Study of Paxil Use in Menopausal Women

Once again exclusion for this includes Suicidal ideation, homicidal ideation, or psychotic symptoms. One has to ask if GlaxoSmithKline know that by including someone with these symptoms could cause serious harm to the volunteer?



Sponsors and Collaborators: Massachusetts General Hospital & GlaxoSmithKline


Information provided by: Massachusetts General Hospital


ClinicalTrials.gov Identifier: NCT00225914

Purpose
To evaluate the efficacy, safety, and tolerability of Paroxetine treatment in perimenopausal and postmenopausal women who present with menopause-related symptoms after discontinuing hormone therapy (HT), in the presence or absence of concomitant symptoms of depression or anxiety.

1: Experimental
Subjects enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability.

Detailed Description:
This study is a 10-week double-blinded treatment study of perimenopausal and postmenopausal women who present with menopause-related symptoms after discontinuing Hormone Therapy(HT), with or without concomitant symptoms of depression and anxiety.

The menopausal transition is a period of heightened vulnerability to mood and anxiety disturbances. It is also a period when women may experience significant vasomotor symptoms (i.e. hot flushes and night sweats). More recently, the occurrence of vasomotor symptoms has been associated with increased risk for depression in menopausal women.

The efficacy of estrogens for the treatment of vasomotor symptoms is well established. In addition, the literature support a modulatory effect exerted by estrogen on various neurotransmitter systems that regulate mood and anxiety.

Despite the efficacy of hormone therapy (HT) for the treatment of menopause-related symptoms, a significant number of women discontinue its use during the first year of treatment. Moreover, recent findings from the Women's Health Initiative Study (WHI) have challenged the safety and the benefits that were initially thought to be associated with long-term use of HT. As a result, many women who have been taking HT decided to discontinue the use of HT, which may result in significant changes in their physical well being, quality of life and, possibly, their mental health status. Therefore, the efficacy and tolerability of other interventions such as antidepressants for these sub-populations warrant further investigation.

Treatment with Paroxetine has shown to be efficacious for menopause-related vasomotor symptoms. To date, no studies have examined the extent to which SSRIs may improve physical and psychological symptoms in women who discontinued HT.

Exclusion Criteria:
Women who present with moderate-to-severe symptoms of depression (MADRS scores > 19) or anxiety (BAI scores > 19) at baseline.

Women who meet diagnostic criteria at screening visit for a current major Axis I psychiatric disorder other than specific phobias (assessed through M.I.N.I. interview). Subjects presenting with symptoms of anxiety or depression, but not meeting criteria for Depressive Disorders, Bipolar Disorder, Panic Disorder, GAD, OCD or SAD, will be allowed in the study.

Regular treatment with hormonal medications, SSRIs, tricyclic antidepressant, mood stabilizer, oral neuroleptics, sedatives or hypnotics, over-the-counter agents known to influence hot flushes or mood within 4 weeks prior to screening visit; used of depot neuroleptics within 12 weeks prior to screening visit.

Suicidal ideation, homicidal ideation, or psychotic symptoms.

Menstrual dysfunction and amenorrhea of other etiologies.

History of seizure disorder

Pregnancy or breastfeeding.

Fid

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Calling Korean Workers - Glaxo Want to 'Help' You

Glaxo are on the look for volunteers from the Korean workforce whom are suffering with panic disorder. They touch on 'productivity' being important to employees as they seek the Koreans who, I would imagine, are pretty much in the dark about the dangers of taking Glaxo's 'wonder pill'.

This is Phase IV of Glaxo's study.

Interestingly, Glaxo do not want any volunteers whom are a current homicidal or suicidal risk.

Makes you wonder why doesn't it?

Maybe Glaxo know paroxetine can push depressed people over the edge and don't want another lawsuit hanging over them?

I feel for the Koreans. They have a great work ethic and if something comes along to improve the chances of employees being able to work despite having a 'panic disorder' then they will embrace that opportunity.

I suspect there will be many Koreans wondering why they are shaking, sweating and having electric like sensations rip through their body in years to come. Meantime, Glaxo will yet again reap the rewards and deny that paroxetine has anything to do with the adverse reactions.

Mark my words Korea, you have some dark days ahead of you if you let GlaxoSmithKline push paroxetine onto your unsuspecting public.

Fid

Source:

Clinical Trials.gov Identifier: NCT00492414

Contacts

Contact: Eun-Joo Jung - menfipro@naver.com

Locations
Korea, Republic of
Seoul Paik Hospital,
Inje University

Sponsors and Collaborators
Inje University
GlaxoSmithKline Korea

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

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CHIPMUNKA PUBLISHING

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Paroxetine and Deformed Children

Thanks to the anonymous 'tipster' for sending me recent files.

The basic message in this one was this:

The present findings are consistent with other recent results suggesting the possibility of a modestly increased occurrence of congenital malformations following first trimester exposure to paroxetine compared to ,other antidepressants.

Paroxetine in the first trimester and the prevalence of congenital malformations

J. Alexander Cole DSc, MPH1*,y, Sara A. Ephross PhD2,
Irene S. Cosmatos MS3 and Alexander M. Walker MD, DrPH1

1 i3 Drug Safety, Auburndale, MA, USA
2 GlaxoSmithKline, Research Triangle Park, NC, USA
3 GlaxoSmithKline, Philadelphia, PA, USA

SUMMARY

Purpose To refine a preliminary analysis identifying a possibly increased prevalence of malformations among infants born to women exposed to paroxetine in the first trimester.

Methods This study used data from UnitedHealthcare, a large U.S. insurer, using datasets originally for a study of bupropion in pregnancy. We identified women with a live-born delivery between January 1995 and September 2004. We classified women according to their first trimester mono- or mono/polytherapy exposure to paroxetine and other antidepressants. We confirmed malformation cases by medical record abstraction. We calculated the adjusted odds ratios (AORs) through logistic regression.

Conclusions These more detailed paroxetine findings confirm previous findings of analyses of these data among women exposed to all types of antidepressants. The present findings are consistent with other recent results suggesting the possibility of a modestly increased occurrence of congenital malformations following first trimester exposure to paroxetine compared to other antidepressants. Copyright # 2007 John Wiley & Sons, Ltd.

Fid

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Young Girls Abused In Care!

I'm currently reading Teresa Cooper's 'Trust No One'. It focuses on her time at Kendall House.

The blurb reads thus:

Thrust into care at six months of age because of an alcoholic father and mentally ill mother, Teresa Cooper's life began in a less than perfect way. Teresa spent an unsettled childhood in a variety of children's homes before being sent to Kendall House in Kent, which would become her prison and worst nightmare. At Kendall House, Teresa became a victim of a terrible regime, being injected with dangerously high doses of drugs and sexually abused. This cruel and vicious treatment, accompanied by punishments such as 163 days spent in solitary confinement, meant that it was not long before Teresa began to harm herself and even attempt to take her life. After three years of hell, Teresa thought her nightmare was over but another was about to begin. Teresa Cooper is a survivor. Fighting against a corrupt social care system, she has taken her case of abuse and drugging to parliament, and is fighting to prevent many more children from suffering at the hands of unethical doctors and abusive foster parents.

Teresa has now petitioned the UK Government to look in to this matter - I've just signed - I urge you all to follow suit. HERE

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Sydney Psychiatrist 'Poo Poo's' Patient Experience

Shortly after the birth of her daughter Rebekah Beddoe was diagnosed with post-natal depression. Two years later she was taking six different drugs, including lithium, a tranquilliser, an antipsychotic, and antidepressants. She had been diagnosed with bipolar disorder; given electric-shock therapy; made numerous attempts on her life; and was alternately manic and consumed by crippling despair during which she could barely move. She had a two-year-old daughter she hardly knew and a mother and partner who were at their wits' end, unable to recognise the formerly ambitious, vibrant and highly successful woman they loved so much.

Her book 'Dying For A Cure' has been on sale in Australia for over a year now and will shortly be launched here in the UK.

Yesterday I recieved an email from an Australian who had stumbled upon my blog. They pointed me in the direction of a critique left by Michael Robertson, a psychiatrist from Sydney, Australia.

Robertson goes about disecting Rebekah Beddoe's experience with what we [SSRi sufferers] have come to expect from those who would rather blame the illness than the drug.

His opening para sets a precedent for his rebuke of Beddoe's experience:


Dying for a Cure reads like a prolonged formal complaint, rather than a considered piece on this controversial area. Rebekah Beddoe makes no attempt to conceal her contempt for the psychiatrists who tried to care for her during her crisis. The book depicts psychiatrists as either lecherous and hapless, or arrogant and officious. Regardless of the accuracy of these portraits, her frank account of her life story betrays a deeper problem which it would seem explains some of her anger. In describing the challenges motherhood presented her psyche, she invites us into the poisonous transference responses which lurk throughout the book’s narrative:

Robertson, also appears to have a dig at Breggin and Healy. He writes:


The book is quite well researched all the main scientific papers addressing the adverse effects of newer antidepressants are mentioned, although this scholarly dimension is undermined by the book’s overemphasis on the opinions of SSRI critics like Peter Breggin and David Healy. Indeed, this incessant use of the rhetorical device of ‘appeals to authority’ weakens Beddoe’s arguments considerably. Beddoe proffers little more than straw-man arguments against psychiatry delivered in an excessively contemptuous tone.

It was hardly surprising to learn that Robertson has recieved over $2 Million in grants from, as yet, unknown sources.

Maybe this rather large sum of money he has recieved 'weakens his argument considerably'

I wrote to Robertson but as yet I have not had a response.

I will keep you posted if he responds.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

MEETING WITH THE MHRA

I have finally been granted a meeting with Kent Woods, CEO of the MHRA to discuss the issue of withdrawal regarding Seroxat. I will tell you the date of the meeting much nearer the time. I will probably announce it a day before.

I choose to do this because of a rather insidious character who helps moderate, it seems, a mental health forum. It seems this person is either infatuated with me or has nothing better to do with his life.

A recent visit to his forum sees a discussion labelling me a 'Scientologist lover'

The same person has also sent photographs of me in Australia to my lawyers and my M.P.

More recently he appeared on another website under the guise of someone else and tried to discredit many more Seroxat campaigners. He also taunted me by saying that I hadn't got a meeting with the MHRA!

Well, I have that meeting now 'Jeremy' - I may invite my 'Scientologist friends' seeing as I love them so much.

The meeting will take place sometime in September. For the record, I will be paying my own travelling expenses.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Seroxat : The Situation As It Stands : August 2008

There's a great post over at the Truthman's GSK : Licence To (K) ill.

Truthman hasn't written anything on his blog for almost a year but believe me he works tirelessly in the background. Never a day goes by where he hasn't sent me links to various articles in the press or hidden away somewhere on the Internet.

Truthman rounds up the past year regarding Seroxat, the MHRA and GlaxoSmithKline in a piece worthy of publication in one of Britain's newspapers.

Highly recommended reading.

Personally, I have some good news that I will share with you all tomorrow regarding my insistence on meeting with Kent Woods, CEO of the MHRA. Meantime, check out the Truthman's summary of the last 12 months HERE

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

COMING SOON - NEW PAXIL/SEROXAT/AROPAX WEBSITE

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

COMING SOON - NEW WEBSITE

Keep an eye out for a new website that will rock GSK to the core!

To be hosted on an ever increasing popular Networking site.

GSK WOULDN'T LISTEN

SO OTHERS HAVE TO BE TOLD

"We just stepped up a gear, it's time for GSK to suffer like those who have suffered at the hands of Seroxat/Paxil/Aropax"

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

DYING FOR A CURE

Currently being revamped for the UK

Shortly after the birth of her daughter Rebekah Beddoe was diagnosed with post-natal depression. Two years later she was taking six different drugs, including lithium, a tranquilliser, an antipsychotic, and antidepressants. She had been diagnosed with bipolar disorder; given electric-shock therapy; made numerous attempts on her life; and was alternately manic and consumed by crippling despair during which she could barely move. She had a two-year-old daughter she hardly knew and a mother and partner who were at their wits' end, unable to recognise the formerly ambitious, vibrant and highly successful woman they loved so much.

Australians have embraced antidepressants: twelve million prescriptions are written annually, mostly by GPs. But, what do we really know of the pills' effects? The idea that they correct a chemical imbalance in our brain is by no means proven, indeed there is much evidence that contradicts this view. It is commonly thought such drugs are not addictive; in fact, as Rebekah found to her great distress, they are hard to come off and those who do may suffer debilitating side effects.

This is a powerful memoir of the nightmarish three years Rebekah endured as she was repeatedly misdiagnosed, only to realise that her medication was the cause of her mental deterioration. In this book Rebekah calls for better information from the pharmaceutical companies about the risks associated with antidepressants and similar classes of drugs - facts, rather than marketing dressed up as medical science - and for a re-examination of the ways some psychiatrists treat their patients.

Australians can purchase the book HERE

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

GSK Duped Norwegian Medicinal Agency it seems.

Not content with duping the FDA and the MHRA, evidence has now come to light that GlaxoSmithKline had not reported to and had misrepresented the frequency of adverse reactions that were noted in the early clinical trials [Paroxetine] – to the Norwegian Medicinal Agency! {1}

The authors write:

Adverse drug reactions are of particular interest when they have been clandestine for many years. We were admitted access to unpublished data through the Civil Ombudsman’s unusual decision to advise the Norwegian Ministry of Health to let us examine files in the archives of the Norwegian Medicinal Agency. We found that reports of a series of randomized controlled studies evaluating the efficacy and safety of paroxetine already existed at the time of the first application for marketing authorization. Common to these studies were that they were small, were of short duration and were mostly published individually. Some of them have remained unpublished and no thorough meta-analysis has been carried out either for efficacy data or for adverse event data. The main published conclusions from these studies are that paroxetine is a safe and effective medication for the treatment of major depression.2–7

During the widely clinical use of paroxetine, more adverse drug reactions have become evident than were evident when the drug was first licensed in 1989. Our hypothesis was that some of these adverse drug reactions were already documented in the initial clinical trials forming part of the application for marketing authorization, but that no adequate pooling or meta-analysis of the data was carried out. We therefore wanted to explore the usefulness of gathering information about the occurrence of adverse reactions to a drug by means of randomized controlled trials at the time of first application for marketing authorization and to analyse these data by a meta analysis.

Purpose

We wanted to determine to what extent adverse drug effects associated with a selective serotonin reuptake inhibitor (SSRI) were known but not assessed before application for registration of paroxetine.

Methods With a special permit from the Norwegian Ministry of Health, we obtained reports from 82 clinical trials presented by the paroxetine license holder in 1989. There were 17 double blind, placebo controlled clinical trials with parallel design with 903 patients on paroxetine and 592 on placebo. Altogether 32 adverse effects showed a risk difference (RD) between paroxetine and control groups of more than 0.5%.We did a meta-analysis for each of these adverse effects. We then compared the outcome with the frequencies stated in the Summary of Product Characteristics (SPC) at the time of registration and those reported in the current SPC.

Results

At the time of registration 19 of the adverse effects were statistically significant. Only eight of these adverse effects were listed as being common in the first SPC from 1989. Five out of the nineteen adverse effects are not mentioned in the current SPC. Among them are headache with RD 5.4%, decreased libido RD 2.6%, nervousness RD 2.0% and paresthesia (brain zaps) RD 1.7%.

Conclusions

Frequently occurring adverse reactions that are included in today’s SPC for paroxetine were evident and documented already in the early studies accompanying the application for marketing authorization in 1989. Some other adverse effects observed then are still not mentioned in the SPC of today. Meta-analyses of adverse effects should be mandatory at the stage of first registration of a drug.

{1} Aursnes I, Gjertsen MK. Common adverse events associated with an SSRI: meta-analysis of early paroxetine data. Pharmacoepidemiol Drug Saf. 2008 Jul;17(7):707-13

I see from my webstats that GlaxoSmithKline from Hertford, UK, have been looking in today.

I have a message for you:

You manufactured and marketed a drug that I took. Because you never reported these adverse events at the time I took it, I put my faith in you, I trusted you. I have since learned that you not only duped me but our regulator too, and now it seems, the Norwegian regulator!

It's my mission to make sure you don't dupe others, be they regulators, doctors or more importantly, patients.

Do you want me to go away Glaxo?

See me as your confessional box, although I won't be telling you to go away and say three Hail Mary's for your sins.

I'm here to stay.

GET USED TO IT.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
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PAPERBACK COMING SOON

Paroxetine effects on emotions

This is a brief summary of a recent 2007 study of a group of thirty healthy psychologists and psychiatrists with the objective to evaluate the effects of paroxetine (Seroxat, Paxil) on their emotional functioning.

It's nice to see a group of healthy psychologists and psychiatrists using themselves rather than 'subjects' in this study.

Basically, the outcome was thus:

In the paroxetine groups, a total of thirty two psychiatric adverse events were recorded, with the authors concluding that they possibly were related to the paroxetine treatment.

There were four psychiatric adverse events recorded in the placebo (sugar pill) group!

Now... DO THE BENEFITS OUTWEIGH THE RISKS?

Paroxetine effects on emotions: a 4-week randomized placebo-controlled pilot study in psychologists and psychiatrists


Purpose of the study: The impact of paroxetine on emotional functioning is questioned, with regards to the known implication of serotonine in emotional regulation. The objective of our study was to evaluate the effects of paroxetine on emotional functioning in three arms: double blind paroxetine (DBPX), single-blind paroxetine (SBPX) and double-blind placebo (DBPL). Healthy psychologists and psychiatrists were elected for their ability to analyze with a correct sensibility changes in their emotions.


Method: 30 healthy participants (mean age: 33.5, gender ratio F/M: 1.5) working as psychiatrists (N = 18) or psychologists (N = 12) were randomly assigned to receive an ambulatory treatment with paroxetine (DBPX: N= 10, SBPX: N= 10) or placebo (DBPL: N= 10). Paroxetine was administered for 4 weeks at 20 mg/day. Emotional functioning was evaluated on D0, D7, D14 and D28 with the Emotional State Questionnaire (ESQ), a self questionnaire designed to assess 4 emotional dimensions: “recognition”, “expression”, “internal emotional experience” and “social context” [1]. The primary assessment criteria were ESQ scores on D28 compared with those on baseline. Impact of paroxetine on anxiety and depression was assessed by the Spielberger State-Trait Anxiety Inventory (STAI) and the Center for Epidemiologic Studies Depression Scale (CES-D). The Addiction Research Center Inventory (ARCI [2]), based on drug users’ experience, was performed to measure euphoria, dysphoria, sedation and stimulant effects. Changes on D28 from baseline were compared between treatment groups, gender and professional status.


Conclusions: This is the first study to assess the impact of a 4-week paroxetine treatment on emotional functioning in a healthy psychiatrists and psychologists population. DBPX was distinguishable from the other groups by a decrease in the internal emotional experience of ESQ. Concordant with this result, DBPX reported more sedation and less stimulant effects. Moreover, differences between DBPX and SBPX were observed in both psychological evaluation and tolerance. Two factors could be involved in the clinical response to paroxetine in patients: a decrease in emotional feeling and treatment awareness.


References
[1] Catherine Cass´e-Perrot Eric Fakra Elisabeth Jouve Olivier Blin Conceptualisation and Validation of the “Emotional State Questionnaire (ESQ)”: Evaluation of an Emotional Profile L’Enc´ephale (in press)

[2] Warot D, Danjou P, Payan C, Puech A-J, 1997, Sensitivity and specificity to amphetamine of a french version of the 49-item form of the addiction research center inventory. Drug and Alcohol Dependence 45, 177–183.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON