Zantac Lawsuit

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

Monday, February 25, 2013

Chimps Given Antidepressants

First of all we take them out of their natural habitat.

We cage them.

We inject them with diseases such as hepatitis and/or aids.

We throw them back in the cages.

We notice they are feeling sad.

We give them antidepressants.

We sing the praises of the antidepressants.

Now watch.

Don't know about you but I feel incredibly sad after watching the above video. Maybe my natural reaction to watching something so harrowing needs medicating. Someone hand me a Paxil to take away my sadness.

There will be many who watch this video who are aware that children, every day, are treated with antidepressants and other psychiatric medication. The results of which can see them suffering severe akathesia, withdrawal problems, adverse reactions such as violence, aggression, suicidal thoughts and completed suicide.

The chimp video should tap into your conscience.

What right do we have, as humans, to use chimps as lab rats?

More importantly, what right do we have, as humans, to treat children with drugs that have been proven time and time again to have little efficacy?

No surprise that the healthcare professional in this video is a psychiatrist.

Martin Brüne  is a professor of psychiatry at the University of Bochum, Germany. He and a number of his collegues carried out a suicide study back in 2011. The conclusion?

Brüne  and his team compared the density of von Economo neurons in nine patients who died from suicide and 30 who died of natural causes, such as heart failure. All subjects had been diagnosed clinically with either schizophrenia or bipolar disorder. The researchers found the density of these neurons was significantly greater in those who died of suicide than in those who had not, regardless of what disorder they had.

WOW! great. So suicide is caused by some sort of neurological disorder?

Interesting that Brune's subjects had been diagnosed with schizophrenia or bipolar disorder. Given this fact maybe Brune and Co should look at the meds these folk were on at the time rather than desperately find a chemical in the brain to blame.

Regarding the chimps, here's an idea Mr Brune... release them back to where they belong.

Then study the chimps to see how being in their natural habitat makes them less sad!



Saturday, February 23, 2013

UK Drug Regulator [MHRA] Cosy Up to Sir Andrew Witty

be in bed with

Definition - to work with a person or organization, or to be involved with them, in a way which causes other people not to trust you

If further evidence were needed to highlight the British drug regulator's close ties to the pharmaceutical industry, in particular, GlaxoSmithKline, then one needs to look no further than this years MHRA's annual Lecture.

I must confess, I had to do a double-take when I heard and read about this [hat tip to Pharmagossip]

The MHRA are usually good at hiding their sycophantic allegiance to Glaxo but this time they are actually broadcasting the fact. This from the MHRA website:

"The MHRA Annual Lecture is an opportunity to hear from international experts on important themes in the regulation of medicines and medical devices and advances in science and research.

"This year’s lecture, on Monday 11 March 2013, will be given by Sir Andrew Witty, Chief Executive Officer of GlaxoSmithKline and member of the Prime Minister’s Business Advisory Group, who will be offering his industry perspective on the strengths, challenges and opportunities facing the UK life sciences industry."

The message to the general public is clear, at least it is to me.

Glaxo recently were handed down a huge $3 billion fine. They agreed to plead guilty to a whole host of fraudulent charges that was laid against them.

Glaxo admitted guilt for promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration, the American version of the MHRA. No safety data was reported to the MHRA either.

The settlement covered criminal fines as well as civil settlements with the federal and state governments.

The case concerns 10 drugs, including Paxil, known in the UK as Seroxat.

Now, this is how perverse the relationship is between Glaxo and the MHRA.

Who better to give a talk to the MHRA than the head honcho of the very same company that admitted guilt to fraud?

I'm actually laughing out loud as I type this.

Let's just look at how the MHRA dealt with the fact that Glaxo, for years, had been lying to them regarding the safety of Seroxat in children.

Here's a recap - Glaxo had sat on information that showed how kids taking Seroxat were at a higher risk of suicidal acts. They also sat on information that showed, in fact, that Seroxat was not effective for treating depression in children and adolescents.

Once the MHRA became aware that they had been kept in the dark about this they decided to investigate Glaxo, an investigation that lasted 4 years - the result of which saw the MHRA publicly tell Glaxo off. "You've been naughty, now don't do it again".

No criminal charges were brought against GSK. Any child that had carried out suicide during this period of suppression from Glaxo was, in my opinion, shown two fingers by the MHRA.

The MHRA let Glaxo off the hook, so much so that the then CEO of Glaxo, JP Garnier, said publicly that Glaxo had done nothing wrong. To hold back information about a drug that can kill children and adolescents is, once again in my opinion, the work of a psychopath.

For years many advocates have been disappointed that Glaxo and other pharmaceutical companies have been allowed to throw money in the direction of plaintiffs in the US. What advocates want is jail time for the top executives at GlaxoSmithKline.

The MHRA, in their investigation, had a golden opportunity to root out the main players in the Seroxat cover-up. They failed on a miserable scale.

After 4 years of trawling through one million documents the MHRA had at their disposal they, through their CEO, Kent Woods, announced, "I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them."

Thanks for your own personal concern Kent, that really reassure's me and, I guess, the likes of Stephanie Gatchell whose daughter, Sharise, hanged herself just weeks before the MHRA announced Seroxat wasn't safe for kids.

Here's where it gets even more perverse. During the 4 year investigation the MHRA did not interview one single employee of GlaxoSmithKline. What kind of investigation was it?

The MHRA relied solely on the fact that they had never granted a licence for the use of Seroxat in children and adolescents. Job done, they slept better in their beds at night.

However, Seroxat was being prescribed to children and the MHRA knew it. Their answer to this?  Well, the usual cop out. Dr's can prescribe drugs off-label [for unauthorized uses] if they so wish. A few deaths here and there means nothing.

You see, the MHRA have their hands tied. They know drugs are prescribed off-label to children yet they claim they cannot do anything about it. In other words, "It's up to the doctor".

Excuse me?

Let's take a scenario, it may be far fetched but it shows how utterly useless the drug regulatory authority is, furthermore it puts holes in their argument about not being able to intervene with doctor's who wish to prescribe off-label.

If the MHRA granted licence to a drug for adults and indicated that it was not for use in children or adolescents then that's fine. They are, for all intents and purposes, doing their job correctly.


Here's the flaw in their argument.

It's 2015 and ThumblyBarmy, a relatively new pharmaceutical company, apply for a licence from the MHRA for a new antidepressant they have produced. They show the MHRA how safe and effective this drug is, let's call it Draxon for the sake of this argument.

Draxon is granted a licence for use in adults.

It's now 2017 and the MHRA, via their adverse reporting system, are aware that Draxon is being prescribed to kids, in fact over 6,000 prescriptions have been dispensed for children since Draxon's release in 2015.

No worries though because the MHRA have already said it's for adults only.

2018 now and the MHRA are inundated with reports of suicide in children and adolescents, so many reports that the public are strongly voicing their opinions about the safety of this drug.

Do the MHRA just shrug their shoulders and say there is nothing they can do, the responsibility is with the prescribing doctor?

In 2019 100 children taking Draxon kill themselves over the period of one weekend. The link to Draxon inducing suicide is proven. Are we expected to believe that the MHRA wouldn't find it in their power to ban the use of this drug?

There's a myth in the UK that Seroxat is banned for use in children, in fact there's a myth that all other SSRi's are banned for use in kids. Truth is, they are not.

The MHRA have issued warnings to doctor's that state that these types of drugs are "not recommended for children and adolescents"

One gain the MHRA will use the get out clause of responsibility that it's the doctor's decision and not their's.

So, Draxon has just saw 100 deaths in one weekend. ThumblyBarmy deny any links to its drug and suicide in children. Are we to believe that a drug regulator would just shrug their shoulders and do nothing? Of course not. The MHRA would immediately act and ban the drug.

In other words, it would take a mass suicide [related to a product] that would make the MHRA act. Do we really need a regulator in place that is of the opinion that isolated suicides related to SSRi use is really, a; of no significance and/or b; not really a concern of theirs?

So, it's 2013. The MHRA, after it's 4 year investigation of Glaxo's suppression of information that could have saved children's lives and after hearing of GlaxoSmithKline's recent admittance that they committed fraud decide to invite the head man at Glaxo, Andrew Witty, to give a lecture.

Sorry Kent but this is akin to the Battered Wives Association inviting Peter Sutcliffe to address an audience.

The MHRA's Chairman, Alasdair Breckenridge, who is apparently resigning this year, was a former employee of GlaxoSmithKline [then SmithKline Beecham]. The MHRA's Head of Licensing, Dr Ian Hudson, is the former World Safety Officer at GlaxoSmithKline.

By the way, neither Breckenridge or Hudson were interviewed during the MHRA's four year investigation into Glaxo.

BBC Panorama have investigated both GlaxoSmithKline and the MHRA. If you haven't watched it yet then I urge you to do so.

The UK needs to call for the MHRA to be disbanded. I, for one, cannot believe that such a band of limp-wristed ignorami are still regulating drugs that UK children take.

Want a better regulator? is a good place to start.

Andrew Witty will be lecturing for the MHRA on Monday 11 March 2013. Meantime, here's the BBC Panorama documentary, "Taken On Trust". At the time of filming, the MHRA were two years into their investigation of Glaxo. Nothing has changed.


Thursday, February 21, 2013

Psychiatric Medication or Play Therapy?

Psychiatric Medication or Play Therapy? For me it's a no-brainer but for millions of unsuspecting parents play therapy is just not an option. Why?

Play therapy has, over the years, steadily grown in popularity among clinicians. It has, however, not been accepted by the scientific community and, more often than not, has been criticized for a lack of evidence showing efficacy to support it's use on a bigger scale. Consequently, its not been offered to parents as an alternative to drugging their children into submission.

So, what is play therapy?

It's roots go back a long way. We've all experienced it at some point in our lives, it's just being a kid. Exploring the world, expressing yourself and interacting with other kids and adults while having fun.

Think about it for a second. What was the one thing we all craved as children at school? Double history, double maths, geography? - We all wanted to hear that bell - PLAY TIME!

Famous philosopher, Plato, once had this to say about play, "you can discover more about a person in an hour of play than in a year of conversation.".

In the eighteenth century Genevan philosopher, Jean-Jacques Rousseau, wrote in his novel, Émile: or, On Education, how important it was to observe play as a vehicle to learn about and understand children.

Most notably it was Friedrich Fröbel, a German teacher, who laid the foundation for modern education based on the recognition that children have unique needs and capabilities who summed up the value of play by saying "Play is the highest level of child development . . . It gives . . . joy, freedom, contentment, inner and outer rest, peace with the world . . . The plays of childhood are the germinal leaves of all later life."

So, in Plato, Rousseau and Fröbel, we have a pretty clear understanding of how play therapy is an important tool in understanding children and their needs. All three are regularly quoted in today's world. Sadly their work and thoughts on how we should all treat children have been eclipsed by the heavy marketing of child disorders and psychiatric medication.

I'd like to step forward in time and offer you three key opinion leaders in the field of mental health, Moreover, I'd like to quote them.

First off, Emeritus Professor John Werry, a child psychiatrist  “as far as we know” giving SSRIs to babies would not harm them. “But one doesn't like to give growing and developing kids medications that affect basic bio-cyclic processes because it just doesn't seem like a good idea unless the kid is really in severe difficulty.” He adds, it would be rare to prescribe antidepressants before the teenage years, and that the youngest child he had prescribed one to was a boy with autism aged 8 or 9, but that was “very exceptional”.[1]

"...the ministry had no concerns about the number of children being prescribed medication for ADHD" - Dr Pat Tuohy, Chief Advisor - Child and Youth Health at Ministry of Health New Zealand [2]

Speaking on why children should be given antidepressants, Andrew Cotgrove, Clinical Director and Consultant in Adolescent Psychiatry at Pine Lodge Young People's Centre, Chester England, said, "We should not deny depressed children one of the few evidence-based available treatments"  [3]

Compare the quotes of Plato, Rousseau and Fröbel with Werry, Tuohy and Cotgrove. What can you see?

Is it just me or do the latter three appear less compelling and enduring than the former?

So, this post is about psychiatric medication vs play therapy. It's about giving an option to parents who think that medication is the only possible treatment for children with behavioural problems and/or depressive signs. It's also a post that may interest counsellors, teachers and others who often refer children to mental health services.

In 2005, The Efficacy of Play Therapy With Children: A Meta-Analytic Review of Treatment Outcomes, was published in the Professional Psychology: Research and Practice [4]

The authors used a combination of online and offline search procedures to exhaust all resources in locating both unpublished and published play therapy outcome studies. The University of North Texas was a primary offline resource, particularly for unpublished studies.

Across the 93 studies, a total of 3,248 boys and girls with diverse presenting issues participated in a play therapy intervention. The 93 studies occurred between 1953–2000.

What the authors found after analyzing the 93 studies was that "play therapy outcome studies support the efficacy of this intervention with children suffering from various emotional and behavioral difficulties."

The meta-analysis concluded the following, "This meta-analysis has significant implications for those who provide mental health services to children and families. These findings should be used to not only educate managed care companies but also to educate and work with parents, government, schools, and the medical and legal communities to provide children with the most beneficial treatments."

So, given that there is an effective non-medical treatment out there for children with diverse presenting issues, or ADHD, as psychiatry would label it, why do we constantly hear stories about children being hooked on Ritalin, killing themselves on Prozac, Zoloft, Celexa and Paxil, gaining weight on Seroquel?

It would be easy for me to suggest that it was just about the money and the way pharmaceutical companies promote their wares. It was also be way too easy for me to suggest that published papers by key opinion leaders [paid by pharmaceutical companies] influence the majority of prescribing healthcare professionals.

But perhaps there are hidden dangers with Play Therapy not reported in the literature, that stop it being the intervention of choice for medical and mental health professionals?

With this in mind I decided to contact Carol Laubscher of Integrated Learning Therapy, a New Zealand based play therapy centre. I asked her:

1. What effect does play therapy have on a child's developing brain?

2. Has any child under your care ever become addicted to play therapy?

3. Has any child during the course of receiving play therapy from you ever attempted to self-harm?

4. Has any child during the course of receiving play therapy from you ever attempted suicide?

5. Has any child during the course of receiving play therapy from you ever gained weight as a result of the therapy?

On the issue of play therapy and how it effects a child's developing brain Carol told me:

"As play therapy works to reconfigure a child's attachment model, it has a huge effect neurologically, releasing the brain from anxiety and reorganising neural pathways."

Carol answered 'no' to questions 2 - 5.

I also contacted Dr Sue Bratton, co-author of The Efficacy of Play Therapy With Children: A Meta-Analytic Review of Treatment Outcomes, and asked if any adverse events were reported in the 93 studies that were analyzed. Dr Bratton told me that there were no adverse events reported. On the issue of how child therapy effects a child's brain she told me:

"In all children, play is essential to healthy brain development (If you want details about the neuroscience of play and brain development, I can give you many good resources: Bruce Perry, MD, PhD and Stuart Brown, MD are two examples).  For children who have had early adverse and traumatic experience, the brain’s development is impacted in such a way that the child’s holistic development is thwarted. Play, in the context of relationship, is crucial to the child’s brain developing new neural pathways that promote healthy brain functioning (again, this is a very simplistic explanation, please see Perry or Bonnie Badenoch’s Brainwise Therapist (2008)."

Dr. Bratton is a professor in Counseling and Director of the Center for Play Therapy at the University of North Texas

Using play therapy in children before medication is even considered should, one would think, be top of any healthcare professional's list. Alas, the odds are stacked against children in favour of psychiatric medication. This is due to a number of factors.

Pharmaceutical companies spend billions on marketing psychiatric medication. If a specific drug is not deemed by the regulatory authorities to be safe or effective for children, pharma will then hire child psychiatrists to run clinical trials, this, to show the regulators, other healthcare professionals and media that these drugs aren't dangerous in this target population.

Front groups that purport to fly the mental health flag are, in fact, nothing more than agents, pimps for the pharmaceutical industry. Examples of these front groups can be seen in the the four articles I highlighted back in 2007 entitled, 'GlaxoSmithKline, Money Trail Down Under'. [5], [6], [7], [8]

Psychiatrists that are well respected among their peers are also targeted by the pharmaceutical industry, often paid huge sums of money to promote the use of antidepressants in children and adolescents.

A and B list celebrities must also carry the shoulder of blame. Quite often they are used as advocates for antidepressant type medications, be they famous sports personalities, Hollywood film stars or TV and radio talk show hosts. These people have huge fan bases, many of their fans hang on to every word they say. In many instances they promote psychiatric medication with financial support from the pharmaceutical industry.

Play therapists are individual practitioners. Neither they, nor their professional associations have multi-million dollar marketing arms which are able to buy doctors, celebrities or journalists to promote their product. Nor are they able to create or take-over patient advocacy groups with the sole purpose of promoting their work and building revenues.

The God factor also comes into play. If you, as a parent, do your own research on the drug your child has been prescribed and you bring your concerns to the prescribing doctor's table you will, more often than not, be dismissed as either not knowing what you are talking about or be accused of reading too many internet conspiracies.

The Play Therapists I have encountered are convinced of the benefits and importance of the work they do but not of their own omnipotence as so many psychiatrists are and are unlikely to promote themselves in quite the way psychiatrists such as Dr Beiderman do in the following famous testimony on his qualifications in a case against pharmaceutical company  Johnson & Johnson.

In a deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered.

“What’s after that?” asked a lawyer, Fletch Trammell.

“God,” Dr. Biederman responded.

“Did you say God?” Mr. Trammell asked.

“Yeah,” Dr. Biederman said.

Hard to believe huh? With the modern wonders of the internet we can see Biederman in action here.


When the competition has that much clout it's hardly surprising that play therapy, despite its proven efficacy, is rarely used by healthcare professionals.

Then there is cost and convenience. It's so much cheaper and easier for a parent to choose psychiatric medication for their child than it is to enroll them in play therapy sessions. Global governments subsidize prescription medication, this makes taking drugs even cheaper. They do not subsidise Play Therapy which makes it both relatively expensive and unavailable.

If your child is distressed, disruptive, anti-social and unhappy, as a parent you need a short term solution but also to weigh the long term risks and benefits of the available interventions.

The following chart shows the relative risk of stimulant medication such as ritalin and play therapy on longer term outcomes for kids.

Chart references at foot of post

Every day parents are taking that risk when they dispense their prescription at the pharmacy on behalf of their children.

If a kid is being a kid then let them continue to be a kid. Psychiatric medication as first-line treatment is absurd when the option of play therapy exists.

If further evidence were needed regarding the importance of play then The Importance of Play in Promoting Healthy Child Development and Maintaining Strong Parent-Child Bonds [10] published in the Official Journal of Pediatrics, clearly sends out a stark message, a message that is somewhat contradicted.

"Play is a cherished part of childhood that offers children important developmental benefits and parents the opportunity to fully engage with their children. However, multiple forces are interacting to effectively reduce many children’s ability to reap the benefits of play. As we strive to create the optimal developmental milieu for children, it remains imperative that play be included along with academic and social-enrichment opportunities and that safe environments be made available to all children. Additional research is needed to explore the appropriate balance of play, academic enrichment, and organized activities for children with different temperaments and social, emotional, intellectual, and environmental needs."

All seems good until you delve deeper into the published article...

"Pediatricians should refer to appropriate mental health professionals when children or their parents show signs of excessive stress, anxiety, or depression."

It's almost like an add-on, a disclaimer - such is the stranglehold psychiatry has on the modern day. Unless we recognise that Play Therapists are mental health professionals and their therapy addresses stress, anxiety and depression by nurturing rather than damaging children's growing brains.

When weighing up the benefits of psychiatric medication against the risks, one should always remember that there are many adverse reactions reported, some so severe that children have died because the prescribed medication induced their cannot get a more adverse reaction than death.

Brain damage has also been linked to children taking these powerful drugs. In 2009, 'Differential regulation of psychostimulant-induced gene expression of brain derived neurotrophic factor and the immediate-early gene Arc in the juvenile and adult brain' was published in European Journal Of Neuroscience. [11] The authors concluded:

"The psycho-stimulant drugs Methylphenidate (Ritalin) and Amphetamine are widely used in children for the treatment of ADHD, but recent data suggest that exposure to these agents in early life could be detrimental to brain development."

Ritalin is widely used in children with behavioural problems.

In another study, Stimulant Induced Psychosis, published in the Child and Adolescent Mental Health Journal in 2009 [12] the authors concluded that:

"Our findings highlight potential issues in the care of children treated with stimulant medication. Throughout the United Kingdom practices differ; many localities have specialist ADHD clinics, which include Paediatric services or Child and Adolescent Mental Health Services. The practice of shared care with the General Practitioner is amongst NICE recommendations. We feel it is important for all professionals involved in the use of stimulant medication to have mental health training, particularly in the careful screening and identification of psychotic symptoms which could easily be mistaken as a deterioration in the symptoms of ADHD and result in an increase in the dose of stimulant prescribed, potentially having serious implications."

Play therapy, however, report no adverse reactions.

Still not convinced yet?

Perhaps the following article will sway your opinion. It was published in the Ethical Human Psychology and Psychiatry journal last year. 'The Risks Associated With Stimulant Medication Use in Child and Adolescent Populations Diagnosed With Attention- Deficit/Hyperactivity Disorder' [13] was written by Jeanne M. Stolzer, PhD of the University of Nebraska-Kearney.

In her summation Stolzer writes:

"ADHD-type behaviors are nothing new. They have been documented across cultures, across time, and across mammalian species (Stolzer, 2005). The fact of the matter is that children have always been fidgety, highly active, inattentive, spontaneous, and prone to engage in behaviors that exacerbate adults. What has been compendiously altered is our collective perception of what constitutes normal-range child behaviors. The simple and reductionistic medical model refuses to acknowledge bioevolutionary based traits, financial incentives to label children with ADHD, inappropriate educational systems, the influence of the pharmaceutical industry, nature deprivation, and alterations in cultural perceptions of childhood. The medical model remains adamant that ADHD behaviors are pathological and can be attributed to a chemical imbalance within the child’s brain in spite of the fact that no empirical evidence exists to substantiate this hypothesis. We have two choices. We can cling to a hypothesis which has no scientific credence, and continue to prescribe dangerous and addictive stimulant medication to millions of children who have been diagnosed with a mythical disease—or we can demand an end to this lunacy."

If, after reading all of the above evidence, you still think medicating children and adolescents is safe and effective then you'll just add to my despair - I can deal with that via some adult play... normally my guitar.

As I said in the beginning of this post, "For me it's a no-brainer."

There are no seven wonders of the world in the eyes of a child. There are seven million.
~ Walt Streightiff

Bob Fiddaman

[1] Babies Given Antidepressants In New Zealand [Link]
[2] NZ urged to shift stress on drugs as first option [Link]
[3] To Give Or Not To Give Antidepressants To Young People [Link]
[4] The Efficacy of Play Therapy With Children: A Meta-Analytic Review of Treatment Outcomes - Sue C. Bratton, Dee Ray, Tammy Rhine, Leslie Jones - Professional Psychology: Research and Practice - 2005, Vol. 36, No. 4, 376–390
[5] GlaxoSmithKline Money Trail Down Under Part 1 [Link]
[6] GlaxoSmithKline Money Trail Down Under Part 2 [Link
[7] GlaxoSmithKline Money Trail Down Under Part 3 [Link]
[8] GlaxoSmithKline Money Trail Down Under Part 4 - Enter Dr Martin Keller [Link]
[9] Knowles v. Minister for Defence [2002] IEHC 39 (22 February 2002)
[10] PEDIATRICS Vol. 119 No. 1 January 1, 2007 pp. 182 -191 (doi: 10.1542/peds.2006-2697)
[11] Differential regulation of psychostimulant-induced gene expression of brain derived neurotrophic factor and the immediate-early gene Arc in the juvenile and adult brain - European Journal Of Neuroscience [serial online]. February 2009;29(3):465-476.
[12] Stimulant Induced Psychosis - Child and Adolescent Mental Health Volume 14, No. 1, 2009, pp. 20–23
[13] The Risks Associated With Stimulant Medication Use in Child and Adolescent Populations Diagnosed With Attention- Deficit/Hyperactivity Disorder - Ethical Human Psychology and Psychiatry, Volume 14, Number 1, 2012


[1] Shatha Shibib & Nevyne Chalhoub Stimulant Induced Psychosis Child and Adolescent Mental Health Volume 14, No. 1, 2009, pp. 20–23
[2] Banerjee P. Differential regulation of psychostimulant-induced gene expression of brain derived neurotrophic factor and the immediate-early gene Arc in the juvenile and adult brain. European Journal Of Neuroscience [serial online]. February 2009;29(3):465-476. 
[3] Lambert N. The Contribution of Childhood ADHD, Conduct Problems, and Stimulant Treatment to Adolescent and Adult Tobacco and Psychoactive Substance Abuse. Ethical Human Psychology & Psychiatry [serial online]. Winter2005 2005;7(3):197-221.
[4] Jeanne, M. S. (2012). The risks associated with stimulant medication use in child and adolescent populations diagnosed with attention- Deficit/Hyperactivity disorder. Ethical Human Psychology and Psychiatry, 14(1), 5-14. 
[5] Samuels, Franco, Wan, & Sorof, 2006
[6] Gould, M., Walsh, B., Munfakh, J., Kleinman, M., Duan, N., Olfson, M., et al. (2009). Sudden death and the use of stimulant medications in youth. American Journal of Psychiatry, 166(9), 992-1001
[7] Stein, M. (2009). Psychiatric reactions to ADHD medications. Pediatric and Adolescent Medicine, 123, 111–120.


Tuesday, February 19, 2013

The New York Times and GlaxoSmithKline

Glaxo Facebook page - covered in garlands.

Glaxo are at it again. Selective reporting that covers them in garlands.

Many readers will know that I follow the GlaxoSmithKline Facebook page with an avid interest. They rarely respond to comments I leave, to debate with me would, "...contravene our Facebook terms of use policy."

Since when have Glaxo adhered to terms of use... or any other policy for that matter!

Today sees Glaxo bigging themselves up regarding their partnership with the World Anti-Doping Agency (WADA), whom I've wrote about before, here here and here.

Glaxo seem to be enthralled that The New York Times have picked up on this partnership. They write [fig 1]

The New York Times published an article looking at our partnership with the World Anti-Doping Agency (WADA). We’re working with WADA to evaluate all the medicines we have in development for their performance-enhancing potential. Our aim is to make sure our medicines are never abused by athletes.

fig 1

Which action, akin to a bad defence lawyer unwittingly opening a line of questioning that's best left suppressed, left the door open for me to highlight other occasions where The New York Times had mentioned GlaxoSmithKline, something that I did a lot of in my book, The evidence, however, is clear...the Seroxat scandal.

For those of you that have never read my book here's some of The New York Times articles that Glaxo definitely won't be posting on their Facebook page.

F.D.A. Pulls a Drug, And Patients Despair
Glaxo's Lotronex was taken off the market on Nov. 28, less than 10 months after being approved by the Food and Drug Administration. About 300,000 people had taken it. It was withdrawn because about 70 patients had developed severe constipation or ischemic colitis, a lack of blood flow to the colon. Some needed surgery, including one woman who had to have her entire colon removed. There were five deaths, including three possibly linked to the drug

Sole Lyme Vaccine Is Pulled Off Market

With tick season approaching, the maker of the nation's only vaccine against Lyme disease pulled it off the market, citing poor sales. The vaccine, Lymerix, had caused controversy in recent years, as patients said they were sickened by it and asked the government to restrict sales. Some filed lawsuits against the maker, GlaxoSmithKline.

Investigators Find Repeated Deception in Ads for Drugs
Since 1997, the report said, the F.D.A. "has issued repeated regulatory letters to several pharmaceutical companies, including 14 to GlaxoSmithKline.

What You Do Know Can't Hurt You
What is disturbing about the recent report is that the purported link between Paxil and suicidal thinking comes from an unpublished study sponsored by the Paxil's manufacturer, GlaxoSmithKline. In fact, GlaxoSmithKline has published only one of its nine studies of Paxil in children and adolescents to date.

New York Sues Maker of Antidepressant Drug Paxil
The New York State attorney general accused the British drug giant GlaxoSmithKline of consumer fraud today, asserting that the company had withheld negative information and misrepresented data about the efficacy and safety of prescribing the antidepressant drug Paxil to children.

There's many more here, page after page of articles reporting fraud, tax evasion, corruption, dodgy clinical trials and much more.

Thanks to the GlaxoSmithKline Facebook administrators for opening the door of rebuttal.


Psychiatric Medication In Children - Why?

Which is the safest, which has proven to be more effective?

I'm often asked if I am opposed to children and adolescents being prescribed psychiatric medication for depression, ADHD and all other reasons they are prescribed them.

Simple answer is yes.

Clinical trials will show us that these medications have no proven efficacy in children yet many psychiatrists, doctors and even parents dismiss the science. There are many reasons for this.

As parents we don't like to admit that we are a failure, it's much more easier to accept that our children are unruly because they have something wrong with them, a brain malfunction, a chemical imbalance. We are told by healthcare professionals that many of the prescription medications available for children are safe and effective, we are told that the adult medications [SSRi's] are effective in children too. The warnings, in other words, mean nothing. Any suicide link is only small and those that did go on to complete suicide whilst on these drugs were probably deeply troubled and no drug could have saved them.

What if we lived in a world where children could be children. What if we treated their low moods or hyperactivity with something interesting, something they would enjoy?

More often than not supporters of psychiatric medications will tell us that "the Zoloft helped Billy" or "the Prozac has been great for Annie" - Many children who were prescribed these drugs years ago are still on them today, so they must be good, right?

Well, if you or I had a headache we may take an aspirin or paracetamol. The headache will clear so we stop the medication. Patients who visit their healthcare professionals because they are depressed or have circumstances that they cannot deal with are prescribed something more powerful than an aspirin or paracetamol. Once their "depression" fades they, unlike the headache patients, will continue to take the medication. They are told that they must take it or the depression may return or the behavioural problems may return or get worse than they was originally.

So, what's the alternatives?

I'm about to start a series of posts regarding psychiatric medication alternatives. No post will lay claim, like pharmaceutical propaganda, that these alternatives will work, one thing, however, is each of them that I feature carry no risk of side effects, that means no withdrawal, no skin rashes, no suicidal thinking, no self harming and no completed suicides. None of these alternatives come in a bottle or blister pack.

Coming soon: - Psychiatric Medication or Play Therapy?

Believe it or not, 93 play therapy outcome studies supported the efficacy of this intervention with children suffering from various emotional and behavioral difficulties. So why isn't this first line treatment for our children?

More soon...



Monday, February 18, 2013

The GSK Anti-Bribery and Corruption Programme

So, the GlaxoSmithKline Facebook page tweaked my interest earlier. Well, it was more of a comment left that tweaked my interest than the 'cover us in garlands' type posts Glaxo add to their page on a nauseating frequent basis.

Here's the comment, it appears that this is one of two things. True or false

Saturday, February 16, 2013

To Hell and 'Back' With GlaxoSmithKline

It never rains but it pours for poor old GlaxoSmithKline, or should that be GlaxoSmithSpine? Fresh on the back [ahem, excuse the pun] of a $3 billion fine from the US Department of Justice they have now been told by the Australian Federal Parliament to set up a charity and look after a possible 60,000...yes, that's 60,000, victims harmed by it's product, Myodil.

There's an estimated 60,000 Aussies who have been left crippled with pain, paralysed and incontinent because they were injected with a dye during an x-ray procedure. The dye was, at the time, the only way doctor's could see the spine clearly.

Wednesday, February 13, 2013

Seroxat - The UK Evidence in US Courts

My blog post, UK Seroxat Litigation - Take 2, has received a significant number of hits over the past few days or so. Many of the 'limbo litigants', as I like to call them, are now coming forward and enquiries are also being made regarding those that discontinued and whether the advice they received was poor. I can't really answer that but I do know that there are many documents publically available that don't really shine a good light on Glaxo regarding Seroxat.

Here's an example. It's yet another ghostwritten study regarding the infamous Seroxat [known as Paxil in the US]. This is particularly interesting as it's a UK based document pertaining to a Seroxat study [704] [fig 1]

Tuesday, February 12, 2013

Glaxo's Profits Down 4%

British pharmaceutical giant, GlaxoSmithKline, have reported profit for 2012, however, the £7.64bn is 4% down on the previous year.

European sales of Glaxo's products were also down by 7% , probably down to news that their revolving door "in and out" of courtrooms in the US filtered through to overseas consumers.

Glaxo CEO, Andrew "All part of an era" Witty, described the current climate as "challenging". He should try withdrawing from Seroxat, now that IS a challenge!

Glaxo, writes the BBC, are "carrying out a review of its "iconic" consumer drinks brands Lucozade and Ribena, looking at "the best ways to ensure their continued growth".

I've wrote about both Ribena and Lucozade in the past on this blog.

"It was the shelves your Honour!"

Back in 2007 it emerged that two Kiwi school girls carried out a science experiment as part of a school project. They wanted to find out exactly how much vitamin c was contained in Ribena. Glaxo had promoted it as containing 7mg of vitamin C per 100ml, or 44 per cent of the recommended daily intake. The two school girls, however, found something completely different. In actual fact there was no vitamin c found in Ribena. [Back story]

How did Glaxo react?

Well, they didn't blame themselves for lying [no surprise there] instead they opted to blame shelves. Yup, the excuse at the time was as laughable then as it is today. This after they were fined a measly $217,000 after pleading guilty to 15 breaches of the Fair Trading Act.

After the court decision, a spokeswoman for GlaxoSmithKline in London told the Daily Telegraph that the problem arose when Ribena in Australia and New Zealand was left on shop shelves for too long, causing the vitamin C to degrade. [Back story]

Regarding Lucozade see the following"

Glaxo's Lucozade Sport Fails Miserably

Glaxo's Lucozade Linked to Hyperactivity

Good old Glaxo and its "iconic" brands.

GSK's shares were up 10.50 yesterday and closed at 1,453.00

Meantime, Glaxo are defending a High Court action against them in the UK regarding their controversial antidepressant, Seroxat.

Monday, February 11, 2013

UK Seroxat Litigation - Take 2

Many readers will know of the ongoing lawsuit against GSK in the UK. The group action claims that Seroxat, GSK's antidepressant, caused withdrawal difficulties in a number of people taking it. This the Company has now admitted through its Patient Information Leaflets.

What isn't known by many, Hugh James of Cardiff, wrote to litigants roughly about two years ago urging them to discontinue the case against GSK.  Myself and many others disagreed and, behind the scenes, we have sought advice and other representation.

With the assistance of the Legal Services Commission (LSC) – the funding agency, we now seem to be heading back on track. The LSC have never pulled funding for this litigation but have re-examined its merit especially with fewer people remaining in the group action after Hugh James’ advice to discontinue.

Monday, February 04, 2013

All That Glitters is Cafepharma

The forums over at Cafepharma are always good for a laugh. There are many to choose from, each one highlighting why the pharmaceutical industry is a place where reps turn into children who argue over the silliest of things and when questioned about ethics, bang the same drum as GlaxoSmithKline's CEO, Andrew Witty - in as much that any problem their company have been embroiled in isn't really a problem anyone should be talking about, it was all part of an era and everything and everyone has changed now.

Reading the forums one would think that it's not just patients and lawyers who don't trust the industry, there are many reps who frequent the forums to sound off and/or bitch about the latest bonus,cutback, layoff or manager.

You reap what you sow guys...and gals.

Cafepharma has a huge list of company boards, I'm going to focus on the big boys, namely, Johnson and Johnson, Eli Lilly and British giant, GlaxoSmithKline.

Friday, February 01, 2013

Baum Hedlund Home In on Pfizer's Zoloft

Glaxo's nemesis, Baum Hedlund, Aristei & Goldman, have teamed up with Pendley Baudin & Coffin and filed a lawsuit against pharmaceutical giants Pfizer Inc. regarding the promotion of their antidepressant, Zoloft.

The suit, filed in the United States District Court for the Northern District of California, San Jose Division, alleges that Pfizer, Inc deliberately and falsely misled consumers regarding the effectiveness of the company’s $30 billion blockbuster antidepressant, Zoloft [sertraline].

The lawsuit also alleges that Pfizer, despite knowing the ineffectiveness of Zoloft, went on a huge marketing campaign that, amongst other things, showed how effective Zoloft was.

Documents, obtained through disclosure, hope to prove that Pfizer...

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