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Sunday, 31 October 2010

why did UK lawyer (Hugh James) drop youth suicide case which could have been won?

From: Mark Harvey


Date: 06/02/2008 13:26:15

To: Jeremy Bryce

Subject: RE: ' Implementation of warnings on suicidal thoughts and behaviour in antidepressants' ..................source MHRA



Thank you for this.

The Seroxat Group Action does not involve suicide issues; only discontinuation where Seroxat is the worst of the comparator treatments."





We found some time ago that there was a Class Phenomenon for suicidal ideation and acts which meant that, together with other notable problems both in science and in law, successful litigation was unlikely. That was a decision I had to make irrespective of my personal concerns about these drugs and their links with suicidal ideation. It is noteworthy however that the original MHRA, EMEA and FDA investigations of SSRIs arose as a direct result of the focus on Seroxat and Paxil by the litigators both here and in the US and the media. That focus has highlighted the class issue.



I cannot, do not and will not talk for the various campaigners or support groups. Nor will I become involved in inter-campaigner disputes. As I have said on many occasions, every time the patients and their supporters snipe at each other it weakens their position and strengthens the Pharmaceutical Industry's.



Best wishes



Mark Harvey

Journalists are not doctors. Indeed, some journalists feel they can play God with peoples' lives simply for a media frenzy

Journalists are not doctors. Indeed, some journalists feel they can play God with peoples' lives simply for a media frenzy. I say this from personal experience of many journalists including being questioned by Panorama at one point. A certain researcher once asked me to take a camera and film patients breaching their confidentiality. I refused. These people are not concerned with the welfare of patients but simply " a story". They also fail to be accountable for the vast range of problems they cause.



http://www.bmj.com/content/326/7402/1282.3.extract/reply




Kind Regards







Dr Rita Pal www.nhs-exposed.com

Panorama unscientific jumping on bandwagon & putting patients at risk - Dr Rita Pal

PANORAMA AND ADDED DRAMA


Rita Pal, Editor NHS Exposed http://www.nhs-exposed.com/

http://www.bmj.com/content/326/7402/1282.3.extract/reply

XXXXXXXXXXXXXXXXXX

Last year, I worked in the north. Panorama had just shown their supposedly well researched material on Paroxetine. Firstly, I think there seems to be an absence of clinical opinions on Paroxetine. I am therefore going to take this opportunity to present my opinion because I feel that clinical opinions from the person dealing with the side effects of the potent drug known as Panorama should be examined.

Many of my colleagues agree that Paroxetine has helped many people. Indeed, having

More...Last year, I worked in the north. Panorama had just shown their supposedly well researched material on Paroxetine. Firstly, I think there seems to be an absence of clinical opinions on Paroxetine. I am therefore going to take this opportunity to present my opinion because I feel that clinical opinions from the person dealing with the side effects of the potent drug known as Panorama should be examined.



Many of my colleagues agree that Paroxetine has helped many people. Indeed, having treated many people with the drug, there has been a significant improvement in their quality of life. Firstly, it should be borne in mind that Paroxetine is used to treat depressed people. This means the probability of suicidal ideation is much higher in this group of patients by the nature of their illness. Suicidal ideation is dependant on multiple factors eg environment, life events, mental state etc. No drug is perfect but this means a number of studies need to be done before the DOH issues guidelines based on a knee jerk reaction governed by Panorama.



After watching Panorama, a large amount of patients deteriorated as they simply "stopped their tablets" because of Panorama. This is an example where the media plays doctor. It is a known fact that abruptly stopping Paroxetine will give a number of withdrawal symptoms. Over that period of two weeks, we must have had about 40 patients suffering from relapses. These are people who had been well for a number of years on this drug.




Personally, having had the unfortunate experience of being in personal contact with Panorama in the past; I found them to be unscientific, jumping on whatever bandwagon they wish, featuring interviews from patients whose histories were not examined ie whether they were non compliant with medication or whether their suicide risk prior and after treatment had been examined. Fear instilled in vulnerable patients by a powerful medium like Panoram who have limited initial information on Paroxetine is dangerous.



The scientific data measuring the number of relapses following the Panorama programme is not publicised. Panorama should also take the responsibility of leaving doctors to pick up the pieces that they have created. They should also realise that they are playing with peoples' lives - which is not worth the terror journalism that was featured.



Currently we see a knee jerk reaction to a media frenzy.People who have recovered stop their medication and relapse badly. If Panorama want to pay for the extra admissions that they have directly caused, then they should provide me with their number. Indeed, perhaps they should sit up at 3am in the morning and take a look at what they have caused.




Journalists are not doctors. Indeed, some journalists feel they can play God with peoples' lives simply for a media frenzy. I say this from personal experience of many journalists including being questioned by Panorama at one point. A certain researcher once asked me to take a camera and film patients breaching their confidentiality. I refused. These people are not concerned with the welfare of patients but simply " a story". They also fail to be accountable for the vast range of problems they cause.



Kind Regards



Dr Rita Pal www.nhs-exposed.com



PS I would be interested to know whether Panorama would fund the beds we require for each relapsing patient with the first presenting line " Doctor, I stopped Paroxetine because Panorama featured all the bad points about it".



Competing interests: Interviewed by researcher from Panorama on a different subject.

SSRI suicide linked Citalopram now UK largest seller - x5+ times greater than seroxat

ST. LOUIS A month after its Earth City subsidiary pleaded guilty of illegally marketing antidepressants to children and adolescents, Forest Laboratories is now settling a string of wrongful death and personal injury lawsuits from the parents of children who took the drugs Celexa and Lexapro.

Fifty-four lawsuits, mostly involving suicides and attempted suicides by teenagers in various parts of the country, accuse the New York-based pharmaceutical company of concealing a negative pediatric study on Celexa, duping physicians about the drug's clinical trials, and targeting children in aggressive promotions of Celexa and a sister drug, Lexapro.

Four of the cases were settled Friday, and two additional cases were settled in recent weeks.

A surge of related settlements, which could total millions of dollars, is expected in the months ahead as the pharmaceutical company attempts to move beyond the controversy surrounding its marketing of antidepressants to children.



http://www.stltoday.com/business/article_c569f2c4-58a7-5432-a939-ff22e90583e5.html
 
 
 
2009 UK Citalopram prescriptions = 10.5 million
UK Escitalopram prescriptions = 1.25 million
i.e together very nearly 50% of the UK market !









Tuesday1st The UK Seroxat Litigation Chronicles


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



Tuesday1st UK : SSRI / SNRI Antidepressant Statistical Politics

http://tuesday1st.blogspot.com/




Tuesday1st Correspondence with the MHRA .. Patient & Public Engagement Strategy



http://tuesday1st-mhra-ppes-correspondence.blogspot.com/















Celexa (cipramil) Lexapro settling suits over drugs tied to suicides

http://www.stltoday.com/business/article_c569f2c4-58a7-5432-a939-ff22e90583e5.html







ST. LOUIS A month after its Earth City subsidiary pleaded guilty of illegally marketing antidepressants to children and adolescents, Forest Laboratories is now settling a string of wrongful death and personal injury lawsuits from the parents of children who took the drugs Celexa and Lexapro.



Fifty-four lawsuits, mostly involving suicides and attempted suicides by teenagers in various parts of the country, accuse the New York-based pharmaceutical company of concealing a negative pediatric study on Celexa, duping physicians about the drug's clinical trials, and targeting children in aggressive promotions of Celexa and a sister drug, Lexapro.



Four of the cases were settled Friday, and two additional cases were settled in recent weeks.



A surge of related settlements, which could total millions of dollars, is expected in the months ahead as the pharmaceutical company attempts to move beyond the controversy surrounding its marketing of antidepressants to children.



Last month, the company's subsidiary Forest Pharmaceuticals, based in Earth City agreed to plead guilty to criminal charges involving its marketing and manufacturing practices and also to pay more than $300 million in criminal and civil penalties. The U.S. attorney's office in Boston is continuing to investigate the potential criminal liability of Forest officers and employees.



According to federal regulators, Forest waged an aggressive campaign from 1999 through at least 2005 to promote the use of Celexa and Lexapro in children and teenagers, although neither drug was approved for pediatric use.



Details of Forest Laboratories' monetary settlements with aggrieved families have not been made public, but the lawsuits themselves present a glimpse of the alleged harm caused by the company, including hefty payments to pediatricians and other physicians to tout the benefits of the drugs.



In vivid detail, the complaints allege that children under the influence of Celexa and Lexapro committed acts of suicide and violence. And the victims' families accuse the pharmaceutical company of fraud and negligence in failing to warn physicians and the public about the drugs' known dangers.



But the settlements are cloaked in secrecy, with each side vowing not to disclose the dollar amounts paid or other aspects of their agreements.



Frank Murdolo, the chief spokesman for Forest Laboratories, was unavailable for comment.



Harris Pogust, a Pennsylvania attorney who is the plaintiffs' lead counsel in the multidistrict litigation, said, "I can't really discuss anything that's going on between the parties."



The Celexa and Lexapro cases have been consolidated in federal court in St. Louis.



Several years ago, some of Pogust's clients testified before Congress and the Food and Drug Administration about the dangers of marketing the drugs to children.



One of the cases settled Friday involves Andrew Tradd of Massachusetts, who was 13 when he tried to hang himself in April 2004. Seven days later, he died as a result of a brain injury suffered in that attempted suicide. He had been prescribed Celexa in 2002.



According to his family's lawsuit, Forest was aware through numerous studies that some patients taking Celexa and similar drugs were much more at risk of suicidal behavior but chose not to warn physicians or strengthen the warning on the drug's packaging.



Celexa's sales skyrocketed from $92 million in 1999 to $1.6 billion in 2002. But the firm was under pressure to sell as much of Celexa as possible because the U.S. patent on the drug would expire in 2004.



H. Lundbeck, a Danish firm that developed Celexa, had placed a suicide warning on the drug in Europe for many years but not in the United States until a "black box" warning was mandated for Celexa and similar drugs in 2004 by the FDA.



The Tradd lawsuit and another suit quote Howard Solomon, the chairman and chief executive of Forest Laboratories, as saying in a letter to shareholders, "We believe that the studies and experience with our products, Lexapro and Celexa, do not indicate any increased suicidality."



But the Tradd family alleged that "contrary to these claims, for years Forest Laboratories Inc., was aware of clinical trials that showed that some persons who took Celexa suffered damaging side affects including agitation, aggressive and suicidal tendencies."



Another settled case involves Rachel Weiss of Belchertown, Mass., who was 16 in November 2002 when she suffered a panic attack while at school. En route to the school nurse's office, her suit alleges, Rachel threw herself down concrete and metal stairs, causing permanent injuries to her back and spine.



A high school sophomore, she had been taking Celexa for about nine days for depression and anxiety. After she began taking Celexa, the suit alleges, "her symptoms worsened dramatically."



In 2002, a four-year clinical trial by the Danish Lundbeck firm revealed that Celexa did not help depressed adolescents more than a placebo. But the results were not made public until 2004, when they appeared on a single line of a chart contained in a Danish textbook, the suit alleges.



The U.S. attorney's office in Boston has asserted that the results of the Lundbeck trial had been provided to Forest two years earlier, but the company chose to keep the negative results hidden from the public.



Another settled case involved Danielle Henrikson, who was 15 when she hanged herself in the garage of her parents' Idaho home in July 2004. Within a few weeks after taking Celexa, their lawsuit alleges, her condition began to deteriorate.



"The company suppressed the negative results of some studies, which showed that Celexa could cause an increased risk of suicidal thinking and acts in those adolescents who were prescribed to it," the suit alleges.



Forest Laboratories denied the allegation in court documents.



A case settled Friday was on behalf of Alex Kim of Gwinnett County, Ga., who hanged himself in June 2004 when he was 13 after his Lexapro dosage had been doubled. He had been taking the drug for about three months.



In their lawsuit, Alex's parents asked for $10 million in general damages, plus $10 million in punitive damages from Forest for "failing to provide information regarding serious health risks, failing to publicize the risks, failing to timely alert the public, and failing to recall the product."



Even if settlements over Celexa and Lexapro end up costing Forest Laboratories tens of millions of dollars, Wall Street experts don't expect the outlays to significantly impact the company's profit margins.



"I don't think that's really going to affect the stock price," said Annabel Samimy, an analyst at Stifel Nicholas & Co. Inc. "People don't really focus on Lexapro as being the long-term future of the company. Any settlement of wrongful death suits can be absorbed by the company, especially given the $4 billion in cash they're sitting on."

"The simple story is that GSK were running a factory in Puerto Rico - so too was Schering-Plough

just don't expect Bob Fiddam to tell the whole story !



In May 2002, Schering-Plough agreed to pay a record $500m (€390m) fine after signing a decree to improve manufacturing standards at its facilities in Puerto Rico and New Jersey used for the production of its antihistamine Claritin (loratadine).





http://bobfiddaman.blogspot.com/2010/10/puerto-rico-defective-drugs-not-unique.html

Saturday, 30 October 2010

Puerto Rico Defective drugs NOT unique to Glaxo - In May 2002, Schering-Plough agreed to pay a record $500m (€390m) fine

In May 2002, Schering-Plough agreed to pay a record $500m (€390m) fine after signing a decree to improve manufacturing standards at its facilities in Puerto Rico and New Jersey used for the production of its antihistamine Claritin (loratadine).


source

http://www.in-pharmatechnologist.com/Processing-QC/GSK-signs-consent-decree-for-Cidra-plant


GlaxoSmithKline has signed a consent decree with the US Food and Drug Administration to correct manufacturing deficiencies at its Cidra, Puerto Rico facility, but could be in a position to return two drugs made at the plant to market within the next few weeks, reports Phil Taylor.




In March, the FDA and the US Department of Justice seized batches of GSK's diabetes treatment Avandamet (rosiglitazone plus metformin), and its antidepressant, Paxil CR (paroxetine), saying they failed to meet quality standards. The interruption in supply has already cost GSK around €300m in lost sales.



The signing of a consent decree means that a company commits to putting problems right, but also lays it open to the risk of fines and complete closure of the offending plant if matters cannot be rectified. In May 2002, Schering-Plough agreed to pay a record $500m (€390m) fine after signing a decree to improve manufacturing standards at its facilities in Puerto Rico and New Jersey used for the production of its antihistamine Claritin (loratadine).





In this case, the liability for GSK is around $10m a year if it fails to meet the terms of the decree, but analysts said this was lower than some had expected, and crucially did not include any penalties for the perod leading up to the discovery of the problem. A number of managerial staff have been fired in the wake of the probe.





The FDA said after news of the consent decree came out that it was concerned that "GSK's violation of manufacturing standards may have resulted in the production of drug products that could potentially pose risks to consumers."





The decree also requires GSK to post a penal bond of $650m to ensure thatproduct previously withheld by the FDA is appropriately destroyed or reconditioned.





Under the terms of this decree, the company has agreed to take measures to ensure that the Cidra facility fully complies with current Good Manufacturing Practice ( cGMP) requirements and to ensure that ongoing shipments have the quality attributes they are required to possess. The decree also requires that all corrections and the firm's compliance with cGMP requirements be certified by a third-party expert.






"The consent decree shows that FDA is serious about enforcing the manufacturing standards essential for safe and effective prescription drugs," said John Taylor, FDA Associate Commissioner for Regulatory Affairs.





The FDA's last inspection of the Cidra found Paxil CR tablets, approved to treat depression and panic disorder, could split apart. This deficiency could cause patients to receive a portion of the tablets that lacks any active ingredient, or alternatively a portion that contains an active ingredient and does not have the intended controlled-release effect. Additionally, FDA found that some Avandamet tablets did not have an accurate dose of rosiglitazone.





SkyePharma compensated





Meanwhile, UK company SkyePharma, which supplied the drug delivery technology underlying Paxil CR, will be paid a lump sum of around $10m to compensate for the loss of royalty revenues resulting from the withdrawal of the drug.





In addition, SkyePharma will also be entitled to an increase in the royalty rate from 3 to 4 per cent on actual net sales of Paxil CR, with effect from March 4, 2005, in settlement of a dispute between the two companies.

GLAXO VIOLATIONS Cidra Puerto Rico - Cheryl D. Eckard - GSK Puerto Rico - Qui tam

http://f1.grp.yahoofs.com/v1/YLTLTONyftFdAUyhBWiaC1zWJYJmHgVUodPVYqQXU45NQnQZoMOZ8RgYilHDEedy4f_8f2vxnv6pxxoDcHsP/GLAXO%20VIOLATIONS%20Cidra%20Puerto%20Rico.pdf

GLAXO VIOLATIONS Cidra Puerto Rico.pdf


Cheryl D. Eckard - GSK Puerto Rico - Qui tam

Paxil Puerto Rico "split pill" total damages $28million @ max$150 per person

Settlement Proposed in Paxil Class Action Lawsuit


Date Published: Friday, March 27th, 2009

http://www.newsinferno.com/pharmaceuticals/settlement-proposed-in-paxil-class-action-lawsuit/





A settlement has been proposed in the so-called Paxil “split pill” class action lawsuit. According to a press release, if approved, the settlement will provide up to $28 million to claimants and their insurance companies.




Paxil is part of a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Paxil was approved to treat symptoms of depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), panic disorder, generalized anxiety disorder (GAD), social phobia/social anxiety disorder, and premenstrual dysphoric disorder (PMDD). Paxil was the first antidepressant formally approved in the US for the treatment of social anxiety disorder.

The drug has been linked to a variety of problems, including birth defects, as well as suicide and suicidal tendencies when taken by young people and children. Yet in spite of these risks, by 2006 Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions.



The Paxil “spit pill” class action lawsuit alleges that Paxil “controlled release” (CR) tablets made between April 1, 2002 and March 4, 2005, contained a manufacturing defect that caused them to split apart. According to the complaint, Paxil CR tablets are intended to deliver the active ingredient over a period of time, and not all at once. When one splits apart, the outside coat breaks up and the drug is released while the tablets are still in the stomach. Patients end up with all of the active ingredient, without the benefits of the controlled-release, and received the entire dose at once. Or they get only the controlled-release ingredient without the active ingredients, the complaint says.



In March 2005, armed marshals with the Food and Drug Administration The Sandlot release (FDA) raided GlaxoSmithKline plants in Puerto Rico and Tennessee after learning that some pills manufactured there had split apart. The FDA had originally discovered the problem at the Puerto Rico plant in February 2002, and the problem continued despite repeated warnings and inspections, the complaint charges.



If approved, the $28 million settlement will be split between consumers who paid for their Paxil and insurance companies seeking to be reimbursed for their expenditures. The amount each class member recovers will depend on how many defective pills they bought, with a maximum recovery of $150 per person. A final approval hearing will be held on July 10, 2009.



Under the settlement, GlaxoSmithKline denies liability and all of the claims in the lawsuit.

NewsInferno.com disclaimer: This article: Settlement Proposed in Paxil Class Action Lawsuit was posted on Friday, March 27th, 2009 at 8:52 am at NewsInferno.com and is filed under Pharmaceuticals.

Friday, 29 October 2010

The effect of publication on Internet-based solicitation of personal-injury litigants

Abstract


Serious adverse drug events can prompt personal-injury lawsuits. However, the extent to which biomedical publication regarding drug-induced harm can influence the legal process has not been well characterized. Using an advanced Google search strategy, we determined the number of Internet "hits" for websites soliciting plaintiffs for medicolegal action before and after publication of a study that highlighted the risk of dysglycemia among patients taking the antibiotic gatifloxacin. We found that early online release and print publication were associated with an immediate and sustained increase in the number of websites soliciting plaintiffs for legal action.





Figure 1: Average number of medicolegal Internet hits before and after publication of an article in the New England Journal of Medicine about the adverse events associated with gatifloxacin.


From:CMAJ. 2007 November 20; 177(11): 1369–1370.

doi: 10.1503/cmaj.070652.Copyright © 2007 Canadian Medical Association or its licensors

http://www.ncbi.nlm.nih.gov/pubmed/18025428

Antidepressant discontinuation (withdrawal) symptoms were first reported 1959 - 5 years before Fiddaman's birth

Antidepressant discontinuation (withdrawal) symptoms were first reported in association with imipramine (Mann & MacPherson, 1959; Andersen & Kristiansen, 1959), the first tricyclic antidepressant (TCA), shortly after it entered clinical use. These symptoms occur with all classes of antidepressant, including the TCAs, monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin and noradrenaline reuptake inhibitors (SNRIs) and miscellaneous others such as mirtazapine, a noradrenergic and specific serotonergic antidepressant (NaSSA). A PubMed review conducted when preparing this article identified reports of discontinuation symptoms with 25 antidepressants (Box 1Go). In recent years the phenomenon has attracted increasing interest, in both the scientific literature and in the lay media (BBC Panorama, 2002, 2003). This article provides an overview of the clinical features of antidepressant discontinuation symptoms, with the emphasis on their recognition, prevention and management. Discontinuation symptoms can occur whenever antidepressants are used, i.e. they are not dependent on the presence of any underlying psychiatric disorder. The pharmacokinetics and dynamics of antidepressants, in particular their half-life, are important determinants of discontinuation symptoms, as are individual patient characteristics, but their discussion is beyond the scope of this article (Schatzberg et al, 1997; Haddad, 1998; Bogetto et al, 2002).

http://apt.rcpsych.org/cgi/content/full/13/6/447


Can Psychiatr Assoc J. 1959 Jan;4(1):38-47.
Clinical experience with imipramine (G22355) in the treatment of depression.
MANN AM, MACPHERSON AS.



PMID: 13629473 [PubMed - indexed for MEDLINE]





MeSH Terms, SubstancesMeSH Terms:Depression/therapy*Tranquilizing Agents/therapeutic use*Substances:Tranquilizing Agents

LinkOut - more resources

Thursday, 28 October 2010

Antidepressants reported to cause discontinuation symptoms - NOT JUST SEROXAT !

Antidepressants reported to cause discontinuation symptoms


http://apt.rcpsych.org/cgi/content/full/13/6/447

Tricyclic and related compounds





Amineptine



Amitriptyline



Amoxapine



Clomipramine



Desipramine



Doxepin



Imipramine



Nortriptyline



Protriptyline



Trazodone



Monoamine oxidase inhibitors





Isocarboxazid



Moclobemide



Phenelzine



Tranylcypromine



Selective serotonin reuptake inhibitors





Citalopram



Escitalopram



Fluoxetine



Fluvoxamine



Paroxetine



Sertraline



Serotonin and noradrenaline reuptake inhibitors





Duloxetine



Milnacipran



Venlafaxine



Miscellaneous antidepressants





Mirtazapine (noradrenergic and specific serotonergic antidepressant, NaSSA)



Nefazodone



(Based on the authors’ literature review)

Recognising and managing antidepressant discontinuation symptoms

Recognising and managing antidepressant discontinuation symptoms


http://apt.rcpsych.org/cgi/content/full/13/6/447

SSRI withdrawal protocols from APRIL - founded 1998 by Millie Kieve

In 1998, I founded the charity April (Adverse Psychiatric Reactions Information Link), which was also the month of Karen's birthday. I hoped that, by increasing awareness, perhaps the terrible waste of her life could save someone else's.




I now receive a constant flow of emails reporting the same kind of experiences as Karen's. People tell me how helpful they find it that someone understands. One woman who was very depressed, showed her doctor medical information that I had sent her. Only then did he agree to change the medication for her heart problems."I feel 600% better," she told me.



I send out withdrawal protocols to help doctors support their patients during withdrawal from SSRI antidepressants and benzodiazepines, as well as presenting workshops for health professionals to persuade them to report ADRs on Yellow Cards, the side-effect reporting system which, 40 years after its conception, is still not effective. I also contribute evidence to department of health and government inquiries and organise conferences. The next one, Adverse Psychiatric Reactions to Medicines and Anaesthetics, is on November 4.



April is now the main focus of my life and I campaign on all sorts of issues, from demanding that coroners record all drugs prescribed, stopped or doses changed, in the months prior to sudden death, to making sure that medical students understand about ADRs. I can never bring my lovely daughter back but it is a comfort to be able to help others. I believe awareness saves lives and have taken on the task of bringing that awareness to the medical profession and the public.



· www.april.org.uk

http://www.guardian.co.uk/society/2004/aug/17/health.lifeandhealth

Hugh James solicitors Mark Harvey a seroxat patient ? - how very disturbing


The Evidence, However is Clear

http://health.groups.yahoo.com/group/seroxat/


Description


"A group to discuss the side effects, withdrawal symptoms and associated addiction to the anti-depressant Seroxat.

Take a look at the websites in the links section for detailed info on safe withdrawal and tapering, professional contacts, media articles and the latest research. "

CCHR - I want to be a Commissioner for CCHR says Bob Fiddaman - The Evidence is Clear

Am I a Commissioner for CCHR? No, but I sure would like to be. They are at the forefront of raising awareness about this fraudulent industry and if that means someone labelling me a Scientologist then that is a very small price to pay for someone else's ignorance

http://bobfiddaman.blogspot.com/2010/10/fiddaman-is-cchr-shill-read-his-words.html

367 community treatment orders (CTOs) have been made each month - UK

The regulator also noted that there was a sharp rise in the doctors prescribing compulsory treatments for mental health problems. On average, 367 community treatment orders (CTOs) have been made each month. This is at least ten times the number anticipated when the legislation was introduced in 2008.





http://www.blogger.com/goog_194618019





Mental health patients 'locked up in hospitals without legal authority'

Health regulator says blanket measures introduced in the name of patient security may infringe human rights law



•Randeep Ramesh, social affairs editor

•The Guardian, Wednesday 27 October 2010

•Article history

Mental health patients are increasingly being locked up in hospitals without legal authority, a practice which may infringe human rights law, the health regulator said today.



The Care Quality Commission said the proportion of people in low secure beds has increased significantly since 2006. More than a quarter of psychiatric patients are now in held in low secure units (LSUs). Three years ago, the figure was less than a fifth.



Such changes in the pattern of care have rung alarm bells at the commission. It says patients were being subjected to a regime of close observation behind high fences and "airlocks", where patients sometimes faced "unsafe or abusive practices".



The regulator cited cases where the mentally ill were limited to "two to six sheets" of toilet paper and where nurses were unable to administer care because they were busy guarding patients.



One example saw a male nurse assigned "to preserve the dignity" of a highly disturbed female patient who was constantly attempting to remove her clothing. Other female patients in a different unit also complained that male nurses were involved "during night-time observation, bathing and toileting".



The commission said these were "serious concerns for the dignity and safety of vulnerable [people]". "Examples of poor practice being followed in the name of patient security included blanket measures that risked infringing human rights law, and disregard for privacy and dignity that was verging on unsafe or abusive practice," said the report.



There had also been an alarming trend of security measures that banned mobile phones or forbade patients from preparing their own meals. The commission said, in some circumstances, this could "amount to an unwarranted infringement of patients' ECHR article eight rights to a family and private life".



The commission recommends reviewing the national policy of standards in such units. Matt Kinton, the report's author, said there was a "real worry that the more mental health wards look like prisons, the less they function as hospitals where people will get better and be able to live independently".



Kinton said one of the driving forces of this trend towards security was that the private sector had built many new low-security wards. "It is the old adage that if you build a hospital, patients will fit it."



The regulator also noted that there was a sharp rise in the doctors prescribing compulsory treatments for mental health problems. On average, 367 community treatment orders (CTOs) have been made each month. This is at least ten times the number anticipated when the legislation was introduced in 2008.



Patients detained in hospital can be discharged under CTOs and supervised by a doctor who stipulates a strict prescription of medicines and can sometimes restrict patients movements. If a patient refuses, they can be returned to hospital. ends

Wednesday, 27 October 2010

Evelyn Pringle - is this really professional journalism research?

Hi all,




I've decided to do a report on people who have committed crimes while on psych drugs or when they went off them.





Many people have emailed me with their stories and I
would like other people to do the same. I probably
won't get to it until after the Aug DC protest but will soon after that.


I'd appreciate any help you can give me in gathering this information.


Cheers,

Evie

http://groups.google.co.uk/group/parents-against-teenscreen/browse_thread/thread/e3525a2918071f91/318bd42b466489b5?hl=en&q=

Seroxat - Paxil "split pill" max payout $150 per person

Under the settlement, GSK denies liability and all of the claims in the lawsuit. If approved, the $28 million settlement will be split between consumers who paid for their Paxil and insurance companies seeking to be reimbursed for their expenditures. The amount each class member recovers will depend on how many defective pills they bought, with a maximum recovery of $150 per person. For a pill to be "defective" under the settlement, it must have split before it was removed from the container.

Paxil - Seroxat defect Puerto Rico was simply split pills - nobody harmed !

A proposed settlement has been reached in a case alleging a manufacturing defect in certain tablets of Paxil, the popular antidepressant drug manufactured by GlaxoSmithKline (GSK). If approved, the settlement will provide up to $28 million to claimants and their insurance companies.



The suit alleges that Paxil "controlled release" (CR) tablets made between April 1, 2002 and March 4, 2005, contained a manufacturing defect that caused them to split apart. In March 2005, armed marshals with the Food and Drug Administration (FDA) raided GSK plants in Puerto Rico and Tennessee after learning that some pills manufactured there had split apart. Two medications — Paxil and Avandamet, a diabetes medication — were being produced at the facilities. Although the investigation didn’t conclusively show that anyone had been harmed by the pills, the FDA said the burden was on the manufacturer to ensure that the medication was safe.



The FDA had originally discovered the problem at the Puerto Rico plant in February 2002, and the problem continued despite repeated warnings and inspections. GSK was unable to determine what was causing the problem, which concerned the FDA.



Paxil CR is a "controlled-release" version of the antidepressant, meaning that it releases medication slowly and evenly, in an attempt to deliver more consistent effects throughout the day. However, the CR version has not been compared to standard Paxil in lab tests, and some believe that any added benefits are negligible at best.



Split pills make it harder for patients to accurately estimate doses, and can render the "enteric coating," which controls the medication's time and rate of release, inactive. More importantly, the medically effective ingredients tend to remain in only one side of the pill after the split, making the other half comparable to a placebo. Taking a pill containing no medication could cause immediate withdrawal symptoms, as Paxil stays in the bloodstream for a shorter time than most other popular antidepressants.



Under the settlement, GSK denies liability and all of the claims in the lawsuit. If approved, the $28 million settlement will be split between consumers who paid for their Paxil and insurance companies seeking to be reimbursed for their expenditures. The amount each class member recovers will depend on how many defective pills they bought, with a maximum recovery of $150 per person. For a pill to be "defective" under the settlement, it must have split before it was removed from the container.



Potential class members who want to recover should fill out a claim form, available at the settlement Web site. Class members can also choose to exclude themselves from the settlement or object to its terms, but must do so by May 15 and July 1, respectively. A final approval hearing will be held on July 10, 2009. Plaintiffs are represented by the firms Strange & Carpenter and Salas & Co.











Read more: http://www.consumeraffairs.com/news04/2009/03/paxil_settlement02.html#ixzz13adNMbV7

Roger Cleghorn of RC:D London - not exactly a suffering seroxater

Search Results[PDF] 2005 Investor Relations Society Conference Sponsorship Proposal


File Format: PDF/Adobe Acrobat - Quick View

Adrian. Clarke. Financial Times. Charlotte Phillips. Hemscott. Timothy Clegg. UBS. Helen. Pickford. Royal Sun Alliance. Roger. Cleghorn. RC:D London Ltd ...

www.ir-soc.org.uk/files/.../IRS_DL_sponsorship_form_Jan05.PDF - Similar

Fiddaman is CCHR shill - read his words - Am I a Commissioner for CCHR? No, but I sure would like to be

Is the agenda of the CCHR to convert people to a religion or is it to create awareness with regard to the safety of patient care?




Watch this DVD and you will have your answer.



Am I a Commissioner for CCHR? No, but I sure would like to be. They are at the forefront of raising awareness about this fraudulent industry and if that means someone labelling me a Scientologist then that is a very small price to pay for someone else's ignorance.



You can watch the full length documentary' and purchase other feature length documentaries by clicking on the 'Dead Wrong' tab in the player, here.

Monday, 25 October 2010

Mad Pride Welfare Benefits & Services Protest "24 Hour Medication Strike" Caution Warning - October 25th - 26th 2010 - madpride.org.uk

Mad Pride Welfare Benefits & Services Protest "24 Hour Medication Strike" Caution Warning - October 25th - 26th 2010 - madpride.org.uk


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





Reposting the following Caution Warning - anyone considering supporting this protest by joining the "24 hour medication strike" please think very carefully - no psychiatric medications should be stopped abruptly, missing doses is putting you, your health, safety and possibly liberty at risk. Please support the protest, but not this way -



thanks Tues



****

Saturday, 9 October 2010





Mad Pride Welfare Benefits & Services Protest Warning madpride.org.uk



Slightly off topic – but It has come to my attention that MadPride.org.uk are organising a protest at Speaker’s Corner, Hyde Park, London on Tuesday October 26th 2010 at 1 pm –



“A Public Execution and Assorted Horrors"

"A Demonstration against Cuts to Benefits and Services”

Promoted in their press release asincluding the promotion of



“A day of action to appose welfare benefit cuts for people labelled mentally ill”

including the promotion of



“A 24 hour nationwide medication strike!”

Whilst the sentiments of the protest against cuts to welfare benefit for the mentally ill is commendable, this suggested action –



given the nature of both the side effects caused by missed doses and the consequences of rapid withdrawal associated with powerful psychiatric drugs that all, including severely mentally ill patients, will be taking –



is irresponsible and possibly dangerous.



For years a few members of Yahoo group UKSurvivors have made great efforts to raise awareness of the dangers psychiatric drugs pose in relation to side effects, missed doses and withdrawal –



which Mark Roberts the groups owner, madpride.org.uk’s founder member, protest and “24 hour medication strike” promoter - has consciously and deliberately chosen to ignore,



whilst putting in place the following Blog, Forum and Twitter accounts to promote his protest campaign and “The 24 hour medication strike”



http://madpride.org.uk/blogs/madprideblog/



http://madpride.org.uk/forum/index.php



http://twitter.com/madpridemark



Please, by all means support the protest – BUT please, under NO circumstances follow the promoted course of action or encourage others on medication to join “the 24 hour medication strike“ - as it may have dire and possibly tragic consequences.



Tuesday

---

Posted by Tuesday

Evelyn Pringle’s articles removed from OpEd

http://cannonfire.blogspot.com/2008/10/who-is-evelyn-pringle-and-why-is.html


This is the first I heard of this.




I did not write my articles because I was a Hillary supporter. I wrote my articles because my investigation turned up what it did, even though I was absolutely not looking or expecting what I found. As a journalist and as a human being, I could not not write about what I found just because I am a Democrat!!!



I find it very disturbing that Rob would even consider such an outright censorship of truthful information.



Shortly after I wrote my first article, I put out a commentary of sorts saying that if anyone found one factual statement that was false or incorrect to contact me and show me where it was wrong and I would make a correction.



NOT ONE PERSON contacted with a single example of an untrue or false statement in any of the 11 articles I wrote.



I will be outraged if Rob removes those articles and I will make it known! I spent 2 and a half months of my life, unpaid, 12 and 18 hours a day 7 days a week, investigating the matters I wrote about and if he does something like this to me I will never forgive him.



The articles are up in full on Scoop and several other websites so if he pulls this, their removal from OpEd will stick out like a sore thumb on the internet

http://therealbarackobama.wordpress.com/2008/10/13/if-this-is-a-sign-of-things-to-come-were-in-big-trouble/

"Seroxat should not be stopped suddenly" - clear advice from MHRA June 2003

Seroxat should not be stopped suddenly because of the risk of withdrawal reactions.
The dose should be reduced very gradually, using half tablets, and then alternating
days, if necessary. If the dose is not tapered, there is a greater chance of experiencing
side effects. For the majority of people, symptoms go away on their own within 2
weeks. If side effects are intolerable on dose reduction or stopping, the dose should be
increased and subsequently reduced more gradually.
 
 
http://www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con019507.pdf
 
 
source - MESSAGE FROM PROFESSOR G DUFF, CHAIRMAN OF COMMITTEE ON SAFETY OF MEDICINES

10 June 2003

Sunday, 24 October 2010

Seroxat P.I.L. 1995 - under 18 years old DO NOT TAKE - the Evidence is clear

If you answer "YES" to any of the following questions, DO NOT take this medicine. Go back to your doctor and ask what to do:



Are you allergic to paroxetine?

Are you pregnant or may you be pregnant soon?

Are you breast feeding?

Are you under 18?

Do you have kidney o, liver trouble?

Do you have heart trouble?

Do you suffer from epilepsy or mania (overactive and sometimes violent behaviour)?

http://www.itri.brighton.ac.uk/projects/pills/corpus/PIL/data/SmithKline_Beecham/Seroxat/Seroxat.html

Saturday, 23 October 2010

Seroxat patient leaflet 1995 - do NOT take pregnant !

BEFORE YOU TAKE ‘SEROXAT’




If you answer "YES" to any of the following questions, DO NOT take this medicine. Go back to your doctor and ask what to do:



Are you allergic to paroxetine?

Are you pregnant or may you be pregnant soon?

Are you breast feeding?

Are you under 18?

Do you have kidney o, liver trouble?

Do you have heart trouble?

Do you suffer from epilepsy or mania (overactive and sometimes violent behaviour)?

Most people find that 'Seroxat' does not affect their normal daily lives. But, as with many medicines you should take extra care when you ere driving or operating machinery



http://www.itri.brighton.ac.uk/projects/pills/corpus/PIL/data/SmithKline_Beecham/Seroxat/Seroxat.html

Seroxat 1993 note high incidence of withdrawal reports from GP's - source Dr Healy

Seroxat & Withdrawal - 3





From shortly after the licensing of this drug on the UK market, the Medicines Control Agency was flooded with reports of withdrawal problems for Seroxat. In 1993, the Drug Safety Research Unit study of Seroxat noted a high frequency of general practitioner reporting of withdrawal problems – although the DSRU suggested without making clear the basis for this suggestion that this high frequency of withdrawal problems did not indicate dependence.



http://webcache.googleusercontent.com/search?q=cache:YsLW-UngSNAJ:www.socialaudit.org.uk/58092-DH.htm+seroxat+1993&cd=12&hl=en&ct=clnk&gl=uk

extract from

SSRIs & WITHDRAWAL/DEPENDENCE

BRIEFING PAPER: 20-06-2003
DAVID HEALY


http://www.socialaudit.org.uk/58092-DH.htm

Friday, 22 October 2010

Seroxat Seroquel® or Zyprexa® - Dr's protect from predatory lawyers

A Simple Way to Avoid Malpractice Litigation


Jeffrey A. Lieberman, MD



Authors and Disclosures



Posted: 10/21/2010



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http://www.medscape.com/viewarticle/730542





Hello, this is Dr. Jeffrey Lieberman of Columbia University speaking for Medscape. The title of this commentary could be, "Physician, Protect Thyself." Recently, I recorded a Medscape blog in which I commented on being very disappointed to see advertisements by personal injury lawyers, looking for patients who had taken second generation antipsychotic drugs like Seroquel® or Zyprexa®They were seeking clients on whose behalf they could file lawsuits.



On the basis of this, I described how physicians need to be aware of the predatory nature of these legal practices and ensure that there is adequate documentation of the rationale for using these treatments and how to advise patients about the potential risks for the medications they are about to receive.



Recently, I was reading the newspaper and saw the report of a settlement between Novartis and the US Justice Department for improper marketing practices for the use of Trileptal® off-label. This follows in the wake of settlements by other pharmaceutical companies with the US Justice Department and the US Food and Drug Administration (FDA), including Lilly, Pfizer, and Astra Zeneca, for infractions in terms of marketing practices for the use of medications, and non-FDA indicated uses (off-label uses).



This raises another aspect of the vulnerability that physicians have to potential legal actions. I just wanted to amplify that concern and tell people my thoughts on that and hope that it can be useful, in terms of protecting physicians' practices against such consequences. Basically, we treat patients with a variety of therapeutic techniques, including medications. Medications are approved by the FDA for specific indications.



When we use these medications, we use them for their therapeutic effects, but virtually all medications have some side effects. When starting, or adjusting, the dose of medications we need to advise patients of the potential consequences, in terms of, side effects, reiterate the rationale for using the medication, and document this in the medical record so that it's clearly stated.



In addition, it is an essential part of medical practice to be able to use medications for illnesses or conditions other than those that are indicated by FDA approval. This is common practice in all areas of medicine. Indeed, sponsors (pharmaceutical companies) are not going to pursue indications for all of the purposes for which their products can be used.



Physicians, in using medications for non-indicated or off-label purposes, need to have an adequate justification for this, in terms of evidence in the literature that justifies the use, or at the very least, a scientific or medical rationale for the use of the medication. It is important to document this in the medical record, so that if there is a question about the purpose of the medication, or whether there was undue influence by a pharmaceutical company (as opposed to having a rationale, in terms of clinical practice evidence in the literature for efficacy, or a pharmacologic rationale for why the drug would be useful for a given patient), this can be reflected in the medical record.



It's unfortunate that we have to be so vigilant for potential assaults on our clinical practice and we have to practice defensive medicine, but such is the world that we live in, so it behooves us as physicians to protect ourselves by documenting our presentations to patients about the risks and benefits of treatment, and (if we are using the medication for a non-FDA indicated purpose, an off-label use of the medication) the rationale for this use.



This will enable you to think through the steps, in terms of prescribing a treatment, whether it's on-label or off-label, and at the same time, it will also serve as a protective practice, in terms of reducing legal liability. This routine, this set of procedures, can be made habitual and systematized. It's a little like the book by our colleagues, Atul Gwand, who wrote about the "checklist approach" to medicine as a way of reducing medical errors and trying to emulate the way that aeronautical engineers and pilots manage their procedures in a very routine, systematic way with a series of checklists.



Physicians can do the same when prescribing of treatments, and in this way, physicians can both ensure that they are thorough, as well as reduce their legal liability. Those are my comments for today -- this is Dr. Jeffrey Lieberman of Columbia University for Medscape.



[ CLOSE WINDOW ]

[CLOSE WINDOW]Authors and DisclosuresAuthor(s)Jeffrey A. Lieberman, MD Professor and Chairman, Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, NY; Psychiatrist in Chief, New York Presbyterian Hospital, New York, NY



Disclosure: Jeffrey A. Lieberman, MD, has disclosed the following relevant financial relationships:

Served as an advisor or consultant for: AstraZeneca Pharmaceuticals LP; Bioline; Cephalon, Inc.; Eli Lilly and Company; Forest Laboratories, Inc.; GlaxoSmithKline; Intra-Cellular Therapies, Inc.; Janssen PharmaceuticaProducts, L.P. (US); Otsuka Pharmaceutical Co., Ltd.; Pfizer Inc.; Psychogenics; Wyeth Pharmaceuticals Inc.

Received grants for clinical research from: Allon; AstraZeneca Pharmaceuticals LP; Bristol-Myers Squibb Company; Forest Laboratories, Inc.; GlaxoSmithKline; Janssen Pharmaceutica Products, L.P. (US); Merck & Co. Inc; Pfizer Inc; Wyeth Pharmaceuticals Inc.

Served on the DSMB for: Solvay Pharmaceuticals, Inc.

Received patents from: Repligen Corporation

Wednesday, 20 October 2010

Seroxat Joe puts Seroxat ahead of all the other brands just like Seroxat Sarah - venal

Bob Fiddaman said


"I can see no benefit of Seroxat, none whatsoever. The longer it remains on the market will mean countless suffering for people on other SSRi's. Once removed, it will open the doors for other SSRi's to be thoroughly investigated and maybe other bloggers, campaigners, advocates can start banging the drum and asking the regulator about Prozac, Zoloft and other SSRi related drugs."

http://fiddaman.blogspot.com/2009/08/seroxat-in-media.html

Tuesday, 19 October 2010

Another Seroxat Liar M/s Venn "saw Seroxat banned in under 18 year olds"

"Over the years more has become known about Seroxat. In my time on the Seroxat Users Group committee, I saw Seroxat banned in under 18 year olds, GSK issue a warning that 1 in four patients will suffer withdrawal problems, the patient information leaflet double in size and listed side-effects. "

http://news.bbc.co.uk/1/hi/programmes/panorama/3710528.stm



extract from -
Seven years of struggle by Sarah Venn Seroxat user
 Sunday, 3 October, 2004,

Sarah Venn barrister wanted Seroxat personal experiences considered but NOT the other brands!!

The Users Group remains concerned, however, that the MCA has still not agreed to consider the personal experiences of Seroxat users in the review of the drug. Sarah Venn said: “We have offered to provide the MCA with all the information we have gathered about adverse reactions, dependence and withdrawal reactions, but they have not decided how or even if they will include patients’ experiences in the review. That is extremely worrying and we will continue to press them on this important point.”






http://webcache.googleusercontent.com/search?q=cache:YNIwlocOuhQJ:www.seroxatusergroup.org.uk/Documents/jw0328%2520ssri%2520review%2520panel%2520dissolved.doc+goodrelations+seroxatusergroup&cd=10&hl=en&ct=clnk&gl=uk&client=firefox-a

Monday, 18 October 2010

Seroxat counterpoint blog

This counterpoint 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

Is the Seroxat Group Action Litigation Order no: 68 Compromised by its Own Defining Issue?

The UK Seroxat Group Action Litigation, Order No:68, is being brought under the Consumer Protection Act 1987 (CPA)

http://the-uk-seroxat-litigation-chronicles.blogspot.com/2010/10/is-seroxat-group-action-litigation.html




“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.”

In proving a case of a “defective product” the only need is to show the product – in this case GlaxoSmithKline’s (GSK) drug Seroxat (Seroxat UK, Paxil USA) - was not up to consumers’ expectations.However, lead Lawyer Mark Harvey of Hugh James Solicitors, Cardiff has chosen to include a Defining Issue stipulation that any adverse effects and discontinuation, withdrawal difficulties suffered by the Seroxat “user” has to be



“to a greater extent than all other Selective Serotonin Re-uptake Inhibitors (SSRIs)”

HM Courts Service: Seroxat Group Litigation Order no: 68.

The report of the Committee on Safety of Medicines (CSM), Expert Working Group (EWG) on SSRI Antidepressants, published December 2004, found all drugs in the class lacking in safety, efficacy and causing discontinuation problems in up to 80% of consumers.


It’s unclear why the “stipulation” has been included, as The CSM Expert Working Group report on all SSRI Antidepressants effectively proved the Group Action litigants case against GSK by finding their product Seroxat not being as "safe as persons generally are entitled to expect,".

December 2004, Seroxat Group Action Litigation case proved and won -

baring lead lawyer Mark Harvey’s inclusion of the apparently unnecessary and possibly untenable Defining Issue “stipulation”.


To prove the Seroxat Group Action by justifying the included “stipulation” raises the need to examine criteria that differentiate the drugs in the SSRI, SNRI class within the restricted Defining Issue of discontinuation, withdrawal and drug classification.



This depends on the two theories of what causes discontinuation and withdrawal and the issues of selectivity nature, affinity and potency; dose related drug action classification; definition by acronym classification; and external evidence.



All interrelate, and other than the issue of selectivity nature, affinity and potency, focus on two drugs in the class the SSRI paroxetine (Seroxat) and SNRI venlafaxine (Wyeth, Efexor UK, Effexor USA).



The CSM EWG into SSRI Antidepressants used pharmacological characteristics and the 1999 Tatsumi et al study to compare Half-life and the Potency and Affinity of the drugs on the central nervous system neurotransmitters. Finding all drugs have binding affinities to different monoamine transporters, primary effects on different receptors and cause secondary changes in receptor numbers and receptor function at the synapse.



1 - The issue of selectivity nature, affinity and potency is the most complicated – defining whether Seroxat is worse than any other drug in the class by comparing drugs with different intrinsic values that despite their acronym name classification titles i.e. SSRI, SNRI etc - are not “pharmacologically “clean”” or defined in action of selectivity “to the Serotonin system”, all also affecting to varying degrees noradrenalin and dopamine. This aspect is covered in more detail here.





The Tatsumi et al study results are valued using Kd or dissociated constant – as explained on the table the lower the Kd the higher the affinity to the transporter.



Affinity Kd ratings show –

Paroxetine (Seroxat) has the highest affinity to Serotonin at 0.1 - just point 0.2 higher that Sertraline (Pfizer, Lustral UK, Zoloft USA) the second highest at 0.3.



Potency findings published by CSM, EWG are not clear because they have not stated whether they are rating Potency on the Affinity to Serotonin alone or Serotonin (5HT), Noradrenalin (NA) and dopamine (DA).



Potency rating show –

Paroxetine (Seroxat) is the “most potent” with the “lowest selectivity” and Sertraline (Lustral) the “second most potent”.



However, when comparing the Affinity and Potency with other drugs in the class - that all to varying degrees effect 5HT, NA and DA and as Paroxetine (Seroxat) is the least selective and only has a negligible 0.2 higher Affinity to Serotonin than Sertraline (Lustral), total Affinity and Potency Kd values to 5HT, NA and DA could be used to assess this point.



Combined Kd Affinity and Potency values to Serotonin (5HT), Noradrenalin (NA) and Dopamine (DA) show –



Sertraline (Lustral) has the highest combined Affinity and Potency with a Kd 445.3 and the least selective Paroxetine (Seroxat) is second highest with a combined Kd of 530.1.



2 - The two theories of what causes discontinuation and withdrawal is explained by Dr David Healy in the “HALTING SSRIs” document, one theory is the shorter half-life of paroxetine (Seroxat) and venlafaxine (Efexor) makes these drugs more problematic, the second theory is regarding the potency of paroxetine and venlafaxine. This aspect is covered in more detail here.



If according to the first theory - which includes a switch to fluoxetine (Ely Lilly Prozac UK and USA) Half-life 1 to 4 days - the cause of discontinuation and withdrawal is dependant on the shortness of Half-life - venlafaxine (Efexor) has the shortest Half-life of 5 hours - paroxetine (Seroxat) is considerably longer at 20 hours.



The second theory - which includes a switch to citalopram (Lundbeck, Cipramil, Celexa) Kd 1.2 - with regard paroxetine (Seroxat) and venlafaxine (Efexor) being “relatively more potent serotonin reuptake inhibitors” is possibly itself called into question by the findings of the CSM, EWG and Tatsumi et al study as venlafaxine has a Kd value of 152 making it, other than mirtazapine, the least “potent serotonin reuptake inhibitor” of the drugs studied.



This possibly places the whole onus of discontinuation and withdrawal problems inherent with all drugs in the SSRI, SNRI class back on a drugs Half-life as citalopram’s Half-life at 36 hours, is longer than both paroxetine (Seroxat) and venlafaxine (Efexor) – and would possibly benefit some as with the fluoxetine switch.



3 - The dose related drug action classification issue, Wyeth are the only manufacturer of those drugs studied to have specified that their drug works on more than one neurotransmitter, however it is the opinion of Dr David Healy in the “HALTING SSRIs” document and the MHRA that although Venlafaxine is named by the acronym SNRI it’s mode of action is that of an SSRI up to doses of 150 mg, over this it has an additional mode of action to become a serotonin and noradrenalin reuptake inhibitor. This aspect is covered in more detail here



4 - The drug definition by acronym classification title by definition the difference between an SSRI and an SNRI should be dependant on selectivity and potency of action i.e. to serotonin or noradrenalin. In the case of the SSRI, SNRI drug class no drug is “selective” to one monoamine transporter, all drugs effect serotonin and noradrenalin, paroxetine (Seroxat) with Kd of 40 to the noradrenalin transporter has a considerably higher affinity than venlafaxine at a NA of Kd 9400. This aspect is covered in more detail here.



5 - The issue of external evidence, as covered briefly here, is dependant on the MHRA, Yellow Card Scheme adverse drug reports and media coverage that has influenced those reports. The MHRA has received considerably more adverse event reports for paroxetine (Seroxat) than any other drug in the class, however, the December 2004 CSM). EWG Report drew attention to the influence of the media coverage and a number of obviously duplicated reports made with regard paroxetine (Seroxat) and it has been noted that BBC Panorama published and issued it’s own Yellow Cards that were accepted by the MHRA.



I will return to the influence of media coverage, the BBC, Panorama, UK Government officials and departments, the Seroxat User Group.org and Hugh James Solicitors in more depth in future posts - but the media coverage has had a profound influence on this aspect, as the Richard M Martin, Margaret May, and David Gunnell, Department of Social Medicine, University of Bristol study “Did intense adverse media publicity impact on prescribing of paroxetine and the notification of suspected adverse drug reactions? Analysis of routine databases, 2001–2004” shows.







Is the UK Seroxat Group Action Litigation, Order No:68 compromised by Lead Lawyer of Hugh James, Cardiff, Mark Harvey’s included Defining Issue “stipulation”?

1 - Does an Affinity and Potency to serotonin of Kd 0.2 higher than Sertraline (Lustral) make Paroxetine (Seroxat) the worst drug in the class …. or does the highest combined Affinity and Potency Kd to serotonin, noradrenalin and dopamine make Sertraline (Lustral) a worse drug than the least selective Paroxetine (Seroxat)?

2 - If the theory is that discontinuation and withdrawal is caused by the drugs short Half-life …. does SNRI venlafaxine’s (Efexor) half-life of 5 hours make it more difficult to withdraw from than the SSRI Paroxetine’s (Seroxat)?In proving a case of a “defective product” the only need is to show the product – in this case GlaxoSmithKline’s (GSK) drug Seroxat (Seroxat UK, Paxil USA) - was not up to consumers’ expectations.

3 - Is Wyeth’s honest mode of action classification of venlafaxine (Efexor) being an Serotonin Noradrenalin Reuptake Inhibitor (SNRI), although acting as an Selective Serotonin Reuptake Inhibitor (SSRI) in doses up to 150 mg, likely to be disregarded as the SSRI Paroxetine’s (Seroxat) has the highest Affinity and Potency Kd to noradrenalin of any SSRI, SNRI studied?

4 - Can a drugs classification be defined by a catchy marketing tool or will the acronym SNRI be overruled by the scientific facts?

5 – Has the unprecedented media coverage and in particular the BBC’s Panorama issued Yellow Cards damaged the integrity of the MHRA, the system and the case dependant adverse events report evidence?

Seroxat - Paxil NOT habit forming says Paxilprogress founder Darcy Baston

Darcy Baston of Paxilprogress said "I believe that Paxil is not habit forming"


Hereʼs why: for a drug to be labelled habit forming, you have
to demonstrate a drug seeking behavior often at the expense
of rationality, safety, and economic feasibility. This means
you have to be highly desiring of the drug for the sake of
having the drug. This isnʼt quite the case with Paxil.



see



http://www.paxilprogress.org/pdf/Paxil-Withdrawal-Guide-2005.pdf

Sunday, 17 October 2010

Seroxat Spitzer suit - part of industry wide agenda

Kevin Scotcher, an analyst at SG Securities, said the attorney general has a "much bigger agenda". Mr Scotcher said: "The question is, 'are consumers and doctors in possession of sufficient knowledge?' GSK pays for trials and has control over whether they are published or not. These trials are then used to sell a drug. His lawsuit is exploring something that will lead him to address conflicts of interests across the spectrum. The FDA is financed by the drug industry, for instance."




The Spitzer case will be examined to see if it sets a legal precedent - and GSK's decision to publish the trials will spark a debate over whether it, too, raises the ethical bar on publication.

http://webcache.googleusercontent.com/search?q=cache:hAQY4DjCquEJ:www.independent.co.uk/life-style/health-and-families/health-news/gsk-fights-back-in-battle-with-spitzer-over-seroxat-731788.html+GSK+fights+Seroxat+claims&cd=1&hl=en&ct=clnk&gl=uk

extracted from -
 
GSK fights back in battle with Spitzer over Seroxat

http://www.independent.co.uk/life-style/health-and-families/health-news/gsk-fights-back-in-battle-with-spitzer-over-seroxat-731788.html

£50 million pounds was spent on Benzodiazepine legal aid - yet patients got nothing in that SCAM

http://www.publications.parliament.uk/pa/cm199899/cmselect/cmhealth/549/99072723.htm

In 1993-94 the Benzodiazepine Litigation ended owing to the withdrawal of Legal Aid Board funding. Over £50 million pounds was spent on legal aid and by the drug companies. Since this event the number of prescriptions for all Sedative/Hypnotic drugs has increased by several per cent overall, and that for Valium has increased by 15 per cent (1994-97). The prescribing of the new Sedative/Hypnotic drugs Zolpidem and Zopiclone, which act on the Benzodiazepine receptors has risen dramatically and is now about two million per year. It is very significant that the number of adverse reactions (No/yr/106 pres.) reported for these drugs is very much greater (x100) than for any of the Benzodiazepines. This coincides with many reports to support groups of dependency on these drugs. It appears that the lessons of history have not been learnt and there is an additional dependency epidemic in the making.

Mark Harvey's group calimed 10,000 yet served 314 Seroxat writs - who keeps the public funded legal aid?




http://209.85.229.132/search?q=cache:HVY-Qp_p-YAJ:www.fiercepharma.com/story/uk-patients-sue-paxil-withdrawal/2008-01-09+harvey+seroxat&cd=14&hl=en&ct=clnk


. It was the first antidepressant to be slapped with a suicide-risk warning. It's drawn fire--and lawsuits--from U.S. patients who say they went into withdrawal when trying to quit treatment. Now, a group of UK patients are suing GlaxoSmithKline for the same withdrawal problems, seeking up to $98,000 per patient, or $31 million-plus with the 314 patients participating so far. Of course, it's not simply the monetary damages that could hurt, but the attendant publicity, which might turn off potential patients

Hugh James dropped 97% clients who should contact SRA Fraud and Confidential Intelligence Bureau

Fraud and Confidential Intelligence Bureau is dedicated to gathering information and intelligence, operating in accordance with the National Intelligence Model.


http://www.sra.org.uk/solicitors/scams/fraud-dishonesty.page

BBC Panorama / Shelley Jofre KNOWINGLY put lives at risk to support Hugh James Seroxat only litigation









2.30 in Jofre says - ” read a little bit in news paper about patients complaints” year 2000 about ” Seroxat difficult to withdraw from” .. Jofre found it intriguing Jofre had only just started working on Panorama at that stage




3.30 in ” Jofre calls SSRI’s “SELECTIVE Serotonin Reuptake Inhibitors”



4.14 Jofre knew little of how the pharmcutical industry worked



4 .30 in Ed says - lets look at antidepressant story



4 45 Jofre says although problems with whole class of antidepressants we (bbc) decided to concentrate on Seroxat Why we narrowed down on Seroxat 1 because it was made by GSK 2 all the drugs in class cause suicidal thinking on dose change 3 Seroxat had a unique problem of withdrawal BECAUSE IT WAS LONGER ACTING … we decided to focus research into this drug



6.00 in - 40 min Panorama film took Shelley Jofre 8 months to make



6.10 in - It’s not something you do lightly WE WERE TAKING ON the worlds second largest drug company



7.30 We were talking to the lawyer the whole way through production



9.30 in - Jofre says “we took a punt” on Dr David Healy

Seroxat withdrawal freefall - how did they get off - expose legalaid fraud - all SSRI/SNRI not just Seroxat

www.ahrp.org/COI/PaxilDeclineUK.pdf -

Chart 5 demonstrates the immense value to Society of free and independent Public Service

Broadcasting and Internet communication. This combination has triggered the growth of
awareness of SSRI danger. It has united the many thousands of victims of SSRIs across the
world with some professionals who have laboured so long in a cause for saving lives, seeking justice and exposing dysfunctional drug regulation. Chart 5 shows that the tide has turned in the UK. Great encouragement should be taken from this life saving victory. However efforts must continue both to expose the known risks of paroxetine (Seroxat, Paxil) and all the other ill validated SSRIs and to call for the establishment an effective independent Drug Safety Regulator in every country, the absence of which is the root cause of this ongoing officially supported tragedy.

Graham Aldred 17 May 2004