then, and only then, can other pharmaceutical companies come along and use the compound [paroxetine]. Pharmaceutical companies don't like this so are always devising ways to extend their patent. A clinical trial that tests the drug in kids will give them that extension and increase profits.

So, Glaxo's patent for Seroxat was coming to an end. Three other pharmaceutical companies were waiting in the wings to produce a generic version of Seroxat, a version that would be sold at a much cheaper price and therefore hitting Seroxat [manufactured solely by GSK] sales.

So here's what Glaxo did [ahem allegedly]

Glaxo made “substantial payments” to Alpharma, Generics UK and Norton Healthcare to stop them releasing version of its paroxetine. This would have meant that Glaxo would have been able to profit from the sale of Seroxat and, at the same time, would have meant that their shareholders and investors would have been kept sweet.

Who accuses them of this?

Well, it's not an activist blogger, it's The Office of Fair Trading [OFT] whose job is to make sure that consumers have as much choice as possible across all the different sectors of the marketplace.

In a statement the OFT "alleges GlaxoSmithKline (GSK) concluded agreements which infringed competition law with each of Alpharma Limited (Alpharma), Generics (UK) Limited (GUK) and Norton Healthcare Limited (IVAX) ('the generic companies'), over the supply of paroxetine in the UK. The OFT also alleges GSK's conduct amounted to an abuse of a dominant position in the same market."

The statement adds:

"The OFT's provisional view is that these agreements included substantial payments from GSK to the generic companies in return for their commitment to delay their plans to supply paroxetine independently."

GSK making substantial payments around Seroxat, surely not.

The allegations in this case concern so called 'pay for delay' agreements, where a manufacturer of branded pharmaceuticals, in this instance GlaxoSmithKline, makes payments to a generic company in return for that generic company agreeing to delay its independent entry into the market for a product, in this instance paroxetine.

Glaxo have responded in usual style. A statement on the GSK website stresses that "GSK supports fair competition and we very strongly believe that we acted within the law"

No mention or excuse that this was just part of an era.

Here's how the BBC broke the news.

Jensen Button and the McLaren team must be wondering if the sponsorship deal with Glaxo was such a great idea after all. [Back story]

Some of the major GSK shareholders today include Dodge & Cox Stock, Vanguard PRIMECAP Inv and the Royal Bank Of Canada.

Bob Fiddaman

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Paxil Birth Defects... (They Knew)

2013-04-19T13:15:00.000+12:00

Today I am going to revisit a Paxil birth defect case from 2009.

What makes this case unique is that court documents were made available, giving us all an insight into how trial lawyers operate and how unsealed evidence proved to be the downfall of British pharmaceutical giant, GlaxoSmithKline.

I'm going to focus on the opening statements that were read to the jury by the plaintiffs attorney. The purpose of an opening statement is for an attorney to tell a jury what he/she expects the evidence to show.

The case, LYAM KILKER, a Minor, by MICHELLE M. DAVID, as Next Friend and Individually VS. SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE, astounded many as little by little the truth came to the surface regarding Paxil's propensity to cause birth defects.

Lyam Kilker was born with heart defects. His mother, Michelle David, had taken Paxil during her pregnancy.

September 15, 2009
13 Courtroom 253, City Hall
Philadelphia, Pennsylvania

Sean Tracey of the Tracey Law Firm [Attorney for Kilker]
Glaxo were represented, as usual, by King & Spalding

To set the scene, in other words, to make this more humane than (as it turned out through the verdict) inhumane. Sean Tracey introduces both Lyam and his mom to members of the jury.

MR. TRACEY: May it please the Court, good morning.
JURORS: Good morning.
MR. TRACEY: I am going to reintroduce myself. My name is Sean Tracey. I represent Michelle David and Lyam Kilker. Before I begin, I want to reintroduce to you Jamie Sheller here, and there are a couple young lawyers up front here. Scott Love and Adam Peavy you are going to see wandering around and probably hearing from during this trial. Who you haven't met are my clients. This is Michelle David. Michelle, will you stand up. This is Michelle David. Over here with Michelle's mother is Lyam Kilker. Lyam is here with his grandmother. Lyam is going to stay a few minutes, then I think his grandmother is going to take him out of the courtroom.

Next we see Tracey explain to the jury the injuries caused to Lyam Kilker.

MR. TRACEY: This is the time for me to talk to you about what I believe the facts are going to be, what I think the evidence that comes in during this trial is going to be through the witness stand starting this afternoon, and through the documents that I have obtained as a result of this lawsuit. And so I want to start that by, this is the name of the case, as you have heard, Kilker versus GlaxoSmithKline. And Lyam Kilker, this is going to be undisputed, Lyam Kilker was born October 24, 2005. And shortly after he was born, Michelle found out he had been born with a series of congenital heart defects. During the time Michelle was pregnant, before she was pregnant, she was taking Paxil. She was on Paxil for her first trimester. Now, Lyam, after he was born, was at the hospital and he was diagnosed and his heart defects, there really are three. One is called the ventricular septal defect. One is called an atrial septal defect. Those are holes on the inside of the heart in the walls that separate the four chambers of the heart. The other heart defect he had is something called an interrupted aortic arch. The aorta, where it is supposed to curve, doesn't fully develop. And so what he has is three different, distinct heart defects, each of them related to the failure of his heart to fully develop.

Tracey then goes on to explain to the jurors about the FDA pregnancy categories.

MR. TRACEY: The first one is pregnancy Category A. Are there adequate and well-controlled studies? Are there human studies that demonstrate there is no risk to the fetus? If it is Category A, you can take this drug with impunity and you don't have to worry about children, you don't have to worry about if she gets pregnant. You will learn during this trial that, I think, over 50 percent of pregnancies in the United States are unplanned. Women aren't planning on getting pregnant. That's why these categories can be so important. You don't just consider these categories when you have a woman who is planning a pregnancy. It is any woman of childbearing years who may become pregnant. The evidence in this case is going to be that GlaxoSmithKline knew that over 50 percent of the women in the United States became pregnant without trying to, they were unplanned pregnancies. They knew this back in the 1990s. So Category A, no problems.

Category B, we have done animal studies, doesn't look like there is any problems. Animal studies have failed to demonstrate a risk to the fetus, but we don't have any human studies.

Category C is, we have done animal studies, we have done animal studies, and the animal studies have shown an adverse effect on the fetus, but we don't have any human studies at all.

Category D is, there is positive evidence, there is positive evidence of human fetal risk based on a number of different things, either adverse reaction data from investigations they do or adverse marketing data from women and doctors reporting problems with the drug or from studies. And in that case in a Category D drug you do not prescribe that drug to women of childbearing age with one exception. If the doctor decides that the benefit to the patient is worth the risk to the fetus, then the drug can be prescribed. Doctor Healy, who is a psychiatrist and neuropyschopharmacologist who is going to testify this afternoon, will explain that there may be times when the disease is so serious that it may be worth the risk to the doctor and the patient if there is a life-threatening illness. If somebody is capable of harming themselves or others, they may make the decision to prescribe the drug if, there is no alternatives.

Category X is, we don't care what the benefits are. You do not give this drug to a woman unless she has a pregnancy test that shows she is not pregnant.

Tracey adds:

MR. TRACEY: In 2004 when Michelle David was prescribed this drug, it was a pregnancy Category C, and GlaxoSmithKline says their animal studies have revealed no evidence of teratogenic effects.

Tracey then explains to the jury the process of human development.

MR. TRACEY: In human development when women get pregnant, what you are going to learn and understand is that the most vulnerable time to the human fetus is from weeks 3 to weeks. That is when the fetus is dividing and growing and is the most susceptible to something called a teratogen to a drug that can cause a birth defect. During weeks 3 through 8 the body is rapidly, rapidly expanding, rapidly developing. Cells are being signalled to go to where they are supposed to go. The heart is developing by week 8. By week 8 the heart, from a cellular perspective, is almost completely developed, and there is nothing you can do after that to prevent the heart, to prevent a heart defect if it has already occurred. The importance of this is that when women don't know or aren't planning on becoming pregnant, many times, most of the time, by the time the woman finds out she is pregnant, the damage has been done. This is when in this time frame, weeks 3 to 8, almost every congenital abnormality -- that is a fancy word for a birth defect -- almost every congenital abnormality happens during this time frame.

Tracey goes on to explain to the jury what a teratogen is. In a nutshell, a teratogen is any agent or factor that induces or increases the incidence of abnormal prenatal development.

Enter Dr Sloot

MR. TRACEY: So during the course of this trial you will hear about teratogens and teratogenicity and you will find out about whether Paxil is a teratogen. And one of the ways you are going to learn about this is through a study, an animal study, an animal study done by a doctor named Sloot. Doctor Sloot is a European doctor who works for another pharmaceutical company called Shearing Plough. Shearing Plough is a pretty big company. You may have heard of it. 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.

The Evidence

MR. TRACEY: I told you earlier that the way you learn about this case is through evidence, through witnesses that take the stand, through documents. And you are going to see documents in this case that have never seen the light of day before. You will see internal GlaxoSmithKline documents that the FDA hasn't seen, that the United States Congress hasn't seen, and that no jury has ever laid their eyes on before. For the first time in this trial you will see these documents. They have been under seal for over three years. And that's the way, one of the ways, you are going to learn about what GSK knew and when they knew it.

Tracey then explains to the jury how Glaxo had purchased the compound [paroxetine] from a Danish company called Ferrosan. He continues...

MR. TRACEY: Ferrosan had done the preliminary animal studies to look at teratogenicity. And they were done, I believe, in 1979 and 1980. And one of the studies was called Study 295. This is a study where they give Paxil, paroxetine, to pregnant female rats. And what the evidence showed in Study 295 is that the rats that got no Paxil, 88 percent of them were alive or 12 percent were dead by the fourth day after they were born. The ones that were given 5 milligrams of Paxil, 65 percent were dead by day 4. The ones that were dosed with 15 milligrams of Paxil, 92 percent were dead by day 4. And in the ones that were given 50 milligrams of Paxil, 100 percent were dead by the fourth day after they were born.

Ferrosan's Dr Baldwin

MR. TRACEY: At the time a doctor by the name of Baldwin, who works for them, Doctor Baldwin looked at the studies. He looked at Study 295, another study called 296, another study called 297. And 12 years before they started selling this drug to women in the world, Doctor Baldwin had some comments about these studies. What he told them internally -- this is a document that nobody has ever seen before. What he told them internally was: There remains the possibility this compound could be teratogenic at higher dose levels. As he saw, as you just did, that the more Paxil you got, the more rats died. And these were not heavy doses of Paxil. What he was concerned about was whether or not Ferrosan or anybody else was going to conduct or intended to conduct peri and postnatal studies to answer the question to why the rats died. He wanted to know that. In 1980 he sent a memo to the powers-to-be at Beecham. He said this needs to be done. The rats died. He talked about embryolethality. That means the fetuses die.

FDA Revolving Door

MR. TRACEY: Because I saw the animal studies that you just saw and the evidence that you will see about the animal studies and the rat pups dying, and I wondered how they could market the drug and say in the beginning that there were no problems with the drug. What I found out is that the FDA investigator that signed off and said you can sell your drug to the public is a guy named Gary Evanuic (sp.?). And Gary Evanuic, who signed off on Paxil being a Category B drug, now works for GSK. He works for GSK in the very department that sells Paxil.

Japan

MR. TRACEY: And as we are rocking along, in 1994 we are selling in the United States, we are selling in Europe. Business is brisk. Business is going well. And they want to move into other countries. They want to sell their drug in other countries. And they have a company called SmithKline or Smith Beecham Japan. It is one of their companies that is in Japan that sells their drug, one of their 70, I think, companies. And the Japanese, they suspected, were not going to accept their dead rat pup studies because they suspected the Japanese, because of the historical things that have gone on in Japan with birth defects related to Hiroshima, Nagasaki, and another environmental disaster there called Minamata, the Japanese had a heightened sense of concern. GSK believed that's what would be going on. And so GSK began discussions internally. Internally among themselves they said: What are we going to do, what are we going to do if Japan makes us do the studies to find out why the rat pups died? What are we going to do? Because what the documents, the internal documents that the FDA has never seen, that nobody else has ever seen, is, their conclusions were, if the Japanese make us do the studies to prove why the rat pups died, we might lose the United States market. So GSK was looking at science and research, not from the aspect of whether or not their drug was going to induce birth defects in children, but the evidence will be their only concern was commercial. Their only concern was whether they would lose the American market. The quote from them is: GSK concludes this is the study, the type of study we wish to avoid. We simply don't want to know the answer to these questions. They say: If the Japanese do request a study, if they do it, there is a potential problem, they may insist on us doing a study to their preferred design. And so what they did in March of 1994, they got a woman or man, I'm not sure which, I haven't been able to find out, named Gwyn Morgan. They got Gwyn Morgan involved. They put Gwyn Morgan in charge of reviewing the study designs that they would give to the Japanese. And Gwyn Morgan was to ensure for the company that any potential negative outcome from the studies is minimized. They designed the study to fail. They wanted the study to fail.

GSK Sales Reps

MR. TRACEY: GlaxoSmithKline has 110,000 employees. I think 40,000 of them are salespeople. What these people do, you will learn, is, they go to doctors' offices. And they take literature and they take cookies and they take lunch and they take pens and they take samples of Paxil. And they tell the doctors why they should prescribe their drug. These are bright, sophisticated, educated salespeople. They are the backbone of this company. And what they were telling doctors in the mid-1990s is that no drug is safer than ours for pregnant women.

Japan Revisited

MR. TRACEY: So we are rocking along. Remember that Japanese study I told you about, Doctor Patrick Wier? Well, they designed a study -- they avoided the studies they wanted to avoid and they designed a study that they thought would satisfy the Japanese, and they were right. But even in the study that was designed to fail, something cropped up, something that was potentially a problem for them. In this study done by GSK, which, quite frankly, by the way, was not a study designed to find out why the rat pups died, it was not a study designed to find out the answer to the questions Doctor Baldwin had in 1980, but some of rat pups did die, and they autopsied one of the rats. And in one of the rats they autopsied, they found that the rat that was found dead had edema, swelling around the heart, and it had a ventricular septal defect. The very same defect Lyam Kilker has. The very same defect that they had started receiving reports of in 1997. But they blew this off. They minimized it. In their conclusions they didn't even mention it. It is buried in the back of the study in an appendix.

Cannot Stop Taking Paxil

MR. TRACEY: Now, this case is primarily, primarily, about birth defects, primarily about what happened to Lyam Kilker and whether they knew about what would happen to him. But in the course of selling Paxil for the past 15 years other issues have come up. One of them is this. In the mid-1990s some studies came out, some literature came out, showing that Paxil had a significant problem with withdrawal. What that means is this. They were finding that women that took the drug and then want to the stop couldn't get off of it. So they would get sick. They would try to stop and they would get sick. And so they would be forced to keep taking the drug so they wouldn't be sick.

Glaxo Burying Data

MR. TRACEY: In the mid-1990s there had been some studies done, not by GSK but by others, and talking about withdrawal. This, you are going to learn from the evidence, caused them some concern. They were concerned about losing their market, losing their market to Prozac. And what they decided to do was, do their own study. And one of the documents you are going to see is this document, a document from a woman named Bonnie Rossello. Bonnie Rossello is the vice-president of GSK's marketing, Paxil marketing. And what Bonnie said in 1997 was: In response to this, let's do our own studies. Then we will own the data. If the results come back negative, we can bury it all. We can bury the evidence that our drug is a problem. In 1997 that's what she said.

The full opening statement can be downloaded HERE

After hearing evidence from both sides Jurors deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker.

The GlaxoSmithKline company tagline is, "Do more. Feel better. Live longer."

Bob Fiddaman

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Crazy Kiwis...According To Modern Medicine

2013-04-17T20:34:00.000+12:00

An article appeared in Stuff.NZ on the 13th of this month that, if reading between the lines, suggests that people living in New Zealand are getting crazier as each year passes.

The article, "Job fears fuel rise in anti-depressant use", starts off by laying blame... not on the prescribers of antidepressants, not on the pharmaceutical companies that manufacture and market them, they blame you, the average person.

The first paragraph of the article reads:

"Mounting financial pressure and job insecurity are driving more Kiwis to anti-depressants. Thirty-two per cent more people are taking the drugs than six years ago, according to Pharmac figures."

Yup, that's right, it appears Kiwis are being driven to antidepressant use. Nothing to do with the prescribers who, it would appear, now deem financial pressure and job insecurity as a mental disorder?

For good measure the article quotes Otago psychiatrist, Pete Ellis, who claims, "The impact of the global financial crisis is resulting in people being uncertain about their jobs, and then there's the effects of people losing their jobs.

"This pressure has been significant in recent years."

Hmmm, I see no reason why antidepressants would be the answer to a global financial crisis, do you?

What we are being told here is circumstance is a mental disorder, whether you are in control of that circumstance or not.

Ellis continues...

"If you're short of money, it's more likely you'll have a row with your partner, and consequently you feel more isolated and burdened and that all adds up."
"Housing stresses, such as paying rent, or trying to buy a home, were all stressful and added pressure to people's lives.
"About twice as many women were prescribed anti-depressants as men."

So, this is a government problem and not a people one then, eh Pete?

So, let me just get this straight.

Poor economy = more antidepressants

More antidepressants = more Kiwis diagnosed with a mental disorder.

I have to question the prescribers here, doctors, psychiatrists. Aren't antidepressants prescribed after a diagnosis that rules out any underlying factors?

When we are given antidepressant treatment are the pills so magical that they can help with the rent, mortgage. If we plant, for instance, a row of Prozac or sow some Aropax, will they, come spring, sprout NZ dollar notes for us to pick so we are never short of money?

Maybe one eye should be on the economy whilst the other tracks the patient [minus their magical beans]

My only surprise here is that Kiwis on state benefits aren't supplied with antidepressants instead of a fortnightly cheque. If antidepressants, according to the prescribers, help people with money problems then why not dish them out at the unemployment office.

As a kid I used to read a lot. Admittedly, I missed out on the fairy-tale type stories, jumping instead to Enid Blyton and her Secret Seven mob.

One story, however, that rings true regarding these latest statistics from Pharmac is one that I'm sure most people are familiar with, it's a story of hope. See if you can guess what it is...

Once upon a time there was a poor mother who lived alone with her son, Jack. All they had in the world was an old cow to give them milk. One day the cow stopped giving milk so the woman had to sell her.

She told Jack to take the cow to market and to get as much money as he could for her.

On his way to market Jack met a man who wanted to buy the cow. He offered Jack five beans for the cow. Jack knew that his mother would be very angry if he sold the cow for beans.

"They are very special beans" said the man. "They are MAGIC ! - they will bring you good luck!" Jack thought that he and his mother needed some good luck, so he gave the cow to the man in return for the magic beans.

As you can imagine, Jacks mother was furious with him when he returned home with no money at all, just a few beans.

She threw the beans out of the window and sent Jack to bed without any supper. Poor Jack ! He really thought that the beans were magic. Now he felt just silly.

Next day he woke up but it was very dark in his bedroom as if it was still night. He looked out of his window and all he could see were lots and lots of dark green leaves.

They seemed to disappear into the clouds.

It was a giant beanstalk ! So they were magic beans after all !

Let's just take a look now at how many magic beans have been prescribed in New Zealand. The areas are broken down by district. DHB stands for District Health Board.

Click Image to enlarge

That's an awful amount of beans, doncha think?

So, what's the implications of prescribing so many pills?

Let's just take a look at the suicide statistics of New Zealand

2008 540
2009 531
2010 541
2011 558
2012 547

And what are we told is the main cause of suicides in NZ, what profound message does the NZ government tell us all?

Well, between the years above we are told "28 percent of people who killed themselves were unemployed"

Which brings me back to the article "Job fears fuel rise in anti-depressant use"

Unemployment = Mental disorder

If healthcare professionals think prescribing antidepressants will somehow magic away the economic blues then they are living in a fairy-tale.

Jack was very quick and as soon as he got to his house, ran to get the axe. He chopped down the beanstalk and the giant came crashing down with a tremendous thud. And that was the end of him !

We should all take a leaf out of Jack's book.

Bob Fiddaman

If you or someone you know have been affected by suicide then visit CASPER, New Zealand's Suicide Prevention charity. Or call 0508CASPER

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First do no harm... providing it's no longer than 8 minutes

2013-04-16T10:38:00.000+12:00

Dr Bhamjee, caused controversy back in 2011 when he called on the Irish Government to add lithium salts to the public water

Dr. Moosajee Bhamjee, a soon to be retired psychiatrist from Ireland, showed exactly why the profession of psychiatry needs to take a long, hard look at itself when he was a guest on the George Hook radio show in Ireland on Thursday [11 April]

Hook had been contacted by Irish blogger, Leonie Fennell regarding a GP he had interviewed a week previously on his show.

The GP, Dr. Ciara Kelly, offered her opinion to a recent article that had appeared in the Irish press [Irish Examiner] that highlighted how GP's handed out antidepressant medication at the drop of a coin. An undercover journalism student, Niamh Drohan, had approached 7 GP's in Ireland and told them she was suffering from stress and anxiety problems from her final year in college. On each visit a prescription for an antidepressant was written for Drohan. Her article ‘Depressing Truth about Treating Depression In The Young’ can be viewed here. Fennell gives her take on it here.

Hook's interview with Ciara Kelly enraged Fennell so much that she emailed the show to set the record straight. Kelly had claimed , during the course of her interview with Hook, that “the drugs themselves are not dangerous, they’re not addictive, they’re not even dangerous at high levels of overdose.”

Fennell's son, Shane, took 39 Cipramil in 17 days and his toxicology report showed a ‘toxic to fatal’ amount in his system. On the 17th day Shane, under the influence of the antidepressant citalopram, killed himself and another man. Podcast with Leonie Fennell here goes into more detail.

Fennell, along with antidepressant expert Prof. David Healy, were invited by Hook to offer their opinion as was Dr. Moosajee Bhamjee.

The interview [below] is interesting in as much that Bhamjee argues that in his 40 years as a healthcare professional he has never seen any patient who has experienced aggressiveness on these types of drugs. He also argues that Dr's only get an 8 minute slot to determine if someone is mentally ill and needs prescription medication. And there I was thinking that the Hippocratic oath taken by Dr's carried no disclaimers!

Bhamjee, caused controversy back in 2011 when he called on the Irish Government to add lithium salts to the public water supply in a bid to lower the suicide rate and depression among the general population.

Anyway... here's the debate from the Hook show.

Podcast Powered By Podbean

If you are having trouble with the audio player then the audio can be downloaded direct to your computer by right clicking and 'save as' HERE

Leonie Fennell's blog

Bob Fiddaman

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Cellphones, Guns and Antidepressants

2013-04-10T09:54:00.000+12:00

When I'm not researching or writing, I'm learning the guitar. When I'm not learning the guitar, I'm reading. When I'm not reading words related to the work I do, I'm escaping with novels, mainly John Grisham, whose words still relate to the work that I do.

A breath of fresh air then would describe the latest novel I have just finished.

'Cell' by Stephen King isn't one of his classics but it did get me thinking that there's a book out there ready to be written along the same lines as 'Cell'.

For those of you who haven't read King's 'Cell' it's book of pure fiction whereby a pulse is sent through satellites to owners of cell phones... or mobile phones as they are known outside of America. The pulse sent makes people crazy who in turn kill one another... they don't know why, they just act on the pulse.

So, why am I wring about this?

It got me thinking.

Let's say each time we picked up a gun which had that same [pulse] - that urge to kill. It was the gun that, somehow, had been coated with a substance that leaked into the pores of the skin and made the person holding it want to go out and kill. Pure fiction, I know but it echoes the work of King.

Cast aside the work of fiction for one moment.

Let's put together the work of another novel.

Let's just assume for one minute that there's a pill that makes people crazy, let's assume that those taking the pill want to go out and kill. Let's assume that there's a power behind the mass production and ingestion of the pill.

You get where I'm coming from yet?

A book about a pulse being sent down a phone line... sent to parts of the brain that makes people crazy is believable because authors like Stephen King have a great knack of making fiction become reality. If he were to write about a gun with a special coating that also made people crazy then I'm sure he could do it just as well as 'Cell'.

Thing is...

A book about a pill making people crazy and turning them into killers wouldn't really be that sexy... it wouldn't be fiction either.

We could take it a step further than King did in 'Cell'. King's characters got the pulse and went on a killing spree. The characters in our book, 'Pill' could not only kill others they could also kill themselves.

Now that would be just too far-fetched, right?

There's a novel waiting to be written. It could, if desired, be set in New Zealand or even Bridgend in Wales. Of course in our book a pill wouldn't almost wipe out the human race as we know it. The Pill would just contribute to a certain amount of deaths and/or slayings, just enough to stop people from making the link - just enough so that the regulators of medicines can dispute any link and keep the pill on the shelves.

Sounds crazy, eh?

1988 - Laurie Wasserman Dann walked into a second grade classroom at Hubbard Woods School in Winnetka, Illinois carrying three pistols and began shooting children, killing an eight-year-old boy - Nicholas Corwin - and wounding five others before fleeing. She entered a nearby house where she shot and wounded a 20-year-old man before killing herself. Dann was taking the antidepressant Anafranil [clomipramine] for Obsessive Compulsive Disorder. [Not a Stephen King novel - Link]

1992 - Stephen Leith, a school teacher shot and killed his superintendent at school. Leith, from prison, later wrote to the FDA explaining how Prozac had made him hostile. He writes, "My temper became shorter and anything could set me off. My anger burned so intensely it was scary. I had never experienced anything like it either before going on PROZAC or since I was taken off of it. I had a headache all the time and was confused much of the time. Something inside felt as if it wanted to crawl out of me, leaving a shell behind; my brain felt like it was sloshing in my skull. After nearly two years of decline, I snapped and killed the Superintendent at a grievance meeting pertaining to my bizarre behavior". [Not a Stephen King novel - Link]

In the same year Calvin Charles Bell opened fire at the Southwest Houston School in Texas. Bell had apparently been "upset about his second-grader's progress report". Just like Leith and Dann, Bell was taking psychiatric medication. [Not a Stephen King novel - Link]

1995 -Toby R. Sincino, a 15 year old, shooting dead a teacher before killing himself. Toby's aunt, Carolyn McCreary, said, "he had been undergoing counseling with the Department of Mental Health and was taking medicine for emotional problems." [Not a Stephen King novel - Link]

1999 - Of the many number of school shootings none have been more reported than Columbine where 15 died and 24 were injured. Eric Harris, one of the shooters, "was taking Zoloft before he switched to Luvox and that he reported 'feeling better' when discontinuing the Zoloft before starting the Luvox." [Not a Stephen King novel - Link]

2005 - Jeffrey Weise first murdered his grandfather before going on a a shooting spree where 9 people were killed and 7 were left wounded. Weise had increased his dosage of Prozac a week prior to the shootings. [Not a Stephen King novel - Link]

There are many more.

In May 2012, an article in People magazine reported that between January 2007 and February 2012, 79 people in the Bridgend area of South Wales had taken their own lives by hanging. AntiDepAware author draws comparisons to the antidepressant link here.

I currently live with my partner Maria Bradshaw out here in New Zealand. Maria's son, Toran, killed himself after just 15 days on Prozac. The New Zealand government and Mylan, the manufacturer of the generic form of Prozac Toran was taking have both concluded that it was probable that Prozac induced his suicide.

Good friends of mine Leonie Fennell and Tony Donnolly lost their son, Shane Clancy. Shane, like many of the above, went berserk killing a young man before stabbing himself in the chest 19 times, resulting in his death. Three weeks prior Shane had been prescribed Celexa, known as Cipramil in Europe.

Brennan McCartney was just 18 years old when in November 2010, he was prescribed Lexapro [known as Cipralex in Canada]. 4 days later Brennan hanged himself.

Again, there are many more.

I'm currently reading King's novella, Rita Hayworth and the Shawshank Redemption, a small story in King's Different Seasons, a collection of short stories. Rita Hayworth and the Shawshank Redemption later went on to become a movie, The Shawshank Redemption. The screenplay by Frank Darabont being, in my opinion, much better than the original work of King.

Shawshank is one of my favorite movies, I love it all, the spine-tingling narration of Morgan Freeman [Red], the innocence of Andy Dufresne played superbly by Tim Robbins. The brutal warden and guard, Samuel Norton [Bob Gunton] and Byron Hadley [Clancy Brown] whose individual downfall was most welcoming. The message of hope Shawshank gives and its hinting of David v Goliath. Everything including the moving musical score by Thomas Newman.

Ironically, back in 2010, I created a video using the score from The Shawshank Redemption.

It fits well with this post.

It's a crazy world that we live in... even without pulses and coated guns.

Bob Fiddaman

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Alistair Benbow on Seroxat/Paxil Suicide

2013-04-05T20:49:00.000+13:00

As a follow on from my last post, Alistair Benbow on Seroxat/Paxil Addiction, I now turn my attention to part two of the interview with Benbow, much of which never went to air on the BBC.

For those that don't know, Alistair Benbow was the spokesperson, nae mouthpiece, for GlaxoSmithKline any time an issue of Seroxat [Paxil] was raised in the media.

Here's Benbow being grilled by BBC's Shelley Jofre over Seroxat and the suicide link.

The transcript was downloaded via the Drug Industry Document Archive

Key:

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.

Less than one year after this interview a review of Seroxat data by the Committee on Safety of Medicines (CSM) showed that children taking tSeroxat may be more likely to self-harm or partake in suicidal behaviour. The Medicines and Healthcare products Regulatory Agency (MHRA) has also warned that adults who are on the drug should not suddenly stop taking it.

The review found that studies on more than 1,000 children also suggested those on Seroxat were at least twice as likely to have suicidal thoughts or self-harm compared to children with similar mental health problems who are not taking the drug.

Ironically, they only found this evidence after GlaxoSmithKline had sent in data because they wanted the MHRA to grant a licence for Seroxat to be used in children.

It was estimated that between the period of Alistair Benbow's interview with Shelley Jofre and the release of the news that Seroxat could cause suicide in kids, 8,000 patients under the age of 18 were treated with Seroxat in the UK.

In 2007, the BBC aired its fourth Panorama documentary regarding Seroxat.

On Monday January 29, 2007 Panorama showed shocking footage that demonstrated how GlaxoSmithKline's Public Relations people and marketing department 'spun' negative trial results on children which showed serious risk of suicide, self-harm and aggression.The trial also indicated Seroxat was no more effective than a sugar pill.

GlaxoSmithKline claimed to doctors that the drug was ‘remarkably' safe and effective for under-18s, with the support of an ‘independent' professor of psychiatry [Martin Keller] who earned $500,000 in fees from drug companies in one year.

Seven out of the 93 children in the Seroxat group had to be hospitalised for adverse reactions ranging from self-harm, aggression, violence to others and suicidality (suicidal thoughts or actions, meaning actual suicide attempts)

In other words, almost 8% of children in the Seroxat group had the above adverse reactions.

What was it Benbow said in the interview?

"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."

Was Benbow lying or was he not aware that data showed this significant [8%] figure?

In an internal company memo dated 14 October 1998, four years prior to Benbow's denial, GlaxoSmithKline executives concluded that Seroxat did not work and that a licence application would be refused: ‘The results of the study were disappointing. The possibility of obtaining a safety statement was considered, but rejected.' The best they felt they could achieve was a statement that 'although safety data was reassuring, efficacy had not been demonstrated'.

Did they go public with this?

Nope.

The self-harm, aggression and suicide attempts were kept quiet as was the lack of efficacy of Seroxat in children. PR people took over to implement a new plan: promote Seroxat to doctors as a treatment for under18's.

GSK's plan was simple and, it has to be said, unethical. They tried to persuade doctors that Seroxat was suitable for their child patients. From the 1998 internal memo showing that efficacy had not been demonstrated they spun the whole trial on its head with the clear message that Seroxat was ‘remarkably effective and safe for children'.

How did they do this?

KOL's - key opinion leaders in the field of child and adolescent psychiatry.

Martin Keller was, at the time, a renowned expert in the field of child and adolescent psychiatry. If Glaxo could get Keller to endorse the use of Seroxat in children then they were on to a winner.

Enter the ghostwriting machine.

Glaxo hired a PR firm to draft an article claiming Seroxat was beneficial for children. Keller put his name to the article which was later published in widely read journals. Job done, suicidal attempts, aggression and self harm were all hidden.

GlaxoSmithKline simply buried the data, including data from another, later trial on children which found that the placebos given to the control group of depressed kids ‘worked' better than Seroxat!

Glaxo later, forced by US medicines regulator the FDA to re-evaluate the raw data from Study 329, admitted to four further adverse reactions in which children became suicidal, raising the number suffering severe reactions to the drug from seven to 11 — a shocking 12 per cent of the total, and representing a 600% increase in events related to suicide.

Benbow knew nothing... apparently.

This half hour documentary goes into more detail about the whole sordid affair.

Bob Fiddaman

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Alistair Benbow on Seroxat/Paxil Addiction

2013-04-03T14:08:00.000+13:00

Former GSK Head of Psychiatry Alastair Benbow

The following is taken from a BBC transcript, much of which never went to air.

It's an interview with GlaxoSmithKline's, then Head of Clinical Psychiatry, Alistair Benbow.

Benbow, you remember, was the spokesperson who defended Seroxat... and even suggested that it may, at some point in time, be used on kids. He's not a fan of mine either, in 2008 I, apparently, caused him unwarranted distress with a video I created [see - Glaxo, An Angry Blogger And Free Speech]

The following segment was taken from a 2002 interview undertaken by BBC journalist, Shelley Jofre and focuses on Benbow's reaction when asked whether or not Seroxat [Paxil in the US] is addictive. It's a marvelous defence of a not so marvelous antidepressant.

Enjoy.

Key:

Q = Jofre
A = Benbow

Q. Your leaflet says 'remember you cannot become addicted to Seroxat', but that's not true is it?

A. Yes, it is true. There is no reliable evidence that Seroxat can cause addiction or dependence, and this has been borne out by a number of independent clinical experts, by regulatory authorities around the world, the Royal College of Psychiatrists, and a number of other groups.

Q. If people cannot stop taking a drug when they want to stop taking it they are addicted are they not?

A. No, that is not correct. The definition of addiction is not as you describe it. Addiction is characterised by a number of different criteria, which includes craving, which includes increasing the dose of the drug to get the same effect, and a number of other features, and those are not exhibited by Seroxat.

Q. That is not with respect what the Oxford English Dictionary says. It says, "Addiction is having a compulsion to take a drug, the stopping of which produces withdrawal symptoms."

A. It is true that a number of patients will experience symptoms on withdrawal.

Q. That is what addiction means is it not?

A. No, it is not.

Q. That is what the dictionary says.

A. That is not a clinical definition of addiction or dependence. Dependence is very clearly laid down by international...

Q. But when people start taking Seroxat they do not consult a medical dictionary.

A. No, and they will not consult the Oxford English Dictionary either.

Q. The Oxford English Dictionary tells you what common usage of the word addiction is. People understand that if they cannot stop taking a drug it is addictive.

A. The reality of the situation is that regulatory authorities around the world, independent clinical experts and key groups like the Royal College of Psychiatrists, have agreed that Seroxat is not habit forming or addictive.

Q. But your patient leaflet is meant to help and inform patients is it not?

A. Yes, it is, and it does I believe.

Q. Not according to the people we have spoken to who feel they were not warned that this could happen to them. They read, "You cannot become addicted to Seroxat" and thought they could stop the drug any time they wanted.

A. No, the reality is they can stop the drug, but it is true...

Q. But you cannot stop any time you want.

A. Yes, they can and the information clearly says that Seroxat is not addictive, and it is not. It is true that a proportion of patients may develop symptoms on stopping the drug. These are generally mild to moderate in nature ... [Inaudible due to interruption] permitting, and will go away usually within a two-week period.

Q. I am sorry, I must take you back to this because the dictionary says, "having a compulsion to take a drug, the stopping of which produces withdrawal symptoms", and we have spoken to plenty of people who say they are compelled to take Seroxat because stopping it produces withdrawal symptoms. They are addicted.

A. If you use that limited description of addictive then most prescription medicines could be defined as addictive. Beta-blockers, which are used for the treatment...

Q. This is the common usage of the word. This is what people understand "addicted" to mean, and you are misleading them in the patient leaflet by saying they cannot become addicted.

A. No we are not misleading them. The information in the patient leaflet, and in the information supplied to doctors, is based on fact. It is based on data, which is generated during clinical trials and during the marketing of the product over the last ten years.

Q. Do patients' experiences count for anything in this?

A. Of course patient experiences count for something, and we take the safety of our medicine extremely seriously, and we take into account all the adverse events that are recorded throughout the world and report them to the regulatory authorities. It is on that data on which decisions are made as to what should and should not be in our leaflet and in the information to doctors. The regulatory authorities are very, very clear on this issue. There is no reliable scientific evidence that Seroxat causes addiction or dependence.

Q. It sounds to me that you are hiding behind the medical definition of addiction. The World Heath Organisation says that proper dependence is "a need for repeated doses of a drug to feel good or avoid feeling bad". We have spoken to countless people who are on Seroxat and the only reason they are still on it is because they cannot stop taking it - they feel too bad when they stop taking it.

A. As a doctor it is my duty to inform patients on the risks and the benefits of our medicines. It is important...

Q. You say it is doctor's responsibility, not yours?

A. No, I am saying as a doctor myself it is my responsibility for my patients to inform them of the risks and benefits of an individual product. Now we help doctors supply information...

Q. But this is not helpful! What I am telling you is that we have spoken to countless people who feel that they have been misled by the patient leaflet. It says you cannot become addicted to Seroxat, and by any definition that the public might look at they are addicted.

A. No, I am sorry I have to disagree with you. When you look at the data it quite clearly shows that on all the models when you do trials in animals - when you look at the data in patients considering taking this in the context of tens of millions of patients who have been on Seroxat over the last ten years - the data clearly shows that this class of drugs, and Seroxat in particular, does not cause addiction or dependence.

Q. It does not cause addiction if you use the medical definition perhaps, but what we are talking about here is information that helps people to make an informed choice when they go on a drug, and that leaflet is misleading them because they think they can stop the drug any time they want. They cannot can they?

A. Yes, they can.

Q. But they cannot. It is quite obvious that there are large numbers of people who cannot stop taking the drug because the withdrawal symptoms are causing them too much distress.

A. With respect, patients can stop taking Seroxat. Of course they should be taking it in consultation with their doctor...

Q. There are some people for whom the withdrawal symptoms are really quite terrible.

A. I understand that, and I have every sympathy with patients who are having difficulty...

Q. So you accept that some people will have a very difficult time coming off the drug, but they would not know that from reading your warning.

A. There is a very small percentage of patients who will experience difficulty coming off Seroxat and a range of other therapies.

Q. But they would not know that, would they, when they are on it?

A. It would be absolutely scandalous if we were to put in our patient information, information that was not correct and we are not going to do that.

Q. But you are misleading people because if you say you cannot become addicted to Seroxat it makes people think it is a benign drug that you can stop taking any time you like.

A. No, that is not correct. We are not misleading the public at all. We are providing factual information that is correct.

Q. If you look at the patient leaflet it also says "withdrawal symptoms from Seroxat are not common". That is not true either, is it?

A. Yes it is true. That information is absolutely accurate. Withdrawal symptoms are not common.

Q. Doctors report far more withdrawal problems with Seroxat than with any of the other anti-depressants.

A. If you are referring to list withdrawal symptoms then in the context of tens of millions of patients who have received Seroxat around the world the numbers of withdrawal symptoms are actually very low.

Q. But you agree Seroxat is far and away the worst offender for withdrawal problems.

A. What I am saying is that in those lists the absolute number of reports, which are relatively low in the context of the tens of millions of patients who have received Seroxat, it is at the top of the list.

Q. The side effects are always notoriously under-reported by doctors. The fact is that Seroxat tops every single list there is of withdrawal problems.

A. The reality is that when you tell people about these side effects, as we have done - we have warned them in the patient information leaflet and we have told doctors about symptoms on withdrawal - it is more likely they are reported. However there are many other confounding factors.

Q. Excuse me if I do a little basic arithmetic here. Seroxat is prescribed slightly less than Prozac, and yet the complaints about Seroxat withdrawal problems are far and away the highest out of any anti-depressant.

A. Let me just tell you a little bit of technical information...

Q. That is true is it not!

A. It is true that in those particular lists Seroxat does feature at the top of the lists.

Q. And why is that?

A. For reasons that I have already outlined you have to take on board a number of different factors, one of which is the frequency of prescribing of the drug. However there are other factors, like the amount of drug that is in the blood over time, so the half-life of the drug ie. how quickly the drug is washed out of the system is also important. With Prozac, for instance, the half-life of the drug is very long so there is therefore a long time between stopping the drug and experiencing symptoms, so long in fact that many people may not recognise that the symptoms they get on stopping are related to the drug. Whereas, of course, when you have a short half-life - and for a product to wash out of the system quickly is a very beneficial thing - then they are more likely to recognise it.

However these symptoms on withdrawal are common to all anti-depressants, not just the SSRI's and is common to many, many other drugs, including treatment for high blood pressure, cardio-arrhythmias and so on.

Q. It sounds like you are trying to say that Seroxat is no different to the other antidepressants, but whatever evidence you can count that is simply not true. Talking to patients, talking to doctors, and looking at any list that complies lists of withdrawal problems, Seroxat is much worse than the other anti-depressants.

A. What I am saying is that you cannot compare absolute numbers...

Q. You must accept that surely?

A. No, I do not accept that. It is my fundamental belief that Seroxat and the other antidepressants of all classes cause symptoms on withdrawal.

Q. There is no difference between Seroxat and the other anti-depressants?

A. There may be a difference in the number that are reported on occasion because we-

Q. Because there are more problems?

A. Because we have highlighted the fact these sort of symptoms have become more apparent since Seroxat was made available, and there are many other factors which need to be taken into consideration as the regulatory authorities will tell you.

Q. Have you looked on the internet, or spoken to patients about this?

A. Yes, I have and actually the majority of patients do not have a problem.

Q. Tell me about the patients who do have a problem because their problems are very real indeed. Your leaflet says 'withdrawal symptoms will generally disappear with a few days'. Have you looked on the internet and seen some of the horror stories?

A. Yes, I have looked on the internet but I have to tell you that the majority of patients who experience withdrawal symptoms - and the majority of patients actually do not experience any withdrawal symptoms - of those that do the majority of those symptoms are mild to moderate in nature and will go away without any treatment within two weeks.

Q. You say you have looked at the internet and spoken to patients, but why have you not heard the stories we have heard of people who are having a terrible time? Sometimes they cannot get off it, other times it takes them a very long time indeed and lots of unpleasant withdrawal symptoms.

A. Of course I have read those same stories. Most of those...

Q. So, they are true are they not?

A. Most of those I have seen in the media and we cannot be driven by anecdote; we have to be driven by facts. We do not...

Q. So you do not listen to patients?

A. Of course we listen to patients. We listen to patients all the time, but the reality is that we have to consider the facts and we will collect data and we do, and the regulatory...

Q. These are facts!

A. And the regulatory authorities collect the facts and data, and then they make a decision as to whether these things should be changed in our label.

Q. Are you saying that these patients' stories are not fact? Do you think they are making it up?

A. No of course I am not saying that. What I am saying is that if you look at the totality of the data - and yes it maybe that a small proportion of patients do get more severe symptoms but in totality of the total patients taking Seroxat, an extremely effective and valuable medicine for the treatment of this severe disease, depression, which kills many people...

Q. It is not just for depression that people are taking the drug.

A. Indeed not - for depression and other anxiety related disorders, all of which have a common feature of being debilitating and stopping people functioning properly.

However, in that context I believe, the company believes, the regulatory authorities believe, and the independent clinical experts believe that the majority of these symptoms on withdrawal are mild to moderate in nature, self-limiting and go-away in the majority of cases within two weeks. Now these symptoms can also be helped if you gradual taper the medicine on withdrawal and that information is in the information that is provided to doctors and to patients.

Q. How long should it take then if you taper the withdrawal?

A. That depends on the dose of Seroxat that the patient is on. In the majority of cases, if you are on one of the higher doses, it will only take a matter of weeks.

Q. We have been filming with a woman - she has actually filmed her own attempts coming off Seroxat - and it has taken her nine months and it has been absolutely horrendous! She has been unable to leave the house on a large number of occasions as the symptoms have been so bad.

A. With respect you are taking, yes I grant an extreme example, which is very disabling...

Q. It hardly an extreme example if you look on the internet!

A. If you will forgive me for saying so, it is an extreme example because although there may be a whole range of anecdotes on the internet, there are also many, many millions of patients who have taken Seroxat for this disabling and stressing condition...

Q. Nobody is denying that a great many people have been helped by this drug. What we are talking about is the information you provide for patients and whether it is accurate. If somebody goes on a drug and they are told they cannot become addicted, withdrawal symptoms are not common and they are generally going to disappear within a few days, you would forgive them for being a little angry when nine months after trying to stop they are still on the drug!

A. I think you will find that the information you just said that is in the patient information leaflet in the summary of product characteristics is accurate, balanced and not misleading.

Q. What warning would there be for anyone who goes through this horrendous withdrawal process?

A. No, what we have said...

Q. There is definitely no warning that they might experience this is there?

A. It is important to understand that what we are trying to do is label for the usual situation. Of course, in medicine and in...

Q. The woman I am talking about took this drug for panic attacks. If she had known at the time that she was going to go through this horrible withdrawal from the drug, she would never have taken it. She would have managed her panic attacks in a different way. She was not properly informed and she is pretty angry.

A. This is an extreme example...

Q. It is not an extreme example.

A. It is an extreme example. The vast majority of patients, as we quite clearly say in our label, have no problem coming off Seroxat. Indeed...

Q. So it is just your tough luck if you happen to have a hard time?

A. No, of course not. I have every sympathy for any patient that has difficulty coming off Seroxat but that is not what normally happens. The vast majority of patients who take Seroxat will not experience any difficulties coming off it.

Q. The fact is that you do not know what normally happens because you do not have a published study that has actually looked in into the single question of addiction and withdrawal problems have you?

A. We have actually looked very carefully at...

Q. No, you have not conducted a study looking into withdrawal problems have you?

A. Yes, actually in all of our clinical studies we have looked to see where there are symptoms...

Q. No, a study designed to look at withdrawal symptoms.

A. We have specifically in all our recent studies looked carefully to see the proportion of
patients who get withdrawal symptoms.

Q. I am afraid you are not really answering the question.

A. Yes, I am.

Q. You have not done a study - a single study - looking purely at withdrawal symptoms have you?

A. What we have done is conducted clinical trials...

Q. Can I take that as a "no"?

A. No, you cannot take that as a "no". What you are saying is incorrect. To study withdrawal symptoms you have to have patients on Seroxat who you then follow during the withdrawal phase. That is exactly what we have done across a range of different indications, and quite clearly that information from those clinical studies
completely supports what we have in our leaflet.

Q. Can you show me the study that was designed to look at withdrawal problems?

A. I can show you a range of different studies that are designed to look at withdrawal symptoms and I can tell you the findings of those studies. In those studies approximately 7% of patients experience dizziness, 2% of patients experience abnormal dreams and 2% experience sensory disturbances. All the other adverse events that were seen on the form were at a lower frequency than that, and it should be remembered that patients who came off placebo also experienced withdrawal symptoms in some cases.

Q. You are not suggesting Seroxat's withdrawal problems are the same as sugar pills are you?

A. No, I am not, but what I am saying is that in interpreting data you have to take on board the consideration of a proportion of patients who take dummy pills who will also experience symptoms.

The interview then moves to the subject of Seroxat induced suicide.

One has to ask here if Glaxo's spokesperson was being honest. A year previously, in 2001, a lawsuit was filed in the US which claimed that Seroxat caused severe withdrawal problems.

The lawsuit showed that GSK deliberately misled both physicians and patients into believing that Seroxat was not addictive and had no or only rare withdrawal reactions with a question and answer pamphlet distributed to doctors' offices to be disseminated to patients, in which GSK asks the question: "Is Seroxat addictive?"

And, in response, the pamphlet states: "Seroxat has been studied both in short-and-long-term use and is not associated with dependence or addiction."

By the time the lawsuit was filed on August 21, 2001, the plaintiffs' attorneys, Baum Hedlund law firm, had been individually contacted by approximately 5,000 Seroxat withdrawal victims.

As a result of GSK's fraudulent marketing of Seroxat Baum Hedlund law firm won a major settlement in this class action filed on behalf of patients who got hooked on the drug, and in many instances, found they were unable to stop taking it. Sadly, because of the settlement, depositions and other important documents were sealed away from the public.

The documents that did surface during litigation showed that before Seroxat was approved, GSK had known about the withdrawal effects from it own clinical trials.

According to the lawsuit's complaint, "GSK's motive of deliberately failing to advise physicians and the public of the adverse effects that can lead to withdrawal problems (and that it knew a percentage of users of the drug inevitably would experience) was for financial gain and its fear that, if properly labeled the drug, Seroxat would lose its share of the SSRI market."

The now infamous 'money bag' memo also appeared during litigation [fig 1]. This showed clearly why Glaxo wanted to play down the dependency issue - something that Benbow, it seems, did a year later on BBC television.

fig 1

In fact, in 1997, some 5 years before Benbow's interview with Jofre, GlaxoSmithKline had sent a memo out to its 'Paxil selling team'.

The memo, from Bill Kinnear and Barry Brand, refers to 'discontinuation syndrome' [withdrawal] and they blame Eli Lilly for mudslinging about Seroxat withdrawal due to the fact that Lilly's Prozac had come under scrutiny for causing severe adverse withdrawal reactions.

Kinnear and Brand instructed the sales team [Glaxo reps] with the following: [fig 2]

fig 2 - click to enlarge

It seemed to be one big joke for Glaxo, as the cartoon image of a patient screaming for his Paxil taken from the same document shows [fig 3]

fig 3 - click to enlarge

GlaxoSmithKline, although settling 5,000 withdrawal cases in the US, still refuse to admit that Seroxat is addictive, still refuse to answer patient questions regarding how one should safely taper from Seroxat, still refuse to meet with patient representatives [ See - GSK's Andrew Witty in Patient Aftercare Snub], still defend their corner, the UK Seroxat lawsuit has never been settled, GSK contest that Seroxat causes withdrawal problems to patients in the UK, a case that has been on-going for approx 7 years.

In fact, Benbow throughout the above interview, refuses to budge on his [Glaxo's] addiction stance, strange then that in the same year as he was interviewed lawyers in America sought a preliminary injunction on behalf of thousands of Seroxat class members as well as individuals who, it was argued, "might be persuaded by the commercials and brochures to take Paxil in the future." Once again it was Baum Hedlund who put a stop to GlaxoSmithKline's TV advertisement claiming that Seroxat was "Non Habit-Forming". [See Paxil Ad Injunction]

More about the UK lawsuit with the 4 links provided at the end of this post, you'll note the MHRA's involvement with the UK Seroxat litigation, a former employee of the MHRA is an 'expert' witness for GSK. You'll also note from the above Benbow interview that he refers to the MHRA as the 'regulator'.

So, is Seroxat addictive?

My answer to that is in my book, The evidence, however, is clear...the Seroxat scandal.

As for Benbow, he no longer works for GlaxoSmithKline, he is now Executive Director of the European Brain Council [EBC]

Coming next: Alistair Benbow on Seroxat/Paxil suicide.

UK Seroxat Lawsuit Links

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money

Bob Fiddaman

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Jenson Button - Gullibility in a Bottle?

2013-04-02T16:56:00.002+13:00

It kinda sickens me when I see highly paid sports personalities, actors, pop/rock legends promote the use of pharmaceutical wares - be they prescription medications or consumer products.

I understand that careers are short in the above industries, unless you acting capabilities of the De Niro, Pacino ilk.

Jenson Button is a young man, idolized by many. He performs miracles as he travels at huge speeds in his race car - He has a huge fan base and it's probably hard for him to decipher who his real friends are opposed to the hangers-on who, when the chips are down, will leave him by the wayside and move on to the next hero.

I have no personal interest in Jenson Button, McLaren or Motorsports - in fact, I find Motorsports mind-numbingly boring, to me it's akin to watching a goldfish swim in circles... only far more noisy.

For those that don't know... and I only know because I've sat and researched, Jenson Button is a British Formula One driver from England currently signed to McLaren. His interest in driving fueled by his love for Karting from the age of just 8 years of age.

I'm not about to write a biography on Button, if you want to know more use Google as a resource.

I am, however, interested in Button's recent alignment to British pharmaceutical giant, GlaxoSmithKline. Sure, it's purely about the money - sponsorship deals usually are, only in this instance Button, I truly believe, has been misguided by his people, the very same people that will leave him by the wayside when a better child protegee comes along.

Button is currently promoting GlaxoSmithKline's Lucozade Sports, a drink that has been the subject of controversy during the past few years or so. This really isn't my issue with Button's gullibility, naivety, ignorance... call it what you will.

The one striking fact is that Button is promoting GlaxoSmithKline, a pharmaceutical company that have a very dark history when it comes to the safety and efficacy of medicines in children and adolescents.

Button, ironically, seen here with a whiskey promotion on his helmet [Fig 1], it would appear is all about the money - and why shouldn't he be, his career will be short.

Fig 1

There are other ways of earning money through sponsorship and to align oneself with a pharmaceutical company with an appaling record of disregard toward children may be something Button's advisers either overlooked or were blinded by the sign of the $$$.

This, is for Button, it's for his advisory team, it's for McLaren.

I doubt for one minute that Button or his highly paid PR team will flinch at the following. I can't imagine that they went into this sponsorship deal without knowing what they were advertising and who the manufacturers were... more importantly, the history of the manufacturers behind Lucozade Sports drinks.

Would Button have agreed to the sponsorship deal if he knew that...

The Rohm & Haas Company and SmithKline Beecham P.L.C. agreed to spend about $125 million to clean up the former Whitmoyer Laboratories site in Myerstown, Pa., the Justice Department said. Whitmoyer Laboratories manufactured veterinary pharmaceuticals from 1934 to 1984. During that time, toxic materials -- aniline and soluble arsenic compounds -- were produced, stored and disposed at the site. [1]

A Wyoming jury awarded $6.4 million to the family of a man who killed three relatives and himself after taking the antidepressant Paxil, manufactured by GlaxoSmithKline [2]

British drug regulators warn that GlaxoSmithKline's popular antidepressant Paxil causes depressed children to become more suicidal and should not be prescribed for them. [3]

Two fourteen-year-old students busted Glaxo for lying about the Vitamin C content of the Ribena drink. [4]

British drug giant GlaxoSmithKline finally admits that thousands of babies in the UK country were inoculated with a batch of toxic whooping cough vaccines in the 1970's. [5]

In September 1992 the Ulverston site (then owned by Glaxo Wellcome) dumped several toxic chemicals in the river Leven, without authorisation. The chemicals included trichloroethylene, chloroform, and chlorobenzene [6]

A new BBC documentary exposes how the city of New York has been forcing HIV-positive children under its supervision to be used as human guinea pigs in tests for experimental AIDS drug trials. GlaxoSmithKline embroiled in unethical clinical trials. [7]

US Senator requests documents from GlaxoSmithKline that highlights the company knew about the Paxil suicide risk in children and adolescents but chose not to go public with its findings [8]

GlaxoSmithKline's Rotavirus vaccine linked to infant deaths [9]

GlaxoSmithKline delayed informing the authorities that a controversial drug increased the likelihood of suicide among teenagers. [10]

A US family awarded $2.5 million (£1.6 million) in damages after a Philadelphia jury decided GlaxoSmithKline's antidepressant Paxil, known as Seroxat in Britain, was responsible for their son's birth defects. [11]

A mass immunisation campaign with a Urabe-containing MMR vaccine was carried out in 1997 in the city of Salvador, NE Brazil, with a target population of children aged 1-11 years. There was an outbreak of aseptic meningitis following the mass campaign in which GlaxoSmithKline's Pluserix was administered. [12]

GlaxoSmithKline Argentina Laboratories Company was fined 400,000 pesos by Judge Marcelo Aguinsky following a report issued by the National Administration of Medicine, Food and Technology (ANMAT in Spanish) for irregularities during lab vaccine trials conducted between 2007 and 2008 that allegedly killed 14 babies. [13]

In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug [14]

Way to go Jenson!

Bob Fiddaman

[1] Smithkline and Rohm & Haas to Clean up Toxic Site [1992 - New York Times]
[2] Jury Awards $6.4 Million In Killings Tied to Drug [2001 - New York Times]
[3] Britain Says Use of Paxil By Children Is Dangerous [2003 - New York Times]
[4] Anna Devathasan and Jenny Suo: The Ribena girls [2007 - New Zealand Herald]
[5] UK babies given toxic vaccines, admits Glaxo [2002 - The Guardian]
[6] North's top polluters named [2002 - BBC News]
[7] Guinea Pig Kids: How New York City is Using Children to Test Experimental AIDS Drugs [2004 - BBC TV]
[8] Sen. Grassley Questions Glaxo on Paxil and Suicide Risk [2008 - Wall Street Journal]
[9] Pneumonia deaths seen with Glaxo vaccine: FDA [2008 - Reuters]
[10] Drugs firms face new laws on test results [2008 - The Guardian]
[11] GSK antidepressant Paxil to blame for baby's heart defects, US jury rules [2009 - The Telegraph]
[12] Outbreak of Aseptic Meningitis associated with Mass Vaccination with a Urabe-containing Measles-Mumps-Rubella Vaccine [2000 - American Journal of Epidemiology, Vol 151, No. 5.]
[13] GSK fined over vaccine trials; 14 babies reported dead [2012 - Buenos Aires Herald]
[14] Glaxo Agrees to Pay $3 Billion in Fraud Settlement [2012 - New York Times]

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Adult ADHD - The Comic

2013-03-26T12:16:00.000+13:00

I've heard about adult ADHD before, never really took much notice as I honestly thought that grown-ups wouldn't be taken in by such mumbo-jumbo. I didn't even know [my naivety] that adult ADHD was being promoted here in New Zealand - kind of makes sense that it is though seeing as the NZ government tackle everyday emotions with drugs. Quit smoking - try Champix - Depressed - Try an SSRi.

Adult ADHD is, it has to be said, one of the more ridiculous mental disorders to hit the streets and make the pharmaceutical industry even richer.

Yesterday, whilst sitting in the waiting room of a doctor's surgery, I was thumb twiddling, bored out of my mind as the only magazines available to read were trashy gossip types, you know the kind, the close-up paparazzi shots of actresses in their mid thirties who [shock-horror] have rings under their eyes or a crease or two on their thighs.

Not one for reading about rings and creases I turned my attention to the array of brochures lining the waiting room wall. Two in particular caught my attention, one was a quit smoking brochure, the other 'Adult ADHD'.

The quit smoking brochure was basically promoting Champix, the smoking cessation drug that can make you want to kill yourself. I've highlighted the whole Champix promotion here in New Zealand in a previous post [see - Sometimes the New Zealand Government Get It Wrong]

In this post I will focus on the second brochure I picked up yesterday. [See Fig 1 and 2]

I was giggling to myself whilst reading the 'science' or lack of. There's even a test adults can take to seek help from their doctor if they score 4 or more out of the 6 questions provided.

I took the test, hey I had nothing better to do and I found it more entertaining than reading about creases and rings on the latest celebrity to be dragged down from a pedestal she never wanted to be on in the first place.

I scored 4 and the brochure recommends that I make an appointment to see my doctor.

Yikes! I may have adult ADHD - How on earth did I get this mental disorder?

Well the brochure tells me, in no uncertain terms, that adult ADHD may be a result of my kids having ADHD?

Now, I'm confused? My kids don't have ADHD, although if they had taken any of the tests designed to make them have ADHD then I'm sure the brochure would have reeled me in.

Okay, so my kids don't have it, how come I do?

According to the brochure common symptoms of adult ADHD are:

Difficulty in relationships - Yup, myself and Maria do have our disagreements and, hey, I was divorced many years ago due to having difficulties in a relationship - They got me.

Difficulty in starting complex tasks and completing tasks - Um, does that include putting a shelf up or prepping a wall to be plastered? If so, they got me again.

Increased incidence of car accidents/traffic violations - well, I don't drive but I do cross the road without using pedestrian crossings - I think that's called Jaywalking in America - maybe it's now been deemed as a mental disorder? You laugh but almost everything else is so why not Jaywalking?

Lack of organisation - Oops, they got me again. I couldn't organise a drinks festival in a brewery!

Apparently, when compared with adults who don't have adult ADHD, I may have higher rates of anxiety, depression and substance use disorders. I'm doomed, doomed I tell ya.

Fear not, the brochure tells me some important news, a lovely big green box with bold white writing tells me, "While ADHD cannot be cured, medication and behaviour management strategies can help to control the symptoms associated with ADHD."

Oh yippie! I'm saved... saved I tell ya.

Okay, so how did I get this brain disorder? - I know it's a brain disorder because the brochure tells me so.

"ADHD is a brain disorder that can cause hyperactivity, impulsivity and difficulties paying attention"

Oh, someone just walked in the waiting room with a limp....

Dang it there goes my concentration.

The brochure continues with the science behind adult ADHD:

"It is estimated that 4% of adults in the US have ADHD" - Golly, must be something they put in the water, right? Anyway, I live in New Zealand and drink rain water [through a filter of course]

"If this rate of occurance is true for NZ", according to the brochure, "this means that approximately 86,000 adults between the ages of 18 and 50 years of age have ADHD."

Gadzooks!

Furthermore, the brochure tells me:

"ADHD is a highly heritable disorder, and approximately 20% of parents of children with ADHD have ADHD themselves."

The test is based around six questions, the answers range from never to very often. You can take the test yourself, just click on Fig 2.

I have to say the whole brochure kept me entertained and lifted my boredom whilst sitting for almost an hour in the waiting room - very uncomfortable on those hard plastic chairs that I found myself fidgeting a lot, ironically that's yet another symptom of ADHD.

The 6 question test that appeared in the brochure, called 'The Adult ADHD Self Report Scale Screener' [ASRS] is copyrighted to the World Health Organisation [WHO]

The information sourced in the brochure comes courtesy of Janssen Pharmaceuticals. Janssen manufacture and market Concerta [methylphenidate], a drug used for ADHD.

The brochure may fall into the hands of someone who actually believes the garbage written within it. How often do people get emails telling them they have won the Nigerian lottery? Many of us do, but many of us recognise that it's just a scam - sadly there's a small percentage sucked in and it's those that often part with money to release the lottery winnings from the Bank of Umberjaja.

This brochure was written in exactly the same way as those Nigerian email scams. They were designed to target the vulnerable, to make those vulnerable people believe that, a; they could have something and b; they just needed to part with some cash to get to that something.

That's pretty much how the pharmaceutical industry work - they plant the seed then offer the remedy. They offer no science but selective science. They'll gather 50 or so studies on ADHD, cherry pick all the bits that benefit them and bury the bits that would actually benefit the patient.

If written in the 1970's, early 80's this brochure would have made a great skit for the 'Not the Nine O'Clock News' team. Messrs Atkinson, Smith, Jones and Stephenson wouldn't have needed to work out a funny routine, the brochure is basically the screenplay.

I've used 'Not the Nine O'Clock News' as an example because the brochure reminds me so much of the 'Constable Savage' skit performed by Rowan Atkinson and Griff Rhys Jones. It's so ludicrously absurd that one has to laugh at the belief.

Constable Savage [Jones] likes to take the law into his own hands. This is frowned upon by his Sergeant [Atkinson]. It's not difficult to make comparisons here.

The comedic brochure, complete with The Adult ADHD Self Report Scale Screener, is below.

Fig 1

Fig 2

Bob Fiddaman

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Glaxo: Beagles, Blacks and Hispanics

2013-03-22T12:26:00.000+13:00

This post was going to solely focus on Glaxo's involvement in the AIDS-related drug tests on parentless children in a home for kids with HIV, known as the Incarnation trials.

Sadly, news has just broke of yet more shenanigans by Glaxo, this time from their Verona HQ in Italy.

Glaxo, it appears, have been accused of holding 32 beagle dogs against their will, something which they claim "has no basis in fact" on their Facebook page. [1]

I'll write about the beagles first then move on to the Incarnation trials.

Browndog is an organisation set up to end all experiments on dogs in the UK. I recently joined their Facebook page as news is filtering through that protesters have gathered outside Glaxo's HQ in Verona, Italy. It's alleged that Glaxo hold 32 beagles for experimentation.

This from the Glaxo Facebook page:

[1]

However, Browndog, seem to think otherwise and have posted a recent photo from outside the Verona plant. [2]

Glaxo have also responded to a comment claiming that they don't do tests/experiments on Beagles anymore, in fact, they go as far to say that, "Aptuit acquired the Verona research centre from GSK in 2010." [3] They even included a link to back up their claim.

Whatever the case may be, Glaxo's Facebook page has been inundated with messages of protests by dog lovers far and wide. It's easy to see why there is such a hoo-har given that beagles are a much loved breed of dog. Here's one undergoing some sort of test [4]

Glaxo are no strangers to controversy, in fact this whole post was going to re-hash a story from some time ago but I had to get in the breaking beagle news, if only to play a small part in their release from either Glaxo or Aptuit. In fact, if it transpires that Glaxo have nothing to hide then the title of this post may be changed from, 'Glaxo: Beagles, Blacks and Hispanics' simply to 'Glaxo: Blacks and Hispanics'

Glaxo and the Incarnation trials

So, what exactly were the Incarnation trials and how are GlaxoSmithKline linked?

Well, at the time of the breaking news Glaxo were, through various media releases, named as one of the sponsors in a pretty shameful trial going on at the Incarnation Children's Center [ICC] in New York.

In 2004, Liam Scheff, an investigative reporter, had gained access to information that foster children at ICC had been subjected to experimental AIDS drug trials. Scheff learned that children were removed from their guardians who had refused to give those they had adopted drugs that were making the children sick. He also learned that children who could not tolerate swallowing the drugs were coerced [forced] to have plastic tubes surgically inserted in their stomachs to ensure that the drugs were administered.

Two days ago I finally managed to track down the BBC documentary, "Guinea Pig Kids", first broadcast on BBC television on Tuesday, 30 November, 2004. The half-hour long documentary, made by Liam Scheff, is harrowing viewing. I've provided the documentary in its entirety at the foot of this post.

If you are looking for an all out attack on Glaxo you'll be disappointed. In fact they are only briefly mentioned. This from the narrator of Guinea Pig Kids, Amanda St John:

In a mass grave owned by the Roman Catholic Church close to Manhattan, over a thousand children’s bodies, including some who were enrolled in the trials, lie beneath a tarpaulin. Officially their deaths are recorded only as resulting from ‘natural causes’.

For months, we tried to get answers from those behind the trials – from Columbia Presbyterian Hospital, where many of the tests were devised. From Incarnation Children’s Centre. From the Catholic Church. And from the ACS; the authority ultimately responsible. None would comment.

The drug companies which have supported trials at Incarnation include some of the world’s largest. Among them Britain’s own GlaxoSmithKline.

They also refused to be interviewed for this program saying only that all trials have stringent standards and are in compliance with local laws and regulations.

You have to watch the documentary to see exactly what Glaxo are suggesting "are in compliance with local laws and regulations." It's pretty grim viewing.

Pay particular attention to what Jacklyn Hoerger has to say. Hoerger was a pediatric nurse who worked at Incarnation for five years.

If they were vomiting, if they lost their ability to walk, if they were having diarrhea if they were dying; that all of this was because of their HIV infection and to be expected and that we were doing the best we could to save them from that.

It didn't come as my first thought at all to question the medication and since I had worked with pediatric AIDS for many years and had given the medication, I just faithfully gave it as I was told by the doctors.

Guinea Pig Kids also features a 15 year old boy who relives the experience of his time at the Incarnation Children's Center:

My friend, Jolice, she never, never ever liked to take her medicine. So they used to hold her down and force it down her throat. I tell her every single day, ‘please take your medicine; you don’t want a tube in your stomach’. But she didn't listen to me. That’s what she got. And my friend Daniel, he didn't like to take his medicine either and he got a tube in his stomach.

The Guardian newspaper broke the story in the UK, they wrote:

Orphans and babies as young as three months old have been used as guinea pigs in potentially dangerous medical experiments sponsored by pharmaceutical companies, an Observer investigation has revealed.

British drug giant GlaxoSmithKline is embroiled in the scandal. The firm sponsored experiments on the children from Incarnation Children's Centre, a New York care home that specialises in treating HIV sufferers and is run by Catholic charities.

The documentary, as you will learn, highlights how the drugs were being used on the kids just to test the 'toxicity' of Aids medications, one of which was Glaxo's AZT [also known as Zidovudine]

As far as I'm aware Glaxo have never been brought to task about their involvement in these trials. It begs the question, why?

Be they beagles, black or hispanic children, GlaxoSmithKline have a lot of unveiling if they are to be true to their word of clinical trial transparency.

Glaxo's major shareholders include, Dodge & Cox Stock, Royal Bank Of Canada, Invesco Advisers, Inc, Bank of New York Mellon Corp and Wells Fargo Bank NA.

Glaxo have also recently formed a partnership with F1 racing group, McLaren. Everybody's hero, Jensen Button, is supporting the GSK initiative. If only he knew...

Here's Guinea Pig Kids.

Bob Fiddaman

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5 years

2013-03-20T09:37:00.000+13:00

5 years ago today my partner lost her only child to suicide.

5 years ago today my partner returned home from work and was faced with the most horrific tragedy any mother should have to endure.

5 years ago today 17 year old Toran Henry said his goodbye because he didn't know any other way to combat the suffering that the antidepressant, fluox [Prozac] was causing him.

5 years on and Mylan, the pharmaceutical company that manufacture fluox have openly admitted that fluox was the most probable cause of Toran's induced suicide.

5 years on and the trainee psychiatrist who told Toran to stop taking his fluox at weekends so he could drink up to six beers, is still a trainee psychiatrist.

5 years on sees fluox still being prescribed to children and adolescents.

I never knew Toran but I have lived with his memories for the past 10 months since my move to New Zealand.

I do know that he would be very proud of his mother, I do know that if he could offer Maria one thing today it would be his arms around her.

5 years and the pain is as fresh as it was on that fateful day.

I'll never know that pain, never be able to fully understand a mother's loss.

Waitemata District Health Board, who were 'caring' for Toran, saw fit to prescribe him fluox. He had no diagnosis of a mental disorder. They saw fit to put him in the care of a trainee psychiatrist who assessed Toran outside a public cafe.

It's taken Mylan 5 years to admit their role in Toran's suicide, namely they made the drug that was the probable cause of his death.

Waitemata District Health Board and Zoran Simovik, Toran's trainee psychiatrist, have never apologised.

Mylan pharmaceuticals have never apologised.

I'm lost for words.

5 years amounts to 1,826 days, 43,829 hours, 2,629,743.83 minutes - each one excruciatingly filled with loss.

Mylan's CEO, Heather Bresch, is a mother with four children.

Zoran Simovik has one child, his whereabouts is currently unknown.

I'm sorry Maria. I cannot relate to the loss you feel, I can only pretend that I think I can.

I'm sorry that I'm not always there for you.

I'm sorry that you have had to endure such a journey and I'm sorry that the likes of the aforementioned have blackened hearts.

Rest in Peace Toran.

Bob Fiddaman

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Are Coroners Ignorant of Facts?

2013-03-18T15:11:00.003+13:00

I think that I am familiar with the fact that you are going to ignore this particular problem until it swims up and BITES YOU ON THE ASS!

Are coroners ignorant of facts?

It's a fair enough question and one that I'd answer with a resounding 'yes'.

I can't imagine for one minute that choosing to be a coroner is a pleasant experience. I'm reminded of when I was a kid and asked what I wanted to be when I grew up - footballer, truck driver. Perversely some might suggest, I even had being a postman marked down as a goal. I cannot recall one single kid either in my class at school or social friends ever wanting to be a coroner - to be honest I don't think anyone knew back then what a coroner was. Who wants to work with dead people anyway?

It takes a special breed of person to become a coroner. Day in, day out, they sit and listen to evidence of how Joe Bloggs was cut from the wreckage of his car or how Jane Doe was brutally gang raped then murdered. All this after eating breakfast, a spot of lunch then home for dinner/tea with their partners and families.

Yes, it takes a very special kind of person to be able to switch off emotions, images, grief.

It has to be said, coroners are exceptional in switching off, they have this in-built mechanism that comes into play - it enables them all to step out the bubble of overwhelming loss - they [think] they know they may be able to shed some light on how and why a person died but they can only do so by 'switching off'.

It's plainly obvious to a growing number of people that coroners not only switch off emotion they also switch off the logic button. One would have thought that coroners, of all people, could apply simple logic to sometimes complex inquests. They choose not to. Having switched off the emotional attachment they also switch off the human attachment. They become God.

Many readers will know that I've recently promoted the website, AntiDepAware. Brian, the author and researcher, has collated over 1600 inquests where the use of antidepressant type medications were involved. One of Brian's latest posts really struck a chord with me - it pretty much sums up what I am trying to say in this post.

Brian has carefully followed the inquests of particular coroners, in his post, Coroner’s Progress 2, he highlights clearly that certain coroners are either playing the God card or, as I suspect, are just pig-headed and ignorant about a problem that is so glaring even a kindergarten pupil could spot it.

"Norfolk Coroner William Armstrong", writes Brian, "is retiring at the end of September 2013."

Brian goes on to write how Armstrong became influential in changing the procedure for licensing shotguns. Apparently Armstrong had been involved in many inquests where firearms were concerned so he decided to do something about it. Kudos to Armstrong for that.

However, where Armstrong saw a link between suicide and firearms he has, on many occasions failed to see the link between suicide and medication. He's not alone, almost every single coroner fail to recognise this common link.

Here's part of Armstrong's career highlights as a coroner, courtesy of AntiDepAware.

Joanne Brown, 41 [1]

… Since about 2005 she had been suffering from serious mood swings resulting from a mental health condition for which she was receiving treatment, although her medication was not always being managed effectively …

….. The coroner said Mrs Brown had suffered for several years from a mental disorder causing mood swings and one happened on December 13. She clearly intended to bring her life to an end and he recorded a verdict of “suicide while suffering from a mental disorder”.

Mark Osler, 51 [2]

Mr Osler shot and seriously injured his ex-lover, then shot himself dead.

… Greater Norfolk Coroner William Armstrong read a statement by Mr Osler’s GP saying he was being prescribed anti-depressants.

He had mentioned having fleeting suicidal thoughts in June. On July 9, he said he was still feeling low and anxious and sleeping badly but never expressed any intention to hurt anyone or take his own life … What happened was completely unexpected and a great shock …

No further comment by Mr Armstrong on antidepressants was reported.

Pamela Thomas, 59 [3]

A CORONER is asking Norfolk police to consider reviewing the scope of firearms licence applications after a woman died from shooting herself, an inquest heard …

… He said there was “no deficiency” in the procedure when Mr Thomas received his latest firearms licence.

But he added: “I have noted that when someone applies for a gun certificate the police will ask questions of their character. There is no obligation to ask about the physical or mental health of everyone in the household.”

Mr Armstrong said at the time the licence was granted Mrs Thomas had not made an attempt to take her own life, but she had been suffering from depression for a long time.

“For a woman to kill herself with a gun is a very rare event,” he said.

The coroner told the hearing this was one of three shotgun suicides in a short period of time and he proposed to ask the chief constable in Norfolk to look at how firearm licences are issued.

However, no comment from Mr Armstrong was reported on the following:

… A medical report from her GP, Adrian Clifton, said she had made good progress on her increased anti-depressants, following her attempted overdose in March which she “regretted” …

These are just three examples of Armstrong's ten reported inquests that AntiDepAware offer for scrutiny. On no occasion has Armstrong ever felt the need to investigate the antidepressant/suicide link - Why?

The three inquests [above] highlight the use of firearms in three separate deaths. They also highlight how all three deaths had another link - antidepressant use.

Armstrong chose to ignore the antidepressant link in a further 7 inquests he conducted, 6 of which involved no firearms.

I find it astonishing that a coroner could turn a blind eyes to overwhelming evidence that, at the very least, warranted further investigation.

Was Armstrong switched off during these inquests, so much so that he missed the link or did he just choose to ignore the link because, hey, depressed people have "mental disorders", right?

We see many Armstrong type figures do the same on a daily basis throughout global coroners courts. They sit in judgement of the dead when in actual fact they should be sitting in judgement for the dead.

Five years ago the 3 month long inquest of 17 year old Toran Henry came to it's conclusion. The coroner stated at the end that children should continue to take their medication as and when prescribed. Toran had killed himself a couple of weeks after being prescribed fluox, the generic version of Prozac. Earlier in the inquest the presiding coroner had stated that in his 8 years of being a coroner, "I struggle to recall a suicide in which Fluoxetine was regarded as being a cause or development."

The pharmaceutical company that manufacture fluox, Mylan Labs, had received an adverse reaction report for Toran. After 5 long years they concluded that the fluox Toran ingested was the most probable cause of his induced suicide. [4]

The inquest of Sara Carlin, an 18 year old from Oakville, Toronto saw Coroner's Counsel, Michael Blain, appear in front of TV camera's on the first day of the inquest. He told reporters and the watching public, "The Courts acknowledge that this medication can increase thoughts of suicide in particular patients but 'they' don't think that the medication played a role in Sara Carlin's death." [5]

This was day one of Sara's inquest. It appears that 'the Courts' had already made their mind up without first hearing the evidence.

Sara hanged herself after being prescribed GlaxoSmithKline's Paxil, known as Seroxat in the UK.

This brings me, conveniently, to a study published in International Journal of Risk & Safety in Medicine [6]

Although the study focuses on violence and not suicide the conclusion pretty much highlights where coroners are either enjoying the role of playing God or ignoring the evidence. The authors conclude:

The deep trench that separates the law from forensic pharmacology is unfortunate and causes injustice, largely invisible to the legal profession. Legal processes generally seem reluctant to implicate the drugs, for whatever reason, preferring instead to look elsewhere. This unexplained bias needs to be examined. Even if people are in general prepared to accept the evidence, many cannot bring it to bear in specific cases.

Two steps could be taken now. First, legal administrations in all countries should ensure that courts under their control obtain appropriate expert evidence from a forensic psychiatrist or pharmacologist in all cases where a prescribed drug could have caused violent or other criminal behaviour.

Second, criminal courts and coroner’s courts should be supplied with an annotated list of drugs that can cause violent behaviour. That need not take long because solid building blocks for such a list have recently been compiled from national pharmacovigilance databases in the United States and in France. The list should be updated regularly.

I cannot for the life of me apply any logic to the stance of coroners regarding antidepressants and suicide. I'm constantly reminded of the line from the movie Jaws.

Mayor Vaughn: I don't think either of one you are familiar with our problems.

Hooper: I think that I am familiar with the fact that you are going to ignore this particular problem until it swims up and BITES YOU ON THE ASS!

It takes a special breed of person to become a coroner...

Bob Fiddaman

[1] Tragedy of mum's shotgun suicide - Published on 28/03/2010 - Lynn News
[2] Gunman took his own life, inquest rules - Published on 28/06/2011 - Lynn News
[3] Coroner’s appeal after Heacham gun death - Published on 19/07/2011 - Lynn News
[4] Mylan Pharmaceuticals Admits their Drug is the Probable Cause of My Son’s Suicide - Published on December 16, 2012 - Mad In America
[5] Sara Carlin Inquest: Day One [VIDEO]
[6] Case histories as evidence - International Journal of Risk & Safety in Medicine - Andrew Herxheimer, David Healy and David B. Menkes 24 (2012) 23–29

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New Website Challenging Coroners About Suicide

2013-03-15T11:32:00.004+13:00

I love it when an idea comes along that has been so blatantly obvious to me... that it's passed me by.

There are many bloggers who have their own styles, their own personal stories to tell, their own take on the pharmaceutical industry, psychiatry, antidepressants.

An area that has interested me has been the whole coronial process. I first became interested in this during my coverage of the Sara Carlin inquest and later the inquests of Shane Clancy and Toran Henry. Three young human beings whose lives were cut short by suicide, all were seemingly normal kids, all were taking antidepressant medication at the time of their deaths, namely, Paxil [Seroxat], Citalopram [Celexa], and Fluox [Prozac].

AntiDepAware is a new website that challenges the coronial system, it's a fascinating read and the author, Brian, has collated many media stories where suicides have occurred but coroners have just ignored the medication link.

Yes, it's another website created to make people aware of antidepressant dangers but where it differs from many is it highlights the failure of coroners to take this issue seriously. It's coming from another angle that I like most about Brian's website, that and the fact that he has meticulously crafted a very strong database of 1600 inquests in England and Wales between 2003 - 2012.

Brian has painstakingly gathered all the information, which he freely admits is just the tip of the iceberg, through various media resources. He writes:

"...all the information here has been found on the Internet, mostly in the archives of local newspapers. I have had no privileged access to any other material. I have limited myself to reports from the past 10 years concerning deaths in England and Wales.

"...this list is far from complete. In fact, it could be subtitled “the tip of the iceberg”. For every inquest report that I was able to include, there was at least another where toxicology was completely excluded from the report, or where medication was hidden behind phrases such as “she was being treated for depression” or “he saw his GP”."

I was reading one of Brian's posts earlier about Coroner Ian Smith. Smith became famous in 2004 when he spoke out about antidepressants during the inquest of a local writer who had hanged himself “out of the blue”.

Smith had heard evidence during the inquest that the local writer was in the course of switching medication from Effexor (Venlafaxine) to Seroxat. To make the transition, he had gradually stopped taking Effexor and had been taking Seroxat for 11 days when he died.

In his summation, Smith pressed for more research into the antidepressant/suicide link as he had previously held two inquests where the person/s had been switching medication.

In 2008 Smith hit the news again.

In March 2008, at the inquest of a retired bank manager, Mr Smith spoke of a link between antidepressants and suicide:

One of Cumbria’s coroners is to contact drug authorities because he fears people are killing themselves after taking antidepressants.

Ian Smith is to write to the Committee on the Safety of Medicines – an independent advisory body …

… Mr Smith told the inquest he knew of several other suspected suicides involving the same group of antidepressants, known as selective serotonin re-uptake inhibitors (SSRIs).

He said: “I have to say this is probably the fifth, if not sixth inquest I’ve heard within a period of three years when somebody either just going on to Citalopram or Seroxat, or coming off it, have killed themselves one way or another, totally out of the blue, totally without expectation, without a history of suicidal thoughts in the past.”

The following month, Mr Smith conducted the inquest into the death by hanging of a farmer.

He … criticised the use of antidepressants and expressed concerns over a pattern of people taking their own lives days after being prescribed the drugs …

Coroner Smith was right, although contacting the Committee on the Safety of Medicines [CSM] would have been frivolous. My experience of the CSM is that they are about as effective as trying to slam a revolving door.

In 2004 the, then, chief executive of Mind, Richard Brook resigned from the Committee after he was told by the British drugs regulator, the MHRA, not to reveal the Committee's findings that Seroxat had, for years, been prescribed by doctors in an unsafe dose and that the regulators had the evidence in their possession for more than 10 years. The MHRA threatened Brook with prosecution if he went public, he basically handed them the middle finger and went public anyhow. [1]

What the MHRA were asking of Brook was to keep secret from the public that GlaxoSmithKline's Seroxat was being prescribed in unsafe dosages. The MHRA, who remember carry the tagline, "Safeguarding human health", had knew this for ten whole years but decided, in their infinite wisdom, that this information would be best kept under lock and key, in other words they didn't see that releasing this information would safeguard human health. Perverse kind of thinking, wouldn't you say?

Not so perverse when you learn three things.

1. The MHRA are entirely funded by the pharmaceutical industry

2. The Chairman of the MHRA at the time had previously been employed by GlaxoSmithKline.

3. The Head of Licensing at the MHRA was former world safety officer at GlaxoSmithKline, one of his interests whilst working for Glaxo was the antidepressant, Seroxat.

Anyway, talking or writing about the MHRA always leaves a bitter taste in my mouth.

AntiDepAware is a must read. It will open your eyes to the closed eyes of Coroners.

The home page is HERE, recent posts are on the right hand side.

Bob Fiddaman

[1] The riddle of the drug regulators [Link]

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Andrew Witty Becomes Chancellor of The University of Nottingham

2013-03-14T11:50:00.000+13:00

Glaxo Chief, Andrew Witty, Sir Andrew if you please, has been installed as the new Chancellor of The University of Nottingham.

Witty, who graduated from The University of Nottingham in 1985 with a BA in Economics, said, “I am honoured to become Chancellor of this great institution, which, alongside my parents and my school, I would credit with having made me who I am. This is a unique and special way for me to give something back.” [Link]

There was no mention of the £12 million donation toward the construction of new research laboratories at the University that Glaxo made last year, the largest single donation the University have ever received. [Link]

No mention of Witty's role in the Wellbutrin/Zyban debacle [Link]

No mention either of Witty refusing to speak with patients harmed by Glaxo's product, Seroxat [Link]

The photo's below, courtesy of uonottingham Flickr photostream, have left me wondering how the parents of kids who died by Paxil induced suicide would feel today if they could see their kids prosper at university.

Be sure to play the video at the foot of this post.

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