blogs created to prevent or detect a crime http://www.opsi.gov.uk/acts/acts1997/ukpga_19970040_en_1

This blog is brougt to you consistent with subsection 3 of the Protection from Harassment Act - i.e. blogs created to prevent or detect a crime http://www.opsi.gov.uk/acts/acts1997/ukpga_19970040_en_1



Wednesday 24 February 2010

uksurvivors : Message: Shelley Jofre Panorama programme removed after complaint

uksurvivors : Message: Shelley Jofre Panorama programme removed after complaint

Panorama found 'in breach of BBC rules' - episode looked at the long-term use of drugs in children with ADHD

Panorama found 'in breach of BBC rules'


http://news.bbc.co.uk/1/hi/entertainment/8534718.stm

The episode looked at the long-term use of drugs in children with ADHD

BBC current affairs programme Panorama will broadcast an apology after the corporation's independent watchdog said it breached editorial guidelines.

The BBC Trust Editorial Standards Committee said it did not accurately report a study into Attention Deficit Hyperactivity Disorder (ADHD).


What Next for Craig? looked at the use of drugs used to control the condition when it aired in November 2007.

The Trust said the show did not intend to mislead, but "distorted" some facts.

An apology will be broadcast during a future edition of Panorama, and the BBC's deputy director general Mark Byford will meet the committee to ensure the breaches are not repeated.

Failings

The committee partially upheld an appeal over a complaint.

It was ruled that Panorama did not accurately report the findings of a follow-up scientific study comparing the treatment of children with ADHD.

The programme makers have been accused of relying on the views of one scientist and viewers were not told that there is a wide range of views on the subject.

The episode also looked into the long-term use of stimulant drugs such as Ritalin.

But it was ruled that show failed to accurately report the findings of a three-year study which was conducted in the US.

Although the committee said that programme makers did not intend to mislead the audience, it did point out that "the programme failed to meet the requirements of impartiality in that the programme makers were not fair and open minded when examining the evidence and weighing all the material facts, nor were they even handed in their approach to the subject".

The report concluded: "The Editorial Standards Committee (ESC) expects the highest standards from Panorama as BBC One's flagship current affairs programme, and this programme failed to reach those standards.

"Due to the serious nature of the breaches the ESC will apologise to the complainant on behalf of the BBC and require the broadcast of a correction."

Sunday 21 February 2010

Psychdata - Doctoring the Evidence: GlaxoSmithKline

Psychdata - Dedicated to exposing the fraud of psychiatry: Doctoring the Evidence: GlaxoSmithKline Pushes Depression Drug

Tuesday, August 14, 2007


Doctoring the Evidence: GlaxoSmithKline Pushes Depression Drug

http://corpwatch.org/article.php?id=14606



Doctoring the Evidence: GlaxoSmithKline Pushes Depression Drug



by Shelley Jofre, Special to Corp Watch

July 30th, 2007


A striking young woman with a talent for painting, Sharise Gatchell was - like many teenagers - painfully self-conscious. At 14, she moved with her family from South Africa to England where at first she found it hard to make friends. By the age of 16 she was acutely embarrassed that her periods hadn't started and felt she was sweating excessively. Just the sort of thing to make adolescence even more painful than usual. Her mother, Stephanie, took her to see a consultant physician at the local hospital. Stephanie Gatchell recalls:

.............
...........................

Meanwhile, Stephanie Gatchell and her husband have moved away from the home that holds so many awful memories, to start a new life in Ireland. They can't forgive GlaxoSmithKline for concealing what it knew about paroxetine:




"I can't understand how they could possibly be so devious, and all just because of profit. I think the decision-makers in that company should be brought to justice. They have a lot to explain."



*Shelley Jofre is a reporter with BBC TV's flagship current affairs program: Panorama. To learn more about Sharise Gatchell, see http://www.gevil.netopti.net/.



GlaxoSmithKline issued a statement in response to Shelley Jofre's investigation.





Posted by Psychdata at 9:30 PM

CorpWatch : Doctoring the Evidence: GlaxoSmithKline Pushes Depression Drug

CorpWatch : Doctoring the Evidence: GlaxoSmithKline Pushes Depression Drug

http://corpwatch.org/article.php?id=14606

by Shelley Jofre, Special to Corp Watch


July 30th, 2007


A striking young woman with a talent for painting, Sharise Gatchell was - like many teenagers - painfully self-conscious. At 14, she moved with her family from South Africa to England where at first she found it hard to make friends. By the age of 16 she was acutely embarrassed that her periods hadn't started and felt she was sweating excessively. Just the sort of thing to make adolescence even more painful than usual. Her mother, Stephanie, took her to see a consultant physician at the local hospital. Stephanie Gatchell recalls:


"During that consultation she became a bit emotional because she was explaining to him about the problems she had and how it affected her social life. Then she started crying

read on -

http://corpwatch.org/article.php?id=14606

Mark Harvey takes 7 years to tell Seroxat suicide client he had no case

We had some bad news today, the solicitors acting on our behalf, wrote to us saying they could not find a link between Susan trying to kill herself (several times) and the use of Seroxat, and that they will no longer handle our case, they have been dealing with this for the past 7 years or so.... and after this time, that is their conclusion.... useless, all they see is text book stuff, they cannot see outside of the box the way I can.

http://groups.yahoo.com/group/uksurvivors/message/55547

Seroxat lawyer can see NO LINK with Seroxat & client suicide !

i...@lancashirecaravans.co.uk View profile We had some bad news today, the solicitors acting on our behalf, wrote to us saying they could not find a link between Susan trying to kill herself (several times) and the use of Seroxat, and that they will no longer handle our case, they have been dealing with this for the past 7 years or so.... and after this time, that is their conclusion.... useless, all they see is text book stuff, they cannot see outside of the box the way I can. Now, we have less than 8 weeks to beat the 10 year time limit to get this to court, I want to know how I can at least start court proceedings against Glaxo without the aid of solicitors, can someone advise us on how to start the proceedings in court. Simon


More options Feb 8 2007, 5:25 pm



Newsgroups: uk.legal

From: si...@lancashirecaravans.co.uk

Date: 8 Feb 2007 09:25:48 -0800

Local: Thurs, Feb 8 2007 5:25 pm

Subject: how do I start court proceedings


We had some bad news today, the solicitors acting on our behalf, wrote
to us saying they could not find a link between Susan trying to kill
herself (several times) and the use of Seroxat, and that they will no
longer handle our case, they have been dealing with this for the past
7 years or so.... and after this time, that is their conclusion....
useless, all they see is text book stuff, they cannot see outside of
the box the way I can.



Now, we have less than 8 weeks to beat the 10 year time limit to get
this to court, I want to know how I can at least start court
proceedings against Glaxo without the aid of solicitors, can someone
advise us on how to start the proceedings in court.





Simon
http://groups.google.com/group/uk.legal/browse_thread/thread/f4a60cf8dc96c472/ef879327dd8aa07b?hl=en&ie=UTF-8&q=shelley+jofre&pli=1

Saturday 20 February 2010

Seroxat USERS collaborate with GSK & MHRA to approve Patient Info Leaflet

http://www.mhra.gov.uk/home/groups/pl-p/documents/committeedocument/con003475.pdf

6.2 DRAFT SEROXAT PATIENT INFORMATION LEAFLET


6.2.1 The Group was informed that the Seroxat Patient Information Leaflet (PIL) will form a key component of any communications around the time of European Commission Decision in relation to the Article 31 referral for paroxetine.

6.2.2 Upon request GSK has submitted an amended version of the Seroxat PIL that reflects the changes to the product information for prescribers recommended

H:JW/SSRIEWGMINSMTG13.doc

by the recommended by the Committee for Medicinal Products for Human Use. GSK has also outlined its plans to user test this leaflet using a company called Consumation. The Group was informed that the MHRA was also planning to have users independently test the leaflet and commitments had been given to various stakeholders that their comments would be sought.


6.2.3 The Group was informed that GSK was provided with initial feedback on the draft Seroxat PIL during a meeting held between the MHRA and GSK on 15 July 2004. In light of these discussions GSK has provided a further draft which takes these comments into account. The Group had the following comments about the content and format of the revised draft Seroxat PIL:


extract from -
COMMITTEE ON SAFETY OF MEDICINES


EXPERT GROUP ON SAFETY OF SSRIs

MINUTES OF THE MEETING OF THE CSM EXPERT GROUP ON THE SAFETY OF SSRIS HELD ON WEDNESDAY 23 JULY 2004 AT 10AM IN CR1 AT MARKET TOWERS.

Friday 19 February 2010

Stalking: false claims of victimisation ..........thanks to our Australian readers for this topical article ROFL

The British Journal of Psychiatry 174: 170-172 (1999)


© 1999 The Royal College of Psychiatrists

http://bjp.rcpsych.org/cgi/content/abstract/174/2/170

Stalking: false claims of victimisation

M Pathe, PE Mullen and R Purcell

Victorian Institute of Forensic Mental Health, Rosanna, Australia.



BACKGROUND: False allegations of victimisation although uncommon are important to recognise. This paper examines those who falsely claim to have been the victims of stalking. AIMS: To highlight the phenomenon of false victims of stalking. METHOD: Twelve individuals who falsely claimed to be victims of stalking were compared with a group of 100 true stalking victims. RESULTS: False stalking victims presented for help earlier than real victims and were less likely to claim harassment via letters. They reported equivalent levels of violence directed at themselves but seldom claimed others were attacked. Five types of false claimants were recognisable. False victims consumed more medical services than genuine stalking victims and they were more likely to be embroiled in legal action. They reported similar levels of distress with suicidal ruminations in over 40%. CONCLUSIONS: The current interest in stalking is promoting false claims of being stalked. Early identification of these cases and appropriate intervention are essential to both minimising abuses of resources available to true victims and equally to ensure appropriate care for those who express their own disordered state in false claims of victimisation.

Fiddaman's publisher Jason Pegler's books available discount price at CCHR/Scientology

A Can Of Madness

http://www.cchr.org.uk/products/product_info.php?cPath=21_22&products_id=30&osCsid=5d1f2ddc99bc7eaf9bd4747002037c1b


[ACOM01] £9.99




Author: Jason Pegler


A vivid, honest and sometimes disturbing memoir about the experience of having a diagnosis of manic-depression. It was written using extracts from a diary written at the time of the author's flights into mania and his descents into depression. Like other books in this genre, the author is often painfully honest about his experiences. He recounts a dizzying, dark and sometimes euphoric journey through a world of elation, despair, binge drinking, drugs, raves and psychiatric wards. As well as attempting to educate the reader, the book also provides optimism and hope, showing that it is finally possible to learn to live with, and accept, having a mental health problem.


This product was added to our catalog on Tuesday, 17. July 2007.

Wednesday 17 February 2010

The Evidence, However, Is Clear…Fiddaman the Scientology stooge

The Evidence, however is clear ... Fiddaman blog bought by Scientology

Click image to enlarge - Fiddaman blog bought by Scientology

Scientology award for Chipmunka publishing, the publishers of Fiddaman's book

From left to right: CCHR Human Rights award recipient, CCHR Commissioner, the founder of the Restorative Health Company and a former Chief Superintendent of the West Yorkshire Police - Peter Bennett, award recipient Jason Pegler, chief executive of the mental health publisher Chipmunka Publishing, award recipient Professor Neil Ward of Surrey University, and Deputy Mayor of East Grinstead, Councillor Ian Dixon.


 
 
http://www.johnalexwood.com/2007/04/worlds-largest-psychiatric-watchdog.html

Tuesday 16 February 2010

The Paxil Papers - from Shyness: How Normal Behavior Became a Sickness

The Paxil Papers

http://www.christopherlane.org/paxil_papers.html


This Paxil Fact File, containing confidential information about one of our most widely prescribed antidepressants and anti-anxiety medications, was drafted and distributed by SmithKline Beecham in 1998 for internal use only. Now GlaxoSmithKline, the drug maker acknowledges in these pages that Paxil/Seroxat causes serious, widespread side effects and withdrawal symptoms -- in the February 2001 paper below, it put that number at a staggering 20% of patients -- but it continued to press for an FDA license to treat social anxiety disorder (with symtoms including "fear of eating alone in a restaurant") and advised its staff on how to spin or mask the problem of withdrawal (change the subject or put the side effects "in context"). The FDA awarded the license in March 1999, just a few months after the fact file circulated.



In the BBC Panorama segments below, which aired in Britain on October 3, 2004, David Healy says we may come to see GSK's masking of data about these withdrawal symptoms as "one of the biggest medical scandals ever." Senior pharmaceutical regulators in the UK acknowledge that they were "disgusted" and "horrified" by the deliberate withholding of information. The President of the Royal College of Psychiatrists, Dr. Mike Shooter, argues that the deception "has serious implications for the whole of psychiatry; it has serious implications for the whole of medicine." An investigative body in Britain is considering whether to indict the drug maker on criminal charges.



Foreword by Paul N. Jenner, Director and Vice President of Neuroscience and Strategic Product Development



Section 1: Towards the Second Billion -- All SSRIs Are Not the Same



Section 2: New Indications: Social Anxiety Disorder / Social Phobia



Section 3: Issues Management: Managing the Discontinuation Issue.



Related Papers and Programs



"Duration of Treatment and Depression: Relapse and Recurrence Rates" (February 2001; GlaxoSmithKline Confidential--Internal Use Only).



"Paxil CR" Product Monograph (GlaxoSmithKline; November 1, 2005).



Paxil Litigation Documents (Filed Under Seal; November 11, 2007).



GSK's Ghostwriting Agency "Budgeted for 50 articles in 2000," According to the Drug Maker Itself (April 2000).



BBC Panorama program "Taken on Trust" (UK; October 3, 2004):



Part 1 of 7 (9:36 minutes); part 2 (9:47 minutes); part 3 (9:41 minutes); part 4 (8:46 minutes); part 5 (9:39 minutes); part 6 (7:28 minutes); part 7 (7 minutes).

Seroxat Book -Shyness: How Normal Behavior Became a Sickness (Paperback)

Reviews




Shyness: How Normal Behavior Became a Sickness (2007):

http://www.amazon.com/exec/obidos/ISBN=0300143176/theenglishdepart

Starred review. "Having gained access to archival materials from the APA, Lane provides a behind-the-scenes look at the haphazard, unscientific process used to revise The Diagnostic and Statistical Manual of Mental Disorders. . . . [A] superb, iconoclastic cultural study. . . . Highly recommended."—Library Journal.



"Lane argues in this well-researched . . . controversial book that shyness [has been] pathologized, to the detriment, especially, of children and teenagers"—Elsa Dixler, New York Times Book Review.



"Lane has exposed a very worrying problem.... Looking at this book and at recent developments in information surveillance, it appears that both Orwell's and Huxley's predictions for the future are coming true"—Martin Guha, Journal of Mental Health.



"Christopher Lane's polemical Shyness features the manipulations that promoted social anxiety disorder to a national emergency."—Frederick Crews, New York Review of Books.



"Overall, Lane's scholarly account of this saga ensures that if you're not already concerned about the over-medicalization of our mental lives, you will be."—Christian Jarrett, BBC Focus.



"A provocative look at an important chapter in the history of modern psychiatry."—Judith Graham, Chicago Tribune.



"[An] excellent new book. . . . Shyness is a welcome contribution to psychiatric discourse."—Juliet Lapidos, New York Observer.



"A detailed and searing account of the cavalier fashion in which the diagnostic and statistical manual (DSM) of mental disorder classification systems was thrown together."—Nigel Wellman, Nursing Standard.



"In his brilliant Shyness: How Normal Behaviour Became a Sickness, Christopher Lane painstakingly shows how the category of 'mental disorder' has been expanded in recent decades, so that what were once considered normal emotions or everyday foibles—shyness, rebelliousness, aloofness, and so on—have been relabelled as phobias, disorders and syndromes."—Brendan O'Neill, New Statesman and Society.



"[A] splendid book. . . Lane gives a compelling description of how shyness—once seen as a normal variation of character or personality—became incorporated into the DSM as social phobia or avoidant personality disorder."—Simon Wessely, The Lancet.



"A fascinating behind-the-scenes look at the making of the bible of modern psychiatry [that] explains how a once-ordinary affliction became a profitable disease."—Michael Agger, Mother Jones.



"The achievement of Shyness is to chart for the first time the events preceding the rise and fall of the SSRIs. Lane has marshalled a cache of unpublished data to explain the academic framework that allowed the rise to happen. [He] tells the complex story with impressive clarity. . . . Lane has done a valuable job in tracing the roots of the current crisis and he certainly isn’t calling for a reinstatement of Freudianism; what is needed now is another map to indicate a way out."—Jerome Burne, Times Literary Supplement.



"This well-written book is a thoughtful examination of shyness and its relation to psychopathology. . . . I very much enjoyed reading Lane's thought-provoking book, and would highly recommend it for psychiatry residents, graduate students in clinical psychology, and other mental health professionals in training who are interested in the field of anxiety disorders, and more broadly in psychopathology and general mental health."—Brian J. Cox, New England Journal of Medicine.



"[A] stunning and revelatory book. . . . For a book that's about the invention of a medical condition, Shyness is as riveting as a detective story. Lane writes elegantly and passionately about the need to maintain our consciousness about the maddeningly rich complexity of human emotion and thought."—Yasmin Nair, Windy City Times.



"Christopher Lane's very readable book describes the process by which aspects of human character and behaviour have been labelled as mental disorders, as illnesses which can and should be treated."—James Docherty, The Salisbury Review.



"Fascinating . . . persuasive . . ., [Shyness] should be read by anyone interested in stopping the rot in the discussion of human emotion and thought."—Helene Guldberg, Spiked Review of Books.



"There is a great deal that's interesting in this book. . . . I recommend this book as a thought-provoking and informative read."—John D. Mullen, Metapsychology.



"As Lane’s research reveals, the cost of blaming anxieties on brain chemistry imbalance goes beyond dollars, to drug dependency, debilitating side effects and consumers convinced they’re hamstrung by their physiology."—Robin Tierney, San Francisco Examiner.



"Where this book stands out . . . is in the data that Lane uses to make his case—evidence confirming once and for all that the emperor really has no clothes. Lane not only manages to gain access to the DSM archives and to previously classified drug company memos—two coups by any measure—but he also interviews key players in the DSM saga, including long-time DSM Task Force Chair Robert Spitzer himself. . . That Spitzer even agreed to be interviewed by Lane—and with such remarkable openness—left this reader, as a fellow researcher with similar interests, green with envy."—Shelley Z. Reuter, Canadian Journal of Sociology.



"[A] scathing indictment of the American Psychiatric Association. . . . Lane finds a trove of troubling (and previously unpublished) material in the APA archive and in drug company memorandums, laying bare the APA’s internal politics (as fierce as academia) and showing the growing influence of drug companies on psychiatry practice. Similarly alarming are Lane’s dissections of big pharma’s marketing of anti-depressants and description of how information about side-effects and withdrawal symptoms associated with popular prescription drugs such as Prozac and Paxil were withheld from the public. This controversial and well-documented book will spark its share of debates."—Publishers Weekly.



Lane "charges that the task force, dominated by neuropsychiatrists, often used bad science or no science at all, that it turned ordinary human emotions into diseases and that it created a climate in which pharmaceutical companies could get rich creating cures for often nonexistent complexes."—Richard Halicks, op ed, Atlanta Journal-Constitution.





"Would Henry David Thoreau and Emily Dickinson be given drugs today? In the1980s a small group of leading psychiatrists revised the profession’s diagnostic manual called the DSM for short, adding social anxiety disorder—aka shyness—and dozens of other new conditions. Christopher Lane, Miller Research Professor at Northwestern University, uses previously secret documents, many from the American Psychiatric Association archives, to support his argument that these decisions were marked by carelessness, pervasive influence from the pharmaceutical industry, academic politics, and personal ambition."—Scientific American.





"Lane . . . notes that when psychiatrists diagnose the shy as suffering from social phobia, they mistake a variation in human temperament for a mental disorder; if anything, the diagnosis only adds to the sense of unease felt by shy people. He is also right in observing that the psychiatrists’ Diagnostic and Statistical Manual (DSM), the profession’s standard 900-page reference work, errs by designating other kinds of normal human variation as mental disorders and so exaggerates the incidence of mental illness. . . [Shyness] provides vivid portraits of how DSM-III was constructed, over the course of six years, by Dr. Spitzer and a team of 15, less from ‘the concentrated energies of brilliant minds than the raucous class of a teacher whose unruly pupils won’t stay quiet.’"—Paul, McHugh, Wall Street Journal.



"Christopher Lane deconstructs the new psychiatric condition ‘social anxiety disorder’ as a creation of corporate psychiatry’s alliance with the pharmaceutical industry. He argues that shyness became a medical condition best treated by drugs as a result of battles between psychiatrists over diagnostic techniques. . . . This book compares best to Ray Moynihan and Alan Cassels’ Selling Sickness. Highly recommended for general readers, healthcare professionals and practitioners."—Choice.



"Christopher Lane . . . calls psychiatry's growing focus on children 'the perfect storm' for overdiagnosis. 'You've got a constituency—children—who cannot make informed medical decisions for themselves,' Lane says. In a fast-moving culture that heaps stress and high expectations on children, 'parents are in many cases under great pressure to ensure their child succeeds and is socially proficient. A child that doesn't negotiate rapidly those hurdles can look very quickly as if he or she is falling behind, or displaying behavior that warrants medical concern.'"—Melissa Healy, Los Angeles Times.





"This is not only an important account of the creation of a modern disease and its treatment, it is an explosive indictment of a system that is too simply materialist in both philosophy and behavior."—Harold J. Cook, Wellcome Trust Centre for the History of Medicine at University College London.



"A marvelous book: disturbing and perturbing, a book that will be widely talked about and debated. It is extraordinarily well written, balanced, witty, and engrossing. Bravo!"—Arthur Kleinman, Esther and Sidney Rabb Professor and Chair of Anthropology, Professor of Medical Anthropology, and Professor of Psychiatry, Harvard University.



"Written with Chris Lane’s brand of verve and scholarship, Shyness is a riveting book about how certain so-called illnesses are complex cultural artifacts, and certain so-called doctors are casting spells called diagnoses. A smart and bracing book about shyness—not to mention a shrewd and subtle book about psychiatric classification—is long overdue; after reading Shyness it is clear that only Lane could have written it."—Adam Phillips, psychoanalyst, author of Side Effects.



"In Shyness, Christopher Lane outlines an apparatus that is one of the most powerful cultural forces in the world today. In pulling back the drapes and revealing the bumbling and hamfistedness of the new engineers of human souls, Chris Lane might help restore sanity to Oz."—David Healy, M.D., author of Let Them Eat Prozac and The Antidepressant Era.

Monday 15 February 2010

Prescription Pricing Authority data for child and adolescent use of Seroxat - source MHRA

EVIE PRINGLE IS BACK - bought & paid for by Paxil Lawyers

The Paxil Birth Defect Litigation Update Series is sponsored by the Houston law firm of Vickery, Waldner and Mallia at www.justiceseekers.com


http://yubanet.com/opinions/Evelyn-Pringle-Paxil-Birth-Defect-Litigation---First-Trial-A-Bust-For-Glaxo.php


Evelyn Pringle: Paxil Birth Defect Litigation - First Trial A Bust For Glaxo

Published on Feb 15, 2010 - 6:47:12 AM


By: Evelyn Pringle

Feb. 15, 2010 - GlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.

Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.


First Trial A Bust for Glaxo

The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo "negligently failed to warn" the doctor treating Lyam Kilker's mother about Paxil's risks and the drug was a "factual

uksurvivors : Message: EVIE PRINGLE IS BACK - bought & paid for by Paxil Lawyers

uksurvivors : Message: EVIE PRINGLE IS BACK - bought & paid for by Paxil Lawyers


The Paxil Birth Defect Litigation Update Series is sponsored by the Houston law firm of Vickery, Waldner and Mallia at www.justiceseekers.com




http://yubanet.com/opinions/Evelyn-Pringle-Paxil-Birth-Defect-Litigation---First-Trial-A-Bust-For-Glaxo.php



Evelyn Pringle: Paxil Birth Defect Litigation - First Trial A Bust For Glaxo



Published on Feb 15, 2010 - 6:47:12 AM



Email this article Printer friendly page

By: Evelyn Pringle



Feb. 15, 2010 - GlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.



Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.



First Trial A Bust for Glaxo



The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo "negligently failed to warn" the doctor treating Lyam Kilker's mother about Paxil's risks and the drug was a "factual

........................

Seroxat rapid decline 2001 onwards - confirmed by MHRA

http://www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con019473.pdf

teratogenic meds taken by millions of women of childbearing age - not just Paxil/Seroxat

http://linkinghub.elsevier.com/retrieve/pii/S0002934305001956


Purpose

The purpose of this study was to identify the potentially teratogenic medications most frequently prescribed to women of childbearing age and the specialty of physicians who provide ambulatory care to women who use such medications. In addition, we evaluated rates of contraceptive counseling to explore awareness of the risks associated with teratogenic medication use.


Subjects and methods

The prescription of teratogenic medications and provision of contraceptive counseling on 12 681 visits made by nonpregnant women, 14 to 44 years of age, to 1880 physicians in US ambulatory practice (National Ambulatory Medical Care Survey) between 1998 and 2000 was analyzed.

Results

Use of a potentially teratogenic, class D or X, medication by a woman of childbearing age is documented on 1 of every 13 visits made to US ambulatory practices. These include anxiolytics (4.1 million annual prescriptions), anticonvulsant medications (1.4 million annual prescriptions), antibiotics like doxycycline (1.4 million annual prescriptions), and statins (0.8 million annual prescriptions). Isotretinoin accounts for less than 5% of potentially teratogenic prescriptions (0.5 million annual prescriptions). Internists and family/general practitioners provide ambulatory care to 45% of women prescribed potentially teratogenic medications, psychiatrists provide ambulatory care to 20% of women prescribed potentially teratogenic medications, and dermatologists provide ambulatory care to 20% of women prescribed potentially teratogenic medications. Contraceptive counseling was provided on less than 20% of visits that documented use of a potential teratogen by a woman of childbearing age. Women using low-risk (class A or B) drugs received contraceptive counseling as frequently as women using potential teratogens (P = .24).


Conclusion

Potentially teratogenic medications are prescribed to millions of women of childbearing age each year. Physician awareness of the teratogenic risk associated with class D or X medications seems low.

teratogenic meds taken by millions of women of childbearing age - not just Paxil/Seroxat

Abstract


http://linkinghub.elsevier.com/retrieve/pii/S0002934305001956







Purpose

The purpose of this study was to identify the potentially teratogenic medications most frequently prescribed to women of childbearing age and the specialty of physicians who provide ambulatory care to women who use such medications. In addition, we evaluated rates of contraceptive counseling to explore awareness of the risks associated with teratogenic medication use.



Subjects and methods

The prescription of teratogenic medications and provision of contraceptive counseling on 12 681 visits made by nonpregnant women, 14 to 44 years of age, to 1880 physicians in US ambulatory practice (National Ambulatory Medical Care Survey) between 1998 and 2000 was analyzed.



Results

Use of a potentially teratogenic, class D or X, medication by a woman of childbearing age is documented on 1 of every 13 visits made to US ambulatory practices. These include anxiolytics (4.1 million annual prescriptions), anticonvulsant medications (1.4 million annual prescriptions), antibiotics like doxycycline (1.4 million annual prescriptions), and statins (0.8 million annual prescriptions). Isotretinoin accounts for less than 5% of potentially teratogenic prescriptions (0.5 million annual prescriptions). Internists and family/general practitioners provide ambulatory care to 45% of women prescribed potentially teratogenic medications, psychiatrists provide ambulatory care to 20% of women prescribed potentially teratogenic medications, and dermatologists provide ambulatory care to 20% of women prescribed potentially teratogenic medications. Contraceptive counseling was provided on less than 20% of visits that documented use of a potential teratogen by a woman of childbearing age. Women using low-risk (class A or B) drugs received contraceptive counseling as frequently as women using potential teratogens (P = .24).



Conclusion

Potentially teratogenic medications are prescribed to millions of women of childbearing age each year. Physician awareness of the teratogenic risk associated with class D or X medications seems low.

Thursday 11 February 2010

SSRI-Crusaders : Message: MHRA's position about the irreversible inactivation of CYP2D6

SSRI-Crusaders : Message: MHRA's position about the irreversible inactivation of CYP2D6


MHRA's position about the irreversible inactivation of CYP2D6 I think it would be helpful if I explain further the circumstances under which the studies by Concept Pharmaceutical Inc were conducted and how this translates to the situation in humans. The studies conducted by this company were in vitro studies (ie test tube studies). They looked at the direct effect of paroxetine on the CYP2D6 enzyme in cells that had been isolated from a liver, most likely an animal liver. The effect of certain medicines on these cells can indeed be to inhibit or even to inactivate the CYP2D6 enzyme.




In real life, when an individual takes a medicine it can inhibit or inactivate the CYP2D6 enzyme in the cells of the liver in the same way. This inhibitory effect will depend on many factors including the amount of a medicine circulating in the body. However, the effect is only on those cells and enzymes actually exposed to the medicine: as we are all continuously replacing the numerous cells, enzymes and proteins in our body any inhibitory effect will only last as long as sufficient levels of the medicine are circulating in the body.



I hope this clarifies our position on this issue.



Yours sincerely



Simon Gregor



Director of Communications







extracted from -



Via email



15 October 2009



Dear Mr Bryce



Ref: FOI request on irreversible inactivation of P450 2D6 (CYP2D6) enzyme activity



Thank you for your email of 21 September regarding your FOI request

Tuesday 9 February 2010

Paxil is NOT linked to breast cancer deaths -Fiddaman gets a slap down in PaxilProgress

Re: Seroxat linked to breast cancer deaths



http://www.paxilprogress.org/forums/showthread.php?t=46303
--------------------------------------------------------------------------------

That's old news, Fiddy. Tamoxifen and ADs have never mixed and in fact, Tamoxifen shouldn't be used with many drugs.

The title of your thread is being changed, as Paxil is NOT linked to breast cancer deaths. This is totally misleading and sounds as though Paxil alone, causes breast cancer deaths.

There is a warning with ALL SSRIs and Tamoxifen in women who have been, or are being treated for breast cancer.

__________________

aka LC

aka Laurie C.

SSRI-Crusaders : Message: avoid Prozac & Seroxat with Tamoxifen NHS warn in 2005 !!!

SSRI-Crusaders : Message: avoid Prozac & Seroxat with Tamoxifen NHS warn in 2005 !!!

avoid Prozac & Seroxat with Tamoxifen NHS warn in 2005 !!!



http://www.ukmicentral.nhs.uk/



Medicines Information Web Site

Trent and West Midlands regional Medicines Information services

http://www.ukmicentral.nhs.uk/headline/database/printstory.asp?NewsID=3854


News Story 05 January 2005

Adverse SSRI - tamoxifen interaction?

Tamoxifen is metabolised to a potent active metabolite (endoxifen) by cytochrome P450 2D6, which is subject to genetic variation. Plasma levels have been shown to depend on CYP2D6 genotype, and this study showed that drugs that inhibit this enzyme accentuate the variation. In an open-label, prospective, observational study, 80 women taking tamoxifen for breast cancer were followed. For those women with the most common genotype (homozygous wild-type), administration of an SSRI reduced endoxifen levels by a mean of 58%; in heterozygotes the mean reduction was 38%. Paroxetine was the most potent CYP2D6 inhibitor, followed by fluoxetine. The authors suggest that according to their data, women taking tamoxifen should avoid paroxetine and fluoxetine, and other potent inhibitors of CYP2D6.



J Natl Cancer Inst 2005; 97: 30-9 - JNCI website; from Reuters Health for 4th January 2005, via Medscape (free registration required)

Monday 8 February 2010

SSRI-Crusaders : Message: The “Addiction” Issue & Hugh James’ need to change the P.I.L..

SSRI-Crusaders : Message: The “Addiction” Issue & Hugh James’ need to change the

The "Addiction" Issue & Hugh James' need to change the Patient Information Leaflet (PIL)






http://the-uk-seroxat-litigation-chronicles.blogspot.com/2010/02/addiction-issue-hugh-james-need-to.html



Patient safety, accurate honest comprehensive information, instructions and warnings to enable patients to make informed choices about treatment is and should be paramount in any discussions with regard literature issued to patients and primary health care providers.

"A product is defective if, at the time of circulation, it is not as "safe as persons generally are entitled to expect," taking account of a number of factors including any instructions or warnings provided with the product and the manner in which it has been marketed. "



Access my Library: Mass tort treatment pharmaceutical



"Mark Harvey, solicitor for the Seroxat Users Group, told BBC News Online: "We would welcome the removal of the suggestion that the drug is not addictive."



BBC: Seroxat safety advice to be changed



"Message from Mark Harvey, Hugh James Solicitors ………

c) For the first time in the 13 years of this drug, the manufacturers have agreed to change the Patient warning sheets to deal with the question of addiction."



Hugh James Solicitors

The Seroxat Patient Information Leaflets (PIL) was predominant in the Seroxat Group Litigation Solicitors and Seroxat User Groups discussions and media coverage, as Mark Harvey of Hugh James Solicitors confirms in the above quotes.



The first of two changes to the SSRI PILs only related to the GSKs Seroxat, the addiction issue and the sentence 'Remember that you cannot become addicted to Seroxat' which was removed from the document in 2003 – an action that Mark Harvey of Hugh James and the Seroxat User Groups took and deserved full credit for – although an empty platitude.



Removal of the Seroxat "addiction" sentence from the PIL was not an admission of guilt – i.e. by doing this GSK were not saying that you could become addicted to Seroxat - although this was the inference in any reports made by or on behalf of those accredited for the action.



Unfortunately bringing the "addiction" issue to the notice of the UK licensing authorities the MHRA in 2002 brought no change to The World Health Organization's (WHO) criterion for addiction, therefore Seroxat and all SSRI, SNRIs remain outside that ruling - despite considerable discontinuation problems.



Had the "addiction" issue been upheld and / or the WHO criterion for addiction changed to encompass any discontinuation problems – the Seroxat Group Litigation would have been proved on "Failure to Warn" in marketing "instructions and warnings" provided with the product.



In real terms the GSK statement 'Remember that you cannot become addicted to Seroxat' although removed from the PIL - still stands – however, GSK, the MHRA and WHO have all been seen to listen to patients complaints & concerns - and have been seen to act promptly on their behalf in a professional & responsible manner

Sunday 7 February 2010

uksurvivors : Message: so much for Seroxat litigation threat - Pfizer roll out generic paroxetine

uksurvivors : Message: so much for Seroxat litigation threat - Pfizer roll out generic paroxetine


Pfizer rolls out new generics portfolio in the UK



http://groups.yahoo.com/group/uksurvivors/message/54527




http://www.pharmatimes.com/UKNews/article.aspx?id=17334





04 February 2010

Drug giant Pfizer has stepped into the UK's generics sector with the launch of six copycat drugs made possible by agreements last year with India's Aurobindo Pharma and Claris Lifesciences.



Back in May the drug giant signed two major deals that would give it a much stronger foothold in the global generics arena, acquiring the rights to 55 generic oral drugs and five injectables in more than 70 emerging market countries as well as US and European rights to a number of generics under its pact with Aurobindo, and the rights to 15 injectables in North America, Europe, Australia and New Zealand from Claris.



Through its Established Products Business Unit portfolio, which houses over 80 off-patent medicines, the group said it has now launched: metformin for diabetes; finasteride for benign prostatic hyperplasia; ondansetron for post-operative nausea and vomiting; and paroxetine, mirtazapine and mirtazapine OD for depression throughout the UK.



With the launch of these products, Pfizer says it has increased the range of "high-quality and cost-effective medicine options" available to pharmacists and healthcare professionals in the UK, under a previously stated commitment of delivering commercial value to its pharmacy and dispensing customers in the country.



Commenting on the move, Steve Poutlon, commercial director and head of the EPBU at Pfizer UK, said the company is "committed to ensuring that its generic medicines continue to build on the strong heritage of its patented medicines, which are known for their quality, efficacy and supply reliability," and that its generics will "continue to deliver commercial value to pharmacists through Pfizer's a healthy partnership pharmacy programme by providing our customers with a wider product offering".



Introduced in 2008, Pfizer's healthy partnership initiative is designed to offer support to pharmacists in the delivery of healthcare and related services to patients, as well as hit objectives laid out in the pharmacy contractual framework.



The scheme is focused on: supporting professional development, such as through Pfizer's Building Confidence in Medicines Use Reviews training course; improving the patient experience, through boosting treatment outcomes via measures such as better drug packaging; and delivering commercial value, through offering a portfolio of generic medicines in the UK, for example, which the company said it intends to further expand with new launches throughout the year.



By Selina McKee

Saturday 6 February 2010

SSRI-Crusaders : Message: Mass Tort: Pharmaceutical Product Liability England

SSRI-Crusaders : Message: Mass Tort: Pharmaceutical Product Liability England


Mass Tort: Pharmaceutical Product Liability England


http://the-uk-seroxat-litigation-chronicles.blogspot.com/




"Mass tort treatment of pharmaceutical product liability cases in England.

Defense Counsel Journal: July 01, 2006: Wilkinson, David: Copyright"

"II. Causes of Action/Remedies

There are three potential causes of actions in product liability cases. Product liability claims may be made under the Consumer Protection Act 1987 ("CPA"), in negligence, or in breach of contract.

A. Consumer Protection Act 1987

The CPA, which implements the Product Liability Directive 85/374/EEC (3) in the UK, imposes liability on the producer of defective products for damage caused by the defect. A "product" is defined as any good that includes "any natural or artificial substance." (4) A product is defective if, at the time of circulation, it is not as "safe as persons generally are entitled to expect," taking account of a number of factors including any instructions or warnings provided with the product and the manner in which it has been marketed. (5) A product cannot be deemed defective solely because an improved product has become available. Liability under the CPA is strict: it is not necessary to prove that the producer was at fault in causing the defect. Producers have strict liability for distributing a product that is "unreasonably dangerous," regardless of whether they are at fault. The claimant need only prove a defect and causal relationship between the defect and the injury; courts will distinguish between products that fail and defective products."



link - Access my Library: Mass tort treatment pharmaceutical

It would appear the Seroxat litigation being brought under the CPA, is solely dependant on the personal expectation of the consumer on safety and withdrawal.
Although producers' liability under the CPA is strict, successful litigation is not dependant on the producer being found at fault for causing the defect – therefore this case will hold no fault to GSK as the producer.

The lead solicitor Mark Harvey of Hugh James confirms the withdrawal and no fault criteria on his website.

"The seroxat group action claims which are being led by Hugh James are being pursued under the Consumer Protection Act (CPA) 1987. The CPA provides for a non-fault based liability if the product is found to be defective and to have caused injury as a result. The Claimants allege difficulties in withdrawing from the drug."





link - Hugh James: Seroxat group action claim

Friday 5 February 2010

SSRI-Crusaders : Message: Good question - why does UK seroxat case NOT include suicide?

SSRI-Crusaders : Message: Good question - why does UK seroxat case NOT include suicide?: "Good question - why does UK seroxat case NOT include suicide?"

http://health.groups.yahoo.com/group/SSRI-Crusaders/message/34879

Although the lead solicitors, Hugh James, in the Seroxat Group Litigation seem to have chosen to limit the action solely to withdrawal, ignoring reports of serious injury such as stroke, dystonia, SSRI induced parkinsonism, tardive dyskinesia, suicidal ideation, suicidal action and suicide completed - why?



http://the-uk-seroxat-litigation-chronicles.blogspot.com/?zx=70f727dd9cdafff1

Thursday 4 February 2010

Consumer Law: Consumer Protection Act 1987: Defective Product - this from Seroxat Litigation Chronicle blog

http://the-uk-seroxat-litigation-chronicles.blogspot.com/2010/02/consumer-law-consumer-protection-act.html

“Consumer Protection Act 1987



Part I: Product Liability: Meaning of defect.



3:-


(1) Subject to the following provisions of this section, there is a defect in a product for the purposes of this Part if the safety of the product is not such as persons generally are entitled to expect; and for those purposes `safety', in relation to a product, shall include safety with respect to products comprised in that product and safety in the context of risks of damage to property, as well as in the context of risks of death or personal injury.




http://www.opsi.gov.uk/ACTS/acts1987/PDF/ukpga_19870043_en.pdf



There is provision within the 1987 Consumer Protection Acts’ “Meaning of defect” and product “safety” criterion to facilitate action being taken for the risk of death or personal injury.



Although the lead solicitors, Hugh James, in the Seroxat Group Litigation seem to have chosen to limit the action solely to withdrawal, ignoring reports of serious injury such as stroke, dystonia, SSRI induced parkinsonism, tardive dyskinesia, suicidal ideation, suicidal action and suicide completed - why?

Wednesday 3 February 2010

Seroxat User Group colluding with the enemy MHRA/GSK to agree changes to GSK's patient information leaflet

Seroxat User Group colluding with the enemy MHRA/GSK








Committee on Safety of Medicines
Working Group on Patient Information

Report on a focus group discussion of the Seroxat patient information leaflet

Wednesday 13 October 2004 at 14:30 at Market Towers



Facilitator:
Mary Chambers, Chief Nurse and Professor of Mental Health Nursing at South West London
& St Georges' Mental Health NHS Trust and a member of the SSRI Working Group of the


Committee on Safety of Medicines

Attendees:
Representatives from patient interest and user groups and MHRA Product Information
Unit/Post Licensing Assessment Group.



Aim:

The aim of this focus group was to obtain the views of attendees on a revised patient
information leaflet (PIL) for Seroxat (paroxetine) and whether this meets the needs of users
for written information provided with the medicine.



Methodology:
All sections of the PIL were reviewed to identify any areas where the information needs to be
clarified to ensure that the key messages are understood. Any omissions that need to be
included in the PIL were flagged. Time did not permit consideration of the validity of the
questions asked in the company-sponsored user test undertaken previously on the PIL.



http://www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con01/9476.pdf

Monday 1 February 2010

Seroxat Group Litigation: Order no: 68 - comments from Seroxat litigation Chronicles blog

Seroxat Group Litigation: Order no: 68

http://the-uk-seroxat-litigation-chronicles.blogspot.com/2010/02/seroxat-group-litigation-order-no-68.html

2001 - the UK litigations lead lawyer Mark Harvey of Hugh James Solicitors (Harmful Products Department), Cardiff, then Hugh James Ford Simey Solicitors, announced in the UK press that there was an *unidentified* problem with Seroxat and the possibility of a UK Group litigation against GSK the manufacturer - he called it “shaking the tree”.



2008, October 29th - the UK Seroxat Group Litigation was lodged in the Royal Courts of Justice – but not publicized in the media or by the Seroxat campaigners.







http://www.hmcourts-service.gov.uk/cms/150_14671.htm



The litigation is being brought under *harmful product* consumer legislation - not under any medical law or legislation.



Although the discontinuation problems, side effects, adverse drug reactions, long term persistent & enduring residual symptoms and suicidal ideation & action are of a medical nature - encompassing psychological, physiological & neurological symptoms and in some cases permanent damage.



(The blog will return to the processes of harvesting litigants, the litigant support groups and the campaign a little later.)