Monsanto Roundup Lawsuit

Wednesday, December 20, 2006

Glaxo SmithKline Deny Seroxat Problems



The Head of European Clinical Psychiatry at the pharmaceutical company GlaxoSmithKline, Dr Alastair Benbow, denied claims that the drug could be responsible for violence in users, saying there was no "reliable clinical evidence that Seroxat causes violence, aggression or homicide".







Let's see shall we?







Click on each link to read story.







A girl who shot a classmate in the shoulder at their Catholic high school three years ago has been released from state custody.



Dr ALASTAIR BENBOW Head of European Clinical PsychiatryGlaxoSmithKline

There is no reliable evidence that Seroxat can cause addiction






Don Schell was taking Paxil antidepressant when he killed his wife,
daughter and granddaughter





Addiction is characterised by a number of different criteria which includes craving, which includes increasing the dose of drug to get the same effect and a number of other features, and these are not exhibited by Seroxat.
Dr ALASTAIR BENBOW Head of European Clinical PsychiatryGlaxoSmithKline






Charges dropped after report links Seroxat [Paxil] to threatening behaviour




A spokesperson for GlaxoSmithKline commented: “Depression affects a huge number of people here in the UK - one in seven of the population at any one time.“It is a potentially deadly condition and Seroxat is an effective treatment that since launch, has helped tens of millions of patients worldwide lead fuller and more productive lives.






Family members and a neighbor said Stewart changed significantly after taking Paxil.


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Available by prescription only








10 Year Old Has Violent Incidents at School




GSK carried out trials of Seroxat on children from the late 1990s at the request of the American drug regulator, the Food and Drug Administration (FDA). But the results were kept secret because they showed that the drug had no more effect than a placebo, while there were some worrying side-effects. Of those on Seroxat, 3.2 per cent suffered mood changes including thoughts of suicide, attempted suicide and trying to harm themselves — compared to 1.5 per cent on placebo.




A document revealed in the Guardian earlier this year showed that GSK was determined to bury the bad news as long ago as 1998.








11 Year Old Boy is Violent & Suicidal on Paxil





Stuart Dollow, medical director of GlaxoSmithKline UK, said his company published the results of all its studies on all drugs "whether negative or positive".





12 Year Old Girl Commits Suicide





An internal strategy document proposed that GSK should not hand the data from two trials to the regulators. To admit the drug did not work in children would be ``commercially unacceptable ... as this would undermine the profile of paroxetine (Seroxat/Paxil)''.





12-Year-Old Driven Insane By Medicine




The Guardian (UK) reports (below) that BBC Panorama had obtained secret 1998 documents from SmithKline Beecham (now GlaxoSmithKline, GSK) showing that the company deliberately concealed the failure of Seroxat / Paxil to demonstrate a benefit for children in two clinical trials in children.






14 Year Old Girl Attempts Suicide




The MHRA was finally given the full trial data on May 27 last year (2003) later it announced it was banning the use of Seroxat in children.






14 Year Old Girl Becomes Suicidal & Violent : Lawsuit



The British manufacturers (GlaxoSmithkline) of an antidepressant drug that was last year banned from use in children knew as long ago as 1998 that it did not work and deliberately avoided publishing the full data because of the risk to their lucrative adult market, according to a leaked internal document.

A position paper dated October 1998 shows that managers at SmithKline Beecham - now GlaxoSmithKline - were concerned at the commercial implications of two clinical trials in which their drug Seroxat was given to children and adolescents with major depression.

The results of both trials, known as protocols 329 and 377, showed that the drug was no better than a placebo - an inert pill - in alleviating the children's depression.







14 Year Old Girl Kills Self




In 2002, more than two million prescriptions for Paxil/Seroxat were written for American children and adolescents alone, worth $55m in sales.






15 Year Old Girl Plans to Kill Mother, Brother & Self





A GSK press release: "... the company "has acted responsibly in conducting clinical studies in pediatric patients and disseminating data from those studies. All pediatric studies have been made available to the FDA and regulatory agencies worldwide. We have publicly communicated data from all pediatric studies."





15 Year Old Stabs his Grandmother



NICK ALCOCK Pharmaceutical Company Analyst Data monitor

In 1999 Glaxo SmithKline were estimated to spend around 30 million advertising Paxil in the US. In 2000 this figure had probably risen to just around 90 million.







15-year-old Sets Fire & Vandalizes School


[Advertisement]

With the help of Paxil you can see someone you haven't seen in a while - yourself. Hey, I remember you.








16 Year Old Girl Commits Murder: Kills Self in Prison




The manufacturers of the SSRIs, including GSK, have continuously and adamantly denied even the possibility of a causal connection and instead have blamed the victim and the ‘disease.






16 Year Old Girl Self Mutilates: Also Attempts Suicide




The 2003 memo cites a discredited published report in the Journal of the Academy of Child and Adolescent Psychiatry (2001, pp. 762-772) that maintained that Paxil was "safe and effective and well tolerated." It was co-authored by leading US child psychiatrists.






16 Year Old Kills his 17 Year Old Brother



Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

I think what parents would be more worried about is the risk that their children have of committing suicide and other symptoms of severe depression if no treatment was available. I think parents would want treatments to be properly evaluated during clinical trials before their children are given any medicine.







16 Year Old: Paxil Still in Body 2 Months After Discontinuing Drug




GlaxoSmithKline has long denied that its drug could cause dependency. Last year one of its executives stated on ABC television in the US that "it happens very rarely".






16-year-old Attacks A Family



GLAXOSMITHKLINE: The information clearly says that Seroxat is not addictive and it is not.







17-Year-Old Murders His Friend (PDF File)



Why were GSK sales reps provided with information about suicide data and admonished NOT to inform physicians?



Glaxo spokeswoman Mary Anne Rhyne said the sales reps were instructed not to speak with doctors about the clinical-trial results because drug companies are forbidden from engaging in any activity that may be considered off- label promotion.



18 Year Old Girl Dies; Mother Campaigns



GLAXOSMITHKLINE: It's quite clear that the phrase "Seroxat is not addictive" was poorly understood.







19 Year Old Commits Suicide After Drastic Behavioral Change



Dr ALISTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

Anybody who suffers side effects of any sort I feel every sympathy for, but that does have to be balanced by the enormous benefit that is seen by many millions of patients around the world.







20 Year Old Jumps from 24th Floor



Shareholders of GlaxoSmithKline have filed a class action lawsuit against the pharmaceutical giant for allegedly concealing problems with Paxil, its antidepressant drug for teenagers.







20 Year Old Shoots Self; Lawsuit Filed



Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

We take every single safety report seriously. Absolutely every single one. And anybody… my heart goes out to anybody who experiences any of the symptoms of depression or the side effects related to the treatment of course.







22 Year Old Woman Kills Self



Sales for Seroxat amounted to almost $4.97 billion worldwide in 2003







64 Year Old Man Kills One in Road Rage Incident




GlaxoSmithKline last night denied that its drug caused adults to become hostile, although it acknowledged there had been a problem in the children's trials






77 Year Old Kills Self: Lawsuit




GSK, which for years denied there was a problem with the drug, has sent a letter to all doctors in Britain warning of the potential risk in some adult patients.






9 Year Old Girl Becomes Worse on Meds




GlaxoSmithKline, manufacturers of Seroxat, deny that the drug is addictive






Blind Man Kills Ex-Girlfriend



Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

We are strengthening the information on side effects, particularly on stopping, so that there is greater clarity in terms of the exact wording







Coroner Calls for Drug to be Withdrawn




Seroxat is the biggest-selling SSRI (selective serotonin reuptake inhibitor) in Britain. In 2003 doctors wrote 19m prescriptions for the drug for patients with anxiety and depression.






Deputy Deliberately Crashes Car into House of Estranged Wife



Paul Flynn, Member of UK Parliament raised the antidepressant drug scandal in Parliament, focusing on the British drug manufacturer giant, GlaxoSmithKline (GSK). "The Seroxat [Paxil] scandal is one of gigantic proportions that affects millions of people."

Flynn notes: "Two years ago, GlaxoSmithKline wrote me a letter that contains very little that is truthful apart from the date. We know that its spokesmen made preposterous claims on "Panorama", and the letter states: "The safety and efficacy profiles of Seroxat has been confirmed through clinical trials involving thousands of individuals and the experience of tens of millions of patients over the 10 years the medicine has been available."

Indeed, the company's October 1998 internal confidential memo reveals the falseness of that claim: http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html





Deputy Shoots Young Man



Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

Addiction is characterised by a number of different criteria which includes craving, which includes increasing the dose of drugs to get the same effect, and a number of other features and these are not exhibited by Seroxat







Diplomat Cleared of Drinking Charges


Sir ALASDAIR BRECKENRIDGE Chairman, Medicines Healthcare and products Regulatory Agency

The primary role of the MHRA is to protect the public health. It also has got a responsibility to ensure that only drugs which are effective and safe come to the market and remain on the market.








Drake Freshman Hangs Himself




Because of the small numbers, GSK says the findings should be interpreted with caution.
It adds that "all of the reported events of suicidal behaviour in the adult patients ... were non-fatal suicide attempts






Employee Kills Supervisor


"paxil has been proven safe and effective in the treatment of depression, panic attacks, obsessive compulsive disorders (OCD), social anxiety disorder (social phobia), generalized anxiety disorder and post-traumatic stress disorder (PTSD)"













Exec Steals $1.2 M



Dr ALASTAIR BENBOW Head of European Psychiatry , GlaxoSmithKline

The evidence, however, is clear, these medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm







Father Drowns Two Children: Kills Self: Lawsuit




GlaxoSmithKline, which earned £100 million last year from UK sales of Seroxat, has always denied there was "compelling evidence" linking SSRIs with suicide.






Father Kills Self on Paxil: Daughter Attempt Suicide on Paxil




GSK says in the letter that it "continues to believe that the overall risk:benefit of paroxetine (Seroxat) in the treatment of adult patients" with depression and other disorders "remains positive"






Father Murders Epileptic Son


RICHARD BROOK Chief Executive, Mind

If the regulator does nothing now and further people die, and ultimately it was proved to be something in relation to Seroxat, then the Regulator would be guilty. The Regulator must resolve this issue.








Former Corrections Officer Murders Girlfriend


Every minute, more than 1,100 prescriptions are written for GSK products worldwide.








Grandmother Shakes Baby




On 'emails from the Edge', Dr Benbow said he had "every sympathy" for any patient suffering from side-effects, and that changes to the PIL would ensure there would be "greater clarity in terms of the exact wording".
He also denied claims that Seroxat is responsible for self-harm and suicidal behaviour in patients who have otherwise not shown such behaviour.







Husband Stabs Wife


Panorama: Did GlaxoSmithKline act promptly in getting this information to you?

Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Health andproducts Regulatory Agency

This is a matter which we are investigating at the present time. There is an investigation going on, being conducted by the.. one of this.. the inspection and enforcement sector of the agency and with lawyers to decide whether or not they did.








Large Doses Impairs Judgment


GSK Culture:

Performance with Integrity - Delivering on promises with organisational and individual trustworthiness.








Lawsuit Filed on Behalf of Child Born with Heart Defects



Dr ALASTAIR BENBOW Head of European Psychiatry, GlaxoSmithKline

...if you imagine a school of more than a thousand children all of whom are deeply troubled by depression, less than a small class size would have these suicidal thoughts or attempts, so it's a small but important signal…







Man Assaults Family with Handgun & Knife




Alan Chandler, a spokesman for GSK denied Seroxat was caused dependency, withdrawal symptoms or violent tendencies.






Man Attempts Murder & Kills Self




GSK yesterday rejected any accusation of dragging its feet on the data on suicidal behaviour in depressed adults






Man Attempts Suicide





Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

Whilst self-harm and suicidal thoughts are clearly a feature of depression, they have not been shown in carefully done studies to be a feature of treatment with these medicines.





Man Becomes Violent at Airport



Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare and products Regulatory Agency

There is very good clinical trial evidence that these drugs do not cause suicide, they do not cause suicidal thoughts in adults. There is a very large database.







Man Dressed as Santa Robs Banks



Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare and products Regulatory Agency

In the adult population the drugs are effective.







Man Has Severe Reaction to Paxil



Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare and products Regulatory Agency

There is a period of time when the drug does not act, it takes a period of 3 or 4 weeks before effect.







Man Kidnaps Wife: Sprays Acid in her Face


Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare and products Regulatory Agency

It’s very important that since safety is an issue which is built up as more experience is gained with the drug, that safety is kept under review and this is why we insist on post marketing surveillance of a drug, which means that its safety is kept under review during its lifetime.








Man Kills Four: Wife, her Two Children & Mother


Prof Sir ALASDAIR BRECKENRIDGE
Chair, Medicines Healthcare and products Regulatory Agency


It is a matter of regulatory and practical judgement as to when information should be transmitted. When it is in the public’s interest that information should be transmitted rapidly, we will do it







Man Kills Police Officer



Prof Sir ALASDAIR BRECKENRIDGE
Chair, Medicines Healthcare andproducts Regulatory Agency

It takes time for clinical trial evidence to become available.







Man Kills Policeman & Self


Dr ALISTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

Now not everybody who tragically takes their own life will say to people: "I'm feeling suicidal, I'm going to kill myself." In fact many people who have decided that they're going to do that, deliberately withhold that information from their friends and family.








Man Kills Wife & Daughter: Attempts to Kill Another Daughter


Prof Sir ALASDAIR BRECKENRIDGE
Chair, Medicines Healthcare andproducts Regulatory Agency

There is no other agency which has kept these.. these drugs under such constant and careful review since 1990 as we have done and we will continue to do so in the interests of the public health.








Man Kills Wife & Himself (PDF File)



Dr ALISTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

We have been asked by the regulatory authorities to provide all our information related to suicides and I can tell you the data that we provide to them clearly shows no link between Seroxat and an increased risk of suicide – no link.







Man Murders Estranged Wife



2001

GlaxoSmithKline sued by Tim Tobin after this father-in-law Donald Schell killed himself, his wife and his grand daughter in Gillette, Wyoming, USA, after being on Paxil (Seroxat ) for only two days.“I felt that something had almost turned him into a monster and the Don that I knew wasn’t that type of person. The only thing that had changed was the medicine he was taking, the Paxil [the US brand name for Seroxat].” Tim Tobin, Panorama, BBC, 2002Donald Schell had apparently been depressed for the previous ten years - but not suicidal. He had taken just two Paxil (Seroxat ) tablets in two days, before he killed his family. The jury found GlaxoSmithKline to be negligent and awarded more than $6mn (£3.8m) in compensation.







Man Murders Two: Lawsuit


June 11 2001:

Thousands of people in the UK could be hooked on the anti-depressant drug Seroxat, without knowing it.Dr David Healy, a UK expert in antidepressants, has said he has seen records of trials carried out by the manufacturers which showed healthy volunteers were suffering withdrawal symptoms after taking the drug for just a couple of weeks. Dr Healy was given access to GSK’s archives because he was an expert witness in the Schell case.








Man Murders Wife & Has No Memory of It


June 14 2001:

People can’t get hooked on Seroxat as they did on the older drugs such as Librium and Valium, claims GSK.For over a decade, the company line has been swallowed, along with the pills. But a court case in Wyoming, USA, has changed all that. The jury decided Seroxat - Paxil in the USA - was to blame for Donald Schell killing his wife, daughter, baby granddaughter and then himself.

Enter Ian Hudson, witness for the defence and at the time of his deposition earlier in 2001, worldwide safety director for GSK. That’s Ian Hudson, now director of licensing at the Medicines Control Agency in the UK.What did he have to say to the evidence of Mr Schell’s closest remaining family and three psychiatrists who all believed the tablets of Paxil/Seroxat Mr Schell took for just two days precipitated him into an unnatural and totally uncharacteristic murderous and suicidal frenzy?

His position is that an individual case cannot tell you one way or the other - only randomised controlled trials will do.








Man Never Diagnosed with Depression Kills Self


Alan Metz, GSK North American medical director told the Wall Street Journal: “Each time it hs been looked at, there is no suggestion of an association with suicidal tendencies in adults






Man Pulls Gun on 3 People


GSK has not carried out that sort of study to establish whether or not Seroxat can make people agitated, suicidal, murderous or hooked. Nor has it carried out a randomised controlled trial. Here is a black hole. There is no proof that the drug does these things, says GSK, and because of that there is no reason to carry out trials that might decide it one way or the other.








Man Robs Congregation Waving Sword



July 10 2001:

People prescribed anti-depressant drugs like Prozac and Seroxat by their GP may be at increased risk of suicide soon after starting the medicine, the British pharmaceutical company GlaxoSmithKline has acknowledged.







Man Sentenced to Life After Brutal Murder



July 2002:

The Guardian reveals that Seroxat tops the league table for complaints of side-effects made by doctors to the government’s committee on the safety of medicines under the yellow card scheme. A total of 1,281 complaints were filed - more than the combined total for the rest of the top 20 most cited drugs.The watchdog group Social Audit complained about the wording on the Seroxat patient information leaflet. It states that “these tablets are not addictive”, and that withdrawal problems “are not common and not a sign of addiction”.







Man Set Girlfriend on Fire


October 13 2002:

The Head of European Clinical Psychiatry at the pharmaceutical company GlaxoSmithKline has denied that the drug Seroxat can lead to addiction. In an interview with Panorama, Dr Alastair Benbow said the drug was well tolerated and had been used all over the world for a decade. Dr Benbow also added: “As with all prescriptions medicines, Seroxat does have side effects, but these are clearly stated in the information that’s made available to doctors and to patients.”








Man Shoots Father Holding Child



October 13 2002:

One of the most widely used anti-depressants in the world can be addictive, it has been claimed. The claims - made on Panorama - come as the makers of Seroxat are attempting to have their drug licensed for use by children in America.







Man [66 Years Old] Murders Wife





Now, GSK admits the drug is associated with increased risk of suicide attempts in adults, but only in young adults





Mom Murders Her Two Children





January 8 2003:

Experts are looking at the safety of widely used antidepressants including Prozac and Seroxat. The review will look at a range of options, including whether the drugs should be banned. The government review began after members of the public and doctors raised concerns that the drugs can be addictive, contrary to manufacturers’ claims - and increase the risk of suicide in some patients.





Mother Drugs her Children




March 11 2003:

A coroner calls for an inquiry into the widely-prescribed anti-depressant drug Seroxat. Powys coroner Geraint Williams has written to the UK Health Secretary to ask for an urgent inquiry and for the drug to be withdrawn from use.It follows the death of a man from Brecon who killed himself two weeks after being prescribed the drug for anxiety - the coroner recorded an open verdict on Tuesday.






Mother Kills 2 Sons & Self



May 11 2003:

The makers of the popular anti-depressant Seroxat have denied claims that their product is addictive and causes suicidal feelings. Speaking on BBC One’s Panorama programme, Dr Alastair Benbow, head of European clinical psychiatry at GlaxoSmithKline, admitted that people could have misunderstood the information on patient leaflets which said the drug was not addictive.







Mother Kills 6 Year Old Daughter & Self




May 11 2003:

GSK, which makes the anti-depressant Seroxat is to drop the wording that it is “not addictive” on its patient leaflets. The move by the drugs giant follows complaints from viewers of BBC One’s Panorama programme, who complain of severe withdrawal symptoms and say they have been unable to stop taking the drug.






Mother Kills her 4 Year Old Twin Sons





May 27 2003:

The government is launching a major inquiry into the safety of some of the most prescribed anti-depressants, including Seroxat. An expert group of the Committee on Safety of Medicines is to be set up to look at the problems some patients have reported while taking selective serotonin re-uptake inhibitors (SSRIs), which include Seroxat and Prozac.And for the first time ever, the inquiry will take first hand reports from people who claim to have problems and investigate reports of suicidal behaviour.





Mother Set House on Fire with 6 Year Old Son Inside



June 9 2003:

Experts are set to update the safety advice provided with the controversial antidepressant Seroxat. The drug has been at the centre of a storm amid claims that it is addictive and could increase the risk of violent behaviour in some patients. Its maker, GlaxoSmithKline, insists that it is a safe drug - prescribed to thousands of patients in the UK.







Mother Turns Gas On While Children are Near



June 10 2003:

Young people under the age of 18 should not be prescribed the controversial drug Seroxat, government advisors have ruled. It follows a review which found children taking the anti-depressant may be more likely to self-harm or partake in suicidal behaviour.The Medicines and Healthcare products Regulatory Agency (MHRA) has also warned that adults who are on the drug should not suddenly stop taking it.







Neighbor Runs Amok: Tries to Set Police on Fire




June 25 2003:

GSK quietly revise prescribing instructions for Seroxat. The company upwardly revises its 2002 estimate of the risk of withdrawal reactions – from 0.2% to 25%.The official risk of Seroxat withdrawal problems had increased overnight from 1 in 500 to 1 in 4.






Pilot on Medication: Six Dead




November 20 2003:

A system designed to highlight dangerous side-effects of medicines is not working, claim researchers. Doctors, and other health professionals are supposed to notify watchdogs if a patient reports an “adverse effect”. However, a researcher from the University of Oxford says that this information is wasted because it is not analysed properly.






Postpartum Depression: Mother Murders Son


February 3 2004:

Drugs giant GlaxoSmithKline knew that the anti-depressant Seroxat could not be proved to work on children in 1998, according to a leaked internal document.The secret document, relating to two clinical trials held in the 1990s, reveals that drug trials had shown little or no effect on helping depression in minors.

The company was also advised to avoid publishing the full data because it would be “commercially unacceptable” and would “undermine the profile” of the drug.The confidential paper, sent anonymously to BBC’s Panorama programme, reveals that the company were advised to publish only the positive aspects of one study and that there were no plans to publish a second - more negative - study.








Postpartum Depression: Wife Stabs Husband



March 2004:

In the USA, The FDA calls for label change for all major antidepressants urging doctors to closely watch both adults and young people for suicidal tendencies and increased depression.







Public Safety Director Commits Suicide



March 11 2004:

Experts have warned doctors not to start patients on high doses of the antidepressant Seroxat. The Committee on Safety of Medicines says patients should initially be given a dose of 20mg a day.







Reporter Writes About her Mother's Suicide



March 13 2004:

The head of mental health charity Mind has resigned from a review of anti-depressants accusing a government drugs watchdog of negligence.Richard Brook acted after GPs were advised to limit doses of the anti-depressant Seroxat.

He claims the Medicines and Healthcare products Regulatory Agency (MHRA) knew about the concerns for 10 years and he was pressured not to reveal them.







Singer Elliott Smith Stabs Self Twice (PDF File)



June 2 2004:

UK drugs group Glaxosmithkline (GSK) has been sued in the US for allegedly lying about the effectiveness and safety of its antidepressant Paxil.







Social Drinker Becomes a Drunk



June 18 2004:

GlaxoSmithKline has announced plans to publish clinical trial results for some of its medicines on the internet.







Student Deliberately Crashes Car into Building




August 2004:

In the USA, The FDA posts new analysis that shows evidence of a link between the drugs and suicidal thoughts or actions in young people.






Suicide of Police Sgt After Stand-Off with Fellow Officers



August 27 2004:

GlaxoSmithKline has agreed to publish results of clinical tests on its drugs, to settle a US lawsuit.







Teacher Sets Herself on Fire



September 2004:

GlaxoSmithKline (GSK) is facing a US lawsuit alleging that it covered up negative research findings on its anti-depressant drug Paxil.The lawsuits were filed on behalf of children and teenagers who were prescribed Paxil, known as Seroxat in the UK and Europe.







Teen Becomes Psychotic (PDF File)



October 15 2004:

The FDA, in the USA, orders that a “black box” warning be included on all antidepressants.







Two Day Withdrawal: Man Kills & Kidnaps



December 2004:

In the USA, ABC News uncovers internal documents that suggest GlaxoSmithKline, maker of the popular antidepressant Paxil, was aware that the drug had little or no effect in treating depression in children and adolescents, and that it may cause suicide-related behaviours in young patients. In spite of this information, GlaxoSmithKline distributed a memo to its sales force in 2001 touting the drug’s “remarkable efficacy and safety in the treatment of adolescent depression.”







Two Dead in Plane Crash



February 18 2005:

Modern antidepressant drugs like Prozac and Seroxat may make patients twice as likely to try to kill themselves than if they were not taking any pills at all, according to a new study published today.The British Medical Journal published three studies on SSRIs (selective serotonin reuptake inhibitors).

Two of the studies look at reported suicides and suicide attempts in trials undertaken by the drug companies before applying for a licence.The larger of the two, by Dean Fergusson of the Ottawa Health Research Institute in Canada and colleagues, looked at data from 702 published trials which included 87,650 patients.

It found a twofold increase in the risk of a suicide attempt on the drugs. The increase is still small - 5.6 attempts per thousand patient years - but, they say, it is significant because of the widespread use of the drugs.The authors say there may be a larger problem because they believe that some suicide attempts were not recorded.







Victory for 'Drug Battle' Man



March 22 2005:

The Select Health Committee publishes The Report of the Fourth Session 2004-05 entitled The Influence of the Pharmaceutical Industry.From the MHRA, Professor Alaisdair Breckenridge (Chairman), Kent Woods (CEO) and June Raine (Director of Vigilence and Risk Management) are asked to attend a hearing for questioning in January 2005. Also from the MHRA, Ian Hudson is asked to attend but does not.

Prior to joining the MHRA, Hudson was Worldwide Director of Safety at GlaxoSmithKline, with a significant involvement in Seroxat. During the hearing, angry MPs are unable to ask specific questions regarding the safety and trials of Seroxat due to Hudson’s non apperance.

Among its recommendations, the Report calls for more control over the way Pharmaceutical companies market their drugs, as well as calling for a complete review of the MHRA itself. The MHRA appoints a Director of Communications (Marketing and PR).







Violence Risk Twice as Likely Among Paxil Users as Among Placebo



August 22 2005:

Commonly used modern antidepressants can cause adults as well as children to attempt suicide, a new study says.An 18-month inquiry convened by the Medicines and Healthcare Regulatory Authority (MHRA) in the UK banned the use of the drugs, known as the SSRIs (selective serotonin reuptake inhibitors) in children and adolescents.

Last December it said the drugs were over-prescribed though they could safely be used by adults.But a study published today in the online journal BMC Medicine casts doubt on the MHRA’s findings.

One of the manufacturers, the British company GlaxoSmithKline, which makes the bestselling Seroxat, did not submit its original detailed data from clinical trials of the drug to the regulator, said the Norwegian author of the report, Ivar Aursnes. “I think the UK investigation could have been even more thoroughly done if they had looked through the primary data,” he said.He had attempted to alert the MHRA to his findings, he said. “I have tried but they have not shown any interest.”







Wife Worries her Husband Is Going Insane on Medication



September 9 2005:

GPs give little support to millions of patients who would like to come off antidepressants because they cannot stand the side-effects, the mental health charity Mind said today.It found doctors wrote 29m prescriptions for antidepressants and 17m for anti-anxiety and sleeping pills in England last year.GPs were keen to hand out the drugs, but they were not able to tell when patients were ready to come off them - and not good at helping them do so, the charity said.







Woman Attacks Acquaintance



September 28 2005:

Doctors were yesterday told to stop giving antidepressants to children and people under 18, because of the risks that the pills will make them feel suicidal.The new NHS guidance marks a watershed in the treatment of children’s mental health.







Woman Attacks Police: Is Killed by Them



February 27 2006:

A previously sealed product liability report against Glaxo SmithKline (GSK) is published. The medical expert report documents how the company systematically hid and manipulated data concerning Seroxat (Paxil) induced suicidality in depressed adults.







Woman Charged with Terrorist Threat



GSK hid the incidence of Paxil-induced akathisia (agitation with hyperactivity) and stimulation. Akathisia and stimulation are risks factors for suicidality and violence. The product liability report also cites previously unreleased FDA correspondence critical of GSK’s marketing and advertising tactics in regard to Paxil. The entire product liability report is reproduced on www.breggin.com and is based on a three-day examination of GSK’s sealed files at the company’s headquarters.







Woman Embezzles $860K from Employer


April 10 2006:

In an email to anti Seroxat campaigner, Robert Fiddaman, Prof. Kent Woods, CEO of the MHRA, stands by Report of the Committee on Safety of Medicines Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants, stating that “I have already given you a full account of the Agency’s position in this matter and there is nothing to add to it.”This, despite recent new evidence suggesting that the Expert Working Group did not have access to all the clinical trial data as recently published in Dr Peter Breggin’s report.








Woman Hangs Self



May 2006:

GlaxoSmithKline (GSK) submits documents to the FDA in the USA and other regulatory agencies worldwide, contradicting its decade long denial that its antidepressant drug, paroxetine (Paxil/Seroxat) increased the risk of suicidal behaviour in the company’s controlled clinical trials. GSK insists the timing of the warning, made so soon after Dr. Peter Breggin’s previously sealed product liability report against Glaxo SmithKline was made public, has nothing to do with that document.







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In a letter to healthcare professionals, GSK warns about the increased suicide risk stating: “There is a possibility of an increased risk of suicide related behaviour in young adults ages 18-29” - whether the drug is prescribed for depression or for other conditions not associated with suicide.







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June 21 2006:

Petition presented to the House of Common by Stewart Hosie MP: “I take enormous pleasure in presenting a petition on behalf of my constituent, Mr. D. Scott, from Dundee, who calls for the precautionary principle to apply to the prescription of Seroxat. He points out that many people who are prescribed Seroxat believe that they suffer side-effects, including aggression, fatigue, agitation and suicidal thoughts. Others suffer severe effects on withdrawal. He observes that a large amount of information on those side-effects is in the public domain, and he demonstrates the requirement for immediate action, including a moratorium on the prescribing of Seroxat to new patients”.







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September 12 2006:

Study links violence with antidepressants.The antidepressant drugs known as SSRIs, which include the British best-seller Seroxat, may precipitate a small number of individuals into violence, according to a paper published today on the Public Library of Science: Medicine website.David Healy of Cardiff University, David Menkes of the University of Auckland and Andrew Herxheimer of the Cochrane Centre reviewed data from several sources including Seroxat’s manufacturer, GlaxoSmithKline. “The new issues highlighted by these cases need urgent examination in all countries where antidepressants are widely used,” they write.







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Dr Ian Hudson

December 20th, 2006 —
While I’m thinking about the MHRA, here’s something else I want to share with you. The MHRA is not funded by the taxpayers of the UK - rather, it is entirely funded by the Pharmaceutical industry - it takes fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income.
The links between industry and the MHRA are very, very close.
Dr Ian Hudson is the MHRA’s Director of Licensing - but the job he had before he joined the agency was at GlaxoSmithKline - he was their Worldwide Director of Safety, and we know that one of the drugs he had “significant involvement with” was, in fact, Seroxat. (Also, the Chairman of the MHRA, Professor Alasdair Breckenridge, sat on
Glaxo’s scientific advisory committee for many years.)

The strange thing is that on the day the House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing.
MPs had expected to be able to question Ian Hudson as well… unfortunately Dr Hudson could not attend as he had a prior engagement.

Roger Cleghorn, UK Seroxat Campaigner






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In relation to the use of SSRIs in young adults the Expert Working Group concluded that there is no clear evidence of an increased risk of self-harm and suicidal thoughts in young adults of 18 years or over. However, given that individuals mature at different rates and that young adults are at a higher background risk of suicidal behaviour than older adults, as a precautionary measure young adults treated with SSRIs should be closely monitored. The Group also recommended that in further research on the safety and efficacy of SSRIs, young adults should be assessed separately.


Professor Kent Woods
Chief Executive MHRA









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You also mention the recent tragic events relating to the young men who suffered serious unexpected adverse drug reactions during the healthy volunteer trial conducted by Parexel at Northwick Park. The immediate priority was to suspend the trial to ensure that no further individuals were harmed. The MHRA has now begun an exhaustive investigation to determine the cause and to ensure that all appropriate action is taken

Dr. Julie Williams Vigilance and Risk Management of Medicines (VRMM) MHRA







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The available clinical trials with Seroxat (paroxetine) were evaluated rigorously during the Expert Working Group’s review. However, I have asked Departmental officials to carefully consider the concerns you have highlighted and Dr Breggin’s report including his claims that GSK has suppressed data, which clearly show paroxetine treatment, may increase the risk of suicidal behaviour in adults. If the claims are substantiated then of course appropriate action will be taken.

Dr. Julie Williams Vigilance and Risk Management of Medicines (VRMM) MHRA








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Robert Fiddaman: Can you confirm that the patient who committed suicide at 17 days had received ECT treatment three days earlier?


Yes

Dr Panos Tsintis
Head of Sector, Pharmacovigilance and safety and efficacy
of medicines, Post-Authorisation Unit
EMEA










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Prof Sir ALASDAIR BRECKENRIDGE Chairman, Medicines Healthcare and products Regulatory Agency

It was a very dramatic change in our thinking about Seroxat in children. Remember Seroxat has never been licensed in children. It has never been licensed in children at all, but nevertheless practitioners have, on their own behest, have used it extensively. Our best evidence is that some 7,000 children a year were.. or children and adolescence were receiving Seroxat.








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Email to Prof Kent Woods
CEO of the MHRA


Dear Mr Woods,

As you are probably aware a recent previously sealed court document was opened in the United States which is damning for Glaxo SmithKline.(See Attached) It clearly shows that they witheld vital information during the clinical trials for Seroxat.

With the evidence attached to this email I would like to know if you still stand by your original letter to me.


Mr R. Fiddaman Dip.Couns MOC & MSFTRGroup Moderator of the Online Seroxat Support Group



Dear Mr Fiddaman

I have already given you a full account of the Agency's position in this matter and there is nothing to add to it.


Prof. Kent Woods
Chief Executive
MHRA








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