Zantac Lawsuit


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

Tuesday, July 26, 2016

Sandy Hook Psychiatrist on Trial






I've teamed up with Sheila Matthews of Ablechild to write this. We've previously worked on a project together (See - Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System)

This post, however, focuses on the 2012 Sandy Hook massacre.

This is one of those cases that has many people talking - The Sandy Hook Elementary School shooting happened almost four years ago on December 14, 2012.

20-year-old Adam Lanza fatally shot 20 children aged between 6 and 7 years old, as well as six adult staff members. Before driving to the school, Lanza shot and killed his mother at their Newtown home in Connecticut. Lanza it is alleged, killed himself by shooting himself in the head as first responders arrived at Sandy Hook Elementary.

There's been many theories floating around the internet since the massacre, some suggest it was all an elaborate hoax and that Lanza never existed - some of the material regarding this theory, it has to be said, is quite convincing but not something that I've ever really bought into - I mean were all the parents who buried their children just actors and part of a mass conspiracy?

Crisis actors are apparently used to conduct drills, such as the research hospital located just 8 miles from where Nancy Lanza was last seen alive. However, the conspiracy and hoax believers draw no real facts and appear to make claims they cannot prove, which takes our eye off the ball (See 'Aurora' later in this post)

It's not really something that I'd want to get into as I'm more interested in the medication Lanza was either on or withdrawing from at the time of the shooting.

Step forward Mr Paul Fox (Pictured above) Lanza's last known treating psychiatrist.

Fox threw gasoline into the 'Lanza never existed' fire when he claimed that he had destroyed Adam Lanza's medical notes. He told Police this from New Zealand where he was then practising after leaving Connecticut around 6 months prior to Lanza's carnage.

Whilst there, Fox came under scrutiny after a patient under his care, Nicky Stevens, 21, killed himself. Fox worked for the Waikato District Health Board (DHB) for 19 months before returning back to the US in and around January 2014.

Earlier this year Fox was arrested in Maine and charged with sexual assault and it was alleged that he, between 2010 and 2011 (His time in Connecticut) had a 'relationship' with a patient. This, it is claimed, led Fox to surrender his licence and flee to New Zealand. According to the CT Post...

Fox's case did not come before the Connecticut Medical Examining Board for a public hearing. Instead, Fox and his attorney brokered a deal with the state Department of Public Health's Healthcare Quality and Safety branch and the psychiatrist surrendered his license in Connecticut and New York.

Fox, it has emerged, treated Lanza five years prior to the Sandy Hook massacre. However, it is unknown exactly what that treatment involved. According to Fox he last treated Lanza when the boy was just 15. Lanza was 20 when he carried out the massacre.

PRESENT DAY

Paul Fox's, now 63, relationship with a female patient was initially uncovered by Connecticut state police investigating Lanza’s history in the aftermath of the Sandy Hook massacre. The female, who came forward during Fox's time in New Zealand, has claimed that she had sex with Fox “in his office” and spent time on his sailboat and that the relationship lasted more than a year. The same patient also alleges that one of Fox’s other patients told her that she was "having phone sex with Fox.,"

Today he appeared in court in Danbury, Connecticut for pre-trial on 3 felony counts of sexual abuse another blow to those who claim Fox didn’t exist.

Since the Sandy Hook massacre lawmakers of Connecticut have been calling for more money to be put into mental health services.   Many of the mass shootings globally have a striking common denominator in as much that the assailant (or assailants) have either been taking or withdrawing from some form of prescribed psychiatric medication. In the case of Lanza it is unknown if he was on or withdrawing from medication at the time of the shooting. It's something that one would assume would be easy to find answers to.

ABLECHILD

Since Sandy Hook, Ablechild, a nationally recognized Non-Profit Organization dedicated to parents, caregivers, and children’s rights, have been at loggerheads with Connecticut state officials after they have refused to release Lanza's medical notes and full toxicology report.

This from Sheila Matthews of AbleChild...

According to the police investigation, Fox told the investigators he had the medical billing records for Lanza stored in the US, the next day when investigators called Fox back to obtain more information, Fox indicated he destroyed the medical records. So, does Fox still have the billing records? Why didn’t the State charge Fox for destroying the records 2 years too early according to Connecticut Law? Also, Fox had an obligation to notify his current and former patients he was discontinuing his practice. Why didn’t the State hold him responsible for the failure to follow that law?

What I find bizarre about this whole affair is the stance Connecticut officials have taken with regard to the release of Lanza's notes. Take a look at this short video that features Sheila Matthews and her attorney. In it, they ask Assistant Attorney General for the State of Connecticut, Patrick Kwansie, for the release of Adam Lanza's toxicology report. His response is incredulous!





He refused to release the full toxicology report because "It is harmful because then you can cause a lot of people to stop taking their medications... stop cooperating with their treating physicians."

Um, yeh, isn't that the point of investigating a product that may or may not be faulty?

What an utterly ridiculous excuse for not releasing the full toxicology report. A report was released earlier but, for reasons unknown Connecticut officials only released the cover note of the toxicology report and not the reports findings.

Okay, thinking outside of the box here. Would Kwansie have released the full toxicology report if parents of those who perished asked him and used the premise that they wanted to know if medication wasn't in his system - they could then go down the mental health road and claim that Lanza should have been on meds - one way or the other, the public have a right to know if any prescription medications showed up in Lanza's toxicology report, be they pro-medication or anti-medication advocates.

It would appear, through his somewhat baffling reasoning, Kwansie is suggesting that Lanza's toxicology report did, indeed, show traces of prescription medication - why give AbleChild the spiel about how harmful it could be to those currently taking medication if Lanza wasn't on medication?

What's the big secret here?

Why are Connecticut state officials so reluctant to release Adam Lanza's full toxicology report ~ there is no logical explanation?

Again, this has fuelled much speculation that the whole Sandy Hook affair was a hoax - but that's a good thing for the state of Connecticut ~ and here's why.

AURORA

Before I became a writer of all things pharmaceutical I was a ufologist, I studied unidentified flying object reports, read countless books and watched many, many hours of documentaries. I quickly learned that the government had a friend in ufologists in as much that they fuelled the media with stories of unidentified black triangles flying over the skies of the world - the black triangle later became known as Aurora, an American reconnaissance aircraft that was secretly being tested in our skies. What better cover-up than to have members of the public claiming to have seen a black triangular flying object doing things that no conventional aircraft could do (at that time - circa 1980's)

With a public interested in black triangular objects controlled by aliens the government could sit back knowing that any sighting of their secret project would be passed off by a bunch of conspiracy theorists as an alien driven craft.

Same thing, it appears, applies to Sandy Hook. There are literally hundreds upon hundreds of videos on YouTube claiming that Sandy Hook was a false flag event and when members of the public put all their energy and focus into this they take their eyes off the ball - just as they did in the 80's when Aurora was roaming the skies.


STATE OF CONNECTICUT

It is left to state officials of Connecticut to put Sandy Hook to bed once and for all - it can't be easy for the parents of the children reading stories such as the false flag events and, dare I say it, even this blog post of mine.

There is no reason for the State of Connecticut to hold on to Lanza's full toxicology report other than the one I stated above (Aurora). Assistant Attorney General for the State of Connecticut, Patrick Kwansie's lame attempt at reasoning why was nothing short of shameful. If a product is suspected to be faulty, as many of these psychiatric medications are, then it should be investigated, despite what those (currently on the product) may or may not think or do.

Patrick Kwansie should have, at the very least, looked at the current labelling on these types of medications. To date there have been 22 international drug regulatory warnings on psychiatric drugs citing effects of mania, hostility, violence and even homicidal ideation, and dozens of high profile shootings/killings tied to psychiatric drug use (Source)

There will obviously be more if lawmakers decide that it would be harmful to state facts because it "can cause a lot of people to stop taking their medications".

It's a crazy world we live in, particularly if you live in the State of Connecticut where lawmakers are still rolling out the Aurora model to keep the public misinformed and from the truth.


Bob Fiddaman & Sheila Matthews.


Further Reading

Adam Lanza’s Psychiatrist’s Ethics Violations Raise Questions About the Legislature’s Controversial Mental Health Increases






Wednesday, March 30, 2016

Q&A With Ablechild's Sheila Matthews-Gallo





As this blog approaches its 10 year anniversary (April 6) I thought it would be fitting to give something back to those that have helped me along my journey. Over the coming weeks I'll be publishing a series of Q&A's from people that have been a part of my journey.

Today, I start with  Sheila Matthews-Gallo, (pictured above) co-founder of Ablechild, an organization that works against the labeling and medicating of children.

I first met Sheila in Los Angeles in 2011. We had lunch together, put the world to rights and, in general, just chit-chatted the afternoon away. Later that year I worked with her on a project in which we intended to expose the foster care system in Connecticut, where Sheila and her family reside. The results of that project, Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System, can be viewed here.

I've got a lot of time for people like Sheila. As an individual she has a heart of gold and a passion to match. Her organisation, Ablechild, is the result of that passion.

Ablechild has been instrumental in trying to get the medical notes of Sandy Hook shooter Adam Lanza released into the public domain ~ despite meeting many brick walls Ablechild continues on its mission for these records to be released.

Sheila isn't afraid to tackle tough issues, she has, in the past, stood up to congress in the US, delivering quite exceptional testimony. See her passionate plea made at The Victim Privacy & The Public's Right-To-Know Task Force privacy panel meeting here.

The world needs more people like Sheila Matthews-Gallo, she's a warrior!

Over the coming weeks I'll be reaching out to other individuals and organisations who have been a major part of my ten years of blogging.

Here's the Q&A's

Full name: Sheila Matthews-Gallo
Location: Westport, Connecticut



Q: Can you tell me why you created Ablechild?

A:  To ensure that every parent has the right to informed consent regarding psychiatric products and services.  To fully understand that there is no medical test to confirm that a child has a mental disorder, called ADHD.  To ensure that parents are provided alternatives to behavioral concerns most of all educational solutions in speech and language.  Behavior is tied directly to how one communicates.

--

Q: Sheila, your website "Ablechild" seems to have become a flagship in seeking the truth with regard to the Sandy Hook massacre, You've built yourself a reputation as being forceful and determined. Can you tell me a bit about that?

A:  I met hundreds of mothers along my journey with AbleChild.  One of the very first mothers I met was from Sandy Hook, Newtown.  I encountered this mother during a visit to the Capitol in Hartford, Connecticut in a line to testify to support a bill that would prohibit the state and schools from force drugging a child against their families wishes.  Her child was, at the time, in state custody and her child was being given psychiatric drugs against her wishes.

We stayed in touch over the years, but it would be the massacre in Sandy Hook, Newtown, CT that would united us and drive me to find out if Adam Lanza was receiving psychiatric drug products prior to the killings.

The day of the Sandy Hook massacre, I received a call from this mother who lived less than a mile away from the school in the center of Sandy Hook.  I was asked to come and visit the area and find out if Adam Lanza was another coerced psychiatric drug user.  As far as being forceful or determined, I can only tell you there is too much at risk not to find out if the psychiatric treatment was a contributing factor and to hold those who provided the treatment accountable.  Afterall, our liberty is at stake.  The psychiatric industry is pushing  mandatory government mental health.  Is this what we want?
 
I have to say, upfront, I knew of the corruption within the state regarding psychiatric drugs and coercion of parents.  I was a strong advocate against the state of Connecticut when it came to psychiatric coercion.  I had personal experience trying to receive help from the state when I was faced with school psychiatric coercion and no help arrived.  I was also working on anti-psychiatric coercion on a national level with two other school massacres, Red Lake, MN and Virginia Tech. AbleChild submitted testimony in the aftermath of both those mass shootings when the psychiatric industry was pushing for mandatory mental health screening using these growing mass killings as the catalyse when if fact we have no idea if their products and services are actually contributing factors to the mass killings.

--

Q: What has Ablechild done in as far as trying to get Adam Lanza’s medical notes?

A.  We went before the Freedom of Information Commission, Ablechild vs. Chief Medical Examiner. We attended every public hearing and voiced our requested, wrote op-eds that appeared locally and nationally.  We testified and met with lawmakers for over 3 years, we are still without the records.

--

Q: On average, how much time do you spend with work that relates to Ablechild?

A. Wow,  I never really calculated it all up.  At least 2 hours daily, but some days with capitol visits, writing, calls, working with families, and summer internships it could produce a full schedule.  It’s a part of me now.

--

Q: Given that the content of the Sandy Hook massacre is pretty dark, what do you do to switch off at night?

A.  Well tonight, lol, I am doing this Q&A.  No, I enjoy my family life, my home, friends, movies, traveling, paddle boarding.  I just got my boating license.  I love the water.

--

Q: Have you ever considered writing a book about your journey?

A. Yes, but I am too busy living it.  I want to see how it ends.

--

Q: What do you say to people who believe that antidepressants are safe and effective?

A. Do your homework, seek alternatives.

--

Q: Back in 2011 I had the pleasure of working with you and together we researched and wrote an article that linked a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF. What was the general feedback you received about that article?

A.  Amazing.  I think it really spelled out the psychiatric industry hold on the foster care system and the front groups claiming to be “child savers.”  I think it stemmed the called I received from Diane Sawyer’s team to do the one year long investigation into the drugging of foster care system on a national level.  AbleChild contributed to that investigation.

--

Q: You are quite a humble person in real life - for the benefit of this Q&A can you tell me about the awards both you and Ablechild have won?

A.  I have received two human rights awards an individual award and group award from the Citizen’s Commission on Human Rights and I also received an Award from the Law Firm of Jonathan Emord that was unbelievable, in honor of George Washington, The Freedom of Informed Choice Award. (See here)


--

Q: For you, what is the most frustrating part about running Ablechild?

A. The lack of financial resources and time I have to give.

--

Q: Where do you see Ablechild in 10 years time?

A. Here for parents and children, for all of us.

--


Q: Finally Sheila, some personal questions...

1. What book are you currently reading?

A.  Im-be-ciles, The Supreme Court, American Eugenics, and the Sterilization of Carrie Buck, by Adam Cohen

--

2. What was the last CD you listened to (in full)?

A very new artist, from New Hampshire, Brook Hubbard.  Snow in the Sunshine is my favorite on his CD.  I listen to it over and over again.

--

3. What is the best movie you have seen this year?

A.  Risen.  The story of the roman soldier and the hunt for Jesus’ body.

--

4. What country would you most like to visit?

A. Spain

--

5. If you had the choice of being either a defence or prosecution lawyer, which would you choose and why?

A.  Shouldn’t a really good lawyer be able to do both?  I would want to be a really good lawyer.  But, to answer your question, I think a prosecution lawyer, they have to make the case.  I think that might be a more secure position rather than defending a position. But, mostly the state prosecutes and the public defends, I probably am more of a defender.  Clearly from my answer, I can’t decide.  I wish I went to law school.

--


Links

Ablechild Official Website

Ablechild Facebook Page



Bob Fiddaman





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


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

















Tuesday, October 22, 2013

Adam Lanza - Why the Secrecy Over His Medical Records?

Adam Lanza



On December 14, 2012, 20-year-old Adam Lanza (pictured above) 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.

There's been a lot of debate surrounding the medications Lanza was taking prior to his killing spree. All we have is speculation and with speculation comes uncertainty.

Authorities have previously told the press that the autopsy investigation revealed no such substances in Lanza's body but never actually released the full toxicology report to back up their claims.

There is, of course, one way to end this speculation. Release his medical records.

Ablechild, a a national parents’ rights organization, founded in 2001 by Patricia Weathers and Sheila Matthews, have been trying to end such speculation. Their mission being Informed Consent.

On March 5 Ablechild hand delivered a letter to H. Wayne Carver II, M.D. requesting the immediate release of the complete autopsy report, toxicology report, and prescription drug history of Adam Lanza.

A fair enough request considering the indisputable link between psychiatric medication and school shootings and other homicidal events. However, Ablechild were denied access without cause, despite federal and state laws requiring transparency and disclosure.

They took their request further, right to the desk of Assistant Attorney General for Connecticut, Patrick B. Kwanashie.

Watch the following two minute video and you will see one of the most bizarre excuses littered with contradictions. Was Kwanashie's statement scripted? If it was it was a very poor delivery on his part.

Here's the video:




"No matter how the outcome of the use of antidepressants, or the causal link between the use of antidepressants and kind of violence that took place in Newtown, that's not a legitimate use of information, that information. You can't generalize just from one case. Even if you can conclusively establish that Adam Lanza - his murderous actions - were caused by antidepressants.

"You can't logically from that conclude that, you know, others would commit the same actions as a result of taking antidepressants. So it's simply not legitimate, and not only is it not the use to which they are proposing to put the information, not legitimate. It is harmful, because they you can cause a lot of people to stop taking their medications; stop cooperating with their treating physicians. Just because of the heinousness of what Adam Lanza did."

So, You can keep a toxicology report from the public because you are afraid the public will jump to conclusions?

What sort of legislation is that?

The full 1 hour 20 minute video of the hearing is even more bizarre. Kwanashie claims the Office of the Chief Medical Examiner does not have any records on Adam Lanza's prescription drugs because the police did not find any. He later claims that they cannot release the toxicology report because people might quit taking their meds.

Why would people stop taking their meds if a toxicology report showed no meds?

The video can be seen its entirety here.

Bob Fiddaman




Thursday, January 03, 2013

Suicide Prevention and Ketamine - Larkin & Beautrais

Ketamine and suicide prevention
Annette Beautrais and Gregory Larkin
Image courtesy of  ingenio-magazine.com



Just when you thought it was safe to walk into the emergency department of a hospital for respite or treatment to an injury comes the latest study in suicide prevention and depression. A study so flawed and bizarre and, dare I say it, misleading.

The study was carried out by Gregory Larkin and Annette Beautrais, the conclusion of which found that the intervention of administering the horse tranquilizer, Ketamine, to patients suffering from depression or displaying suicidal tendencies is "likely to be effective and appropriate for only some subgroups of the depressed and suicidal emergency department population."

The study, carried out on 15 patients, ran over a period of just 10 days and saw patients given a single dose of Ketamine [dose depending on weight] and then monitored over a period of four hours whereby they were given a set of questions using the Montgomery–Ă…sberg Depression Rating Scale [MADRS]. These ratings  were obtained at baseline, and at 40, 80, 120 and 240 minute intervals. Patients were then contacted over a period of 10 days

There was no control group in this study, funded by Connecticut College of Emergency Physicians.

In essence it appears that the study only lasted 4 hours and the follow-up [10 days] was presumably to follow-up on the 15 patients to see how they were coping [ie; side effects, if depression or suicidal thoughts had returned]

This, it has to be said, is one of the most bizarre studies I've ever seen when time and outcome are taken into account... not to mention the drug used.


Thursday, March 10, 2011

Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Image: 2.cdn.turner.com




By Bob Fiddaman and Shelia Matthews

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut's Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF - an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1.Child welfare;
2.Children's behavioral health;
3.Juvenile Services; and
4.Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticu DCF held a 'behind closed doors' meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth


Medications for ADHD

Ritalin (10%)

Adderall (5%)

Vyvanse (4%)

Strattera (3%)


Atypical Antipsychotics

Abilify (11%)

Risperdol (10%)

Seroquel (8%)


Anti-anxiety

Hydroxyzine (2.5%)


Antidepressants

Prozac (4.5%)

Zoloft (4%)

Zyban (3%)

Desyrel (2.5%)

Celexa (2%)


Mood Stabilizers

Lithum (3%)

Depakote (3%)

Lamictal (2.5%)


Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

... the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving...

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a "check-off" list that verifies the status of medications, Dr Kant replied, "I don’t think a “check off” for each medication would work in terms of verifying their status."

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] - APPROVED

Forest Lab’s escitalopram [Lexapro] - APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] - APPROVED

Pfizer's sertraline [Zoloft] - APPROVED

GlaxoSmithKline's bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] - APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, "MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS - A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS" where it writes, "Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment." The guide also points out possible side effects of SSRI's/SNRI's:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn't even make the 5 bullet-pointed list. The Guide does, however, add the following: "Watch for worsening of depression and thoughts about suicide."

The DCF Approved Medication List writes:

"The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals."

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children's Rights, a non-profit charity based in New York City.

In 2005, Children's Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children's Rights had in fact filed a suit against William O'Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children's Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm's REIT Group [Real Estate Investment Trust].

Also, listed on the Children's Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon - Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New Jersey - Drinker Biddle & Reath - GlaxoSmithKline attorneys - defended Paxil as local counsel in Philadelphia cases.

Oklahoma - Kaye Scholer LLP - provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer's predecessors alleged "off-label" marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer's anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of "off-label" indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the 'abuse and neglect' category?

If Children's Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed "off-label" psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children's Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn't check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into "good cause victims" and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children's Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what's the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children's Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend pscyhotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious - and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin


Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, "The evidence, however, is clear... the Seroxat scandal." Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.


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