Blogging Since 2006

Blogging Since 2006
WHEN INJUSTICE BECOMES LAW, RESISTANCE BECOMES DUTY

Friday, July 25, 2014

Are GSK Breaking Bad?





Recent revelations arising from a whistleblower sent to GSK and the Reuters news service has alleged that GSK were embroiled in a smuggling scheme to ship the drug component pseudoephedrine to Iran from Syria via Iraq. 

GlaxoSmithKline manufacture and market Sudafed, a drug used to treat Bronchospasm, Nasal congestion, Rhinitis and Upper respiratory tract infections. The composition of Sudafed is pseudoephedrine, the same compound GSK have been accused of smuggling, or scheming to smuggle, to Iran.

What is a "Sudafed Smurf"?

According to Bob Cooke, a retired special agent-in-charge, California Department of Justice, Bureau of Narcotic Enforcement, organized crime members are part of a network that go from store to store buying PSE (pseudoephedrine). In some cases, they are addicts. They shred the pills/tablets from the blister packs and sell them in bulk to a wholesaler that will furnish them to a methamphetamine lab operator. [1]

Last year a letter appeared on the National Center for Biotechnology Information website. The letter, written by Zahra Alam Mehrjerdi, was titled, "Crystal in Iran: methamphetamine or heroin kerack". [2]

He writes...

Using opiates has a long history in Iran . Opium and its pharmacological and psychotropic effects were known for several thousand years among Iranians especially for managing general medical conditions such as pain, colic problems, headaches, and implementing anesthesia but methamphetamine (MA) is a new psychostimulant drug and its abuse has recently surged in popularity especially among young individuals in Iran. Methamphetamine is available in different forms such as pure crystalline hydrochloride salt. The main routes of methamphetamine administration include smoking, sniffing, injection and ingestion.

If the allegations against GSK are true then are we to believe that they merely schemed to ship Sudafed to Iran to treat people with nasal congestion problems or were their motives more sinister?

According to a 2013 study by the United Nations [3], the first report of the manufacture of methamphetamine in Tehran, Iran's capital, was in 2008 when authorities seized four mom-and-pop labs operating in the city. By 2012, Iran was the world's fourth biggest importer of pseudoephedrine, the main precursor chemical used in crystal meth production. More than half a million Iranians have used the drug at least once.

Although the recent GSK/Syria allegations may only seem mild in comparison to the allegations they are currently facing in China, if one digs deeper into the alleged smuggling scheme then one may just find that GSK were illegally exporting... or had plans to illegally export a compound used in crystal meth production.

If true then GlaxoSmithKline have stooped to a new level.

Back in 2010 GSK's Cidra plant in Puerto Rico came under the spotlight. Part of the complaint filed alleged that employees of GlaxoSmithKline diverted reject drug product from the Cidra plant to black markets in Latin America. This, however, was never proven... or it was, more than likely dropped as part of the settlement agreement made with whistleblower Cheryl Eckard [4]

Now, I'm a blogger and researcher. I don't have the money or means at my disposal to look into the pseudoephedrine smuggling allegations.

Plenty of media outlets out there that do though.

Food for thought, huh?

Some good resources for journalists

From the French Monitoring Centre for Drugs and Drug Addiction -  The drug market in Iran

From  the National Center for Biotechnology Information website - Methamphetamin abuse a new concern in Iran

From  the National Center for Biotechnology Information website - Emergence of a methamphetamine crisis in Iran

Finally, if allegations are proven to be true what does the future hold for GlaxoSmithKline's partnership with the Save The Children charity organisation?

There is a critical drug abuse crisis among Iranian high school students, street children and generally Iranian youth and adolescents. [5]

If allegations are proven then it could be argued that GSK have been part of the drug problem in Iran rather than the solution.

Glaxo's alleged violations in Syria is just one country where they are currently under investigation for similar incidents, others include Bahrain, China, Iraq, Jordan, Kuwait, Lebanon, Oman, Poland, Qatar, UK, United Arab Emirates, USA.





Bob Fiddaman.


[1] What is a "Sudafed Smurf"?
[2] Crystal in Iran: methamphetamine or heroin kerack
[3] United Nations World Drug Report 2013
[4] GlaxoSmithKline - Filthy, Disgusting, Abhorrent...and that's Just the Plant! Read the Charges!
[5] Substance abuse among Iranian high school students








Thursday, July 24, 2014

GSK: This Time It's Syria!





Welcome to the world of GlaxoSmithKline, a world where allegations of bribery and corruption are commonplace.

Reuters have just broke the news that British pharmaceutical giant GlaxoSmithKline are under investigation for bribery in Syria.

Add this to the following:

USA
UK
CHINA
IRAQ
POLAND
BAHRAIN
JORDAN
KUWAIT
LEBANON
OMAN
QATAR
UNITED ARAB EMIRATES


Reuters, in an exclusive, claim to have received an email from a person familiar with GSK's Syrian operations alleging bribes in the form of cash, speakers’ fees, trips and free samples.

"The detailed 5,000-word document, addressed to Chief Executive Andrew Witty and Judy Lewent, chair of GSK's audit committee, said incentives were paid to doctors, dentists, pharmacists and government officials to win tenders and to obtain improper business advantages.
"GSK has been engaging in multiple corrupt and illegal practices in Syria and its internal controls for its Syrian operation are virtually non-existent," the email said."

Reuters are also reporting that the email claimed that GSK "had engaged in apparent Syrian export control violations, including an alleged smuggling scheme to ship the drug component pseudoephedrine to Iran from Syria via Iraq."

Included in the email was information on alleged violation including payments of $1,500 each to two doctors to promote Panadol. Also alleged was that GSK bribes paid to pharmacists and payments for medics to visit a Mediterranean holiday resort.

These latest revelations come on the top of news earlier that GSK's shares fell by about 6%, a familiar downtrend for GSK, as the stock is now down 8% since July 10.

One word.

Karma.

Bob Fiddaman

Hat Tip - The Truthman




Wednesday, July 23, 2014

For Dame Kelly Holmes







Dear Dame Kelly Holmes,

I have learned recently that you are now Technical Advisor, GSK Human Performance Lab.

I'd congratulate you but any person associated with GlaxoSmithKline [without researching their abhorrent history] kind of leaves a bitter taste in my mouth.

I have approached you on Twitter but you have failed to answer me. I understand that you receive thousands of tweets from fans, admirers on a daily basis so mine may have passed you by.

I am writing an open letter to you, via my blog, in the hope that you will, at the very least, research this British pharmaceutical company who in my opinion, have, over the years, had a complete disregard for human life, particularly where children are concerned.

You may dismiss me as just a blogger who has a gripe against GlaxoSmithKline because of my own personal experience with one of their products - this couldn't be further from the truth as I have, during my 8 years writing and researching GlaxoSmithKline, covered many stories of children killing themselves as a result of antidepressant induced suicide and also children that have been born with serious birth defects as a result of their mother's ingesting GlaxoSmithKline products.

These articles are not conspiratorial, read them and then ask yourself if being associated with GlaxoSmithKline sits right with you.

It's difficult to know where to begin as GlaxoSmithKline have been involved in so many violations, the majority of which have been settled out of court in the United States.

I first started researching GlaxoSmithKline after I had endured horrific withdrawal reactions to their antidepressant Seroxat [Known as Paxil in the US] - I wanted to know why it was taking me so long to taper from an antidepressant that, according to GlaxoSmithKline at the time, only took approx two weeks to taper from. It took me a staggering 21 months. I am one of many thousands who have suffered at the hands of Seroxat.

I'm one of the lucky ones as I have lived to tell the tale.

Others have not been so lucky.

I'd like to tell you about a few of those.

Let me start with Sharise Gatchell [Below], an 18-year-old British girl who killed herself in 2003.


Sharise Gatchell

Sharise was prescribed GlaxoSmithKline's Seroxat at the age of 16 to help with depression and shyness.

Here's what her mom, Stephany, had to say...

"I noticed that there was just a dramatic personality swing and at times I found her hostile and aggressive," Mr Gatchell said.
"I couldn't put it together, I couldn't make sense of this dramatic change."

At the time GlaxoSmithKline made claims that there was no link between Seroxat and suicide. A spokesperson told BBC's South East Today...

"By treating depression Seroxat helps to prevent suicide and the associated suicidal thoughts.
"Numerous investigations by independent bodies made up of doctors who are expert in this field have found no links between Seroxat and suicide."
I'd like you to remember the second paragraph Kelly.

One month after Sharise killed herself Government advisors [The MHRA] ruled that Seroxat should no longer be prescribed to under-18's.

It came a month too late for Sharise.


Cecily Bostock

Cecily Bostock (25), a young Stanford graduate, had been prescribed Seroxat by a psychiatrist for racing thoughts and anxiety.

“She was having a lot of trouble sleeping and she had racing thoughts, and she was over-analysing and she was overly sensitive… that is what prompted the prescription.”, said her mom Sara.

Within three weeks of taking Seroxat, Sara says, her daughter became a totally different person.

Sara:

"The last two days she was just a complete zombie I have to say. She was just agitated, jumping at every noise and not making sense. I was very concerned. We were very close to Cecily. I just loved her deeply.
"So I went into the kitchen and I turned the light on and she was lying on the floor. And I knew she was dead. And there was a knife on the floor by her and there was just a trickle of blood from her chest.”

Cecily had stabbed herself twice through the heart.

Since her daughter's death Sara has been campaigning and creating awareness about the dangers of  Seroxat and other SSRi type drugs.

Sara attended the APRIL charity conference 2008 and spoke about her experience and knowledge from years of research. This video has finally surfaced.

Here she speaks about Seroxat/Paxil (paroxetine) suicides.







Sara Carlin

Sara Carlin was an 18-year-old graduate of St. Ignatius of Loyola Catholic Secondary School in Ontario, Canada. She began to experience anxiety and visited a doctor in an effort to alleviate it. The doctor prescribed Sara, then 17, Seroxat (paroxetine). 

On Sunday, May 6, 2007, Sara, suffering from the side effects of Seroxat, grabbed a piece of electrical wiring and hanged herself in the basement of her parents' house.

GlaxoSmithKline issued this statement:

"Any suicide is tragic and the greatest risk for suicide is untreated depression.
"Paroxetine has been used by tens of millions of patients and has been proven to be a safe and effective treatment since its launch more than 15 years ago
."The label contains instructions regarding the use of paroxetine and important safety information about the product.
"If patients have questions regarding the use of paroxetine, or the management of their depression, they should contact their health-care professional.
"Also, it is very important that patients do not stop taking paroxetine without first consulting with their doctor."

More about Sara here.





The above three articles feature three young women whose lives were cut drastically short. GSK will have you believe that these are just anecdotal stories and, therefore, cannot be taken at face value.

If either Sharise, Cecily or Sara were high profile sports stars like yourself Kelly then their deaths, or rather the circumstances surrounding their deaths, would have received far more media attention.

I was saddened to hear that you, yourself, have endured depression and self-harm. You will know from experience how this can effect your daily routine, let alone the sport that you excelled in.

Sharise, Cecily and Sara went one step further, they did so as a result of Seroxat induced suicide.

Now Kelly, let me show you exactly what GlaxoSmithKline hid during the marketing of Seroxat. I'm assuming you are not aware of this, if you were then I doubt very much that you would have joined forces with GlaxoSmithKline.

This is what your advisors, or indeed GlaxoSmithKline, have not revealed to you.

GlaxoSmithKline's Paxil 329 study

In a nutsell, Study 329, took discouraging data on the efficacy and safety of paroxetine [Seroxat] in kids and spun it into an article claiming excellent results:

GlaxoSmithKline hired the services of  Scientific Therapeutics Information to 'ghostwrite' a study regarding the use of Seroxat in children and teenagers, the ghostwriter, Sally K. Laden,  was given approx 200 pages of a clinical trial they had carried out using Seroxat. 

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. 

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?

This is for you Dame Kelly. It's Sally K. Laden's deposition [under oath]

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.

So, you see Dame Kelly, Glaxo knew during the clinical trials of Seroxat that 5% of the children taking it attempted suicide. You'll also note that GSK knew this but, through a ghostwriter, they claimed it showed "Remarkable efficacy"

Would Sharise, Cecily and Sara be alive today if they had been privy to this study that GlaxoSmithKline kept hidden from the public?

Remember I told you earlier in this letter to remember the paragraph "Numerous investigations by independent bodies made up of doctors who are expert in this field have found no links between Seroxat and suicide."

How do you feel about GlaxoSmithKline's statement now?

I'll leave you to ponder on that one Dame Kelly.

GlaxoSmithKline haven't just hid results in Seroxat clinical trials for children and adolescents Dame Kelly.


Joanne Thomas


Joanne Thomas filed a Paxil birth defect lawsuit against GSK in 2006. GSK argued that she was out of time. [Statute of Limitations] The Judge and subsequent appeal panel agreed with GSK.

During a previous Seroxat birth defect trial [Kilker v GlaxoSmithKline] evidence emerged that back in 2001 GlaxoSmithKline had received an email from a mom who had to abort her child because of birth defects.

Internal emails used as evidence in the Kilker trial saw Glaxo officials admit that the cause of these birth defects was related to Paxil [known as Seroxat in the UK]

An internal GSK document relating to the correspondence, headed "re-investigation of case number A0348482B", dated 13 June 2001, states: "Relatedness assessment to medication – almost certain."

The woman who sent in the email was, for many years, unknown. Last year she and I corresponded.

I don't know if you have children Dame Kelly, regardless of whether you have or not you will find the story of Joanne Thomas harrowing and may ask yourself why GlaxoSmithKline rejected her plea for compensation on a statute of limitations argument when they knew that she had contacted them in 2001.

Furthermore Dame Kelly, it may also interest you to learn that GlaxoSmithKline sat on the birth defect link for many years...just as they did the suicide link in children and adolescents.

This from the Kilker v GlaxoSmithKline birth defect trial...

[Teratogen is an agent or factor that causes malformation of an embryo, such as the drug thalidomide]

"In May of this year, 2009, a study was published by Doctor Sloot. The study said this.

What Doctor Sloot did is, he took Paxil and all the other reuptake inhibitors and he exposed rat fetuses to these 12 different drugs, including Paxil. And what Shearing Plough was trying to figure out, what they were trying to do was figure out whether one of the drugs that they were going to put on the market to compete with GSK's drug was capable of causing birth defects. And so they took the drug they were going to take to market, and before they took it to market, they did this test. And they compared it to all the other SSRIs. Because, as you will learn, GSK never did this test.

What Doctor Sloot discovered in May of this year is that out of all the teratogens, out of all the SSRIs, the 12, only one was a clear teratogen, Paxil. He discovered that Paxil in May of this year was actually more powerful a teratogen than cocaine.

It would be safer, according to Doctor Sloot's study, to take cocaine than it would be to take Paxil while you were pregnant.

Now, Shearing Plough, quite rightly, took their drug that they were thinking about taking to market to compete with Paxil, and even though it was just a possible teratogen, they scrapped their plans to take it to market and decided the risk was not worth the benefit.

GlaxoSmithKline, Dame Kelly, the pharmaceutical company that you have joined forces with, refused to carry out such a study - you have to ask yourself why.



I hope when reading this open letter to you, Dame Kelly, that you don't think that these instances above are just a few minor incidents and that Seroxat is actually a great drug.

I hope you don't think that this is just about one drug.

I hope you are aware of GlaxoSmithKline's recent $3 billion dollar fine in the US. A fine that they paid after pleading guilty to a host of violations, including the promotion of Seroxat to children. They blamed it on an 'era' at GlaxoSmithKline - That 'era' was when somebody else was in charge at GlaxoSmithKline. That 'era' continues today. Links at the foot of this post Kelly.

Do you still wish to be associated with GlaxoSmithKline Dame Kelly?

It would be refreshing if a high profile sports star and Dame actually spoke out against GlaxoSmithKline rather than work with and alongside them.

If you wish to know more then please feel free to contact me - Email on right hand sidebar.

Yours sincerely

Bob Fiddaman.


Seroxat Suicide

Sharise Gatchell RIP.

Mother Speaks Out [Seroxat Suicide]

Sara Carlin Inquest - We Know How, Now Tell us Why!


Birth Defects

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists




GSK - Bribery and Fraud

















Thursday, July 17, 2014

GSK CHINA - Bribery was Rife 13 Years Ago




The Financial Times (FT) are reporting that the recent allegations of bribery and corruption by GlaxoSmithKline employees in China is nothing new. Furthermore, the FT claim that Peter Humphrey was part of the team in 2001 that investigated GSK's  China vaccine business, resulting in the firing of about 30 employees.

Humphrey, along with his wife, Yu Yingzeng, were arrested over a year ago for breaching data protection rules. The breach was in connection with GSK’s current scandal. A few days ago they were formerly charged by Chinese authorities and their trial has been set for Aug 7.

According to the FT...

Two people familiar with the 2001 scandal said GSK found that staff were bribing Chinese officials and taking kickbacks. The company acknowledged the matter for the first time to the Financial Times, but said it had dealt with the issue rigorously.
The earlier scandal came the year after GSK was formed via a merger of Glaxo Wellcome and SmithKlineBeecham. In late 2001, Paul Carter, GSK’s new China head, asked PwC to investigate after suspicions of corruption emerged, including the fact that two staff had been detained in China without him being told.
PwC confirmed the suspicions, and Mr Carter fired the Chinese head of vaccine sales in China. Mr Carter left GSK in 2005 long before the current problems emerged. He declined to comment.
Chris Baron, the general manager for the vaccines unit in 2001, denied knowledge of the bribery at the time. He was suspended and, soon after, left the company.

Andrew Witty, Glaxo's current CEO has denied knowing anything about the current Chinese allegations.

The same was said back in 2001 when Witty was the company’s head of Asia-Pacific.


According to the FT...

At the time of the 2001 incident, Sir Andrew Witty, GSK chief executive, was the company’s head of Asia-Pacific, but his responsibilities excluded China. GSK said Sir Andrew “was not involved in and was not aware of” the case at the time.

Anyone see a pattern here?

In 2012, Andrew Witty was accused by a GSK whistleblower as being part of a criminal cover up regarding GSK's recent $3billion fine to the Department of Justice.


Bob Fiddaman



Back stories.

Glaxo - The Sex Tape Scandal

Peter Humphrey's 2012 Presentation - Pharma Bribery

GSK's Chinese Whispers and David Cameron 

“GSK were really cagey", Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

Related

GlaxoSmithKline: The Andrew Witty "Era"

Andrew Witty... I know narrrrrrrrthing







Tuesday, July 15, 2014

Not Recommended





People that know me pretty much know that the words 'not recommended' mean absolutely nothing to me.

When used on drug information leaflets, 'not recommended' serves as a reminder to prescribing physicians that the drug they are about to prescribe to the patient is not recommended for them, be it because they don't have an illness that the drug is indicated to treat or that it could be potentially dangerous.

Last week British tabloid, The Mirror, ran with an article about pensioner Ron Sheppard.

Sheppard had been campaigning for almost 22 years to force changes to the way a steroid [Depo-Medrone] was used on millions of patients. And now, writes The Mirror, "drug company Pfizer has applied to UK drug regulators to change the drug labelling.

"It is likely to be switched from “not recommended” for use in epidurals to “must not be used”."

22 years on and now Pfizer decide that the drug must not be used in epidurals. It would appear that Pfizer know the difference between “not recommended” and “must not be used”, either that or they fear future lawsuits.

“Not recommended” is simply not good enough, particularly when it comes to children being prescribed antidepressants.

Would it be practical for the likes of antidepressant manufacturers to change the patient information leaflets for antidepressants from 'Not recommended for children' to 'Must not be used in children'?

The defence of the pharmaceutical industry has, for many years, been this 'not recommended' nonsense.

"It specifically states that our product is not recommended for use in children", is a line thrown around when pharmaceutical products have been implicated in child/teen suicides. Hidden in their defence, however, are facts that they have promoted the use of antidepressants in children - reps, armed with cash incentives or other lavish gifts have, for decades, persuaded doctors that  "not recommended" are just two words that have to appear on leaflets for legal reasons. A rep from Glaxo would have told doctors that Paxil was safe to use in kids...it was the other SSRi's that were unsafe. A rep from Lundbeck would have told doctors that Celexa was safe to use and that it was other SSRis that were dangerous.

That's how marketing works and it was those two words that allowed pharmaceutical companies to get away with it for decades.

If a rep had visited a doctor and offered him cash incentives to prescribe a drug that said “must not be used”, would the outcome have been the same?

"Not recommended" can be written off as a legal requirement, it can be a discussion starter with a pharma rep and doctor, it can be twisted to convince the doctor that it's okay to prescribe adult drugs to children or drugs with a link to birth defects to pregnant mothers.

It's time to change all of that.

The following “must not be used” in children, adolescents and pregnant mothers.

Citalopram
Fluvoxamine
Escitalopram
Paroxetine
Sertraline
Fluoxetine

They “must not be used” to treat illnesses other than those indicated on the leaflet.

It doesn't take a rocket scientist to figure out why this has never been done.

'Not recommended' has helped the pharmaceutical industry get away with murder and, at the same time, earned them billions of dollars. Money over life.

Just a small example here.



Bob Fiddaman.


Thursday, July 10, 2014

Two Boys, Two Suicides, One Antidepressant.



Two inquests looking into the deaths of two 14 year-old boys bear striking similarities that should be a stark warning to all parents...and European medicine regulators.



Jake McGill-Lynch, [above] from Clondalkin, Dublin, was just 14 when he was referred to a psychiatrist in January 2013. Jake was feeling anxious due to an forthcoming 'Juinor Cert', a qualification awarded in Ireland by the Department of Education and Skills to students who have successfully completed the junior cycle of secondary education.

Jake's appointment with Consultant child psychiatrist Dr Maria Migone resulted in a prescription for Prozac [fluoxetine]. Just a few months later, Jake, armed with a gun, shot himself to death.

Jake was declared dead at 3.00am on the 20th March.




On March 20th another 14 year-old, Tom Boomer [above] of Bloxham, Banbury, started taking Prozac.

A a multi-disciplinary team at the Child and Adolescent Mental Health Service in Banbury had decided that Prozac would alleviate his symptoms.

Tom was “quite upset” at moving schools, from The Warriner School in Bloxham to Chipping Norton School in January 2014.

11 days later, on March 31, Tom killed himself by jumping off a multi-storey car park.

The inquest of Jake McGill-Lynch is still ongoing but the inquest of Tom Boomer has recorded a verdict that he took his own life.

Oxfordshire coroner Darren Salter said: "Overall, it seems Tom intentionally jumped from the car park with the intention to take his own life."

If Slater delved deeper into the side effects of Prozac he would have learned that suicidal completion is a side effect and has been reported and acknowledged by makers of generic Prozac, Mylan. If he had bothered to research he would not have returned such a ludicrous statement.

Maybe Tom Boomer did not intentionally jump from a multi-story car park, maybe he was pushed  by Prozac?

Despite these two inquests and despite many years of critics urging the British drug regulator to alter their stance of prescribing Prozac to kids, Doctors and adolescent psychiatrists still prescribe it to this vulnerable population.

What does it take for them to take their heads out of their arse?

Here we have two young boys facing life problems. Prozac was prescribed to them both. Prozac is indicated to treat a mental illness.

Let's just take a look again at the apparent mental illnesses of young Jake and Tom.

Jake was feeling anxious due to a forthcoming 'Juinor Cert'. He was prescribed a drug to treat a mental illness.

Tom  was “quite upset” at moving schools. He was prescribed a drug to treat a mental illness.

Both prescribing 'professionals' have claimed that they had discussed the side effect issues with both sets of parents. A claim that is not acknowledged by the parents of both Jake and Tom.

"Jake was with his father John Lynch when Dr Migone prescribed the Prozac. She said she would have discussed some side effects and said Ms McGill-Lynch should feel free to call her having read the patient information leaflet that would come with the Prozac.
"Ms McGill-Lynch said only Mr Lynch had signed the consent form. Dr Migone said that it was her understanding that Ms McGill-Lynch was in favour of the medication." [Source]

In Tom's case...

"Mr Boomer told the court he and his wife were not involved in the decision-making process about Tom taking Prozac, which he started on March 20.
"The father said it had been “presented as a done deal”.
"However, child and adolescent psychiatrist for Oxford Health, Dr Ann Rowlands, who was head of Tom’s treatment team, said: “It wasn’t a done deal.”
"She said it was a joint decision by a multi-disciplinary team at the Child and Adolescent Mental Health Service in Banbury that had been treating Tom’s depression.
"Dr Rowlands added she had discussed “the increased risks of self-harm” with his parents."
The following is chilling. It highlights the ignorance of Jake's treating psychiatrist.

"Dr Migone said the US black label was based on a meta-analysis carried out in 2003 but later studies found no increase in suicidal ideation in young people with anxiety taking Prozac."

Those 'later studies' she refers to were industry driven and have, many times, been criticised and shown to have serious flaws. Migone did not mention this though.

My opinion, for what it's worth, is that Migone and the Child and Adolescent Mental Health Service in Banbury need to go back to training school and learn about the dangers of these drugs when given to kids.

Both psychiatric units also need to try and understand that feeling anxious about a forthcoming school award and/or feeling anxious about moving school are not mental illnesses. They are life experiences.

Jake and Tom should have been allowed to talk through their anxious feelings, instead they were given a drug that is known to increase suicidal thoughts.

Way to go medicine.

Bob Fiddaman.










Tuesday, July 08, 2014

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.





Unconfirmed reports have surfaced that GlaxoSmithKline have hired the services of  Ropes & Gray, a US law firm, to conduct an external investigation of its China business.

Colleen Conry and Brien O’Connor, co-leaders of the Ropes & Gray government enforcement practice, were successful in winning an acquittal for former GlaxoSmithKline associate general counsel Lauren Stevens in the U.S. District Court for the District of Maryland back in 2011.

Stevens was acquitted on charges that she withheld documents from the U.S. Food and Drug Administration in its inquiry into possible off-label marketing of the antidepressant Wellbutrin.

I'm really struggling with the whole GSK Chinagate debacle.

It's bizarre, to say the least.

Firstly, they receive a bunch of emails from a whistleblower, at least 23 anonymous emails were sent to government agencies around the country and to GSK’s top management alleging that bribery was rife in GSK China sales and that the practice was endorsed by senior GSK management.

Instead of investigating the claims, Glaxo decided to investigate who they thought was behind the emails.

Why?

Vivian Shi, the company’s former head of government affairs in the country and the person GSK suspected was trying to damage the company, was investigated by Peter Humphrey and his wife, Yu Yingzeng.

However, Humphrey found nothing that pointed toward Shi as being the whistleblower.

In his report, Mr Humphrey warned the company that, by focusing on Ms Shi, it might not be seeing the wood for the trees.
     
“GSK should be wary of possible operational loopholes that make it vulnerable,” he concluded in the confidential report submitted to his client, adding that such loopholes included “wrongdoings committed by employees or business partners”. [Source 双语新闻Bilingual News]

Humphrey and his wife were, shortly after their investigation into the whistleblower, arrested by Chinese authorities, which, to me at least, suggests they used illegal means when investigating Shi.

Humphrey and his wife are currently being held custody in Shanghai’s Pudong District Detention House. They are awaiting a trial that will be held behind closed doors, away from the public.

Why?

Shortly after their arrest Chinese authorities turned their attention to GSK's Mark Reilly. Reilly was arrested on suspicion of ordering GSK employees to form a massive bribery network.

The whereabouts of Reilly is unknown, other than he is currently in China.

He is not being held in any detention centre.

Why?

Hiring Ropes & Gray to conduct an external investigation of its China business seems to confirm that their own investigation of the allegations just wasn't good enough.

GSK carried out their own internal investigation into the allegations but found nothing on the scale of what the Chinese authorities found...or have alleged.

Why?

By hiring Ropes & Gray aren't GSK admitting that their own internal investigation team failed?

Have Ropes & Gray really been hired to conduct an external investigation or have they been hired to help with Reilly's defense?

An email to Ropes & Gray asking them to confirm that they have been hired by GSK went unanswered.

My thoughts in this post are based purely on the unconfirmed reports that Ropes & Gray have been hired by GSK.

Bob Fiddaman


Back stories.

Glaxo - The Sex Tape Scandal

Peter Humphrey's 2012 Presentation - Pharma Bribery

GSK's Chinese Whispers and David Cameron

“GSK were really cagey", Claims Whitehall Official.



Monday, July 07, 2014

Celexa and Lexapro Refunds




A federal judge has ruled that parents, whose children were prescribed the antidepressants Celexa [citalopram] and/or Lexapro [escitalopram] are entitled to refunds.

Forest Laboratories and its subsidiary Forest Pharmaceuticals, have agreed to shell out up to $10.4 million in refunds.

Back in 2010 Forest  pleaded guilty to federal charges that its sales force team illegally marketed Celexa and Lexapro for use in children and teenagers when they knew that both drugs were only approved by the FDA to treat depression in adults. According to the charges, Forest bribed doctors with cash, meals and travel in efforts to persuade doctors to prescribe the drugs to children.

Why aren't we surprised by this anymore?

Once again we are seeing a pharmaceutical company quietly settle matters, once again there is no jail time for any of the executives, once again money is thrown at the problem.

The 2010 charges also allege that Forest covered up the negative results of their pediatric trials.

So they knew their drugs were no better than placebo yet still targeted doctors to prescribe them to kids.

Anyone familiar with the story Hansel and Gretel?




Dr. Greg Mattingly with his wife Judi


Dr. Greg Mattingly, a psychiatrist in St. Charles, was also named in court documents as one of the country’s top prescribers of Celexa. Evidence shows notes made from a phone call with Mattingly and a Forest sales representative where he agreed to include information about Celexa for children into his talks. Mattingly is alleged to have received more than $107,000 from Forest Pharmaceuticals in meals, travel and speaking fees in 2012 and close to $38,000 in 2013, according to trial documents.


Dr. Brian D. Barash


Dr. Brian Barash, a Kansas City psychiatrist and chief medical officer of the Marillac Children’s Psychiatric Treatment Center, was paid “thousands of dollars to give dozens of speeches to Missouri doctors about Celexa,” according to trial docuuments.

Take a good look at the photos above. Both have, it seems, been promoting drugs that not only don't work in children but drugs that are dangerous for children.

Forest has already agreed to pay out $313 million to settle allegations with the government and millions more in dozens of personal injury lawsuits.


  • 13-year-old Andrew Tradd of Massachusetts, who died of a brain injury days after he tried to hang himself in 2004, two years after being prescribed Celexa. 
  • The family of Danielle Henrikson, 15, sued the company after she hanged herself in her Idaho home the same year, weeks after starting the drug. 
  • Alex Kim of Georgia, hanged himself in 2004 after his dosage of Lexapro was doubled.
Full article, 'Parents can get refunds for some anti-depressant drugs given to kids', here.

Celexa is known in the UK as Cipramil. Lexapro uses the brand name Cipralex in the UK.

Both drugs are also under scrutiny for causing birth defects.

More on the settlement agreement here.


Bob Fiddaman.



Sunday, July 06, 2014

“GSK were really cagey", Claims Whitehall Official.




The Telegraph are running with a fascinating story regarding the 'goings-on' in China.

Two men, both, at some stage, employed by GlaxoSmithKline, are facing trial over the coming months. One for mastering a network of bribery, the other, well, it's unknown exactly what he is being tried for?

Peter Humphrey is set to face the Chinese gavel on Aug 7th. Initial reports suggested that both he and his wife, Yu Yingzeng were arrested for  breaching data protection rules. The Telegraph elaborate further and now claim that the pair's arrest is in connection with Humphrey's investigation of a former employee of GSK.

This is quite a scoop as the arrest of Humphrey was clouded in mystery - nobody knew if it was in connection with GSK - Now, according to the Telegraph, it appears that his arrest is in direct connection with the investigation he carried out for the British based pharmaceutical company.

GSK executives were sent a series of emails that alleged that bribery was rife amongst their operations in China and the main man behind the bribery network was GSK's Mark Reilly.

GSK then hired the services of ChinaWhys, a company run by Peter Humphrey and his wife.

Humphrey targeted Vivian Shi, GSK's former head of government affairs. His investigation of her could have possibly been done by using illegal means - hence his arrest.

Question is, who informed the Chinese authorities that he was investigating Vivian Shi? Did Shi catch wind and inform the Chinese authorities?

The Telegraph are using the human interest angle in their article.

Humphrey and his wife are currently being held in Shanghai’s Pudong District Detention House, they, as expected, have been segregated and have no contact with one another. Their son, Harvey, has not been allowed to visit them but, according to the Telegraph, "officials from the British consulate are allowed to collect letters from his father."

The Telegraph have had access to some of those letters, they write..

Last November he said was suffering “severe frequent pain” in both legs, and numbness in his right leg. “Seems to be a blood circulation problem,” he wrote.
In January, he wrote: “All I get now is one sleeping pill and in the morning one so-called pain killer. But the reality is that I am in constant pain from my legs and joints and my damaged spine, especially the neck vertebrae. And I am not getting any treatment from my prostate problem now or any further investigations into it [ ...] I need surgery on my hernia.
"I simply despair over my collapsing health and mummy’s.”
Of his wife Mr Humphrey wrote: “I have spoken to other prisoners who have seen her and they say she is in constant pain from joint problems caused by her confined conditions. They say her weight has fallen to below 40kg (six stone). I have lost 10kg of body weight and am very skinny.”

The Telegraph are also reporting that a Whitehall official involved in representations to the Chinese over Mr Humphrey’s detention claimed that GSK refused to reveal the reasons why they had originally employed his services and that this impeded British attempts to intervene on his behalf.

The official said: “GSK were really cagey. They just kept saying it was routine work and kept the information deliberately vague. When we went to the Chinese we were arguing with one hand tied behind our backs.”

On the flip side of the coin we see GSK's Mark Reilly who faces charges that, as far as I am aware, are far more serious...yet, Reilly, it appears, is not being detained in any Chinese prison, he has just been told that he cannot leave the country.

Where exactly is Mark Reilly and why is he being afforded the luxury of not having to spend his time in a detention centre whilst he awaits trial?

I feel for Humphrey and his wife Yu Yingzeng, I feel for their son, Harvey.

It would appear that Glaxo don't seem to be bothered about the wellbeing of the very same people they hired to investigate bribery allegations.

Glaxo boss, Andrew Witty, remains tight-lipped about the whole sordid affair. Meantime, Peter Humphrey and Yu Yingzeng have the prospect of facing a trial while their health deteriorates inside Pudong District Detention House.

There's been some string pulling here, I'm sure of it. I can't prove it though but would love to be a fly on the wall when Humphrey and his wife go to trial. Sadly, Chinese authorities are conducting the trial in secrecy on August 7.

One has to ask why and whether or not the British Prime Minister and Andrew Witty have had an influence in proceedings.

If, by any chance, Harvey, Peter Humphrey's son, reads this blog post of mine, I'd love for him to get in touch, maybe write a guest post.

I'm not a fan of GlaxoSmithKline, I suspect neither he, Peter Humphrey and Yu Yingzeng are fans either.



The article in the Telegraph, 'GSK crisis: Two British fathers face Chinese prison in a tale of corruption and sex.', can be read here.

Bob Fiddaman



Back stories.

Glaxo - The Sex Tape Scandal

Peter Humphrey's 2012 Presentation - Pharma Bribery

GSK's Chinese Whispers and David Cameron






Saturday, July 05, 2014

Swedish Journalist Takes on British Drug Regulator



Janne Larsson is a tenacious so and so. He'll dig, stumble across something that isn't right then ask questions to try and seek the truth.

He has given me permission to publish his recent letter to the British drug regulator, the MHRA.

Larsson has, for some time now, been gunning for Janssen, makers of Concerta, also known as Ritalin.

Like any good journalist Larsson has meticulously studied the adverse events of Concerta in Janssen’s clinical trials. What he found were huge flaws. [Back story]

Here's his latest letter to the MHRA.

The approval of Ritalin for adults – where did all the aggression go?

Dear Dr Hudson,

As you may remember I wrote to you in February and March about MHRA and the scandal with the ADHD drug Concerta  [http://jannel.se/MHRA.Concerta3.pdf]

I made the “prophecy” that several drug regulatory agencies in Europe, who had allowed alarming levels of off label prescription for adults, like Sweden, would have to make sure that we quickly forgot the Concerta scandal. And the best way to do that would be to push through another application of methylphenidate for adults – like Ritalin. And to then claim “that we now have evidence”.

I said that we could expect Novartis to have learned from the failed Concerta submission, and to design more “smart” studies, showing its drug Ritalin (in all important aspects the same as Concerta) to be “safe and effective”. We could expect that the submitted studies would get a positive assessment this time – no embarrassing questions – and suddenly the concealed and alarming Concerta results could be expected to no longer exist!

We have now arrived at that point.

It has been a secret up to now how Novartis planned its conquest of Europe, or as Financial Times said, how to get everyone “on board with adult ADHD” [http://www.ft.com/intl/cms/s/2/8b721a20-b8e9-11e2-a6ae-00144feabdc0.html] . We have not known in which countries the application was submitted or via which procedure. We know now.

Novartis succeeded to get through some kind of “informal worksharing procedure”, as there was “currently no legal basis” for a formal work sharing procedure. As the Swedish Medical Products Agency stated in its assessment report:

“The worksharing procedure included all European (EU) countries where Ritalin LA is currently registered. As Ritalin LA is registered via national procedures in EU, there is currently no legal basis in EU for using ‘formal’ worksharing procedure for nationally registered products.”

We also know that Germany was leading this “informal work sharing procedure”.

I have read the Swedish “investigation” about Novartis’ submitted studies, and as expected – no embarrassing questions. Much could be said about it, but at this point I only want to take up one important, even vital aspect.

Where did all the aggression go?

As you know MHRA, leading the European investigation about Concerta concluded: “A causal relationship with Concerta was established for aggression, tics and depression.” (Preliminary Variation Assessment Report, juli 2010 page 112, [http://jannel.se/PVAR.Concerta140710.pdf )]

The investigation showed that in the three Janssen-submitted, double-blind studies (3013, 02-159 and 3002) “13 of the 596 subjects receiving Concerta … were withdrawn for aggression-related adverse events (vs. none receiving placebo)”. (Page 65, Preliminary Variation Assessment Report, Concerta, July 2010, see also FVAR, page 12, 26 April 2011.)

These 13 persons suffered so severe aggression that they had to be taken out of the trials. None of those on placebo suffered such serious aggression that they had to end the trials.

The investigation also showed that a total of 71 out of 596 subjects (11.9%) from the Concerta group had suffered aggression (compared to 17 ​​persons, 5.5%, from the placebo group). In the combined studies of Concerta in adults (placebo-controlled, and others) 202 of a total of 1369 subjects, 14.8%, suffered aggression. [10] (See FVAR, page 12, 26 April 2011.)

Clear evidence also emerged in the studies that Concerta could cause anxiety and agitated conditions in adults – ”evidence for the risk of new-onset anxiety, tension and agitation”. “Adult studies have identified anxiety as a very common risk in adults.” (See Preliminary Variation Assessment Report, page 117.)

In the investigation it was concluded: “The main new safety concern from the study data is around the frequency of psychiatric adverse events and that this is often de novo [new]. Of note is the incidence of anxiety but also rates of depression and aggressive and hostile behavior are raised.” (See Preliminary Variation Assessment Report, page 66.)

MHRA asked for and Janssen submitted (January 2011, Response Document) the following illuminating table over adverse events in the Concerta studies:


We would of course expect a similar picture in the clinical trials of Ritalin for adults.

And so we take a look at the comparable table in the Swedish investigation of Ritalin for adults. It looks like this (National Type II variation – Overview, page 35, 16 July 2014):


We can see, for the first 9 weeks, that “Psychiatric Disorders” are lumped together, with 188 persons (34.7%) in the Ritalin group affected by these, compared to 25 (13.9%) in the placebo group.

But nowhere in the 58 pages long Swedish “investigation” can we read specifics about what comprised these psychiatric disorders. We find nothing at all in the document about “aggression”. We find nothing about “new safety concerns” for aggression, hostile behavior, anxiety, depression.

While the assessment of the Concerta studies showed: “A causal relationship with Concerta was established for aggression, tics and depression”, we find nothing at all about this in the Swedish document.

So in some way the Swedish authorities together with Novartis succeeded to get rid of, or not go further with, these serious adverse effects, which must have been about the same in the studies of Ritalin as in the studies of Concerta. And which could have – as for Concerta – formed the basis for disapproval of the application. How this was done is not clear at the moment. Maybe we have a case of “recoding” the adverse events, like the famous renaming of suicide attempts by pharmaceutical companies, instead calling them “emotional lability”. Anyhow the Swedish authorities could not “afford” to ask too many questions about this.

What did the MHRA do about it?

At the moment I don’t know how much of the text in the Swedish assessment report is copied from the text originated by the Reference Member State (RMS), Germany, leading the handling of Novartis’ application.

And we come to the role of MHRA and my questions to you:

1. Did MHRA “handle” aggression, and other serious adverse events, in the same way as the Swedish authorities did? (In other words, not at all.)

2. If so, how could MHRA, considering what the agency knew about the harmful effects of the almost identical drug Concerta, fail to go further with the investigation about this manipulation of data?

3. If MHRA actually challenged the manipulated data about adverse effects in Novartis’ application for Ritalin, I assume the agency arrived at the same conclusion as in the Concerta investigation – that the drug could not be approved. I would be happy to get a copy of that important assessment report.

Yours sincerely,

Janne Larsson
Reporter
Sweden

--



 Janne Larsson has, for many years, in his free time, worked using the Swedish FOI Act to make the “misdeeds” of psychiatry, Big Pharma and government agencies public.

Bob Fiddaman










Thursday, July 03, 2014

GSK's Chinese Whispers and David Cameron




News today that Peter Humphrey's trial is to be held behind closed doors should come as no surprise to those that have been following GSK's Chinagate with interest. [GSK-linked investigators Peter Humphrey and Yu Yingzeng face secret trial]

Peter Humphrey and his wife, Yu Yingzeng, were arrested by Chinese authorities last year for illegally buying and selling private information.

Just a few months previous to Humphrey's arrest he was hired by GlaxoSmithKline  to do some background searches on the person they believed to be a whistleblower. Vivian Shi, GlaxoSmithKline's head of government affairs in China was the subject of Humphrey's investigation, however, he was unable to find anything that pointed the finger of blame toward Shi.

Humphrey was then told that top executives at GlaxoSmithKline had received a series of emails and a video recording of  GSK's Mark Reilly who, at the time, was General Manager of GSK China.

Reilly was later detained and charged by Chinese authorities and stands accused bribery and fraud in connection with a scheme to boost drug sales.

Today's South China Morning Post is reporting...

"US consular officials had been informed on Wednesday when visiting Yu that they would not be able to attend the trial, and that the decision to keep the trial closed had been made on the grounds of privacy, according to the couple’s family friends, who declined to be identified because of the apparent sensitivity of the case."


Two schools of thought here.

1. Humphrey has plea bargained in the hope of a lesser sentence or fine.

2. British Prime Minister David Cameron and Glaxo CEO Andrew Witty have used their influence on the Chinese Prime Minister, Li Keqiang.

Point 1 is feasible given that Humphrey knows all about pharmaceutical fraud and probably would have seen more allegations of the whistleblower than the emails GSK have admitted to.

Point 2 is also feasible when we look at David Cameron's recent trip to China.

Here's an article published around the time of Cameron's visit to China. [It's worthy to note that Andrew Witty also accompanied Cameron on this 'business' trip]

David Cameron has risked angering the Chinese government by launching a robust defence of GlaxoSmithKline  as the UK drug company steps up its battle to save its reputation in the country.
GSK is facing prosecution from Chinese authorities over allegations of bribery, while dozens of its local employees and a UK man it used as a corporate investigator remain in detention.
The prime minister gave public backing to the company on Tuesday during his three-day trade mission to China . He told reporters in Shanghai: "They are a very important, very decent and strong British business that is a long-term investor in China."
Mr Cameron raised the GSK case with Li Keqiang, the Chinese premier, during talks in Beijing on Monday, as investigators probe allegations the company bribed local doctors to sell GSK's medicines.
Andrew Witty, GSK chief executive, is part of a business delegation accompanying Mr Cameron in China, signalling an intensification of efforts to resolve the dispute.

During this visit Peter Humphrey's son, Harvey, called on Andrew Witty to raise his father’s case while in China for high-level meetings.

“My father was working for GSK. I know Andrew Witty is in China this week and I hope he can take a few minutes to raise my father’s case,” Harvey, 18, a university student now in London, told the Financial Times. “I understand everything is complicated in China but it seems my parents are paying a big price.”
Harvey Humphrey is right, his parents are wrapped up in something quite complicated here.

Question is, did Andrew Witty, or indeed, David Cameron influence  Li Keqiang, the Chinese premier?

I guess we shall have to wait and see what the outcome is of the trial of Peter Humphrey and his wife, Yu Yingzeng is.

Personally, I hope Humphrey took option 1 and spilled the beans on GSK in an effort to receive a lesser sentence from the Chinese authorities.

The trial is set for Aug 7.

Bob Fiddaman.

Back Stories.

Glaxo - The Sex Tape Scandal

GSK's Private Investigator [The Video]

Peter Humphrey's 2012 Presentation - Pharma Bribery












GSK: Racketeer Influenced and Corrupt Organizations Act




So, what exactly is the Racketeer Influenced and Corrupt Organizations Act [RICO]?

Basically it's a federal law designed to combat organized crime in the United States, it was introduced in 1970 and has been used to prosecute members of the Mafia.

On June 30, 2014, Attorneys representing GlaxoSmithKline, asked the Court of Appeals to throw out racketeering claims in three class actions that had accused them of hiding heart disease risks associated with the diabetes drug Avandia.

In 2013 Pennsylvania U.S. District Judge Cynthia M. Rufe refused to dismiss claims made by three union benefit funds under the Racketeer Influenced and Corrupt Organizations Act, ruling the plaintiffs had adequately alleged a scheme whereby GSK suppressed evidence of Avandia’s cardiovascular risks to increase the number of prescriptions written and covered.

The crux of GSK's appeal is that District Judge Cynthia M. Rufe erred in her initial ruling. They claim, “A plaintiff cannot be injured by a misrepresentation about a health care product unless the plaintiff personally receives a ‘compromised or diminished’ benefit from the product as a result.”

More on GSK allegedly violating the Racketeer Influenced and Corrupt Organizations Act here [Subscription only]

Back in 2011 GSK also failed in their efforts to have Plaintiffs' Proposed Specific Causation Expert Witnesses Nicholas DePace, M.D excluded from giving testimony. Their motion was denied, once again by Pennsylvania U.S. District Judge Cynthia M. Rufe   [More here]

Bob Fiddaman