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Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Paxil 329. Show all posts
Showing posts with label Paxil 329. Show all posts

Tuesday, October 17, 2017

Karma Catches up with Dr. Graham Emslie



Disgraced Psychiatrist, Dr. Graham Emslie

It's no secret several unethical doctors pretended to write the Paxil 329 Study. Adding their names to the shady ghostwritten article was sequentially responsible for persuading doctors to prescribe Paxil off-label to children and adolescents despite that the drug is dangerous and ineffective.

One of these despicable 'experts' was Dr. Graham Emslie (67), a psychiatrist based in Dallas, Texas. Emslie received research support and consultant money from several drug companies, including GlaxoSmithKline, the company for whom he agreed to add his name to the ghostwritten 329 Study. Emslie's dishonesty participation in the 329 Study put children at risk of harm and death despite that Emslie claims his clinical expertise is in child and adolescent depression.

In 2009, Emslie was investigated by the US Senate Finance Committee, led by Senator Chuck Grassley, as one of many medical academics with serious conflicts of interest and financial ties to Big Pharma. The Senate committee was concerned these conflicts resulted in fraudulent research that promoted prescriptions of harmful and ineffective drugs to unsuspecting consumers and without adequate safety warnings. (Source)

Today Karma Catches up with Emslie

Recently Emslie has been reprimanded by the Texas Medical Board after it learned one of Emslie's patients, an unnamed male, died by suicide whilst under the "care" of Emslie. The doctor demonstrated a lack of due care in several areas. Emslie's punishment was far lighter than he should have received for likely contributing to the suffering and death of his patient, but at least the Texas Medical Board took some action regarding Emslie's careless remote prescribing.

On the 25th August 2017, the Texas Medical Board heard evidence surrounding Emslie's conduct and charged Emslie with breaching the medical standard of care. It was learned Emslie prescribed stimulant and sedative medications to the patient for several years without appropriate evaluation, monitoring, and medical record-keeping. The patient went on to kill himself. Emslie claimed he knew the patient who was the brother of an acquaintance of Emslie's daughter.

When asked for the 17-year medical records of the now-dead patient, Emslie told the Texas Medical Board the records could not be produced. Emslie claims he only kept "scant" records scribbled on a notepad. The board was also told that Emslie regularly prescribed benzodiazepines and amphetamines over the telephone without physically examining his patient. (remote prescribing)

Further, Emslie also assisted the patient in "pharmacy shopping" to ensure drug refills could easily be obtained at various pharmacies. Despite that the patient's history included a "drinking problem," Emslie did not refer his patient to an addiction specialist for alcohol dependence nor does it appear Emslie adequately informed the patient regarding the possible ADRs associated with Emslie's prescriptions and alcohol consumption.

Despite all of the above conduct, Emslie does not think he erred in the care of his patient.

The Texas Medical Board imposed a range of disciplinary actions against Emslie, none of which, in my opinion, fit Emslie's crime.

Emslie received a "public reprimand" (whoopy-doo) and 8 consecutive monitoring cycles of his clinical practice. The board also imposed 24-hours of  "continuing medical education" for Emslie. Emslie was ordered to pay costs to the Texas Medical Board. However, no costs for the funeral of his deceased patient were imposed.

The agreed order, signed by the disgraced Emslie, can be obtained by contacting me via email.

Special thanks to Jan Eastgate of the Citizens Commission on Human Rights for alerting me to Emslie's latest scandal.

Bob Fiddaman


Friday, November 15, 2013

If Study 329 Were a Fence



Nuff said.

Now watch the video




Bob Fiddaman



Thursday, November 14, 2013

Witty's Era Still Smells of 329 Rotten Eggs





We all remember Glaxo's CEO, Andrew Witty, 'tail between the legs' excuse when the Department of Justice handed down a $3 billion fine for his company's fraudulent activities don't we?

"It's all part of an era", or words to that effect, was the excuse Witty used. It was an excuse that distanced him from the problems of his company, although Whistleblowers in the $3 billion suit claim he knew exactly what was going on and that he even participated in the off-label promotion of Zyban when he was, at the time, VP in marketing circa 1997-2000.

Witty's 'era' excuse has never really held water with me. Here we have a boss who apparently oversees the running of his company. When his company is caught out for acting fraudulently he blames the past. More recently Glaxo have been in the news again, this time senior managers in China have [allegedly] been bribing doctor's with money and prostitutes in efforts to get them to prescribe more of GSK's drugs. Witty, being Witty, denies any knowledge of it. Turns out, if reports are correct, that GSK are not going to be charged for these crimes in China, instead Chinese authorities are going after the individuals who acted fraudulently.

Not on my watch guv.

I'm reminded of a rib-tickling scene from the movie Dumb and Dumber here.

Witty, in this scene, is played by Jim Carey.





What is it about Andrew Witty that makes him blame other people?

What does Andrew Witty fear by speaking with members of the public who have questions about his company's products?

Before I move on to the latest news about the Paxil 329 study... or rather the retraction of it, it's important to note that Glaxo's Andrew Witty has refused to meet with patient advocate Janice Simmons.

Simmons, who runs the Seroxat User Group, contacted Witty back in 2011. The Seroxat User Group had amassed over 60,000 emails from Seroxat patients, most of them were/are struggling to get off Seroxat. Janice cannot tell them how to combat the side effects such as; electric zaps, suicidal thoughts, intolerance to sudden loud noises, bouts of crying, headaches and visionary disturbances etc.

So, Janice decided to request a meeting with GlaxoSmithKline's CEO, Andrew Witty. To her surprise, GSK’s UK medical director Dr Pim Kon wrote back asking what she wished to discuss...adding that they cannot give advice to patients, they need to seek that from their healthcare professionals. [Yawn]

Janice informed Dr Kon that she wished to discuss the issue of Seroxat withdrawal. Kon wrote back telling Janice that they was not allowed to discuss personal matters with patients and that they should 'talk to their doctor'. [Another yawn]

You'll note that Witty chose not to reply to Janice Simmons, instead he, it appears, got Dr Kon to reply.

Seroxat is the UK brand name for paroxetine which is known as Paxil in the US and Canada.



Witty Sends In The Clowns


A few days ago a feature appeared in the British Medical Journal [BMJ] entitled 'Putting GlaxoSmithKline to the test over paroxetine'. [1] The feature contained  a fascinating exchange of letters between Jon Jureidini and GlaxoSmithKline between April 26 and November 8, 2013, in which Jureidini requests data from paroxetine study 329.

Please take note at who Jureidini addresses his correspondence to. Also take note that Jureidini never once gets a reply from the person he originally contacted.

Jim Carey at play again?

For those that don't know 'Paxil 329' was a study of Paroxetine vs Imipramine vs Placebo in Adolescents with Unipolar Major Depression.

The results of the study appeared in the Journal of the American Academy of Child and Adolescent Psychiatry and listed Marty Keller as the primary author. However, the study was not written by Keller at all, it was written by Sally Laden, a ghostwriter hired by GSK.

The results of the study were favourable. However, the paper was misleading in as much that it exaggerated benefit and downplayed adverse effects, including suicidal thoughts. In 2004 the Canadian Medical Association published an Editorial which showed that in 1998 an internal GSK document clearly acknowledged that GSK were aware that 329 was negative and they knew that paroxetine had no beneficial effect in treating adolescents [2]

The GSK internal document was prepared by the Central Medical Affairs team (CMAt), a division of GSK who back then were known as SmithKline Beecham.

This from the Canadian Medical Association:

The document provides guidance on how to manage the results of 2 clinical trials conducted into the efficacy of paroxetine (Seroxat). Given that the clinical trials results were, according to the document, “insufficiently robust” to support an application to regulatory authorities for a label change approving Seroxat for use in pediatric depression, CMAt recommended the firm “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.”
The CMAt document advised that “Positive data from Study 329 will be published in abstract form at the [European College of Neuropsychopharmacology] meeting” in November 1998 and that “a full manuscript ... will be progressed.” It also stated that “It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.”

Eventually GSK had to acknowledge the failure of all three of their child and adolescent paroxetine depression studies [3] but the original results [the lies] still appear in the Journal of the American Academy of Child and Adolescent Psychiatry.

Jureidini and many others have, on numerous occasions, called for the journal article to be retracted. The editor of the journal won't retract it so maybe Witty could be instrumental in its retraction?

Here's the letters:











The final exchange sees Glaxo wishing to communicate by telephone [tactics like this get rid of paper trails]




So, despite addressing Andrew Witty, Jureidini is given the runaround by GSK's Kraus and Shannon. Where was Witty in all of this, why is he, seemingly, afraid to debate with Jureidini?

Maybe Witty is still stuck in his own era and believes that the Paxil 329 study is the responsibility of his predecessor JP Garnier. Nonetheless, it's a dog shit on Witty's doorstep yet it is one that he refuses to acknowledge or is in denial about.

We all know what happens when you tread in dog shit, right?

I sincerely hope Sir Andrew knows a reputable carpet cleaner.




Bob Fiddaman






[1] BMJ 2013; 347 (Published 12 November 2013)
[2] CMAJ March 2, 2004 vol. 170 no. 5
[3] http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/GSKtoDrs.pdf

Thursday, December 27, 2012

"Remarkable efficacy of Paxil" - Endorsed for Kids by the JAACAP




Okay, the JAACAP [Journal of the American Academy of Child and Adolescent Psychiatry] aren't exactly endorsing Paxil for kids but, in my opinion, they are doing the next best thing.

GlaxoSmithKline's... [Strike that]... Sally Laden's published study, in which eminent psychiatrists pretended they had wrote, Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial, has been the subject of much debate over the years. When it was flagged as being incorrect the pretend authors defended it. When it was proven to be incorrect the pretend authors went all quiet on us.

Now, we have a piece of literature purportedly written by the likes of Martin Keller, Neal Ryan and Karen Wagner to name but a few, that still causes controversy, this time from the publishers of the said piece, the Journal of the American Academy of Child and Adolescent Psychiatry.  I've Previously wrote about one of the more lesser known authors, Stan Kutcher. [Links at foot of post]


Wednesday, March 07, 2012

EXCLUSIVE - Paxil Author in Sex With Patient Scandal

Paxil author Ray Berard. [Pic timeslive.co.za]

Forgive the News of the Worldesque type headline for this blog post but I just couldn't resist it. I always love it when psychiatrists, particularly those connected with 'bigging up' the use of Paxil in children, give me the opportunity to play some AC/DC.

Read on.

South Africa's Cape Times is running with a story today that implicates Paxil [Seroxat in UK] author and psychiatrist Ray Berard in a sex scandal with one of his former patients.

Sylvia Ireland has accused Berard of misusing their therapy sessions to have sex. Ireland claims that she and Berard had a sexual relationship for two years whilst she was under his care. At the time, claims Ireland, she was using three types of medication, all prescribed by Berard for bipolar and having a personality disorder.

Berard, who is the co-owner of Selous House, a facility for patients with chronic mental illness in Western Cape, South Africa, has pleaded not guilty to all charges against him, including:


Entering into an intimate physical relationship with his patient.
Having sexual intercourse with her more than once.
Failing to refer her to another psychiatrist or to cease the doctor-patient relationship with her when the intimate sexual relationship developed.
Misusing the position of trust and confidence towards his patient.
Acting in a way likely to bring his profession into disrepute.

Selous House now runs under the name of St Anthony’s Home, a lavish psychiatric care facility whose fees seem even more lavish. For  R7,500 [£630 - $990] per month patients can opt for a cubicle in a dormitory setting. R9000 per month [£750 - $1,185] will give you a single room without a shower...on top of which you are expected to pay the 8.4% VAT.

I never knew psychiatrists wages were so good that one could go out and make such a great investment.

Not yet reported and exclusive to Seroxat Sufferers is the news that Berard has links to the Paxil pediatric studies in adolescents.

Berard, who along with Pharma favorite Karen Wagner, co-authored A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial of Paroxetine in Children and Adolescents With Social Anxiety Disorder, the results of which showed "Paroxetine [Paxil] as an effective, generally well-tolerated treatment for pediatric social anxiety disorder."


He also, along with Neal Ryan [he of Paxil 329 fame] presented a poster presentation to The European College of Neuropsychopharmacology [ECNP] in 1998 entitled, 'Adolescent Depression: Efficacy of paroxetine'

Late last year The Star reported that Berard had also entered into a business relationship with Ireland's husband. The Star claims that Stuart Ireland appointed Berard as a director of his company Prestige Cosmetics while the psychiatrist continued to send erotic text messages to Sylvia Ireland. Hey, nice set of ethics Raymundo. One of the messages allegedly sent by Berard was: "It's hard as a rock." 


Nothing to be ashamed of Raymundo... but those Paxil claims, tut tut.

Ironically, I hear Paxil is good for keeping your pecker up, also keeps the wolf from the door too, that's if you don't mind turning into a homicidal maniac whilst you're on the job. - Woof! Woof! AWOOOOOOO


This one's for you Dr Berard.





The case in front of the Health Professions Council of SA committee of inquiry continues today.

Full article HERE








Tuesday, February 07, 2012

Brown University School of Medicine and the "Get Out Clause"





I always sit in bewilderment at the exemption rules and clauses that exist inside the cogs of the pharmaceutical industry and its shills. For those that don't know, a 'shill' is a person who helps a person or organisation without disclosing that he or she has a close relationship with that person or organisation [1]

So, what if one finds something that is so way off mark that it could be detrimental to the health and safety of patients worldwide?

Well, I guess the first plan of action would be to contact the person/persons who created that 'something' and to show them that what they actually created had serious safety issues regarding the safety of children and adolescents.

Scientific misconduct appears to be a noose around Brown University School of Medicine's neck, much akin to the same noose that has taken the lives of children and adolescents prescribed Paxil [known as Seroxat in the UK]

For some time now Jon Jureidini, associate professor of psychiatry at the University of Adelaide, and Leemon McHenry, a lecturer in philosophy at California State University, have been calling for a retraction of, the now infamous, Paxil 329 study, a study that has, since its publication in 2001, been discredited for its use of selective reporting and ghostwriting shenanigans.


Martin Keller

Brown University, whom, at the time, employed lead author of the Paxil 329 study, Martin Keller, were approached by McHenry and Jureidini who sought a retraction of the skewed study which, despite showing huge flaws, still appears in the Journal of the American Academy of Child and Adolescent Psychiatry [JAACAP] today and, more than likely, is still used as a guide by many prescribing physicians who will read that "Paxil is safe and effective in the use of children and adolescents."

The fact that Paxil isn't safe and effective in children does not seem to bother Brown University, whom have replied to McHenry and Jureidini with what can only be described as a "D'uh so what" type of response.

The Dean of Medicine and Biological Sciences, Edward J. Wing, writes to McHenry and Jureidini with the following excuse:

"The University will not submit a letter requesting retraction to the editor of the JAACAP for the journal article written by Dr. Keller."

The reasons being a six year statute of limitations, which basically means McHenry and Jureidini were too late in filing their complaint.

Don't you just love the way corporate entities surround themselves in that protective red-tape.

Here we have a study with Keller cited as the lead author when in fact the whole study was ghostwritten by Sally K Laden, a shill hired by GlaxoSmithKline to say nice things about Paxil and to promote it in such a way that healthcare professionals would prescribe it to children and adolescents. Keller, merely put his name to the study because...well, because that's what Glaxo paid him to do.

The wording of Edward J. Wing's response to McHenry and Jureidini is interesting in as much that it claims that Keller wrote the article.

It's unknown if Wing has been on the planet Zog for the past 10 years or so or whether he is just towing the line. [self bondage in red tape]

Brown University are really showing a lack of ethics here, it's almost as if they have been skinny-dipping in icy cold waters and their balls have shrivelled to the size of peas, a great role model for students just starting out at Brown, doncha think?

They must hold Keller in high esteem to protect him so much, they must hang on to his every word regarding Paxil seeing as they claim he wrote the study.



Brown, as the name suggests, stinks like a river of floating turds, each one wrapped in red tape, each one stamped with a six year statute of limitations, each one so gut wrenchingly gaseous that nobody dare go near them for fear of seeing that sickly smile from Keller.

Swim beneath the Brown river and you'll find the voices of the dead Paxil children that Brown University wish to suppress, to ignore, to be swept into the pooper-scooper because their memories of their short lives mean absolutely nothing to Brown Uni officialdom.

Brown's reluctance to intervene is a two-finger salute to any child or adolescent being prescribed Paxil today. They should be utterly ashamed of themselves for using a statute when they knew well before the six year time limit that 329 seriously misrepresented the safety of Paxil in children and adolescents.

Unforgivable and cowardly are just two words that spring to mind...another is Karma.




Fid


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


AUSTRALIAN ORDERS HERE




Wednesday, June 01, 2011

Dalhousie University Stand By Their Stan



Stan Kutcher, the Halifax, Novia Scotia child & Adolescent psychiatrist, who ran unsuccessfully as the Liberal candidate for Halifax in the last Canadian federal election, last month, came under fire from myself and a bunch of other patient advocates after it was learned that he had threatened a local newspaper after they had ran a story about his involvement with the infamous Paxil 329 study.

High jinks on the social networking sites, Twitter and Facebook, ensued and many of Kutcher's supporters allegedly were behind a smear campaign of Alsion Bass, the author of Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial. Bass had been quoted in the original article that ran in the 'The Coast' newspaper.

Investigative journalist, Ed Silverman, who writes the popular Pharmalot blog, has been following the story with interest and recently contacted the University where Kutcher is a Professor in the Department of Psychiatry.

It appears that Nicholas Delva, who heads the department of psychiatry, is defending Kutcher to the hilt with regard to his involvement in the Paxil 329 study, quite strange seeing as the Dalhousie guidelines on ghostwritten material are:

“Presentations, publications, slides or media products of any kind, oral or written, should not be ghostwritten by any party, industry or otherwise. To be listed as an author indicates responsibility for the content and meaningful participation in preparation of the document. Appropriate authorship and contribution should be noted for materials prepared for someone other than the presenter. Transparent writing collaboration (with attribution) between academic and industry investigators, medical writers, and/or technical experts is not ghostwriting”

Pharmalot has the full investigative story HERE.

It will be interesting to see if Kutcher threatens Pharmalot with a lawsuit.

In the meantime, for those of you who are unaware exactly what the Paxil 329 Study was, watch this:



Related Articles:



Stan Kutcher "Vote Paxil"

Newspaper Issues Apology to Canadian Politician Stan Kutcher

Why 'The Coast' Pulled the Stan Kutcher Article

Paxil Study 329 - The Secrets of The Drug Trials

Stan Kutcher's Followers Doing Him No Favours


Other blogs:

Ghostwritten text books & skewed Paxil 329 study Nemeroff, Kutcher demand apologies for truth exposures

Paxil, Seroxat : Reputations for sale? a review of the PAXIL 329 scandal: Stan Kutcher


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

Tuesday, May 03, 2011

Early Intervention, McGorry, Politics & TV Shows


PART I - Early Intervention - Patrick McGorry

I cannot browse the Internet these days without reading about Australian psychiatrist Patrick "Dr. Emmett Brown" McGorry.

Whatever I seem to be researching these days leads me to McGorry.

McGorry was voted Australian of the year in 2010, an award given for the achievement and contribution of eminent Australians.

McGorry is an international researcher and clinician who bangs the drum loudly for the youth mental health reform agenda. He is Executive Director of Orygen Youth Health (OYH), an organisation for the prevention and treatment of mental illness. OYH apparently targets the needs of young people with "emerging" serious mental illness, including first-episode psychosis.

First episode psychosis, according to the Centre for Addiction and Mental Health [CAMH] is the first time a person experiences a psychotic episode, the 'episode' being a loss of contact with reality, in which people have trouble distinguishing between what is real and what is not.

Medication used to treat this 'illness' is varied

Typical antipsychotic medications that are commonly used include:

Thorazine/Largactil [chlorpromazine]
Depixol/Fluanxo [flupenthixol]
Modecate/Permitil/Prolixin [fluphenazine]
Aloperidin/Bioperidolo/Brotopon [haloperidol]
Loxapac/Loxitane [loxapine]
Etrafon/Trilafon [perphenazine]
Orap [pimozide]
Mellaril/Novoridazine/Thioril [thioridazine]
Navane [thiothixene]
Eskazinyl/Eskazine/Stelazine [trifluoperazine]
Cisordinol/Clopixol/Acuphase [zuclopenthixol]

Atypical antipsychotic medications include:

Clozaril/Zaponex [clozapine]
Zyprexa [olanzapine]
Seroquel [quetiapine]
Risperdal [risperidone]


I've included the brand names in the list to avoid any confusion.

So, where does McGorry fit in? Patrick McGorry has claimed that nearly half the Australian population will experience mental ill-health during their lifetime. His early intervention program, based on a series of box ticking forms, diagnoses people, many of them children, before they develop a "mental disorder" - to nip this "illness" in the bud [before the patient actually gets it] drugs, such as the ones listed above, can be used.

McGorry has received grant support from Eli Lilly, Janssen-Cilag, Bristol Myers Squibb, Astra-Zeneca, Pfizer, and Novartis. He is also a paid consultant for, and has received speaker’s fees from all or most of the above.

When requests, under the Freedom of Information Act, were requested regarding McGorry's dealings with the pharmaceutical industry, he screamed that he was the victim of Scientologists, a worn out defence psychiatrists and the pharmaceutical industry often use when backed into a corner.

PART II - Politics

McGorry often turns up at symposiums [that's seminars to you and I] to discuss, rather than debate, his program.

It should come as no surprise that fellow supporters/psychiatrists also attend these seminars.

Psychiatrist turned Liberal candidate for Halifax, Nova Scotia, Stan Kutcher, is one such person.

Last week I broke the news story that Kutcher had been featured in The Coast, a newspaper that serves the Halifax area of Nova Scotia. The story picked up momentum, particularly after Kutcher threatened to sue The Coast - they subsequently removed the article, apologised and made a donation in Kutcher's name to the Mental Health Foundation of Nova Scotia

The article cited Kutcher's involvement with the infamous Paxil 329 study, a study that has since been discredited by many peers and attorneys in court rooms across the US. Kutcher, for whatever reason, has stood by the study claiming that the article was "confusing opinion with science." In fact the whole study was ghostwritten by Sally K Laden, not to be confused with Bin Laden. The question we, as patient advocates, have every right to ask, is did Kutcher know the paper was ghostwritten or did he just take it on trust that what he was overseeing came from those listed as the authors?

Kutcher, just like McGorry, is a big fan of the early intervention program and has attended and given talks at many seminars where McGorry has been in attendance.

Source


Those that spoke out against Kutcher's involement in the Paxil 329 study, myself included, were...wait for it...labelled Scientologists. It is unknown whether Kutcher was aware that an anti-Scientology movement were orchestrating a smear campaign against one of those that spoke out against Kutcher. [More Here]

Update: Kutcher failed in his attempt to get elected.

Part III - TV Shows

Early today I was sent a link to a TV show aired in Ireland back in 2009. The show featured the parents of Shane Clancy, a young man who was prescribed Cipramil [Celexa in US] then weeks later, and totally out of character, went berserk with a kitchen knife, stabbing a young man to death, injuring two others before finally plunging the knife into his body 19 times.

His parents, Leonie and Tony, made the unprecedented step of going public about their son by appearing on a popular Irish show called 'The Late Late Show.'

The 24 minute video of the interview is a bit difficult to navigate to when accessing the RTE website. For those wishing to view the interview:

Go to - http://www.rte.ie/tv/latelate/20091002.html

Below the date 'Friday, 2 October 2009' you will see a large screen plus four small ones. Under the smaller ones click on 'More'

The video you are looking for is called 'The Clancy's'

During the harrowing interview, a number of doctor's in the audience offer opinion regarding SSRi drugs. One such doctor, Dr Harry Barry, refers to 'a visiting professor, "one of the world's experts on youth mental health" who gave a talk in Ireland.

That visiting professor was Patrick McGorry who according to Dr Barry described Ireland's young adult mental health services as non-existent.

Dr Barry, a best-selling Irish medical doctor based in County Louth, went on to say that "...in Australia they have managed to get around this problem by realising that young people are only mature [brain wise] at the age of 25. They brought in a system called *Headspace, which basically is scattered throughout Australia, which is allowing young people easy and free access to all of the mental health services they require."

*Headspace receives huge funding from the Australian government. In fact, only last month it was announced that $3AUS million had been pledged by the Federal Government who announced 10 new sites for the Headspace youth mental health service will begin operating by the end of the year. [Source ABC News Australia]

Dr Harry Barry is a board member of AWARE, a depression support organisation.

AWARE offers a diagnostic tool on its website, a three minute assessment for anxiety, depression, PTSD and bipolar disorder.

The tool, known as the M-3, was created by primary collaborators Robert M. Post, MD Head of the Bipolar Collaborative Network, Bernard M. Snyder, MD Assistant Clinical Professor of Psychiatry at Georgetown University and a cognitive behavioral therapist, Michael L. Byer, President of M3 Information and Gerald Hurowitz, MD Assistant Clinical Professor of Psychiatry at Columbia University and a clinical psychopharmacologist.

You can read more about the diagnostic tool here - they have even launched it on Apple iPad.

I'd love to know how McGorry's program actually works, indeed if either McGorry, Kutcher or Dr Harry Barry can tell me then I'd be most grateful. Pre-drugging a child simply because his parent, grandparents or great-grandparents had some form of mental illness is not science, it's guess work and it is wrong to treat guess work with powerful antipsychotic and Atypical antipsychotic medication.

Be careful what boxes you tick folks... you could be labelled as having a mental disorder - not now...but sometime in the near future.

Time for McGorry and co to fire up that old Delorean.







Sunday, May 01, 2011

Stan Kutcher's Followers Doing Him No Favours

"Stangate" seems to have gone viral since I first blogged about the newspaper article from The Coast.

42% of visitors to this blog have come from Halifax, Nova Scotia, Twitter is inundated with Kutcher followers defending him opposed to the advocates who are, rightly, pointing out that Kutcher put his name to the infamous Paxil 329 study.

Alison Bass, who was quoted in the original article from The Coast, has even blogged about this intriguing story HERE.

Alison, who authored the book, 'Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial' asks pertinent questions regarding the reasoning behind The Coast pulling the article and issuing an apology. She writes:

Last Thursday, five days before the Halifax elections, which are being held May 2, Bousquet posted this article about Kutcher's involvement in study 329. Bousquet quoted me as saying that the researchers "essentially distorted the outcome measures." He also quoted Kutcher as saying that he stood by study 329 and didn't think it had caused any particular controversy.

She adds:

Kutcher's lawyers immediate responded to Bousquet's April 28 article by threatening to sue the newspaper for libel unless it immediately issued a retraction. Even though Bousquet backed up his article's assertions with documentation, the Coast decided to issue an apology and retraction anyway.

All of this makes me wonder: where have The Coast and its editors been all these years? And do they really want to go down in history as an example of the not-so-free press buckling under to craven threats?

Kutcher's followers have been joined by an anonymous group who gather on the 'Why We Protest' forum, a forum where like-minded individuals discuss Scientology in the media, when I say discuss, I actually mean they try to make connections to Scientology if a person happens to have an opinion.

What is interesting with the Stangate story is that a bunch of posters on this forum have, it appears, tried to orchestrate a smear campaign against Alison Bass.

The thread starts with the usual nonsense that one would expect from a bunch of conspiracy theorists.

The title of the thread reads:

REQUEST: Canadian Liberal Party candidate and psychiatrist under attack by scilons?

The content of the post by the user and moderator who calls himself 'Trouble' is:



This kind of makes me laugh as the same forum has labelled me a Scientologist in the past - to be honest it would be easier for me to convert to Scientology than it would to keep on stating that I'm not one.

I have many friends who are Scientologists, as a matter of fact I have never met a better bunch of people. They are warm, considerate human beings who care about human rights. I also have Catholic, Christian, Hindu and atheist friends who are equally warm and considerate human beings.

That said, I expect the usual rebuttal from my critics. Fiddaman is a Scientologist, Fiddaman blog funded by Scientology, Yadda yadda.

The thread is interesting, if only for the last post by someone who calls himself 'Roomr'

The avatar used by 'Roomr' is striking.


Skip to Twitter and you will find the same Avatar used by one of Kutcher's supporters:


Even more interesting is the photo section of Stan Kutcher's Facebook Election page:

Check out the fourth image on the right:


Coincidence? I guess it could be argued that this particular image is used by many people, just unusual that when one joins the dots it comes back to the old anti-Scientology brigade orchestrating an attack on a published author whose book, 'Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial', was a winner of the 2009 Science in Society Journalism Awards, sponsored by the National Association of Science Writers. [NASW] I suspect the crazies will somehow try and link the NASW to Scientology next!

Kutcher's response to the original article posted in The Coast was expected - The Coast's pulling of the article was surprising to say the least. Had they have stood firm and told Kutcher that the article was based on evidence then their newspaper, judging by the response across the Internet, would have had themselves one hell of a story. They missed out on a trick there eh?

The Scientology labeling is as old as the hills, it's tiresome and has been used by the pharmaceutical industry as a way to discredit.

With so many people discussing Stan Kutcher, the crazies are going to have some fun on the Internet coming up with connections that fit in with their blinkered views.

For the record, I have won two awards from the CCHR, judging by the logic the crazies use, I'm a Scientologist. Hey, I can live with that, just don't get labeling me a Catholic, I distanced myself from that religion once I hit senior school.

I once went to a Hindu wedding so I must be a Hindu. I've seen AC/DC in concert more times than I can remember, so I must be a devil worshipper. Oh, and I once got caned at school for farting...so I must be part of that new religion the Fartologists! [Breaking wind near you soon]

In fact, the crazies would have me down as being an Australian because I have visited Australia!

If people's beliefs in religion is the only tool critics can use then those critics are doing Kutcher's election campaign more harm than good.

Kutcher must be squirming at the connection he has [more than likely] unwittingly made.

More on Kutcher after the election votes are in tomorrow.

His early intervention stance mirrors the great one from Australia.

Back stories:

Stan Kutcher "Vote Paxil"

Newspaper Issues Apology to Canadian Politician Stan Kutcher

Why 'The Coast' Pulled the Stan Kutcher Article

Paxil Study 329 - The Secrets of The Drug Trials

Other blogs:

Ghostwritten text books & skewed Paxil 329 study Nemeroff, Kutcher demand apologies for truth exposures

Paxil, Seroxat : Reputations for sale? a review of the PAXIL 329 scandal: Stan Kutcher


Fid

Fartologist
Devil Worshipper
Hindu

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













Paxil Study 329 - The Secrets of The Drug Trials

I'm quite astounded at the recent controversy surrounding the decision by a Canadian newspaper [The Coast] to pull an article it had published about a politician/psychiatrist/doctor from Halifax, Nova Scotia.

The Twitter website has an array of accounts suggesting that Stan Kutcher is being attacked by the Church of Scientology. Bah humbug! What those behind these Twitter accounts fail to comprehend is that they are drawing attention to Kutcher's involvement with the study. This is not about religion, it is about suppression of data in clinical trials, trials that should be protecting consumers.

This is not a witch hunt against Kutcher, he, like anyone else, has a right to object to newspaper articles that may be libelous. Given that right, he threatened to sue The Coast and they removed the article, issued an apology and made a donation in Kutcher’s name to the Mental Health Foundation of Nova Scotia.

To be honest, it may have been advisable that Kutcher ignored the article because more and more people are asking why the article was pulled. It has created an interest and the whole Paxil 329 study has resurfaced.

Back stories can be found here:

Stan Kutcher "Vote Paxil"

Newspaper Issues Apology to Canadian Politician Stan Kutcher

Why 'The Coast' Pulled the Stan Kutcher Article

The controversy is with regard to Kutcher's involvement with GlaxoSmithKline's infamous Paxil 329 study, a study that he stands by.

So what was the Paxil 329 study all about?


Watch and learn.





Fid


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

Saturday, April 30, 2011

Why 'The Coast' Pulled the Stan Kutcher Article



The Internet and social networking websites are awash with the controversial decision of the Canadian newspaper, 'The Coast', to retract and apologise for an article it printed and disseminated online on Thursday April 28.

According to an article posted on Scribed, Kutcher had demanded a retraction of the article that he claimed was "confusing opinion with science."

The article on Scribed writes:

Kutcher demanded a retraction and threatened to launch a defamation suit against the publication as a result of its inflammatory innuendo and the potential to damage his personal,professional and political reputation.

The Coast complied and removed the article.

The original article pointed out that Kutcher was a co-author of Efficacy of Paroxetine in the Treatment of Adolescent Major Depression:A Randomized, Controlled Trial, a trial that concluded that paroxetine [Paxil,Seroxat] provided evidence of the efficacy and safety of the SSRI, paroxetine, in the treatment of adolescent depression. Additional studies are called for to define the optimal length of therapy and dose of SSRIs in this population

In other words, the authors, of which Kutcher was one, agreed that paroxetine was safe for children and adolescents.

Kutcher also co-authored SAFETY OF PAROXETINE AND IMIPRAMINE IN THE TREATMENT OF ADOLESCENT DEPRESSION, the conclusion being :

The results of this study demonstrate the safety of paroxetine in the treatment of adolescent depression. Side effects were modest with paroxetine. Given the high rate of adverse cardiac events with imipramine, clinicians should carefully monitor cardiovascular functioning when treating depressed adolescents with imipramine.

Kutcher is quoted as saying that The Coast is confusing opinion with science. What science? Even the manufacturers of paroxetine, GlaxoSmithKline, have claimed that paroxetine is not recommended for children and adolescents. This from the GSK web page:

Paroxetine is not approved for the treatment of patients younger than 18 years of age. Please refer to the approved prescribing information for additional warnings and information.

This after misrepresenting information concerning the safety and efficacy of paroxetine for treating MDD in children and adolescents.

The following is from SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF NEW YORK

THE PEOPLE OF THE STATE OF NEW YORK, :
by ELIOT SPITZER, Attorney General of the State of New York, :

against

GLAXOSMITHKLINE, pIc.,
d/b/a/ GIaxoSmithKIine,
SMITHKLINE BEECHAM CORPORATION.

[PDF]


An internal GSK document from 1998 concluded that, in light of the mixed efficacy outcomes from study 329 and the entirely negative results of study 377, GSK's "target" was "[t]o effectively manage the dissemination of these data in order to minimise any potential negative commercial impact.


As part of its campaign to "manage the dissemination of these data," the document recommended that GSK prepare and cause the publication of a full artic]e on the on]y study with some favorable conclusions, study 329.

Thereafter, and in accordance with the recommended plan, an article that described and analyzed the results of study 329 was published in a professional journal. The authors of this article included two GSK employees who authored GSK's final clinical report for study 329.

The 329 study has recently been the subject of yet more controversy.

Jon Jureidini and Leemon McHenry have pointed out to the Journal of the American Academy of Child and Adolescent Psychiatry that the published evidence of fabrication, plagiarism and failure to disclose conflicts of interest on the part of its authors should deem that the original publication be retracted.

Unlike The Coast, the Journal of the American Academy of Child and Adolescent Psychiatry refused to retract the study finding that paroxetine was safe and effective in adolescents.

For more on Paxil 329 visit the Healthy Skepticism website and view the internal documents. Another great source is the book 'Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial' by Alison Bass.

Investigative journalist Evelyn Pringle has written 41 articles on Paxil HERE

If reading isn't your thing then sit back and watch the following video HERE







Newspaper Issues Apology to Canadian Politician Stan Kutcher



Yesterday I ran with an article regarding Halifax doctor/psychiatrist/politician Stan Kutcher. Kutcher, who is hoping to be elected on Monday, is the federal Liberal candidate in Halifax, Nova Scotia.

Kutcher had been featured in an article in an online newspaper called 'The Coast.'

It now appears that 'The Coast' have retracted the article and offered Kutcher a full apology, furthermore, they have agreed to make a donation in his name to the Mental Health Foundation of Nova Scotia.

The statement can be viewed HERE

The back story to the now retracted article can be read HERE







Friday, April 29, 2011

Stan Kutcher "Vote Paxil"

Image: deliberation.ca




Denial - a psychological process by which painful truths are not admitted into an individual's consciousness.

It's not often you come across public figures running for office in Canada who have controversial ties to the Paxil 329 study, quite rare, so rare that the newspaper who initially ran with the headline, "Stan Kutcher involved in controversial drug test, Liberal candidate for Halifax co-authored problematic Paxil study." has now removed the story from its online page.

Kutcher is the Liberal candidate for Halifax [Canada] in Monday’s federal election. It appears he is using his expertise as a doctor to get his foot on the political ladder.

For those that don't know, Kutcher was involved in the controversial drug trials known as the Paxil 329 study.

Healthy Skepticism, the website which brought the study to light, writes:

The study was published in 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry with Martin Keller as the primary author. This misleading paper has been a focus of interest for Healthy Skepticism since 2002. In 2003 we wrote to the Editor of JAACAP raising concerns about the misleading reporting by the authors that exaggerated benefit and downplayed adverse effects. (We also questioned editorial functioning, which drew an angry response from the Editor). In 2004 CMAJ published an Editorial which showed that in 1998 an internal GSK document clearly acknowledged that GSK were aware that 329 was negative. A subsequent law suit by New York Attorney General, Eliot Spitzer, was settled out of court.

It was Kutcher's job to oversee the trials, the results of which were published in 2001, with Kutcher as a co-author.

The article, initially published in the The Coast Halifax yesterday [but now removed] wrote:

Documents later made public through lawsuits demonstrate, the initial outcome measures in the study showed that there was no difference in therapeutic benefits between Paxil and the placebo, but those measures were changed to give Paxil a more favourable result.

Yesterday's article continued with:

Kutcher was in the past paid by GlaxoSmithKline and other drug companies, but has not made the dollar amount of those payments public.

Kutcher says he stands by the Paxil 329 study. “I don’t think that study caused any particular controversy,” he says. “There certainly is a group of people who would like to cause a controversy around it, but science is nasty, brutish and long.”

Indeed, as co-author of a 2008 Canadian Academy of Child and Adolescent Psychiatry “Position Paper on Using SSRIs in Children and Adolescents,” Kutcher refers to “positive” results in the problematic Paxil 329 study and completely ignores negative results published in 2006 from further GSK-sponsored research on Paxil in treating depression in adolescents in which he was also involved.

Kutcher's campaign page kind of leaves a bitter taste in the mouth wihere he writes the following:

I believe that my broad experience in health care, community activism and international social issues has given me the skills necessary to represent you in Ottawa. With your support I will be a staunch advocate for the economic and social prosperity of our region and for the future of our children.

His biography page, once again, emphasises his work with children:

Stan is a doctor, teacher, researcher and innovator working in adolescent mental health locally, nationally and with the World Health Organization. He has spent his career working to improve the lives of young people and their families.

What was it Stan told The Coast newspaper again?

“I don’t think that study caused any particular controversy,” he says. “There certainly is a group of people who would like to cause a controversy around it, but science is nasty, brutish and long.”

With respect Stan, you were not paid to think, you were paid to oversee a pediatric clinical trial, a trial that promoted the use of Paxil in children.

Nice work Stan! Let's hope you get the votes you crave on Monday.








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