Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Ritalin. Show all posts
Showing posts with label Ritalin. Show all posts

Monday, August 01, 2016

Ian Hudson of the MHRA challenged over the safety of Concerta (Ritalin)






Former Glaxo World 'Safety Officer', Dr Ian Hudson



In an attempt to seek the truth and learn how the regulations of prescription drugs work, Swedish investigative journalist, Janne Larsson, has been, for many years now, corresponding with the British medicines regulator, the MHRA.

Larsson, it appears, is ruffling some feathers at MHRA HQ, none more so than the feathers of the always evasive CEO, Dr Ian Hudson.

You see, the MHRA and Larsson have been going over reports regarding the ADHD drug Concerta, more commonly known as Ritalin.

Head of the MHRA, Dr Ian Hudson, has told Larsson that  “the safety of Concerta is being continuously monitored” - but Larsson is having none of it.

In his latest open email to Dr Ian Hudson, Larsson suggests that Hudson's handling of this whole affair is "scandalous". After reading much of the correspondence between Larsson and the MHRA I must say he has a valid point.

His open email (link at the foot of this post) also calls into question why the MHRA, in particular, Dr Ian Hudson, have not approached Concerta makers, Janssen, with regard to a "distortion of facts" that they presented to the MHRA a few years ago.

Larsson, in his open email to Hudson, points out that Janssen says that Concerta “continues to have a favourable benefit-risk profile for ADHD in children and adults” and that it is authorized for the treatment of ADHD in adults. They also claim that that the benefits of Concerta for adults “are supported by prospective, randomized, active-comparator controlled trials” 

However, Study 3013, the longest of all the Concerta studies, shows something completely different - furthermore, the MHRA, themselves, after reviewing 3013, said, “A causal relationship with Concerta was established for aggression, tics and depression.”

Larsson accuses the MHRA of sitting on this information for over two years.

It's unlike the agency to sit on anything regarding patient welfare. I mean, they have their fingers right on the pulse, huh?

Dr Ian Hudson, is the former World Safety Officer for GlaxoSmithKline (then SmithKline Beecham)

Kind of worrisome that someone sitting on important safety information regarding Concerta used to be in control of safety at one of the most heavily fined pharmaceutical companies known in history.

Here's Janne Larsson's correspondence.

ADHD drugs – MHRA and the Concerta scandal – did this really happen?



Bob Fiddaman.


Back story

Swedish Journalist Takes on British Drug Regulator






Wednesday, January 20, 2016

Goldilocks, the Untold Paxil Story





I wrote this back in 2011 and think it's worthy of a re-post.

It's a modern day version of a tale we are all familiar with - it's also something we should all pay heed to - when reading you can substitute 'Paxil' for any other antidepressant currently on the market.

**WARNING** Contains profanity.


Goldilocks and the Three Bears...A 21st Century Perspective


Once upon a time there was a little girl called Goldilocks.

Goldilocks was 10 years old and had been diagnosed with a mental disorder, her inability to stay awake in the classroom and consequent poor marks meant she had been deemed as having GAD, Generalized Anxiety Disorder. The school psychiatrist said that Goldilocks was "stressing" about things at night and not getting enough sleep, this would often result in her falling asleep during school lessons. He prescribed her Paxil, a selective serotonin reuptake inhibitor [SSRi] but it didn't agree with her, in fact she became suicidal whilst on it. Later, her psychiatrist switched medications, opting instead for Cymbalta. She was to take her dose just before she went to bed at night.

On the morning of May 20, 2011, Goldilocks had decided to "bunk off" school. Her morning had started badly, her parents had been arguing again about money, her father was pissed off at her mother because there was no food in the cupboards, this meant Goldilocks had to go without breakfast. She left her parents house hungry and sought solace in the forest adjacent to the family home.

It was around about midday that Goldilocks felt severe hunger pangs, these were increased by a sweet smell in the distance, she knew immediately that the aroma drifting through the forest was that of Porridge and she was certain she caught a whiff of maple syrup too. "Yummy", she thought as her little legs carried her toward the sugary delight.


The Bear family were rushing around that morning. Mummy Bear was panic-stricken as she had run out of her medication, ironically that medication was Paxil. Baby Bear looked on in horror as he saw his mummy anxious, agitated, shaking violently and yelling at the top of her voice, "WHERE'S MY PAXIL?"



**Actual document from SmithKline Beecham**




Daddy Bear was busying himself making Porridge. Baby Bear liked it when daddy made the Porridge as he always added maple syrup.

"Have you taken your Ritalin Baby Bear?" Daddy Bear asked.

"Yes daddy, with my milk as I always do each morning", replied the 9 year old Baby Bear.

"OH, IT'S ALRIGHT FOR YOU ISN'T IT. AS LONG AS YOU'VE TAKEN YOUR MEDS THEN EVERYTHING IS OKAY. WHAT ABOUT ME...WHERE'S MY PAXIL?", Mummy Bear howled.

"Calm down dear," Daddy Bear interjected.

"CALM DOWN...CALM FUCKING DOWN? DO YOU KNOW WHAT IT'S LIKE WHEN I MISS MY DOSE OF PAXIL? HAVE YOU EVER FUCKING EXPERIENCED THE BRAIN ZAPS AND NAUSEA, YOU INCONSIDERATE PRICK"

Mummy Bear was having one of those bad days thought Baby Bear.

"Okay, let's head on down to the pharmacy, the Porridge can wait, it's too hot to eat at the moment anyhow. We can take a drive down to the village and let it cool down, it will be just perfect by the time we get back", announced Daddy Bear.

Daddy Bear wasn't looking forward to driving the car, he had a fear of driving, a deep rooted problem from his childhood, his psychiatrist had told him. Daddy Bear had been prescribed Xanax, a benzodiazepine.


Goldilocks had saw the Bear family climb into the family saloon, the mother seemed like a right bitch, swearing and shouting at her husband and child.

Once the saloon had turned the corner, Goldilocks made her way toward an open window she had spied upon her approach. The sweet smell of maple syrup was overpowering. She climbed through the aperture and made her way to the kitchen where she saw three bowls of Porridge on the table.

She tested each bowl before gulping down the contents of the small child bowl, the others were just too hot.

Goldilocks was feeling comfortable in her surroundings and she lost all sense of time and fear. She sat on a chair in the lounge and flicked on the radio that was close by.

"...and we are going over to to our reporter on the scene right now. Ed, what can you tell us about the shooting?"

"Well, it appears that a woman walked into the Mahoney Drug Store about 15 minutes ago and calmly walked up to a shop assistant and shot her in the head. I've been privy to see the CCTV footage and it appears the woman had been somewhat agitated upon entering the store. It also appears that she was refused medication by one of the staff members, the video shows her trashing the store before leaving through the door. 5 minutes later she returned, walked calmly up to the shop assistant and pulled out a firearm and shot the assistant in the head. Police have secured the area and it seems another two people have been found shot in a family saloon, early indications report that it is a man and small child but we cannot confirm that just yet..."

Goldilocks knew Mahoney's Drug Store, it was just a five minute journey from her school. Oh well, she thought, probably someone with mental health problems.

She turned off the radio and headed up the stairs where she found a bed, the overpowering urge to sleep had come on like a speeding train. She lay on the bed and reached for the half empty glass of milk on the bedside cabinet, next to the glass was a box of Ritalin, she had heard of this drug before, sixteen of her classmates were taking it. She carefully opened the blister pack and, one by one, swallowed the 14 tablets.

It was to be the final sleep she would ever have.


Bob Fiddaman










Saturday, May 16, 2015

Children Facing Long-Term Health Risks!





Fox News investigates why children are being prescribed powerful psychiatric medicine.

Pediatric shrinks who prescribe these mind-numbing drugs should be utterly ashamed of themselves.




MyFoxAustin | KTBC | Fox 7 Austin | News Weather Sports



Why?

Here's a study I carried out myself a few years ago.


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.



PRESS PLAY




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.


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 suicide...you 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

CHART REFERENCES

[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.







Saturday, January 03, 2015

ADHD - Market Challenge - Unknown Etiology





A market report carried out by TechNavio analysts predict that the Global ADHD Drugs market will grow at a rate of 5.33 percent over the period 2013-2018.

The 80 page report, if you are financially well off, costs a staggering $2,500 to purchase. The report covers...

The present scenario and the growth prospects of the Global ADHD Drugs market for the period 2014-2018. To calculate the market size, the report considers the revenue generated from the sales of various therapies used in the treatment of ADHD, which include:
Stimulants
Non-stimulants
TechNavio's report, the Global ADHD Drugs Market 2014-2018, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the Americas, and the EMEA and APAC regions; it also covers the Global ADHD Drugs market landscape and its growth prospects in the coming years. The report also includes a discussion of the key vendors operating in this market.

Interestingly, one of the main market challenges the report found was...wait for it... are you ready yet?

Unknown Etiology

In other words, those manufacturing the drugs to treat ADHD don't actually know the causes of ADHD.

To combat this (small flaw) the Pharmafia (that's pharmaceutical companies and medicine regulators combined) will use various marketing strategies to say how bad ADHD can be if not treated... and actually skip the fact that they, themselves, do not know the etiology of it.

The report suggests that the Pharmafia must "increase the awareness" so expect a lot of pseudo-science over the coming years folks.

Drugs discussed in the report include Strattera, Concerta/Ritalin, Focalin, Intuniv and Vyvanse/Elvanse/ Venvanse.

The key vendors, according to the report, are Eli Lilly, Janssen, Novartis and Shire.

Between now and 2018 it appears that the goal is to not only target children who have a brain disease but adults too.

A brief abstract of the report reads...

ADHD is a psychiatric disorder, which is mostly found in children. However, adults have also been reported to be diagnosed with ADHD. The patients with ADHD suffer from several problems including hyperactivity, impulsiveness, and lack of focus and concentration. The causes of ADHD are not known. It is believed to be linked with genetic and environmental causes. However, it has been reported to be related with the decrease in the extraneuronal levels of norepinephrine and dopamine. In addition, the patients have an abnormality in the brain structure. It is more prevalent in boys than girls. The management of ADHD is done by counseling, medications, and lifestyle changes.

Notice how the causes of ADHD are played down and followed with the standard Pharmafia scaremongering line... "It is believed to be linked with genetic and environmental causes. However, it has been reported to be related with the decrease in the extraneuronal levels of norepinephrine and dopamine. In addition, the patients have an abnormality in the brain structure."

What you, as a prospective consumer, need to take from this are two key words...

1. Believed
2. Reported

In other words, the Pharmafia "believe" in a theory because it, coincidentally, means they will be able to treat a population based on this theory.

It has been "reported" basically means that the Pharmafia have cherry-picked reports, once again to suit their own agenda (selling drugs)

They did this with SSRi's when they were first launched. Back then we were told that SSRi's such as Prozac and Paxil could correct a chemical imbalance... (the cause of the anxiety and depression we were feeling)

When this theory was proven to be incorrect one would have thought that trading standards would have slammed the Pharmafia for selling products on a lie. However, the Pharmafia still had the luxury of tweaking their wording.

Look at any SSRi on the market today and you will see a key line...

"It is thought"

So, "it is thought" that anxiety and depression are caused by a chemical imbalance. It still gives us the message that they are right and we have something abnormal with us.

And that's exactly how they want it to remain folks.

If you want an alternative treatment for your child then read Psychiatric Medication or Play Therapy?

If you are an adult who has been diagnosed with ADHD and, as a result, you have been offered medication to control it then... well, you are grown up enough to know that the Pharmafia just want your money and want you hooked on their wares.

Some of the side effects of the drugs mentioned in the report are pretty severe - Pharmafia will play those down too.

In a nutshell, before you decide to go down the road of drugging yourself...or your children, do your homework.

Don't believe me? When diagnosed answer your doctor with a two-worded question and watch his face.

The 40 second video perfectly shows this.




Bob Fiddaman.









Saturday, July 05, 2014

Swedish Journalist Takes on British Drug Regulator



Janne Larsson is a tenacious so and so. He'll dig, stumble across something that isn't right then ask questions to try and seek the truth.

He has given me permission to publish his recent letter to the British drug regulator, the MHRA.

Larsson has, for some time now, been gunning for Janssen, makers of Concerta, also known as Ritalin.

Like any good journalist Larsson has meticulously studied the adverse events of Concerta in Janssen’s clinical trials. What he found were huge flaws. [Back story]

Here's his latest letter to the MHRA.

The approval of Ritalin for adults – where did all the aggression go?

Dear Dr Hudson,

As you may remember I wrote to you in February and March about MHRA and the scandal with the ADHD drug Concerta  [http://jannel.se/MHRA.Concerta3.pdf]

I made the “prophecy” that several drug regulatory agencies in Europe, who had allowed alarming levels of off label prescription for adults, like Sweden, would have to make sure that we quickly forgot the Concerta scandal. And the best way to do that would be to push through another application of methylphenidate for adults – like Ritalin. And to then claim “that we now have evidence”.

I said that we could expect Novartis to have learned from the failed Concerta submission, and to design more “smart” studies, showing its drug Ritalin (in all important aspects the same as Concerta) to be “safe and effective”. We could expect that the submitted studies would get a positive assessment this time – no embarrassing questions – and suddenly the concealed and alarming Concerta results could be expected to no longer exist!

We have now arrived at that point.

It has been a secret up to now how Novartis planned its conquest of Europe, or as Financial Times said, how to get everyone “on board with adult ADHD” [http://www.ft.com/intl/cms/s/2/8b721a20-b8e9-11e2-a6ae-00144feabdc0.html] . We have not known in which countries the application was submitted or via which procedure. We know now.

Novartis succeeded to get through some kind of “informal worksharing procedure”, as there was “currently no legal basis” for a formal work sharing procedure. As the Swedish Medical Products Agency stated in its assessment report:

“The worksharing procedure included all European (EU) countries where Ritalin LA is currently registered. As Ritalin LA is registered via national procedures in EU, there is currently no legal basis in EU for using ‘formal’ worksharing procedure for nationally registered products.”

We also know that Germany was leading this “informal work sharing procedure”.

I have read the Swedish “investigation” about Novartis’ submitted studies, and as expected – no embarrassing questions. Much could be said about it, but at this point I only want to take up one important, even vital aspect.

Where did all the aggression go?

As you know MHRA, leading the European investigation about Concerta concluded: “A causal relationship with Concerta was established for aggression, tics and depression.” (Preliminary Variation Assessment Report, juli 2010 page 112, [http://jannel.se/PVAR.Concerta140710.pdf )]

The investigation showed that in the three Janssen-submitted, double-blind studies (3013, 02-159 and 3002) “13 of the 596 subjects receiving Concerta … were withdrawn for aggression-related adverse events (vs. none receiving placebo)”. (Page 65, Preliminary Variation Assessment Report, Concerta, July 2010, see also FVAR, page 12, 26 April 2011.)

These 13 persons suffered so severe aggression that they had to be taken out of the trials. None of those on placebo suffered such serious aggression that they had to end the trials.

The investigation also showed that a total of 71 out of 596 subjects (11.9%) from the Concerta group had suffered aggression (compared to 17 ​​persons, 5.5%, from the placebo group). In the combined studies of Concerta in adults (placebo-controlled, and others) 202 of a total of 1369 subjects, 14.8%, suffered aggression. [10] (See FVAR, page 12, 26 April 2011.)

Clear evidence also emerged in the studies that Concerta could cause anxiety and agitated conditions in adults – ”evidence for the risk of new-onset anxiety, tension and agitation”. “Adult studies have identified anxiety as a very common risk in adults.” (See Preliminary Variation Assessment Report, page 117.)

In the investigation it was concluded: “The main new safety concern from the study data is around the frequency of psychiatric adverse events and that this is often de novo [new]. Of note is the incidence of anxiety but also rates of depression and aggressive and hostile behavior are raised.” (See Preliminary Variation Assessment Report, page 66.)

MHRA asked for and Janssen submitted (January 2011, Response Document) the following illuminating table over adverse events in the Concerta studies:


We would of course expect a similar picture in the clinical trials of Ritalin for adults.

And so we take a look at the comparable table in the Swedish investigation of Ritalin for adults. It looks like this (National Type II variation – Overview, page 35, 16 July 2014):


We can see, for the first 9 weeks, that “Psychiatric Disorders” are lumped together, with 188 persons (34.7%) in the Ritalin group affected by these, compared to 25 (13.9%) in the placebo group.

But nowhere in the 58 pages long Swedish “investigation” can we read specifics about what comprised these psychiatric disorders. We find nothing at all in the document about “aggression”. We find nothing about “new safety concerns” for aggression, hostile behavior, anxiety, depression.

While the assessment of the Concerta studies showed: “A causal relationship with Concerta was established for aggression, tics and depression”, we find nothing at all about this in the Swedish document.

So in some way the Swedish authorities together with Novartis succeeded to get rid of, or not go further with, these serious adverse effects, which must have been about the same in the studies of Ritalin as in the studies of Concerta. And which could have – as for Concerta – formed the basis for disapproval of the application. How this was done is not clear at the moment. Maybe we have a case of “recoding” the adverse events, like the famous renaming of suicide attempts by pharmaceutical companies, instead calling them “emotional lability”. Anyhow the Swedish authorities could not “afford” to ask too many questions about this.

What did the MHRA do about it?

At the moment I don’t know how much of the text in the Swedish assessment report is copied from the text originated by the Reference Member State (RMS), Germany, leading the handling of Novartis’ application.

And we come to the role of MHRA and my questions to you:

1. Did MHRA “handle” aggression, and other serious adverse events, in the same way as the Swedish authorities did? (In other words, not at all.)

2. If so, how could MHRA, considering what the agency knew about the harmful effects of the almost identical drug Concerta, fail to go further with the investigation about this manipulation of data?

3. If MHRA actually challenged the manipulated data about adverse effects in Novartis’ application for Ritalin, I assume the agency arrived at the same conclusion as in the Concerta investigation – that the drug could not be approved. I would be happy to get a copy of that important assessment report.

Yours sincerely,

Janne Larsson
Reporter
Sweden

--



 Janne Larsson has, for many years, in his free time, worked using the Swedish FOI Act to make the “misdeeds” of psychiatry, Big Pharma and government agencies public.

Bob Fiddaman










Monday, February 03, 2014

Rebadge, Reinvent and Reap Rewards of ADHD Medication




One thing I've learned over the past 8 years of writing this blog is that the system that is supposed to protect us from dangerous drugs is a system that has been infiltrated by pharmaceutical dollars. Be it the FDA, MHRA or any other drug regulatory agency.

I've also learned that the only way one can change how we, as patients, view these psychiatric medications is by opposing the claims of pharmaceutical companies that they actually work and are safe for human consumption.

Be a pain in the ass, the big man doesn't like it. Ask questions, the big man doesn't like it.

I've got a lot of admiration for other folk who have dedicated their lives to getting to the truth about antidepressant type medication, be they human rights movements, professors, journalists, grieving parents or just folk who have the tenacity to never give up in their pursuit for the truth.

Janne Larsson is one such person.

Larsson, who hails from Sweden, has, for many years, been investigating the drug Concerta, an investigation that has now led him to the doors of the British drug regulator, the MHRA.

What we have here is deception of the highest order...a deception that Larsson wishes to make public.

Larsson has wrote to the new chief at the MHRA, Dr Ian Hudson. The question he has put to the former World Safety Officer for SmithKline Beecham is simple...Will the MHRA handle the Concerta scandal by approving Ritalin for adults?

Larsson, after many years of investigation, has kindly copied me in on the email to Hudson. It makes shocking reading.

He writes...

In the beginning of 2011 secret internal MHRA documents revealed: The application to get the ADHD drug Concerta approved for adults was refused; Concerta was found to have “negative benefit/risk balance” for adults.

The disapproval of the drug for adults has been a well-kept secret: NO information whatsoever has been issued by the MHRA or the other European medical agencies about the disastrous results.

Let’s look on what was hidden for doctors and the public.

This is the not published table over the Adverse Events of Concerta in clinical trials. It is part of the manufacturer Janssen’s “Response Document” (page 84) to the MHRA, from 11 January 2011.



In the Company’s three best (!) studies of Concerta on adults, the ones chosen for Janssen’s application, the following harmful events emerged in the short-term studies (up to 13 weeks), where Concerta was compared to placebo:

·         The persons who received Concerta had a 270% increased risk for heart disorders in form of Arrhythmias;
·         The persons who received Concerta had a 116% increased risk for Aggression;
·         The persons who received Concerta had a 62% increased risk for Depression;
·         The persons who received Concerta had a 225% increased risk for neurological disorders in form of Tics/Dystonias;
·         The persons who received Concerta had a 190% increased risk for Psychosis/Mania;
·         The persons who received Concerta had a 295% increased risk for Anorexia;


Meantime, in Larsson's native Sweden, Concerta prescriptions have risen by 60%, netting the manufacturer, Janssen, a cool 488 million SEK (45 million GBP)

Fear not... If one bad drug can be pushed in one country then expect the very same drug to be pushed in other countries. Step into the fray Novartis, manufacturer of Ritalin, an ADHD drug that is, in essence, exactly the same as Concerta.

Larsson finishes his email to the MHRA with the following...

I am sure Novartis has learned from the failed Concerta submission and that there is a big interest from the officials mentioned above to push through the approval of Ritalin for adults. We can expect that the submitted studies will get a positive assessment this time – no embarrassing questions – and suddenly the concealed and alarming Concerta results can be expected to no longer exist! Janssen will also be saved; no criminal actions will be taken.
But it’s hard to see how the above can fit with the MHRA declaration: “We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.”
So Mr Hudson, will the MHRA take part in this dirty game of approving Ritalin, so that we can forget about the Concerta scandal?

It's a fair enough question but I don't expect an immediate response from Dr Ian Hudson. I wrote him in November as I was concerned about MHRA consultant, Stephen J W Evans and his recent call for a re-evaluation of the current prescription of SSRIs in young people.

Ironically, I received a reply a few hours ago, not from Hudson but from Sarah Morgan, Group Manager, Benefit Risk Management Group, Vigilance and Risk Management of Medicines.

My query wasn't really addressed by either Hudson or Morgan [no surprise there] - it was the bog-standard "the MHRA has comprehensively reviewed evidence on the benefits and risks of SSRIs" type of email.

I have to take off my hat to Larsson for pursuing this. I hope he is made of strong stuff, my experience with the MHRA and their limp-wristed buck-passing cahoots has been highlighted on my blog and in my book on many occasions.

Good luck Janne!

The full email sent to Hudson from Larsson can be downloaded here.


Bob Fiddaman



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.

PRESS PLAY


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 suicide...you 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

CHART REFERENCES


[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.







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Saturday, January 12, 2013

Tenacity Pays Off For Swedish Journalist Larsson




I've corresponded with many great writers since starting this blog almost 7 years ago, I've met a few in person too.

What makes a great health activist/advocate?

Well, in the main, a great advocate is someone who has experienced the darker side of the pharmaceutical industry. A person who, through no fault of their own, has endured horrific withdrawal at the hands of a pharmaceutical product or, worse, had to lay a loved one to rest because a pill that was meant to make them better actually induced suicide.

Then we have ex-pharma employees and current and retired psychiatrists, these people also add a tremendous weight to the debate regarding antidepressants.

Journalists banging the drum are few and far between but they do exist in this murky pharma world. One such journalist is Janne Larsson, a Swedish man whose investigative skills and tenacity have to be admired by the street man and revered by the top executives within pharma, medicine regulators and apparent experts in the field of psychiatry.


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 cure...in 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.






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