Blogging Since 2006

Blogging Since 2006
WHEN INJUSTICE BECOMES LAW, RESISTANCE BECOMES DUTY

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




Tuesday, July 01, 2014

Peter Humphrey's 2012 Presentation - Pharma Bribery





In 2012 Peter Humphrey gave a presentation, the gist of which was fraud in China. At the time Humphrey was Managing Director, ChinaWhys Co Ltd.

The opening slideshow presentation offered the following:

China is undergoing a get-rich-quick social revolution and economic development phase. 
After the Cultural Revolution there was a spiritual vacuum a loss of moral compass.
The pressure to make money is enormous, especially among the young. Money means lifestyle and prestige. 
Fraud, embezzlement and corruption is rife in both the public and private sectors – read the local press! 

The 81 page slideshow then offered some past examples of fraud committed in China.

Page 36-38 focuses on Pharma bribery. It's quite eye-opening, although the pharmaceutical company isn't actually mentioned by name.


Slide 1


Slide 2


Slide 3


It's recently been revealed that Humphrey was hired by GlaxoSmithKline China to investigate a potential whistleblower.

Why did Glaxo specifically hire Peter Humphrey?

Surely they would have done their homework on Humphrey and his company ChinaWhys?

Why would Glaxo hire a person or organisation who has a history of presenting examples of pharmaceutical fraud and bribery?

Glaxo claim that they hired Humphrey to do some background searches on the person they believed to be the whistleblower [the person emailing them the bribery allegations and the sex tape] - they, according to media reports, thought it was Vivian Shi, the company's head of government affairs. At the time they never told Humphrey about the emails and sex tape. [Back story]

Despite his best efforts Humphrey was unable to find any discrepancies or wrong-doings by Vivian Shi.

It was shortly after his investigation finished that Glaxo informed him of the emails they had received [the allegations]

Something just isn't sitting right with me here.

Was the 'sex tape' merely a smoke screen?

Glaxo can now use this as a form of defence, they can say that they were being bribed and carried out their own investigation. I don't know, maybe ask the Judge for leniency or reduced sentence...maybe even try to strike a deal with the Chinese government, as they did with the US Justice of Department.

Glaxo caught wind that fraud and bribery was being committed in China. Shouldn't that have been their main priority to investigate rather than find the person 'spilling the beans'?

In any event, why go to a private investigator in the first place? Wasn't this a job for the Chinese fraud squad?

Or did Glaxo, as I suspect, want to keep this in-house?

The final slide [Slide 3] in his presentation is quite revealing.

"Almost one year's business was lost but the firm avoided a public scandal or prosecution"

Did Glaxo really hire Humphrey to investigate Vivian Shi or were their motives to try and seek help in keeping the allegations from going public?

If Humphrey can present a slide show in 2012 that shows how a pharmaceutical company was saved from embarrassment from in-house fraud then maybe Glaxo wanted to pick Humphrey's brain on exactly how that could be achieved.

Hey, I'm just thinking out aloud here.

Bob Fiddaman.




Monday, June 30, 2014

GSK's Private Investigator [The Video]



GSK's Mark Reilly


The Chinese website that hosted the video of  Peter Humphrey's arrest doesn't seem to be hosting the video anymore but I've managed to obtain a copy of it.

Humphrey was hired by GSK's Mark Reilly [above] to investigate Vivian Shi, the company's head of government affairs, as it was thought that she was behind a series of emails sent to GSK executives [including Andrew Witty]

An email was also sent which contained an attachment video of Mark Reilly having sex [see back story]

It's alleged that Humphrey was never told about the emails or video sent to GSK execs, he was just told to investigate Vivian Shi.

According to Jim Edwards over at Business Insider, "Inside GSK, management suspected that Vivian Shi, the company's head of government affairs, sent the emails. There was no evidence, but GSK investigated her travel expenses and eventually she left the company sometime after October 2012 along with her boss, John Lepore, who joined media group Reed Elsevier as head global government affairs. (There are no allegations of wrongdoing against Lepore or Shi."

Business Insider also reports that Humphrey's didn't know about the emails and video during his initial investigation of Shi but was told at a later date about them.
On July 10, 2013 Humphrey and his Chinese-American wife were arrested by Chinese officials and have been held in detention ever since.

One month later Humphrey made a confession on Chinese TV to accessing private information on Chinese citizens illegally. It's unknown if his arrest has anything to do with the bribery allegations made about GSK.



Here's Humphrey on Chinese TV.



video


Bob Fiddaman

Glaxo - The Sex Tape Scandal





Hey, sex is a natural thing for most of us [depending, of course on the pharmaceutical drugs we take]. When I was on Seroxat the 'wolf was kept from the door', a side-effect I wasn't warned about - did wonders for my ego but left me sexually frustrated at the same time.

Oooh er, Mr Fiddaman... don't be so course!

The bribery allegations in China have taken a rather bizarre twist this weekend. GSK's Mark Reilly, who was arrested on charges of ordering employees to form a massive bribery network, has, it appears, been the subject of a GSK internal investigation before he was outed as the brains behind a massive bribery scam in China.

The Sunday Times is reporting that Reilly was the subject of a secretly-filmed sex tape sent to GSK executives shortly before Chinese officials opened its investigation into alleged bribery of doctors.

The video, writes the Sunday Times, was sent anonymously by email to several senior GSK executives, including chief executive Sir Andrew Witty, in March 2013 along with allegations that the company was paying kickbacks to doctors and officials for using GSK drugs, according to people familiar with the situation.

The Telegraph claims that the anonymous email was an attempt to bribe GSK so, writes The Telegraph, "GSK authorised Mr Reilly to spend an initial £20,000 of the company’s money on hiring a private investigator, Peter Humphrey, to discover the perpetrators of the sting, believed to be part of wider attempts to expose the drugs giant to punitive action by Chinese authorities."

Humphrey’s report, code-named “Project Scorpion”,did not find who allegedly planted the camera in Reilly’s bedroom but his snooping around led to Chinese authorities launching a probe into GSK corruption just a few months later.

Humphrey [pictured below] and his business partner-wife, Yu Yingzeng allegedly illegally trafficked a huge amount of personal information on Chinese citizens to seek profits via registering so-called research companies in Hong Kong and Shanghai since 2003.



Humphrey and Yu run the Hong Kong-registered, ChinaWhys Co, a business risk advisory firm, and have, in the past, worked for GlaxoSmithKline.

Ironically Humphrey lists his successes as neutralizing a counterfeit-and-fraud syndicate that hijacked the business of a global consumer goods manufacturer, eliminating fraud from the buying operation of a leading megastore chain and uncovering fraudulent JV deals for a global appliances manufacturer.


I have to say that I feel kinda sorry for Mark Reilly here...I mean who would want Andrew Witty watching them have sex!

Reilly, if found guilty of forming a massive bribery network, faces up to 10 years in prison.

The sex-tape scandal has broke at a convenient time, for me at least.

Last week I met with GSK whistleblower Blair Hamrick. We sat and chatted over dinner and he told me how Glaxo promoted an antidepressant [Wellbutrin] off label for use in people with [ahem] sexual problems.

Glaxo marketing came up with the line the "happy-horny-skinny pill" so reps could convince doctors to prescribe it to patients who were overweight and also those who were experiencing a low sex drive [decreased libido]

This has left me pondering if Reilly ever took it.

Hey, wouldn't it be amusing if there was a box of Wellbutrin on Reilly's bedside cabinet and it appeared in the video sent to Witty and co?

Chinese authorities could throw a product placement charge at them too :-)

I also wonder if Witty ordered in popcorn for the premiere of Romping Reilly.

Bob Fiddaman.