Hickierie Dickory Doc - McGorry Turns Back the Clock

Prof Ian Hickie

McGorry's Delorean continues on it's trip back to the future in Australia, it's new passenger, Prof Ian Hickie.

I say new, Hickie has been around for years.

Judging by an article in today's Australian Telegraph, there seems to be questions being asked regarding the number of Australian children being prescribed antidepressant medication.

Elissa Doherty and Marianne Betts write:

The number of children aged six and under being prescribed anti-depressants has soared by almost 50 per cent since the federal government pledged to investigate the issue, new figures show.

Thing is, just two meetings have been held since Australian Health Minister, Nicola Roxon, ordered an investigation over three years ago!

In the meantime, McGorry's Delorean [early intervention program] continues to pick up speed...with government backing!

Ian Hickie was the inaugural CEO (2000-2003) of 'beyondblue: the national depression initiative', which has very successfully sold depression in Australia, with many millions of dollars of government money. This has worked brilliantly for the drug companies, and beyondblue does not accept pharma funding, so the drug companies get the promotion for free. I've previously wrote about beyondblue back in November 2008.

Graham "Biff Tannen" Burrows, whom I wrote about here, is now retired but has played a huge role in promoting psychiatric diagnoses and psychotropic drugs in Australia, particularly in the 1990's.

It would appear that Burrows has been totally in bed with the pharmaceutical companies. More importantly, he influenced government policy in the 1990's to focus on depression. Without him, it could be suggested that beyondblue would not have come about nor would McGorry's meteoric rise a decade or so later.

Beyondblue and Hickie paved the way for EPPIC, a psychiatric service aimed at addressing the needs of older adolescents and young adults with emerging psychotic disorders.

Hickie, it would appear, is the Burrows of the 21st century.

McGorry shot to fame last year when he was appointed Australian of the Year. Hickie and McGorry had already been working together for several years, in fact Hickie is a key player in McGorry's 'Headspace').

Anything they say to the Aussie government seems to be taken at face value, this is something that baffles me. We can all make claims about "fixing" mental disorders because they simply cannot be diagnosed. The way forward for Australians is nipping these disorders in the bud by 'catching them early.' I cannot believe the Aussie government could fall for this - what evidence has McGorry supplied to back up these claims?

Whatever they say is usually accepted as gospel, and it is very rare for either of them to be criticised, save for a handful of advocates, a few Australian MP's and the Citizen's Commission on Human Rights [CCHR]

SPHERE




The PDF above is a seemingly egregious example of the conflicts of interests that exist: a whole journal supplement based on the SPHERE project clinical audit. The audit was funded by Bristol-Myers Squibb (see p. S54), the manufacturer of Serzone. The publication of the supplement was funded by beyondblue with Commonwealth [Australian] Government money (see title page).

The audit, which used Hickie's SPHERE questionnaire, found ridiculously high rates of mental disorders. This was reported in the supplement by Hickie, Davenport, Naismith, & Scott (2001, p. 52) as:

'Sixty-three per cent of people attending general practice have some evidence of mental disorder (including alcohol or other substance misuse) by self-report or GP's diagnosis of psychological difficulties.'

63%?

That's some cash cow huh?

Not surprisingly, if you scroll to the bottom of the PDF you will find: Source: Hickie et al. Educational Health Solutions; 2000

McGorry claimed in a recent interview, "...we are trying to do is provide effective treatment for those young people for what they are presenting with and trying to reduce the risks. There are other effective ways of reducing the risk including cognitive behaviour therapy, the use of omega-3 fatty acids and so on."

With previous involvement of Hickie and the pharmaceutical industry, I'd really love to believe that McGorry would use CBT and omega-3 fatty acids etc to help kids diagnosed with a mental disorder...before they actually get it!

I am left wondering if the Australian government have done their homework on McGorry & Co or if they just like to throw money into projects without first taking a look at the scientific proof - Has the current Australian Prime Minister, Julia Gillard, ever sought to seek evidence about the chemical imbalance myth? Has she taken a good look at the deaths associated with psychiatric drugs?

Here's an idea for the Aussie PM, ask for scientific proof of McGorry & Co's time-travelling prediction vehicle, don't just take it as gospel that it works.

For the record, and so Patrick McGorry and his cronies totally understand, I was raised a Catholic. I denounced myself as one in later years. McGorry & Co can throw the Scientology tag at me if they wish, they have done it in the past when backed into a corner by CCHR. If that is all they have in their armour then I envisage a future of mind altering drugs being prescribed to Australian children on the basis that they may have an illness rather than they actually have an illness. If parents of those children dare question McGorry & co, prepare yourselves for some mud slinging - you may as well sign yourselves up to the Church of Scientology, you'll be labelled one regardless...and we all know how psychiatrists, such as McGorry, just love to use labels.

How do I know this? Well, like McGorry & Co, I travelled forward in time...in my Tardis - my DeLorean is at the garage in need of a new flux capacitor.

Fid






Back stories on Patrick McGorry:

Patrick McGorry: "Hey... Paddy... Leave Those Kids Alone"

Patrick McGorry - Torn Asunder Down Under

Early Intervention, McGorry, Politics & TV Shows

Psychiatrist Patrick McGorry Slams His Critics [Diddums]

Is Australia's "Number One Man" Misleading The Public?

Pre-Mental Disorder Screening & Drugging - THE PHARMACEUTICAL DELOREAN

Patrick McGorry's Delorean Pulls Over For New Passenger

Patrick McGorry & Co Under Fire

GSK Australia and the Aropax Promotion

Nothing, and I mean nothing, ever ceases to amaze me when it comes to GlaxoSmithKline and Seroxat. Their ways of promoting the drug [in the early days] was a huge PR campaign that must have cost them millions of dollars. The 'a plus project' is nothing short of propaganda that promotes the use of Aropax, for those that don't know, Aropax is the brand name used in Australia for Seroxat [Known as Paxil in the US/CANADA]

I'm awaiting delivery of one of these packages, good friend of mine from down under has 5.

So, what exactly was the a plus project? Well, it's basically counselling...on the proviso that you continue taking Aropax. A carrot dangled in front of depressed people, "Hey we will give you counselling but only if you take our drug, Aropax." To make matters more easier for the patient, the starter pack comes complete with a FREE box of Aropax.

Don't you just love this company!

It's pretty difficult to research this particular promotion by GSK as all traces of it seem to have disappeared from the Internet - luckily for me, I have some pretty astute readers. I can't wait to get my hands on one of these packs, until then I can tell you that included in the box was a fold-out card providing an explanation about the project and some information about depression and Aropax, including:

Depression is not just a 'bad mood' that you can 'snap out of' when you feel like it. It is a medical illness like asthma and diabetes, which can be successfully treated in most people by using a combination of medication and counselling.

Also included as part of the fold-out card were two pre-addressed free-post registration cards. Patients who received the starter packs could use the first of these cards to register themselves on the program, provided this was authorised by their doctor. They could also register to attend a plus meetings, conducted by psychologists and 'specially trained doctors', if they mailed the second card with the barcode number of a packet of Aropax dispensed by a pharmacy, as proxy proof that they were continuing to take Aropax after they finished the starter pack.

Participants were also sent other "educational information to complement your treatment", according to the fold-out card.

The a plus project created controversy when it was revealed that the psychologists delivering the program were bound by their contracts to deliver one message – that participants should keep taking Aropax – and were otherwise not permitted to discuss drugs at all (Robotham 2002a). Robotham described the program as 'counselling with a corporate twist'.

The a plus project was part of a broader campaign promoting Aropax. Orange featured very prominently in the campaign (Robotham 2002b), functioning as a de facto logo: Australian doctors were subjected to an onslaught of orange Aropax advertisements and promotional materials. This included several orange issues of the Depression Awareness Journal, which enthusiastically promoted the project (Singh 2002; Burrows 2002).

This is not the first time Glaxo have used the prominent colour of orange to subliminally promote Aropax in Australia. Orange is the colour of the boxes of Aropax in Australia [Fig 1]

Fig 1

Back in 2002, the Sydney Herald ran a story entitled, "Sponsor's advert a happy coincidence" - the article pointed to GlaxoSmithKline Australia's donation of $200,000 to comic relief and GSK's subsequent promotion of that donation.

The Herald wrote:

Earlier this year the company took out ads in the same publications, touting its $200,000 donation to Comic Relief and announcing a fund-raising program in which its drug sales people would visit doctors dressed as clowns.

The notices bore no direct reference to Aropax, but nevertheless had an orange backdrop and they continued the smiling theme. "We're dropping in to make you smile for a very worthy cause," the company explained.

GlaxoSmithKline Australia's commercial director, Lisa Bonadonna, said the Comic Relief sponsorship was not a promotion for Aropax. The similarity between the advertisements' colours and copy was "completely unintentional".

Some coincidence doncha think?

Another point of interest regarding the a plus project was that it was promoted by the Depression Awareness  journal. The Editor in Chief of that journal was none other than Graham Burrows, remember him?

Burrows has recently come under fire in Australia, in fact Victorian Liberal senator, Julian McGauran, has called for his resignation.

Burrows had testified at a trial that a man [Arthur Freeman] had a "major despondent disorder" - Freeman had thrown his four year old child off a bridge and Burrows was diagnosing him 14 months AFTER he killed his daughter! [LINK]

It is Burrows that also supports Patrick McGorry's Australian sideshow 'The early intervention program' [How cute, two peas in a pod]

The only reference to the APlus program I can find is the 2002 article from The Age where Julie Robotham writes:

It's counselling with a corporate twist. The maker of a leading antidepressant is funding therapy sessions for patients.

But the psychologists running the program are committed to delivering one message - keep taking the tablets.

People using Aropax, the second most commonly used antidepressant in Australia, can be signed up for the program, dubbed "APlus", by their doctor. They may then attend five 90-minute sessions of cognitive behaviour therapy over two months, in groups of up to 14 other patients.

The drug's maker, GlaxoSmithKline, has recruited psychologists, psychiatrists and GPs to run the sessions across Australia. In their contract, they must agree that "Adherence to (Aropax) is to be encouraged at all times".

Beyond this, the group leaders may not discuss drugs at all. Under the heading of "Non-interference", the contract states: "APlus practitioners are not permitted to discuss pharmacotherapy issues with patients in their care." Instead they must refer patients back to their doctors.

Once I receive the starter pack I shall scan and upload to this blog. Regular readers can rest assured, I won't be taking any of the free Aropax supplied with the pack.




References

Burrows, Graham D. (2002a, June). From the Editor in Chief. Depression Awareness Journal, 11, inside front cover.

Robotham, Julie. (2002a, January 17). Depression therapy for free, but stay on the pills. Sydney Morning Herald. http://www.smh.com.au/news/0201/17/national/national1.html (19 February 2003).

Robotham, Julie. (2002b, January 17). Firm binds therapy doctors to its drugs. The Age. http://www.theage.com.au/news/national/2002/01/17/FFX2ASODIWC.html (18 January 2002).

Singh, Bruce. (2002, June). The a plus project: A partnership in action. Depression Awareness Journal, 11, pp. 8-11.


Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE

Surviving Antidepressants

A new help forum has been created with regard to bringing people together who are struggling with their antidepressant medication.

It looks simple enough to sign up to and a quick browse shows there's plenty of useful links.

Go check it out at http://survivingantidepressants.org/

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

US/CANADA COPIES HERE
UK/IRELAND FROM CHIPMUNKA PUBLISHING

Patrick McGorry & Co Under Fire

Martin Whitely, a Western Australian politician and former school teacher, is concerned about Patrick McGorry & Co, he has every right to be.

It would appear that McGorry has been zipping around Australia in his time travelling DeLorean promoting his early intervention program, a program that can "diagnose" not only if your child has a mental disorder but if they will get one in the future!

Whitely recently gave a speech to the Western Australian Legislative Assembly where he voiced his concerns at the government money being thrown at McGorry's projects.

His edited speech can be read HERE

I'll be adding another Back to the Future cast member to this blog soon, Whitely mentions him in his speech. Prof Ian Hickie.


Fid

Back stories on Patrick McGorry:

Patrick McGorry: "Hey... Paddy... Leave Those Kids Alone"

Patrick McGorry - Torn Asunder Down Under

Early Intervention, McGorry, Politics & TV Shows

Psychiatrist Patrick McGorry Slams His Critics [Diddums]

Is Australia's "Number One Man" Misleading The Public?

Pre-Mental Disorder Screening & Drugging - THE PHARMACEUTICAL DELOREAN

Patrick McGorry's Delorean Pulls Over For New Passenger


ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE

Ashley Smith inquest becoming a bad joke

Christie Batchford, a journalist from the Globe & Mail, throws out the question, Why So secretive?, in regard to the current inquest into the death of Canadian teen, Ashley Smith.

I'm stumped by recent events, in fact the presiding coroner seems to be under fire from lawyers at this inquest.

The article shows three videos:

• Ashley Smith incident in Grand Valley prison
• Ashley Smith in prison days before her death
• Prison video: Guards remove Smith's ligature

There's links to back stories which are well worth a read too.

Story HERE

Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

US/CANADA COPIES HERE
UK/IRELAND FROM CHIPMUNKA PUBLISHING

FREE SCREENING OF 'DEAD WRONG' - ACOCKS GREEN, BIRMINGHAM

Dead Wrong, the brilliant documentary from the stable of CCHR, is to get its first public screening [in Birmingham] on June 11.

There's a bunch of feisty Birmingham advocates who have worked their socks off to get this documentary shown to the Birmingham public.

If you want to learn the truth about psychiatric drugs and the dangers they carry to your children then this is a must see.

The screening will take place at 1pm on June 11, 2011

Fox Hollies Forum
Greenwood Ave, Acocks Green
Birmingham B27 7RA
Google MAP Link - http://goo.gl/maps/hRWS

Admission: FREE

To read my review on this documentary - visit HERE

GET THE FACTS.


SAVE A CHILD.


Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

US/CANADA COPIES HERE
UK/IRELAND FROM CHIPMUNKA PUBLISHING

UK Patients Drug Reporting Better than Doctors!

Image: nottingham.ac.uk

To be filed under the banner "No Shit, Sherlock"

An article by Susan Mayor in the British Medical Journal [BMJ] shows that UK patients are better than reporting adverse drug reactions to the Medicines and Healthcare products Regulatory Agency [MHRA] than doctors.

This should come as no surprise to most people. I have often wondered if pharmacists have to go to special schools to get to grips with doctors handwriting.

Mayor writes:

Analysis showed that patients’ reports of suspected adverse drug reactions were more likely to include information about symptoms (93%) than reports made by health professionals (78%) and to describe their extreme nature (47% versus 17% of reports). They were also more likely to explain the effect of the reaction on the patient’s life (47% versus 12%).

Mayor did well on this article, she even managed to get a quote in from June Raine:

June Raine, director of vigilance and risk management of medicines with the Medicines and Healthcare Products Regulatory Agency (MHRA), said, “Medicines have important benefits; however, they may also have side effects. We welcome the results from this important study, which confirm the MHRA’s experience that patients make an important contribution to monitoring the safety of medicines through yellow card reporting.

“The findings from this study will help us continue to strengthen the role of patients as reporters to the scheme. The more reports the MHRA receives about suspected adverse drug reactions, the sooner we can relay important safety messages to the public and healthcare professionals—everyone benefits from better information.”

This is all well and good but the MHRA have been told countless times about how drugs effect the lives of those taking them.

Question is...what are they going to do about it?

Experience tells me that they will just log the report and... well, that's it.

It would be of interest if a study was undertaken to see how many of the patient reports the MHRA actually followed up. What protocol [if any] do they have in place to go and visit a patient who needs help tapering off an addictive antidepressant for example?

The MHRA's stance is thus:

SSRi medication is not addictive.

It does not matter how many reports they get regarding this issue, their reluctance to come out and agree with patients on this matter is blindingly obvious.

One would think that a regulator would help those it deems to protect - The patients.

Alas, my experience with them suggests otherwise.

As for the MHRA spokeswoman mentioned in the article, she [June Raine] was told by David Healy 11 years ago about the dangers of Seroxat. [LINK]

Hat-Tip Pharmagossip


Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

US/CANADA COPIES HERE
UK/IRELAND FROM CHIPMUNKA PUBLISHING

In Memory of Sharise and Sheryl

During my time writing this blog I have heard many stories of people dying as a result of taking SSRi medication. The first I ever heard about the Seroxat link to suicide in children and adolescents was when BBC TV broadcast one of its four Panorama programmes about Glaxo's antidepressant, known as Paxil in the US and Aropax in Australia.

Sharise Gatchell

Sharise Gatchell was just 18 when she hanged herself, an empty blister pack of Seroxat lay next to the suicide note left for her family. Glaxo admitted no liability but just days later doctors in the UK were issued warnings about prescribing Seroxat to children and adolescents.

Today sees the 8th year anniversary of Sharise's death.

Sheryl Tilbook

As fate would have it, yesterday saw the 10 year anniversary of the death of Sheryl Tilbrook. Sheryl overdosed on citalopram, another SSRi, whose brand names include Cipramil and Celexa.

SSRi type drugs were heralded as safe to take, if one overdosed there shouldn't be a problem, unlike the benzo family of drugs that had been used for years to treat depression/anxiety.

Sheryl overdosed and was admitted to hospital, staff there didn't know what to do, they had no protocol in place, why would they? The pharmaceutical industry had claimed SSRi type drugs were easier to flush from the system.

This is not just about two young women dying, it's about the trail of devastation left behind. Families and friends are left to pick up the pieces, their quest for answers ignored by GlaxoSmithKline [Seroxat] Lundbeck [Cipramil] and the Medicines Healthcare and products Regulatory Agency [MHRA]

Neither the parents of Sharise or Sheryl have ever received an apology from any of the above. Both drugs, despite warnings, are still prescribed to children and adolescents. The MHRA have just made recommendations that doctor's should not prescribe them to kids. Those recommendations come along with the "benefits v risks" factor. In other words, if a doctor thinks either Seroxat or Cipramil will benefit a child in managing their depression then they can still be prescribed, the risk against the benefit just has to be weighed.

It's laughable and highlights how pathetic our medicines regulatory body are. They are, for want of a better word, powerless. To call themselves a 'regulatory agency' is perverse. Kudos has to be given to them for warning doctors but they should have warned them years before the deaths of these two young women. To plead ignorance about the dangers of these drugs is an insult to the memories of Sharise and Sheryl.

The cycle will continue because many doctors have blinkered views when it comes to prescribing drugs like this. Seroxat prescriptions have declined, the death of Sharise has played a major part in that decline, her death highlighted on BBC TV's Panorama. Those who have had the balls to stand up and be counted and speak out against Seroxat should also take a bow.

Cipramil continues to be prescribed to both adults and teens on a regular basis, the suicide of Shane Clancy recently brought it under the spotlight again.

For Sheryl Tilbrook & Sharise Gatchell.

RIP



Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

US/CANADA COPIES HERE
UK/IRELAND FROM CHIPMUNKA PUBLISHING

GlaxoSmithKline & AstraZeneca - Voodoo You Think You Are

Image: danse-macabre.net

I had to laugh at a couple of pictures sent into me by a reader. He was walking along Brighton beach front last week and came across a 'Gypsy style' caravan that was offering tarot card readings. On closer inspection of the sign he saw that 'Ivor' had a list of corporate clients, two of which were pharmaceutical companies AstraZeneca and GlaxoSmithKline!

CLICK ON IMAGE TO ENLARGE

I'm left wondering if this is a genuine attempt at 'putting something back' into the public purse or if both GSK and AZ follow the cards from the tarot pack. One would assume that their futures are in their own destiny's. Here's an idea guys, try making your drugs safer and give some respect to the consumers of your products. Oh, and while we are on the subject of respect, try and explain the sense in giving children a drug in a clinical trial when you already know that the drug you are giving them can bring on suicidal thoughts and acts, I think you call it "emotional liability."

Maybe GSK should consider 'putting something back' by setting up detox clinics so patients can taper safely and effectively off their addictive antidepressant Seroxat or maybe some sort of counselling service to those left behind whose children, brothers, sisters, husbands and wives have committed suicide as a result of Seroxat use. Furthermore, they could offer it to parents whose children have been born with heart defects as a result of the expectant mother taking Seroxat during her pregnancy.

They could offer the same counselling to family members whose loved ones have died from heart attacks after taking their diabetes drug Avandia.

Maybe AstraZeneca could really help the community by offering lump sums of money to children's families who have been harmed as a result of taking their atypical antipsychotic Seroquel - hey, wouldn't they feel so much better helping families rather than promoting and paying kickbacks to Doctors for prescribing the drug for unapproved uses.

Just a thought.


Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK - 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT [PAXIL] SCANDAL'

US/CANADA COPIES HERE OR UK/IRELAND FROM CHIPMUNKA PUBLISHING

Are GlaxoSmithKline Japan Putting Children At Danger With Paxil Trial?

Some of you may know that I've been closely following the Paxil Clinical Trial in Japan. The trial, now completed, was labelled, "Clinical Evaluation of Efficacy and Safety of Paxil Tablets in Children and Adolescents with Major Depressive Disorder: Placebo-Controlled, Double-Blind, Parallel Group Study."

I wasn't the only one voicing my concerns about this particular trial. Medwatcher Japan, an independent Japanese drug watchdog, were also concerned. Back in July 2009 they wrote to GlaxoSmithkline Japan.

(1) The justification for determining the conduct of this study to be necessary and valid (how and why the conduct of the trial was determined to be necessary and valid)

(2) In particular, if the premise of conducting the clinical study is that effects can be expected for Japanese children, what information was used as justification for making that determination

(3) The most recent version of the study protocol (including records of previous revisions)

(4) Subject recruitment status (the names of the sites participating in the study to date, the number of people recruited at each site, and the Patient Information Sheet used at each site)

(5) Information on adverse events reported to date (information on number of emergent cases and clinical course of individual cases, etc.)

Concerned letter from Medwatch to GSK Japan



Now, for the first time, we can see GlaxoSmithKline's response. The original response was in Japanese. Here's the rough translation:

To: Mr. Toshihiro Suzuki
Representative of Medwatcher Japan

From: Public Relations Department of Glaxso Smith Kline
4-6-15 Sendagaya, Shibuya-ward Tokyo

Answer to "the demanding paper which requests for information disclosure about post-marketing clinical trial of anti-depressant PAXIL to children and adolescents"


The following shows the answer to "the demanding paper which requests for information disclosure about post-marketing clinical trial of anti-depressant PAXIL to children and adolescents" which we received 16 July this year. [2009]

Thank you for pointing that out. We answer each of your items regarding your demand with my company's point of view and related information. We will continue to pay more attention to this clinical trial taking into account your points.

Your continued support will be greatly appreciated.

Summary of the demanding of the paper.

"We demand you to open the following information about "Clinical evaluation for efficiency and safety of PAXIL for major depression disorder to child and adolesecen: placebo-controlled parallel-group double-blind trial"

(1) What is the reason of considering executing this clinical trial as necessary and suitable? (How did you go over the necessity and suitability of this clinical trial?)

(2) If the efficiency for Japanese children is expected as premises for executing the clinical trial, what is the information that backed up your decision?

[Answer]
Major depressant disorder (MDD) is one of the conduct disorders that can begin in children and adolescents. It can cause academic failure, absence without notice, alcohol intake and use of drugs. It can also cause suicide. The prevalence rate of MDD is presumed to be about 2% in children and about 4-8% in adolescents in Europe and the United States.

But it is fact that examination of SSRI's, including PAXIL for MDD to children and adolescents, has not been sufficiently executed even in foreign countries. On the other hand, as you point out in the demanding paper, there is a situation that most psychotropic drugs are used as non-approved indications in Japanese psychiatric treatment for children and adolescents. Therefore, in order to utilize such drugs properly, it is needed to establish evidence for efficacy and safety of them by executing a clinical trial in Japan.

We consider that the result of our clinical trial as help for medical doctor's decisions in the treatment for children and adolescents. Therefore, we planned to execute the post-marketing clinical trial in order to confirm the dosage and administration for children and the efficacy and safety for the children's group.

On 24 August 2006, re-examination period for PAXIL going with post-marketing clinical trial was deliberated at the First Committee for Drugs in Pharmaceutical and Food Hygiene Council. In the committee, a committee member said that "Though the efficacy of PAXIL was not verified in other countries clinical trials, there are opinions from clinical sites in Japan that SSRI's were effective for child's depression."

A psychiatric society is demanding the use of PAXIL.

The Japanese Society for Child and Adolescent Psychiatry filed a petition entitled: "Demand for the Ministry of Health, Labour and Welfare about psychotropic drugs for children and adolescents (Date: 30 May 2007)". So we recognize that clinical site demands strongly.

In addition, we prescribed various care for safety of trialists in the protocol. Also we take a measure for safety of trialists bv explaining sufficiently about warning signs and symptoms of MDD, especially suicide related event to trialists' parents.


(3) Latest edition of test protocol (including the log of revised version in the past)

[Answer]
This test protocol has already opened in the Clinical Study Register
(http://www.gsk-clinicalstudyregister.com/protocol_detail.jsp?protocolId=112487&studyId=24207&compound=Paroxetine+10mg+Tablet)


(4) Real situation of recruit for trialist (Name of each participating facility, number of people recruited in each facility and briefing paper for trialist used in each facility in present time)

[Answer]
Outline of participating facilities and information about recruits in each facility is gradually opened in ClinicalTrials.gov (Please refer http://clinicaltrials.gov/ct2/home and "Location and Contact Information" in the test protocol)


(5) Information about adverse events so far (number of event and any information about clinical course of each case)

[Answer]
Now, the clinical trial is in action we don't have any information about adverse events defined. By 30 September 2009, there were no serious adverse events reported about this clinical trial.


Answer from GSK Japan [Japanese]



So, judging by this response from GlaxoSmithKline Japan, it would appear that this study has been carried out because the Japanese Society for Child and Adolescent Psychiatry are demanding the use of Paxil in children and adolescents!

Furthermore, it seems apparent that GSK Japan have warned children and adolescents on this trial about the dangers of MDD causing suicide - but did they warn the subjects and their parents that Paxil can also induce suicide and/or suicidal thoughts?

What is wrong with GlaxoSmithKline saying, "No, we have already carried out trials for the safety and efficacy of Paxil in children and adolescents, there is no need for another trial?"

Well, why would they?

This response from GlaxoSmithKline should come as no surprise. I have never known a company who show such obvious disdain when it comes to the safety of children. Quite how they thought they could get away with this trial still baffles me? Did they think people, such as myself, wouldn't eventually find out? My only surprise is that GSK Japan didn't throw in the line, "Paxil has benefited millions of people worldwide."

It would now appear that drugs that are not recommended for use in children can be re-trialled in Japan on the demands of a psychiatric association. The question that has to be asked is why?

The members of the Japanese Society for Child and Adolescent Psychiatry Council can be viewed HERE

It is not known if any of its members have financial ties or other conflicts of interests that connect to GlaxoSmithKline Japan, I'd bet my left nut that there are ties - there always is!


Although the trial was concluded in February 2011, GlaxoSmithKline Japan have refused to send me the conclusion of the trial, citing; "The expected official release was planned to be October."

One can only begin to imagine the heartache many families in Japan are going through right now. The recent earthquake and tsunami killed many. That will have a knock on effect of all those family and friends who have lost loved ones. Children will have lost mothers, fathers, brothers sisters, grandparents, friends and even loved pets. What better way to treat their loss than a pill that has been promoted in Japan with advertising campaigns such as an advertisement where a beautiful young lady comes out all smiles and says, "I went to a doctor and now I'm happy.' You know, depression is not that easy. And if it is that easy, it might not be depression."

In contrast, and what Glaxo Japan have failed to acknowledge with regard to this trial is the Bloomberg report from 2007, which ran with the headline: 'Japan Says Suicidal Cases Rise Among Paxil Users.'

The number of patients who committed suicide or planned suicide after taking GlaxoSmithKline Plc's antidepressant Paxil rose to 39 last year, Japan's Ministry of Health, Labor and Welfare said. [SOURCE]

With all the evidence pointing to Paxil NOT being safe and effective in children and adolescents, GlaxoSmithKline Japan, it appears, are sticking a huge index finger up to the rest of the world. This clinical trial should never have been given the go-ahead. GlaxoSmithKline should be hauled over the coals about this. I suspect drug regulators around the world will turn a blind eye, hey, it's not our problem after all is it?

Finally, this is how GSK promoted this children's trial, it's a poster asking for recruits. Are you, like me, sickened by this poster?

Special thanks to Medwatcher Japan


Bob Fiddaman

Here are the links where I previously wrote about this study:

Thursday, January 15, 2009 - Email to Japanese Embassy regarding New GSK paroxetine study in Children. ClinicalTrials.gov Identifier: NCT00812812

Friday, April 03, 2009 - Japan/GSK - 329 All Over Again!

Friday, April 03, 2009 - Email to Ministry of Health - Japan

Saturday, July 25, 2009 - Paxil Study 329 All Over Again?

Friday, May 21, 2010 - Email To GlaxoSmithKline Re; Paxil Study In Children

Friday, September 24, 2010 - HEY, GLAXO!... LEAVE THOSE KIDS ALONE

Friday, May 13, 2011 - Glaxo remain tight-lipped on new Japanese Paxil study in children.

Wednesday, May 18, 2011 - GSK JAPAN - PAXIL STUDY IN KIDS UPDATE

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

Image: Google Images

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?"

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.

OPEN LETTER TO ANDREW WITTY, CEO OF GLAXOSMITHKLINE

Image: Google Images

Dear Mr Witty,

I thought I would make this public rather than send it to you direct, if there was an address where people could email you direct that is.

I'm pretty pissed off you see.

This week I have had two members of the public write me, both are struggling at the hands of Seroxat, both have electric-like zaps ripping through their bodies, both have profuse sweating and horrific nightmares, both have been on Seroxat for over 9 years.

I'm not a doctor Mr Witty but I have experienced Seroxat withdrawal, you will know it as 'discontinuation' but let's be clear, it's withdrawal. I don't know if you have ever experienced an addiction to a prescription drug Mr Witty, it isn't very pleasant, particularly when you have spokespersons for the manufacturer of that drug claim that "discontinuation will last approximately two weeks." My discontinuation lasted 22 months, the two people that have contacted me this week have a combined 'discontinuation reaction' of over 8 years.

With all that said, I take umbrage to GSK Japan trialling out Seroxat in children. By your company's own admission, Seroxat is not safe for children...yet here we have your Japanese branch recruiting and drugging children with Seroxat. I am left wondering if these Japanese children or their parents were informed that deaths due to suicide have occurred whilst children were on Seroxat, or do you deny that Seroxat caused this?

Pushing Seroxat aside, for the time being, I'd like to focus on another story concerning your company, GlaxoSmithKline PLC.

A current trial in India where your company is comparative testing to see if rosiglitazone, more commonly known as Avandia, is associated with more risk for patients.

As I understand it, both the MHRA and FDA have pulled your product, Avandia, from the shelves because of its high risk of causing heart attacks/strokes. To administer a banned drug in a comparative trial is a tad naughty Mr Witty and, dare I say it, highly unethical. Are the sites of this proposed trial in Bangalore, Karnal, Kottayam, Vijaywada, Mumbai, Nasik, Pune, Trichy, and two sites in Kochi, aware that Avandia has been banned in the USA ans Europe?

Are you still trying to defend Avandia by comparing it with another drug? Is this how your company works Mr Witty? One of your drugs gets lambasted and you yell like a school child and make claims that there are other drugs that are just as bad.

While we are on the subject of comparative studies, why have you never compared the severity of Seroxat withdrawal...sorry, discontinuation, with other SSRi's? Are you [your company] fearful of the outcome of such a study?

You know, Mr Witty, Seroxat withdrawal does not end two weeks after stopping, it continues long after stopping. The more adverse reactions to prolonged use of your drug are things like sleep disorders, short term memory loss, intolerance to sudden loud noises...there are more.

Now, the above reactions may seem trivial to you so I'd like to play out a scenario with you Mr Witty, if I may?

I come to you for a job interview. My record is impeccable and, it appears, I'm the right man for the job. All seems good until I ask you if provisions can be made for me should I be successful in my application. I ask you to show leniency with me should I fall to sleep at my desk, I also ask you to make sure there are no sudden loud noises around my workstation and further add that I should not be reprimanded for forgetting things.

All of a sudden Mr Witty, I'm not the right person to fill in the vacancy am I?

Never mind eh? I can always claim benefits, although that is proving more difficult as there is no acknowledgement from your company that long term Seroxat use causes any of the above reactions. So I and many others like me are left in limbo due to a drug your company manufactures.

You see Mr Witty, your product, Seroxat, has left me with those impairments. You, just like your highly paid law team, argue that I may have been left with those impairments had I have taken a similar product. That, Mr Witty, is the school child yelling again, it's shirking your responsibilities.

All I have left is the silence of my one bedroom flat, a keyboard and a willingness to see this through to the end. I will keep on questioning the ethics of your company and I will keep on telling those who contact me with severe Seroxat withdrawal problems that they have to take it nice and slowly. I'll still offer them the chance to give me a call should they feel suicidal, I'll still try and talk them down off the ledge because the zaps are so intolerable to them that they just want to end it all, I'll still offer them documented evidence that shows Seroxat withdrawal is a huge problem and that they should provide their doctors with that evidence - despite what your reps have told them.

Now, you can throw out the tired and tested GSK spin if you like, "Seroxat has benefited millions of people world-wide." At this point may I become the school child and compare my reaction to your product with someone that took a placebo?

Your company professes to be a leading healthcare company that helps people to do more, feel better and live longer.

Testing Avandia on subjects, a known drug to cause heart attacks, and Seroxat on children, when your own company have said that Seroxat is not effective in children and can cause suicide, laughs in the face of your company statement Mr Witty.

I'd like to meet with you Mr Witty, no lawyers, no intimidation tactics, just you and I in a coffee bar, a quiet one if you wouldn't mind. I want to tell you my story of Seroxat withdrawal, I want to look into your eyes whilst I tell you how bad your drug is and then I want you to tell me what advice I should give to people who contact me because your company will not offer them any advice at all. Oh, please don't invite Alistair Benbow along either, his public comments about the safety of Seroxat make me want to wretch and I don't want to vomit over your expensive Armani suit Mr Witty.

If you don't want to meet with me, tell me where to send a copy of my book to you. It makes great bedtime reading and pretty much shows the state of your company during the reign of your predecessor JP Garnier.

So, you up for a coffee and a chat? It would make great headlines don't you think? 'GSK CEO MEETS WITH COMPANY CRITIC'

Oh, by the way, call off the wolves [Addleshaw Goddard, King & Spalding] they have nothing in their armour that can harm me, your drug did all the harm.

You up for it?

Bob Fiddaman

PS - If you deem accepting my book as a gift as a possible admittance of guilt then you can purchase it HERE

70% Rise in "ADHD" Type Drugs in UK

Image: Google Images

The Daily Mail is reporting that the number of prescriptions for children with ADHD like "disorders" has risen by a massive 70% in the past five years.

A staggering 12,000 prescriptions are written out weekly for "mental disorders" that, in essence, are based purely on theory.

The types of drugs used for these theoretical disorders include Ritalin and Concerta.

"Department of Health figures", writes Sophie Borland, "show last year 661,500 prescriptions were written out for Ritalin and similar drugs such as Concerta – up from 382,000 in 2005.

"Most will have been handed out to those under the age of 19 diagnosed with attention deficit hyperactive disorder, with symptoms including an inability to concentrate and restless or impulsive behaviour."

Hey ho everybody. Here's the deal.

You go up against a pharmaceutical company and you ask them to provide evidence that their drugs are safe and effective in children, they hum and har before releasing data that shows you the opposite. Naughty pharma are then told "not to do it again" by our wonderful drugs regulator the MHRA. Not criminal because those clever pharma execs saw a loophole in the EU law.

Sales of the particular group of drugs plummet as more and more docs read about the dangers. So, pharma try another angle. Label the kids with a disorder and then manage that disorder with a product... their product.

WAKE THE FUCK UP PEOPLE!

You are being hoodwinked into believing your child has a disorder, a disorder that just happened to manifest itself during a meeting of psychiatrists, whom are all on he payroll of the pharmaceutical industry.

WORLD WARS I & II saw much sadness, death brought mourning, war brought poverty, but hey, guess what? No pills were around back then to make Johnny Smith forget about the death of his father on some battlefield in northern France nor were they around when Lucy Jones would cry because she was mourning the death of her pet cat who was found in the rubble of her bombed parents house.

We are fast becoming a nation of citizens who are being dumbed-down by psychiatric drugs, if not us, then our children.

12,000 prescriptions per week for brain altering drugs, so we, as parents, can let the pharmaceutical industry babysit our children because we cannot be bothered anymore!

Don't expect any input from your medicine regulator folks, unless you want to hear the "benefits outweigh the risks" line.

Over 30 years ago I was sitting in a classroom, flicking paper clips with an elastic band, hey, I was known to stick a drawing pin on someones chair...just for a laugh. The majority of us did it - it was part of growing up. Guess what? I even played truant from school, usually skipping the days when religious education was rammed down my throat [no priest jokes please]

"Why hasn't your homework been handed in?"

"Dunno Sir"

"Detention for you Fiddaman!"

What do we have today?

A kid plays truant on a regular basis - label him/her with a psychiatric disorder - Drug him.

Young Billy Jones keeps flicking bogies [US spelling boogers] at passers-by in the corridor - he must be mental - Drug him.

Pretty little Lucy Lovett looks withdrawn and constantly falls to sleep at her desk - she has a disorder - Drug her.

Our government won't tell you about the dangers of these drugs, instead they offer incentives such as an increase in benefits.

We live in a topsy-turvy world people, is this payback for stealing the apple off the tree in the garden of Eden?

C'mon 'God' help us out here because if you don't that figure of 12,000 will soon rise to 20,000 then 50,000 and before you know it children will be a thing of the past, they will be objects sat in a corner dribbling and talking mumbo-jumbo because their brains have been nullified by dangerous chemicals - all in the name of psychiatric labelling.

I hereby sentence the UK to a life of fucked up children who shall never experience human emotion again.

Signed

Louis Cypher

RANT OVER!



Fid



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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Canadian Coroners Suppressing Voices?

Those familiar with the case of Ashley Smith will find the following article baffling. Law, in general, isn't as straight cut as we expect it.

In this instance we have an inquest of a young girl who died in the early hours of Oct. 19, 2007, in her cell at the Grand Valley Institution for Women in Kitchener.

Smith was found with a ligature around her neck, one of many attempts she had made during her incarceration in various mental institutions.

Ashley Smith was just 15 years of age when a 30 day sentence was handed down to her. Her crime? She threw a crab apple at a postman.

The 30 day sentence spread to 4 years as Smith was transferred on 17 separate occasions by Corrections Canada. The transfers spanned four of the five regions of the Correctional Service of Canada.

Her inquest, which should give her a voice, has been marred by controversy.

The Correctional Service of Canada are seeking to deny the public and press access to exhibits which amounts to a complete publication ban.

What do they want to hide? Well, maybe the video that surfaced on youtube, a video that shows staff outside the cell of Ashley Smith during her final hours? Not so, the video has been shown to the 5 person jury.

The video, first broadcast on The Fitfh Estate, shows how seven guards stood outside Smith's cell and, as the narrator puts it, "Ashley had choked herself to death while seven guards stood outside her cell and did nothing to save her."

Here we have a girl, who at the age of 15, was thrown into the system, drugged up to the eyeballs and handed down further sentences for not being the "model prisoner." Her 30 days turned in to a living nightmare.

Presiding coroner at the inquest, Bonnie Porter, has approached the five member jury in this case and told them, “anyone approaching counsel” for copies of exhibits “may be cited for contempt.”

This is not how things are run in a world of democracy, surely?

The inquest should take all the facts and if the Coroners Court wish to adhere to their own statement, "We speak for the dead to protect the living", then they should allow the jury access to all the facts.

It would appear that the presiding coroner wants to speak for the dead to protect the Correctional Service of Canada.

Smith was not the model inmate, she kicked up a stink, so much so that she had over 500 violations against her, each time her sentence was increased. With drugs, restraints and tazer guns used against her, it's hardly surprising that this teenager fought back the only way she knew how., wouldn't you?

Smith's miserable time at the hands of this system should be brought to the front. A young girl thrown into various cells and various states of drug induced hysteria is one thing. To have her voice suppressed in a coroners court is an atrocious act!

Full story in the Globe.

Here's the video. Here's Ashley Smith's voice.




Related:

Monday, November 15, 2010 THE ASHLEY SMITH REPORT

Thursday, March 31, 2011 "We Speak For The Dead...To Protect The Living" - Unless Drugs Are Involved.


Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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GSK JAPAN - PAXIL STUDY IN KIDS UPDATE

Well, I'd love to tell you that the Paxil study in children that was carried out in Japan was deemed a failure. Truth is, I don't know and Glaxo, it appears, remain to be tight lipped over this particular study.

A few days ago I wrote how they [GSK] had promised to get back to me regarding my query of the outcome of the NCT00812812 clinical trial, "Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)"

Remarkably the Clinical Trials webpage has now been updated regarding this trial...no conclusion though.

The study was completed back in February this year [2011].

Glaxo wrote me this morning with the following:

Thank you for contacting the GSK Clinical Support Helpdesk.

Unfortunately conclusion can’t be disclosed before the official CTR is released.

Adding in a further email:

The expected official release was planned to be October.

Thanks for clearing that up.

I wrote back asking if Paxil was currently recommended for use in children between the ages of 7-17 in Japan?

No reply.

For back stories regarding this trial visit:


Thursday, January 15, 2009 - Email to Japanese Embassy regarding New GSK paroxetine study in Children. ClinicalTrials.gov Identifier: NCT00812812

Friday, April 03, 2009 - Japan/GSK - 329 All Over Again!

Friday, April 03, 2009 - Email to Ministry of Health - Japan

Saturday, July 25, 2009 - Paxil Study 329 All Over Again?

Friday, May 21, 2010 - Email To GlaxoSmithKline Re; Paxil Study In Children

Friday, September 24, 2010 - HEY, GLAXO!... LEAVE THOSE KIDS ALONE

Friday, May 13, 2011 - Glaxo remain tight-lipped on new Japanese Paxil study in children.


Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK - 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT [PAXIL] SCANDAL'

US/CANADA COPIES HERE OR UK/IRELAND FROM CHIPMUNKA PUBLISHING

The Four Things Drug Companies Don't Want You to Know

Image: Google Images

This is seriously riveting stuff.

Glaxo's Alli gets hammered by audience member. Glaxo declined to take part in an interview despite Alli being related to 13 cases of liver failure.

And listen to what the panel says about antidepressant drugs!

We're being duped people and our medicine regulators are playing the game along with the pharmaceutical industry.

I hear cries of "NO SHIT, SHERLOCK!"

Former pharmaceutical rep and author of Confessions of an Rx Drug Pusher, Gwen Olsen, also makes an appearance and tells the panel and audience how she, along with other reps "side-stepped the side effect profile of drugs to physicians."

Statins come under fire in Part II


The Four Things Drug Companies Don't Want You to Know

1. Drug companies underestimate dangerous side-effects.

2. Drug companies control much of the information your doctor gets about a drug.

3. You're often prescribed drugs you don't need.

4. Drugs target the symptom and not the cause.


Watch and learn.








Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT [PAXIL] SCANDAL'
US/CANADA COPIES HERE OR UK/IRELAND FROM CHIPMUNKA PUBLISHING

Good Grief!...It's the DSM-IV

Image: Google Images

Just when you thought you'd heard of every mental disorder shortened to acronyms such as ADHD, OCD etc, along come those wacky puppets, namely the authors of the Diagnostic and Statistical Manual of Mental Disorders [DSM] with a label so hideously funny - Ladies and gentlemen, I give you "grief disorder."

DSM IV is set to be re-written by the end of 2013 and to keep the bible of psychiatry up to date with sheer lunacy its authors have come up with a gem of a "mental disorder."

Bereavement-related disorder, it appears, is going to make the final edit. A "disorder", that was originally thrown out in 1994 due to lack of evidence, is set to become a cash cow for the pharmaceutical industry.

Yes, that's right folks, a human emotion is being turned into a disorder, apparently prolonged grieving is unnatural and our inability to let it go means we each have a mental disorder.

This DSM proposal goes by different names;

"Prolonged grief disorder", "complex grief", "traumatic grief", "pathological grief" and, most commonly, "complicated grief."

We all grieve at some point in our lives, be it whether a family member, a friend, a dog, a cat or dog dies. Some of us take longer than others to mourn. It appears that the authors of the DSM now want to judge the length of our grief and then... deem it unnatural.

Are these people so distanced from reality that they cannot see people pointing and laughing at them?

It's genius marketing. We'd all love for that pain of loss to be taken away from us, we've all, I'm sure, wondered how long that pain lasts and we've all wished, at some stage of the grieving process, for someone to wave a magic want to make the pain go away.

Never fear...Pharma is here!

Your "disorder" can be eased with drugs, your sadness lifted because of that "chemical imbalance" occurring. Oh thank you DSM people...thank you, thank you.

I've seen this industry preying on the vulnerable, preying on children, preying on our minds and now, it would appear, preying on those that are suffering at the hands of grief. I half-expect the authors to hang around cemetery's and hand out leaflets to those wailing by gravestones or maybe Funeral Directors will be approached and asked to promote this latest scam from the field of the psychopharmaceutical monopoly.

Days of grieving will be but a blip in history.

"We're sorry to inform you Mrs Smith but your son was killed in a road accident...but fear not, once you have identified the body down at the local morgue we will show you how your grief can be managed."

Fuck, they may as well go the whole hog and promote "early intervention" of grieving. All of us will experience it at some point in our lives.

Box ticking forms at the ready.

I am left wondering when joy will be deemed a mental disorder.

I think it's time to collect copies of the DSM, arrange a huge bonfire on top of an ancient hill and burn each copy. 'Hubblebubble, toil and trouble' anyone?

Time is no longer a great healer... drugs are.

Read more about the proposal in the Canadian Medical Association Journal HERE


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT [PAXIL] SCANDAL'
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The Box Ticking Nation

Image: Google Images

Now this IS an educational video.



Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT [PAXIL] SCANDAL'
US/CANADA COPIES HERE OR UK/IRELAND FROM CHIPMUNKA PUBLISHING

Glaxo remain tight-lipped on new Japanese Paxil study in children.

Some of you may remember I highlighted sometime ago on this blog that GlaxoSmithKline Japan were carrying out studies with Paxil/Seroxat in children. [See links at foot of this article]

Naturally I was, like many others, appalled at Glaxo's need to carry out such a study, particularly as they had already deemed Paxil unfit [unsafe and ineffective] for this particular age group. [7-17 years]

It seems I wasn't alone in voicing my concerns.

The following is a letter sent to GlaxoSmithKline from Yakugai Ombudsperson Medwatcher Japan and Toshihiro Suzuki, Representative. It's dated July 16 2009.

Demand for Publication of Information Related to Post-Marketing Clinical Trials on Children and Adolescents Using the Antidepressant Paxil.

I. Purpose of the Demand

We are requesting the following information on "Clinical Evaluation of Efficacy and Safety of Paxil Tablets in Children and Adolescents with Major Depressive Disorder: Placebo-Controlled, Double-Blind, Parallel Group Study."

(1) The justification for determining the conduct of this study to be necessary and valid (how and why the conduct of the trial was determined to be necessary and valid)

(2) In particular, if the premise of conducting the clinical study is that effects can be expected for Japanese children, what information was used as justification for making that determination

(3) The most recent version of the study protocol (including records of previous revisions)

(4) Subject recruitment status (the names of the sites participating in the study to date, the number of people recruited at each site, and the Patient Information Sheet used at each site)

(5) Information on adverse events reported to date (information on number of emergent cases and clinical course of individual cases, etc.)

Both the Yakugai Ombudsperson and Suzuki added:

"We strongly desire the disclosure of detailed information and a public re-examination of the question of whether it is truly necessary and valid to conduct a new clinical trial with Japanese children on a drug whose efficacy could not be confirmed in overseas clinical trials and which furthermore is suggested to potentially increase the risk of suicide."

I echo their sentiments. Are GlaxoSmithKline suggesting that it may be okay for Japanese children to take Paxil? I cannot quite grasp why Glaxo would carry out such a study on this age group.

The letter can be viewed in PDF format here:





According to the GlaxoSmithKline web page, the study is now completed. However, the results of that study still remain a mystery.


I emailed GlaxoSmithKline this morning to ask them for the conclusion of study NCT00812812, I anticipated either silence from them or a reply stating that under some twisted pharmaceutical law they are not allowed to divulge such information.

I was wrong. Their response was even more elusive:


Dear Mr. Fiddaman,

Please be advised that we have sent your request to our Business Representatives in regards to your question. Someone will contact you in the next few days.


No time like the present - I phoned them and asked if they could give me the results of the trial, they informed me that my request had been passed on to a "business representative" - they also asked me if I was a doctor or patient, I told them I was a former patient and writer and added that I write specifically about paroxetine [Paxil]

When asked if the trial results would be made public within the next 48 hours, I was told, "We don't know, we have to wait until the business representative gets back to us."

Jeez, it would be easier to ask Shania Twain if she wanted to play a game of hide the salami with me - at least I'd get a definitive answer!

Rather than wait for their "Paxil has benefited millions of people world-wide" type of response I thought I'd press ahead with this post, if only to highlight that Glaxo are [once again] not being transparent with regard to clinical trials with Paxil and children!




Here are the links where I previously wrote about this study:

Thursday, January 15, 2009 - Email to Japanese Embassy regarding New GSK paroxetine study in Children. ClinicalTrials.gov Identifier: NCT00812812

Friday, April 03, 2009 - Japan/GSK - 329 All Over Again!

Friday, April 03, 2009 - Email to Ministry of Health - Japan

Saturday, July 25, 2009 - Paxil Study 329 All Over Again?

Friday, May 21, 2010 - Email To GlaxoSmithKline Re; Paxil Study In Children

Friday, September 24, 2010 - HEY, GLAXO!... LEAVE THOSE KIDS ALONE

Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT [PAXIL] SCANDAL' By Bob Fiddaman
US/CANADA COPIES HERE OR UK/IRELAND FROM CHIPMUNKA PUBLISHING