Marty "Bling Bling" Keller Retires from Brown Uni

Lead author of the now infamous Paxil 329 paper, Martin Keller, has, it seems, retired from his position at Brown University. This will no doubt free up some time for the hard working child shrink so he can sit on more pharmaceutical advisory boards [for a fee] or attend more symposiums [for a fee] or maybe give after-dinner speeches [for a fee].

Keller, along with the study he is supposed to have wrote, became infamous around the time GlaxoSmithKline were trying to push their antidepressant, Paxil, on children and adolescents.

Paxil, known as Seroxat in Europe and Aropax in Australia and NZ, was never meant for children and adolescents but Glaxo pushed it on this population regardless.

The study, "A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression", has caused much controversy over the years. In a nutshell, it's a piece of fraud and lists Martin Keller as the lead author. The study itself was penned by Sally Laden, a ghostwriter hired by GlaxoSmithKline. Laden miraculously turned three poor Paxil clinical trials into one good one. In truth, children and adolescents would have had a better chance of survival in a clinical trial for Russian roulette.

Calls for Keller to be removed from Brown Uni have been loud. Brown Uni have stood by their man as much as the Journal where the ghostwritten study appeared all those years ago.

I'm not the first to slam this study, many have done it before me, Leemon McHenry, John Juriedini, Evie Pringle, Shelley Jofre, Alison Bass, to name but a few. For what its worth, I even added my two penneth for the study to be retracted.

Many continue to dissect it, One Boring Old Man author being one such advocate.

What I do know is that this study has been responsible for persuading doctor's around the world to prescribe Paxil to children and adolescents 'off-label'. This sits perfectly well with Keller et al and the editor of the Journal of the American Academy of Child and Adolescent Psychiatry [JAACAP]. It would appear that having a misleading piece of literature which, in essence promotes an unsafe drug to children and adolescents doesn't really bother GlaxoSmithKline either, if it did surely they would have asked for its retraction. Why would they though, it would be an admittance of fraud.

Sara Carlin and Sharise Gatchell are just two examples of what can happen to children on Paxil. They both hanged themselves. The 329 study showed there was an increase in suicide for Sara and Sharise's age group, an increase that was hidden by GlaxoSmithKline.

For those unfamiliar with the whole fraud behind Glaxo's study it's easily explained in the half hour documentary aired by BBC TV's Panorama team, the fourth investigation into Paxil. [Video below]

GlaxoSmithKline have been let off the hook on numerous occasions. Their role in the 329 study should never be forgotten. Keller and all those other key opinion leaders who added their names to the study should, along with ghostwriter Sally Laden, be utterly ashamed that the influence of their names has caused so much heartache for families bereaved by suicide.

Those who added their names to the study are listed below. Not one of them, to my knowledge, has apologised for their part in influencing doctor's in prescribing Paxil to children and adolescents. They can argue that they didn't know but they have each had more than enough time to retract their names from the study or, at the very least, speak out about how it... or they was manipulated by GSK.

Martin B. Keller

Neal D. Ryan

Michael Strober

Rachel G. Klein

Stan P. Kutcher

Boris Birmaher

Owen R. Hagino

Harold Koplewicz

Gabrielle A. Carlson

Gregory N. Clarke

Graham J. Emslie

David Feinberg

Barbara Geller

Vivek Kusumakar

George Papatheodorou

William H. Sack

Michael Sweeney

Karen Dineen Wagner

Elizabeth B. Weller

Nancy C. Winter

Rosemary Oakes

James P. McCafferty

News of Keller's retirement can be seen on the blogs of Alison Bass and Ed Silverman

BBC Panorama documentary about the fraudulent study is below.

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Frances Kelsey - Thank You

Frances Kelsey, prevented thalidomide from entering the market in the United States

A fascinating interview with the women who was responsible in stopping the drug, thalidomide, being widely prescribed in the United States.

Frances Kelsey was the reviewer for the U.S. Food and Drug Administration [FDA] who refused to authorize thalidomide for market because she had concerns about the drug's safety.

Kelsey, against all odds, stood up to be counted. She knew there was something wrong with the drug and she stood firm in not allowing herself to be manipulated by the company that was trying to push it on American citizens.

The FDA needs more people with a conscience, with ethics.

Frances Kelsey prevented a disaster. In her honour the FDA have now established 'The Frances Kelsey Award', which is given to an FDA staff member annually.

Kelsey is now 98, the interview with her [below] is one that we, as patient advocates, should listen to.

One for the sisterhood.

LISTEN HERE


Back stories:

The Thalidomide Apology and the SmithKline Suppression

GSK's Paralympic Irony




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The Thalidomide Apology and the SmithKline Suppression

What was the role of GSK's predecessors in the  thalidomide scandal?

Many people, particularly those affected by the thalidomide disaster, are just not satisfied with Gruenenthal, the German manufacturer of the drug who, after 50 years, have just issued an apology via their CEO, Harald Stock.

It's a surprising move considering Gruenenthal are the subject of litigation, also surprising because pharmaceutical companies don't often admit to their mistakes, let alone make a public apology.

So, what happened all those years ago?

Well, court documents are alleging that Gruenenthal knew that their sedative, thalidomide, marketed in Germany as Contergan caused harm to the fetus as early as 1956 but never revealed that risk. Five years later the drug was withdrawn from the market after it was learned that babies were being born with foreshortened and distorted limbs, including curved spines, malformations to the eyes, ears and genitals, which were sometimes missing and malformations to the intestines, kidneys and hearts. One of the more common birth defects was a complete absence of the anus.

Not to be deterred by such trivial adverse events, they went ahead and gave it the all clear.

The lawsuit, also states that Gruenenthal were a Nazi led company whose motto was "succeed at any cost". At the time, Gruenenthal's director of their research and development group was Dr Heinrich Muckter. Two years before this role Muckter was a medical scientist for the army of the Third Reich. The lawsuit states:

"Specifically, he was the medical officer [Stabsarzt] to the Superior Command of the German Occupation Forces occupying Krakau, Poland, with the additional ominous title of 'Director for the Institute of Spotted Fever and Virus Research'. Given the role that military medicine played in the objectives and methods of the Nazi occupation of Krakau, Muckter's work there involved the science of killing rather than healing."

If this wasn't in black and white on a court documernt we'd be correct to assume this was some sort of Hollywood horror movie. Documents are provided at the end of this post.

I'll move on from the Nazi link, I once got threatened by GlaxoSmithKline's lawyers for referring to their head of psychiatry, Alistair Benbow, as a former Nazi dictator - far be it for me to draw comparisons.

The Apology

The apology by Harald Stock on behalf of Gruenenthal is cold, so cold that it chills to the bone. Gruenenthal have kept this suppression under wraps for 50 years, in fact, in 1972 they settled a lawsuit in Germany, a settlement where they accepted no liability, they just paid out plaintiffs and kept quiet.

It's always been said that it takes a brave person to apologize and, I guess, in this instance Stock was on a hiding to nothing. No apology would be seen as cruel whilst an open apology would show how transparent Gruenenthal were, particularly if it could be shown that they had learned from their mistakes. It's also classic deflection of blame, new CEO means 'not my fault, it was the fault of my predecessors.'

Enter the blame of the 'era'

Just like GlaxoSmithKline's CEO, Andrew Witty, did about a month ago, apart from apologizing, Gruenethal blamed this tragedy on an era. "...the suffering that occurred with Contergan 50 years ago happened in a world that is completely different from today"

Great detective work Mr Stock.

We have computers, phones that we can take out with us, more TV channels than we could possibly watch and we can even send men to the moon and robots to Mars.

An apology quickly followed by a reason for that apology is not an apology at all. It's a disgraceful act of depravity that, sadly, we, as onlookers, just shrug our shoulders at and go about our daily routines of uploading fluffy bunny pictures to our Facebook buddies or typing out our 140 characters to Twitter.

There should be global outrage about this latest stunt by a pharmaceutical company, alas we are all too busy to spare a thought for the families affected, we are all too busy to stand up with them and demand that criminal charges be sought and that those responsible be imprisoned for life for their part in covering up this utterly abhorrent scandal.

The role of GlaxoSmithKline

The lawsuit has also implicated British pharmaceutical giant GlaxoSmithKline for it's role in keeping the birth defects behind close doors. Glaxo, who were known back then as SmithKline and French, [SKF] are alleged to have carried out clinical trials of thalidomide on 875 women, some of whom were pregnant. During the trials it is alleged that two women gave birth to babies who were deformed.

SKF decided not to market thalidomide, a wise move. They also, the suit alleges, decided not to inform anyone that two women had given birth to deformed babies during their own clinical trials. SKB, cites the suit, had a legal duty and a common law duty to report these findings, at least, to Gruenethal. They also had a legal duty to report their findings to US Congress. When asked for results SKB told Congress that all the results had been submitted to Gruenethal.

Quite why SKB never told Gruenthal or indeed the public remains a mystery.

To date Andrew Witty, head of SKB's succsessor GSK, has issued no apology.

Andrew Witty was knighted in the 2012 New Year Honours for services to the economy and the UK pharmaceutical industry.

Here's those documents that should, but probably won't, see Andrew Witty blame another era of the company he is head of.

Brain Scan Bedlam From Leading Psychiatrist

A recent article that appeared on the Bloomberg Business Week website had me in a complete state of apoplexy [pass me the Paxil] so comical so that I nearly chewed off the side of the couch arm.

The antidepressant market... or those that find unique ways to push the poison pills, are always on the lookout for innovative ways to sell their wares. None more so than the latest from the school of the ridiculous and the latest scam offering patients a safety procedure before they take their drugs, like every good little person should.

Thee companies, namely, CNS Response Inc. (CNSO), AssureRx Health Inc. and Brain Resource Ltd. (BRRZY), are rolling out the latest in bio-technology. You are just going to love this...

The brain scan, offered by CNS, apparently works by matching electrical activity that’s recorded in the brain. From this, it is claimed, a medication can be prescribed that is just right for you.

"If a number of people with similar brain waves do well on the same medicine, then that drug will probably work for the new patient as well", CNS Chief Executive Officer George Carpenter said.

Oh yippie!

The article also quotes Mark Schiller, a San Francisco-based psychiatrist.

“I’ve had a number of patients tell me it’s really been life changing.

“They’ve been in treatment for God knows how many years, never got the right medication, and suddenly we got the right medication and they’re no longer suicidal.”

Wait a minute, is Schiller actually saying that the previous meds these people were on made them suicidal?

One thing Schiller definitely isn't saying is that he is director of medical affairs for CNS Response, Inc which provides the technology he is referring to.

Schiller practices out of the MindTherapy Clinic in California, his specialties include, addiction, adoption, anxiety or fears, attention deficit (ADHD), child or adolescent depression, divorce, domestic abuse, domestic violence, eating disorders, infertility, life coaching, loss or grief, obsessive-compulsive (OCD), relationship issues, substance abuse, trauma and PTSD, dissociative disorders, impulse control disorders, personality disorders and psychosis.

So, pretty much all bases covered then.

That's nice!

With more and more people speaking out against these drugs and with lawsuits being filed all over America it's hardly surprising that some white-coated organisation has come up with a remedy...as a pre-cursor to a remedy... that isn't really a remedy at all.

The chemical imbalance theory has been debunked - now we have the electrical activity that’s recorded in the brain to target the pill pushers.

Psych: I've recorded your electrical activity and Prozac or Paxil just isn't for you. Counting the electrical impulses and adding a multiplication of 7, because there's 7 days in a week, I recommend that you take Celexa because others with the same electrical pattern as you are also on it.

Patient: Thanks God.

Psych: Oh, I'm not God...I'm just second to him.


Hubble, bubble, toil and trouble.

Whatever next?

Gotta fly, need to contact someone who can  reupholster the arm of my couch.

The wacky article can be seen in full HERE.




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Plea For MHRA and EMA to Get Their House in Order

Bravo to Patrick H for starting this petition. It takes courage and resilience to stand up for what you believe in. Too many people sit around and wait for others to act, whilst others criticize those for standing up to be counted. Respect Patrick.

This from the online petition:


To the UK’s MHRA and EU’s EMA: The drugs on our shelves and those recommended by our doctors should first do no harm. As concerned citizens we call on you to put safety first and implement the reforms below:

1) Investigate and act against pharmaceutical companies employing illegal marketing activities by appointing an independent watchdog not funded by the drug industry who can be freely contacted by patients and by doctors witnessing bribery and encouragement to prescribe a drug ‘off label’- for a condition it has no licence to treat - by pharmaceutical representatives.

2) Tighten up requirements for licensing new drugs to include a thorough assessment of benefits versus risks, as well as withdrawal effects.

3) Record and minute meetings to be made publicly available, including representation from consumer groups.

4) Enforce pharmaceutical companies to publish their trial data, without hiding adverse effects, on their website for free access.

5) Take patient reported adverse reactions seriously and encourage patients who have had adverse effects to share them on the website rxisk.org so other patients and doctors are informed.


Why this is important

The profit-hungry drug company GlaxoSmithKline has been peddling a diabetes drug they knew was causing heart attacks without informing doctors or patients of the risk. Regulators in the EU knew about the dangers but failed to act fast enough, putting lives unnecessarily at risk. Previously, UK regulators knew about anti- depressants causing suicide but took over ten years to do anything about it. The same complacency is happening again with new anti-depressants and other drugs.

Earlier this month GSK pleaded guilty to criminal charges relating to anti-depressant and diabetes drug frauds and agreed to pay a $3 billion fine. That brings total fines against big pharma in the US in the last four years to almost $10 billion! But no fines in the UK or EU. Why do we put up with it?

A massive push from thousands of people right now will add to pressure from the media and force regulators to act faster and more decisively against dangerous drugs. As a citizen of the UK I need to know that my family and I are safe and that drug companies put patients before profits. But drug companies will only do the right thing if regulators force them.

Let’s join together in a gigantic outcry for the UK’s Medicines and Healthcare products Regulation Agency and EU’s European Medicines Agency to put safety first. Sign the petition!

----

I truly hope the petition will make the MHRA stand up and listen. I suspect they will, as usual, pretend to listen then do absolutely nothing about the issues raised. They are limp-wristed and powerless and claim to be the best regulator in the world. To be the best of a truly awful bunch is not something I'd be proud of.

The MHRA are in bed with the pharmaceutical industry, they are not just sleeping with them they are performing all sorts of kinky sex acts. Just follow the money trail folks, case in point being these 4 articles I wrote back in 2010.


GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician


GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money


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No Free Lunch at GSK

So, I was browsing the the Cafepharma message boards and it appears that Witty has cracked the whip at GSK.

Disgruntled reps are complaining that they have received news that they can no longer have more than two lunches with doctor's in the space of a month, furthermore, they cannot bring doctor's staff any foodstuffs.

Dang it, no more doughnuts for the, already heavy, receptionist.

This got me thinking.

What if Witty really did start to crack the whip at GSK, maybe his memo would look something like this...




NEW GSK REP POLICY

Dress Code:

1. You are advised to come to work dressed as a gopher. Costumes can be hired from the Department of Justice Department for a small fee.

2. You cannot wear anything from the 80's or 90's - they are both era's that we wish to forget about.

3. We have a range of product memorabilia, including t-shirts, that you can purchase for a small fee. Unfortunately we have no adult sizes as these product placement shirts were not intended for adult use.

XX Small - "I Just Took My Paxil" T-Shirts - 200,000 in stock

XX Small - "We Love Karen Wagner" T-Shirts [Paxil logo on back]- 200,000 in stock

XX Small - "Keller Is Da Daddy" T-Shirts - [Paxil logo on back] - 200,000 in stock

Kiddy Lunchboxes [Paxil Logo on Lid] - 200,000 in stock

Mr Men Series, Vol 9 - "Mr Grumpy Gets Better" - [Mentions Paxil] 200,000 in stock

Fake Dog Turds [Paxil 329 Limited Edition, signed by Sally K. Laden] ONLY 99 LEFT!

Paxil Rope - 12 LEFT

Paxil Razor Blades - 4 LEFT

Benbow Bear - A true to life talking teddy bear. Just pull the chord and hear, "These drugs are  not addictive", "Dr Healy has been proved to be wrong on every single occasion", "The evidence, however, is clear, these medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm", "Generally these symptoms are mild to moderate", "The information in the patient leaflet and in the information we supply to doctors, is based on fact", "I think patients have nothing to fear from taking Seroxat", "I utterly refute any allegations we are sitting on data", and "We take the safety of our medicines extremely seriously".


Sick Days: 
We will no longer accept a doctor's statement as proof of sickness. If you are able to go to the doctor, you are able to come to work, unless you are involved in an internal dispute with the company, in which case you shall remain on sick leave without pay. Any doctor's statement as proof of being fit to work will not be accepted.

Bereavement Leave:
The drugs you promote for off-label prescriptions, are known to cause death in the populations they are not indicated for. By now you should be used to death. Any friend, family member or pet that dies... suck it up and deal with it. We don't pay you to have a conscience.  

Toilet Breaks:
Will only be permitted if you ingest ALLI, our failed dietry supplement. Batches of ALLI can be ordered for $2 on Ebay or for $160 from one of our executives.

Lunch Break:

No more free lunches for doctor's and their staff.

No more vouchers for Wing's Chinese restaurants, the Gringo's Mexican chain etc.

Glaxo Foodles will be available for all reps [for a small fee] along with a carton of Ribena [Vitamin D extracted due to carton staying in sun for too long]


Thank you for your loyalty to our company. If you have any issues regarding compliance then please forward them to our compliance department and we will make sure your grievances are heard... Be prepared to lose your job though. Nobody likes a smart ass!

Sir Witty.

GSK's Paralympic Irony

The GSK Facebook page is proudly boasting the following message:

"We're supporting London 2012 to help ensure the Olympic and Paralympic Games are the cleanest possible. To see the journey of an athlete's sample watch this video"

The GSK Facebook posse then highlight a video in which they basically blow their own trumpet about how good they are at what they do.

What GSK fail to tell its 49,761 Facebook followers is that they have just been implicated in a lawsuit in the US for their part in distributing doses of thalidomide to physicians for human trial, along with Sanofi Aventis.

The complaint alleges GSK's predecessor Smith Kline & French conducted a clinical trial on at least 875 people, which including pregnant women, in 1956 and 1957 in the U.S. as it pondered over a licensing agreement for the drug with Gruenenthal, which made thalidomide.

Sanofi predecessor Richardson-Merrell are alleged to have distributed more than 2.5 million thalidomide tablets to about 20,000 patients.

Research suggests that a pregnant woman participating in the Smith Kline & French trial delivered a malformed baby. Smith Kline decided not to market the thalidomide drug but, at the same time, never let the public know about its clinical trial results.

One can only assume that if Smith Kline did release information from its thalidomide clinical trial then maybe, just maybe, it would have rang alarm bells and the distribution of the drug may have been slowed, or better still, halted in its tracks.

Kevin Colgan, a spokesperson for GSK stated:

“GSK intends to vigorously defend itself against this lawsuit and the others filed previously. 

“This lawsuit involves events dating back over 50 years by a predecessor company, Smith Kline French, that no longer exists. Moreover, the plaintiffs’ complaint is replete with scientific inaccuracies and factual misstatements.”

The case, Valerie Spence et al. v. Avantor Performance Materials, case number 120800665, was filed August 9, 2012 in the Pennsylvania Eastern District Court.

Meantime, GSK's Facebook page continues to cover itself in garlands, one striking comment sums them up:

As with the Olympic Games, antidoping testing will also be carried out at our laboratory for the Paralympic Games with every athlete that wins a medal and up to 50% of all competitors being tested. Approximately 5000 tests were carried out during the Olympic Games and a further 1250 will be conducted during the Paralympic Games.

No problem in releasing these test results then, huh?



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Paxil - Multiple Symptoms, One Solution

So, we all know how Glaxo failed to show the efficacy and safety of Paxil use in kids, we all know how they buried data and hired a ghostwriter to dupe doctor's, journal editor's and parents of kids. Basically, a suicide link was seen in the clinical trials, Glaxo covered it up. We all know how Glaxo reps were given carte blanche by executives at Glaxo to pay doctor's large sums of money, carefully disguised as preceptorship's and/or fees for attending and sitting on advisory boards. All this on top of the lavish weekend breaks for doctor's and, in some instances, their partners.

That's business, eh folks?

The following is a letter from the FDA's Division of Drug Marketing, Advertising and Communications [DDMAC] to GlaxoSmithKline warning them about their promotional activities regarding Paxil and children.

Remember, Glaxo had not got a licence for Paxil in children, none the less they saw fit to push it on them in the despicable way.

Basically, Glaxo distributed a T-shirt during a Health Fair function at the Children's Advocacy Center of Brevard in Brevard, Florida. The front of the T-shirt saw the logo and name of the Children's Advocacy Center, while the back of the T-shirt saw the claim "Multiple Symptoms, One Solution" followed by the Paxil logo.

Here's the letter, courtesy of the Drug Industry Document Archive, from the FDA to Eloise R. Scott, D.V.M. Associate Director, U.S. Regulatory Affairs at Glaxo, formerly Smithktine Beecham Pharmaceuticals.

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Email to Editor of JAACAP - Re Paxil 329

Below is an email I've sent to the editor of the Journal of the American Academy of Child and Adolescent Psychiatry [JAACAP]

It follows on from the recent abhorrent behaviour of British pharmaceutical company, GlaxoSmithKline and their agreement to plead guilty with regard to the way they knowingly misbranded Paxil and knowingly falsified a ghostwritten study [329] for the sole purpose of making money from a product that had a propensity to induce suicide in children and adolescents.

A call for this fraudulent study to be retracted has previously been asked for by Jon N. Jureidini and Leemon B. McHenry, whom are both mentioned and referenced below.

I've previously called for Glaxo CEO, Andrew Witty, to contact JAACAP, seeing how it was his company that hired a ghostwriter for the article.

His limp-wristed excuse that this was part of an era just doesn't wash. If he had any morals then he would tell the journal to pull the study, although the damage has been done now and many children may have died as a result of this study being published.

More about Witty coming soon on this blog... there's some disgruntled whistleblowers out there.

Anyway, here's the email to the editor of the Journal of the American Academy of Child and Adolescent Psychiatry.


Dear Mr Martin,

I am the author of the book, The evidence, however, is clear; the Seroxat scandal, and the blog, Seroxat Sufferers. Seroxat is the UK brand name for GlaxoSmithKline's antidepressant, you will know it by its US brand name, Paxil.

The reason I am contacting you is with regard to the publication in the Journal of the American Academy of Child and Adolescent Psychiatry entitled, "A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression." - Martin Keller et al.

It is my understanding that the particular study was used as a marketing tool by British pharmaceutical giants, GlaxoSmithKline, and was in fact not written by the authors, Martin Keller et al, at all but by Sally Laden, an editorial director for Scientific Therapeutics Information.

Given that this publication has been widely available since 2001 its safe to assume that many inquiring doctors, pediatrics, child psychiatrists and, in general, healthcare professionals, have used it as a guide when making a decision whether or not to prescribe Paxil off-label to children and adolescents.

It is also my understanding that the study, better known as Paxil 329, has been brought to your attention in the past by Jon N. Jureidini and Leemon B. McHenry and despite pointing out to you Paxil 329'S flaws you refused to retract it. In fact, you added that, “We have found no evidence for such errors nor any justification for retraction according to current editorial standards and scientific publication guidelines. We therefore will not proceed further with your request” [1]

I am sure you are aware of recent events regarding GlaxoSmithKline's guilty plea surrounding the illegal marketing and promotion of many of their products, one of which was Paxil.

Glaxo agreed to plead guilty to distribution of a misbranded drug due to false and misleading labeling, in violation of 21 U.S.C.  331(a), 333(a)(1) & 352(a). That 'misbranded drug' was Paxil.

Transcripts of GSK's plea and settlement agreements are available on the Department of Justice website. [2]

Regarding Paxil and their guilty plea, Glaxo settled allegations that:

From 1999 to 2003, during sales calls, dinner meetings, spa programs, lavish weekend conferences to places such as Puerto Rico and Hawaii, through a false and misleading medical journal article, and through the distribution of free samples for patient use, GSK promoted Paxil to doctors for the treatment of depression and, to a lesser extent, obsessive-compulsive disorder in patients under age 18.

and

That they conducted three placebo-controlled clinical studies to study Paxil’s safety and efficacy in treating depression in patients under age 18. In all three studies, GSK failed to demonstrate efficacy on the endpoints identified in the study protocols.

and

That they hired a contractor to write an article on one of the studies that was published in July 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP). The article stated that Paxil “is generally well tolerated and effective for major depression in adolescents.” The article did not explicitly state that the study failed to demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints that had been identified in the study protocol.

and

There marketing team distributed the JAACAP article to all of the Paxil sales representatives with a cover memo that stated that Paxil had demonstrated “REMARKABLE Efficacy and Safety in the treatment of adolescent depression.” Some GSK sales representatives used the article to urge doctors to prescribe Paxil to treat patients under age 18.

Given that they have pleaded guilty one would assume that the next natural step would be for the study to be retracted. I gather the responsibility falls upon you to issue such an order.

Can you tell me if you plan to retract "A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression." - Martin Keller et al, and/or issue an explanation as to why you wish to retract it?

If you plan not to retract it could you please explain why?

Could you please also state, for the record, that your position is that you can still see no evidence of errors nor any justification for retraction according to current editorial standards and scientific publication guidelines.

Meantime, I look forward to your reply and hope that you will find it in your heart to remove this fraudulent publication as a goodwill gesture to the parents of children that have killed themselves as a result of Paxil induced suicide after it was prescribed to them by doctor's, pediatrics, child psychiatrists and, in general, healthcare professionals, whom used your journal as a reference when weighing up their decisions to prescribe it to this vulnerable population.

Yours sincerely,

Bob Fiddaman.

[1] Jureidini, Jon N. and McHenry, Leemon B.(2011) 'Conflicted Medical Journals and the Failure of Trust', Accountability in Research, 18: 1, 45 — 54
[2] Department of Justice - GLAXOSMITHKLINE SETTLEMENT FACT SHEET - http://www.justice.gov/usao/ma/news/GlaxoSmithKline/Settlement_Fact_Sheet.pdf







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Glaxo's Andrew Witty and Paxil 329

Two recent articles grabbed my attention of late, both are brilliantly written, both drag up the Paxil 329 study once more.

Jonathan Leo, Ph.D. - wrote, 'Study 329′s Authors: Should Those Who Live in Glass Houses Throw Stones?' Whilst Paul Basken penned, 'Academic Researchers Escape Scrutiny in Glaxo Fraud Settlement'

Both are well worth the read.

Both got me thinking.

With Glaxo Chief, Andrew Witty, blaming everyone but himself for the abhorrent way his company, GSK, hid the Paxil suicide link in children I can only assume that the fraudulent marketing by his company would be something he wants to obliterate from his company.

There have been calls for the academics involved in the shameful Paxil 329 study to be criminally prosecuted. The study, headed by child psychiatrist, Martin Keller, was actually written by Glaxo. Keller, along with other key opinion leaders, added their names to the paper to make it look like they had each played a part in testing the safety of Paxil in kids. Truth is, they didn't.

Truth is Paxil wasn't safe for children to take.

Keller and the rest of the 'experts' have to live with that.

The study itself was, after being passed around for three years between child psychiatrists, lawyers and PR firms, published in 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry. Calls for it to be removed/retracted have been ignored by the journal.

Now, if Glaxo chief, Andrew Witty, had indeed been ashamed by his company's recent $3 billion payout for illegally promoted, among other drugs, Paxil, then surely it's down to him to contact the Journal of the American Academy of Child and Adolescent Psychiatry to ask them to retract the offending fraudulent study?

I'd like to give Witty a helping hand here. His company, Glaxo, haven't really done anything to help me or the  thousands of others wean off their addictive Paxil but, hey, you don't give to receive, right?

With this in mind I've devised a letter for Witty to simply sign and send off to the American Academy of Child and Adolescent Psychiatry.

All you have to do is sign it Witty. [Just print off and send to the journal, there's a good chap.]

For those, like me, who can't read small print, here's the letter in full:

Sir Andrew Witty

GlaxoSmithKline

980 GreatWest Road

Brentford

Middlesex

TW8 9GS

Dear, Journal of the American Academy of Child and Adolescent Psychiatry,

It is with great regret that I have to report that a study, A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression- Acute Phase, sent to you under the guise of many highly thought of and influential psychiatrists, is actually false and misleading and could potentially cause harm to the patient population it was supposed to protect... children and adolescents.

The company I am now chief executive of, GlaxoSmithKline, have recently plead guilty and paid $3 billion as part of this criminal and civil resolution. 

We agreed to plead guilty to three misdemeanor violations of the Food, Drug and Cosmetic Act.

Regarding Paxil, we agreed to plead guilty to distribution of a misbranded drug due to false and misleading labeling, we also agreed to plead guilty to distribution of a misbranded drug due to inadequate directions for use, that drug was called Wellbutrin, you may know it as Zyban, that's down to me and my former role as VP Manager back in 1997... those were the days. Anyway, I digress, we also agreed to plead guilty to failure to report data to the FDA the adverse effects our diabetes drug, Avandia, was having on people. I heard a ripple that some folk died whilst taking this drug but I don't believe in anecdotal reports.

Anyway, back to the study.

We conducted three placebo-controlled clinical studies to study Paxil’s safety and efficacy in treating depression in patients under age 18. In all three studies, we failed to demonstrate efficacy on the endpoints identified in the study protocols.

Because of this we hired a contractor to write an article on one of the studies [329] that was published in July 2001 in your journal.

The article stated that Paxil "is generally well tolerated and effective for major depression in adolescents." The article did not explicitly state that the study failed to demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints that had been identified in the study protocol. We kind of thought that if we would have mentioned that it had failed  demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints then we would not have been able to have a fair fight with Eli Lilly, who, at the time, were winning the antidepressant war with their particular poison, Prozac.

The study that our article referred to wasn't in fact written by any of the names that appear on it, namely, Martin B. Keller,  Neal D. Ryan, Michael Strober, Rachel G. Klein, Stan P. Kutcher, Boris Birmaher, Owen R. Hagino, Harold Koplewicz, Gabrielle A. Carlson, Gregory N. Clarke, Graham J. Emslie, David Feinberg, Barbara Geller, Vivek Kusumakar, George Papatheodorou, William H. Sack, Michael Sweeney, Karen Dineen Wagner, Elizabeth B. Weller, Nancy C. Winters, Rosemary Oakes, and James P. McCafferty.

I realize that by coming clean on this I am bringing into dispute the names of those above, who, for years, have all claimed that they played a part in the study. In fact the whole thing was drafted by Sally Laden, an editorial director for Scientific Therapeutics Information. You may have already seen the leaked memo from my company that sees the apparent lead author of the study, Martin Keller, write to Sally with, "Dear Sally, You did a superb job with this. ... It is excellent. Enclosed are rather minor changes from me."

As you may be aware, Martin Keller, or Marty as I like to call him, has gone on to earn vast amounts of money sitting on Advisory Boards for various pharmaceutical companies who want their antidepressants given that golden hallmark. Many others in the list have faced the wrath of a growing army of patient advocates/bloggers too. Poor old Stan Kutcher took a hammering a while back and subsequently failed to get elected in Novia Scotia, Canada. Karen Wagner seems to be doing well, although I understand she's under close scrutiny for a paper she wrote [ahem] about the safety of another antidepressant apparently being safe for kids, despite a previous study claiming that it wasn't. Neal Ryan made himself look rather silly when he was confronted by that Scottish bint, Shelley Jofre, from the BBC whilst the others have been pretty good at deflecting questions about their role in writing our study.

Many children have died by suicide whilst taking our drug, Paxil, many of whom should have been protected by us as we, as a caring company, had a duty to protect the most vulnerable. Alas, we failed and we failed on a huge scale.

Well, it's time to push that era away and to start making amends. So please could you retract the Paxil study from your journal and maybe offer an apology on my part for all the kids that have died since its publication. Although we can't say for sure that they carried out killing themselves because they were taking our drug, we still can't rule it out.

Sorry for any inconvenience this may cause you but I'm turning over a new leaf to get the public believing in GlaxoSmithKline again. I'm even going to blow the lid on my own past as VP Marketing Manager, that's if that pesky whistleblower, Greg Thorpe, doesn't beat me to it.

I hope to hear from you soon.

Please remember to to do more, feel better and live longer.

Yours sincerely,

Sir Andrew Witty

{SIGN HERE}

Fid

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ILL-INFORMED CONSENT - A child Psychiatrist's Perspective

Dr Laura Davis:  "The pills do not change who people are. And there is no way to become addicted to these pills."
Pic savodnik.com

A recent article by Dr. Laura Davies was recently sent to me via the medium of Facebook.

More about her article in a bit.

First off,  the author, Dr. Laura Davies, is a child psychiatrist who, it seems, is either totally misguided or just plain ignorant. Either way, her stance may be putting the children, adolescents and adults she treats in serious danger.

I felt so angry at this article which lacked any scientific facts that I felt the need to subscribe to Dr Laura Davies' Facebook page. Others followed suit but, along with myself, were all removed from her page for asking a series of questions. I'd asked her if the article was ghostwritten... okay slightly tongue in cheek but I was astounded that there are still doctor's out there promoting the use of these drugs, especially child psychiatrists!

In fact browsing her Facebook page one is greeted with messages of self-indulgence, just a few included below:

"I am the expert"

If you say so Laura.

Just a few things about her article, 'Antidepressants often needlessly avoided'

First off, Laura Davies claims that antidepressants [pills] do not cause addiction or do they change people's personalities. That's quite a broad statement for an expert to make. Sadly, she offers no scientific data to support her claims.

Depression, she claims, "does not mean that one is crying all the time", she adds, "sometimes it can be a withdrawal from friends and family, irritability, difficulty sleeping, a change in appetite, thoughts of death or even suicide, a loss of hope for the future, anxious thoughts and lowered self-confidence."


So the definition of depression, according to Dr Laura Davies, being separated from friends or family, being irritable, having difficulty sleeping, not feeling hungry, being low in confidence and feeling suicidal.

I wouldn't call actual suicide, depression... I'd much prefer to call it death than give it one of Davies' psychiatric labels, but hey, she's the expert.

Her definition of depression must cater for anyone that she sees.

Who hasn't felt sad when being separated from family of friends?

Who hasn't felt irritable or had difficulty sleeping?

Not feeling hungry and feeling low in confidence are pretty normal but, then again, I'm not the expert.

Her one-sided article continues with, "Children of a depressed parent generally do worse in school and are more likely to be abused." and "Antidepressant medications have helped millions of Americans regain their interest in life and relationships. They do this in part by rebalancing serotonin, a chemical in the brain that helps relay messages from one part of the brain to another and also affects mood."

Once more Davies offers no scientific data for her claims.

The chemical imbalance theory has been debunked so many times that even the manufacturers of antidepressants have conceded this marketing spin by now adding the words, "It is thought", in front of, 'your depression is caused by a chemical imbalance.'


In fact, it could be argued that treading in a dog turd could cause a chemical imbalance. There's as much science attached to doggy-doo mishaps as there is Davies' claims about rebalancing serotonin.


Her claim of children doing in worse in school and being more likely to be abused because their parents are depressed defies all logic. It does, however, mean that this belief, however incredulous, gives carte blanche to psychiatrists to treat whole families when only one has a diagnosable 'illness'. "Hey, if mom is depressed then lets get the kids in to treat, we wouldn't want them doing bad at school or suffering abuse."


It's quite a scare tactic and one that Davies actually tries to sell in her article.

Her article finishes with, "The pills do not change who people are. And there is no way to become addicted to these pills. If you have any concerns that you may be depressed, talk to your doctor."

Well, I've seen evidence of addiction in antidepressant medication, I've also seen evidence of both doctors and psychiatrists prescribing more because they see the addiction as a return of the original 'illness'.

For a child, adolescent and adult psychiatrist at California Pacific Medical Center in San Francisco to write such an ill-informed article smacks of irresponsibility of the highest order. It also highlights how the belief system ingrained into psychiatry is unscientific, ignorant and dangerous.

I wanted to debate with Laura Davies on her Facebook page. I, along with others, wished to discuss the above points with her. She opted to block anyone from entering into such a debate. She may, if she so desires, wish to debate her claims via the comment section of this blog, let's see shall we.

Davies is a Qualified Medical Examiner who was once a Faculty Member of REACH (Recommendations for Employing Antipsychotics in Children and Adolescents)


“If the world should blow itself up, the last audible voice would be that of an expert saying it can't be done.”  ― Peter Ustinov






Fid

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Glaxo's Lucozade Sport Fails Miserably

GlaxoSmithKline came under fire again…from BBC investigative reporter, Shelley Jofre, [again]
No mentions of their illegal promotion of antidepressant medication to children in this particular expose by the Scots ankle-biter Jofre, this piece was about their boasts and claims of their popular “energy” drink, Lucozade Sport. ‘Claims’ being the operative word here because that’s all they have, no science just trumped up claims aimed at you, the consumer.

I’ve not heard any stories [yet] of Lucozade inducing suicide or causing addiction, unlike Glaxo’s top selling antidepressant Seroxat [Paxil].  What we do know about Lucozade Sport is that one single bottle contains up to 8 spoonfuls of sugar.

What I find ironic is that GlaxoSmithKline are heavily involved with the dope-testing of athletes at the current Olympic games going on in London. Judging by the findings of Jofre, Glaxo should be getting their own house in order before weeding out the Olympic cheats.

A research team at Oxford University wanted to find out if Glaxo’s Lucozade Sport really did what it said on the bottle and in the multi-million pound advertising campaign seen in magazines, billboards and TV commercials up and down the UK. Their findings shouldn’t shock anyone who knows this company and their history of spinning clinical data.

Glaxo being Glaxo sent the research team over 80 studies that apparently proved that Lucozade Sport delivered the goods, goods such as drinking it makes you last longer and finish stronger - Ooh er missus, sounds like a tagline from a Carry On movie. [Insert Sid James laugh here]

The team sifted through the documents with 3 main criteria:

Quality of evidence
Size of effect
Who does it apply to?

What they found was that the quality of evidence was poor, the size of effect was miniscule and that Glaxo’s claims didn’t apply to the population at large who were buying Lucozade Sport. In other words Lucozade Sport has no impact on performance for ordinary people.

Are you surprised?

Back in 2010 I wrote about the hyperactivity link in Lucozade, a number of other suspect food colourings were found in Lucozade after a study by Southampton University, commissioned by the Food Standards Agency, identified 'psychological harm' caused by the additives.

Back then Glaxo were finding it difficult to find a replacement for the colouring agent Sunset Yellow, which is among a number of suspect food additives and also used in Lucozade. Instead, they opted to put a warning on the bottles:

'Sunset Yellow may have an adverse effect on activity and attention in children'.

Children again eh.

Déjà vu anyone?

Anyway, I  digress [slightly]… the Panorama programme, aired in the UK, isn’t available for view here in NZ so I downloaded it for my viewing pleasure.

The programme, ‘The Truth About Sports Products’, was aired on BBC TV July 19th and can be watched  here [UK only]

This latest exposure comes on the back of a $3 billion settlement fee to the US government which saw Glaxo plead guilty to a number of illegal promotional activities with prescription drugs. Their CEO, Andrew Witty, claimed [there's that word again] that it was all part of an era, suggesting that illegal promoting and falsifying data doesn't exist any more at Glaxo. Hmm, okay Andy, we believe you.

GSK were given the heads up of the BBC broadcast and released a pre-statement that was full of the usual denials, lines such as, "Lucozade Sport and the Maxinutrition range have become leading sports nutrition products and play a valued role in the active lives of millions of people in the UK." and "The evidence supporting the performance benefits of carbohydrate-electrolyte drinks such as Lucozade Sport is strong", and the classic, "We take our responsibilities to consumers very seriously..."


Oh well, at least they didn't blame an era.

Jofre, once again, highlighted Glaxo's desire to spin data - I doubt if she is on their Christmas card list... I doubt if she gives a hoot.

Fid

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