Zantac Lawsuit

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

Wednesday, May 27, 2015

MHRA Seek Pharmaceutical Assessor

Those limp-wristed buffoons, the MHRA, are on the lookout for a Pharmaceutical Assessor.

They have 6 positions. If successful I'll put a good word in for five of my friends.

Job Role:

Reporting to the Unit Manager in a Product Licensing Assessment Team, Pharmaceutical Assessors are required to assess the quality aspects of both initial and variation applications for marketing authorisations for chemical products and take decisions on their suitability for approval.

**Jumps up and down waving arms in the air shouting "ME, ME, ME."**

I'd much rather make my application public. So here goes.

First, there are, apparently, a few things I need to know.

If you are a successful candidate you will be expected to undertake Basic Checks.

Okay, will I need to take my clothes off for these 'basic checks'? Should I wear the thong and shave the bush? I have no visible scars due to self-harm, although I did once try to kill myself whilst on Seroxat. Sadly, no marks as I chose death by overdose.

Grade entry qualifications
Degree in pharmacy and registration with the GPhC or eligible to be registered with the GPhC through equivalent registration body for pharmacists in another EC country.

Oh fook! I fell at the first hurdle.

Um, how about my experience in speaking with patients harmed by antidepressants. You know, the parents whose kids killed themselves whilst taking medication that you, as a regulator, failed to flag as being dangerous. Anyway, it's blindly obvious, to me at least, that qualifications for these positions mean nothing. I think you need someone who can see beyond the spin that pharmaceutical companies throw your way when applying for a licence. I can smell the bullshit a mile off.

Further information
To apply for this post, please email the following documentation by the closing date specified:

a copy of your CV (max 4 pages);

How bout I just send you 4 pages of my blog instead? In any event, I'm sure you know more about me than...well, than I do.

Now the interesting part. Here's where I get to state reasons for why I should get the job.

I would love the position of Pharmaceutical Assessor because I would get to meet your CEO, Ian Hudson. I've always wanted to meet him. You see, Hudson used to be World Safety Officer at GlaxoSmithKline and you pretty much know how I feel about them, right?

I'd love to have tea and sticky buns with him so we could discuss the case of Donald Schell. He's familiar with it as he was depositioned by American attorneys. Some of his answers to the questions that prosecuting attorneys put to him were priceless. Oh, how I laughed. Here's a few.

Q. In reviewing your CV, it appears that you did not have any real direct relationship in your practice, with psychoactive drugs until such time as you became Worldwide Director of Safety for SmithKline in January of '99; is that accurate?
A. Yes, that's correct.

Oh yipeeeeeeeeeeeeeeeeeeeee! So, technically, I don't really need any of the qualifications for the Pharmaceutical Assessor role then?

Q. Okay.  Do you believe that it is possible that Paxil has caused any person, worldwide, to commit an act of homicide or suicide?
A. I have seen no evidence to suggest that at all.

I'd love to ask Hudson this question, just to see if he has changed his mind or if he still believes Paxil has not caused any person, worldwide, to commit an act of homicide or suicide? We can do this in our spare time, maybe over a few beers or Martini's. I'm unsure what Hudson's favourite tipple is?

Q. Okay.  Well, Doctor, let me ask you this:  I assume that if we go to trial in this case in Wyoming, or in any other case in the United States, if SmithKline Beecham asked youto come and testify live, you will do so won't you? A. Well, SmithKline Beecham will have to decide who its most appropriate witnesses are to be.  I will be leaving the company at the end of the year because I'm taking up anotherappointment at the Medicines Control Agency in the U.K. Q. Okay.  What will be your position at MCA?
A. I'll be Director of the Licensing Division at the Medicines Agency -- Medicines Control Agency.

I can just see it now.

Fiddaman: "Hey, Ian, me ol mucka, fancy another pint. Let's talk some more about how you left GSK and joined the MCA (Now MHRA). I'll get a bag of pork scratchings too."

Hudson: "Oh, I'm sorry sweetie, I can't stay for another. I have lots of work back at the office. Some absolute cock is drawing reference to my time at GSK and my stance that Paxil does not cause suicide."

Fiddaman: "Yeh, that cock is me."

Camera stays on Ian Hudson's face, slowly zooming out to see a smiling Fiddaman.

**Insert the 'duff duffs' to Eastenders here**

The role of Pharmaceutical Assessor at the Medicines and Healthcare Products Regulatory Agency is online here.

Applications close later today.

Bob Fiddaman.

Jeffrey A. Lieberman - Answer the Questions

Who is Jeffrey A. Lieberman?

Jeffrey Alan Lieberman (born 1948) is an American psychiatrist who specializes in schizophrenia and related psychoses and their associated neuroscience (biology) and drugs. He was principal investigator for CATIE, the largest and longest independent study ever funded by the United States National Institute of Mental Health to examine existing therapies for schizophrenia. He was past president of the American Psychiatric Association from May 2013 to May 2014. (Source)

Back story.

On May 25 Jeffrey A. Lieberman tweeted the following.

What followed was a series of questions put to Lieberman regarding this statement. They were, for the most part, asked in a civil manner. Here's three of them.

Three fairly straightforward questions, I'm sure you'd agree. Lieberman, it appears, felt uncomfortable and instead of answering the above questions he decided to block myself and the mother of Shane Clancy, a young man who killed himself in a state of psychosis caused by the antidepressant citalopram.

So, why did Lieberman decide to take the cowards way out and not only avoid the questions put to him but block those who asked the questions? Well, one can only assume.

Lieberman proudly promotes his book, 'Shrinks: The Untold Story of Psychiatry', on his Twitter account. The book is available in bookstores and Amazon and has received some decent feedback from those that have read it.

One such person is Andrew Solomon, who writes, "Jeffrey Lieberman has produced a masterful behind-the-scenes examination of psychiatry--and, by extension, the human condition. A wise and gripping book that tackles one of the most important questions of our time: what is mental illness?"

A fair enough review until we learn that Andrew Solomon is the son of Howard Solomon (Former head of Forest Laboratories Inc)

Ironically, Forest Laboratories Inc market and manufacture citalopram in the US.

Let's dig a little deeper.

Here's what I found for Lieberman. (Verbatim)

In 2006, Lieberman co-signed a letter to the editor of The Wall Street Journal with about thirty other doctors. With this, he disclosed honoraria, consulting fees, research grant support from AstraZeneca, Bristol-Myers Squibb, Upjohn Pharmacia, Novartis, Eli Lilly, Janssen, Pfizer, Hoechst AG, and AstraZeneca. He also listed as corporate speakers bureaus AstraZeneca, Janssen, Eli Lilly, and Pfizer.

Lieberman disclosed in 2007 in the journal Primary Psychiatry that he was a consultant to Eli Lilly and Pfizer. He was on the advisory boards of AstraZeneca, Eli Lilly, GlaxoSmithKline, Lundbeck,Organon, and Pfizer. He has a patent from Repligen Corporation. Lieberman received research support from Acadia, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, Merck, Organon, and Pfizer. In 2009, Lieberman disclosed grants from Allon, Forest Laboratories, Merck, Pfizer, AstraZeneca, Bristol-Myers Squibb, Cephalon, GlaxoSmithKline, Janssen, Otsuka, Solvay, and Wyeth to the American College of Neuropsychopharmacology for their annual meeting in which he participated.

In 2011, his disclosure at Medscape of relevant financial relationships says he served on the advisory board of Bioline, GlaxoSmithKline, Intra-Cellular Therapies, Eli Lilly, Pierre Fabre, and Psychogenics, and that he received research grants from Allon Therapeutics, GlaxoSmithKline, Ortho-McNeil-Janssen, Merck, Novartis, Pfizer, Sepracor, and Targacept.

He also disclosed in 2013, as a member of the psychiatry editorial board at Medscape, that he received research grants from Allon, Novartis, Sepracor, and Targacept; and he served on the advisory boards at Bioline, Intra-Cellular Therapies, Pierre Fabre and Psychogenics. In additional disclosures at Medscape in 2013, he received research grants from Allon, GlaxoSmithKline, Eli Lilly, Merck, Novartis, Pfizer, Psychogenics, Hoffmann-La Roche, Sepracor, and Targacept, and he served on the advisory board of Alkermes, Bioline, Intra-Cellular Therapies, Pierre Fabre, and Psychogenics.

The source for all the above can be found here - APA President Jeffrey Lieberman urges support for big pharma

Irish blogger, The Truthman, has also recently questioned the stance of Lieberman regarding comments he recently made about best-selling and award winning author, Robert Whitaker.

Lieberman made claims that Whitaker was a  "menace to society" on Canada's popular national CBC radio program The Sunday Edition. On the same show Lieberman also compared taking antidepressants to taking insulin for diabetes. (Source)

Are we wrong to question Lieberman's payments from pharmaceutical companies?

Are we wrong to question Lieberman's stance on addiction being a mental disorder?

Was myself or Leonie wrong to ask Lieberman the questions we did via Twitter?

What motive was behind Lieberman's reason to not answer us and then block us?

More importantly, why aren't journalists posing the same sort of questions to Lieberman?

It would appear that Lieberman comes out with these rash statements then, like so many other psychiatrists before him, goes into hiding. Surely by making such claims, the burden of proof falls on Lieberman to substantiate them?

You can follow Lieberman on Twitter here. Be warned, if you, unlike myself and Leonie Fennell, like sticking your tongue down the back of Lieberman's pants then he'll keep you on his list. If you, like myself and Leonie Fennell, have inquisitive minds and wish to ask Lieberman questions about any of his statements or, indeed, his vast amounts of money he has received from pharmaceutical companies, then you too will be blocked. Lieberman, it would appear, surrounds himself with people who believe everything that he tells them... and never question him. They are, if you like, his garlands and Lieberman just loves covering himself in them.

People like Lieberman make life so much easier for bloggers. We can throw out the questions and, at the same time, highlight how defensive certain psychiatrists become.

The physiology of defensive behavior is defined as...

The Self-Protective System of the brain is there to ensure that we, as human beings, physically and psychologically survive. Behaviors of the Self-Protective System are self-focused. They are only concerned with the preservation of the self, self-image or self-concept. While the behaviors look different, the self-centered approach and the insistence that they are right and others are wrong or that they have been wronged or victimized come from the same place.

Hmm, I bet my left testicle that there's a pill for such behaviour!

Bob Fiddaman.

Tuesday, May 26, 2015

Jaws and the Pharmafia

We remember it all, well most of us. The scary musical score from John Williams, Da-dum... da-dum, dum-dum-dum-dum-dum-dum. Then the shark, the great white, the killing machine. Next came the chief of police, (Brody) played brilliantly by Roy Scheider. Brody is told one morning that the cause of death of a mangled and mutilated body recently washed up on Amity beach is down to a shark attack. On hearing this news he does what any sane human would do - he attempts to close down the beach until the problem is fixed (the shark is killed)

The Mayor of Amity, Mayor Larry Vaughn (Murray Hamilton) realizes that by closing the beaches he, along with all the retail outlets on Amity island, will lose money. He somehow convinces the coroner to lie to Brody about his original 'shark attack' report. Brody, knowing no better, decides not to warn the public about the danger roaming the Amity waters.

Sadly, just days later, Brody witnesses a young boy (Alex Kitner) being killed by a shark. The beaches are closed and days later a shark is caught. The Mayor is obviously delighted, but for all the wrong reasons. He's delighted because the cash can once again flow. However, there's one voice who questions if the fishermen caught the shark responsible for the two shark attacks - he tells them that the bite radius on the first victim do not match with the shark they caught. They ignore him and the beaches are reopened - more deaths ensue.

Now, does any of the above remind you of the way pharmaceutical companies, mental health specialists and medicine regulators behave regarding antidepressant use?

Jaws (the novel) was written byPeter Benchley, he, along with Carl Gottlieb, wrote the screenplay for the movie. The message, to me at least, is obvious - it's all about the money, baby.

I'd like to say that Messrs Brody, Quint (Robert Shaw) and Matt Hooper (Richard Dreyfruss) represent the medicine regulators (MHRA/FDA). Sadly they represent everything that the current medicine regulators aren't about. Three working class men who wish to right a wrong because they care about the safety of the residents of Amity.

My experience of the British drug regulator is that they do not care about the safety of you, I or our children. If they did then they would have moved hell and earth to thoroughly investigate the link between antidepressant use and suicide (not just in children but in adults too) - Making recommendations is simply not good enough.

Next time you sit down with your kids (who may have not yet seen the movie Jaws) tell them that it is purely fictional - in fact shark attacks are rare.

Induced antidepressant suicide on the other hand...

This quote goes out to medicine health regulators globally.

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

Quote from the movie JAWS

Bob Fiddaman

Tuesday, May 19, 2015

Danilo Terrida - Zoloft Suicide

Danilo Terrida (20)

It's been said that writing with emotion can either a, turn you into a great writer or b, land you in hot water.

This is the story of  Danilo Marcello Terrida, a 20 year-old student from Denmark.

What you are about to read defies all belief, it's malpractice of the highest order. Its secrets and lies designed to make one pharmaceutical company rich at the expense of taking a kid in his prime, a young man that had his whole life in front of him and everything to live for.

Danilo was 5 hours away from home - he'd enrolled at the Maritime college in Frederikshavn, Denmark and on one evening in mid-October 2011 he was missing his family and friends back home in Sjælland.

Feeling low and lonely Danilo decided to visit the Emergency Medical Service in Frederikshavn for help. Once there he was given an antipsychotic and told by staff that he should go back to Maritime College and contact a General Practitioner (GP)

Danilo contacted a GP in Frederikshavn but was told that it would be best to contact his own GP in  Hellerup, some 400 km away.

What happened next really does not surprise me. It still shocks and saddens me that doctors can be so ignorant when it comes to diagnosing someone who was just feeling lonely and distant from his family.

Danilo made the call to his GP, Dr. Ole Knudsen. and, after just 8 minutes, was prescribed sertraline (Zoloft) - Remember, this was not a face-to-face consultation, this diagnosis and subsequent prescription was all done over the phone. Zoloft is manufactured and marketed by pharmaceutical giants, Pfizer.

The prescription, I presume, was faxed to Danilo who then dispensed it.

This from his parents...

"In the following 11 days, Danilo followed the doctor’s recommendations about how many pills he should take, and after seven days, he doubled his dose, as he had been told, despite the fact that research has shown how dangerous high doses of Sertraline can be to young people. Meanwhile he got worse and worse. He complained of extreme headache, could not concentrate or sleep and had nausea.

"On October 25, 11 days after Danilo had begun his recommended treatment with “happy pills”, he hanged himself from a crane on the Maritime College. Family and friends were shocked. Danilo had no history of mental illness, he had never before been on antidepressants and that he could kill himself, came as a shock to all who knew Danilo."

 So, another kid killing himself. He was depressed and that's what depressed people do, right?

His prescribing doctor, Ole Knudsen, somehow waved a magic wand, looked into his crystal ball and, after just 8 minutes, deemed that 20 year-old Danilo was in need of a box of pills to make his loneliness disappear. What kind of knucklehead thinks he has the right to prescribe a lonely 20 year-old powerful mind-altering drugs over the phone?

Hey, Knudsen, I'm talking to you!

As if losing their son wasn't bad enough, Danilo's parents then learned, six months after Danilo’s death, that Dr Ole Knudsen had been modifying and adding to Danilo’s health records.

They also learned that the Danish National Board of Health, the limp-wristed equivalent to the FDA and MHRA, had known since 2003 that sertraline increased the risk of suicidal thoughts and behavior among children and adolescents up to 25 years of age.

After being stonewalled, down almost every avenue they have walked, Marianne and Denis Terrida, Danilo's parents, have now decided to go public and a new website has been launched that highlights the story of their son and their son's drug pusher, Ole Knudsen. (Because that's what you are, Knudsen!)

The website is in both Danish and English and shows how a doctor at the emergency medical service chose to hand over 25 grams Buronil – an antipsychotic agent also known Melperone. It is indicated for use in Treatment refractory schizophrenia and, in the UK at least, has not been granted a licence.

So, just to clear things up. Danilo was feeling lonely, he missed his family so some lunatic in a white coat decided that he needed a drug that was suitable for those with Treatment refractory schizophrenia.

It's normally prescribed to patients who cannot tolerate clozapine. So, why did Moron number one prescribe it to Danilo?

Moving on to Moron number two, Dr Ole Knudsen.

This from the Danilo website...

"In eight minutes you can boil an egg. Or run the subway from Nørreport to Flintholm. If you are a busy practitioner, you can also manage to diagnose a patient telephonically and prescribe a dangerous medicine in that time. It did not take longer for Danilo’s own general practitioner, Ole Knudsen to make the decision to prescribe antidepressants to Danilo. A medication that 11 days later would cost him his life. Eight minutes on the telephone was all Ole Knudsen needed to diagnose Danilo with depression and prescribe the antidepressant “Sertraline." Usually, it is normal professional standards for doctors to see the patient for a personal consultation at least twice before a depression diagnosis is made and treatment begins. The fact that Ole Knudsen had only spoken on the phone with Danilo one single time, is very much against the proper treatment when prescribing antidepressants."

You can see the discrepancies Danilo's parents found in Dr Ole Knudsen's notes on this page here.

Toward the end of 2013, some two years after Danilo's suicide was induced by Zoloft, Dr Ole Knudsen was criticized by the Health Authorities Disciplinary Board. They found that Knudsen's record-keeping was inept, that he hadn't given informed consent to Danilo, and never followed up (made contact with Danilo to see how he was coping on the drug)

Knudsen was further criticized by several other authorities for his role in the case, but despite this, according to his parents, he can now continue as a practitioner – without being subject to any legal or economic punishment.

The findings were never made public, they were just sent to Danilo's parents.

The story continues on the website here.

Now, please run the hot water and let me immerse myself.

Dr Ole Knudsen, you are one incompetent asshole. You hide behind the nonsense notion that a 20 year-old who is lonely must be mentally ill because you gave him a whole 8 minutes, during which time you miraculously diagnosed him and treated him with a pill to help with the diagnosis. Well, Knudsen, your diagnosis was wrong as was your treatment and no altering of medical notes can change those two simple facts.

He was just 20, Knudsen. 20 years-old and you gave him a box of pills that are known to induce suicide. Moreover, you didn't even bother to see how he was doing. Your ignorance and lack of care is staggering. Hey, don't worry about it though. Danilo was 'just one of them things that happen', right?

It couldn't have been the drug, the kid had mental health problems, right? He had a shift in the chemicals in his brain and you was only trying to correct that shift, right Knudsen?

If there were a shit list, Knudsen, you'd be sitting at number one.

My thoughts are with the Terrida family.

Bob Fiddaman.

More Info -

Monday, May 18, 2015

The Mysterious Disappearing Facebook 'Likes'

Through fear of being labelled an 'angry smeary conspiracy theorist'... actually, that's quite a badge of honour - thank you Mr Goldacre [see Andrew Witty: The Acceptable Face of Big Pharma?] - I am quite bamboozled by recent events on this blog.

A while ago I added the Facebook widget to highlight how many times a blog post of mine had been 'liked' on the popular social network. All was going good until fairly recently.

In a nutshell, 'likes' are being wiped off and reset to zero - I have no idea why?

This guest post by Stephanie Lynch had 249 likes... days later, the 'likes' reset to zero.

The tribute I did for Sara Carlin was climbing with approx 150 likes - days later it was reset to zero.

Cher Buchannan's guest post about citalopram and birth defects reached about 300, before it was reset to zero - it's currently at 45.

Elizabeth Kenny, Caught in the System has also been rest to zero likes.

Others reset to zero

GSK Use Delay Tactics on Grieving Widow

Shane 22nd February

Very strange.

Are Facebook in allegiance with pharmaceutical companies or is it merely coincidental that glitches would appear in these 6 very popular posts? Between them they have had over 3,500 views.

Just asking.

Bob Fiddaman. - The angry smeary conspiracy theorist.

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


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.


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 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.

Thursday, May 14, 2015

GSK Given Warning Over Baby and Infant Medicine

It's only being reported in one news media outlet and I have wrote to them to ask for confirmation but, it seems like, GSK have been given a warning by the UAE ministry regarding the dosage instructions for Panadol.

The National UAE write the following...

The Ministry of Health has issued a warning to pharmaceuticals company GlaxoSmithKline telling it to modify the dosage instructions on the packaging of Panadol Baby and Infant Suspension. 
The ministry said that it discovered a mistake in the prescribed dosage that could lead to overdose, which could cause liver poisoning in children. 
Paediatricians, pharmacists and medical practitioners have been told to calculate the adequate dose based on the child’s age and weight and not rely on the dosage instructions shown on the outer package of the medicine until they are duly modified and approved by the drug department at the ministry.

It's a surprisingly short article given that parents may be administering potentially lethal doses of Panadol to their infants and children without actually realizing it!

The Ministry of Health UAE make no mention of the above on their website so I flicked GlaxoSmithKline an email to ask for confirmation of the alleged warning they had received.

Dear GSK,
I am writing to you in regard of a recent article that appeared in The National UAE that made reference to your product Panadol.
The article suggests that GSK were issued a warning by the UAE Ministry because, and I quote,  "they discovered a mistake in the prescribed dosage that could lead to overdose which could cause liver poisoning in children."
 Can you confirm if, in the interests of transparency, this article is correct please.
Bob Fiddaman

Given that GSK normally make you jump through hoops before they answer a straight forward question, I've decided to run with this article and also highlight where Panadol has been in the news before.

In 2013 the Essential Baby online magazine wrote an article regarding a safety scare over GSK's Panadol. At the time, GSK acted promptly. They had learned that Children's Panadol Baby Drops syringes were faulty and could lead to parents giving their children more medication than is required.

Here's a photo of the faulty syringe compared to the correct syringe.

I'm sure you'll agree that's quite a faulty product. GSK's Children's Panadol Baby Drops  is for babies and children aged between one month and two years of age.

At the time GlaxoSmithKline medical director Andrew Yeates said even if babies had been given the incorrect doses of medication using the syringes, there was a "low risk" to their health.

Hmm, thanks for the reassurance!

One year later and the Essential Baby online magazine were once again reporting on GSK's Panadol.

This time they learned that GSK's Children's Panadol 1-5 Years Colour free Suspension also had a faulty syringe. Here's what they wrote...

The confusion with the Panadol syringe stems from the fact that to measure a correct dose, the widest part of the plunger needs to be in line with the desired dosage marking on the syringe.
"This differs from most syringes which measure to the tip of the plunger where the liquid finishes," the advisory reads. 
"With the Children's Panadol syringe, the liquid continues past the tip of the plunger and therefore needs be measured to where the widest sides of the plunger meet the barrel of the syringe."
If the syringe is used to measure in the incorrect way, an extra 1.26mls will be given with each dose of Children's Panadol.
Excessive doses of paracetamol can be harmful to the liver and the harmful effects can be fatal if not detected and treated.

So, if the story currently being covered by The National UAE is, in fact, correct then one has to ask, why can't GSK get their dosages right, more importantly, isn't it about time that they did? The target population for these products, infants and babies, really can't do it for themselves!

When we also take into account that GSK have been accused of making payments of $1,500 each to two doctors to promote Panadol in Syria then alarm bells must surely be calling for Andrew Witty to get his house in order.

This company, it could be argued, could damage your child's health.

Bob Fiddaman.

**If I get a response from either GSK or The National UAE then I shall amend this blog post accordingly.**

Thursday, May 07, 2015

Cymbalta - Australian Doctor's Warned

A subscription only based website aimed at Australian healthcare professionals is reporting that doctors in Australia are being urged to prescribe Eli Lilly's antidepressant Cymbalta (duloxetine) with caution after a 35-year-old Victorian truck driver died of serotonin syndrome from a dose increase.

Nicholas Moorby died in April 2013, four months after his GP increased his Cymbalta dose from the recommended maximum daily dose of 120mg (three 60 mg capsules) to 240mg/4 capsules per day.

According to the Australian Doctor website, "friends of Mr Moorby noticed he was "agitated", "really out of it", "blabbering" and "making no sense" in the days leading up to his death."

Moorby's GP, who increased the dose, admitted that he had made an "error of judgement" and did not face any criminal charges over the death.

This from the Australian Doctor:

His GP was told by Mr Moorby that his psychiatrist recommended the dose increase due to his severe depression. The unnamed GP told the told the Coroners Court of Victoria last month,“Unfortunately, a lot of the specialists nowadays do not write scripts, they would tell the patient, go and see your GP and get the GP to write them. There are many cases where specialists prescribe big doses of anti-depressive so while I go to one or two tablets it’s not unusual for specialists to go to four, so I did not question him on that,” 

Moorby had amphetamine, methamphetamine, duloxetine, oxycodone, promethazine and alcohol in his system when he died. However, Forensic pathologist, Dr Heinrich Bouwer, told the court that an adverse drug reaction to excessive duloxetine could occur with or without the interaction of amphetamines.

The Australian medicines regulator, The Therapeutic Goods Administration, recorded 21 cases of serotonin syndrome due to duloxetine in their Dec 2013 report.

For those that don't know, serotonin syndrome, also known as serotonin toxicity, is a  life threatening drug reaction that causes the body to have too much serotonin. This leads to excessive stimulation of the central nervous system and peripheral serotonin receptors.

When you take poor metabolizers into account and you see what the friends of Nicholas Moorby said... he was "agitated", "really out of it", "blabbering" and "making no sense"  - there really is a strong argument that these drugs can induce suicide and homicidal acts. Alas, the pharmaceutical companies and the blinkered views of psychiatrists often blame the "underlying illness" for the cause of suicide and/or homicide.

In the United States Eli Lilly and Company are facing a number of lawsuits regarding Cymbalta.

Over 20 lawsuits have been filed in federal courts across the US which sees claims that Lilly deliberately omitted information about the true risk of withdrawal in the product label and in marketing materials.

More information about those lawsuits can be found on the Baum, Hedlund, Aristei & Goldman, P.C here.

Bob Fiddaman.

Tuesday, May 05, 2015

May 6 - One Angel (Sara Carlin) and Paxil

As a writer of factual based evidence, and now fiction (manuscript, 'No Other Man', currently with agent in New York), I often walk into a lot of stories not knowing the ins-and-outs. I sit down and research or, if contacted, I offer people to write guest posts.

Back in 2007, Sara Carlin, a beautiful 18-year-old girl grabbed a piece of electrical wiring, fashioned a crude noose and hanged herself in the basement of her parents house while under the influence of the antidepressant drug Paxil (Seroxat in the UK).

I learned about Sara's plight when I stumbled upon her story in the Oakville Beaver, a Canadian newspaper. At the time, her inquest was approaching and this is when I took an interest.

It was a turning point for me personally and for the direction of this blog. Up until then I had targeted the British drug regulator for their limp-wristed approach to safeguarding the British public.

Sara Carlin changed all of that.

In her death she opened many doors for me. Her inquest, which was basically GSK & Friends Vs The Carlin Family, was reported on in the Canadian press. It was reporting that was biased beyond belief so I took it upon myself to cover the inquest by liaising with Sara's dad after each night of the inquest. I would write what the Canadian press were too afraid to write.

Now, without getting too 'spiritual' and delving into what some might deem as fiction, I was helped along the way by Sara herself. I felt her presence around me and today, which marks the 8th anniversary of her death, I still feel her presence.

In a twist of fate, divine intervention, call it what you will, my son and his wife gave birth to my granddaughter, Ruby-Rose, three years ago. She came into this world on the anniversary of Sara's death.

Sara had a profound effect on my life, she made me realise that this blog shouldn't just be a platform for me to vent my anger toward GSK and the MHRA, it should be a platform for all of those who have lost loved ones due to antidepressant induced suicide and, indeed, those who have lost children to birth defects caused by antidepressants.

As it stands today, my blog is vast approaching one and a quarter million hits, a large chunk of those hits came when I wrote during Sara's inquest. She put me on the map and for that I shall live forever in her debt.

I have become great friends with Sara's parents, Neil and Rhonda. Neil is the brother I never had and when we met in person for the first time some years ago, it was a moment that only a grieving father and passionate writer could fully comprehend. We embraced, cried then talked into the small hours, just Neil, Rhonda and I.

The Carlin family lost their daughter through the incompetence and failure of many. Treating physicians, a lacklustre regulatory system and a pharmaceutical company who chose, and continue to choose, profit over the life of a young woman who had everything to live for.

The inquest saw 16 recommendations made, to date, not one of those recommendations has been put into place. What a slur on the memory of Sara!

Sara Carlin opened my heart and my mind and, as a result, I now report on individual antidepressant induced suicides, or offer guest posts to help the grieving process of those left behind. She gave me the opportunity to give others a voice.

Take a bow angel.

I will be saluting your life later tonight with a bottle of wine.

Nessun Dorma Sara.

Bob (Your dad's soul brother)

This is for the Carlin's, they know what it means.

Back stories

Sara Carlin Inquest – Failure of Oakville Medical Profession

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

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

SARA CARLIN Ontario, Canada

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

Sara Carlin Inquest – Local MP Slams GlaxoSmithKline



SARA CARLIN INQUEST - What The Jury Should Know

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

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

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

Sara Carlin Inquest - We Know How, Now Tell us Why!

Monday, May 04, 2015

An Open Request For Dr Max Pemberton (TV Doctor)

Dear Max,

I'd refer to you by your real name given that 'Max Pemberton', as I understand, is a pen name you use. However, I feel using your first pen name, 'Max', is suitable for the purpose of this request.

I'm am writing in response to your editorial in the Daily Mail (The Real scandal about happy pills) in which you quite openly disagree with the opinions of  psychiatrist, psychopharmacologist, scientist and author, Dr David Healy. (Real name)

My response is simple and one that will cut out the need for a pissing match on social networks.

I would like to sit down with you and debate some of the statements you made in your editorial, specifically, where you state...

"You never hear anyone opining that chemotherapy is over-prescribed, do you?"

I would also like to discuss your stance on whether or not depression is caused by a lack of the brain chemical serotonin, if not, then what is depression caused by?

You also claim that, "As an academic, Professor Healy doesn't have to pick up the pieces. As a psychiatrist working in the NHS, I do."

Which is very interesting because as a writer I, myself, often find myself helping families harmed by antidepressants.

So, here's the request.

I would love to debate the above issues (and more with you) - I would also like to bring with me supporting evidence, although this may prove to be difficult financially as those that I wish to attend live in different parts of the world, namely,..

Neil and Rhonda Carlin (Canada) - Their daughter, Sara, was just 18 when she tied a knot in an electric wire, placed it around her neck then hanged herself. Sara, at the time was on the antidepressant Seroxat, known as Paxil in the US and Canada. A total of 16 recommendations were made at the end of her inquest. You can read about some of those recommendations here. Here's a photo of Sara.

Leonie Fennell (Ireland) - Her son, Shane, was just 22 when he was prescribed the antidepressant Cipramil, known as Celexa in the US. 17 days later Shane took his life and the life of another. Shane didn't hang himself, he plunged a knife into his chest 19 times. His mom told the inquest she believed his actions were the result of his taking Cipramil. The inquest returned an open verdict. Leonie has her own website here. Here's a photo of Shane.

Stephany Gatchell (Ireland) - Her daughter, Sharise, was just 18 years of age when she took her own life. Sharise chose death by hanging. An empty packet of Seroxat was found beneath her lifeless body. Two weeks after she killed herself the MHRA made an announcement that SSRI'S should no longer be prescribed to under 18's. Too little too late for the parents of Sharise. You can read a speech that her mom gave at the  Brighton convention regarding Seroxat here. Here's a photo of Sharise.

Stephanie Lynch (Ireland) - Her son, Jake, was just 14 when he put a rifle inside his mouth, pulled the trigger and killed himself. He'd been prescribed Prozac because his was worrying about school exams. His mother wrote a guest post. If you can stomach it, click here. Here's a photo of Jake.

Stuart Jones - (Wales) His daughter, Sheryl, was 28 when she was prescribed Cipramil because, according to her father, she was having a 'down day'. Sheryl took an overdose of the antidepressant just three days later. Her life support machine was switched off four days after she was admitted to the intensive care unit. The inquest returned an open verdict. You can read her father's eulogy here. Here's a photo of Sheryl.

Kim Witczak (USA) - On August 6, 2003 Kim's husband, Woody, died of a Zoloft-induced suicide at age 37.  In Kim's own words, "He was not depressed, nor did he have any history of mental illness or depression. He died after taking the drug a total of 5 weeks with the dosage being doubled shortely before his death. He was given the antidepressant from his general physician for “insomnia.” - You can read more about Woody here. Here's a photo of Woody.

Mathy Milling Downing (USA) - Her daughter, Candace, was just 12. When Candace entered middle school, she began having problems on tests and frustration over certain homework assignments. She would block on answers she knew on tests, or write so illegibly that some answers were marked incorrect, even if she had them correct. Because of her parents’ concern, she saw her pediatrician, who recommended that she see a child psychiatrist. The psychiatrist wrote Candace a prescription for Zoloft. Some time later Candace hanged herself. - You can read more about Candace here. Here's a photo of Candace.

Celeste Steubing (USA) - Her son, Matthew, was 18 when he plunged more than 160 feet from the Silas Pearman Bridge before slamming into the Cooper River. Matthew was prescribed the antidepressant Lexapro after a visit to a psychologist. Both Celeste and her husband, Daniel, said Matthew had never been suicidal before going on the drug, which was prescribed by a doctor to correct a perceived chemical imbalance. -You can read more about Matthew here. Here's a photo of Matthew.

With the exception of both Stepanie's from Ireland and Stuart from Wales, I have met each and everyone of the parents, and wife, mentioned. I feel, Dr Pemberton, that you should too.

I'm unsure of your stance on antidepressant use during pregnancy - If you feel it's safe then I can introduce you to a number of parents who have lost children due to their mothers taking antidepressants during pregnancy - hey, the more the merrier, eh Dr. Pemberton?

You are going to need a rather large couch to accommodate us all. Hey, I can even tell you about my personal experience at the hands of Seroxat. I was prescribed it for work related problems. It took me a total of 19 months to taper down from 40mg per day to 22mg per day - in the end I was forced to go cold turkey. I had one suicide attempt and felt compelled to cause bodily harm to complete strangers. (Don't worry Dr Pemberton - I'm off it now so don't feel suicidal or homicidal) I've met with the MHRA a few times and no violence was aimed in their direction.

Are you up for it? I feel we should debate the points you make in your editorial. I do feel that you should look at all of the above in the eye and tell them that antidepressants are perfectly safe. Or will you just pass them off, like the MHRA do, as 'anecdotal stories'?

You can contact me on Twitter or by direct email if you so desire.

I look forward to your reply.


Bob Fiddaman.

Author of The evidence, however, is clear, the Seroxat scandal.

Optimism Bias

Optimism bias. Now there's a phrase.

I actually stumbled upon it earlier today when running a google search with the question, "People who ignore risks are called?"

So, what is Optimism bias and where does it fit in with this blog?

Well, here's the definition:

Optimism bias (also known as unrealistic or comparative optimism) is a cognitive bias that causes a person to believe that they are less at risk of experiencing a negative event compared to others. (Wikipedia)

The UK government also use this phrase in 'The Green Book'.The Green Book is guidance for central government produced by the Treasury on how publicly funded bodies should prepare and analyse proposed policies, programmes and projects to obtain the best public value and manage risks.

I wonder if the British drug regulator, the MHRA, refer to the 'Green Book' when making decisions about granting licences to drugs, in particular, SSRI's?

On our behalf (because remember, they are supposed to be working on our behalf) the MHRA grant licences to drugs based on the evidence supplied to them by the pharmaceutical industry. A licence indicates all the proper checks have been carried out and the benefits of a medicine are believed to outweigh the risks.

Now, let's look at the definition of Optimism bias once more, this time, a more in-depth look.

This from Psychlopedia, a psychology website.

Optimism bias, originally referred to as unrealistic optimism (Weinstein, 1980), is the tendency of individuals to underestimate the likelihood they will experience adverse events, such as skin cancer or car accidents. As a consequence of this bias, some individuals might disregard precautions that might curb these risks. They might not, for example, wear seatbelts.
Optimism bias, although a distortion that could provoke risky behavior, has also been conceptualized as a hallmark of wellbeing. In particular, according to Taylor and Brown (1988), optimism bias-together with illusions of control and unrealistic positive perceptions of the self-can foster positive thoughts and ultimately enhance self esteem and wellbeing.
Nevertheless, optimism biases might instead reflect defensive mechanisms, such as denial, which are inversely related to wellbeing (e.g., Colvin & Block, 1994; Myers & Brewin, 1996). Furthermore, optimism biases coincide with failures to engage in suitable precautionary acts. 

I don't know about you but I thought this line was particularly telling, even more so if you substitute the word 'humans' with 'medicines regulators'.

"Humans, however, exhibit a pervasive and surprising bias: when it comes to predicting what will happen to us tomorrow, next week, or fifty years from now, we overestimate the likelihood of positive events, and underestimate the likelihood of negative events."

So, on our behalf, yet on their own behest, the MHRA show an unrealistic optimism that underestimate the likelihood that WE will experience adverse events on the drugs that they grant licence to.

I've got that right, haven't I?

Tali Sharot of the Department of Cognitive, Perceptual and Brain Sciences, Division of Psychology and Language Sciences, University College London, pretty much hits the nail on the head with a published paper that, to me at least, could be describing the actions of the MHRA, FDA, in fact any global medicine regulator. Sharote writes...

The ability to anticipate is a hallmark of cognition. Inferences about what will occur in the future are critical to decision making, enabling us to prepare our actions so as to avoid harm and gain reward. Given the importance of these future projections, one might expect the brain to possess accurate, unbiased foresight. Humans, however, exhibit a pervasive and surprising bias: when it comes to predicting what will happen to us tomorrow, next week, or fifty years from now, we overestimate the likelihood of positive events, and underestimate the likelihood of negative events. For example, we underrate our chances of getting divorced, being in a car accident, or suffering from cancer. We also expect to live longer than objective measures would warrant, overestimate our success in the job market, and believe that our children will be especially talented. This phenomenon is known as the optimism bias, and it is one of the most consistent, prevalent, and robust biases documented in psychology and behavioral economics.

Ergo, I accuse the MHRA, FDA and all other global medicine regulators as having Optimism Bias.

Any authors of the DSM reading this? Then again, I think those same authors have optimism bias too.

Bob Fiddaman.

Sunday, May 03, 2015

Prozac Took My Child (Guest Post)

The following is a guest post. It was sent to me by Stephanie Lynch, the mother of Jake McGill Lynch who, at the age of 14, took a .22 rifle, placed it in his mouth and pulled the trigger. Jake, at the time, was on a course of medication, the controversial selective serotonin re-uptake inhibitor (SSRi), Prozac.

I have much to say regarding Stephanie's guest post. My thoughts follow her heartbreaking story.

Prozac Took My Child

On May 2 we should have celebrated our beautiful child's 17th birthday, instead we got to place flowers and balloons on his grave.

Jake McGill Lynch was 14 years old when he took a .22 rifle and placed it in his mouth and pulled the trigger, all the while his dad and I sat downstairs unaware there was a problem.

You see this was not unusual when you are members of a gun club, what was unusual, and is now unfixable, is that Jake took his own life that night. This young child did not suffer from any suicide ideation, nor did he suffer from depression, psychosis, heightened anxiety or any other label that psychiatrists like to place on normal children who are facing exams and going through hormone changes at the same time.

Jake (14) Photo taken two months prior to his death.

Jake had a diagnosis of aspergers syndrome, it was so mild that it went undetected until he was 12. We all have anxiety in life, but when you have aspergers you worry about things you shouldn't worry about. So we, as loving parents, wanted to make Jake's transition from a teenager to a young man as easy as possible so we took advice from a school counsellor to have Jake assessed, wow, did we ever get that wrong!

Jake attended our GP first, who saw no problems, he then went to a psychologist were he would visit once a month, sometimes it went 3-4 months without a visit, I thought he could tell her things he did not feel he could tell us without being embarrassed. She then, in her wisdom, decided to refer him to her colleague, a Psychiatrist, we did not know the difference between counselling and psychiatry back then.

Skip to his first meeting which his dad took him to. It lasted all of 10 maybe 15 minutes, they left with a prescription for a drug called Prozac. She said it would help him get through his exams.

Six days later Jake walked out of an exam halfway through and had his first meltdown that night, He cried for 3 hours..we thought it was the stress of the exams. (This was his 6th day on Prozac)

After 7 days his dosage was doubled without seeing his psychiatrist. When he did see her, two weeks later, I told her what happened, she said, "This will wear off after 3-4 weeks and that he (Jake) should continue on the Prozac."

His 46th day on Prozac saw him take his own life.

Now, she nor the pharmacist, or anybody else for that matter, ever showed us an information leaflet or told us the side effects, she has said since that she went through a suicide check list with Jake and he said 'no' to all the questions put to him by her.

"Nobody would take Prozac if such a black box warning was put into place." - Irish Medicines Board

In Ireland, where we live, Prozac, which I believe is responsible for so many deaths, does not carry a black box warning.

When we met with the Irish Medicines Board (IMB) and asked why there was no black box warning we were told that nobody would take Prozac if such a black box warning was put into place.

At no stage did I ever sign a consent form nor has the psychiatrist got one with my husband's signature on. In the meantime we are left with the aftermath of a child, who should be on the cusp of something wonderful in his life, now being buried 6ft under ground.

Why is nobody in the medical profession shocked or saddened that Jake is dead? Why do they tell so many lies afterwards? Why do they not want to stop the deaths of children? Why in God's name do they see fit to produce and prescribe a drug with side effects of suicide and self-harm, amongst hundreds of others to children? If they think this is okay then why is ecstasy, cocaine or LSD illegal, what is the difference? The side effects are all the same.

When Jake, towards the end, looked or acted in any way stressed, I, his mother, would ask did he take his medication, thinking his exams were stressing him and the Prozac would make it better. Little did I know, at the time, that it would kill him.

How, do we fix it? Well, we can't but what we can do is speak and fight for our child.

We as Jake's parents will never stop fighting for justice for Jake, no matter what the cost or time. I know the psychiatric profession hope I get bored and/or go away, I know Eli Lilly, who market and manufacture Prozac, hope I stop mentioning their drug. That's never going to happen! They, Eli Lilly and the treating psychiatrist are, I believe, both guilty and both carry Jake's blood on their hands for not informing us that this could happen.

Let's face it, what happened to Jake could happen to any family. We thought we were helping Jake, all we done by listening to the so called professionals, and I use that term lightly, is help kill Jake. This can never be fixed but this should be stopped. Anxiety is part and parcel of life, so is sadness, grief and relationship breakdowns, unemployment too. No tablet is ever going to fix any of the above, these are life circumstances not some made up disorder or a made up chemical imbalance.

If only we had been informed of the side effects I would not be writing this now because we would never have allowed Jake to have Prozac, what parent would?

If your child, or anybody you know, is a little anxious why in the world would you give them a drug with those side effects?

Jake's death was so preventable from start to finish, he was let down by all involved and I include us, his parents, in that statement. How stupid were we to listen to a "professional" when really nobody knows their child like a parent?

Shame on Eli Lilly, shame on the psychiatrist, shame on the IMB and Medical council, shame again on the coroners for not pointing out the dangers when all these inquests come before them.

We will have a voice for Jake, that I am certain of, it will never bring him back but everybody will know that our child was not at any time a depressed suicidal teenager, he was a normal child who died from a legal drug that induced self my son to kill himself.

Stephanie Lynch - Ireland.

My thoughts.

The story of Jake isn't isolated. Many parents who lose children to suicide often don't make the connection between an antidepressant induced suicide. Many coroners, who have a duty to give the dead a voice to protect the living, also rarely make the connection. In the case of the latter I believe it boils down to one of two things.

1. Coroners have a blind ignorance when it comes to making the connection between antidepressant induced suicide.

2. Coroners are aware of the link but choose not to publish their findings because they feel they may put people off taking their medication.

What strikes me as an odd statement in Stephanie's above post is the response of the Irish Medicine's Board regarding the black box warning.

"Nobody would take it if such a warning was put into place."

Isn't that the whole point?

When a land owner erects an electronic fence around his/her property he/she has a duty to warn that the fence is electric, ergo, do not touch it. He/she is warning you because you may die if you touch it. Shouldn't the same be said for Prozac? Exactly what is it that the Irish Medicine's Board are trying to say here?

I'm left scratching my head at this bizarre response from a regulator who are supposed to protect the public from unsafe drugs.

Stephanie blames herself for Jake's death, most parents, if not all who have lost a child to suicide, often do. I couldn't disagree more but do understand the guilt, obviously not through experience of losing a child to suicide because I'm fortunate to have all of my three children alive.

Jake was prescribed Prozac, a drug that has been given a clean bill of health by the Irish Medicine's Board and the British drug regulator, the MHRA. In both countries Prozac can be prescribed to children. Strangely, in the United States, Prozac is approved for use in children and adolescents for the treatment of major depressive disorder and for the treatment of obsessive compulsive disorder. Jake had neither of these. He was just worried about his exams.

Moreover, Eli Lilly, who market and manufacture Prozac, have placed the following warning on the package insert for Prozac in the United States.

"Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults: Monitor for clinical worsening and suicidal thinking and behavior."

Clever marketing and deflecting of laying the blame individually on Prozac sees the manufacturer lump all antidepressants together when they write on the package insert the following message

"Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants."

You'll note that they don't mention their product by name in this statement.

Jake and his parents should have been told about the suicide link when he was prescribed Prozac. His inquest, which will be taking place shortly, should also go into the reasons why Jake or his parents were not warned in the same way that American children are.

A quick look on the MHRA website shows that there has been 111 reported suicides on Prozac - it's my belief that these figures should also be placed onto boxes or package inserts, consumers and parents have a right to know.

The Rxisk database, which gives more up to date figures and includes worldwide reports, shows that there has been 1,560 reported suicides on Prozac. Once again, I believe, that this information should be implemented into package inserts or, at the very least, relayed to patients or the parents of patients.

The system failed Jake, the whole system. The treating psychiatrist, the Irish Medicines Board, and Eli Lilly. Jake's parents put their trust in this system and their son paid the price of the incompetence of all of the above.

I do hope the coroner will, at the very least, ask questions on Jake's behalf... and also on behalf of any children who may in future years be labelled by some apparent mind expert who will, no doubt, prescribe these mind-altering, dangerous class of drugs. I also hope that the coroner returns a verdict of a drug induced suicide. Jake and his family deserve recognition that Prozac played a major role in Jake's death.

Worrying about school exams is not a brain disease. Prescribing mild altering drugs to children because they are worried about pending exams would, in my opinion, suggest that the prescriber has the brain disease.

Bob Fiddaman.

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