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

A Psychiatrist, a 3 Year-Old and Psychotropic Drugs

Owen Osamogie Osagie

Psychiatrist Owen Osamogie Osagie,  from Rosenberg in Texas, was, last year disciplined by the Texas Medical Board.

The basis for action was Dr. Osagie’s failure to meet the standard of care in his prescribing to one 3-year-old foster care patient.

According to the Texas Medical Board, Dr. Osagie prescribed Clonidine to Rachel in excess of the dosing guidelines, while simultaneously increasing her dose of Risperdal, then failed to properly monitor the little girl.

"There's paperwork saying she was screaming for mommy and daddy," Rachel's mother said.

"And the easiest way to handle her acting up was to medicate her," said Rachel's father.



The following video is another example of these utter lunatics who feel medicating children is the answer to control their apparent mental disorder.

Child abuse?

The video is pretty disturbing. If you think this is an isolated incident then think again. This is happening to children everywhere, adults too. Let's not forget that.

Osagie, 60, continues to practice and is currently employed by Texana Mental Health Services, 4910 Airport Ave Suite A, Rosenberg, TX 77471.

Bob Fiddaman

Why Was the Japanese Paxil Pediatric Study Terminated?

Regular readers of this blog will know how I broke the news back in 2009 regarding GlaxoSmithKline's attempts to push Paxil [known as Seroxat in UK] on kids in Japan.

I was so outraged at this that I wrote to the Japanese Embassy and the Japanese Ministry of Health, more or less to give them a detailed view of how GSK had previously claimed Paxil was safe for kids to take...when in actual fact they knew that it wasn't.

I never heard back from either one of them.

I also contacted GlaxoSmithKline in 2010, you can see the email I sent to them here.

In 2008, one year before I broke the news, Glaxo were recruiting kids for a clinical study. I say Glaxo, they, in actual fact were sponsoring the study.

The study was designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily.

Oral paroxetine is a sickly orange syrup, I've been on it myself. It was the only safe way to taper from this highly addictive antidepressant.

And just who were being used as the guinea pigs in Japan?

One look at the inclusion study criteria would have showed you.

Ages Eligible for Study:7 Years to 17 Years.

Yup, that's right folks. Despite being dragged through numerous courts in the US where evidence was shown that Glaxo manipulated previous clinical trials in children, here they were again back in 2008 recruiting more kids.

A marketing campaign went out in the form of a poster... which I just happened to obtain from a source at Medwatcher Japan. Medwatcher were also furious at this particular clinical trial involving kids and Paxil.

Take a good look at the imagery used in the recruitment poster.

If a picture paints a thousand words, eh?


Well, folks... **drum roll** - the trial has been terminated.

**Cue a spectacular display of fireworks**

According to GSK's clinical trial database the study was terminated in 2011. They give no reasons as to why this study was terminated.

What we do know is that 56 kids were enrolled. 29 were in the Paxil group whilst the remaining 27 were in the placebo group.

The study results claimed that there were 3 reports of suicidal ideation in the placebo group but none in the Paxil group. [More about this later]

The subjects enrolled had to have a diagnosis of a depressive disorder before being allowed into the study.

So, it would appear that 3 of the kids taking placebo had suicidal ideation. Not one report in the Paxil group. Glaxo must have loved this.

Unfortunately for the Glaxo sponsored trial, Paxil didn't really show much efficacy.

Open the Outcome Measures on the Clinical Trials website and it tells us how Paxil failed.

Paxil didn't reduce the depression scores of the children sufficiently to be considered effective and the primary purpose of this study was efficacy. In this study all participants had to have a depression score of 45 or greater to be included. A 50% reduction on the CDRS-R is required to consider children have responded to treatment.

So, not only did Paxil not reach the standard for efficacy but in comparison to, let's say, fluoxetine, it would be seen to be less effective.

In the Fluoxetine studies [1] [2] the average decrease was 28.9%. In this Japanese study, the decrease was only 16.9% therefore the kids would not be considered to have responded to Paxil treatment.

No wonder the study was terminated, right?

It would appear that GlaxoSmithKline didn't want to expose the fact that Paxil is less effective than that of their competitor.

Another interesting finding from the Japanese study was the participants only had to have been free from any antidepressant for 1 week prior to the trial commencement.

Anyone who's anyone will know that one week off an antidepressant is hardly a time to get the champagne corks popping and decorate rooms with bunting and balloons. Any number of these participants could have been suffering withdrawal even before they were entered into the Japanese trial. Any of these patients suffering withdrawal, which remember can mimic depression, would have had immediate relief if they were selected for the Paxil arm of the trial. As the phases of the trial progressed they would have, obviously, reaped the benefits of Paxil but not for their apparent depression, their benefits from Paxil would have merely meant they would not be going through withdrawal anymore.

Take the three patients from the placebo arm of the study who, according to the results, suffered suicidal ideation, and we may just find that these three were also taking antidepressants a week or so before they entered the Japanese study.

Could their suicidal ideation have been caused by the withdrawal effects of the medication they were taking prior to the Japanese study?

Glaxo pretty much shot themselves in the foot with this study, a study that should never have taken place given the findings of the Paxil 329 study.

So, once the Japanese trial was over did the sponsors, GlaxoSmithKline, do any follow-up to see if these kids were okay? The doses used in the study were between 10mg and 40mg, the latter being enough to put a horse into a coma.

The withdrawal phase of the Japanese study lasted three weeks. Two weeks later the participants were contacted to see how they were.

Can you imagine a 7 year old child on 40mg of Paxil a day just having three weeks to taper? Even if the 7 year old was on a lower dose it's still mind-boggling how one adult human could give someone so young a pill known to increase suicidal thoughts, known to increase completion of suicide.

What on earth were GlaxoSmithKline thinking by using kids in a study for Paxil?

The Japanese public, particularly the children and adolescents, just don't know what a lucky escape they've had from this truly awful abomination of an antidepressant.

Bob Fiddaman

[1] Psychometric Properties of the Children's Depression Rating Scale–Revised in Adolescents - J Child Adolesc Psychopharmacol. 2010 December; 20(6): 513–516.
[2] Early Prediction of Acute Antidepressant Treatment Response and Remission in Pediatric Major Depressive Disorder - J Am Acad Child Adolesc Psychiatry. 2009 January; 48(1): 71.

Back stories:

Thursday, January 15, 2009 - Email to Japanese Embassy regarding New GSK paroxetine study in Children. ClinicalTrials.gov Identifier: NCT00812812

Friday, April 03, 2009 - Japan/GSK - 329 All Over Again!

Friday, April 03, 2009 - Email to Ministry of Health - Japan

Friday, May 21, 2010 - Email To GlaxoSmithKline Re; Paxil Study In Children

Friday, September 24, 2010 - HEY, GLAXO!... LEAVE THOSE KIDS ALONE

Friday, May 13, 2011 - Glaxo remain tight-lipped on new Japanese Paxil study in children.


Wednesday, May 18, 2011 - GSK Japan, Paxil Study in Kids Update

Under The Influence of Seroxat

A strange case from 2003.

Mark Douglas-Hamilton stood accused of armed robbery and theft and was facing a prison sentence.

Miraculously, just before the trial, all charges were dropped and Douglas-Hamilton walked free.

The Crown Prosecution never gave any reason for the case being dropped but ten years on Mark Douglas-Hamilton is now starting to ask questions regarding the evidence that was the deal breaker.

An expert witness, Dr David Taylor, then working as head of pharmacology at the British psychiatric hospital, Maudsley, had prepared a report for the defence, passed to the CPS, which concluded that the effects of Seroxat could have contributed to his behaviour.

Upon seeing this, it is alleged by Douglas-Hamilton, Crown Prosecution decided to throw the case out.

Furthermore, Douglas-Hamilton, who is now asking questions via his Twitter account, is alleging that lawyers for GlaxoSmithKline approached his defence lawyer who was told to keep his client quiet.

Douglas-Hamilton told me in a private conversation that his medical records seem to have gone missing and he cannot get access to any of the evidence provided in court. His defence lawyer is, according to Douglas-Hamilton, not returning his calls.

Back story:

Two days after stopping Seroxat, Douglas-Hamilton used a pair of wire cutters to hold up a garage in Oxford where he walked away with a packet of cigarettes. A CCTV recording of the event showed his bizarre behaviour, where he joked with customers. Two weeks later, the theatre stage manager stole some CDs from a record shop. Douglas-Hamilton says he committed the acts, but claims his personality and behaviour were completely altered by the withdrawal effects of Seroxat. [Source]

Why did the Crown Prosecution pull the case, up until the point of Dr David Taylor's evidence they must have thought they had a good case, right? CCTV footage, witnesses, they had Douglas-Hamilton bang to rights, as they say. Why was Dr Taylor's evidence deemed so detrimental to the Crown's case, more importantly what was that evidence and why has Douglas-Hamilton never been allowed access to it?

Did GlaxoSmithKline's lawyers really tell Douglas-Hamilton's defence lawyer to tell his client to keep quiet?

Why did the Crown Prosecution offer no explanation as to why they dropped all charges?

Douglas-Hamilton was due to plead not guilty using non-insane automatism as his defence. The defence of non-insane automatism exists where a person commits a crime in circumstances where their actions can be said to be involuntary. A finding of non-insane automatism may also exist where the defendant is not conscious of their actions due to an external factor often as a result of medication. [1]

A spokeswoman for GlaxoSmithKline said, at the time: "Violence and aggression are a feature of anxiety and depression disorders. Seroxat will reduce levels of these, and neither violence or aggression are withdrawal symptoms."

She has to be kidding, right?

A survey carried out by the mental health charity MIND, in collaboration with bbc TV's Panorama, found that 97% of respondents knew of someone who had experienced unwanted or uncomfortable reactions to Seroxat [Paxil]. These included: reduced sexual desire, sleep problems, fatigue, irritability and sweating. One in five reported violent behaviour. Half who had experienced a reaction had feelings of self harm or suicide and more than four out of five experienced withdrawal problems. [2]

Seroxat is known as Paxil in the United States and Canada. Let's just take a look at some of the media reporting of bizarre behaviour whilst on or tapering from Seroxat:

First off, lets take a look at some of the bizarre behaviour of children and adolescents whilst on Seroxat [Paxil]

1996 - 11 Year Old Goes On Robbery & Shooting Spree - Dr. Ann Blake Tracy, director in the International Coalition for Drug Awareness, worked with this young boy's attorney for some time because he was on Paxil at the time of this incident and was obviously having toxic reactions to the drug. This was manifested by the flu-like symptoms he had at school before his parents picked him up and put him into bed at home. Yet another case of someone going to bed just before getting up to act out a dream or nightmare under the influence of these drugs. [Source]

2001 - Young Man Holds Three People Hostage in Duke University President's Office - Paragraph 12 reads:  "Some of the evidence presented Thursday provided a glimpse of Malone's personality. In his day planner were two index cards, one quoting lines from "Macbeth" and another that said, "For evil to prevail, good men have only to do nothing." In the black backpack he carried, which contained a box of 32 bullets, he also had a paperback copy of "The Odyssey," a manila envelope, some toiletries and a bottle of Paxil, a prescription antidepressant." [Source]

2002 - 15 Year Old Girl Kills 6 Year Old Brother - Paragraph 14 reads: "Mr. Schwartz said he thinks his niece, who has a history of criminal behavior including setting fires, may have been suffering an adverse reaction to being taken off the prescription anti-depressant Paxil at the time of the killing". [Source]

2002 - Unusual Personality Change on Paxil Caused 15 Year Old to Set Fires inside High School - Paragraphs 1 reads:  "The lawyer for the 15-year-old Howell High School freshman accused of setting fire to the high school on Monday said the anti-depressant prescription drug Paxil was to blame."

Paragraphs 3 & 4 read: "Plunkett said the boy's parents, who were in Juvenile Court on Thursday for the hearing, took him to a psychiatrist who prescribed the drug less than two weeks before a series of fires tore through the high school, closing classes for two days and causing an estimated $500,000 in damage."

"The drug changed him," Plunkett said. "He indicated it made him feel different." [Source]

2004 - Student Shoots Teacher in Leg at School - Paragraph 11 reads [in part]: "At the time, Romano was taking the anti-depressant medication Paxil and had recently left Four Winds Psychiatric Center in Saratoga Springs." [Source]


Bizarre adult behaviour whilst on Seroxat [Paxil]

2001 - Jury Finds Paxil Was Cause of Murder-Suicide - Donald Schell was taking a Paxil when he killed his wife, daughter and granddaughter, then turned the gun on himself. His son-in-law sued GlaxoSmithKline - and won £5m. [Source]

2002 - 'Santa' who bungled bank robbery says anti-depressant drug made him do it - Next to last paragraph reads: "Chevrier told a sentencing hearing that he committed the offence after he experienced a marked change in character when he took extra doses of Paxil, a commonly prescribed anti-depressant." [Source]

2006 - Not Guilty by Reason of Paxil Induced Insanity - Paragraphs 11 & 12 read: "The argument was bolstered by testimony from three psychiatrists, including the psychiatric research director of the University of South Florida medical school, that Stewart probably knew his actions were wrong but was unable to control them. 

"Family members and a neighbor said Stewart changed significantly after taking Paxil." [Source]

2008 - Father Who Murdered Son Four Years Ago Campaigns Against SSRIs - Paragraphs 1 & 2 read: "He popped his antidepressants like candy and believes Paxil made him kill his son." [Source]

2010 - Famous Singer For Blue October Rock Band Has Strange Episode: Only Drug Involved Is Paxil - Paragraphs two and three read: "During a series of phone interviews, the frontman for the Texas rock band Blue October was asked repeatedly about blacking out in an airplane on the tarmac in Minneapolis."

"Supposedly, I was waving my hands,'  said Furstenfeld, who has no memory of the outburst, "saying I was going to hurt someone and hurt myself'."

Paragraph five reads: "During the episode, he wasn't under the influence of any substance except the prescription antidepressant Paxil, he said." [Source]



There are literally hundreds of stories about bizarre behaviour on Seroxat and other SSRis on the the superb SSRi Stories database.

What bothers me most about these sort of cases is the media tend to miss out on the link between the incident and antidepressant, claiming instead that the person was being treated for some form of mental illness.

I, myself, experienced bizarre behaviour when going cold turkey on Seroxat. It's all been documented in my book, The evidence, however, is clear: the Seroxat scandal. 

Meantime, Marc Douglas-Hamilton continues to push for answers and for those elusive documents from the trial that appear to have vanished into thin air.

Bob Fiddaman.



[1] Defence of Non-Insane Automatism in Criminal Law - e-law
[2] Dark secrets lurking in the drugs cabinet - The Observer 2004

The Glaxo Corporate Integrity Agreement - "Patient First Program"

Glaxo's Deirdre Connolly. "The edge in her voice became very noticeable after that question asking if there would be changes to Patient First."

CafePharma is a wonderful place to hang out.

For those that don't know, CafePharma is a forum designed for pharmaceutical reps to discuss all things pharma. The GlaxoSmithKline forum is a hot bed for potential whistleblowers. Lots of disgruntled ex-employees of Glaxo seem to come under fire if they say anything negative about GSK. Those firing the abuse are reps that currently work for GSK.

A thread caught my attention earlier, it was something I just had to save to PDF as I think, at some point, it may get pulled.

The thread, entitled, "Dierdre's Call", (sp) discusses recent events at GlaxoSmithKline, something the public don't ever get to read about.

First off, the back story...

After Glaxo were found guilty last year of a whole host of violations they had to enter into a corporate integrity agreement with the Office of Inspector General (OIG) of the United States and the Department of Health and Human Services (HHS)

Part of this agreement was to enter into a "Patient First Program". The program was implemented and agreed upon by GSK to ensure that "it will not provide financial reward (through compensation, including incentive compensation or otherwise)"

Seems a tad ironic considering the latest news from China.

Anyway... it appears that GSK's Deirdre Connolly is the subject of debate regarding a phone seminar with Glaxo reps. The topic of conversation was the Patient First program.

Apparently Connolly "lost it" when asked "if assessments and sims (simulations) were still the most effective way to assess reps?"

One poster writes, "The edge in her voice became very noticeable after that question asking if there would be changes to Patient First."

Another interesting comment comes in the shape of , "Total disdain for her teammates is what I heard in her voice. Perhaps she knows the field can't stand her beloved program of test taking and simulations but she is so hard headed that her attitude is its her way or the highway. Either way the call was further verification of the crap hole direction we have been led into. Steve Sons and HR play a big role in all this too - they have never sold a dose/script of anything yet they can tell everyone else how it is done - right."

Comically, and I just love this, a poster then adds, "Please keep us updated on Patient First China Edition."

The CafePharma thread, as usual, turns into a playground school fight with words such as 'retard' and  'moron' being thrown around. And these are the people employed by GlaxoSmithKline!

I wrote about Connolly back in July.

In an interview with the New York Times Connolly describes how both she and Witty shared coffee [how romantic] after she had read an article about him.

Soon after that meeting Connolly joined forces with Witty.

She told the NYT, "Our company is facing a changing health care market that demands higher-quality care, lower costs and better outcomes. As part of rethinking and redesigning our commercial model in the United States, we have revamped our procedures for training, evaluating and compensating our 5,000 sales people.

"This was under way when, last year, the company paid $3 billion in fines to the federal government because it had earlier promoted some antidepressants for unapproved uses and failed to report the status of studies about our diabetes drug. We are committed to ensuring that this never happens again."

I think whoever came up with the name "Patient First" program either has a perverse sense of humour or is just plain ignorant of Glaxo's history regarding patients.

If Glaxo CEO Andrew Witty refuses to meet with disgruntled patients to discuss their horrific withdrawal experiences on Seroxat (Paxil) then what hope does Deirdre Connolly have trying to sell the Patient First program to Glaxo reps!

I'm just loving the Andrew Witty era at GlaxoSmithKline.

Bob Fiddaman

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.

Cidra

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 improving manufacturing 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.

Avandia 

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

Andrew Witty... I know narrrrrrrrthing - Part II

"When the problems were exposed, the company pushed all responsibilities to individual employees."

Back in late August I wrote about the denial coming from GSK UK regarding Chinagate. Glaxo chief, Andrew "All part of an era" Witty, claimed that GSK HQ in London knew nothing about the fraud occurring in China. [Not on my watch, honest guv]

Well, now it seems that the whole operation was set up from the UK headquarters, at least that's what Reuters seem to be reporting.

To be fair to GSK, the Reuters article doesn't really elaborate on its opening of, "A Chinese police investigation into drugmaker GlaxoSmithKline has discovered that alleged bribery of doctors in China was coordinated by the British company and was not the work of individual employees, state media reported on Tuesday."

In fact what follows is claims that it was organised by GSK China and not just individual employees. This kind of makes a mockery of the company statements we've seen over the past couple of months, statements such as: "We remain deeply concerned by the allegations of fraudulent behavior and ethical misconduct in our China business." [Psychopath Alert]

The Chinese news agency Xinhua are reporting that Huang Hong, general manager for GSK's business operations in China, has claimed that GSK implemented salary policies based on sales volumes and such goals could not be achieved without "dubious corporate behavior". Furthermore Xinhua are also reporting that Guo Jianhua, head of recruitment at GSK China, was quoted by the official People's Daily newspaper as saying the company had turned a blind eye to illegal behavior.

"When the problems were exposed, the company pushed all responsibilities to individual employees," Guo said.

Witty, of course, can still deny that he didn't know what was going on and I'm sure he will. I've yet to see anyone from this company take account for their abhorrent behaviour.

Can you imagine Witty coming out and apologising and telling the global public that he did indeed know and the whole thing was part of GSK's global business plan. His knighthood would be taken away from him, company shares would sky dive and lawsuits would follow.

Next time you read or hear any statement coming from GSK, bear in mind that they may only be saying what they want their shareholders to hear.

On a footnote U.S. authorities are now investigating GlaxoSmithKline for violations of U.S. anti-bribery laws in China.

This British company really should be being investigated by British authorities, don't you think?

Bob Fiddaman

Shout Out For The Truthman

Since I've been blogging [started in 2006] I've seen bloggers come and go. I've witnessed blogs being removed because the authors...well, they just get too frightened.

Going up against the likes of pharmaceutical companies like GlaxoSmithKline can give people the jitters [Seroxat can be prescribed for that]

One blogger who has stood the test of time is The Truthman.

His blog, brilliantly named, GSK : Licence To (K)ill, is a wealth of information. He, like me, has a pop at GSK, in particular their management, namely Andrew "All Part of an Era" Witty and his predecessor JP "Monty Burns" Garnier.

If you wish to know the origins of Glaxo's addictive Seroxat then GSK : Licence To (K)ill is the place to visit. One look at the categories section and you will see just how far The Truthman has researched Glaxo's not so wonderful drug.

For convenience, I'll list Truthman's efforts to get the truth out to the public.

Seroxat Link 1 : Hypnotic Narcotic

Seroxat Link 2 : Origins : NeuroSearch

Seroxat Link 3 : The Yugoslavia Trials

Seroxat Link 4 : 1991 : Seroxat Holocaust

Seroxat Link 5 : 1998 – Seroxat Holocaust

The Truthman has a further 5 'Seroxat links' that will tell you all you need to know about this vile drug that has been the cause of so many thousands suffering its propensity to cause horrific side effects, inducement of suicide and birth defects.

I met The Truthman last year, I'm hoping to meet him again... sometime very soon.

The Guinness is on me brother because just like the dark stuff, you sir, are pure genius.

I salute you.

Bob Fiddaman


GSK : Licence To (K)ill

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

The Mysterious Suicides of Tony Scott and Tooker Gomberg

Today I'd like to draw comparisons to two suicides that happened years apart and in different parts of the world. Both persons were famous, both deaths came out of the blue and left family members and friends in deep shock and wondering why?

Tooker Gomberg

Tooker Gomberg [above] was a bike and climate activist who made headlines a number of times.

In 2001 Tooker fell into depression which took him out of action for around 9 months - a year or so later he locked himself into a vault in Alberta Premier Ralph Klein's office and faxed out hand-written press releases on Klein's own letterhead, this was in protest at the Kyoto Protocol and global climate change.

In 2004 Tooker, who was now enduring another bout of depression, started taking antidepressants which, according to his bio written by his surviving wife, Angela Bischoff, "lead to increased anxiety and agitation, a common adverse reaction and potent predictor of suicide. After just five weeks on the drug, he was driven to end his anguish by jumping off the MacDonald bridge into the Halifax harbour. His bicycle, helmet, and suicide note were found on the bridge. His body has never been recovered."

Tony Scott

In 2012 Hollywood and the rest of the world woke to the news that Tony Scott, a British film director and producer, had killed himself by jumping off the Vincent Thomas Bridge in Los Angeles.

Scott, who was the younger brother of Sir Ridley Scott (English film director and producer) had been taking an antidepressant at the time of his death.

Both Scott and Gomberg were prescribed the SNRi Remeron, (mirtazapine) a drug indicated for use in patients suffering with major depressive disorder.

Scott's autopsy report showed that he had a “therapeutic level of mirtazipine (Remeron) and zopiclone (Lunesta), a sleep-aid” in his system on the day of his death on August 19.

During the past year or so I have collected information [gained under the Freedom of Information Act] regarding suicides in New Zealand.

I asked for information on patients who died from suicide between 1 January 2007 and 31 December 2010 and a list of drugs they were taking at the time of or 6 months prior to their suicide.

Zopiclone appears a lot in the information provided to me, although in the main it was prescribed alongside a whole host of other psychiatric drugs.

In Auckland, just one of the many DHB's I contacted, there was a total of 31 suicides by patients under the care of Auckland DHB, of these 31 there were 10 on Zopiclone at the time of or 6 months prior to their suicide. That's almost a third!

In the UK, the British drug regulator, the MHRA, have received 1,451 adverse drug reaction reports related to Zopiclone use, of these 68 have been fatal. When we look at the adverse drug reaction to mirtazapine [Remeron] we learn that there have been a total of 2,728 reports filed to the MHRA, 87 of which are fatal.

This doesn't mean that 87 patients killed themselves whilst on Remeron, to look at the deaths one has to look further into the MHRA's drug analysis prints. [DAP's]

Remeron, it appears, is associated with 10 cardiac disorders that led to the patient dying, 18 deaths are listed as "general disorders" 13 deaths listed as "injuries", whilst 21 are listed as "psychiatric disorders".

Apart from cardiac disorders these explanations are rather vague, don't you think?

Digging a little deeper into the Remeron DAP we can see it get even more confusing.

Fig 1 shows that there were 3 deaths reported, 1 drowning and 13 "sudden deaths".

Fig 1

This has confused me somewhat, so much so that I Googled 'Sudden Death'. The Merriam medicine dictionary defines sudden death as "unexpected death that is instantaneous or occurs within minutes or hours from any cause other than violence."

So, given that there have been 13 sudden deaths reported to the MHRA why then are the 3 deaths listed above not 'sudden'?

Are we to assume that the 3 deaths were prolonged deaths as opposed to sudden? I would have thought that any death is sudden, wouldn't you?

Again, I referred to the Merriam medicine dictionary, it defines death as "the irreversible cessation of all vital functions especially as indicated by permanent stoppage of the heart, respiration, and brain activity : the end of life."

It becomes even more confusing when we see there have been 12 adverse reactions reported regarding overdose. [fig 2] Overdose is, just like death, split into three categories, namely; intentional overdose, overdose and prescribed overdose. No deaths were reported for prescribed overdose but there was 10 reported for overdose and 2 for intentional overdose.

Fig 2

Are we to assume that 'overdose' actually means accidental overdose? If so, how can we determine whether or not an overdose is accidental? If 10 patients on Remeron died as a result of overdose then it could be deemed as suicide, could it not? It could also mean that these 10 patients overdosed not by their own choice, was it homicide then? Were these 10 patients killed by someone slipping large amounts of Remeron into food?

It's bizarre that the MHRA don't add 'accidental' given that they add 'prescribed' and 'intentional' to the other categories.

Remeron is considered to be relatively safe in the event of an overdose. [1] The figures from the MHRA database would suggest otherwise. 41 overdose and survived. 10 overdosed and died - I wouldn't call that relatively safe, would you?

Further into the DAP we learn that the 21 psychiatric disorders I mentioned earlier are all listed as 'completed suicide.' [Fig 3] So, is completed suicide a psychiatric disorder?

87 deaths attributed to Remeron in Britain alone, 21 of those deaths were by suicide but the MHRA, in what I can only describe as a cover your ass tactic, decide to mask these suicides by labeling them as "psychiatric disorders".

Fig 3

They fail to mention exactly what these psychiatric disorders were. One can only assume that anyone who takes their own life has a psychiatric disorder of some sort... I mean, it couldn't have possibly been the Remeron that caused these 21 patients, Tony Scott and Tooker Gomberg to take their lives, right?

The Remeron product monograph [Merck] treads carefully.

Adults and Pediatrics: Additional Data

"There are clinical trial and post-marketing reports with SSRIs and other newer antidepressants, in both pediatrics and adults, of severe agitation-type adverse events coupled with self-harm or harm to others. The agitation-type events include akathisia, agitation, disinhibition, emotional lability, hostility, aggression and depersonalization.

"In some cases, the events occurred within several weeks of starting treatment.

Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages. This includes monitoring for agitation-type emotional and behavioural changes."

Merck cleverly omit the brand Remeron from this important piece of information for the consumer. Other pharmaceutical companies use this tactic too. It's designed to lump all the group of antidepressants together, it's then the job of the Remeron rep to convince a doctor that Remeron is safer than the other antidepressants on the market, they do this with company written documents, lavish dinners, gifts and payments [disguised as consulting fees] for doctors.

You'll note that Merck also list emotional lability as an "agitation-type event."

I first came across the term "emotional lability" when I read through the infamous Paxil 329 study.  GlaxoSmithKline used this term to hide the 5 attempted suicides that had occurred during the clinical trials of Paxil.

In fact, all of the agitation-type events Merck list for Remeron are precursors to suicide. Remember they are not talking about an illness here, they are talking about a drug that can induce these thoughts... something the MHRA adverse reports for Remeron fail to do.

Tony Scott and Tooker Gomberg both took Remeron, both killed themselves by leaping to their deaths. Family and friends will tell you that they were completely shocked by their acts.

Keeping an eye out... or monitoring patients on these drugs is nigh on impossible. Suicide is impulsive and these types of drugs inhibit emotion.  Fear is an emotion inhibited by these drugs and if we, as humans, do not fear death then we will embrace it.

The makers of Remeron have a lot to answer for as do the makers of other groups of antidepressants.


Bob Fiddaman.


[1] Relative safety of mirtazapine overdose.
Velazquez C, Carlson A, Stokes KA, Leikin JB. - http://www.ncbi.nlm.nih.gov/pubmed/11757992