Monsanto Roundup Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Thursday, November 28, 2013

Adam Lanza and the GC/MS Screening Method




A few weeks ago I wrote about Adam Lanza, moreover, the secrecy surrounding his medical records. [See
Adam Lanza - Why the Secrecy Over His Medical Records?]

Lanza fatally shot twenty children and six adult staff members in a mass murder at Sandy Hook Elementary School in the village of Sandy Hook in Newtown, Connecticut. He then took his own life by shooting himself in the head.

Now, it seems, we can simply put to bed the link between Lanza and any medication he may have been taking prior to his murderous and suicide act, at least that's what the mainstream media are telling us.

There are many conspiracies that have evolved since Lanza killed himself and others. He never acted alone, he doesn't even exist, are just a couple of theories doing the rounds.

Quite often the truth is missed by misinformation. Now I'm not suggesting for one minute that the US government or the pharmaceutical industry would start such rumours but it's one we have to take on board if we are to get to the truth about Lanza and the treatment he was receiving.

Open the Lanza files and you are faced with the proverbial can of worms, with each wriggle and slither these worms are telling us that there is more to this than meets the eye.

A few days ago Connecticut authorities released a 44-page summary of their investigation into the Sandy Hook shootings, 'summary' being the operative word here because none of it really adds up, particularly with regard to Lanza and any treatment he may have been receiving.

By way of proving that Lanza wasn't on any medication at the time of his 11 minute rampage officials have released his toxicology report [Fig 1] which, bizarrely, is incomplete and, let's say, less than vigourous if we see the tests that were carried out during post-mortem.

Fig 1 - Click to enlarge
The cause of death was pretty obvious, Lanza shot himself in the head. As I am led to believe a medical examination would not routinely look for recent past use of prescription medicines including psych drugs where the cause of death is obvious.

If Lanza had abruptly stopped taking medication then this could have led to akathisia and rage, meaning that the parent substance may not have been detectable.

If we look at Fig 1 we can see the term 'GC/MS'. This stands for gas chromatograph/mass spectrometry. What it does not tell us, however, is the Limit of Detection (LOD) when using the GC/MS method.

A 2011 published paper by Thomas G. Rosano, Michelle Wood and Thomas A. Swift highlights just how limited the GC/MS test is when it comes to detecting medications.

The study, Postmortem Drug Screening by Non-Targeted and Targeted Ultra-Performance Liquid Chromatography–Mass Spectrometry Technology, was published in the Journal of Analytical Toxicology [1]

It showed that the detection sensitivity using the GC/MS screening method came in at just 71%.  However, when combined with other screening methods, the GC/MS performed much better. In Lanza's toxicology report we see no sign of any medication. We also see that the GC/MS screening method was used.

Let's just take you through some of their findings.

When using the GC/MS screening method no traces of Aripiprazole [Abilify] were found.

However, when they combined GC/MS with other screening methods they found 7 traces of Aripiprazole.



Here's some more.

Fluoxetine [Prozac]

GC/MS found 11. When combined with other screening methods 14 were found. In other words using the GC/MS screening method alone missed 3.

Nortriptyline [a tricyclic antidepressant]

GC/MS found 9. When combined with other screening methods 12 were found. GC/MS screening method alone missed 3.

Quetiapine [Seroquel]

GC/MS found 8. When combined with other screening methods 15 were found. GC/MS screening method alone missed 7.

Risperidone [Risperdal]

GC/MS found 0. When combined with other screening methods 5 were found. GC/MS screening method alone missed 5.

Trazodone, an antidepressant of the serotonin antagonist and reuptake inhibitor (SARI) class.

GC/MS found 10. When combined with other screening methods 17 were found. GC/MS screening method alone missed 7.

Lorazepam [Ativan] 

GC/MS found 1. When combined with other screening methods 2 were found. GC/MS screening method alone missed . [Just a 50% success rate]


So, the burning question here is why did Adam Lanza's medical examiner just use the GC/MS screening method?

Was it purely down to the fact that the cause of death was obvious so there was no need to determine if Lanza was on any particular type of medication? Was it down to cost? To run a combination of screening methods would cost a lot of money. Or, in Dr H. Wayne Carver [Chief Medical Examiner], do we have a professional who is already of the opinion that psychiatric medications do not cause homicidal and suicidal acts - ergo no reason to screen for specific medications using more robust screening methods?

The investigation [44-page summary] suggests that Lanza had "significant mental health issues". Such statements would suggest that Lanza was, or had at some point, been on medication.

Today we see some of the parents of those who died at Sandy Hook asking why Nancy Lanza [Adam's mother] didn't do more for her son. If the GC/MS screening method had been combined then maybe we might have been asking different questions. If Lanza's psychiatrist/psychologist were to step forward then maybe they could shed light on whether or not Lanza was, at any point, taking prescription medication.

Adam Lanza, like other school shooters before him, had, according to the mainstream press, mental problems. What exactly were those problems, what was he diagnosed with? Depression, Bi-Polar, ADHD, Aspergers? Which one of the many hundreds of psychiatric disorders show a symptomatic checklist that states "Patient may have the urge to kill his mom" or "Patient may have the urge to kill innocent adults and children then self".

The parents have a right to know and they have a right to call it as they see it.

Unfortunately using the GC/MS screening method as a standalone may be sending out the wrong messages and, once again, giving a clean bill of health to psychiatric medication. Or maybe we just need to convince medical examiners that there is an undeniable link to prescription medications and homicidal/suicidal acts.

It may be worth revisiting this post, if only to witness Assistant Attorney General for Connecticut, Patrick B. Kwanashie and his two minute performance captured on film. The whole reason why this video surfaced on youtube is explained in the post.



Bob Fiddaman







[1] Postmortem Drug Screening by Non-Targeted and Targeted Ultra-Performance Liquid Chromatography–Mass Spectrometry TechnologyJournal of Analytical Toxicology, Vol. 35, September 2011


Letters From Generation RX - Radio Interview



Kevin has been instrumental in creating awareness regarding the way psychiatric prescription medications are handed out willy-nilly to patients whom are rarely informed about the side-effects.

In Kevin's ground-breaking first movie, Generation RX, he showed the infiltration of the DSM and FDA by pharmaceutical companies and the volume of people who seem to be profiting from the sales of these drugs.


In this interview, from Truth News Australia, Miller talks about his new movie, 'Letters From Generation RX'.
It's well worth the listen particularly for the way Miller explains how people are targeted when they speak out against the pharmaceutical industry and psychiatry.







If you are having difficulty with the player then you can download the MP3 direct HERE


Kevin P. Miller can be followed on Twitter here and the 'Letters' Facebook page is here.



Bob Fiddaman



Related:

Exclusive: Interview With Kevin P. Miller (Letters From Generation RX)





Tuesday, November 26, 2013

ADHD - Making the invisible visible






ADHD - Making the invisible visible.

Quite a catchy title and one would expect anything that followed such a headline would be groundbreaking news.

In fact, the title should be ADHD - Making the backroom staff visible.

Alas, 'ADHD - Making the invisible visible.' is nothing more than an apparent  "Expert" White Paper on the 'disease' that nobody can see or prove yet is diagnosable and treatable.

The paper, we are led to believe, was put together by Susan Young (King’s College London, Institute of Psychiatry, UK), Michael Fitzgerald (Trinity College, Dublin, Ireland) and Maarten J Postma (University of Groningen, the Netherlands). I say 'led to believe' because we really don't know anymore if anything published by key opinion leaders is actually their own work. I guess we just have to accept that Young, Fitzgerald and Postma are the original authors and these are their own findings.

The paper, we are told, was "initiated, facilitated and funded by Shire AG and supported by the European Brain Council and GAMIAN-Europe (Global Alliance of Mental Illness Advocacy Networks.)"

We are also told that "Medical writing support was provided by APCO Worldwide and Complete Medical Communications, and funded by Shire AG."


Ah, I see. So, it probably was ghostwritten, right?

What exactly is "Medical writing support" and who, exactly, are APCO Worldwide and Complete Medical Communications?

APCO are an independently-owned PR firm in the United States who have an impressive list of former and current clients including, Bristol-Myers Squibb and Merck Sharp & Dohme.

Complete Medical Communications [CMC] are, in essence, a retail by proxy outlet for the pharmaceutical industry. A 2012 snapshot of their webpage clearly shows the service they offer:

"CMC is a leading healthcare communications company, in business for over 20 years. Over that time we have helped global clients negotiate an array of challenges along the drug-development pathway, combining tried and trusted approaches with fresh and creative ideas."


So, it's really quite easy to see why the financial backers of this paper, Shire AG, wanted CMC on board. CMC have nothing to do with diseases [ADHD is supposedly a brain disease.] By CMC's own admission they "negotiate an array of challenges along the drug-development pathway" - in layman's terms, they think of ideas to promote a drug without it actually looking like promotion.

Furthermore, CMC offer the following services:


  • Brand consultation at all phases of product life-cycle (pre-launch, launch, post-launch) 
  • KOL programs
  • Journal submissions and supplements 
  • Slide kits
  • Posters 



They also plan events for...


  • Regional, national and international meetings 
  • Advisory boards
  • Speaker tours 
  • Preceptorships 


Do Shire AG have any interest in getting this ADHD information out there to the masses?

You betcha.

Shire, market and manufacture Adderall, one of the most popular ADHD drugs in the world. The patent for Adderall expired in 2009 but it was soon back in the hands of Shire when, in 2011, they released Adderall XR (extended release) - basically, they changed a molecule here and there, rebadged the original Adderall and came up with Adderall XR.

Genius hey?

Not quite, we've seen this happen so many times with other drugs. Celexa patent runs out and Lexapro arrives [same drug] Wellbutrin patent runs out and Zyban arrives [same drug], Prozac patent expires and Sarafem appears to treat premenstrual dysphoric disorder, that's PMS to you and me. Prozac and Sarafem are the same drug. Eli Lilly saw sales of Prozac fall when the patent expired around 2001 so they, probably with the help of someone like CMC, re-evaluated the situation and overnight Prozac was changed from a neutral green and white capsule to a feminine Pink-and-purple capsule.It was then aggressively marketed with women being the target population.

In 2007 the FDA granted a licence for another Shire drug, namely Vyvanse. In 2008 it was approved for use in adults, in 2010 the FDA approved it to be used in adolescents.

So, what is Vyvanse indicated for?

In a nutshell, ADHD.

Back to the 'expert' paper "ADHD - Making the invisible visible"


Without looking into it's content we see that it is funded by Shire AG and supported by the European Brain Council.

I've wrote about the European Brain Council before.

In 2012 the European Brain Council  launched "The Year of the Brain". It's something that the EBC have been promoting for the past few years now, so much so that they are pushing for 2014 to be made the European Year of the Brain.

Here's their goals:

1. Increased public profile of all brain diseases in every member state
2. Increased access to education and information for patients
3. A measurable reduction in stigma
4. Raising the profile of good brain health and how to optimise brain health /prevent deterioration
5. Draw political attention to the costs and impact of brain diseases now and into the future
6. Increased research funding through the framework programmes and in the member states

And who is the Executive Director at the European Brain Council?

Step forward Mr Alistair Benbow, former European medical director at GlaxoSmithKline. Benbow was also Glaxo's Seroxat spokesperson back in the early 2000's. Seroxat, if you didn't know, is the UK brand name for paroxetine, better known as Paxil in the US and Canada and Aropax in Australia and New Zealand.


So, do we really need to open this 'expert paper' to read it's content or does the financial backing, medical writing and conflict of interest already tell us that it is going to be nothing more than a push to use more drugs on a condition that was invented by the pharmaceutical industry?

The paper is split into three chapters:

Chapter 1 provides information on the burden of ADHD on the individual, families and society.

Chapter 2 reports data from recent studies of ADHD, which further highlight the need for timely diagnosis and effective management approaches.

Chapter 3 outlines a number of policy considerations and recommendations for action with regard to raising informed awareness of ADHD, improving access to early and accurate diagnosis, improving access to treatment and care, involving and supporting patient organisations and encouraging a patient-centred research agenda.

I don't know about you but it's hardly going to be a cliffhanger, is it?

None the less, it's probably a great work of fiction.

You can download it here, if you so desire.






ADHD is a huge cash cow for the pharmaceutical industry. They have, over many years, carefully structured a marketing plan of which the first rule is to get the public to fear ADHD. A disorder becomes a disease because the word 'disease' has negative connotations.

ADHD - Making the invisible visible is just part of a huge jigsaw. When the jigsaw is complete it will have a hidden message, one that reminds me of the movie 'Contact' with Jodie Foster. Basically, Dr. Eleanor Arroway [Jodie Foster] works with SETI (Search for Extraterrestrial Intelligence Institute).

One day Arroway unexpectedly hears a powerful signal: a prime number pattern emanating from the star Vega, confirmed by others the world over, undeniable and strong in its pulsing power.

However, a video feed of Hitler is found mixed into the prime number pulse pattern. It is from the 1936 Olympics.

Look carefully into the whole ADHD promotion and you will see pretty much the same, a hidden message so famous that we have all started to accept it without questioning it.

Slice ADHD in half and you will see something not to dissimilar to what Arroway witnessed in Contact.

You just have to join the dots until eventually it hits you in the face.

"If you tell a lie big enough and keep repeating it, people will eventually come to believe it. The lie can be maintained only for such time as the State can shield the people from the political, economic and/or military consequences of the lie. It thus becomes vitally important for the State to use all of its powers to repress dissent, for the truth is the mortal enemy of the lie, and thus by extension, the truth is the greatest enemy of the State." - Joseph Goebbels, Reich Minister of Propaganda 

Question I'm asking here is quite simple, who is the modern day Goebbels, is it the medical writers, the key opinion leaders, Alistair Benbow or Shire?

Contrast all of the above with two recent news stories.

This one from the Irish Examiner, "Children prescribed ADHD medication unnecessarily, study claims", which highlights a 60% increase in the prescription of drugs for children with ADHD in the past six years.

...and this one that appeared on the CCHR website yesterday, With Nearly 5 Million U.S. Children on ADHD Drugs, Doctors Finally Express “Concern”, an article that states, "Recently published research in the British Medical Journal says doctors are concerned that children may be receiving an inappropriate diagnosis of ADHD."

So, you want to know who is telling the truth here?

Do what Dr. Eleanor Arroway [Jodie Foster] did.

Investigate it!







Bob Fiddaman




Monday, November 18, 2013

Sally K. Laden, The Paxil Ghostwriter Part III - Summation








"So Sally can wait, she knows it's too late as we're walking on by
Her soul slides away, But don't look back in anger, I heard you say."

"Don't Look Back In Anger" - Noel Gallagher



My summation is based upon two previous entries.

PART I

PART II




Raw data is like raw sewage. Dive into it and you'll be able to taste a lot of shit.

Fellow blogger and ex-psychiatrist, Mickey Nardo, who writes the 1boringoldman blog, hit the nail on the head a couple of days ago.

Nardo, like many others, has been writing about Study 329. He's dissected it bit by bit and thrown up some valid points. One such point, which really sums 329 up, came about after he read the depositions of both Sally K. Laden and Marty Keller.

"Neither the first author nor the ghost·writer looked at the actual data. I find that remarkable…", Nardo writes.

My  previous two posts highlighting Laden's deposition show that she was handed a summary of the clinical trial GlaxoSmithKline carried out in depressed kids. The actual clinical trial findings were bundled into a 1400 page document. Laden worked from just 200 pages that Glaxo gave her.

Keller, who was paid by Glaxo to add his name to Laden's work, had this to say when he was deposed:

"I've reviewed data analytic tables. I don’t recall how raw it was. Huge printouts. You know, that list items by item number. Item numbers and variable numbers. And don’t even have words on them. I tend not to look at those. I do better with words than I do with symbols."

Let's imagine for one minute that Laden and Keller are airline crash investigators and GlaxoSmithKline are an airline company. [GSK Airlines]

One of Glaxo's aircraft, Flight 666, goes down, killing all passengers on board. Laden and Keller are called upon to investigate the crash. The black box is found, it contains an hour of audio that is vital to the investigators but Glaxo, for some reason, deleted 40 minutes of that audio before handing it over to Laden and Keller.

Laden and Keller then work from the 20 minutes of audio that they have. As experienced investigators neither ask Glaxo if there is any more audio, they are happy to work from just 20 minutes of audio.

With the investigation complete Laden and Keller lay no blame on GSK Airlines, they blame pilot error.

Just before the press release GSK Airlines contact other experts in the field of aviation. They show them the findings of Laden and Keller and ask them if they would lend their names to the report. The following internationally respected air crash investigators add their support to the findings of Laden and Keller, like Laden and Keller none of them have had access to the original 60 minutes of audio from the black box.

Boris Birmaher, Gabrielle Carlson, Gregory Clarke, Graham Emslie, David Feinberg, Barbara Geller, Owen Hagino, Rachel Klein, Harold Koplewicz, Vivek Kusumakar, Stan Kutcher, James McCafferty, Rosemary Oakes, George Papatheodorou, Neil Ryan, William Sack, Michael Strober, Michael Sweeney, Karen Wagner, Elizabeth Weller and Nancy Winters.

This, for me at least, is the perfect analogy but there's a further twist...

Some years down the line GSK Airlines are sued by a passenger. John Doe slipped on an apple peel whilst walking to his seat on Glaxo's 747.

During the trial, John Doe v GSK Airlines, items of disclosure reveal secret emails between GSK Airlines, Keller and Laden that pertain to the crash investigation. Doe's law team have stumbled upon something that they weren't supposed to. They learn that GSK Airlines have covered-up the crash, they learn that the principle investigators, Laden and Keller worked from 20 minutes of audio and not 60. Further investigation shows that the missing 40 minutes of audio highlights what really happened aboard Flight 666. It was not pilot error, the airline company [GSK Airlines] were at fault. Ground control at GSK Airlines had put in the wrong flight coordinates causing Flight 666 to crash into a hillside killing all on board.

These findings are handed over to the Civil Aviation Authority who, after a 4 year investigation, find that GSK Airlines withheld vital information. However, the Civil Aviation Authority announce that no criminal charges will be brought against GSK Airlines, instead they send a letter to GSK Airlines CEO telling him that they are not happy with the cover-up/fraud [See GSK investigation concludes]

In one final twist, it is learned that the Civil Aviation Authority have two ex-employees of GSK Airlines on their board, one of whom, Ian Hudson, was a former airline safety expert during his time at GSK Airlines, he also worked very closely with overseeing the safety of Flight 666.

Perversely, and some years down the line, Ian Hudson accepts the role of CEO of the Civil Aviation Authority [See Former Glaxo Safety Officer Becomes Head of MHRA]


You smell corruption here?

There are a number of reasons why I chose, back in 2006, to create this blog. There are many more reasons why I continue to write.

You see, I was prescribed Paxil and I had a number of adverse reactions to it. I became addicted to it, I couldn't get off it, any attempt to do so was met with severe electric head zaps, feelings of aggression and, more importantly, one suicide attempt.

The more I dug, the more I learned.

A hat tip goes out to investigative journalist Evelyn Pringle. It was only through reading her work that I continued to push for answers from both GSK and the UK Medicines Regulator, the MHRA.

Another hat tip must go to BBC journalist Shelley Jofre. Four Panorama investigations into GSK, Paxil and the MHRA put fire in my belly.

Alison Bass, who wrote Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, also deserves a lot of credit for highlighting the fraud behind Study 329.

There's also the work of David Healy, originally chastised by fellow psychiatrists for speaking out about the suicide link between kids and Paxil and other antidepressants.

Plaudits must go to John Jureidini and Leemon McHenry. Their tireless pursuit in trying to get Study 329 retracted from the Journal of the American Academy of Child and Adolescent Psychiatry should be met with a standing ovation.

The guys and gals over at Healthy Skepticism, who really started the ball rolling when they published 329 study documents online. A huge thanks should go to the team there.

The Citizen's Commission on Human Rights, have been banging the drum since God knows when regarding the suicide link and antidepressants, they too should take credit here.

Former US Senator Charles Grassley for giving GSK many headaches deserves, at the very least, an honourable mention as do the team at Baum, Hedlund, Aristei & Goldman, California's top ranked law firm who have spanked Glaxo and King & Spalding on numerous occasions.

There are many more who deserve credit, many of them bloggers...far too many to mention.



I walk alone across the outskirts of town
I can’t control what I’m going through now
Will you light the fire that I need to survive
Will you donate the life blood
Coursing through my veins
Will you open up the door & let me out of this place

"Strength" - The Alarm 1985




Further down the line I learned of the devastation Paxil had caused to families who were left to grieve the loss of their children, namely Sharise Gatchell and Sara Carlin, two young teens who both hanged themselves after being prescribed Paxil.

I have since met a number of families who have lost children and partners to a number of selective serotonin reuptake inhibitors [SSRIs] of which Paxil is one. As a parent I would just hate to utter those words, "my child killed himself/herself". It would be so hard for me to accept that one of my children had killed themselves, even harder to accept that they had suicided as a result of the drug they were taking. A pill that was meant to help them actually caused psychosis resulting in them killing themselves. The company/s that made the pills knew that this was a possibility but failed to warn because it would have affected their sales.

Death by hanging, death by jumping from a bridge, death by stabbing, death by overdose all because top pharmaceutical companies wanted to stay ahead of competitors.

It's the loss of life that carries me. It was so needless, particularly when we learn that these deaths could have been avoided if it wasn't for greed.

I am an extremely lucky person. My own experience at the hands of Paxil has, quite possibly, saved the lives of my three children. I was the guinea pig and I am thankful for experiencing Paxil induced suicide and the horrific withdrawal problems [addiction]. It was information that I was able to relay to my children. They, in turn, will relay the same information onto their children.

I'm lucky I can write about other people's kids killing themselves because I can always switch off and sleep at night, I don't have that overwhelming burden of grief to carry.

It's quite a position to be in. My heroes are not the academics, lawyers, journalists and human rights movement I listed above. My heroes are the parents of the dead children and partners. Neil and Rhonda Carlin, Steph Gatchell, Leonie Fennell and Tony Donnolly, Elaine Billings, Sara Bostock, Kim Witczak, Mathy Downing, Stuart and Claudette Jones, Celeste Steubing. And these are just the people I have met or corresponded with. My heroes are also those parents who lost their children because they were not warned about the risk of SSRI toxic poisoning during pregnancy. Christian and Matt Delahunty, Amery and Christiane Schultz, all of whom lost their babies to the antidepressant Effexor.

I've met many more in passing.

Each time I look at the list of my heroes I feel terrible sadness but a deep, underlying fighting spirit emerges from within. My sadness for their loss is insignificant. Why should I care about my own sadness when it is nothing compared to theirs? These parents and partners don't need my sympathy or empathy, they need answers as to why their children and partners were allowed to be given a drug that could induce their suicide and/or toxic poisoning. I want to embrace each and every one of them and somehow make their pain go away. I know that is an impossibility. Their loss will be with them forever, meantime I can sleep it off.

I will never be able to understand where they get their strength from to continue, they will probably tell me it's just a natural instinct to survive but as I sit here now and ponder... or at least try to ponder the unthinkable, I don't actually know if I could find the strength in me to survive after such a loss. All of the above have and continue to do so, each of them spreading awareness when it would have been so much more easier [and beneficial to the pharmaceutical companies] for them to accept death, deal with the rawness of the loss then try to move on in life as best as they could. For that they are heroes in my eyes. they are dealing with their own loss yet preventing, or trying to prevent the loss of others with the awareness they create. That's heroic by anyone's standards, it's a superhuman effort and they should each stand tall.

If I knew something was afoot about their deaths and did nothing about it then I, unlike the Paxil 329 Study authors, wouldn't be able to sleep at night.

If 329 was an airline crash study then the general public would, I'm sure, be outraged. At the very least there would be calls for a retraction of the findings from Laden, Keller et al. There would, I'm sure, be calls for the Civil Aviation Authority to be policed due to the blindingly obvious conflict of interest.

Alas, GSK are not an airline.

The MHRA are not an airline regulator.

Laden, Keller et al are not airline crash investigators.

They are all, in essence, part of a huge cover-up instigated by a British pharmaceutical company who sought profit before safety.

Sally Laden, Marty Keller, Boris Birmaher, Gabrielle Carlson, Gregory Clarke, Graham Emslie, David Feinberg, Barbara Geller, Owen Hagino, Rachel Klein, Harold Koplewicz, Vivek Kusumakar, Stan Kutcher, James McCafferty, Rosemary Oakes, George Papatheodorou, Neil Ryan, William Sack, Michael Strober, Michael Sweeney, Karen Wagner, Elizabeth Weller and Nancy Winters should all take a bow. They each have a responsibility to safeguard the public. Not one, to my knowledge, has called for Study 329 to be retracted. Not one, to my knowledge, has been angered enough to publicly chastise GlaxoSmithKline for duping them [if indeed they were duped]

All of the above should acknowledge that the study, initially drafted by Sally K. Laden, is misleading. By adding their names they have each persuaded a doctor to write a prescription for Paxil... for kids.

They should be utterly ashamed of themselves for duping fellow professionals and for putting kids in danger. They can each argue that they didn't know. Maybe so, but two points here.

1. They would have known if they would have asked for the full data

and

2. They know now but continue to defend their corners.


Finally, for now at least, there is one more twist in the tail.

The CEO of GlaxoSmithKline, Andrew Witty, was knighted back in 2012 for services to the economy and the UK pharmaceutical industry. For this he was given the title of 'Sir' and handed a medal from the Queen.

Witty has been asked, in a series of letters, to retract study 329 from the Journal of the American Academy of Child and Adolescent Psychiatry [see Witty's Era Still Smells of 329 Rotten Eggs]

Witty, via his spokespersons, does not agree that Study 329 was fraudulent and misleading.

Only John Grisham could come up with such a story.

I guess Witty has been instructed by Glaxo lawyers to never admit Study 329 is fraudulent. Deny, deny, deny is the rule of thumb here.

Glaxo's American lawyers, King & Spalding, who have defended Paxil on many occasions, have a Twitter account. If after reading Parts I, II & III of my Sally K. Laden series of posts you feel inclined to drop them a message then please feel free to do so. - @kslaw

They probably won't answer you but someone on their friend list may just get into debate with you. Glaxo, their lawyers and the likes of Sally K. Laden and Keller et al cringe at Study 329 debate, particularly when members of the public call for its retraction.

If, after reading this series of posts about Laden and 329 you feel compelled to share via Twitter and/or Facebook you, like me, will become frustrated at the lack of response from those on your friend lists who take little interest in antidepressants and suicide. I call these the 'fluffy  bunny brigade', although they are good people and great friends they much prefer not to involve themselves in your world of grief. A photograph of a fluffy bunny, cute kitten or puppy would get more responses if you were to post it on Twitter or Facebook.

These are the people that need educating because they too need to warn their children and their children's children that there's a bunch of adults who ghostwrite and add their names to published studies who really have no interest whether children or grandchildren live or die. We have, in GlaxoSmithKline, a company who have kept social media acquaintances in the dark about the safety of Paxil in children and adolescents, a company who refuse to retract 329.

I'll always strive to do my bit.

The rest is up to you.


Bob Fiddaman



Sally K. Laden's deposition can be downloaded here.






Sunday, November 17, 2013

Sally K. Laden, The Paxil Ghostwriter Part II - Emotional Lability






One, two, three, four, five,
Once I caught a fish alive,
Six, seven, eight, nine, ten,
Then I let it go again.
Why did you let it go?
Because it bit my finger so.
Which finger did it bite?
This little finger on my right.



Following on from Part I, today I am trying to decipher, along with Sally K. Laden, what the term 'emotional lability' means, more to the point whether or not Sally K. Laden knew as far back as 1998 if 'emotional lability' meant suicide attempts.

Before I move on I'd like to list Laden's qualifications again.

Laden graduated in 1981 from the University of Connecticut with a Bachelors degree in Pharmacy and in 1983 from the Kansas University with a Masters degree in Hospital Pharmacy.

In 1985 Laden became the Associate Editorial Director - Scientific Therapeutics Information [STI]

She has been self employed since 2003, working from home for the business she founded, MSE Communications LLC where she is a Freelance Medical Writer. According to her LinkedIn profile she is also a Developmental Editor for Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, and has been since January 2013.

Laden is also a member of the American Medical Writers Association.

So, a Bachelors degree and a Masters degree. Quite safe to assume then that Laden is quite well educated, in other words she's not stupid, the definition of which is; lacking intelligence or common sense.

In part I it was established (If Laden was telling the whole truth, that is) that GlaxoSmithKline handed over approx 200 pages of a clinical trial they had carried out using paroxetine [Paxil] to treat depression in children and adolescents. By Laden's own admission, "I believe it's considered a synopsis of the report rather than each individual patient's data".

In fact the entire clinical study report was over 1400 pages long yet Laden only saw 200 of these. Hardly the basis of drawing up such an important draft, particularly when it involved medicating children and adolescents. Here, I do question Laden's lack of intelligence or common sense. It's okay to question, right?

Nonetheless, Laden came to the conclusion [based upon the 200 pages] that Paroxetine is a safe and effective treatment of depression in the adolescent patient."

Maybe her conclusion was correct on the basis that Glaxo only gave her 200 pages. Maybe Glaxo omitted the other 1200 pages because Laden may have arrived at a different conclusion?

Key:

Q = George Murgatroyd (Baum Hedlund)
A = Sally K. Laden


Q: So you relied upon GSK in providing you with accurate information, correct?

A: Yes

Q: And to the degree that that information is inaccurate that's not your fault right?

A: It's not my fault?

Q: Yes. If you wrote something in the manuscript that's inaccurate, that was based upon information that was provided to you by GSK, it would not be your fault if you wrote something inaccurate, correct?

A: I guess, correct.

Q: Okay. Now I mean do medical writers have the responsibility to go back and look at the raw data to see if the interpretation of that data is correct?

A: I don't believe so

...

Q: Okay. You know GSK coded the suicide events in Study 329 as Emotional Lability. Are you aware of that?

A: Yes

Q: Were you aware of that fact at the time you prepared the first draft of the manuscript?

A: I don't know

Q: How did you become aware that that term was being used to cover suicide attempts?

A: It must have been in a document. In whatever document I was given.

Q: Okay. So when you prepared the first draft you knew that Emotional Lability was included?

A: Again, I don t know if I had this at the time of the first draft. I don't know. I cannot say that I had this document that is sitting in front of me at the time I wrote the first draft and I would have to look and see what is in here.

Q: Okay. Well let me maybe back up for a second. When you prepared the first draft of the manuscript were you aware of the number of adolescents who experienced events involving suicidality? Just suicidality events, suicide events?

A: Completed suicide?

Q: No just events involving suicidality?

A: I don t recall

At this point Murgatroyed tells Laden to look at her draft.

Q: Did you find something in the first draft that talks about suicidality?

A: There is the Emotional Lability

Q: Okay. How about suicidality?

A: No

Q: Okay. My question is do you know what the term Emotional Lability means?

A: Emotional means you have emotions. Lability means you re waxing and waning.

Q: Okay. And when you wrote the manuscript did you know that that was the topic that GSK stuck the suicide events under?

A: I don't know.  I don't remember.

Murgatroyed then asks Laden if she was aware that the FDA analysed Study 329 with regard to adverse events. Laden replied, "I am aware of that."

Murgatroyed then showed the results of the FDA to Laden.

Q: And it says drug, meaning Paxil 6.5%,  Placebo 1.1%, Risk ratio equals 5.9%, do you see that?

A: I see that

Q: Do you know what a risk ratio is?

A: My understanding is that it's statistical language comparing one thing with another of the probability of an event happening.

Q: Okay. In this instance an adolescent taking Paxil is almost six times at the risk of experiencing possible suicide related event compared to an adolescent taking placebo, correct?

At this point the attorney representing Laden, Stuart Margohs (Berdon Young & Margohs), interrupts...

"That is one question. The other question is whether or not you can tell if that is a depressed adolescent or not."
Murgatroyed points out that Study 329 was a study involving depressed adolescents.

Back to the questioning of Laden

Q: Do you think it s appropriate to promote Paxil as safe when over 5 percent of the adolescents taking Paxil during clinical trials of 329 attempted suicide?

A: I can't answer that question. I am not an expert to know whether 5 percent is a dangerous risk in a dangerous disease or 50 percent is a dangerous risk in a dangerous disease. An expert would know that. I'm not an expert.



Is it safe to assume that Laden is not answering the question put to her by Murgatroyed because she actually knows that over 5% of kids taking Paxil who attempted suicide is really an appallingly high figure?

Let's just take a look at Sally Laden's education once more.

Laden graduated in 1981 from the University of Connecticut with a Bachelors degree in Pharmacy and in 1983 from the Kansas University with a Masters degree in Hospital Pharmacy.

And yet Laden cannot seem to answer a simple question about whether or not she thinks over 5 percent of the adolescents taking Paxil during clinical trials of 329 who attempted suicide is appropriate.

One does not need to be an expert. All Laden needed to do here was hold up both hands, keeping one closed in a fist and the other fully open showing her five digits. Her closed fist representing placebo, her open hand showing her fingers and thumb representing the percentage of kids attempting suicide whilst on Paxil.

If this question was not answerable because Laden is 'not an expert' then her degrees in Pharmacy (a four-year course) really mean nothing.  The course would have given Laden a broad understanding of the pharmacy-related aspects of chemistry and biology. The course would have also covered the science behind the preparation, supply and monitoring of medicines.

Are we expected to believe that she could not answer the above question because she wasn't an expert or was there some other reason?

Laden knows how to read a prescription, she knows exactly how many pills she should put in a bottle but she cannot answer a question on whether it was appropriate that more kids attempted suicide on Paxil then they did placebo?

C'mon!

As I mentioned in Part I, Laden is married. What I failed to mention is that Laden has a son.

Here's my question to Laden. Her son is believed to be in his 20's. He would have been a small child around the time Laden prepared her first draft. If, during his teen years, let's say 13-18, he would have been dignosed with depression, would Laden have allowed a prescribing physician to give him Paxil to treat his depression?

I can only assume that the answer would be 'no' given that 5 percent of kids attempted suicide on the very same study that she wrote, "Paroxetine is a safe and effective treatment of depression in the adolescent patient."

Does she not feel that every parent has a right to know this information, if so, at what point did they need to know? 1998, 99, 2000?

Another way of looking at it is this.

Laden takes her son to see a child psychiatrist. The child psychiatrist tells her that her son is depressed. He informs her that he wants to try Paxil to help alleviate his symptoms of depression. He also tells her the results of the Paxil 329 study. "Mrs Laden, I have to inform you that five percent of kids attempted suicide during the clinical trials of Paxil, all of them were on Paxil at the time. I also have to tell you that none of the kids on placebo attempted suicide." Would Laden shrug her shoulders and say, "Ah well, I'm not really an expert, go ahead and write the prescription for my son."

I think not.

It's a luxury that many parents have never had. They were told it was safe. Doctor's prescribing it were told it was safe. Psychiatrists reading her ghost-written article have been told it was safe. The study has never been retracted from the Journal of the American Academy of Child and Adolescent Psychiatry. One would think, as a mother, Laden would be calling for its removal. Morally it would be the right thing to do. Her silence is, in my opinion, embarrassing.

Here's just one victim who died by suicide after being prescribed Paxil. Sadly, the young girl in this video never made it to her 20's. Glaxo denied that Paxil had anything to do with her death. Laden can bury her head in the sand and believe the same if she wants.




Bob Fiddaman

Part III HERE









Friday, November 15, 2013

Sally K. Laden, The Paxil Ghostwriter Part I

Sally K. Laden  The Paxil Ghostwriter



Much has been said about the fraud behind GlaxoSmithKline's Paxil 329 study, most of it negative. Fingers have been pointed at Marty "Bling Bling" Keller for putting his name to the study...or rather accepting money from GSK to have his name as the lead author. Glaxo themselves have been blamed, and rightly so.

I've yet to see anyone point the finger of blame on the ghostwriter, one Sally K. Laden.

Laden [no relation to Osama Bin] has pretty much come out of this unscathed, hey she was only doing her job - maybe so, but over the years she has had more than one opportunity to come clean or, at the very least, chastise Glaxo for duping her... if indeed she was duped?

So, who is Sally K. Laden?

Laden graduated in 1981 from the University of Connecticut with a Bachelors degree in Pharmacy and in 1983 from the Kansas University with a Masters degree in Hospital Pharmacy.

In 1985 Laden became the Associate Editorial Director - Scientific Therapeutics Information [STI]

She has been self employed since 2003, working from home for the business she founded, MSE Communications LLC where she is a Freelance Medical Writer. According to her LinkedIn profile she is also a Developmental Editor for Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, and has been since January 2013.

Laden is also a member of the American Medical Writers Association.

Her home and business address is situated in an affluent part of Cheshire, Connecticut, where she lives with her husband Michael.

The Deposition of Sally K. Laden

On March 15 2007 Laden was deposed (gave evidence under oath) by attorneys for the cases Cheryl J Cunningham et al versus SmithKline Beecham Corporation (GlaxoSmithKline), William P Williams versus SmithKline Beecham Corporation (GlaxoSmithKline) and Christopher Shibley versus SmithKline Beecham (GlaxoSmithKline). It's a fascinating deposition, particularly the way GlaxoSmithKline's defence attorney, Todd Davis (King & Spalding) is, on many occasions, shot down in flames by plaintiff attorney, George Murgatroyd (Baum Hedlund).

Representing Laden were Attorney Stuart Margohs (Berdon Young & Margohs) and Deanna Levine.

I'll address the 'shooting down in flames' later in this post. It's actually very satisfying to see a representative of King & Spalding being firmly put in their place.

Key:

Q = George Murgatroyd (Baum Hedlund)
A = Sally K. Laden


Q: Now you understand that you're here today in connection with lawsuits involving the drug Paxil?

A: Yes

Q: Okay, are you familiar with what the allegations are in any of the complaints?

A: Yes I am

Q: Okay, and what is your understanding of what they are?

A: Well my understanding is that the Plaintiffs children took their own lives while taking Paroxetine.

----

I think it's a good idea to read that last line of Laden's depo again. This deposition of Laden wasn't about her being paid to write the 329 study, it was about children taking their own lives whilst on GlaxoSmithKline's antidepressant Paxil.

The question is, did Sally K. Laden know that Paxil wasn't safe or effective in children before or during the time she wrote the study?



Let's move on...

Laden confirms to Murgatroyd that she was employed by Scientific Therapeutics Information [STI]


Q: Okay, is having articles published in peer review medical journals one way in which a drug company can promote it s drug to prescribing physicians?

A: No I don't consider that promotion.

Q: Okay, and would you agree that a journal article that you wrote that was positive in terms of the drug's efficacy and safety would help the drug company with the sale of it s drugs?

A: No I can't agree. I don t agree with that.

Q: Okay Well other than medical writing you said you were also involved in the business of setting up meetings?

Laden answers 'yes' and is then asked what type of meetings  she set up for GlaxoSmithKline...

A: Advisory boards Large CME (Continuing Medical Education) symposia at national meetings Such as the American Psychiatric Association (Laden later adds the American Academy of Family Physicians, Consulting meetings and consensus conference programs to her list)

----

Once I arrived at page 12 of the depo I was greeted with redacted text, this, as I understand, is due to the fact that Glaxo obtained a protective order. I may be wrong and there may be another reason for redaction. You can read about protective orders here, if so inclined.

The First Draft

Q: Do you know why it took you until December 18 1998 to prepare the first draft of this Study 329?

A: No

Q: Okay, where did the data come from that ended up in this first draft?

A: A clinical study report was provided to me.

Q Okay, who was that provided by?

A: I don't remember the person who sent it to me.

Q: Okay, but it came from GSK?

A: Yes


Murgatroyed then asks Laden if she received the entire clinical study report, which, he adds was "over 1400 pages."

Laden answers, "A clinical study report that STI would normally receive would probably be about 200 pages in length." She later adds, "I believe it's considered a synopsis of the report rather than each individual patient's data"


So, it's pretty crystal clear, to me at least, that Glaxo handed over a report to Laden that was condensed, watered down, cherry picked.


Lighting the Blue Touch Paper

Murgatroyed asks Laden to read the conclusion of her first draft. She reads:

"Paroxetine is a safe and effective treatment of depression in the adolescent patient. Further studies are warranted to determine the optimal dose and duration of therapy"


Q: Okay, and when you wrote those words were you aware that Paxil failed to achieve statistical significance in any but four of the 25 efficacy parameters that were analyzed by GSK?

A: I don't remember, you know, what I was aware of. This does not look outside the realm of what is standard. I reported the data accurately as far as I can tell in this result section that listed the items that were statistically significant.

Q: Well the final clinical study report clearly identifies two primary efficacy variables right?

A: Yes

Q: Yet your table three lists eight?

A: Yes

Q: How did that happen?

A: I don't know

Q: The primary study report lists five secondary efficacy variables. Your table four entitled Secondary Efficacy Variables lists three.

A: Yes

Q: How did that happen?

A: Again I do not remember those specifics.


Later Murgatroyed asks Laden the following:

"Prior to you preparing the first draft of the manuscript for Study 329 were you made aware of a position piece that GSK had internally developed that discussed the results of Study 329?"

Laden answers, "I don't remember". Murgatroyed replies, "Okay, then let me show you."


This seemed to cause great concern for the GlaxoSmithKline representative Todd Davis [King & Spalding]. Here's the dialogue between Murgatroyed and Davis.

DAVIS: I will object to the use of that document. This witness there wouldn't be any foundation that can possibly be laid that the witness is familiar with it or had any involvement with it And if you grant me a standing objection that will prevent me from having to object every time. Any problem with that?

MURGATROYED: I think we have already agreed Todd that all you have to object to is the form of the question. All other objections are reserved for the Court's ruling.

DAVIS: So will you grant me that objection both of you?

MURGATROYED: I'm not going to grant you any objection. We already agreed that all objections are reserved until time of trial with the exception to the form of the question.

Finally...

DAVIS: Let's move it along.

MURGATROYED: I know this document is very upsetting to you and GSK but that s tough.

DAVIS: It's not upsetting, It's just the fact that we are here talking about a document with a witness that doesn't know anything about it. It s not a very effective use of everyone's time.


Murgatroyed 1 Davis 0


Murgatroyed then discusses the document that Davis was, it appears, panic-stricken over.

Q: Were you made aware that GSK was disappointed about the results of Study 329?

A: No

Murgatroyed then asks Laden to read an internal GSK email from the document. She reads the following:

"As you well know the results of the studies were disappointing in that we did not reach statistical significance on the primary end points. And thus the data do not support a label claim for the treatment of adolescent depression."
King & Spalding attorney Todd Davis tries one more time to halt Murgatroyed from proceeding with his line of questioning...

DAVIS: Excuse me. And of course there has been no foundation laid by the questioning that this witness can answer any questions about this document.

Back to Murgatroyed questioning Laden...

Q: Let's take a look at the position piece that is attached to this email. What is that date?

A: October 1998

Q: And again that's two months prior to you submitting your first draft of the manuscript for Study 329?

A: Yes

Once again, Murgatroyed asks Laden to read the attachment. She complies:

"However the study failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures."
Murgatroyed then asks Laden to read another paged of the attachment, once again she complies with his request:

"To effectively manage the dissemination of this data in order to minimize any potential negative commercial impact."

Murgatroyed then asks Laden, "Are you familiar with the term potential negative commercial impact?"

Once again, King & Spalding's Todd Davis seems to blow a gasket.

DAVIS: This witness cannot speak to that document and what it means. And you have already deposed somebody We are wasting our time.

MURGATROYED: I m sorry, you can object to the form.

DAVIS: I object to the form. I also object that this is just a complete waste of time to ask this witness questions about a document she knows nothing about.

MURGATROYED: Todd, just object to the form and let s move on. That's the rules.

DAVIS: When did you say you're going to be done because I'm going to hold you, this is silly. It's silly.

MURGATROYED: Todd, I'm sorry this is upsetting to you.

DAVIS: It's not upsetting, It's a waste of time.


Murgatroyed 2 Davis 0


I must remember that should I ever cross paths with George Murgatroyed to buy him a drink of his choice.



End of Part One


Part II HERE


Bob Fiddaman

















If Study 329 Were a Fence



Nuff said.

Now watch the video




Bob Fiddaman



Children In Need




Children in Need  is the BBC's UK charity. Since 1980 it has raised over £600 million to change the lives of disabled children and young people in the UK.

Whilst I'm all for helping under privileged children, I also don't forget them when they die.

This is my tribute to those who have lost children to antidepressant induced suicide and antidepressant toxic poisoning.

Each and every victim in this video is someone's child. Let's never forget that.


They are children in need of justice.





RIP

Sara Carlin
Matthew Steubing
Sheryl Tilbrook
Sharise Gatchell
Toran Henry
Woody Witczak
Indiana Delahunty
Matthew Schultz
Candace Downing
Shane Clancy





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

Wednesday, November 13, 2013

ADHD Debunked by Human Rights Movement




Attention Deficit Hyperactivity Disorder, better known as ADHD by some, is, we have been led to believe, a neurobehavioral disorder or, in layman's terms, a brain that isn't working normally.

There are some who wear ADHD like a badge, many parents, school teachers etc will argue that ADHD does exist because they have witnessed it first hand. "You should come to the school where I work and see little Johnny in class, his behaviour disrupts the rest of the kids, he has ADHD."

Amazing isn't it, teachers and, to an extent, parents, have become brain specialists overnight.

ADHD is a controversial subject, particularly with the aforementioned. Tell a parent that the diagnosis given to their child is based on guess work and you will, more than likely, be met with defiance. It's the God factor coming into play folks.

Stick a white coat on a male or female, add one stethoscope and one copy of the British National Formulary and Voila, God is born.

Parents believe this quackery because Dr God has told them it exists.

This brings me conveniently to an article that appeared in the Irish Examiner earlier today. The article, entitled, 'Beware psychiatrists’ advice on ADHD', is the other side of the coin,  the side that prescribing physicians, parents and teachers choose to ignore because it flies in the face of Dr God, who remember knows what he is talking about.

Brian Daniels [Citizens Commission on Human Rights] hits the nail right on the head with:

"For decades, psychiatrists have been busily reclassifying sets of behaviour and emotions as ‘mental illnesses’. Strip away all of the psychiatric jargon, and you won’t find a scrap of scientific evidence to support the psychobabble."
I think the above quote from Daniels should be inscribed in stone and should be in every classroom across Britain nae the world. It's a gentle, yet persuasive, reminder that kids with behavioural problems are just that. They have nothing chemically wrong going on inside their, as yet, fully developed brains, in fact, according to the Children's Hospital Boston, teen brains are only around 80 percent developed, those that aren't teens 0-12, have less developed brains. [Source]

I have met Brian Daniels on a number of occasions, we have become very good friends during the time we have known one another. He's a passionate man, he's a rational man, a true humanitarian.

Most readers of my blog, according to my Google analytic stats, were kids back in the 1970's. Most, if not all, would have, at some point, been reprimanded at school. Poor quality handwriting, running in corridors, not wearing the correct school uniform or wearing the school tie with one of them huge knots we all thought looked so damn cool.

We would have all met those naughty kids, you know the ones, they used to backchat the teachers, those defiant kids.

9 times out of 10 they were sent to see the Headmaster/Headmistress who (if you were from my neck of the woods) were caned. Six of the best, three on each hand. Thank you sir, you have just given me my badge of honour. Yup, I used to love showing the marks on my hand to the other kids in the playground, two lovely red hands because farting is prohibited in church - Good old Catholic religion punishing flatulence!

Today, we don't have any form of physical punishment in our schools, rightly so if my experience of brutality for passing wind is anything to go by.

Instead we have children being naughty or who lack attention, all being punished with pharmaceutical drugs. This is what we have accepted because, well, because there really isn't much else in place to keep bad behaviour in check. Detention doesn't really work because those pesky kids just won't turn up for detention. Banning them from the sports team would only be met with 'Am I bovvered'.

So, something had to be done, right?

ADHD.

Not only will it explain away the behavioural problems as a brain disease it will also allow the child to proudly wear that badge. He/she can't show the red marks on their hands but they can proudly announce that they have something wrong with their brain because Dr God told their parents.

To be honest, I am sick to death of arguing with those who claim their child has ADHD. I think in future I will just reply, "No, they haven't" and then just continue walking away from them.

The full explanation of the fraud of ADHD can be read here.

Brian Daniels, take a bow sir, it's a profound interview with words so powerful that even Dr God could not argue with... although Dr God would probably diagnose you with some sort of delusional disorder, not because he can see it via a scan but because you disagreed with him.

Daniels and the CCHR continue to ply their passion via the CCHR UK website.

More power to them. CCHR just ain't gonna roll over, they are here, like me, for the long haul.

Here's just one small example of their work, it shows how children from the ages of 0-5 years are being labelled with disorders that just don't exist.

I salute Daniels. I salute CCHR.



Bob Fiddaman

Tuesday, November 12, 2013

GSK's Breo: "Don’t ignore the pneumonia risk!"




In the past GlaxoSmithKline have wined and dined ["dine and dash"] doctors as a means of getting their drugs ahead of competitors when it comes to filling out prescription pads. They are not the only pharmaceutical company to apply this tactic.

In the past GlaxoSmithKline have invited doctors to symposiums at lush holiday resorts, an all-expenses paid trip to do what you want to do providing you attend the symposium on this or that drug. Again, they are not the only pharmaceutical company to use this tactic.

On Oct 5, 2013, 100 of the top lung doctors in the U.S. gathered at a Hilton hotel in Houston. You see, Glaxo have a new baby they wish to hit the public with and one of the most effective ways to target the public is to target the agents who sell [prescribe] to the public.

Breo, Glaxo's new respiratory drug, is now on the advertising [by proxy] table but now the rules have changed. They can no longer tell doctors about the efficacy without first warning them of the dangers and much of the Hilton promotion was spent spelling out the dangers of Glaxo's new blockbuster drug.

Last year Glaxo were handed down a $3 billion fine for illegally marketing medicines, one of which was Advair, a respiratory drug. Glaxo were found guilty of pushing Advair for all asthma patients, even though it was only recommended for severe cases. Glaxo executives through their reps bribed doctors to prescribe Advair to patients that it wasn't meant for, in other words they told doctors that Advair was beneficial for minor asthma sufferers... when they knew that it wasn't. As a result FDA researcher David Graham estimated that long-acting beta agonists, of which Advair was one, contributed to an estimated 14,000 asthma deaths from 1994 through 2007.

“With the old way we did things, you emphasized the efficacy and benefits,” said James Donohue, a professor of medicine at the University of North Carolina who received a fee from Glaxo for chairing the Oct. 5 Houston meeting. “At the end, you’d always include the safety, but you just brushed over it. Now there’s a huge emphasis on the side effects.” [1]

So, what's with the new approach from GlaxoSmithKline, are we expected to believe that they have turned over a new leaf and are telling us everything about their drugs so we, the public, can make an informed decision as to whether we use their product?

It would be nice to think so wouldn't it. Alas, it appears that this new initiative only applies to Glaxo's new products and they are, more or less adhering to the US Justice Department. Glaxo are not doing this because it is right, they are doing it to avoid further fines.

If GlaxoSmithKline were that concerned about its products they would come out of that dark closet of denial and warn the public about the dangers of Seroxat [known as Paxil and Aropax].

Of course, they've already made their billions on Seroxat, it's since gone generic, which means other pharmaceutical companies can sell it.

Glaxo are claiming to be transparent and, in essence, they are. But this transparency was forced upon them. It's akin to giving a small child razor blades to play with, you know it's wrong but you continue to hand out the blades. You will do so until you are caught. Once caught you, because you are a pharmaceutical company that will always avoid jail time, will pay the fine and announce that you have changed your ways, "The razor blade thing was just part of an era".

In the UK there are a number of patients who took Seroxat and had severe withdrawal problems when trying to come off it. A lawsuit was filed but Glaxo have denied any wrong-doing, spouting the line "Seroxat has benefited millions of people world wide", at every given opportunity.

The UK group action is yet another classic example of how GlaxoSmithKline operate. Let's just say that those razor blades were Glaxo's Seroxat. Those people that were injured are ignored by Glaxo. They hire top lawyers to defend the claims against them... even though they have settled similar claims in the US [without liability]

If the UK litigation, which has been dragging on for 10 years, does get to the High Court then Glaxo will defend the test case, it's testing the water to see whether or not they will defend the other 100 or so cases.


So when I see articles about how Glaxo have changed their ways I think 'Nah, they are still exactly the same'.

Glaxo are a business and they want to make money, lots of it. Publicly they now have to be seen to be the good guys, hence the reason for highlighting the downside of their new product Breo.

However, what goes on behind closed doors is another matter. District managers at Glaxo have a unique way of selling products to people that don't need them, if they didn't tell their reps to target those who didn't need their products then, well, they'd be out of a job.

Changing times at Glaxo?

I think not


Bob Fiddaman.



[1] Changing times: GSK sells bad with good to doctors in safety push

Saturday, November 09, 2013

New Glaxo Game Leaked



How to play and rules will follow shortly


Bob Fiddaman



Friday, November 08, 2013

Email to CEO of the MHRA, Ian Hudson




I've just flicked the following email to the new MHRA Chief, Ian Hudson.

Any reply will also be made public.


Dear Mr Hudson,

As I understand you are now Chief Executive of the MHRA. I'd congratulate you but we both know that I'd be lying with those congratulations given your past links to GlaxoSmithKline and Seroxat.

That aside, I have to remain professional.

My question to you is one of great concern and one that I shall be making public on my blog http://fiddaman.blogspot.com

Are you, or do the MHRA plan to reevaluate the current recommendations that pediatrics should not be prescribed SSRi's?

I ask as it has come to light that MHRA consultant, Stephen J W Evans, has recently co-authored a study where he and the other authors call for a re-evaluation of the current prescription of SSRIs in young people - Back story here.

This email, along with your answer, if you are brave enough to answer that is, will be published on my blog.

Best wishes

Bob Fiddaman.





Please contact me if you would like a guest post considered for publication on my blog.