GSK and the MHRA: Conflict of Interest?

Thursday, September 26, 2013

Former Glaxo Safety Officer Becomes Head of MHRA

Ex Glaxo Employee Ian Hudson. Now in charge of  the safety and well-being of the British public.

Former Glaxo [then SmithKline Beecham] World Safety Officer Director Dr Ian Hudson has took over the role of Chief Executive at the MHRA.

Hudson, who after leaving Glaxo in 2001, became the MHRA’s Licensing Director, responsible for overseeing the benefits and risks of drugs before they hit the market.

It is unknown why Former MHRA chief, Kent Woods, whom I’ve had much correspondence with over the years, retired.

Hudson, whilst working for GSK, was a witness for the defence [GSK] during the Tobin v SmithKline Beecham Pharmaceuticals. Donald Schell was put on Paxil [Seroxat]. Forty-eight hours later he put three bullets from two different guns through his wife’s head, as well as through his daughter’s head then through his granddaughter’s head before shooting himself through the head.

Hudson was appointed GSK’s World Safety Officer in 1999. His department was responsible for adverse events that were sent in by health professionals and members of the public.

Whilst under oath Hudson told Andy Vickery, attorney for Tobin, about his role in reviewing the link between Paxil and aggression.

“We reviewed the topic of aggression last year. At that time we said that we would keep aggression under review.  In addition, there was considerable noise in the media earlier this year about Fluoxetine.  So having said that we would keep this topic under review, we rereviewed this topic this year and it was also prompted by considerable concern being expressed, considerable noise being expressed in the media.  There were a series of articles in the “Guardian”. [British Newspaper]

Hudson was then asked by Vickery what he intended to do with the report once it was finalised, adding; Do you intend to submit it to any governmental agency?

Hudson replied:

“If a Government agency requests information on aggression and Paroxetine, we would, but we do not intend to proactively send it to them at this stage.  This was an internal review. We do many internal reviews on many topics.”

This doesn’t really install confidence in informed consent. If Hudson was back then stating that his findings would not be reported to the drug regulator then one can only assume that he still holds the belief that pharmaceutical companies are entitled to hold on to information that could endanger the public.

Later in the deposition Andy Vickery put the following to Ian Hudson:

“Dr. Hudson, are you aware of the body of literature concerning the relationship between serotonin and suicide?”

Hudson replied with…

“In general.  I’ve seen some summary information on that.  I’ve not reviewed that information in detail.  I would, again, delegate that to people within my department and also other psychiatrists within the company who are more closely involved in Paroxetine then I am, people such as Dr. Wheadon.”

Pushing Hudson for an answer Vickery then asked…

“Let me just ask you this:  Do you know whether or not there is any association between levels of serotonin or the serotonin metabolite 5-HIAA and suicidal behavior?”

Hudson answered…

Yes, I believe there is a correlation. I have seen in the literature summary
information that implies that there is a correlation between low levels of serotonin or 5-HIAA in patients’ suicidal activity.

Vickery later asked Hudson:

“Do you believe that it is possible that Paxil has caused any person, worldwide, to commit an act of homicide or suicide?”

Hudson answered:

“I have seen no evidence to suggest that at all.”

Hudson’s deposition can be viewed in full here.

Now Ian Hudson is the head honcho at the MHRA. If you take the time to read the complete deposition of Hudson you will see how he [whether under instruction or not] clearly deflects the blame of suicide and aggression onto other ‘factors’ rather than implicating Paxil.

And now this guy is in charge of regulating medicines in the UK. Do you think his presence will alter the MHRA’s stance on the safety and efficacy of SSRi type medications?

Well, I have seen no evidence to suggest that at all.

Bob Fiddaman



GSK’s Extensive and Long History of Corporate Misconduct… Bob Fiddaman Investigates..

And this is just the tip of the iceberg where GSK and bad deeds are concerned… 

Saturday, September 14, 2013

GSK – A Runaway Train…Running Right Off The Track

If there is one corporate company still operating when it really shouldn’t be that company that stands head and shoulders above any other I know is British based GlaxoSmithKline.No sooner had they been found guilty for a whole host of violations in the US [Resulting in an estimated $3 billion fine] they are back in the news again for yet more violations, this time in China.The Chinese violations are currently under investigation. GSK head honcho, Andrew Witty, has denied knowing about the shenanigans going on in China which include:

  • Bribing doctors with cash payments
  • Bribing doctors with sexual favours
  • Using a network of more than 700 middlemen and travel agencies
  • Inventing meetings that required travel payments (these payments were given to doctors to persuade them to prescribe GSK products)
Glaxo’s $3 billion fine in the US is just another piece of the jigsaw. Before this they have made settlements in and out of US Courts, paying defendants compensation and slamming down gagging orders as part of the settlements… in other words nobody can go public with amounts paid to them.
Let’s just take a look at some of the other violations committed by GlaxoSmithKline over the past few years.
Glaxo’s Puerto Rico plant, Cidra, was infested with violations of federal rules and regulations with regards to the operation of the plant, which violations had a large and detrimental effect on the Company’s sale of Paxil (Seroxat) and Paxil CR.
A lawsuit was filed by Cheryl Eckard, who, at the time, was Glaxo’s Manager of Global Quality Assurance. (United States ex rel. Cheryl Eckard v. GlaxoSmithKline, Case No. 1:04-cv-10375-JLT (D.Mass. Feb. 25, 2004
Eckard was assigned by GSK headquarters in Research to lead a recovery team in Cidra after Glaxo had received a warning letter from the FDA regarding the abhorrent state of the plant. GSK had nine years to iron out the problems at Cidra… they didn’t.
After leading her recovery team Eckard found more violations that the FDA had missed first time round.
In a nutshell, she brought this to the attention of her senior managers, her managers ignored her… then fired her.
According to Eckard’s complaint: “persons at the Cidra plant were skimming product during manufacture, including reject product, and diverting the product to Latin America. … rejected batches of drug product, including Avandamet, were sent from Cidra to [MOVA Pharmaceuticals], (which is located near Cidra) for “black market” packaging and distribution …”
Nearing the end of the trial Glaxo said in a statement that it regretted the way it operated the Puerto Rico plant, which has since been closed, and it’s committed to continuously improvingmanufacturing quality. The company denied Ms. Eckard’s allegations, and said her lawsuit will be dismissed as part of the settlement and payout to her.
Glaxo were fined $750M and Eckard walked away with $96 million for her whistleblowing efforts.
No criminal charges were laid against Glaxo despite allegations of their involvement in selling on rejected batches of drugs to MOVA Pharmaceuticals.
Glaxo suppressed patient-level meta-analysis of safety data from Avandia trials which demonstrated an estimate of excess risk of ischemic cardiovascular events and other potentially life-threatening complications.
A two-year investigation by the U.S. Senate Finance Committee revealed GlaxoSmithKline knew of the cardiovascular dangers associated with Avandia for years and tried to stifle concerns noted by several doctors about the medication.
During the first round of Avandia lawsuit settlements in May 2010, the company agreed to pay approximately $60 million to settle more than 700 cases. Later that year, GlaxoSmithKline agreed to a $460 million settlement, which resolved approximately 10,000 cases. In early 2011, as the first federal Avandia trials began, GlaxoSmithKline agreed to pay a reported $250 million to settle 5,500 claims that Avandia had resulted in death.
In 2012, after being ordered to pay $90 million to resolve allegations by prosecutors in 38 states that the they illegally marketed Avandia, Glaxo had this to say:
 “The company did not admit to any wrongdoing or liability of any kind under these states’ consumer protection laws in this settlement” 
Paxil (Seroxat) Birth Defects
After deliberating for seven hours, a state court jury in Philadelphia found that GlaxoSmithKline failed to properly warn doctors and pregnant women about risks associated with Paxil. The jury awarded $2.5 million in damages to the family of Lyam Kilker, who was born with heart defects after his mother took Paxil during her pregnancy.
The case was the first to go to trial of more than 600 suits claiming that Glaxo hid knowledge of birth defect risks allegedly tied to Paxil.
What did Glaxo have to say after being found guilty?
“While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition.” 
You’ll probably find that the jury thought otherwise Glaxo.
Paxil (Seroxat) Suicide
On December 14, 2009, Bloomberg published an article entitled “Glaxo Said to Have Paid $1 Billion in Paxil Suits.” 
The article reported:
GlaxoSmithKline PLC has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases.
Why did they do this?
Well, it’s down to the Schell case in 2001.
Donald Schell, 60, had been taking Paxil for just two days when he shot and killed his wife, his daughter, his granddaughter and then himself.
Remaining members of the family filed suit.
During the trial GSK [then SmithKline Beecham] internal documents showed the company was aware that a small number of people could become agitated or violent from Paxil. Despite this knowledge, Paxil packaging didn’t, at the time, include a warning about suicide, violence or aggression.
Glaxo were found guilty and ordered to pay $6.4 to the remaining family members.
What did Glaxo attorneys say after this particular defeat?
“Paxil is a very effective medication in helping depression,” attorney Charles Preuss said after the trial. “Our only regret is that Mr. Schell did not have Paxil for a longer period of time.” [Link]
The link between Paxil and suicide has been raging for years.
Here’s what former Head of Psychiatry at GlaxoSmithKline, Alistair Benbow, had to say in a BBC interview.
Benbow {A} was being interviewed by investigative journalist Shelley Jofre.{Q}
Q. Let us move on. What has the company done about the Wyoming (Schell) verdict?
A. As I told you before, in this matter because of a confidentiality agreement between the family and GSK I am not able to specifically comment on the mitigation, but what I can say is that there is no reliable clinical evidence that Seroxat causes violence, aggression or homicide. This tragic, tragic case is something that does occur from time to time in patients who are depressed…
Q. This man had no history of suicidal thoughts or tendencies. The jurors sat and listened to all the evidence and decided that there were four deaths that were mainly caused by Seroxat. Your company was found guilty of negligence. You cannot ignore that.
A. No, and nor would we want to ignore it. This was a tragic case but we remain firmly convinced that Seroxat did not cause the tragic events in this case.
Again, I think the jury would disagree with Benbow here.
If Glaxo believed their product was innocent in the suicides of these people why would they settle further cases? One such case involving the death of a 14-year-old boy who had been taking Paxil for two months. The parents of Scott Cunningham, of Valparaiso, Indiana, sued after the boy hanged himself in 2001. They alleged Glaxo suppressed evidence that Paxil use was linked to the risk of suicide attempts by adolescents. Glaxo denied the allegations, according to court papers.
They then settled with the family later.
Paxil (Seroxat) Addiction
In its 2008 annual report, Glaxo officials said they had reached a “conditional settlement agreement” in January 2006 with Paxil users who alleged they suffered withdrawal symptoms after taking the drug. The case, filed in Los Angeles federal court, was marked closed in court records in February.
In other words a gagging order was place. This enables Glaxo to defend any further lawsuits regarding Paxil addiction. One such lawsuit is the UK Seroxat litigation which Glaxo are defending.
The UK lawsuit has been dragging on for over 10 years now. Glaxo have refused to make any such compensatory settlements to any UK citizen.
So, just a few reasons why it comes as no surprise to learn that Glaxo have been behaving badly in China. No surprise that Witty is denying any knowledge of what went on in China either.
Even when found guilty Glaxo continue to deny any wrong-doing… that trend will continue until compensation is put to one side and criminal charges are laid against the top executives at Glaxo. They are the past masters of buck-passing, of laying blame on others, of waving wads of cash [dangling carrots] in front of victims in the hope that a settlement can be reached. With settlement comes suppression and Glaxo just love suppression.
I anticipate that the bad behaviour in China will be settled and those responsible [the top management] will deny knowledge and let the area managers take the fall.
That’s their style, always will be until someone has the balls to come down hard on the senior management at GlaxoSmithKline.
Someone really needs to put a stop to this runaway train.
Bob Fiddaman

“Bribery part of GSK business plan”… (no surprises there then…)

A police investigation in China has found that drugmaker GlaxoSmithKline’s alleged bribery of doctors ‘was coordinated by the British company and was not the work of individual employees,’ according to a report Tuesday by Reuters.

GSK allegedly paid up to $490 million to doctors in China through 700 travel agencies in exchange for sales of drug products.

‘It is becoming clear that it is organized by GSK China rather than … sales people’s individual behavior,’ Reuters said, citing the official Xinhua news agency.


GSK… Rotten To The Core

GlaxoSmithKline: Drugged Up On China’s Culture of Corruption?

Thursday 12th September 2013 in CommentLead articles

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Can GSK's practices in China be linked back to their HQ in Brentford? Sir Andrew Witty says no. Photo: Maxwell Hamilton.

GSK insist practices in China cannot be linked to Brentford HQ. Photo: Maxwell Hamilton.

It has not been a good couple of years for GlaxoSmithKline (GSK) on the publicity front.

2012 began with GSK paying a hefty fine in Argentina for ‘experimenting with human beings’ during vaccine trials which allegedly led to the death of 14 babies. Another settlement in July broke the record as the largest payment by a drug company in the biggest healthcare fraud case in U.S. history (a settlement totalling $3 billion).

Now, a scandal in China promises lengthy procedures, heavy press coverage, and potentially huge fines. Prompted by investigations from the Chinese, authorities claim that GSK has been using hundreds of middlemen and travel agencies to bribe doctors and officials since 2007. The money involved has been estimated at 3 billion yuan, in addition to sexual favours in exchange for the prescription of the company’s drugs, an increase in market share and higher selling prices.

Yet GSK have made it clear that the wrongdoing was not part of any corporate strategy – “The issues identified would be a clear breach of our corporate values and we have zero tolerance for any behaviour of this nature”. Instead, they have shifted the blame onto individual executives who they state “acted outside of our processes… to both defraud the company and the Chinese healthcare system”.

We have zero tolerance for any behaviour of this nature – GSK

Meanwhile, four senior executives have been arrested and appear to have confessed. The Chief Executive of GSK andChancellor of University of Nottingham, Sir Andrew Witty, described the allegations as “shameful” and was “personally deeply disappointed”.

Contrary to this, the Chinese police believe that GSK had a structured bribery programme. The Xinhua news agency asserted: “…it is becoming clear that it is organised by GSK China rather than drug salespeople’s individual behaviour”.

With the revelation that the company had set targets for annual sales growth at 25% (approximately 7% higher than the average growth rate for the industry), a general manager for GSK admitted that this could not be reached in the absence of ‘dubious corporate behaviour’. Nonetheless, this might not be strong enough proof that salespeople were forced into illegal practices.

Confirmation of these suspected corrupt practices implies serious consequences – such as charges under UK/US anti-bribery laws. Indeed, it has recently been reported that US authorities have opened investigations on GSK for violations of their anti-bribery laws. Despite being a British company, GSK’s listing on the US stock exchange gives them jurisdiction over the issue.

Amongst all this, some have raised the question: why did Chinese authorities choose GSK? Such corruption is common practice in Chinese pharmaceutical companies, partly due to low salaries for doctors. The Chinese authorities appear to be holding onto the affair tightly, leading to speculations of political motives.

These speculations have arisen from the company’s links with Betsy Li Heng, a former director of GSK’s corporate affairs. Li’s two brothers, Hu Deping and Hu Dehua, have long been advocating political reform – going so far as to criticise President Xi. This is almost unheard of amongst Chinese officials and intellectuals, and the scandal could be a warning for them not to overstep the mark.

China’s anti-corruption rules ultimately have yet to override traditional business practice. But times are changing; continuing protests across China over corruption and its slowing economic growth has left tensions bubbling. Declining social stability is a major fear for the government, yet clamping down on corruption is a complicated matter.

Distinguishing between money spent on corruption with money spent on developing relationships (‘guanxi’) can be difficult, as it is a significant part of the way business is done in China.

As relationship building involves banqueting, President Xi has reduced the number of dishes allowed in official banquets; a sign that he is serious in pushing forward his anti-corruption measures. For China, this may just be the beginning of a long and thorny path towards a more respected and regulated business environment.

Lucinda Chow

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Remembering Jamie Hoole (18) : One of the many “Seroxat-Suicides”

From 2008:

Seroxat makers escape prosecution despite failing to reveal link to teenage suicides for FOUR years


Last updated at 00:02 07 March 2008

jamie hooleSuicide: Jamie Hoole, who died aged 18 after taking Seroxat

Drug company bosses concealed information about the dangers of the anti-depressant Seroxat for five years while it was still being prescribed to children – yet they will escape prosecution over the cover-up.

Documents released yesterday as part of a four-year criminal investigation into GlaxoSmithKline show that the pharmaceutical giant had evidence that the drug didn’t work in children as early as 1998.

There were also suggestions the firm was aware of possible links to attempted suicides and suicidal thoughts.

But Glaxo did not alert Britain’s drugs’ watchdog to the problem until 2003, when the suicide link had become clear. The move led to an almost immediate ban on their use in under-18s.

Since it was first prescribed in Britain in 1990, the tablet, which makes GSK £1billion a year, has been associated with at least 50 suicides – both adult and child – in the UK alone.

Yesterday, the Medicines and Healthcare products Regulatory Agency hit out at Glaxo for withholding the information, and ministers promised to tighten the law.

But the watchdog came under fire itself over the failure to bring criminal proceedings against the firm for the cover up.

Ministers and officials insisted a prosecution was not realistically possible under the law as it stood at the time.

MHRA chief executive Professor Kent Woods said: “I remain concerned that GSK could and should have reported this information earlier than they did.

“All companies have a responsibility to patients and should report any adverse data signals to us as soon as they receive them.”

He said that although the law on disclosure of clinical data had been tightened in recent years, it would now be strengthened again.

In a letter to Glaxo, Professor Woods said: “Such a course of action should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards.

“I would have thought it self-evident that such information should be made available promptly to the regulator in order that action can be taken to public health.”

He added that Glaxo would not be prosecuted, as there was no realistic chance of a conviction under the legislation in place at the time.

However, the criticism may boost the case of British patients privately suing Glaxo after reacting badly when they tried to come off Seroxat.

Charles Medawar, of pharmaceutical watchdog Social Audit, said not just Glaxo but also the MHRA had “a great deal to apologise for”.

He said: “They say the decision not to prosecute was decided by the inadequacy of the law.

“My reaction is that before launching a million-pound investigation it might have been a good suggestion to check what the law actually says.”

Accusing the MHRA of a ‘naive and absurd’ level of trust in drug companies, he said: “The deviousness companies employ when promoting their drugs and minimising their side-effects is really quite extraordinary.”

Health Minister Dawn Primarolo said the Government would take “immediate steps” to strengthen the law, making it clear that drugs firms must disclose any information they had which could have a bearing on public health.

Glaxo denied it had withheld data, saying it “firmly believed” it had acted “properly and responsibly” and safety of its medicines was “paramount”.

It said there were no child suicides in any of the safety drug trials it carried out and it was only when the data from all nine trials was analysed together that any link with suicide emerged.

A spokesman added that Seroxat has never been licensed for use in under-18s in the UK and labelling stated that it was not recommended for children.

However, Seroxat, which is also known as paroxetine, was taken by an estimated 50,000 British children and teenagers before being banned for use in youngsters in 2003. Doctors are allowed to prescribe unlicensed drugs.

Prescribed to children as young as six, it was hailed by doctors as a “wonder drug”, capable of helping people overcome shyness.

However, it gradually became clear that the drug, which alters levels of mood-regulating chemicals in the brain, was not all it seemed.

As children taking it began to commit suicide, parents described how their sons and daughters suffered mood swings, nightmares and personality changes.

‘It was like giving him a loaded gun’

Jamie Hoole was just 18 when he was prescribed Seroxat for depression. Two months later, he killed himself.

His mother Jean Bambrough is convinced he would still be alive had it not been for Seroxat.

Miss Bambrough, 47, said: ‘It was like prescribing him a loaded gun.

“Jamie was depressed but I strongly believe he wouldn’t have done what he did if it wasn’t for Seroxat.”

The talented pianist and artist was given Seroxat after he lost his self-confidence and started to withdraw from everyday life. Initially, his depression seemed to lift.

Miss Bambrough, a personal assistant who split from Jamie’s father 20 years ago, said: “For the first few days, he was smiling and looked happy.

“But that didn’t last long. He became very agitated and couldn’t sleep. He was having really awful dreams.

“He couldn’t keep still and rocked backwards and forwards. He thought he was going mad.”

Jamie, a builder, then turned to self-harming, cutting his arms, legs and stomach with a knife.

Not long afterwards, his brother Daniel, then 13, came home from school to find him hanging from a belt in a bedroom of the family home in Northwood, North-West London.

An inquest into his death concluded it may have been “wholly or in part” linked to his use of the drug.

After the inquest in 2003 Miss Bambrough said: “All data on drugs should be made public before they are used on anyone – adults or children.”

Another Seroxat patient, Laura Davey, now in her 20s, was put on Seroxat because she was suffering from depression.

But instead of making her better the drug led to her self-harming.

She said: “As soon as I was put on Seroxat I started cutting myself every day. I was sitting in my bedroom with a compasses or a knife and I would slit my wrist so there would be blood.”

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Bob Fiddaman Examines GSK’s Seroxat and Birth Defects

Tuesday, September 03, 2013

SSRi’s – Changes to the Labeling

Former GSK employee Jane Nieman

I’ve just re-watched the Jane Nieman deposition that I uploaded to YouTube a couple of years ago.It’s a fascinating insight into how causality assessments come about…or not as was the case with GlaxoSmithKline regarding birth defects and their product Paxil.The audio is out of sync with the video but it still makes fascinating viewing.Something toward the end of the video grabbed my attention.There’s one question put to Nieman by the claimants lawyer.At 48.27 he asks Nieman, Do you know what a manufacturers duty is under the FDA when they make a determination that a drug is responsible for an adverse event, what their labeling duties are?Nieman does not answer.Lawyer then says “I can show it to you if you like”, he then reads the following to her:“Under the section heading the label shall describe serious adverse reactions and potential safety hazards, limitations in use imposed by them and steps that should be taken if they occur. The labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with the drug, a causal relationship need not have been proved.”
This particular blog post of mine is more of a reach out to consumers of pharmaceutical prescription products.Has anyone ever reported a serious adverse event to a pharmaceutical company and had a causality assessment returned that linked the product to the adverse event, if so, was the labeling changed as a direct result of that causality assessment?I know one case where a pharmaceutical company [Mylan] have not made any effort to change the labeling despite the assessment that their product was the probable cause of death. Do these rules, mentioned in the video, just apply to the FDA, what about other global medicine regulators?Be great if I could get some feedback on this either via email or my Facebook page.Meantime, here’s the video in question. I recommend watching it all but if you just want to skip to the labeling question then drag the cursor on the video to around the 48.27 mark.

Bob Fiddaman