Zantac Lawsuit

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

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.



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


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.


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