UK Seroxat Litigation Lead Lawyer Mark Harvey of Hugh James Solicitors, Cardiff, used the threat of “judicial review” and complaints made by the Seroxat User Groups (SUG) to facilitate unseating members of a Committee on Safety of Medicines (CSM) expert group investigating the safety and efficacy of the SSRI, SNRI drug class. As shown by the following quote from the CSM new Expert Working Group (EWG) report On the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants published December 2004 -
the remit of the CSM and expert group did not change – sidestepping the problem without further delay to allow what they considered “important” work on the SSRI, SNRI issues started in 1998 to continue.
The new Expert Working Group was formed due to complaints raised against two members of the original expert group by the SUG groups, whose influence is evident in the CSM EWG final report published December 2004 - but not exclusively in the above statement.
The “Membership of the Expert Working Group on the safety of SSRIs“ (section 1.5 of the report copied below) details not only the members of the group, but all who participated including experts “Visiting” for the meeting of June 4th 2003, “Invited experts who presented evidence to the EWG” and “Patients, relatives and their representatives who gave evidence to the EWG”.
Although as it’s name implies, the investigation of the “CSM EWG on the safety of SSRI Antidepressants” encompassed all drugs in the SSRI, SNRI class, it appears that representation from the prescribed population or their representatives was restricted to members of SUG groups and those involved due to a direct link to the drug Seroxat.
With regard ADRs, side effects, discontinuation problems, aggressive and suicidal behaviour suffered by patients who had or were taking SSRI, SNRI drugs other than Seroxat - there was no personally delivered advocacy or representation by or on their behalf - despite Mark Harvey, the Invited expert witnesses and the CSM having previously liaised with established UK action groups concerned with prescription drug adverse reactions and addiction who were collating information and patient experiences caused by various SSRI, SNRIs from the 1990s.
There are a great number of prescription drug support groups, many dedicated to SSRIs, most Internet and American based, started by individuals in the 1990’s when the drug class ADR problems became apparent and litigation's against manufacturers were instigated, firstly in the USA and then the UK. In this realm the “Seroxat User Groups” are relatively new as they were not formed until 2002, after the Seroxat Litigation had been preannounced by Hugh James’ Mark Harvey in December 2001 on behalf of 30 to 40 who came forward following news of a USA legal case filed on August 24th 2001.
When the threat of “Judicial Review” was used against the original expert group in late 2002 the Seroxat User Group.org reported to represent “4,000” people, at the SUG MIND MHRA demonstration in May 2003 they reported representing “5,500” and at the meeting with “The European Agency for the Evaluation of Medicinal Products” (EMEA) held April 2004 they reported representing over “10,000” people – yet late last year there was an announced that the number of people being represented at court in 2011 is only about 350.
“Online Seroxat Support Group” (OSSG)
The original and first UK Yahoo Group then called the “Seroxat-SeroxatUserGroup” (SUG) set up in April 2002 and owned by Anti-Seroxat and Glaxo Smith Kline (GSK) campaigner Derek Scott, a ‘supposed’ support group and additional SUG discussion forum, later abandoned and replaced with another Seroxat OSSG website.
Derek Scott actively encouraged group members to join the Seroxat litigation, supplying Solicitors contact details in “Welcome to group” letter, whilst he also actively discouraged and disallowed drug related -unless adverse and Seroxat orientated- information or withdrawal advice and help being posted, kept the group locked down for members only (non Seroxat prescribed members not tolerated) and banned members for inter group posting.
In about 2004 Derek Scott wiped the groups early post archives, renamed the group OSSG and in 2006 culled and banned most of his members without notice, the group has had little traffic since. It is believed Derek Scott moved to the blogs in 2006, along with several of his most ferociously outspoken activist group members, all Anti-Seroxat and GSK campaigners, including litigant Bob Fiddaman, fiddaman.blogspot.com under the title “SEROXAT SUFFERERS” who was a SUG group moderator and claims to be a self appointed “patient advocate” - Roger Cleghorn, seroxatsecrets.wordpress.com - Mathew Holford, itsquiteanexperience.blogspot.com.
The correspondence lobbying Derek Scott and this select activist group have subjected members of the UK government and government drug regulatory authorities to - has been at times relentless, engineered to monopolise the officials and authorities time, rude, often derogatory and ongoing until 2009, and appears to have alienated many of those in authority who were at least willing to listen - quite possibly to the detriment of all efforts by others to get the SSRI, SNRI issue and other drug problems addressed.
Sarah Venn was a member of this SUG group before becoming involved with the Lawyer set up SeroxatUserGroup.org (SUG.org) of which she was made a Committee Member and started up the second and successive SUG support forum and groups. Derek Scott was involved with the 2002 lawyer led formation of SUG.org but did not take up his offered seat on the committee.
“SeroxatUserGroup.org” (SUG.org) and “Seroxat User Group” (SUG)
Owned by Sarah Venn (Barrister), whose father Ernest Venn had alerted her to a problem with Seroxat in 2000, although run by Janice Simmons and Andrew Issac (then Medical Student) since 2004. Set up in June 2002 by Mark Harvey of Hugh James Solicitors, for the Seroxat Group Litigation litigants. According to Issue 1 of the “Seroxat User Group Newsletter” published September 2002 on Hugh James headed paper, Mark Harvey, presumably on Hugh James’ behalf, undertook to continue with IT support, newsletter production and, again presumably, funding for the SUG.org website which is still running.
In the SUG newsletter Issue 1 Mark Harvey states strategy’s for future action by himself and those involved with the Litigation and all SUG Groups including in the case of changes not being made to the patient information and data sheet.
Directing all group members to take the following action
Along with the dictate that
Mark Harvey, Hugh James and their Media and Public Relations Company "Good Relations" were actively generating publicity in their own right, also promoting and in total control of both SUG group members who were in contact with the press and what they said. The SUG.org committee reiterated the need to keep all communications centralised, professional and through them in the March 2003 Seroxat User Group Newsletter issue 2,
both SUG support groups owners, Derek Scott and Sarah Venn, openly encouraged group members to go to their local press, any approaches by the mainstream press and media for people to be interviewed were published on the SUG groups message boards and all resulting contact channelled through them or the SUG.org committee back to Hugh James Solicitors and “GoodRelations”.
In the March 2003 SUG Newsletter issue 2 the SUG.org committee congratulated themselves and SUG members for their successful achievements in the “MP letter campaign” and the resulting “intense review of Seroxat”,
which is a little confusing and misleading - as the only “Review” being lead by Angus Mackay whom they were in communication with along with the MCA and CSM – was the original and ongoing 1998 expert group investigation instigated, which following Mark Harvey’s 2002 threat of “Judicial Review” and SUG complaints - became the newly formed “CSM EWG into the safety of SSRI Antidepressants” – who planned to meet May 2003.
Other than numerous articles in papers and magazines, two of the candidates for the SUG.org committee Paula Boddington (Research Associate, HeLEX , Senior Researcher in Ethics and Genetics, Ethox, Oxford University) and Sarah Venn took part in TV programs.
Paula Boddington appeared along side Dr David Healy and Mark Harvey in the first program about the SSRI, SNRI drug class, BBC Wales’ “Week In Week Out” program “Mind Games” which aired May 28th 2002. Paula Boddington’s manifesto submission for a place on the SUG.org Committee was not successful and she subsequently disappeared from active campaigning.
The BBC’s Panorama aired the first Seroxat program “The secrets of seroxat”, October 13th 2002, under the helm of their newest reporter Shelley Jofre – who self reported liaising where the production took place in London, with UK Lawyers throughout the eight months of production. The airing was preceded by a BBC Panorama article “Anti-depressant can be addictive”, announcing the forthcoming program, detailing the worse discontinuation withdrawal ADR symptoms, the American Attorney’s involved with the Tobin v SKB (GSK) Schell case including the amount of compensation awarded, although the amount actually paid at appeal has not been disclosed.
BBC Panorama’s “The secrets of seroxat” program and announcement was strangely void of any mention of the UK based Lawyers, the 2001 preannounced UK Seroxat litigation, SUG.org, SUG groups, Charles Medawar’s Social Audit or the mental health charity MIND - although following the programs airing viewers who contacted the program were given their details and asked to fill out ADR reports by way of a “special version of the Yellow Card designed for Panorama by MIND” - as reported in the SUG.org March 2003 Newsletter Issue 2,
these exceptional Yellow Cards formed an integral and “substantial” part of the SUG.org and SUG groups representatives evidence presented to the CSM EWG. According to SUG Newsletter Issue 1 Hugh James Solicitors’ Mark Harvey had, in mid 2002, “invited” the MCA to take SUG and 800 clients evidence of dependency / withdrawal as “official reports” (without medical accreditation), at this , at this time he also highlighted the possibility of “Judicial Review” if it continued to decline.
The MCA / MHRA did eventually accept the SUG evidence along with the Panorama generated Yellow Card reports and included all in the MHRA Pharmacovigilance Services Yellow Card Data and Drug Analysis Prints (DAPs).
Sarah Venn appeared on day time TV interviewed with GSKs Dr Alistair Benbow and was featured in the BBC Panorama’s third Seroxat program “Taken on trust” with Dr David Healy, Charles Medawar, Richard Brook of MIND and Graham Aldred, the program aired October 3rd 2004 shortly before the CSM EWG report was published. Although Sarah Venn became one of the four SUG.org Committee members, she resigned to resume her legal career in late 2003.
The SUG Newsletter Issue 1 detailed formation of a committee to run the organisation and associated meta-linked Internet “support” group and contained the “manifesto’s” of nine prospective members, from which four members were chosen and instated - although there appears to have been no formal election. After the initial two meetings and publication of SUG.org Newsletters Issue 1 and Issue 2 in March 2003, there also appears to have been no further formal committee activity, annual general meetings, minutes or donation / funds bank account published, and Charity status although announced has not been acquired from the Charity Commissioners.
The Seroxat User Group.org validity was called into question by Lord Hunt who, after meeting SUG representative Janice Simmons who was seeking funding, June 18th 2007, reported in Hansard that “he would look into it, but there must be some sort of formal structure to the Seroxat User Group in order to qualify for funding”. It appears no funds were received by the SUG.org group, presumable it would be safe to assume the SUG group had no “formal structure” or legitimacy.
Janice Simmons and her husband John also attended meetings with –
April 19th 2004, EMEA, a decentralised body of the European Union, also attended by John Janyga (SUG), Derek Scott (OSSG), Faye & Peter Elliott (OSSG) and Millie Kieve (APRIL.org.uk), experts Dr Andrew Herxheimer (Emeritus Fellow at the UK Cochrane Centre in Oxford) and Richard Brook (MIND)
March 2nd 2006, Jane Kennedy MP the Public Health Minister, Charles Walker MP and as reported unnamed SUG colleagues
November 29th 2007 - her MP Jonathan Djanogly and the then Prime Minister Gordon Brown
Earlier SUG Campaign activities included a May 2003 demonstration with members of mental health charity MIND at the MHRA London offices. When their chairperson Sarah Venn reported representing “5,500” SUG members, also that the intention was to “put pressure on the agency” to disallow new Seroxat prescriptions until after the “review” involving their evidence of peoples experiences with drug finished and unsubstantiated opinion “that there have been more than 30 suicides within days of people starting to take Seroxat”.
The SUG.org website was set up meta-linked to the Hugh James website. To gain access to the SUG.org website, make enquiries, ask for advice, information or to access the SUG Discussion Forum and two further Yahoo SUG (SUG) support Groups for support - all enquirers were redirected to the Hugh James website; once there a registration form asking for personal details including full name, address, telephone numbers and medical questionnaire was required to be filled out and submitted prior to gaining access to the SUG groups website. Presumably all who registered will have been logged and counted as members.
Meta-linked - “Seroxat User Groups”
The SeroxatUserGroup (SUG) Discussion Forum and two further Yahoo SUG support Groups were all set up in succession by Sarah Venn, and run independently of, but in competition for the highest membership numbers with Derek Scott’s original SUG Group, although posting drug related information was not restricted, inter group posting was frowned on.
Due to the obvious link to the Lawyers website, pertinent questions were asked of the Committee members with regard group members not being given important and relevant information. Especially as to how any successful claim and payout would affect the many dependant on state benefits because of health problems – most in the wake of the Tobin v SKB (GSK) Schell case seemed to have been given the false impression that more realistic but still substantial life changing compensation sums would be paid.
In all probability, in the UK for the “no fault liability to GSK” on a “defective product” claim any payouts for a “withdrawal” problem will not be life changing amounts, those dependant on benefits would possibly find their benefits stopped completely leaving them in a worse situation. The government also have in place a “Compensation Recovery Unit” (CRU) a supplementary agency of the Department of Social Security, whereby any benefits paid to claimants on the grounds of the drug caused incapacity - can be clawed back from the any lump sum compensation paid to individuals in receipt of benefits.
Despite these questions being asked of the committee, along with requests that direction or advice be sought from Mark Harvey and Hugh James on the members’ behalf - no answers, directions or advice was forthcoming at the time or to current knowledge - since. The only action taken was that Sarah Venn, the group owner and SUG.org committee member, closed the original meta-linked SUG Discussion Forum without notice to the members, moved it to Yahoo Groups, when the same type of questions were asked this group was also closed, a third group was set up but was closed after the post archives were deleted, 2003/4.
Mr Graham Aldred
The only person from the “Patients, relatives and their representatives” contingency independent of the SUG Groups to give evidence to the CSM EWG was Graham Aldred, a colleague of Dr David Healy, his personal link and interest in Seroxat is through his late wife Rhona who sadly took her own life in 2001, eleven days after starting treatment with the drug.
Graham Aldred, a research associate at North Wales Department of Psychological Medicine, Hergest Unit, Ysbyty Gwynedd, Bangor, North Wales carried out a statistical research study on the prescribing trends of Seroxat resulting in the paper “The Decline of use of Paroxetine in England” being published May 17th 2004.
The study concentrated on the suicide issue, above all else clarifying that the problem affected all age groups not just under-18’s and shows a gradual decline in Seroxat total prescription numbers 2001 to 2002, this gradual decline as a result of adverse publicity given to the drug went into a virtual freefall 2002 to 2003, resulting in a 36% decline for the period 2001 to 2003 and highlights the relevant publicised events which obviously influenced the decline through public and prescribing medical professional awareness being raised.
“On 21 November 2002, a group of CSM and external experts was called together to hear Dr (now Professor) David Healy present his research in relation to suicidal behaviour, including a reanalysis of human volunteer studies on fluoxetine
The conclusions of this meeting were that:
• the evidence presented did not justify a change to the regulatory position;
The meeting recommended the following further work to investigate suicidal behaviour:
A further meeting of this expert group had been planned for March 2003. However, the Seroxat User Group, a group of 4,000 patients and former patients, called into question the independence of the members of the group in view of declarations of interest in the pharmaceutical industry by two members. Following legal advice, the meeting in March was cancelled and the group dissolved. It was important that this work was continued, and in May 2003 the CSM established its Expert Working Group on the Safety of SSRIs.”
the remit of the CSM and expert group did not change – sidestepping the problem without further delay to allow what they considered “important” work on the SSRI, SNRI issues started in 1998 to continue.
The new Expert Working Group was formed due to complaints raised against two members of the original expert group by the SUG groups, whose influence is evident in the CSM EWG final report published December 2004 - but not exclusively in the above statement.
The “Membership of the Expert Working Group on the safety of SSRIs“ (section 1.5 of the report copied below) details not only the members of the group, but all who participated including experts “Visiting” for the meeting of June 4th 2003, “Invited experts who presented evidence to the EWG” and “Patients, relatives and their representatives who gave evidence to the EWG”.
Although as it’s name implies, the investigation of the “CSM EWG on the safety of SSRI Antidepressants” encompassed all drugs in the SSRI, SNRI class, it appears that representation from the prescribed population or their representatives was restricted to members of SUG groups and those involved due to a direct link to the drug Seroxat.
“Patients, relatives and their representatives who gave evidence to the EWG
With regard ADRs, side effects, discontinuation problems, aggressive and suicidal behaviour suffered by patients who had or were taking SSRI, SNRI drugs other than Seroxat - there was no personally delivered advocacy or representation by or on their behalf - despite Mark Harvey, the Invited expert witnesses and the CSM having previously liaised with established UK action groups concerned with prescription drug adverse reactions and addiction who were collating information and patient experiences caused by various SSRI, SNRIs from the 1990s.
There are a great number of prescription drug support groups, many dedicated to SSRIs, most Internet and American based, started by individuals in the 1990’s when the drug class ADR problems became apparent and litigation's against manufacturers were instigated, firstly in the USA and then the UK. In this realm the “Seroxat User Groups” are relatively new as they were not formed until 2002, after the Seroxat Litigation had been preannounced by Hugh James’ Mark Harvey in December 2001 on behalf of 30 to 40 who came forward following news of a USA legal case filed on August 24th 2001.
When the threat of “Judicial Review” was used against the original expert group in late 2002 the Seroxat User Group.org reported to represent “4,000” people, at the SUG MIND MHRA demonstration in May 2003 they reported representing “5,500” and at the meeting with “The European Agency for the Evaluation of Medicinal Products” (EMEA) held April 2004 they reported representing over “10,000” people – yet late last year there was an announced that the number of people being represented at court in 2011 is only about 350.
- - - - -
“Online Seroxat Support Group” (OSSG)
The original and first UK Yahoo Group then called the “Seroxat-SeroxatUserGroup” (SUG) set up in April 2002 and owned by Anti-Seroxat and Glaxo Smith Kline (GSK) campaigner Derek Scott, a ‘supposed’ support group and additional SUG discussion forum, later abandoned and replaced with another Seroxat OSSG website.
Derek Scott actively encouraged group members to join the Seroxat litigation, supplying Solicitors contact details in “Welcome to group” letter, whilst he also actively discouraged and disallowed drug related -unless adverse and Seroxat orientated- information or withdrawal advice and help being posted, kept the group locked down for members only (non Seroxat prescribed members not tolerated) and banned members for inter group posting.
In about 2004 Derek Scott wiped the groups early post archives, renamed the group OSSG and in 2006 culled and banned most of his members without notice, the group has had little traffic since. It is believed Derek Scott moved to the blogs in 2006, along with several of his most ferociously outspoken activist group members, all Anti-Seroxat and GSK campaigners, including litigant Bob Fiddaman, fiddaman.blogspot.com under the title “SEROXAT SUFFERERS” who was a SUG group moderator and claims to be a self appointed “patient advocate” - Roger Cleghorn, seroxatsecrets.wordpress.com - Mathew Holford, itsquiteanexperience.blogspot.com.
The correspondence lobbying Derek Scott and this select activist group have subjected members of the UK government and government drug regulatory authorities to - has been at times relentless, engineered to monopolise the officials and authorities time, rude, often derogatory and ongoing until 2009, and appears to have alienated many of those in authority who were at least willing to listen - quite possibly to the detriment of all efforts by others to get the SSRI, SNRI issue and other drug problems addressed.
Sarah Venn was a member of this SUG group before becoming involved with the Lawyer set up SeroxatUserGroup.org (SUG.org) of which she was made a Committee Member and started up the second and successive SUG support forum and groups. Derek Scott was involved with the 2002 lawyer led formation of SUG.org but did not take up his offered seat on the committee.
- - - - -
“SeroxatUserGroup.org” (SUG.org) and “Seroxat User Group” (SUG)
Owned by Sarah Venn (Barrister), whose father Ernest Venn had alerted her to a problem with Seroxat in 2000, although run by Janice Simmons and Andrew Issac (then Medical Student) since 2004. Set up in June 2002 by Mark Harvey of Hugh James Solicitors, for the Seroxat Group Litigation litigants. According to Issue 1 of the “Seroxat User Group Newsletter” published September 2002 on Hugh James headed paper, Mark Harvey, presumably on Hugh James’ behalf, undertook to continue with IT support, newsletter production and, again presumably, funding for the SUG.org website which is still running.
“Hugh James will prime the Group and continue to support it, for instance with IT support and production of the newsletter.”
In the SUG newsletter Issue 1 Mark Harvey states strategy’s for future action by himself and those involved with the Litigation and all SUG Groups including in the case of changes not being made to the patient information and data sheet.
“the possibility of Judicial Review of the Medicines Control Agency if it continues to decline to act in response to the substantial evidence of dependency.”
Directing all group members to take the following action
“At the first meeting of the Group it was decided that all members should write to their local MP's along the lines of the letter attached at the end of this newsletter (It need not be copied exactly). The MP has an obligation to respond to the letter within 14 days and should be directing their constituents' concerns to the Department of Social Security and then the Medicines Control Agency (MCA).
Those Group members who have not written are encouraged to do so. Hugh James has written to the MCA inviting it to take the evidence offered by its clients of the withdrawal problem. To date the MCA has only ever accepted Adverse Drug Reaction reports from doctors.”
Along with the dictate that
“Mark Harvey of Hugh James continues to invoke media interest wherever possible to generate public pressure on GSK and the government. If any Group members have any links with any media would they please let Mark know through his secretary, Marlene.
It would be helpful however to ensure consistency of approach and efficiency of useage if interviews could be channelled through Hugh James, who can offer the use of a Public Relations company to manage the media effectively and with as little intrusion to members as possible.”
Mark Harvey, Hugh James and their Media and Public Relations Company "Good Relations" were actively generating publicity in their own right, also promoting and in total control of both SUG group members who were in contact with the press and what they said. The SUG.org committee reiterated the need to keep all communications centralised, professional and through them in the March 2003 Seroxat User Group Newsletter issue 2,
"It is in the interests of the Group that communication with the media, Seroxat experts and related organisations is channelled through the committee. Please forward your views to a member of the committee and help us maintain a uniform and professional approach.”
both SUG support groups owners, Derek Scott and Sarah Venn, openly encouraged group members to go to their local press, any approaches by the mainstream press and media for people to be interviewed were published on the SUG groups message boards and all resulting contact channelled through them or the SUG.org committee back to Hugh James Solicitors and “GoodRelations”.
In the March 2003 SUG Newsletter issue 2 the SUG.org committee congratulated themselves and SUG members for their successful achievements in the “MP letter campaign” and the resulting “intense review of Seroxat”,
“The Group’s first achievement is an intense review of Seroxat by the government, which follows the MP letter campaign. The review was prompted by a well supported Motion in the House of Commons (thanks to your letters) calling on the Department of Health to look into the labelling and availability of Seroxat. The committee is in communication with the MCA, CSM and Professor Mackay, who is leading the Review, and will be meeting with them shortly.”
which is a little confusing and misleading - as the only “Review” being lead by Angus Mackay whom they were in communication with along with the MCA and CSM – was the original and ongoing 1998 expert group investigation instigated, which following Mark Harvey’s 2002 threat of “Judicial Review” and SUG complaints - became the newly formed “CSM EWG into the safety of SSRI Antidepressants” – who planned to meet May 2003.
Other than numerous articles in papers and magazines, two of the candidates for the SUG.org committee Paula Boddington (Research Associate, HeLEX , Senior Researcher in Ethics and Genetics, Ethox, Oxford University) and Sarah Venn took part in TV programs.
Paula Boddington appeared along side Dr David Healy and Mark Harvey in the first program about the SSRI, SNRI drug class, BBC Wales’ “Week In Week Out” program “Mind Games” which aired May 28th 2002. Paula Boddington’s manifesto submission for a place on the SUG.org Committee was not successful and she subsequently disappeared from active campaigning.
The BBC’s Panorama aired the first Seroxat program “The secrets of seroxat”, October 13th 2002, under the helm of their newest reporter Shelley Jofre – who self reported liaising where the production took place in London, with UK Lawyers throughout the eight months of production. The airing was preceded by a BBC Panorama article “Anti-depressant can be addictive”, announcing the forthcoming program, detailing the worse discontinuation withdrawal ADR symptoms, the American Attorney’s involved with the Tobin v SKB (GSK) Schell case including the amount of compensation awarded, although the amount actually paid at appeal has not been disclosed.
BBC Panorama’s “The secrets of seroxat” program and announcement was strangely void of any mention of the UK based Lawyers, the 2001 preannounced UK Seroxat litigation, SUG.org, SUG groups, Charles Medawar’s Social Audit or the mental health charity MIND - although following the programs airing viewers who contacted the program were given their details and asked to fill out ADR reports by way of a “special version of the Yellow Card designed for Panorama by MIND” - as reported in the SUG.org March 2003 Newsletter Issue 2,
“BBC Panorama is planning to broadcast a follow up to the ‘Secrets of Seroxat’ documentary in May. Many of you who contacted the programme will have been asked by the producer to fill in a special version of the Yellow Card designed for Panorama by MIND. The Yellow Card system is used by GPs to report drug safety issues to the Medicine’s Control Agency. If your GP has not already filled in a Yellow Card about Seroxat, please ask them to do so.”
these exceptional Yellow Cards formed an integral and “substantial” part of the SUG.org and SUG groups representatives evidence presented to the CSM EWG. According to SUG Newsletter Issue 1 Hugh James Solicitors’ Mark Harvey had, in mid 2002, “invited” the MCA to take SUG and 800 clients evidence of dependency / withdrawal as “official reports” (without medical accreditation), at this , at this time he also highlighted the possibility of “Judicial Review” if it continued to decline.
The MCA / MHRA did eventually accept the SUG evidence along with the Panorama generated Yellow Card reports and included all in the MHRA Pharmacovigilance Services Yellow Card Data and Drug Analysis Prints (DAPs).
Sarah Venn appeared on day time TV interviewed with GSKs Dr Alistair Benbow and was featured in the BBC Panorama’s third Seroxat program “Taken on trust” with Dr David Healy, Charles Medawar, Richard Brook of MIND and Graham Aldred, the program aired October 3rd 2004 shortly before the CSM EWG report was published. Although Sarah Venn became one of the four SUG.org Committee members, she resigned to resume her legal career in late 2003.
The SUG Newsletter Issue 1 detailed formation of a committee to run the organisation and associated meta-linked Internet “support” group and contained the “manifesto’s” of nine prospective members, from which four members were chosen and instated - although there appears to have been no formal election. After the initial two meetings and publication of SUG.org Newsletters Issue 1 and Issue 2 in March 2003, there also appears to have been no further formal committee activity, annual general meetings, minutes or donation / funds bank account published, and Charity status although announced has not been acquired from the Charity Commissioners.
The Seroxat User Group.org validity was called into question by Lord Hunt who, after meeting SUG representative Janice Simmons who was seeking funding, June 18th 2007, reported in Hansard that “he would look into it, but there must be some sort of formal structure to the Seroxat User Group in order to qualify for funding”. It appears no funds were received by the SUG.org group, presumable it would be safe to assume the SUG group had no “formal structure” or legitimacy.
Janice Simmons and her husband John also attended meetings with –
April 19th 2004, EMEA, a decentralised body of the European Union, also attended by John Janyga (SUG), Derek Scott (OSSG), Faye & Peter Elliott (OSSG) and Millie Kieve (APRIL.org.uk), experts Dr Andrew Herxheimer (Emeritus Fellow at the UK Cochrane Centre in Oxford) and Richard Brook (MIND)
March 2nd 2006, Jane Kennedy MP the Public Health Minister, Charles Walker MP and as reported unnamed SUG colleagues
November 29th 2007 - her MP Jonathan Djanogly and the then Prime Minister Gordon Brown
Earlier SUG Campaign activities included a May 2003 demonstration with members of mental health charity MIND at the MHRA London offices. When their chairperson Sarah Venn reported representing “5,500” SUG members, also that the intention was to “put pressure on the agency” to disallow new Seroxat prescriptions until after the “review” involving their evidence of peoples experiences with drug finished and unsubstantiated opinion “that there have been more than 30 suicides within days of people starting to take Seroxat”.
The SUG.org website was set up meta-linked to the Hugh James website. To gain access to the SUG.org website, make enquiries, ask for advice, information or to access the SUG Discussion Forum and two further Yahoo SUG (SUG) support Groups for support - all enquirers were redirected to the Hugh James website; once there a registration form asking for personal details including full name, address, telephone numbers and medical questionnaire was required to be filled out and submitted prior to gaining access to the SUG groups website. Presumably all who registered will have been logged and counted as members.
- - - - -
Meta-linked - “Seroxat User Groups”
The SeroxatUserGroup (SUG) Discussion Forum and two further Yahoo SUG support Groups were all set up in succession by Sarah Venn, and run independently of, but in competition for the highest membership numbers with Derek Scott’s original SUG Group, although posting drug related information was not restricted, inter group posting was frowned on.
Due to the obvious link to the Lawyers website, pertinent questions were asked of the Committee members with regard group members not being given important and relevant information. Especially as to how any successful claim and payout would affect the many dependant on state benefits because of health problems – most in the wake of the Tobin v SKB (GSK) Schell case seemed to have been given the false impression that more realistic but still substantial life changing compensation sums would be paid.
In all probability, in the UK for the “no fault liability to GSK” on a “defective product” claim any payouts for a “withdrawal” problem will not be life changing amounts, those dependant on benefits would possibly find their benefits stopped completely leaving them in a worse situation. The government also have in place a “Compensation Recovery Unit” (CRU) a supplementary agency of the Department of Social Security, whereby any benefits paid to claimants on the grounds of the drug caused incapacity - can be clawed back from the any lump sum compensation paid to individuals in receipt of benefits.
Despite these questions being asked of the committee, along with requests that direction or advice be sought from Mark Harvey and Hugh James on the members’ behalf - no answers, directions or advice was forthcoming at the time or to current knowledge - since. The only action taken was that Sarah Venn, the group owner and SUG.org committee member, closed the original meta-linked SUG Discussion Forum without notice to the members, moved it to Yahoo Groups, when the same type of questions were asked this group was also closed, a third group was set up but was closed after the post archives were deleted, 2003/4.
- - - - -
Mr Graham Aldred
The only person from the “Patients, relatives and their representatives” contingency independent of the SUG Groups to give evidence to the CSM EWG was Graham Aldred, a colleague of Dr David Healy, his personal link and interest in Seroxat is through his late wife Rhona who sadly took her own life in 2001, eleven days after starting treatment with the drug.
Graham Aldred, a research associate at North Wales Department of Psychological Medicine, Hergest Unit, Ysbyty Gwynedd, Bangor, North Wales carried out a statistical research study on the prescribing trends of Seroxat resulting in the paper “The Decline of use of Paroxetine in England” being published May 17th 2004.
The study concentrated on the suicide issue, above all else clarifying that the problem affected all age groups not just under-18’s and shows a gradual decline in Seroxat total prescription numbers 2001 to 2002, this gradual decline as a result of adverse publicity given to the drug went into a virtual freefall 2002 to 2003, resulting in a 36% decline for the period 2001 to 2003 and highlights the relevant publicised events which obviously influenced the decline through public and prescribing medical professional awareness being raised.
Graham Aldred appeared with Dr David Healy, Charles Medawar and Richard Brook in the second BBC Panorama Seroxat program “Seroxat: e-mails from the edge” aired May 11th 2003, and the third BBC Panorama Seroxat program “Taken on Trust” which aired October 3rd 2004. Both programs airing appears to have been timed to pre-empt CSM events – the second program days before the new CSM EWG inaugural meeting and the third just prior to the publishing of the final report early December 2004.
The published Aldred Study paper is a damning document to the reputation of both Seroxat and its manufacturer GSK; in conclusion Graham Aldred also pays tribute to the Public Service Broadcasting and Internet communication that triggered awareness of the SSRI issues and highlights the efforts of some medical professionals and those pursuing legal recourse.
“6.0 Conclusions.
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.”
Although their have been other suicides in the UK attributed to drugs in the SSRI, SNRI class - the devastating loss of his wife Rhona, his understanding of the core issues with the SSRI, SNRI drug class, his courage and willingness to speak out despite his grief placed Graham Aldred, as an accredited academic, and his evidence in an exceptionally powerful position at the first new CSM EWG meeting in May 2003, with the ability to - besides the obviously incriminating involvement of GSKs Seroxat - make a difference to the whole drug class suicide and ADR situation.
Undoubtedly Graham Aldred’s evidence, along with that of the “Invited” experts Dr David Healy, Dr Andrew Herxheimer and Charles Medawar, of Social Audit, raised awareness of the suicide issue in all age groups and facilitated recommended changes to the treatment of depression and unmonitored, ever increasing, over prescribing trend of the SSRI, SNRI drug class at primary care level as highlighted in the CSM EWG group report and the simultaneously published National Institute for health and Clinical Excellence (NICE) new Clinical Guidelines for the Treatment of Depression in adults.
- - - - -
For reason that would not become apparent until 2009 when Seroxat Group Litigation Order No:68 was discovered - the SUG group members, Anti-Seroxat and GSK campaigners, Mark Harvey and Hugh James’ PR Company “Good Relations” made considerable efforts to take and keep control of the ongoing SSRI, SNRI drug class investigation, to dominate media coverage, concentrate and keep the drug class issues focused solely on Seroxat –
effectively excluding other UK based independent campaigners, groups and organisations, some who had been liaising and working with Dr Healy and Charles Medawar since the 1990’s on behalf of those taking specific or any SSRI, SNRI drug, antidepressants and other psychotropic drugs from giving representation to the CSM EWG.
The same excluded independent campaigners, group and organisation owners - had been working to support those affected by drug ADRs and raise awareness along side the experts with the MCA, CSM and NICE - and had been instrumental in attaining the original expert group investigation into SSRI, SNRI class drugs.
Including but not limited to -
Pam Armstrong, “Back to Life” website and with Peter Ritson the “Council for Information on Tranquillisers” (CITA) set up in 1987, additionally now encompassing information and withdrawal of “Antidepressants, and Painkillers”.
Millie Kieve, who started investigating ADRS and side effects of psychoactive medication following the untimely and devastating death of her daughter in 1995, going on to set up APRIL.org.uk a registered Charity working to raise awareness about drug dangers and their responsible safer use on behalf of patients.
Ramo (Ramzia) Kabbani, who set up the first UK based SSRI, SNRI support group the “Prozac Survivors’ Support Group” in 1999. [Link broken group no longer open]
Ray Nimmo, campaigner and Web Master of Benzo.org.uk, set up in 2000, again another website that encompasses SSRI, SNRI information and has related archived information from 1999 onwards.
Paula, “SSRI Withdrawal Support Site” UK based SSRI, SNRI support site started 2001, Info Board and Discussion Forum, referred to by Seroxat Campaigners as “network54”, an uncompromising neutral group dedicated to exposing the truth about all psychoactive drugs, psychiatry and the misdemeanours of the pharmaceutical industry. Derek Scott and Sarah Venn were both members prior to opening their SUG group.
It appears Millie Keive was the only non SUG patient representative to attend the 2004 EMEA meeting - or any meeting arranged by SUG groups with authorities and government officials.
They all had an immense amount of knowledge, information, articles and personal stories of those adversely affected by the SSRI, SNRI drug class archived on their websites that could have been utilized by the CSM EWG. However, it appears it was not considered relevant, useful or needed by the SUG group members, Anti-Seroxat, GSK and pro Litigation Campaigners, Mark Harvey and Hugh James’ PR Company “Good Relations” - either then or since –
and although the excluded independent campaigners, group and organization owners have unquestioningly supported the SUG Seroxat Litigation Campaign - that support does not appear to have been reciprocated.
Since its publication neither Graham Aldreds’ damning anti Seroxat and GSK study or his later work on Baseline Suicide Rates (BSR) and Investigative Medication Routine (IMR) models have featured in or been used by SUG campaigners to raise awareness of either the Seroxat or SSRI, SNRI drug class issues.
Similarly the Report of the CSM EWG in finding all SSRI, SNRIs including Seroxat, lacking in safety and efficacy and causing discontinuation, withdrawal problems - effectively proved the Seroxat Litigation case being brought under Consumer protection Law for a Faulty Product on the caused discontinuation withdrawal problems, but has - aside from the initial furore of claiming credit for the report and hypothetical under-18’s SSRI’s “banning” – not featured in the ongoing SUG and Seroxat Litigation campaign.
Although the Aldred study was focused on Seroxat and the CSM EWG report named Seroxat more times than any other SSRI, SNRI drug - in their conclusions, recommendations and in the case of the CSM report actions taken neither actually singled out or categorically stated that Seroxat was worse than any other drug in the class. Likewise the excluded independent campaigners, group and organization owners although supportive of the SUG and Litigation campaign, raised awareness of the whole SSRI, SNRI drug class problem - not just Seroxat’s.
It appears the neutrally written supportive evidence that suicide, aggressive behaviour, ADRs and discontinuation problems appertain to Seroxat and all drugs in the SSRI, SNRI class – was and still is superfluous as it undermines the ultimate aim of the in SUG and Seroxat Litigation campaigners - to prove Mark Harvey’s Seroxat Litigation Order No: 68’s 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)”
Other than instigating the re-formation of the CSM EWG, the investigation into GSK and inflating the number of Yellow Card reports for Seroxat - unfortunately - it appears the one real achievement of the SUG, Seroxat litigation campaign thus far, is the welcome 57% decline in annual total Seroxat prescriptions issued - from it’s 2001 3.78m peak to it’s 2009 total of just 1.63m -
all be it at the expense of those now possibly unable to discontinue taking one of the 24.31m other brand SSRI, SNRI prescriptions issued in 2009 - over and above that decline.
Indeed the SUG and Seroxat Litigation campaign “orchestrated” by Mark Harvey appears to have been detrimental to progress being made by others in raising awareness of or just trying to help those affected by the problems and issues with any psychiatric medication and the whole SSRI, SNRI drug class - whose prescriptions are still escalating.
As the prescription total decline detailed in the Graham Aldred study shows it is not impossible to stop taking Seroxat – have the SUG group members, Anti-Seroxat and GSK Campaigners, Mark Harvey, Hugh James and their PR Company “Good Relations” - ultimately become victims of their own propaganda and campaigns success?
And at whose expense?
The CSM Expert Working Group (EWG) report On the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants - published December 2004.
“1.5 Membership of the Expert Working Group on the safety of SSRIs
Professor Ian V D Weller MD FRCP - Chairman
Professor of Sexually Transmitted Diseases and Director of Centre of Sexual Health and HIV Research, Royal Free and University College Medical School, University College, London
Professor Deborah Ashby BSc MSc PhD CStat Hon MFPH Hon MRCR
Professor of Medical Statistics, St Bartholomew’s and the London, Queen Mary’s School of Medicines and Dentistry, University of London
Mr Richard Brook (from May 2003 to March 2004)
Chief Executive of MIND
Professor Mary G A Chambers Bed (Hons) DPhil RN DN (Lond) RNT
Chief Nurse and Professor of Mental Health Nursing at South West London and St George’s Mental Health NHS Trust
Dr Jonathan D Chick MA MB ChB MPhil FRCPsych FRCP (Ed)
Consultant Psychiatrist, Alcohol Problems Service, Royal Edinburgh Hospital, and part-time Senior Lecturer at Edinburgh University
Professor Colin Drummond MD FRCPsych
Professor of Addiction Psychiatry, St George’s Hospital Medical School, London
Professor Klaus P Ebmeier MD
Professor of Psychiatry, University of Edinburgh
Professor David J Gunnell MB ChB MRCGP FFPH MSc PhD
Professor of Epidemiology, Department of Social Medicine, Bristol University
Ms Hilary Hawking (from October 2004 to date)
Clinical Governance User representative for South West London and St George’s Mental Health NHS Trust
Dr Elizabeta Mukaetova-Ladinska MD PhD MRCPsych
Consultant Psychiatrist, Newcastle General Hospital, and Senior Lecturer in Old Age Psychiatry, Newcastle University
Mr Eamon O’Tierney MA (Cantab) ASA (from May 2003 to September 2003)
Member of the Royal College of Psychiatry’s Committee for Patients and Carers
Dr Ross J Taylor MD FRCP (Edin) FRCGP DCH
Senior Lecturer in General Practice, University of Aberdeen
Dr Ann York MB BS MRCPsych
Consultant and Honorary Senior Lecturer in Child and Adolescent Psychiatry, Child and Family Consultation Centre, Richmond Hospital, Surrey
Dr Morris Zwi MBBCH FRCPsych
Consultant Child and Adolescent Psychiatrist, South West London and St George’s Mental Health NHS Trust
Visiting experts for the meeting of 4 June 2003
Dr Santosh Paramala
Consultant Child and Adolescent Psychiatry, Guy’s Hospital, London
Professor Peter Hill
Professor of Child and Adolescent Psychiatry, Great Ormond Street Hospital for Sick Children, London
Professor Eric Taylor
Professor of Child and Adolescent Psychiatry, Institute of Psychiatry, King’s College, London
Invited experts who presented evidence to the EWG
Professor David Healy
Professor of Psychological Medicine, Hergest Unit, University of Wales, Bangor
Dr Andrew Herxheimer
Emeritus Fellow at the UK Cochrane Centre in Oxford
Mr Charles Medawar
Social Audit
Professor Munir Pirmohamed
Professor of Clinical Pharmacology, Liverpool University
Patients, relatives and their representatives who gave evidence to the EWG
Seroxat User Group
Online Seroxat Support Group
Mr Graham Aldred”
Derek Scott actively encouraged group members to join the Seroxat litigation, supplying Solicitors contact details in help being posted, kept the group locked down for members only, and banned members from inter-group posting.
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