Zantac Lawsuit

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

Wednesday, November 30, 2011

Rise In Antipsychotic Drugs Taken By Children

Last week Channel 4 News aired a special report regarding the prescribing of antipsychotics to children.

For those that didn't get a chance to see it, now's your chance.





Monday, November 28, 2011

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

Following on from parts I & II, today I'm covering the withdrawal effects advice given to clinical practitioners by the MHRA. You will note that I refer to it as withdrawal whilst the MHRA add [in brackets] the word "discontinuation," it's almost as if they are explaining the word withdrawal to clinical practitioners, as if they didn't know what the word withdrawal meant! Then again, the pharmaceutical line is "discontinuation" so no surprise that the 'impartial' regulator should go against their paymasters. I'm not convinced the MHRA are behind this at all. Read on.

Section - Principal Risks - Page 7

SSRI learning module: Withdrawal (discontinuation) effects

The MHRA relay the following information to clinical practitioners:
Withdrawal effects may occur, particularly after abrupt discontinuation of SSRI treatment. Patients most commonly report dizziness, anxiety, insomnia and vivid dreams, tremor, paraesthesia, headache, nausea, and lethargy. Other symptoms may also occur including, vomiting, ‘electric shock’ sensations, ’flu-like symptoms, agitation, emotional lability, and confusion. 
I am now convinced that the MHRA's SSRi Learning Module is in fact not the MHRA's at all. I'll go out on a limb here and state, for the record, that it is my belief that this module was either put together by the pharmaceutical industry or was heavily influenced by them.

"Discontinuation", "Emotional lability"?

You notice how they painstakingly inform doctors that withdrawal also means "discontinuation" yet fail to explain to doctors what "emotional lability" actually means..

Nothing like spin coming from a regulator who, at the end of the day, is supposed to be looking after the welfare of patients.

What the MHRA do not inform the unsuspecting clinical practitioners is that the term "emotional lability" covers a wide-ranged of emotional changes, including suicidal thoughts. Very convenient that the MHRA should leave this particular adverse event out considering the number of SSRi incidents associated with deaths that have been reported to the MHRA via their yellow card reporting system..

So, they inform the clinical practitioners about withdrawal effects [minus the suicidal thoughts] - what advice do they recommend?

This is the pure genius of the MHRA/Pharmaceutical industry at work..

Risk-reduction measures
On commencing treatment with SSRIs, the patient should be advised as with all psychotropic medicines to consult their clinician before suddenly reducing or stopping the dose.
When planning to end SSRI treatment, clinicians should reduce the dose gradually in staged intervals over at least four weeks (some patients will require longer) and review the patient for symptoms of withdrawal.

Symptoms after sudden SSRI discontinuation usually last about one to two weeks and then resolve spontaneously, but they can persist for longer in some patients. Close clinical observation is required to ensure that withdrawal symptoms are not getting worse. Severe cases may call for specialist advice and possible switch to an SSRI with longer half-life before gradual tapering.

"Discontinuation lasts usually about one to two weeks" - Bullshit!

"...but they can persist for longer in some patients." - How long?

"Close clinical observation is required to ensure that withdrawal symptoms are not getting worse." - How close, is it being suggested that the clinical practitioner move in with their patient to monitor them? Define close?

"Severe cases may call for specialist advice..." - Name the specialists, what training have they had, who have they been taught by?

"...possible switch to an SSRI with longer half-life before gradual tapering." - Round and round a garden, like a teddy bear...

It would appear that the so-called minority who get the worst out of these drugs are being ignored in favour of the supposed majority who can withdraw from an addictive medication apparently at the drop of a hat. The fact that many thousands of patients have been taking these drugs for 5 years plus does not seem to be important enough to mention to clinical practitioners, just the same old company line spewed out so many times by pharmaceutical spokespersons defending their drug's withdrawal problems, "Discontinuation usually last about one to two weeks." The addition of the line, "but they can persist for longer in some patients", is a throw away comment with no offer of a; an explanation and b; help. Severe cases may call for specialist advice? Name me one GP in Britain who knows of a specialist who is expert in the field of SSRi withdrawal. I can think of one but I bet my left testicle that a good majority of family doctors have never heard of Professor Healy [and I say that with respect]

It was Healy who met the MHRA back in 2009. It was the MHRA who clearly stated, "MHRA thanked Prof Healy for attending the meeting and agreed that it would be important to keep in contact on important new evidence in this area."


Since that 2009 meeting the MHRA have made no effort to contact David Healy.

So who are these "specialists" that can offer 'severe cases of withdrawal' advice?

They don't exist, they exist only in the minds of the creators of the SSRI Learning Module. Unless of course the MHRA can provide me with a list of specialists experienced in SSRi withdrawal that are available on the NHS?

Well, it's in black and white so I guess I can ask them. [request sent]

I was going to cover more of the SSRI Learning Module but I see little benefit it counterpointing what the pharmaceutical industry have to say, they are more powerful than I and have so much more money to throw at the promotion of their drugs and they have a huge advantage by having the people that are supposed to protect patients on board their gravy train.

It's apparent that all the consultations the MHRA has had over the years with stakeholders has meant nothing. Once again they ignore the huge problem of SSRI withdrawal. Simply recommending alternatives and specialists that don't exist is clearly an agency shirking its responsibility, simply because they do not know how to deal with this problem, they never have...they never will.

Hats off to the creators of this module. You have created a genius work of fiction [probably ghost-written] with characters [specialists] and solutions [alternatives] that are merely ghosts in your well-oiled machine of denial.

The SSRI Learning Module can be read in its entirety HERE

Previously in this series:

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I 
MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

Sunday, November 27, 2011

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

Following on from Part I , today I assess more of the MHRA's SSRi Learning Module for clinical practitioners throughout the UK.

SSRI learning module: Sexual dysfunction

The MHRA write:

Sexual dysfunction is a common reason for the patient to discontinue SSRI treatment. Sensitive and frank questioning and discussion of sexual side effects during medication review can help promote adherence to treatment. 

Their advice to clinical practitioners:

Sexual counseling may be called for and specific treatment for erectile dysfunction can be considered. If symptoms persist, consider reduction in dose or alternative treatment.

There they are again banging on about "alternative" treatment without actually mentioning what that alternative treatment is.

No surprise, from me at least, that the MHRA are recommending specific treatment for erectile dysfunction. My only surprise here is that they didn't actually name the actual drug.

Back in 2009 I wrote a blog about how the MHRA had teamed up with Viagra manufacturers Pfizer to air a series of ads on national TV and also in cinemas across the UK. The ads warned of the dangers of purchasing medication online. The commercials showed a man opening a package which contained a packet of pills, he opened the pills, swallowed one then seconds later is seen pulling a dead rat from his mouth. The purpose of these 'public safety' commercials was to warn the public that buying drugs online was dangerous.

I was kind of skeptical about the whole exercise and saw it more of a promotional tool for Viagra, allbeit by proxy as it is illegal to advertise prescription drugs in the UK.

Here's the Ad.

This wasn't the first time advertising by proxy had hit UK TV screens. The following ad promoted the website, a website sponsored by Eli Lilly and Company.

I pondered complaining to the MHRA but it seems they had already received a complaint about this particular ad, a complaint that they did not uphold!

Is it just me or can others see a different reason behind the MHRA recommending erectile dysfunction drugs to patients... who, let's face it, have only got erectile dysfunction because of the SSRi medication they were prescribed, a medication given the all clear by the very same people who are now trying to educate doctor's about their dangers.

[Insert laughter here]

Page 6 of the SSRi Learning module - SSRI learning module: Other common adverse effects.

The MHRA write:

Sweating may occur and in some patients can be profuse. Some patients may experience numbness or tingling (paraesthesia), pain in joints (arthralgia) or muscles (myalgia) or muscle cramps.

and their risk reduction measures...

Profuse sweating may indicate that the dose of SSRI is excessive. If symptoms do not improve, switching to another SSRI may resolve the adverse effects.

I scratch my head at this logic. What is the point of switching to another SSRi when all SSRi's may cause the above? It's hardly reducing risk, it's more of a 'put the patient on a carousel and watch him/her go round and round until they eventually fall off'.

I love the use of the word "may". In truth, they just don't know, it's guesswork and poor guesswork. Switching to another SSRi can cause a whole heap of problems...something the MHRA fail to mention in this section of the "Learning" module.

Coming up in Part III - SSRI learning module: Withdrawal (discontinuation) effects.

I'm going to need a few hours to assess that particular advice!

In the meantime, keeping to the theme of erectile dysfunction, here's a video to enjoy. Courtesy of the double entendre masters AC/DC.

If clinical practitioners are going to be re-educated on the dangers of SSRi's, the last people I'd want teaching them would be an agency wholly funded by the pharmaceutical industry. - Bob Fiddaman

Previously in this series:





Saturday, November 26, 2011

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

SSRi problem?

What problem?

One would think that the British drug regulatory agency, the MHRA, would eventually admit there was a problem with SSRi's, so much of a problem that the risks of prescribing them outweigh the potential benefits of taking them.

Now, after years of being bombarded with yellow cards, anecdotal reports and meetings with SSRi patient advocates, they have decided to offer advice to clinical practitioners in the form of an "SSRi Learning Module."

Fantastic, superb, about bloody time, may be some of the terms used upon hearing this news. I agree that is a step in the right direction but, through experience liaising with the MHRA in the past, I see it as a mere 'cover our ass' type of module. The MHRA want to be seen to be doing something about the SSRi problem yet the module offers nothing that isn't already on the patient information leaflets that accompany this family of medicines.

I have to admit that browsing through the module had me shaking my head in disbelief, it's more of an industry stance than one that is impartial and protecting the consumers. It offers nothing new to clinical practitioners and appears to be yet another buck-passing operation that shows the MHRA admit there is a problem but they really do not know how to handle it.

I'd like to know where they gained their information from, particularly the section entitled "Principal Risks."

Before I dissect what I believe to be a token gesture to all those suffering SSRi withdrawal problems, I'd like to ask why this Learning Module is flying under the radar, why hasn't this been announced to the mainstream press by MHRA CEO Kent Woods? One can only assume that the MHRA don't want people like me shouting from the rooftops, "I told you so". Assumptions is all people like me are left with when a body of regulators are less than transparent.

SSRI learning module: Principal risks

The MHRA module states:

Some noteworthy risks for SSRIs are discussed in this module. Summaries of product characteristics and the BNF should be consulted for a fuller account of the risks of individual SSRIs.

The BNF is close to my heart. On 2 September 2008 I pointed out to Kent Woods that the advice given for SSRi withdrawal in the BNF was minimal. Kent, without making any promises [cover your ass stance] told me that the MHRA would approach the BNF to see if the advice could be changed. In the same meeting I also urged Kent Woods to seek the advice of an expert on SSRi withdrawal. I put forward the name of Professor David Healy. A year or so later, 26 June 2009, MHRA officials met with Healy in a meeting to discuss awareness and management of withdrawal reactions with SSRIs and related antidepressants.

To my knowledge the BNF gives no sound advice on SSRi withdrawal, three years after I asked for it. Healy's withdrawal protocol he offered the MHRA over two years ago remains on the table collecting cobwebs no doubt.

Back to the module.

Two items of note on page 1 of the 18 page module:

Pregnancy and breast-feeding:
The decision to prescribe an antidepressant during pregnancy involves very careful assessment of risks to the mother and fetus of untreated depression during the pregnancy and the risks to the fetus of adverse effects including teratogenic [1] effects from exposure to an antidepressant.


Features of overdose include the usual adverse effects of SSRIs, but very large overdoses can also lead to cardiac features (tachycardia, rhythm disorders, hypotension or hypertension), convulsions, and coma. SSRI overdosage is managed by treating specific symptoms as they arise.

It appears that the MHRA are clearly stating here that SSRi's are teratogenic. Bravo. The penny has finally dropped.

In my book, The evidence, however, is clear...the Seroxat scandal, I dedicate a chapter to my correspondence with the MHRA when I wrote them and asked a specific question, 'Is Seroxat a teratogen?' The response I got was limp-wristed at best and about as clear as mud. It took the MHRA over three weeks to give me an answer that was basically them fence-sitting.

Dear Mr Fiddaman, 

The question “Is paroxetine a teratogen?” is not as straightforward as it may appear, set the tone for what must have caused a severe case of splinters on the ass for whoever drafted it. No doubt it was run by lawyers first...and probably GlaxoSmithKline too, whom I had also contacted with the same question, their response was about as useful as an inflatable dartboard in as much that they told me to "talk to my doctor."

On overdosing, the module now admits that a large overdose may cause cardiac features (tachycardia, rhythm disorders, hypotension or hypertension), convulsions, and coma.

Here's what the MHRA wrote in 2008 [2]:

Selective Serotonin Re-uptake Inhibitors (SSRIs) are a class of medicines that have been used in the treatment of depressive illness and anxiety disorders since the late 1980s. The general adoption of SSRIs into clinical practice reflected in particular their greater safety in overdose, an important advantage in comparison with risks associated with the previous generation of antidepressants, known as tricyclic antidepressants.
Ho hum, what a difference almost 4 years make.

I'm probably being pedantic here, they never actually said that SSRi overdoses didn't cause cardiac features (tachycardia, rhythm disorders, hypotension or hypertension), convulsions, and coma back in 2008 - at least that's probably the argument they'd use in their defence today. It appears that one has to ask these questions before the MHRA answer them, they don't think it important enough to tell you first and, hey, if you don't ask then that kinda leaves them in the clear.

Page two of the module leads with...

SSRI learning module: Gastrointestinal adverse effects.

The module goes on to say that "Gastrointestinal side effects increase with the dose. Drugs that raise the concentration of SSRIs (eg cimetidine with citalopram, escitalopram or sertraline) may increase the risk of side effects. There is no specific treatment for gastrointestinal adverse effects of SSRIs. If unwanted effects do not subside over time and continue to be troublesome then dose reduction can be considered; alternatively, the antidepressant could be changed."

In other words, we don't really know so we suggest doctor's reduce or change the antidepressant. And this is a 'learning module'? Exactly what are clinical practitioners learning from this advice?

Page three moves on to:

SSRI learning module: Central nervous system adverse effects.

Here they mention the more 'common' side-effects, I beg to differ. The ones they list as being rare seem to be more prominent these days.

I'm finishing off Part I of this blog post with section 4 of the module;

SSRI learning module: Psychiatric adverse effects.

This is head-shaking stuff, yet more of 'we don't know what to suggest so we'll just put the patient on a carousel until we can figure out how to combat this problem.

They write:

SSRIs can produce an uncomfortable mental sensation of tension, restlessness or anxiety (akathisia—feeling of restlessness and inability to sit or stand still). This paradoxical state of anxiety can occur when initiating treatment. Severe agitation, psychotic symptoms and suicidal ideation are rare but these serious symptoms must be recognised and addressed.
As far as treating the above symptoms, the MHRA offer this advice:
Anxiety symptoms often settle within a few days of treatment. Regular review and reassurance of the patient may be all that is required. If anxiety symptoms do not abate, the dose of SSRI may have to be reduced. For severe and distressing symptoms use of a benzodiazepine early in the treatment may be considered but, to reduce the risk of benzodiazepine dependence, the duration of such treatment should not exceed two weeks. If symptoms persist, an alternative treatment should be considered.

What alternative treatment? Chicken in a basket, fried eggs on toast, jogging on the spot perhaps? It's all well and good offering advice to doctors but when that advice is so blatently vague it just leaves the doctor's who, like all human beings, have differing opinions on matters. If the MHRA are going to go to great lengths of an SSRi Learning module then for the love of God don't be half-arsed about it. Don't leave the doctor to make his own decision because you just don't know?

In truth, the MHRA are burying their heads in the sand. The 'alternative' treatment is not mentioned here because they don't know what the alternative treatment is - they are putting the onus on the doctor to make that call which, in my opinion, is basically a Carte Blanche for more prescription scribbling for more medication that the patient does not need. A blank cheque, if you will.

Judging by the advice given to doctors by the MHRA on patients suffering psychiatric adverse events it would appear that they are shrugging their shoulders and muttering, "Um...we dunno." They are merely disguising that 'advice' as "alternative."

If clinical practitioners are going to be re-educated on the dangers of SSRi's, the last people I'd want teaching them would be an agency wholly funded by the pharmaceutical industry. - Bob Fiddaman

Part II coming soon.

[1] Teratogenic: Able to disturb the growth and development of an embryo or foetus
 Teratogen: Any agent that can disturb the development of an embryo or foetus. Teratogens may cause a birth defect in the child. Or a teratogen may halt the pregnancy outright. The classes of teratogens include radiation, maternal infections, chemicals, and drugs

[2] MHRA Investigation into Glaxosmithkline/Seroxat




Wednesday, November 23, 2011

FDA Approve Another Addictive Drug

I thought I was seeing things when I read this. The FDA, in their infinite wisdom, has just approved Intermezzo, the pill that... well, it basically knocks you out for the count.

Designed by Transcept Pharmaceuticals Intermezzo is for people who wake in the middle of the night. Slip it under your tongue and you'll be out like a light. It's basically the equivalent of stepping in to the ring with Iron Mike Tyson.

Intermezzo - nice brand name. I have a thing about brand-names, I briefly touch on it in my book.

Intermezzo is is interesting. Inter - (tr) to place (a body) in the earth; bury, esp with funeral rites. Mezzo - (a person having) a singing voice between soprano and alto. In music, an intermezzo (Italian, plural: intermezzi), in the most general sense, is a composition which fits between other musical or dramatic entities. Oh, and it's also a coffee so there may be some objections to the name at some point down the line.

The FDA had on two occasions previously refused to approve Intermezzo, their main worry being that people might get up and try to drive before the drug fully wears off. Studies clearly show that the drug badly impairs driving, and that this effect lasts longer in some people than in others. To get around this the manufacturers changed the labelling to state that the drug should only be taken when people have at least four hours of sleep time remaining. They also added, "Moreover, people should not take Intermezzo if they've been drinking alcohol or if they've taken other sleep aids."

A simple tweak of a label and the FDA give it a clean bill of health. Amazing aren't they?

The final three paragraphs from the WebMD website say it all really:

Intermezzo, like other sleeping pills, can cause serious side effects. These include getting out of bed not fully awake and being unaware of doing things or remembering you did them.

Activities reported to the FDA while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking. Alcohol or other sleep medicines increase the risk of doing such things.

And like other forms of zolpidem, Intermezzo is a controlled substance that can be abused or that can lead to drug dependence.
"...getting out of bed not fully awake and being unaware of doing things or remembering you did them."

Any defence lawyers out there, I feel a bank robbery coming on.

Ironically, after taking Seroxat for 6 years I now have a sleep disorder, I wake in the middle of the night and can never get back to sleep. In fact, I can fall asleep at inopportune moments too and in the past I have fallen asleep waiting to be served at a bar, on a bus and even a telephone box! Thank you GlaxoSmithKline.

Will I be sampling Intermezzo?  HAHA! Once bitten...





I'm left scratching my head at the logic of this approval. It's not a cure, it's merely papering over the cracks and I can guarantee that more cracks will appear, they always do with these drugs that act on the brain.

Nice job FDA.

Tuesday, November 22, 2011

GlaxoSmithKline Parodied

I do love it when a good post comes along using the art of parody to slam GlaxoSmithKline.

Two posts of note are by two separate bloggers. First off is The Truthman with the brilliantly titled blog, GSK Licence to [Kill]

The Truthman has been hard at it for years, posting relevant information relating to GlaxoSmithKline's unsavory history.

His latest post is in comic-strip form and rips a new hole into GSK CEO Andrew Witty.

The Truthman living up to his name and spreading the truth.

You can read the full comic over at The Truthman's blog HERE

Next up is one of the most consistently funny bloggers out there. Pharma Giles has been kicking ass for some time now, his latest parody is a work of genius.

You can read the full parody over at Pharma Giles' blog HERE

Keep up the great work guys. One thing I've learned during my years writing this blog is that Glaxo, the regulators and psychs hate it when you make fun at their expense.





Thursday, November 17, 2011

Drug Pushers Target 4 Year Old Kids

"You are depressed because you have a chemical imbalance"

"You are shy because you have a chemical imbalance"

"You are anxious because you have a chemical imbalance"

""You have ADHD because we said so"

Back in the day, when SSRi's such as Prozac and Seroxat came to market, the drug companies reeled in the consumers by telling them they had something wrong with them, a chemical imbalance was deemed to be the cause of their feeling anxious, shy or depressed. "Seroxat", we were told, "corrects that chemical imbalance."

Amazing how they actually got away with such false and misleading statements.

These days it would appear that no explanation is needed. Psychiatrists and drug companies no longer use the chemical imbalance fact...because it never was fact. If they do tout the chemical imbalance theory at you then I recommend you watch the short video at the end of this post for a suitable response to them]

Today sees drug companies advertising by proxy. Key opinion leaders, better known as leading psychiatrists in the world of pediatrics, do the pushing for them. They promote illnesses such as ADHD then announce that there is a the shape of a pill. Because there are no advertising guidelines for a psychiatrist's opinions they can say pretty much what they want to without backing up their claims with any scientific data.

Apparently it's heredity that is one of the causes of ADHD. That's right folks, if you were a little boisterous in childhood then chances are that your offspring will be born mentally ill.

Now, I wasn't the model pupil in my schooldays, quite the opposite in fact. I kind of questioned what was being taught, it was confusing to be told in history lessons that we derived from apes yet an hour or so later, in Religious Education , I was told that we were created in the image of God. "So God looks like an ape, right?", I'd ask. This was usually greeted with the cane or a detention or in some cases I was told to seek confession for my sins. The sin of an inquisitive mind - where's that in the Bible?

There were lessons where I would get bored so I'd craft paper aeroplanes or flick paper pellets with an elastic band. Then there were the times of puberty when all I could think of was mattress dancing with any of the girls whose eyes I happened to meet. This, in turn, would have me day dreaming out of the window and thinking of The Bionic Woman [Lindsey Wagner] or tennis ace [Chrissie Evert]

Nowadays such behaviour would be deemed as something only a mental child would do and I'd probably be carted off to the headmaster [straightjacket affixed] and be sent home on the proviso that I met with my GP to discuss my 'abnormalities'.

Puberty huh, such an imbalance on the brain.

Today, it seems, kids can have a mental disorder before they attend their senior schools, in fact before they attend their primary schools...which leads me nicely to a recent article published in today's Telegraph.

The headline reads "Give Ritalin to four-year-olds with ADHD, say experts." The article, by Stephen Adams, reports on how the American Academy of Pediatrics [AAP] claim, "Treating children at a young age is important, because when we can identify them earlier and provide appropriate treatment, we can increase their chances of succeeding in school."

He [Dr Mark Worlaich, professor of paediatrics at the University of Oklahoma College of Medicine] and colleagues, writes Adams, advised that a doctor "should initiate an evaluation for ADHD for any child four through 18 years of ago who presents with academic or behavioural problems and symptoms of inattention, hyperactivity, or impulsivity".

Ah, I see. So, four year-olds who are not interested in learning the alphabet or reading along to Thomas the Tank Engine stories are actually mentally ill?

WAY TO GO Mr Pediatric man!

You know, it would be great if you could give 4 year-olds a leg up to childhood rather than drug them and turn them into a dribbling mess. Interestingly, the AAP came under fire, albeit moderately, from Dr John Houston, a consultant paediatrician based at Lorn and Islands Hospital in Oban, who said, "In the UK we are more reluctant to medicate our kids, and I think that's a very good thing."

Reading between the lines it would be nice to think that Dr Houston was telling the AAP to head on back to America with their delusions. Sadly, it's the opposite as more and more UK doctor's have bought into the idea that normal behaviour [daydreaming, tiredness, being boisterous] is now treatable with mind altering drugs.

I can't wait for their day of Judgement.

This post is dedicated to Chrissie Evert and Lindsey Wagner, whom collectively made my childhood and teen years so much more pleasurable than any doctor today thinks they can.




Tuesday, November 15, 2011

GlaxoSmithKline's Cervarix Under The Spotlight [Again]

Fresh from paying off a recent fine of $3 billion for illegally marketing it's brand of drugs, Paxil, Wellbutrin and Avandia, pharmaceutical giants, GlaxoSmithKline, were yesterday embroiled in another tale of woe regarding another of their products.

This time it's their widely promoted safe vaccine for teenage girls, Cervarix.

Many of the British newspapers are covering the story of Lucy Hinks who, at the age of just 13, has been left in a "waking coma" after suffering suspected side effects from the Cervarix vaccine.

Glaxo, in usual style, have rolled out the tired and trusted one-liners that has stood them firm for years when defending drugs such as Avandia and Seroxat.

This from MSN News:

"It [Cervarix] has been shown to be generally well tolerated".

and the old faithfull:

"...we take these reports very seriously."

Ring any bells?

2002 [BBC] GlaxoSmithKline spokesperson Alastair Benbow defending Seroxat with:

"Seroxat is an effective and generally well tolerated treatment for the management of depression."


"We take the safety of our medicines extremely seriously." - Transcript GSK Tape – Panorama Interview – Dr Alastair Benbow 9 October 2002

Personally, I think the comments from GSK spokespersons are being generally well tolerated by the British public, be nice if we had some transparency occasionally, doncha think?

In June 2008 a promotional DVD was sent to every G.P in the UK just hours before the launch of the Cervarix vaccine in the UK. The DVD was posted with the G.P. magazine and was a clever marketing strategy aimed at busy G.P.'s to 'brainwash' them into believing that the Cervarix vaccine protected young women from the perils of cervical cancer.

The comments at the start of this video juxtapose the claims made by GSK in the promotional video.

For more information:

Thursday, November 10, 2011

Hey Pharma, Look At What Your Drugs Did

To watch the full length documentary 'Dead Wrong', click HERE

For Matthew

For the sisterhood.



Tuesday, November 08, 2011

Healthy and Living...The Patricia Casey Way

I was recently alerted to a newspaper article penned by Irish psychiatrist Patricia Casey. The article, which first appeared in the magazine 'Healthy & Living', covers the "brain disorder" known as seasonal affective disorder, otherwise known as SAD.

I couldn't conjure up a better name for a brain disorder than this particular one, well, I could but it would never be accepted by the white-coated posse who write the Diagnostic and Statistical Manual of Mental Disorders [DSM]

What better way to tell someone they are telling them sad is a brain disorder?

Whilst I'm aware that the rolling of the clocks back an hour changes people's moods, I really don't think it's necessary to treat those moods with antidepressant medication, I don't think it should be labelled as a mental disorder either. Furthermore, those that think it is, probably have some sort of disorder themselves.

Sure, these early dark evenings are pretty miserable, particularly when accompanied by the harsh weather conditions of recent years in the UK and Ireland, but should we really be reaching for the medicine cabinet as Casey suggests in her article?

Admittedly, Casey writes about another treatment as well.before she goes down the antidepressant route. Light boxes, where the person with this mental disorder sits and stares at a light. I really cannot envisage a picture more 'sad' than someone sitting alone in a room and staring at a light - that would be enough to send the white-coated gents around with a straitjacket and forcibly inject the subject staring at the light.

There is no doubt that the sun makes us feel happy, the dark fills the majority of us with a sense of fear - even the word 'Dark' has negative connotations, something that the DSM seemed to have pounced upon.

Casey writes about studies from Canada that have shown that when clocks shift backwards the incidence of depressive illness increases, probably mediated by the effect on sleep. It is found in both hemispheres, especially in northern latitudes and is almost unknown in those living within 30 degrees north or south of the equator.

I'm loving that word 'Probably'.

If this is 'probably' down to a lack of sleep then why isn't the sleep problem tackled? Why is it ignored and replaced with a mental disorder?

Long gone are the days when Horlicks was promoted to help you sleep better, ironically Horlicks is manufactured by GlaxoSmithKline, the company that apparently helps people do more, feel better and live longer. Judging by their recent $3 billion fine for illegally marketing it's products I'd suggest that they change their tagline to something more appropriate, something like, "Buy more, don't ask questions and live shorter lives."

I digress.

Casey, to me at least, is seen in a bad light [excuse the pun]. Touting antidepressants in a magazine that is widely read in doctor's surgery waiting rooms around the UK and Ireland is nothing short of advertising by proxy.

"Hey Doc, I was here to see you because I have a wart on my toe but I was just reading about SAD in a magazine and it appears I have it!"

"Describe your symptoms for me"

"Well, the clocks went back last week and around 4.30pm my mood changes"

"Yup, sounds like you have seasonal effective disorder to me, have you tried staring at a light?

**Patient stares at doctor and walks slowly backwards out of the door.

Even more preposterous would be the suggestion of antidepressant medication but we...or at least the majority of us, take it as a given that feeling blue, because it is dark, is a mental disorder. Articles, such as Casey's, throw no real light on the root cause [excuse the pun again]

Coming soon to the Healthy & Living magazine, 'Why the moon makes us insane' by Dr Looney.


Casey has, in the past, set solicitors on to people who have different opinions to hers, you can see those threatening letters here and here.

In the meantime, this is for Patricia Casey, it's a poem I penned many years ago, it ended up in an anthology of poetry for children. It kind of explains the dark... and there is no mention of antidepressant medication either.


Don't be afraid as I enter your room
Just let your mind drift like a floating balloon.
I've come to take the remains of the day,
Go deeper little one and let your mind stray.
Dream of the swings over the park,
Hurry now small child for it will soon be dark.
If you wake up you'll have nothing to fear
Just sit up in bed and let your mind clear.
For I am your friend, I mean you no harm,
So don't be afraid, stay cool, stay calm.
Let your eyes wander through my blanket of black
And don't wish me away for I'll always come back.
It's light that is evil as it enters your world,
Ordering you to see things that make your toes curl.
So don't be afraid as your day turns to night
Just remember I'm here to cast out bad light.


 Casey's article, "Don't be afraid of the dark", can be read HERE

Monday, November 07, 2011

European Drugwatch Agency Under Investigation

The Independent is reporting that The European Medicines Agency [EMA] is under investigation by the European Anti-Fraud Office (OLAF) over allegations of conflicts of interest.

The investigation into the European medical regulator, writes Jeremy Laurance for The Independent, relates to the scandal over the French diabetic drug, Mediator, which was withdrawn from the European market in 2009, a decade after initial signs that it could be responsible for fatal heart problems.

Mediator, a weight loss drug, was banned in Europe after it was found that it caused between 500 - 2000 deaths and, it appears, the EMA didn't act quickly enough.

The crux of the investigation stems from the fact that the EMA are 80% funded by the pharmaceutical industry, much like the UK regulator who are wholly funded by the industry.

I find it odd that an investigation would start now, surely it's been public knowledge for years that this is how the system works?

It's simple really.

A drug is put up to be granted a licence - The regulator reads the supporting evidence - The pharmaceutical company provide the positive results from the clinical trials of that drug - The regulator doesn't bother asking for the negative trial results - The drug is granted a licence.

Some years down the line consumers complain of side effects, some so severe that they cause death - The regulator review the drug and give it a clean bill of health, on the odd occasion they send out warning letters to doctor's to "monitor" the patient. This covers their ass should any future deaths occur.

Everyone is happy and conscience free.

At some point a bunch of patients may kick up a stink about the drug, the regulator will hold meetings with them, appease them and make promises to investigate. They then go all out to target fake drugs flooding the European market - they can't have poor quality drugs going up against the 'safe' drugs that they have granted licence to you see.

I see no point in a regulator that is funded by the very same people it is supposed to be regulating, it's akin to asking an alcoholic to look after a crate of Vodka or giving an arsonist a gallon of petrol and a book of matches.

A spokesman for the EMA said, "We have a robust process for dealing with conflicts of interest. It is transparent and there's no attempt to hide anything.

Yeh, and I've just seen a cow jump over the moon.

Related video:

 *Hat - Tip - Leonie Fennell




Sunday, November 06, 2011

GlaxoSmithKline - The "Maladaptive" Company

There are many people/organisations that I greatly admire for their part in creating awareness in this minefield of deceit and fraud associated with the Seroxat scandal. Bloggers that have stood the test of time, Seroxat Secrets and GSK Licence To Kill have been at the forefront of spreading awareness about the dangers of Seroxat and the less than honest approach of it's manufacturer, GlaxoSmithKline.

Then we have support groups such as The Seroxat User Group, whose owner hasn't even taken Seroxat but sees there is a huge problem and has striven to help expose that problem through her advocacy work.

There's also been people like Alison Bass, Evelyn Pringle, Shelley Jofre, three journalists who have put their careers on the line, all of whom have, at one time or another, exposed the failings of GlaxoSmithKline and the regulatory systems, namely the MHRA and the FDA.

I've great admiration for the parents of both Sharise Gatchell and Sara Carlin, two teen who both took their own lives after being prescribed Seroxat. The strength of their parents to expose that dangers of Seroxat has given me strength over the years I have known them.

Charles Medawar for his tireless work in showing how the MHRA showed utter contempt for Seroxat Sufferers also deserves a mention, as do Prof David Healy, Peter Breggin and Joseph Glenmullen.

Attorney's in the US whom have shown dogged determination to get to the truth include The Tracy Law Firm, Donald J. Farber, Baum, Hedlund, Aristei & Goldman

There are many more, some I've met in person, others I hope to meet someday.

One such person is Rob Robinson, an activist who, with balls of steel, took the fight right to the doorstep of GlaxoSmithKline. If there was any justice in this world Rob, along with the aforementioned would be commended by their respective governments for exposing the dirty deeds of the UK's biggest pharmaceutical company.

The author of the Seroxat Secrets website recently posted about the recent $3 billion fine imposed on GlaxoSmithKline, the biggest fine in history to settle United States government civil and criminal investigations into its sales practices for numerous drugs. Seroxat Secrets wrote:

$3 billion – yes that’s record – but still no prison time.

It strikes me there are a couple of points coming out of this story:

1 – it seems if you have enough money you can buy your way out of trouble… even if that ‘trouble’ is criminal.

2 – Andrew Witty thinks he’s changed Glaxo – he said “…This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today…”

Well Andrew, this deal is in the US – what about the UK?

You’re not quite so happy for the new, improved GlaxoSmithKline to settle claims in the UK are you, now Andrew.

Could it be because you know the UK legal system works in your favour, so you can effectively ignore UK cases… in the UK cases like this are not heard in front of a jury, but in front of a high court judge – and funding is not easy to get. Basically in the UK we have no real chance to take on big business and patients not protected by the MHRA.

He is absolutely correct.

His post prompted me to browse through the archives of the Paxil Protest website, a site created by Rob Robinson, a site that was a minefield of information, a site that GlaxoSmithKline wanted shut down. One does not have to be a highly paid lawyer to see why they wanted it removed.

I've been writing about the MHRA, GlaxoSmithKline and Seroxat for 6 years. If I continued to write for a further 20 years I wouldn't come anywhere near what Robinson achieved. The man is a legend.

The following shows how effective Robinson was. It ends with a quote from Karen Barth-Menzies, yet another hero/heroine of mine. This is especially for Addleshaw Goddard, GlaxoSmithKline's UK law team.

Paxil Addiction

....there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been.— Sworn testimony of Dr. David WheadonSenior Vice President, GlaxoSmithKline Regulatory Affairs and Product Professional Services (10/19/2000)


Controlled Substance Class: Paxil is not a controlled substance. Physical and Psychologic Dependence: Paxil has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of Paxil (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).— Paxil June, 2005 Prescribing Information

Disregard for the moment that perjured testimony, and the studies that were never done (or ever will be): Any man, woman, or child, who has crawled through the "Hell beyond Hells" that is a severe Paxil withdrawal will tell you (assuming they lived) that, yes, he or she was dependent on the drug; a prisoner, if you will, for the simple reason that continuing to take Paxil staved off horrifying, debilitating and protracted withdrawal symptoms.

It is INSANE that I and others have had to stumble into and through this hell ... and then try to figure out how to get out of it basically on our own! Its like being thrown into a chemical version of Dante’s Inferno with no map showing you how to get out — or even if you can get out at all! I think (but don’t hope) I’m close to clawing my way out, but who knows? I hate to say it, but the thought just drifted into my head: All ye who enter here abandon all hope.— Journal entry, day #89 from a Paxil withdrawal diary kept by Rob Robinson, a Paxil survivor.

In the mind of a lay person this inability to quit Paxil qualifies as "addiction" regardless of whether a Paxil user craved the drug to "get high," like a "real" addict craves, for example, heroin.

How GlaxoSmithKline has dealt with the issue of Paxil dependency (i.e. addiction) mirrors efforts it undertook regarding the issue of Paxil withdrawal. GSK flatly denies that Paxil can cause dependency or addiction and, in fact, the company has gone to extraordinary lengths to keep the label of dependency or addiction from being associated with the use of Paxil.

The truth is GSK knows Paxil can, sans studies, cause physical dependency in significant numbers of people. That is absolutely the case. It is one of the principal reasons why GlaxoSmithKline has, for years, instructed its sales reps to, whenever possible, substitute the word "discontinuation" for "withdrawal" in communications with healthcare professionals — because withdrawal implies dependency. And dependency, quite naturally, suggests addiction.

Yet the volume of anecdotal information available to GlaxoSmithKline and the world — proving Paxil can, and does, cause dependency — is widespread, dramatic, compelling and overwhelming.

Charles Medawar, of Social Audit framed the issue perfectly when he wrote:

“There is obviously some confusion about the concept of dependence ... The simplest definition of drug dependence given by W.H.O. (the World Health Organization) is ‘a need for repeated doses of the drug to feel good or to avoid feeling bad’ (W.H.O., Lexicon of alcohol and drug terms, 1994). When the patient needs to take repeated doses of the drug to avoid bad feelings caused by withdrawal reactions, the person is dependent on the drug. Those who have difficulty coming off the drug even with the help of tapered discontinuation should be regarded as dependent, unless a relapse into depression is the reason for their inability to stop the antidepressant medication.”

Thanks to Mr. Medawar’s relentless efforts to expose the truth about Paxil (Seroxat in the U.K.) GlaxoSmithKline was forced to remove from its U.K. Patient Information Leaflet the following language:

“These tablets are not addictive” and “remember that you cannot become addicted to Seroxat,” and further that the withdrawal symptoms some people experience when stopping Seroxat “are not common and (they) are not a sign of addiction.”

Shattering GlaxoSmithKline's DSM IV "No Dependency" Shield

For now forget the studies GlaxoSmithKline refers to in Paxil's prescribing information mentioned above; those studies will never be performed for the simple reason they would provide conclusive evidence that use of Paxil can induce dependency. Evidence which would present an insurmountable threat to the fortunes of GlaxoSmithKline.

Today, the GlaxoSmithKline public act which claims Paxil cannot induce dependency — based on the latest version of the Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR (a.k.a. the DSM IV) — would play well if this were the "Theater of the Absurd." But not out here in the real world where lives are being shattered and people are dying because of Paxil.

The GSK dodge seeks refuge under cover of language which changed when the DSM III was supplanted by the DSM IV in which, according to Charles Medawar of Social Audit "the new definition of dependence specified that the presence of withdrawal symptoms — in the absence of at least two distinctive features of a drug problem — was not "dependence" at all. At a stroke therapeutic dependence ... officially ceased to exist. Once again, the problem revolved around the true meaning of "dependence" but, this time, the new definition both radically changed the meaning and defied common sense. To compound the problem the authorities then failed to explain, or even acknowledge, that this enormous shift in meaning had taken place.

The Pharmas zealously promoted the new definition, but the medical establishment welcomed it too — because it characterized "dependence" as something that no competent doctor would ever cause. As if by law, and at a stroke, "dependence" had again come to mean something like frank drug abuse. In line with tradition, dependency problems were pinned on users once again.

Internationally, the risk of New Dependence was considered so small, that the regulators never requested the SSRI Pharmas test their drugs.

For the sake of argument let's have the public give GlaxoSmithKline the benefit of the doubt, even though it's unwarranted. We can "test" GSK's specious DSM IV claim by parsing the manual's criteria for substance dependency on a point-bypoint basis

Remember, only three of the following criteria must be meet within a 12-month period for a diagnosis of substance dependency.

The Diagnostic and Statistic Manual (DSM IV), defines addiction (which it refers to as “substance dependence”) as follows:

A maladaptive* pattern of substance use, leading to clinically significant impairment or distress, as manifested by three (or more) of the following, occurring at any time in the same 12-month period:

(1) Tolerance, as defined by either of the following:

a. A need for markedly increased amounts of the substance to achieve intoxication or desired effect.

Many Paxil users must take larger doses of the drug over time as the efficacy of the drug wears off in order to achieve the desired effect.

b. Markedly diminished effect with continued use of the same amount of the substance.

Many Paxil users experience "SSRI poop out" (see D.J. Rapport, J. R. Calabrese, Tolerance to fluoxetine. J Clin Psychopharmacol 1993 Oct, 13 (5), 361.) after taking a fixed dose of the drug for a number of years. As a result they must increase their dosage in an attempt to regain efficacy. Even then, the increase in dosage sometimes has no effect.

(2) Withdrawal, as manifested by either of the following:

a. The characteristic withdrawal syndrome for the substance.

The phenomenon of Paxil withdrawal is an established fact now, and one acknowledged in the manufacturer's current drug labeling.

b. The same (or a closely related) substance is taken to relieve or avoid withdrawal symptoms.

Individuals trying to quit Paxil sometimes switch to another "SSRI" with a longer half-life (i.e. Prozac) in a attempt to simultaneously get off the drug and ameliorate its oftentimes severe withdrawal symptoms. (Like heroin addicts who use methadone.)

(3) The substance is often taken in larger amounts or over a longer period than was intended (loss of control).

Many individuals continue taking Paxil — long after they would like to stop taking the drug — to stave off extremely severe, debilitating and prolonged withdrawal symptoms that sometimes occur when stopping Paxil.

(4) There is a persistent desire or unsuccessful efforts to cut down or control substance use (loss of control).

"Same comment as for #3." Many individuals continue taking Paxil — long after they would like to stop taking the drug — because of the withdrawal symptoms that occur when stopping Paxil.

(5) A great deal of time is spent in activities necessary to obtain the substance, use the substance, or recover from its effects (preoccupation).

If Paxil was illegal many users would spend whatever time was necessary to get the drug "on the street," thus engaging in the same behaviors "real" addicts exhibit in their quest to obtain the drug they are dependent upon. A Paxil addict doesn't have to go this route since the doctor who (unwittingly) prescribed Paxil to him or her hands out refill prescriptions; all that's necessary to get more Paxil is a trip to the local pharmacy.

(6) Important social, occupational, or recreational activities are given up or reduced because of substance use (continuation despite adverse consequences)

(7) The substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance. (adverse consequences)

This is the situation lived out on a daily basis for thousands of Paxil dependents who have (quite often) discovered through the Internet why it is they are unable to quit the drug without experiencing disabling withdrawal symptoms.

Paxil and proof of dependency: In basketball it's what they call "a slam dunk."

In legal documents GlaxoSmithKline appears to make much out of the word "maladaptive" as used in the DSM pre-qualifier. In this context an acceptable medical synonym for the word "maladaptive" is "dysfunctional." If Paxil dependency is not a state of dysfunction (i.e. maladaptation) then the condition doesn't exist.

Based on what the world knows about Paxil today: Paxil should be — if not summarily banned — then at a minimum classified as a "Schedule II" drug by the United States Drug Enforcement Agency. (At the same time the DEA should change its scheduling guidelines under "(C)" to read "use of" vs. "abuse of" since that language lags behind today's realities.)

Rob Robinson - Paxil Protest

"We have been trying for years to raise public awareness about these issues because we have seen, through our litigation, the secret internal company documents that no one ever gets to see, not even the FDA. Even now, we are prohibited, due to confidentiality orders, from disclosing these documents. But, you can only hide the truth for so long. Too many people have been harmed by these drugs, too many lives have been shattered." - Karen Barth-Menzies - Paxil plaintiffs' attorney

Friday, November 04, 2011

Dissecting Glaxo's "Marketing Practices" Statement

GlaxoSmithKline have released a press statement on their website in reaction to the latest news that they have been fined $3 billion [yes, that's billion] over the marketing and selling and their products such as; Wellbutrin [Also known as Zyban] Paxil [Also known as Seroxat, Aropax] and Avandia.

The press release, which features a statement from Glaxo's CEO, Andrew Witty, makes no apology to Glaxo's customers harmed by their marketing and selling tactics of their products nor does Witty make any apology to the US government for marketing and selling drugs in such a way that could have been detrimental to the people of the United States.

Speaking on behalf of it's shareholders the GSK statement reads:

The GSK Board and management team have been focused on resolving these long-standing legal matters and reducing financial uncertainty for the Group and believe this agreement in principle to be in the best long-term interests of shareholders.

Witty goes the extra mile with:

This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today. In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the US to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently. We reiterate our full commitment to ensuring appropriate promotion of our medicines to healthcare professionals and to the standards rightly expected by the US Government.

One could be duped into believing that Witty was sincere but history tells us that this is just another cash settlement with a total disregard for those that matter - the GSK customers.

I was enlightened to see Patrick Burns, spokesman for Taxpayers Against Fraud, an advocacy group for whistle-blowers pose the ultimate question to GSK's latest non-compliance of marketing and selling in the US. He asks:

“Who at Glaxo is going to jail as a part of this settlement? Who in management is being excluded from doing future business with the U.S. government?”

Who indeed?

Former GSK boss, J.P Garnier

Looking again at Witty's statement it would appear that he is deflecting the blame on his predecessor at GSK, Jean Pierre Garnier: "In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the US to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently."

The New York Times [NYT] further highlights Glaxo's wrongdoings with a statement from Brian Bourdot, an analyst at the investment bank Barclays Capital, who called the settlement an important step but also noted that GlaxoSmithKline “remains involved in other legal disputes, including alleged violations of the Foreign Corrupt Practices Act.” [1]

The NYT also adds:

In a separate case last year, GlaxoSmithKline agreed to pay $750 million, including a $150 million criminal penalty, to resolve federal complaints about manufacturing quality at a plant in Cidra, P.R., since closed. [Back stories here, here, here and here]

Mary Anne Rhyne, a spokeswoman for the company, said Thursday that it was still negotiating with the government over whether to include a corporate integrity agreement in that deal. The agreement could provide further penalties for other violations, though in manufacturing.

Mary Anne Rhyne, equipped in the art of deflection, is the same Glaxo spokesperson who, when speaking of Paxil [Seroxat] withdrawal, once said, "If ‘discontinuation reactions’ occur in patients stopping the majority will experience symptoms that are mild to moderate in intensity, and are usually limited to two weeks."

Ho hum.

Whilst Witty ensures future commitment to ensuring appropriate promotion of Glaxo medicines one has to ask why he has not issued an apology to Glaxo's consumers. Resolving criminal matters by throwing money just smacks of burying the problem, something GlaxoSmithKline are past masters at.

I live for the day when I see a law-firm criminally prosecute GlaxoSmithKline, be it Garnier or Witty. It's pretty difficult to sing the praises of a corporate criminal when that corporate criminal is behind bars.

Glaxo's and Witty's joint statement finished with:

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit

Is it just me or does anyone else think they are taking the piss?

[1] Foreign Corrupt Practices Act is a United States federal law known primarily for two of its main provisions, one that addresses accounting transparency requirements under the Securities Exchange Act of 1934 and another concerning bribery of foreign officials.




Thursday, November 03, 2011

Glaxo Fined $3 Billion!

GSK, fined $3 billion - The Olympic Committee must be so proud of them.
Image [Source]

The company that uses the promotional tagline of making it's consumers "do more, feel better, live longer" have agreed on a $ 3 billion settlement with the US government over the way they marketed their diabetes drug, Avandia.

Glaxo, as ethical as ever, were accused of paying its sales force teams hefty bonuses based on the number of prescriptions they generated, which ultimately may have led to doctors issuing prescriptions to patients for un-approved usage of nine of GlaxoSmithKline's drugs, including Paxil [Seroxat], Wellbutrin [Zyban]

The $3 billion fine, writes The Times, also brings to an end other investigations in the US into Glaxo’s marketing of the diabetes drug Avandia and the possible inappropriate use of the Medicaid Rebate Program.

Andrew Witty, Glaxo's CEO, is quoted in The Times article:

“This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today.

“In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the US to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently.”

Meanwhile the UK Seroxat group action against GlaxoSmithKline which, despite rumours, is still on-going, sees Glaxo defend their antidepressant and the propensity it has to cause severe withdrawal problems in a number of patients. Glaxo, reflecting the way in which the company are today, are disputing that Seroxat has been problematic for the claimants in this case.

Regarding Avandia, it was withdrawn in Europe last year after it emerged that side effects included increased risk of heart attack. In the US it remains in place.

Now there's Openness and Transparency!




Wednesday, November 02, 2011


Tuesday, November 01, 2011

Canadian Psychiatric Association Roll Out The Pregnancy and Depression Tool

Self reinforcing delusion:

1. a delusion is a false belief or opinion
2. and a self-reinforcing delusion is one that creates conditions that reinforce that false belief or opinion.

October 14, 2011 the Canadian Psychiatric Association [CPA] presented their 61st Annual Conference where they rolled out a soon-to-be published tool that, they claimed, may help ease the decision-making process for physicians and patients alike.

Sophie Grigoriadis, MD, PhD, from Sunnybrook Health Sciences Centre in Toronto, Ontario, Canada, presented preliminary data from a pilot test of an "urgently needed" tool to help clinicians assist pregnant patients who have moderate to severe depression make more informed treatment decisions.

Urgently needed?

Informed treatment decisions?

"Conflicting information about antidepressant medications in pregnancy has made it difficult for clinicians to figure out how to treat these women. What we're trying to do is help them cut through some of the confusion by summarizing the literature in a way that will make it easier apply to clinical practice," Dr. Grigoriadis told Medscape Medical News.

And what exactly was that help in summarizing literature?

Grigoriadis explains:

There were conflicting reports about antidepressant use in pregnant women. In addition, evidence was also published highlighting the risks associated with discontinuing antidepressant medication, and specifically highlighting the increased risk for depression relapse in women.

In the end we need to understand that patients are at risk no matter what decision they make. They are at risk because they are exposed to depression, and they are at risk because they may be exposed to antidepressant medication.

Fair enough, although I would err on the side of caution when treating a pregnant mother with antidepressant treatment, the risk of malformations in the fetus would far outweigh any benefit.

Grigoriadis continued with:

The investigators looked at more than 38,000 abstracts and 821 scientific papers. Of these, 187 articles were selected for inclusion in the tool and underwent a quality assessment by 2 independent reviewers, based on a number of predetermined criteria, and received a final quality rating: high, moderate, low, or very low.

Not surprisingly, she said, almost none of the papers garnered a high rating because very few were randomized controlled trials. Most, she added, were deemed to be of moderate or low quality.
In the face of FDA warnings, she added, one of the finer points about antidepressant medications that is often lost is that these drugs still confer minimal risk to the offspring.

"Depending on the number of studies, the results change slightly, but what we're seeing is that these drugs are not hugely teratogenic, and I think people may feel more comfortable regarding that when they understand that these are not huge effect sizes. You have to consider that 3% to 4% of women can have a baby with a congenital malformation just by chance alone, and people need to understand that," she said.

Not hugely teratogenic?

How huge does it have to be?

Sagar Parikh, MD, FRCPC, a psychiatrist and researcher with the University Health Network in Toronto, who was not involved in the development of the tool, said it will definitely help fill a clinical gap.

He concluded: "There are clearly some studies that show some harm from some medications, but studies like the Paxil study are difficult to interpret on a case-by-case basis. Even from a societal perspective, it is difficult to interpret. If I told you 100 children in Canada were hospitalized at birth because of their mothers were on Paxil, but that the drug prevented 300 women with depression from being hospitalized because they were on Paxil, how do we weigh that? And right now, no one knows how to approach this dilemma."

Ah, no one knows.

Pretty much like a game of Russian roulette then, huh?

The CPA could always ask the pharmaceutical companies that manufacture these drugs if they are teratogenic, or maybe even approach Health Canada and ask them.

It's simple really but would, of course, throw a spanner in the works of this latest tool rolled out by psychiatry.

I applaud the Ying and Yang arguments but the debate about whether or not antidepressant medication can cause birth defects is a no-brainer - See Kilker Vs GlaxoSmithKline

Or, if you can stomach it, watch this short video:

The study was supported by the Canadian Institutes of Health Research. Dr. Grigoriadis reports she is on the advisory board of Servier Canada. Dr. Parikh reports he has financial/research relationships with Mensante, AstraZeneca Canada Inc, Bristol-Myers Squibb Inc, CANMAT, Eli Lilly Canada Inc, Lundbeck Canada Inc, and Pfizer Canada Inc.

Say's it all really.




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