Category: The Seroxt Chain

Participant In Original GSK Seroxat (Paxil) Trial Speaks Out


From David Healy’s Blog: 

http://davidhealy.org/lives-touched-by-gsk/

Lives Touched by GSK

November 25, 2013 3 Comments

Anonymous

Notes of a Paxil Guinea Pig

What does GSK owe to the youngsters in its infamous Study 329 who became suicidal while taking the company’s paroxetine (Paxil/Seroxat)?

As someone who was briefly a GSK Guinea Pig, I’d say the most important thing they’re owed is the truth. It’s a highly delinquent debt – but it’s not too late for GSK to pay up.

I took part in a study of Paxil back in 1994. Like many U.S. subjects, I signed up mainly for the free medical care: I was tired of battling my employer’s HMO which doled out mental health treatment with an eyedropper. However, having already taken Prozac with little or no effect, I was also as curious as anyone to find out if these drugs “worked” or not, according to Big Science. I was willing to be a guinea pig if it would lead to some answers.

The protocol was that everyone was put on Paxil for a number of weeks, after which half of us would be switched cold-turkey to placebos, the other half would continue on Paxil.

Supposedly, this would determine whether people with “recurrent depression” should stay on long-term Paxil maintenance therapy. Looking back, however, what the study really did was to produce drug-withdrawal distress, then interpret that as the original depression coming back.

And most likely, by 1994, GSK knew that.

Treatment Related Injury?

After the switch to either placebo or Paxil I fell asleep at the wheel of my car and had an auto accident with minor injuries. I didn’t want to drop out – I was pretty sure the cause of my accident wasn’t Paxil, but working a sixteen-hour shift. But I was told the study protocol demanded my removal. Not knowing the research design, I never found out whether they were being conscientious, or just the opposite – dropping my results to cover up problems.

The Paxil hadn’t helped me much. But after the switch, I quickly felt the ground under my feet get rockier, at least for awhile.

Well, I thought, it didn’t feel like the Paxil was doing me any good – but here I was feeling worse without it. It didn’t occur to me that this could be down to Paxil withdrawal, because I had never heard of it.

Once the blind was broken, the researchers confirmed I had indeed been switched to placebo.

I never found out if my study was published. When I finally saw a psychiatrist, his reaction was that this had been a “pretty stupid study,” because “everyone already knew” that people like me who’d had several depressive spells should be on medication for life. That makes me think there were already multiple published studies of this type – and possibly dozens more that the drug companies never bothered to publish.

GSK & Responsibility

I’m angry with GSK, not only for putting me through Paxil withdrawal, which, thank god, was not severe in my case, but also for what they later did to me and other patients by hiding the results. They and the other drug manufacturers led millions of us to believe we needed these drugs for life, “just like diabetics need insulin.”

At a minimum this deprived millions of people of a normal sex life, and may have numbed their ability to respond to life in other ways. Untold numbers of children have been exposed in utero. And I and millions of others became part of a twenty-year uncontrolled experiment on the long-term use of these drugs to control a “deficiency” that we may never have had.

Study 329

For the kids in Study 329 who became suicidal on Paxil, GSK’s deception may have done much worse. To this day, I’d bet some of them don’t know the role of the drug in their suicide attempt. Being “the kid who tried to hang himself at fourteen” affected how they saw themselves, to say nothing of how their families, schools and juvenile courts may have seen them. It’s long overdue – but not too late – to tell them that “what you did was not necessarily your own doing.”

Knowing the facts about the limited effectiveness of these drugs could also open doors for those who have not responded to them. For two decades we’ve been told we were a small minority whose condition, being Treatment Resistant, must be very grave indeed. That verdict led many to accept punishing multidrug treatments, ECT, or simply becoming resigned to a life of disability.

Like the kids in Study 329, we deserve the opportunity to rewrite the life story handed to us by well-meaning professionals acting under the influence of GSK.

GSK owes…

It’s not too late to learn something useful from the changes GSK put us all through. It might help us learn more about SSRI withdrawal and SSRI-induced agitation, including who suffers what effects and why. I have no idea what consent forms I signed 20 years ago, but I sure as hell never intended to give GSK the right to hide the results of the experiment they ran on me.

GSK owes me the truth. It owes at least as much to many others, like the kids in Study 329, who suffered far more than I did. To say nothing of the patients who never took part in research, but whose lives were altered by it nonetheless. It would have been infinitely better if they had owned up twenty years ago. But that’s no reason to write off the debt now.

– See more at: http://davidhealy.org/lives-touched-by-gsk/#comments

BBC Panorama Investigates Seroxat Withdrawal 13 years ago


Listen to the podcast here :

http://fiddaman.blogspot.co.uk/2009/08/podcast-from-shelley-jofre-bbc-panorama.html

Tuesday, August 25, 2009

Podcast from Shelley Jofre BBC Panorama

 Podcast from Shelley Jofre BBC Panorama speaking at Coventry University UK.

Shelley has taken on the likes of GSK, The MHRA – Confronted the patronizing Martin Keller.

She has grilled MHRA Chairman, Alasdair Breckenridge, put GSK’s Head of European Clinical Psychiatry, Alastiar Benbow, on the spot [“We haven’t got a licence in children yet”]

In this Podcast, Shelley discusses the four Panorama programmes where Seroxat was highlighted.

We all owe a great deal of thanks to Shelley – The decline in Seroxat prescriptions since the airing of her investigative programmes is not a coincidence.

This blog gives Shelley a 21 gun-salute.

You rock!

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Let’s talk (a little more!) about Dr Ian Hudson (of the MHRA/GSK Quango)


Whilst researching Hudson’s GSK career on the web I came across these two very interesting articles. Since this blog was set up 6 years ago in order to document the Seroxat Scandal- and all that it entails -it seems Ian Hudson might be a major player in unravelling the truth about Seroxat- therefore some coverage of him is entirely warranted.

   I would realy like to know what he knows about Seroxat… What was his role at GSK? Did it involve Seroxat? Does he know what GSK have hidden in their Seroxat files? As  the  previous head of “Global Safety” at GSK and now the guy responsible for safe-guarding the UK public from potentially harmful drugs such as Seroxat and Avandia how does Ian Hudson reconcile his conscience when a drug he once defended has been proven to kill?

  Does Ian Hudson still take the stance of his previous employers (GSK) in regards to Seroxat efficacy and safety? It was- after all- way back in 2001 when Ian Hudson defended Seroxat (Paxil) in a case where GSK were found guilty. Since that time- there have been numerous settlements involving Paxil withdrawal cases, suicides and birth defect class actions in the US. There have been petitions, documentaries, web-sites, patient groups and media coverage on the dangers of Seroxat/Paxil and much public outcry about the behavior of GSK (Ian Hudsons previous paymasters). Since 2001, GSK have paid Billions in fines, and been found guilty of numerous crimes of fraud and corruption – crimes and lies which have cost patients their lives. I wonder does Ian Hudson still stand by the credibility of GSK now- in light of their current reputation? Does he still believe their word is trustworthy?…

   What was his role in all of this way back when he was working for GSK defending Seroxat in court cases in the US? As CEO of the medicines regulator, is he on the side of patients or the pharmaceutical industry?

   Interesting stuff…

(1)http://www.seroxat.pwp.blueyonder.co.uk/Gloucester%20Citizen.htm

IS THIS THE RIGHT MAN TO HEAD SEROXAT INQUIRY?

10:30 – 11 July 2003

A City MP is demanding to know why the UK is being represented in a European review of the antidepressant drug Seroxat by a man who used to work for GlaxoSmithKline (GSK).

Parmjit Dhanda, MP for Gloucester, is asking the Government why they allowed Dr Ian Hudson to take part in the European Medicines Evaluation Agency (EMEA)’s review of Seroxat. As well as working as worldwide safety director for GSK – the manufacturers of Seroxat – from 1999 until 2001, Dr Hudson acted as witness for the defence in a trial in which Seroxat was accused of triggering a man’s violent and suicidal behaviour.

But the Government’s Medicines and Healthcare Products Regulatory Agency (MHRA) says it is satisfied Dr Hudson’s previous links with GSK will not compromise the review.

They say he will not be allowed to participate in Seroxat discussions during the review.

Mr Dhanda said: “I am really determined to get to the bottom of this.

“We need to make people aware that there are representatives involved in this inquiry into the drug who have worked with GSK in the past.

“Secondly, we have got to change this completely and we need to get some fully independent people involved.”

Mr Dhanda yesterday tabled four questions in the House of Commons demanding answers from the Secretary of State for Health, John Reid.

Earlier this year, a UK review into Seroxat was disbanded after it emerged many of the members held interests in GSK.

Alongside another representative from the MHRA, Dr Peter Arlett, Dr Hudson is part of a team of 30 experts from across Europe who are evaluating the safety of Seroxat following concerns raised in the UK and in the United States.

Noel Wadhion, head of the post-licensing of human medicines at the EMEA, told The Citizen: “We are looking at safety concerns relating to a potential risk of emotional changes and withdrawal reactions in the use of Paroxetine – the medical name for Seroxat.”

The experts, who began their review in June, hope to announce their results by the end of this year.

According to the EMEA, there are four possible recommendations to come as a result of their review – no action, change advice about the drug given to doctors, suspend the drug or withdraw it altogether.

Their recommendation will then be passed to the European Commission who will then make a final decision to be implemented throughout Europe.

GSK maintains that Seroxat – now the company’s best selling drug – is an effective treatment that has helped tens of millions of patients worldwide to lead fuller and more productive lives.

The appointment of Dr Hudson has angered Seroxat users in Gloucestershire who still hope for a full independent inquiry into the drug they claim has destroyed their lives.

Faye Elliott, spokeswoman for the Gloucestershire Seroxat Support Group, said: “Knowing that the European decision will be final, it is very worrying for the thousands of us who are still suffering with either side-effects or withdrawal symptoms from this drug.

“We would like to see this drug banned, as we believe there is enough evidence to suggest that this drug can cause suicidal ideation and self-harming.”

But the EMEA remain confident of its ability to reach a fair conclusion.

Mr Wadhion said: “We ask all members of our committee if there is any potential conflict of interest that we should be aware of.

“They must declare their interests before a debate can take place and must leave the room if a conflict arises.”

A spokesman for the MHRA said: “The Government actively encourages interchange between the Civil Service and industry, but takes care to ensure that there are no conflicts of interests.

“In line with this principle, Dr Hudson has had no involvement in matters relating to Seroxat since joining the agency and will have no involvement in the referral.”

_________________________________________________________ 

(2)

http://davidhealy.org/burn-in-hell/

Burn in Hell

January 31, 2012 3 Comments

In my last post, Psychotic doubt, we saw the most successful maneuver that has ever been devised for hiding dead bodies and silencing us when we are injured. We saw a mechanism that acts like the authority of a psychoanalyst (when Freud was still in vogue), or an ecclesiastical authority (until recently), to silence dissent and cause someone who has been abused to doubt their sanity and blame themselves for something done to them. This mechanism that allows companies, regulators, and academics to hide dead bodies by an appeal to evidence that in actual fact shows an increased risk of death on treatment is not just psychosis-inducing; it also has a Burn in Hell component to it. This is how it happens. Here is Ronald Krall being deposed in 2007. He is the head of Global Safety at GlaxoSmithkline. Q:             Are you willing to tell the jury under oath that you are not aware of a single side effect that is caused by Paxil? A:              I am prepared to say to the jury that I am not sufficiently familiar with all of the data for all of the adverse events to tell you that there is an adverse event that is caused by Paxil.[1] Here is Ian Hudson being deposed in 2001, then head of Global Safety at GSK, later a member of the British regulatory apparatus, the MHRA:Q.             Okay. So, your view is: It’s simply impossible for SmithKline Beecham to decide whether Paxil did or did not contribute to the homicidal or suicidal behavior of any one given individual; is that your testimony?A.              We would certainly gather all the information, but on an individual case basis it would be impossible to decide whether paroxetine caused an event or not… It is impossible, on an individual case basis, from individual reports, to assign causality especially in a very complicated area such as this. That’s why, when we have issues, we review all the available data and make a determination, on the basis of all the available data, whether there is an issue or not.Q.             Okay. Do you believe that it is possible that Paxil has caused any person, worldwide, to commit an act of homicide or suicide?A:              I have seen no evidence to suggest that at all.[2]If there is even a small possibility the problem could have been caused by chance, then it has been caused by chance.Hudson and Krall are demonstrating the standard company approach to determining causality. In this case GSK had lots of reports of suicide, aggression, birth defects, or dependence. In many cases the doctor, or patient, or a company employee notes that the problem happened soon after the drug was started, cleared up when the drug was stopped, and reappeared when the drug was restarted. As a result in many cases a GSK employee has said the drug has caused the problem. Both men know this, but for Hudson and Krall there is still no evidence that their drug causes a problem — even when the dependence on Paxil (Seroxat) is universally recognized. Why not? For Hudson and Krall and regulators like Bob Temple or Ian Hudson (who is now a member of the British regulatory apparatus), if a clinical trial hasn’t confirmed a statistically significant link between treatment and an adverse event, then the adverse event hasn’t been shown to be caused by the treatment. If there is even a small possibility the problem could have been caused by chance, then it has been caused by chance. The refusal to do a study while events pour in that meet all the standard criteria for causality is the real Burn in Hell moment. While the company avoids doing a sufficiently large clinical trial to test out the link, there will never be any evidence that the drug causes a problem. The refusal to do a study while events pour into the company that meet all the standard criteria for causality is the real Burn in Hell moment. Thousands of reports can pour in, each making a compelling case that the drug has caused the problem, but a Hudson or Krall or Temple will feel comfortable saying under oath they have seen no scientific evidence that the drug causes a problem.

Unbelievable though it will seem, lawyers for pharmaceutical companies have recently advised that company coding staff, when faced with convincing evidence a drug has caused a problem (that is, when a problem appears after the drug is started and clears when it is stopped and reappears when it is restarted), should not code this as caused by the drug as they have been doing.

Catch-22

When patients report problems to the company and ask if there is any evidence the drug might be contributing, they are commonly referred back to the doctor who has prescribed the drug — who will be faced with the scientific literature, which will say there is no evidence that the drug has caused the problem. When patients ask for evidence on a drug, they are referred back to their doctor — who will be faced with the literature, which will say there is no evidence that the drug has caused the problem. Here is an unknown woman in 2001 contacting GSK. She terminated her first pregnancy, after radiology showed the baby had a serious heart defect (truncus arteriosus) and would likely not survive. The response from GSK is as follows:

‘We are attaching a copy of our current product information for Paxil… Please review the section on USE DURING PREGNANCY.Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition. Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician. We believe because you physician knows your medical history, he or she is best suited to answer your questions. Our Drug Information department is available to answer any questions your physician or pharmacist may have about our products.

She responds:

‘This response is in regards to an email I sent you preciously [sic].  I was asking to see if you have any, or were in the process of any clinical trials for women who are currently on Paxil and pregnant.  I wanted to find out any information on women who were on Paxil during pregnancy and if they were able to have healthy babies.  I am in no way insinuating your product did this to my child.  I love the product and don’t think that I could have gotten through my panic attacks without the wonderful help of this miracle drug.  I just want to get pregnant again soon.  I do not want to put my unborn child through anything that would hurt him/her.  Please, if you do not have information, where is this information held?  Does anyone do studies like this?  Please any information that you may give me would be great’.

The birth defects this woman’s child had suffered were coded as almost certainly linked to Paxil but neither she nor her doctor were told this. In internal company documents, the birth defects this woman’s child had suffered were coded as almost certainly linked to Paxil but neither she nor her doctor were told this.

This seems eerily reminiscent of appeals by Catholic cardinals to Canon Law (an idiosyncratic take on legal significance) when asked to account for their handling of abuse cases in the Church.

[1] Deposition of R Krall, Head of Global Safety GlaxoSmithKline, 2007.
[2] Deposition of Ian Hudson in Tobin vs SmithKline Beecham, December 15th 2000, 30–33.

– See more at: http://davidhealy.org/burn-in-hell/#sthash.nN1KuCvg.dpuf

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http://www.thisismoney.co.uk/money/news/article-1509445/Beefing-up-the-Glaxo-probe.html

Beefing up the Glaxo probe

By ALEX BRUMMER and DAILY MAIL REPORTER and ALEX BRUMMERUPDATED: 23:00 GMT, 7 June 2004

http://www.whale.to/v/gsk3.html

“The MCA is of course headed by a former top executive at SmithKline, Dr Ian Hudson.”–Private Eye

http://www.theguardian.com/uk/2004/mar/13/politics.highereducation

The riddle of the drug regulators

Critics press for review of licensing system
The resignation last night of Richard Brook, the chief executive of the mental health charity Mind, from an expert working group on antidepressants has prompted calls for a review of the system of regulating and licensing medical drugs.

Mr Brook was appointed as a lay member of the group, set up by the Committee on the Safety of Medicines last year for a thorough look at all the allegations against the antidepressant Seroxat, after years of patients’ and consumer groups’ concern about the side-effects of modern antidepressants. Some people say they cannot stop taking them, because withdrawal makes them feel so bad, others say the drugs have made them violent or suicidal.

On Thursday the CSM issued a warning to doctors about the appropriate dosage of Seroxat, a warning for which Mr Brook had been pressing in the light of trial data more than 14 years old which the CSM failed to consider in three successive reviews of the drug.

Mr Brook’s appointment was a departure from the CSM’s normal practices of drawing on a pool of scientists and drug experts who, with few exceptions, have or in the past had links with the drug companies, from shareholdings to research grants to their universities. All members have to declare their interests and either withdraw from the room or not vote when conflicts arise. Even so, there have been allegations of “institutional bias”.

The suggestion is that the regulating authorities and the drug companies are too closely interrelated. Key figures not only on the CSM but also in the Medicines and Healthcare Products Regulatory Agency – the drug licensing body which it advises – have a history of consultancy, research or even employment by pharmaceutical companies. Ian Hudson, for instance, the worldwide safety director of GlaxoSmithKline (GSK) until 2001, is now director of licensing at the MHRA.

The MHRA and CSM say that they have to draw on the expertise of a relatively small pool of highly qualified individuals who inevitably have gained their experience in the industry, but critics say it would be possible to find academics who are completely independent.

One of the fiercest critics, Charles Medawar of the consumer group Social Audit, will allege in a book to be published on Tuesday, Medicines Out of Control?, that the system is dangerously secretive, riddled with conflicts of interest, and indelibly flawed by chaotic and incompetent procedures for evaluating drug benefits and risks.

“These revelations [of the Seroxat trials] provide compelling evidence of the need for transparency in drug regulation. Had the evidence from these dose-ranging studies been made publicly available the regulators’ errors would have been apparent years ago,” he said.

Mr Medawar believes that there may be problems with the dosage of many other drugs, not only antidepressants. Eli Lilly, he points out, conducted a study of its own SSRI (selective serotonin reuptake inhibitor) drug Prozac in both 20mg and 5mg formulations. About 53% of patients responded satisfactorily to the low dose and 64% to the higher dose. Yet the 20mg tablet was licensed for everybody. “That means 50% of people are being exposed to four times the dose they need.”

Mr Medawar is one of those who are troubled by the revolving door between the drug regulators and the pharmaceutical industry. The MHRA chairman, Sir Alastair Breckenridge, resigned his position on Glaxo’s scientific advisory committee to take up his previous position as chairman of the CSM, although he has usually left the room when Seroxat has been discussed.

“For many years Breckenridge had close ties with the manufacturers of Seroxat, yet he played a key role in the regulation of that drug,” Mr Medawar said. While he was still on GSK’s advisory board Professor Breckenridge took part in the Seroxat licensing discussions, although he did not vote.

The data at the heart of the matter showed Seroxat to be ineffective and unsafe at high doses. An estimated 17,000 patients were put on doses higher than the recommended 20mg last year, according to the Department of Health. Seroxat is made by GSK in 20mg and 30mg tablets. But higher doses are no more effective than the 20mg pill, and carry the risk of increased side-effects.

The data on the drug comes from one of the original trials carried out to establish the effect and safety of different doses before GSK applied for a licence to sell it in 1990. Patients in the trial, which was conducted in 1985-86, were started on 10, 20, 30 or 40mg doses. Many of those on the higher doses dropped out because of the side-effects.

The MHRA and CSM were given this information by the company and they licensed it for depression, with 20mg as the recommended dose.

The MHRA, it is understood, did not employ statisticians at the time of the 1990 licence approval and must therefore have relied on GSK (then SmithKline Beecham) for an explanation of the data.

David Healy, director of the North Wales department of psychological medicine of the University of Wales, who claims that there is a suicide risk for a minority of patients on SSRIs, said: “This would look like a case of the MHRA taking what the company said. It’s only when they get pushed beyond a certain point that they begin to systematically check things out.”

Alastair Benbow, GSK’s head of European clinical psychiatry, said yesterday that GSK did not agree with the MHRA’s interpretation of the early study. He said the dosage study had been carried out in a way that would not be done today and that other studies, which had started patients on 20mg and then gradually increased the dose, should have been taken into account. Gradually increasing the dose was safe and some patients would benefit from taking doses of more than 20mg a day.

___________________________________________________________

http://www.darkpharma.nl/uploads/7/3/2/8/7328594/davidhealy.org__shit_happens_again.pdf

This is an industry that has succeeded in building a culture in which even good descriptions of the effects of drugs are dismissed as anecdotes – except of course for patients reporting stunning benefits on treatment.

An industry where Ian Hudson, then of GSK, now head of Britain’s FDA (MHRA), can get hundreds of reports of a problem like violence on Paxil-Seroxat and still say he has seen no evidence that Paxil-Seroxat causes any problems (See Burn in Hell).

Seroxat : The Situation As It Stands : August 2008



(Note : I noticed that the MHRA and GSK were both looking in on this blog today after I posted a lengthy post yesterday, I often wonder what they make of the Seroxat Situation, surely they are aware that this drug needs to be pulled urgently ? So to the MHRA and GSK, how can you sleep at night knowing that Seroxat is destroying lives?)

I set up this blog over a year ago and I haven’t posted or updated it since that time. The reason I originally set up the blog was because I wanted to provide a portal to links documenting the many stories , experiences and news articles about Seroxat and also to bring awareness to the dangers of the drug. I had a terrible and painful experience with the drug myself and I hoped that upon discovering the information provided here , others could be spared the same fate as me. My fate being; a torturous 4 years on Seroxat which not only cost me my sanity at the time but also my mental, physical and emotional health. It took me some years to recover from a full blown withdrawal and the side effects still lingered long after my last toxic dose. I think Paroxetine (Seroxat-Paxil-Aropax) is one of the most dangerous chemicals ever created for human consumption and I think it is high time this medication was withdrawn from the market. It is astounding that it is still available as an “option” for depression and anxiety because as is evident, the case against its efficacy and effectiveness has long overwhelmed its purpose. Seroxat is lethal, and Seroxat should never have been licensed. 

During the past year or so since I originally created this blog ,the Seroxat Story raged on and many other people began to set up blogs and websites about Seroxat. I didn’t update my blog during that time, I just wanted the information to be available in one place so I left it up as a reference blog to provide easy access to links about the drug. Among the many voices now speaking out against the seroxat scandal and the behavior of GSK there are two whom I hold in very high esteem. If you want the definitive Story on Seroxat, the MHRA, GSK and their role in the Seroxat Scandal, you should begin with these two Seroxat blogs; “Seroxat Secrets” and “Seroxat Sufferers – Stand Up And Be Counted” 

http://seroxatsecrets.wordpress.com/

http://fiddaman.blogspot.com/

The sheer volume of information which has come out about Seroxat in the 18 months since this blogs creation is staggering. However, it is also heartening and inspiring to see more blogs and videos about Seroxat appearing on youtube. More brave voices are being heard and It seems the seroxat sufferers did indeed begin to “stand up and be counted”. 

This blog has had tens of thousands of hits in 18 months (the others much more, as far as I know) , and it is interesting to note also that GSK regularly monitor all of the blogs that I am aware of. It never ceases to amaze me just how widespread the Seroxat Scandal became and how many thousands of people’s lives have been negatively affected by Seroxat. It is also shocking to know that this drug is still being prescribed, not just to current addicts of the drug but also to “new users”. The Case against the current sale and promotion of this SSRI antidepressant is blindingly obvious and has been for years. The only solution to the current Seroxat Situation is a gradual banning of the Drug. It should be gradually withdrawn from pharmacy shelves and those currently unable to wean should be guided into a monitored tapering regime. It should not be prescribed to new users and it should eventually be banned from sale. It is defective and dangerous and it has destroyed countless lives. 

Amongst the current news about Seroxat , the following events are worth noting : 

http://www.iht.com/articles/ap/2008/03/06/business/EU-FIN-COM-Britain-GlaxoSmithKline.php

UK agency rules out prosecution of GlaxoSmithKline on Seroxat

The Associated Press
Published: March 6, 2008

LONDON: A British regulatory agency said Thursday that it will not prosecute pharmaceutical company GlaxoSmithKline for allegedly withholding data on clinical trials of Seroxat, an antidepressant drug.

Clinical trials have indicated that people under age 18 who took the medication had an increased risk of suicide.

The Medicines and Healthcare Products Regulatory Agency, announcing the conclusion of a four-year review, said Thursday that there was no reasonable prospect of a conviction in the case.

“The legislation in force at the time was not sufficiently strong or comprehensive as to require companies to inform the regulator of safety information when the drug was being used for, or tested outside its licensed indications,” the agency said. The drug was only licensed for adults.

Glaxo handed over data from clinical trials in 2003 which indicated that patients under 18 had a higher risk of suicidal behavior if they were treated with Seroxat compared to those receiving a placebo. The research also indicated that Seroxat was ineffective in treating depressive illness in under 18.

Andrew McCulloch, chief executive of Britain’s Mental Health Foundation, criticized the agency’s decision.

“It is totally unacceptable to hear that, when information can be made available at speed, young people may have taken their own lives due to a lack of transparency by a pharmaceutical company,” McCulloch said.

Kent Woods, the agency’s chief executive, said he was still concerned that Glaxo “could and should have reported this information earlier than they did.”This investigation has revealed important weaknesses in the drug safety legislation in force at the time. Subsequent legislation has partially addressed the problem, but we will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies obligations to report safety issues,” Woods said.

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So, after 4 years of investigating GSK, the MHRA decided not to prosecute because of “insufficiently robust laws” , which means that basically GSK were let off the hook because of a “loophole”. Children died because of GSK suppressing negative data and inflating the positives of their pediatric seroxat study , the infamous “study 329”, and does justice come? . No, it does not.

There was much outrage about this , particularly in the blogosphere 

Some comment and articles worth checking out about this can be found here : 

(MHRA Official Statement regarding 4 year criminal investigation of GSK) 

http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON014153 

(GSK , Seroxat investigation : the legal questions which must be answered) 

http://fiddaman.blogspot.com/2008_03_09_archive.html

(seroxat secrets : 3 questions for JP Garnier , who after all “has nothing to hide”) 

http://seroxatsecrets.wordpress.com/2008/03/16/3-questions-for-jp-garnier-who-after-all-has-nothing-to-hide/

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It seems to me, that although this investigation concluded with no criminal charges brought against GSK, it did not bring closure to those whose children were prescribed Seroxat and it also brought no justice for those who died from Seroxat induced suicide. The fact of the matter is, by attempting to close this can of worms , the MHRA indirectly opened many others. Many questions will continue to be asked for a long time to come. A crime of that magnitude does not just simply die with a whisper. And while the investigation in the UK came to a sad and unjust end, the situation in the US is only just beginning. For information on the current US investigation, check out these links :

Sen Grassley investigates GlaxoSmithKline and Paxil/Seroxat

http://seroxatsecrets.wordpress.com/2008/08/03/sen-grassley-investigates-glaxosmithkline-and-paxilseroxat/

 

Senator Charles Grassley (R-Iowa), a ranking member of the Senate Finance Committee, launched an investigation of GlaxoSmithKline (GSK) regarding its controversial antidepressant Paxil based on GSK documents collected by Baum Hedlund during Paxil suicide litigation.
See: http://finance.senate.gov/press/Gpress/2008/prg061208.pdf

The documents include a comprehensive report (based on GSK’s internal documents, studies and data analyses) from Harvard psychiatrist, Dr. Joseph Glenmullen. Dr. Glenmullen’s report has been provided to the FDA, which is said to be investigating the report, as well as accusations GSK hid Paxil’s link to suicidal behavior.

Concerned about the public health implications of the documents obtained in the Paxil suicide litigationBaum Hedlund asked GSK to allow it to share the documents with the FDA, but GSK declined to allow the firm to do so.

In addition to the Grassley investigation, Baum Hedlund attorneys were contacted by the Department of Justice for information concerning GSK’s marketing practices related to Paxil. Attorneys from the firm met with DOJ and other government attorneys and staff in 2007.

____

It is not surprising to me that GSK were not prosecuted in the UK. They operate within a status in England which could only be described as “above the law”. They are a UK company and they contribute huge revenue to the UK economy. They have their monetary tentacles in almost every facet of the British health system,  from pharmaceutical research, regulatory affairs , sponsorship, universities, grants, scientific discovery , patient groups to corporate advice to the UK government. They are a certifiable English institution which provides a lot of employment and their stocks and shares are insidiously intertwined with the UK  economic system. Their sphere of influence is huge in the UK and it is also very powerful. Personally I think the UK failed to bring criminal charges against them because they dare not bite the hand which feeds them. It will be interesting to see how the scenario plays out in the US, they have power there too, but nowhere as close to what they yield on their home turf of England. Maybe the case against Paxil (Seroxat) there will be very different? Is GSK above the Law in the US? Or do the American authorities perceive GSK as an arrogant foreigner who dares to commit corporate crimes on American soil? The answer remains to be seen.

http://www.pharmalot.com/2008/06/us-investigation-into-glaxo-and-paxil-widens/

• Pharma Blog » 2008 » June » 20

US Investigation Into Glaxo And Paxil Widens


A Justice Department investigation of Glaxo’s handling of the marketing and safety research of its antidepressant, appears to be widening, The Wall Street Journal reports. The drugmaker confirmed that a previously disclosed Colorado-based Justice Department investigation of marketing practices also includes the US Attorney’s office in Boston and is being coordinated by the agency in Washington.

At a meeting convened in Boston by an agency prosecutor last year, plaintiffs’ lawyers representing families suing Glaxo say they were asked about info, documents and depositions concerning Paxil’s potential link to suicidal behavior in adolescents and adults, and how the company portrayed that risk to doctors and the FDA, the Journal writes.

This follows a recent demand by Chuck Grassley, the ranking Republican on the Senate Finance Committee, for an FDA investigation. Glaxo issued a statement to the paper saying it has responded to questions from the government and cooperated fully with the department, but couldn’t comment further, but has requested a meeting with Grassley’s staff to clarify “misunderstandings.”

The lawyers, George “Skip” Murgatroyd and Karen Barth Menzies, said in interviews that they were asked in detail about info they had collected for lawsuits about what Glaxo told the FDA about Paxil’s potential risk of suicidal behavior, between 1989 and 1992, while the drug’s approval was pending, the Journal writes.

They were also asked if they had info about any activities by company reps involving the promotion of Paxil’s safety and efficacy for teens and children, they told the paper. “They (government officials) wanted to know about the research Glaxo did that said there were no suicidality problems, and what the data really showed,” Murgatroyd tells the Journal.

Glaxo says it didn’t promote Paxil off-label to adolescents. However, the paper writes that, in 1998, the FDA sent a warning letter to SmithKline Beecham, which merged with Glaxo Wellcome in 2000, about a T-shirt distributed “by or on behalf of SKB” at a children’s health affair in Florida, saying the T-shirt “is promoting an unapproved use of Paxil.”

In setting up the conference, Menzies tells the paper, Jasperse told her his efforts “could take a while.” The Justice Department said it doesn’t comment about ongoing cases. A different witness who testified later in Boston confirmed to the Journal that he was asked about Paxil’s safety data, but he declined to give the date of his appearance.

The Justice Department was particularly interested in controversial documents disputing research conclusions that Glaxo submitted to the FDA on suicidality. Those documents had been sealed at Glaxo’s request, but the Journal reports the Justice Department asked Glaxo to release confidential material to them prior to their meeting.

In the meeting, Justice officials asked detailed questions related to a controversial medical analysis paid for by Glaxo that has become known as the infamous Study 329, which indicated Paxil was safe and efficacious for teens and children. You can read about 329 here.

The 2001 study has come under fire from several independent medical researchers. The prosecutor and FBI “were quite interested in how Study 329 was used to promote Paxil for teenagers and kids by clinical researchers Glaxo had underwritten,” Murgatroyd tells the paper.

And this is interesting: Glaxo hasn’t allowed Baum Hedlund’s lawyers to share with the FDA the same sealed info the company gave the Justice Department. Glaxo’s outside counsel wrote, “If the FDA wanted additional information, such as the internal documents you propose providing it, they could have requested them from GSK,” in an October 15, 2007, letter. This is the letter.

This past March, UK authorities concluded a four-year investigation on whether Glaxo failed to inform regulators in a timely manner about a link between Paxil and suicidality in children and teens. But the government didn’t pursue a criminal prosecution of Glaxo because UK laws were unclear on whether companies were obligated to report certain drug data.

But the regulator said it was “concerned that GSK could and should have reported this information earlier than they did.” Glaxo at the time said: “We firmly believe we acted properly and responsibly.”

As we can see, there are many questions which still need to be answered about Seroxat. GSK was under pressure from the UK regulator to reveal the truth about Seroxat in the UK, but they say because there was no chance of a conviction , they could not file criminal charges. Personally I find it strange that the UK authorities failed to secure a criminal conviction. Surely they would have known from the very beginning that GSK would have used the “loop” hole to get off? Why did they investigate GSK for four years if there was no possibility of a conviction? What documents did they find and who were the witnesses that refused to be interviewed? And why were they not forced to be interviewed? It was after all a “criminal investigation”. Some people might interpret the outcome as another “cover up” by the MHRA. Some might perceive it as a “white wash”. Personally, I am not sure, all I know is my instinct tells me that something stinks about the whole thing. I can only imagine how the families of people who committed suicide in a “seroxat induced-lapse of reason” feel. Disappointed , angry and let down again, I would imagine. We can only hope that the US authorities do not fail in their investigation of Seroxat (or Paxil, as it is called in America). People need closure. And they deserve it.

There are some interesting points raised relating to the GSK Seroxat investigation in the UK, they are contained in a letter from Kent Woods (MHRA CEO) to (ex) GSK CEO , JP Garnier and the subsequent reply by a representative of the company.

Links to the correspondence can be found here :

http://seroxatsecrets.wordpress.com/2008/03/09/jp-garnier-glaxo-has-nothing-to-hide-prove-it-then-jp/

http://fiddaman.blogspot.com/2008/03/kent-woods-sycophantic-letter-to-jp.html

letter from the Kent Woods at the MHRA to JP Garnier:

Dear Dr Garnier

I am writing to advise you that the Medicines and Healthcare products Regulatory Agency is today announcing the conclusion and outcome of its investigation into a number of allegations regarding GSK, in particular that the company withheld from the MHRA important clinical trial data relating to the safety and efficacy of Seroxat in children and adolescents, and promoted that product for use in this age group despite safety and efficacy concerns.

In immediate practical terms, the outcome of the investigation is that, having considered our investigation report, government lawyers have decided not to pursue a prosecution of GSK. Their view is that the law at the time these events took place did not require a pharmaceutical company to inform the regulator of clinical trials date in groups for whom the medicine was not licensed, and that there is insufficient evidence of GSK promoting the product for “off-label” use in under 18s. We will today be issuing a press release to confirm that, and will be publishing on our website a short report setting out the conduct and conclusions of the investigation. I am attaching both the press release and the report for your records.

This is the immediate practical outcome but there are a number of other issues arising from the process. There is obviously a need to tighten the law to make it absolutely clear that pharmaceutical companies have a legal responsibility to inform the regulator of any information that changes the benefit risk profile of their products, regardless of whether the information relates to a licensed indication. We will be using the current European Commission consultation on pharmacovigilance regulations and other opportunities to press for changes to the law in this area.

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 protect public health. However, that moral responsibility now needs to be insisted up by the unambiguous force of law.

You will be aware that we have reviewed a large quantity of documents from GSK. Legal provisions prevent us from releasing publicly any information gained under our statutory powers in the course of a criminal investigation. However, there has been a significant level of quite legitimate public interest in this case, and I would there like to release that information into the public domain. This of course requires your consent. GSK has regularly asserted that it has nothing to hide in this matter and so I should be grateful if you could confirm in writing your consent to the release.

Finally, I have no doubt that the content of this letter will be the subject of numerous Freedom of Information requests to the Agency in the coming weeks. The MHRA takes the view that any considerations of confidentiality are outweighed by the public interest in disclosure, and we will therefore be publishing this letter today alongside our investigation report.

If you have any queries about the contents of this letter, please do not hesitate to contact me.

It is clear that Kent Woods is far from satisfied with GSK’s conduct regarding the submission of Data about Seroxat harming children. It is also obvious that he is on some way rebuking JP Garnier and offering him the chance to possibly redeem the company by releasing all the data into the public domain. The letter from Kent Woods did receive a response, but it is far less interesting, and also in typical GSK style it was more of a standard corporate mantra and interestingly, (but not surprisingly) Garnier did not reply personally. 

A link to JP’s response can be found here :

http://seroxatsecrets.wordpress.com/2008/04/24/glaxo-refuse-to-co-operate-with-the-mhra-once-again/

“Finally, it is our strong wish to be as transparent as possible in disclosing information around this investigation. However, from GSK’s standpoint there are legitimate concerns which would need to be addressed prior to any disclosure. These include, for example, the identification of individual employees, independent clinicians and patients, as well as the need to preserve commercial confidentiality of certain information. On this basis, we would be happy to consider requests for information, under the Freedom of Information Act, on a case by case basis in relation to specific documents or categories of documents.”

Basically what GSK is saying here is , if you ask for specific information about the Seroxat criminal investigation we “might” give it to you. But how is the MHRA supposed to know what to ask for when it does not know what the documents are? Again, it seems that GSK have bamboozled the MHRA, and personally I think the only transparent thing about this exchange is the weakness of the MHRA and the arrogance of GSK.

On the Subject of “revelations” , amongst the many interesting news which surfaced about Seroxat this year was Dr Peter Breggins testimony. According to Breggin, GSK duped the FDA by doctoring the original clinical trials before submission for a license.

A link to Dr Breggins “Paxil-Seroxat revelations” can be found here :

http://www.huffingtonpost.com/dr-peter-breggin/the-fda-wants-to-stop-you_b_107162.html

I had known for years about GSK manipulating its data and had attempted without success to get the FDA to acknowledge and to examine the problem. I originally discovered the shenanigans eight years ago when I was examining the secret files of GlaxoSmithKline (GSK) as a medical expert in a product liability suit against the company. California attorney Don Farber and my assistant Ian Goddard accompanied me.

The suit was brought by the family of a man named Lacuzong who had drowned himself and his two young children in a bathtub a few days after starting to take Paxil. He had no previous history of violence or suicidal thoughts.

As I went through the hundreds of boxes of materials packed into a large room in the GSK company headquarters, I came upon something remarkable. GSK had managed to hide that Paxil was causing an increased rate of suicide attempts compared to placebo. The company jacked up the number of suicide attempts in the placebo group, until it looked more dangerous to take placebo than to take Paxil. In reality, there were more suicide attempts among the patients taking Paxil.

I wrote a lengthy report charging the company with negligence in the development and marketing of Paxil and it was submitted to the court in 2001. Despite attorney Don Farber’s best attempts, the court refused to unseal the data, even though it disclosed a public health threat of suicidal behavior induced by an antidepressant drug that was being prescribed to millions of unsuspecting citizens. The case was settled for a substantial amount of money without GSK admitting any negligence, and the smoking-gun files were kept secret. Nonetheless, I wrote about my findings and even told the FDA about the manipulated data when I addressed the agency’s panel on two occasions at its 2004 hearings on antidepressant-induced suicide. I invited the FDA to make use of my knowledge about how GSK was fudging its research findings, but the agency ignored my offer and my written reports. This was not unusual. The FDA has always failed to utilize the otherwise unavailable information gathered by medical experts, and yet it will not carry out its own investigations.

A few years later I participated along with attorney Farber in another product liability suit against Paxil and GSK involving suicide. Again the case was settled to the satisfaction of the plaintiffs without GSK admitting any wrongdoing. But this time the new court made public my original Lacuzong report. As a result, in 2006 I was able to write three articles about my findings in the scientific journal, Ethical Human Psychology and Psychiatry, and I put the articles along with the original Lacuzong product liability report on my website, www.breggin.com where they can still be found. The report and the articles describe many ways in which GSK managed to hide the truth that Paxil increases the risk of a person attempting suicide. This is the same information now released byTheWall Street Journal as a result of yet another expert’s product liability case report that drew in part upon my original data.

To this day, the FDA continues to act as if drug company data can be trusted, including GSK’s invalid manipulation of the Paxil suicide studies. The FDA has also ignored data that I discovered in product liability suits against Prozac and Eli Lilly. Eli Before Prozac went on the market, Lilly knew that patients taking their drug had a hugely increased rate of suicide attempts compared to similar or the same patients taking placebo. Even after the British medical journal BMJ released this data, the FDA has continued to ignore it.

Although this information is hardly new to those of us who have researched Seroxat for many years now, it was widely publicized this time, even the Wall Street Journal did a piece about it. What I find shocking about this whole sordid affair is not that GSK duped the FDA and the MHRA, or GSK suppressed data or GSK deceived the public about Seroxat side effects, Seroxat induced suicide and Seroxat withdrawal. All that is bad enough, but what is worse is that there has been virtually no outcry from the medical community. Where are all the GP’s, Doctors and Psychiatrists who prescribed this toxic junk? Why are they not speaking out? Why are GSK still allowed to license drugs? Why are they not shunned by the medial community? Surely, this news should cause utter condemnation from every corner of the world of medicine, why is it always the patients who have to carry the burden of bringing awareness to all this? Why is a drug which increases the chances of suicide still being prescribed to vulnerable people? 

An answer could be found perhaps in the other big news about Seroxat in 2008

News concerning an investigation into Dr Martin Keller of Brown University. Dr Keller was involved in the infamous GSK “Paxil Study 329”.

http://seroxatsecrets.wordpress.com/2008/07/16/pressure-builds-on-marty-keller-as-grassley-senate-finance-committee-probe/

http://www.pharmalot.com/2008/07/grassley-targets-browns-keller-over-grants/

Among the 30 or so physicians at two dozen universities that the Senate Finance Committee is probing concerning disclosure of grants from drugmakers is Martin Keller, a psychiatrist at Brown University who is a controversial figure for his role in studying Glaxo’s Paxil antidepressant. The committee, according to sources familiar with the investigation, sent a letter to Brown as part of its investigation. We are awaiting a reply from Brown and will update you shortly.

In recent weeks, the committee has acknowledged focusing on three academic psychiatrists – Harvard University’s Joe Biederman, Stanford University’s Alan Schatzberg and the University of Cincinnati’s Melissa DelBello. Last week, Chuck Grassley, the ranking Republican on the committee, also asked the American Psychiatric Association to open its books (read the e-mail here).

Keller, you may recall, was the lead author of an infamous study published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry that Paxil, which is known as Seroxat in the UK, was “generally well tolerated and effective for major depression in adolescents.” Known as study 329, the findings were used to widely promote the drug, which became a huge seller.

However, the study was later held in disrepute after it was learned the results didn’t tell the whole story. In fact, 329 was one of three studies cited by former New York Attorney General Eliot Spitzer, who filed a suit charging Glaxo with “repeated and persistent fraud,” alleging the drugmaker had promoted positive findings, but hadn’t publicized unfavorable data (back story).

As it turns out, study 329, which already had a sordid history that included ghostwriting charges (here’s some background), were worse than imagined. A recent study in the International Journal of Risk & Safety of Medicine disclosed that, after sifting through some 10,000 documents that surfaced during Paxil litigation, highly selective reporting was used to skew the results favorably.

Curious to hear how Keller explains the process by which study 329 was drafted? Then feel free to wade through this lengthy deposition from September 2006 in which he discusses the role played by Scientific Therapeutics Information in preparing the study (see pages 242-266). You can also read more about Keller in the recent book about Paxil, Side Effects, by Alison Bass.

It seems to me that the medical community at large has remained silent about the Seroxat scandal because the medical community is complicit also in the Seroxat Scandal. So instead of condemning it, they choose to ignore it, but like a bad smell with a stink of epic proportions , the scandal of Seroxat will not go away. Another interesting development in so far as patients speaking out about the Seroxat debacle came in the form of a meeting between Seroxat Users Group (SUG) and the MHRA. The Audio of this meeting was recorded and released into the public domain by the mental health advocacy blog “Furious Seasons”. For those interested in gaining an insight into the attitude of the MHRA and their role in Seroxat, this audio is essential listening.

A Link to the MHRA-SUG meeting can be found here 

http://www.furiousseasons.com/archives/2008/05/recording_british_paxil_users_meet_with_brit_fda.htm

There was also a transcript of this meeting which was made available 

http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON014153

Another interesting audio recording which made its way on to the web from the BBC was an interview with (ex) GSK CEO JP Garnier. When asked about the Seroxat Scandal, Mr Garnier rudely abandoned the live interview and walked out of the broadcast. Read into that what you will. Personally, I gained more insight into the GSK corporate mindset from this short audio recording than I have from 6 years of researching the Seroxat Scandal. It’s well worth listening to.

See and Hear the BBC Audio Interview of JP Garnier here :

I won’t personally comment on this recording, I think it speaks for itself. 

During this year a book was written about Paxil (seroxat) study 329, it was written by Alison Bass

http://www.alison-bass.com/

Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial

Buy the Book

Buy Alison Bass´ books at your local independent bookseller (booksense.com) or online fromAmazon.com.

bookjacket

“Alison Bass has put on trial in her book far more than just a bestselling antidepressant–she has used the case of Paxil to expose the unsavory and self-serving relationships among members of the pharmaceutical industry, psychiatrists, and members of the FDA. And she does it in a book that has the brio of a crime thriller….”-The New England Journal of Medicine

I have not read the book yet, although I am pretty sure I would be knowledgeable about most of its contents, as most of it can be found in earlier posts of mine on this blog. Actually, I could have written the book myself and maybe I should have. But anyhow, it is good to see at least some aspects of the Seroxat Scandal in book format.

On the subject of books, there is another Paxil related book on its way. It is a very worthy project by another Seroxat sufferer, Shelly Hart. Shelly is documenting paxil withdrawal stories , for those that might be interested, you can contact her through her blog or videos about Paxil on Youtube (the blog and video’s are well worth checking out) :

http://shelly-hartheaven.blogspot.com/

Another topic which has always concerned me in relation to Seroxat is its effect on the unborn and newborn infants. I wrote a post on this blog over 18 months ago about the link between damage to the fetus and ingestion of Seroxat during pregnancy. I called It “paroxetine womb” . For more information about Seroxat effects on the fetus and the damage it can cause I suggest a read though the following blog “Big Pharma Victim”. The blog itself is written by the mother of Manie. Manie’s heart was damaged by Seroxat as his mother Julie took it during Pregnancy and was not warned of the dangers. The blog pulled at my own heart strings and I think Manie and all the other babies born with defects deserve to know why their mothers were not warned about the dangerous and deadly effects of Seroxat-Paxil. Check out Manie’s blog here :

http://bigpharmavictim.blogspot.com/

There has been so much news about Seroxat – Paxil so far during the last year that it is difficult to wade through, but thankfully , Bob fiddaman of “Seroxat Sufferers” has updated his blog almost daily, as has the author of “Seroxat Secrets” , so for more news stories, comment and articles relating to the Seroxat and Paxil Scandal, Please check out both blogs.

http://fiddaman.blogspot.com/

http://seroxatsecrets.wordpress.com/ 

On a (almost) final note for now from me, here are some more Seroxat-Paxil related articles which I think are very relevant and worth exploring further.

The first is an article about Paxil (Seroxat) promotion in Japan

It is a an excellent piece of journalism and also provides a valuable insight into how GSK markets Paxil in other countries. People have said that GSK and other pharmaceutical companies market the disease before they market the drug and I think this article illustrates that concept.

http://query.nytimes.com/gst/fullpage.html?res=9800EEDD133FF931A1575BC0A9629C8B63&sec=health&pagewanted=all

Here is an Excerpt :

Did Antidepressants Depress Japan?

Like the Bush administration, GlaxoSmithKline has spent the last four years staying relentlessly on-message. Its 1,350 Paxil-promoting medical representatives visit selected doctors an average of twice a week. Awareness campaigns teach general practitioners and the public to recognize the following symptoms of depression (the translation is the company’s): ”head feels heavy, cannot sleep, stiff shoulders, backache, tired and lazy, no appetite, not intrigued, feel depressed.”

The psychiatrist Yutaka Ono advocates raising awareness about depression, but GlaxoSmithKline’s marketing made him uncomfortable: ”They ran a very intense campaign about mild depression where a beautiful young lady comes out all smiles and says, ‘I went to a doctor and now I’m happy.’ You know, depression is not that easy. And if it is that easy, it might not be depression.”

Whatever misgivings Ono and other doctors may have about the medicalization of mild depression, it has been a resounding financial success. As one psychiatrist, Kenji Kitanishi, noted wryly, ”Japanese psychiatry is in the bubble economy now.” Between 1998 and 2003, sales of antidepressants in Japan quintupled, according to IMS Health. GlaxoSmithKline alone saw its sales of Paxil increase from $108 million in 2001 to $298 million in 2003. According to the company, during one seven-month ad campaign it ran last year, 110,000 people in a population of 127 million consulted their doctors about depression.

On the subject of Paxil In Japan, it seems that the UK, US and Canada are not the only places to experience cases of Seroxat and Paxil induced suicide. This article is from 2007.

http://www.hkllp.com/paxil-news/japan-sees-an-increase-in-suicide-among-paxil-users-2.html

Japan sees an increase in suicide among Paxil users

June 28, 2007
A Japanese health official says that cases involving suicide or suicidal behavior among patients taking Paxil were 13 times higher last year than in the previous year. The Minister of Health, Labor and Welfare says that approximately 920,000 people in Japan suffered from depression during 2005.According to reports by doctors to Japan’s Pharmaceutical and Medical Devices Agency, 15 patients taking Paxil committed suicide last year, compared with only one in 2005. An additional 24 patients attempted or contemplated suicide in 2006 while taking Paxil, compared with only two patients during the previous year.

In addition to the possible link between Paxil and suicide, reports suggest that birth defects in babies born to mother taking the antidepressant may be another possible Paxil side effect. In 2006, GlaxoSmithKline, the drug’s manufacturer, added a “black-box” warning to the drug’s labeling in the U.S. The label was designed to warn patients and doctors of the risk of suicide in children and adolescents taking Paxil. The Food and Drug Administration issued a warning about the risk of Paxil birth defects in 2005. Despite these measures, however, neither the FDA nor Glaxo have issued a Paxil recall.

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Another very sad article which caught my attention this year is the case of Sara Carlin , Sara was 18 when she killed herself in Paxil induced despair. More about Sara can be read here on the blog “Death By Paxil” (by Euchred).
Sara is one of many young persons who were driven to Suicide from Seroxat’s disturbing and frightening side effects. One such side effect is Akathisa, which is basically an inner turmoil and restlessness which literally drives sufferers to the absolute edge of sanity and reason. And because Seroxat also disconnects people from their minds and emotions through side effects like depersonalization and de realization for some users this proves too much to bear. Having experienced them myself, i know how this drug negatively affects the human mind and can induce a state of absolute physical and mental torture. My sincerest sympathies go to Sara’s family who were brave enough to speak out and have this letter printed in memory of their daughter.
July 16 2008

My Darling Sara,

Happy Birthday Baby.

July 21 1988 was such a happy day for us. You were such a gift and remained a gift for 18 short years. I guess that counting the birthdays you will never celebrate lets me age you in my mind;but the pictures and the memories all stay the same, no new ones to add. You only lived 18 years and nothing will ever change that. I miss you so much ‐ we all miss you so much. The pain is really not speak able, the intense longing unbearable. Your family, friends, and teachers they all are in shock at losing you. Even strangers wrote on your face book: “Sara, you probably don’t remember me, but you tutored me in Math, you were so beautiful and smart and made me feel so good about myself”. Your math teacher and the students you helped talked about your gifted nature in teaching others not as fortunate as yourself Your school hockey team had a service for you and Mr. Mac and your team was stunned in sorrow. You were so excited your last year of high school. You took calculus the summer before so that you could get top marks in your remaining courses. You got 98% on that calculus and you were so proud of yourself. You got accepted into Western Health Sciences and were set you go after your dreams. But you got a bit anxious in your last semester and went to the doctor about your anxiety. I didn’t agree that you should take Paxil® but you said the doctor said it would make you feel better. You told you sister that it made you “not worry about things”. It seemed to me that you became unwell when you started this antidepressant you had bad dreams, had trouble sleeping, started to go out more and stay up late, quit hockey. Then in the summer you became so tired and lethargic we found by September that you had mononucleosis affected by the medication you were taking. You told your doctor you had trouble sleeping and were not feeling well so she gave you sleeping pills, and when you couldn’t sleep through the night she gave you another antidepressant to take along with the Paxil® to help you stay asleep. When we questioned this you said the doctor knew best and didn’t agree that you should come off the Paxil®; and in fact doubled the dosage. Well, a few months later, you hung yourself in desperation. Afraid to go to sleep and face your dreams, sitting at your computer half way through taking off you make‐up, you decided to cut a length of electrical cord that your dad had left out to wire some lights, and you ended your life in an instant. Oh my God Sara, I am so sorry that I didn’t realize the depth of your pain, that I didn’t take you away and get you off these prescription drugs. We found out after, when we looked into the drugs that we had trusted to your doctors – that there was a Health Canada Warning about Paxil® to not prescribe the drug to anyone under 19 years of age, and to carefully take them off if they were currently on the drug. You were only 17 and you were prescribed this drug. If only we knew this before, but no one told you or us about the hazards of these drugs. Your dad is doing everything he can to help other families – there are so many others who are suffering as you did. Your dad’s life purpose now is to do everything he can to warn others of the dangers of these drugs. 

We have some of you friends coming over on Sunday to celebrate the beautiful life you lived. 

Wish you were here too.

With All My Love, Mom XXX OOO

Another interesting web site about Paxil-Seroxat which also sprung up in 2008 was

http://www.paxilharmschildren.com/

                                                                                                                        This web site was developed with the intention of bringing awareness to ordinary Canadians, and the general public worldwide, the dangers of the prescription drug Paxil  ( paroxetine HCL ), as it is marketed and known in Canada, and as Seroxat in the United Kingdom (UK), by the GlaxoSmithKline company (GSK).

This site is especially dedicated, in bringing attention to the deaths and damage that Paxil has caused, and continues to cause children, adolescents and young adults.

It would not be necessary to develop and maintain a web site such as this if GSK was an ethical pharmaceutical company, and if our doctors that prescribe Paxil were properly educated in its risks, and did provide proper medical care and monitoring of their young patients.

We truly believe that the medical community has relinquished their responsibilities to their patients, in favour of large pharma companies such as GSK.  We believe that this in part due to the slick, multi-billion dollar marketing campaigns targeted toward our primary care physicians.

It is very sad that we can no longer rely on our family doctors to protect us and our children…

 

Here is just one paragraph from the official GSK Paxil monograph (in quotation marks), a whopping 52 pages no less,  describing some of the very nasty negative effects associated with this drug.

And last, but by no means least ,another blog from a UK seroxat sufferer which contains links to more info about the drug, the MHRA/FDA and also petitions to the UK prime minister in relation to the drugs effects.

The Seroxat Web Log

http://shutah.wordpress.com/

News and Views about Seroxat/Paxil/Paroxetine

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For those of you who are currently taking Seroxat (paroxetine -Aropax -Paxil)and happen to stumble upon this blog searching for information on how to get off it or deal with side effects etc, I recommend you visit the following ” SSRI withdrawal forums” and ”  Paroxetine advice websites” for guidance on how to do so safely and effectively.

http://www.paxilprogress.org/forums/

http://www.seroxatmad.co.uk/

http://www.seroxatusergroup.org.uk

http://www.network54.com/Forum/182310/


Seroxat Link 10 : Paroxetine Womb : Foetus Poisoning


GSK admit that Seroxat can double the risk of heart defects and other malformations in babies born to Mothers ingesting Seroxat during pregnancy. This has been well documented already and the FDA and MHRA have issued warnings recently about the risks to newborns and the unborn.
There is also much documentation and research about babies suffering withdrawal and other side effects from exposure to Seroxat. But this is still a relatively new issue and there hasn’t been a lot of coverage of these terrible tragedies or these issues in the mainstream media ( although there is a lot of info on the internet about it).. It is a sensitive issue, but I feel it is one that needs to be explored further…

Seroxat was also recently reclassified from a category C drug to a category D…
Which means it does “officially” pose a significant risk to the foetus…

But… In this post I am going to concentrate on some other interesting information relating to Seroxat in the womb , and what I am interested in also is; how do we relate the malformations in newborns to the affects on adult use of Seroxat?

Well, you will notice that from a Seroxat study from the EMC website , there is an interesting fact about Seroxat’s effects on pups (baby rats)…
There was increased pup mortality ( dead baby rats) and also delayed ossification (delayed development/fusion of bones) was observed in the pups..
You can see from the links that problems with Ossification has actually happened to babies born with Seroxat induced defects …

When the seams of the skull close prematurely ( they fail to fuse or ossify) it is called craniosynotosis

Could this development of craniosytosis possibly be related to the severe headaches and head pressure documented in Seroxat withdrawal cases in adults?

What is craniosynotosis?

Craniosynostosis is the term for a group of conditions in which a baby’s head develops abnormally because the seams between the bones close prematurely. This prevents the head from developing normally and may be associated with changes in the upper facial bones. Craniosynostosis can usually be recognized at birth, but for a very small number of children it does not become obvious until one year of age or older.

Why was this not noted and explored further? and why did GSK not draw attention to this? Why was this dismissed?

Reproduction toxicity studies in rats have shown that paroxetine affects male and female fertility. In rats, increased pup mortality and delayed ossification were observed. The latter effects were likely related to maternal toxicity and are not considered a direct effect on the foetus/neonate. So , how does this relate to adults? …

Well, considering the drugs affects on the foetus can be seen as an indication that Seroxat can damage the Skull, the internal organs and cause breathing problems in neonates…. surely similar effects could happen in adult use of Seroxat?

Another example of how we can relate the problems seroxat causes in babies , is the evidence of babies born with PPHN (Persistent pulmonary hypertension) from exposure to Seroxat in the womb. PPHN is a life-threatening condition that typically involves severe respiratory failure in a newborn infant and requires immediate treatment.

Would this explain the breathing problems which have been reported extensively by adults suffering Seroxat withdrawal affects?…

There has also been widespread reporting of Seroxat affecting male fertility…

This was also reported in rats ..

    (See Links At Bottom Of Post)

Fertility

Animal studies in rats found impaired pregnancy rates at high concentrations. High doses over many weeks led to irreversible atrophic changes in the seminiferous tubules of male rats.

Why has more attention not been brought to Paroxetine’s effects on rats, babies, in the womb and its relation to how it affects adults… ?

http://www.medscape.com/viewarticle/450390_7

http://emc.medicines.org.uk/emc/industry/default.asp?page=displaydoc.asp&documentid=2057

http://seroxatkillsbabies.wordpress.com/

( Blog from mother who gave birth to a baby with a paxil induced heart defect)



Seroxat Link 7 : The Players Part 2 : The MHRA


Note : All information is provided with a link to source ( you might have to copy and paste it into your web browser to access the original information)

As we can see from the previous links, where Seroxat came from, how it was marketed and how it was sold and how it was released for public consumption…

Also from link 6, we can see that Marty Keller, Sally Laden, James MacCafferty and Neal Ryan all played a part in Study 329 , Glaxo’s dubious and ultimately flawed Seroxat Child study…

The result of which meant that Seroxat/Paxil was pushed on children , many of whom harmed themselves and committed suicide because of its promotion…

In the UK however, We think that the most important players to focus on in order to try to understand the Seroxat Scandal and how it came into being are the MHRA…

The MHRA is the UK’s equivalent of the FDA in America…

The organisation itself is in charge of drug regulation…

The BBC’s Panorama have done 4 exposes on Seroxat and some of it has touched on the failure of the MHRA in regard to Seroxat …

Who are the Seroxat Players in the MHRA…?

Namely they are Alasdair Breckenridge and Ian hudson…

Ian Hudson and Sir Alasdair Breckenridge were both once high level employees of GSK and now work for the MHRA ( the UK equivalent of the FDA) ..
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http://209.85.129.104/search?q=cache:URk6cw9FglYJ:www.dh.gov.uk/prod_consum_dh/idcplg%3FIdcService%3DGET_FILE%26dID%3D4685%26Rendition%3DWeb+Breckenridge+GSK&hl=en&ct=clnk&cd=13&gl=ie

Alasdair Breckenridge : “We must not get hung up on safety but instead must focus on risk-benefit”


When asked by Panorama whether GSK had acted promptly in getting the information about Seroxat’s use in children to the regulator, the MHRA’s chairman, Sir Alasdair Breckenridge, says: “This is a matter which we are investigating at the present time.

http://www.telegraph.co.uk/money/main.jhtml?xml=/money/2004/10/03/ccgsk03.xml

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In a letter to Professor Sir Alistair Breckenridge in January, Dr John Patterson, the ABPI president, wrote: “We remain concerned at the lack of representation of the pharmaceutical industry at board level within the MHRA … As the only regulatory agency that is fully industry-funded, we believe it is essential that we have a say on a variety of issues, not least financial matters relating to fees and service levels.”

http://www.guardian.co.uk/uk_news/story/0,3604,1318946,00.html

______________________________

I would be obliged if you would bring our concerns to the government
regarding the MHRA, and in particular the recommendation that they should
not be as close to the pharmaceutical industry. Please do also ask the
government to explain why they continue to allow the MHRA to be funded by
industry rather than from general taxation. Clearly by allowing the MHRA to be
funded 100% by the pharmaceutical industry the government have allowed the
system of drug regulation to become corrupt!

Please read the following excerpt from a transcript of the Health Select
Committee Investigation of the Pharmaceutical Industry Influence where Dr
Ian Hudson Director of Licensing for the MHRA had been called to give
evidence but failed to appear:

Q783: John Austin – I also note that we do not have Dr Ian Hudson with us
this morning, although he was listed as one of the witnesses. Is there any
reason why not?

Professor Sir Alasdair Breckenridge: Yes, Dr Hudson is one of our delegates at
the CHMP, the Committee on Human Medical Products at the EMEA and he is
there today. He is fulfilling a different role for the agency down there

http://209.85.135.104/search?q=cache…&ct=clnk&cd=67

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    The Infamous Shell Murder Trial in which Paxil was found to blame as the cause for murder :

Glaxo’s representative in court, Ian Hudson, who now works for the Medicines Control Agency in the UK, argued that the occasional suicide or killing by somebody on Paxil is not sufficient evidence that there is a problem with the drug, considering the millions who take it.

The chief executive of Mind, the mental health charity, last night resigned from a high profile review of modern antidepressant drugs, accusing the British medicines regulatory body of negligence.
Richard Brook had a unique position as a lay member of the expert working group on the class of antidepressants which includes Seroxat and Prozac.

His resignation came in protest at what he considered a cover-up by the regulators, after months of pressure on him not to reveal the review’s findings that Seroxat has for years been prescribed by doctors in an unsafe dose and that the regulators had the evidence in their possession for more than 10 years.

Mr Brook’s resignation sheds a rare light on the workings of the secretive drug regulation agency and its advisers, and will heighten public concern over their relationships with the pharmaceutical manufacturers.

http://society.guardian.co.uk/mental…168612,00.html

___________________________________
Dr Ian Hudson is a physician who has practiced as a paediatrician for a number of years. He was formerly a research fellow at the University of Glasgow. He joined SmithKline Beecham in 1989 where he held various appointments in clinical research and development. He joined the MCA (Medicines Control Agency) in January 2001 as Director of the Licensing Division. He is the CHMP (Committee for Human Medicinal Products) delegate for the UK.

________________________________________________________
So, on Monday 29 January, Panorama promises to reveal the secret trail of internal emails which show how GSK manipulated the results of Seroxat trials in children for its own commercial gain.

The documents also reveal how the company continued to deny safety problems with the drug despite three investigations by Panorama reporter Shelley Jofre.

Almost a year ago there was another leak of secret data, this time from Dr Peter Breggin.

Each and every time more damning information becomes public, we are asked to believe that Ian Hudson did not have full knowledge of ALL the trials and data that appertained to Seroxat. Hudson was Glaxo’s Worldwide Director of Safety and had, in his own words, “a significant involvement in Paroxetine” (Seroxat).

What adds insult to injury is that this is the same Ian Hudson who now heads up the drug licensing operations of the UK regulator, the MHRA.

This is also the same Ian Hudson who decided not to appear to be questioned by the House of Commons Health Select Committee – although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. MPs wanted to question Dr Hudson about the company’s drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States).They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18.

And so we come back to the subject of the new Panorama programme which shows how GSK manipulated the results of Seroxat trials in children for its own commercial gain…

I’d like someone to ask Dr Ian Hudson where he was and what he was doing when all this was going on at Glaxo – when he had “significant involvement in Paroxetine” (Seroxat) and he was Glaxo’s Worldwide Director of Safety.

Panorama, Monday 29 January 2007, BBC One 20.30.

http://seroxatsecrets.wordpress.com/…nd-ian-hudson/
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The Seroxat Chain


seroxat20mg21.jpg

I believe that to solve the puzzles and riddles of the Seroxat Scandal , that first we have to view it as a Seroxat Chain. There are many links on this Chain, some have been understood and discussed already in the media, some have yet to be added and some are dubious, unsettling and still shrouded in mystery. The aim of this website is to cut through the propaganda, and to look at Seroxat from a rational perspective but also to seek answers as to why such a dangerous, defective and toxic drug was ever permitted to be released for public consumption. It is not our intention to place blame , but rather to understand through logic and reason. So I hope that this blog, by providing links to information which is freely available, but not always easy to find, we will try to put the pieces together.