where did the clients go;did they die whilst Mark kept in with Big Pharma

[Guest guest]

PREVIOUS; Claims that Cardiff based solicitors Hugh

(Mark Harvey) represent 9000 litigants in a POTENTIAL class action

against GSK has now been " down " reported to 3500 people

???? what happened to the other 5500 people

???? WHY have THOUSANDS of Hugh Clients been dropped??????

http://news.independent.co.uk/uk/health_medical/story.jsp?

story=53028

GSK fights back in battle with Spitzer over Seroxat

Drug giant defends $300m lawsuit by releasing safety studies on

antidepressant

By Foley

11 June 2004

Glaxosmithkline, the UK drugs giant facing a legal onslaught from

the New York state attorney general, yesterday moved to shore up its

reputation for probity by promising to publish research on the

safety of its leading antidepressant which Eliot Spitzer claims has

been illegally kept secret since 1998.

GSK is defending Mr Spitzer's claim for damages of at least $300m

(£163m), but some investors fret that the damage to its reputation

could cost it much more. Meanwhile industry observers believe the

outcome of the case could handicap the pharmaceuticals industry's

ability to discover new drugs.

The company is accused of putting youngsters' lives at risk as

doctors prescribed Seroxat - or Paxil, as the drug is known in the

US - for use by under-18s. GSK, claims Mr Spitzer and others, did

not publish a number of studies which concluded that Seroxat was

ineffective against depression for under-18s, and which, in

aggregate, suggested the drug might increase suicidal thoughts.

The drugs giant took the decision yesterday to publish nine

summaries of clinical trials after a week of internal wrangling over

how to head off the repuational damage unleashed by the intervention

of the combative Mr Spitzer, whose previous assaults have wrung

massive settlements and vicious headlines out of the investment-

banking and fund-management industries.

In a statement, GSK said: " Data have previously been made available

to healthcare professionals through publication in peer-reviewed

journals, poster presentations at scientific meetings and medical

letters to physicians. This approach is accepted standard practice

for making data available. However, to clarify that nature of these

data, GSK will shortly be making available summaries of the safety

and efficacy data from individual reports of the clinical studies

conducted in adolescent and paediatric patients. "

The company - Europe's biggest drug maker and the global number two -

has faced a gathering storm over the side effects and withdrawal

symptoms of Seroxat, and last year had to stop claiming the drug was

not addictive. Exactly a year ago, the UK's medicines regulator

banned doctors from prescribing Seroxat to under-18s, unleashing a

torrent of questions over when GSK first realised the drug was

potentially unsafe.

Jean-Pierre Garnier, the chief executive, has come out fighting,

saying evidence of increased suicidal thoughts emerged only when the

results of several studies were added together, and accusing Mr

Spitzer of bullying and political grandstanding.

The explosive centrepiece of Mr Spitzer's case is a 1998 internal

memo on the first two trials of Seroxat in depressed under-18s. Its

unnamed author argues the company's aim is " to effectively manage

the dissemination of these data in order to minimise any potential

negative commercial impact " .

One City analyst said: " A drug company would be destroying its

reputation by acting in the way that Mr Spitzer is alleging, because

who is going to use their drugs again? "

And executives at other major pharmaceuticals groups are watching

nervously. One said: " I think the reputation of the pharmaceuticals

industry is lower than many in the industry have been prepared to

realise. Dr Garnier's combative response does leave a taste in the

mouth, and we could all suffer because this all affects the

environment in which we operate. "

The apparently damning internal memo was penned by a scientist in

Kline Beecham's clinical medical affairs team, which was set up

to disseminate scientific information internally among the company's

different international businesses. The document - described by Dr

Garnier as one memo among millions - must have been approved by his

superiors, since it was distributed across the organisation, but Dr

Garnier insists its recommendations were not followed. Look at what

we did, he says, not what one employee wrote down.

He also points out that the memo describes the side effects of

Seroxat as being no worse than in adults - supporting the company's

case that it was only later that the suicide risk became apparent.

The memo's author has since quit for another job, and internal

procedures have been changed since the merger of Kline Beecham

with Glaxo Wellcome in 2000. It is unclear whether yesterday's

decision to publish the nine summaries will alleviate or stoke the

controversy, but GSK is acutely aware that it is acting outside the

normal practice of the industry. Regulators do not demand to see all

trial results and do not demand the public dissemination of even all

the information it does see. GSK discussed yesterday's dramatic move

with the US Food and Drug Administration before going ahead with the

publication.

Commercial sensitivity and preventing unjustified health scares are

cited as reasons for the closed dialogue between pharmaceuticals

companies and their regulator. Many in the industry are fearful that

Mr Spitzer's intervention could overturn this system.

ph Baker, the head of pharmaceutical investigations in Mr

Spitzer's office, has said he is investigating further conflicts of

interest across the industry.

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.

Case Study: 'After two days my son tried to stab his brother'

After two days on Seroxat, 17-year-old took a knife and

slashed his arm and wrist, later tried to stab his younger brother

and finally took an overdose of the tablets he had been prescribed

after several years with ME and a low immune system.

" Why did he do that? " asks his mother, Toni. " He only ever

answered, 'I don't know'. I used to think if I hear those words

coming out of this brilliant child again I will scream. "

's violence has fractured relations between Toni's three sons

and she is still haunted by the 11 months she spent nursing him back

to health. " It was 11 months of seeing monsters and me holding him. "

Now 20, is studying for his A-levels, heading to university

and aiming to become a doctor.

Toni and her son are among 3,500 people in the UK hoping to join a

legal action against GlaxoKline over Seroxat. Like the claims

being made in a raft of lawsuits facing GSK in the US, their

solicitor is claiming that Seroxat's side effects make it a

defective drug for adults as well as under-18s.

Toni asks: " What is the difference between my son at 17 years and

364 days and at 18 years and one day? "

PREVIOUS; Claims that Cardiff based solicitors Hugh

(Mark Harvey) represent 9000 litigants in a POTENTIAL class action

against GSK has now been " down " reported to 3500 people

???? what happened to the other 5500 people

???? WHY have THOUSANDS of Hugh Clients been dropped??????

> " But group actions face particular problems in Britain. Attempts

to

> litigate against the makers of benzodiazapines - including Valium,

> Librium and Ativan, which were also said not to be addictive when

> they were launched - collapsed because the legal aid granted to

the

> claimants was used up in the lengthy investigations of the cases

> demanded by the companies before the action reached

court. ........ "

>

>

>

>

>

http://society.guardian.co.uk/mentalhealth/story/0,8150,616291,00.htm

> l

>

>

>

>

>

>

>

> Anti-depressant 'addicts' threaten legal case

>

> Boseley

> Monday December 10, 2001

>

> More than 60 people in Britain who say they have become hooked on

> the anti-depressant Seroxat - a drug in the Prozac class - are

> exploring the possibility of legal action against the

pharmaceutical

> company which they claim failed to warn doctors that that it could

> create dependency.

>

> Two firms of solicitors say they already have between 30 and 40

> cases each. The people have come forward following news of a legal

> case in the US in which 35 people allege they suffered severe side-

> effects when they tried to stop taking the drug.

>

> The Los Angeles law firm Baum, Hedlund, Aristei, Guilford and

> Schiavo - which filed its action against the British manufacturers

> GlaxoKline in September - has since had more than 2,000 calls

> from people to tell of their addiction to the drug, which is known

> in the US as Paxil. The side-effects they suffer when they try to

> stop taking the tablets, include jolting pains in the head,

vertigo,

> loss of coordination, abdominal discomfort, agitation and

confusion.

>

> The US lawyers have asked GSK to set up treatment centres to help

> people attempting to withdraw from Paxil/Seroxat. GSK say there is

> no reliable scientific evidence that the drug causes addiction or

> dependency.

>

> The British solicitors, Ross & Co, based in the Wirral, and Hugh

> Ford Simey of Cardiff, have been receiving calls from people

> who did not realise that others had suffered the same symptoms

when

> they tried to cut down and come off the drug.

>

> " We have been contacted by 30 to 40 people, most of whom have

> startlingly similar tales to tell of being put on the drug and

being

> taken off it, and then going back on, " said Mark Harvey of Hugh

> Ford Simey.

>

> Mr Harvey said most people are told by the doctor that their

> problems are the symptoms of their depression re-appearing and do

> not suspect that the drug might be to blame. " This does have the

> smell of something that is a problem, " he said. " The patient

> information sheet says it is not addictive twice. "

>

> Graham Ross, of Ross & Co, thinks that there is a good potential

> case against the manufacturers. " So far as evidence of dependency

is

> concerned, that is pretty strong, " he said.

>

> " I feel we can prove that. Failure to ensure that GPs are aware of

> that risk and therefore warn patients accordingly - there is

plenty

> of evidence that they are not doing that. "

>

> But group actions face particular problems in Britain. Attempts to

> litigate against the makers of benzodiazapines - including Valium,

> Librium and Ativan, which were also said not to be addictive when

> they were launched - collapsed because the legal aid granted to

the

> claimants was used up in the lengthy investigations of the cases

> demanded by the companies before the action reached court.

[Guest guest]

PREVIOUS; Claims that Cardiff based solicitors Hugh

(Mark Harvey) represent 9000 litigants in a POTENTIAL class action

against GSK has now been " down " reported to 3500 people

???? what happened to the other 5500 people

???? WHY have THOUSANDS of Hugh Clients been dropped??????

http://news.independent.co.uk/uk/health_medical/story.jsp?

story=53028

GSK fights back in battle with Spitzer over Seroxat

Drug giant defends $300m lawsuit by releasing safety studies on

antidepressant

By Foley

11 June 2004

Glaxosmithkline, the UK drugs giant facing a legal onslaught from

the New York state attorney general, yesterday moved to shore up its

reputation for probity by promising to publish research on the

safety of its leading antidepressant which Eliot Spitzer claims has

been illegally kept secret since 1998.

GSK is defending Mr Spitzer's claim for damages of at least $300m

(£163m), but some investors fret that the damage to its reputation

could cost it much more. Meanwhile industry observers believe the

outcome of the case could handicap the pharmaceuticals industry's

ability to discover new drugs.

The company is accused of putting youngsters' lives at risk as

doctors prescribed Seroxat - or Paxil, as the drug is known in the

US - for use by under-18s. GSK, claims Mr Spitzer and others, did

not publish a number of studies which concluded that Seroxat was

ineffective against depression for under-18s, and which, in

aggregate, suggested the drug might increase suicidal thoughts.

The drugs giant took the decision yesterday to publish nine

summaries of clinical trials after a week of internal wrangling over

how to head off the repuational damage unleashed by the intervention

of the combative Mr Spitzer, whose previous assaults have wrung

massive settlements and vicious headlines out of the investment-

banking and fund-management industries.

In a statement, GSK said: " Data have previously been made available

to healthcare professionals through publication in peer-reviewed

journals, poster presentations at scientific meetings and medical

letters to physicians. This approach is accepted standard practice

for making data available. However, to clarify that nature of these

data, GSK will shortly be making available summaries of the safety

and efficacy data from individual reports of the clinical studies

conducted in adolescent and paediatric patients. "

The company - Europe's biggest drug maker and the global number two -

has faced a gathering storm over the side effects and withdrawal

symptoms of Seroxat, and last year had to stop claiming the drug was

not addictive. Exactly a year ago, the UK's medicines regulator

banned doctors from prescribing Seroxat to under-18s, unleashing a

torrent of questions over when GSK first realised the drug was

potentially unsafe.

Jean-Pierre Garnier, the chief executive, has come out fighting,

saying evidence of increased suicidal thoughts emerged only when the

results of several studies were added together, and accusing Mr

Spitzer of bullying and political grandstanding.

The explosive centrepiece of Mr Spitzer's case is a 1998 internal

memo on the first two trials of Seroxat in depressed under-18s. Its

unnamed author argues the company's aim is " to effectively manage

the dissemination of these data in order to minimise any potential

negative commercial impact " .

One City analyst said: " A drug company would be destroying its

reputation by acting in the way that Mr Spitzer is alleging, because

who is going to use their drugs again? "

And executives at other major pharmaceuticals groups are watching

nervously. One said: " I think the reputation of the pharmaceuticals

industry is lower than many in the industry have been prepared to

realise. Dr Garnier's combative response does leave a taste in the

mouth, and we could all suffer because this all affects the

environment in which we operate. "

The apparently damning internal memo was penned by a scientist in

Kline Beecham's clinical medical affairs team, which was set up

to disseminate scientific information internally among the company's

different international businesses. The document - described by Dr

Garnier as one memo among millions - must have been approved by his

superiors, since it was distributed across the organisation, but Dr

Garnier insists its recommendations were not followed. Look at what

we did, he says, not what one employee wrote down.

He also points out that the memo describes the side effects of

Seroxat as being no worse than in adults - supporting the company's

case that it was only later that the suicide risk became apparent.

The memo's author has since quit for another job, and internal

procedures have been changed since the merger of Kline Beecham

with Glaxo Wellcome in 2000. It is unclear whether yesterday's

decision to publish the nine summaries will alleviate or stoke the

controversy, but GSK is acutely aware that it is acting outside the

normal practice of the industry. Regulators do not demand to see all

trial results and do not demand the public dissemination of even all

the information it does see. GSK discussed yesterday's dramatic move

with the US Food and Drug Administration before going ahead with the

publication.

Commercial sensitivity and preventing unjustified health scares are

cited as reasons for the closed dialogue between pharmaceuticals

companies and their regulator. Many in the industry are fearful that

Mr Spitzer's intervention could overturn this system.

ph Baker, the head of pharmaceutical investigations in Mr

Spitzer's office, has said he is investigating further conflicts of

interest across the industry.

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.

Case Study: 'After two days my son tried to stab his brother'

After two days on Seroxat, 17-year-old took a knife and

slashed his arm and wrist, later tried to stab his younger brother

and finally took an overdose of the tablets he had been prescribed

after several years with ME and a low immune system.

" Why did he do that? " asks his mother, Toni. " He only ever

answered, 'I don't know'. I used to think if I hear those words

coming out of this brilliant child again I will scream. "

's violence has fractured relations between Toni's three sons

and she is still haunted by the 11 months she spent nursing him back

to health. " It was 11 months of seeing monsters and me holding him. "

Now 20, is studying for his A-levels, heading to university

and aiming to become a doctor.

Toni and her son are among 3,500 people in the UK hoping to join a

legal action against GlaxoKline over Seroxat. Like the claims

being made in a raft of lawsuits facing GSK in the US, their

solicitor is claiming that Seroxat's side effects make it a

defective drug for adults as well as under-18s.

Toni asks: " What is the difference between my son at 17 years and

364 days and at 18 years and one day? "

PREVIOUS; Claims that Cardiff based solicitors Hugh

(Mark Harvey) represent 9000 litigants in a POTENTIAL class action

against GSK has now been " down " reported to 3500 people

???? what happened to the other 5500 people

???? WHY have THOUSANDS of Hugh Clients been dropped??????

> " But group actions face particular problems in Britain. Attempts

to

> litigate against the makers of benzodiazapines - including Valium,

> Librium and Ativan, which were also said not to be addictive when

> they were launched - collapsed because the legal aid granted to

the

> claimants was used up in the lengthy investigations of the cases

> demanded by the companies before the action reached

court. ........ "

>

>

>

>

>

http://society.guardian.co.uk/mentalhealth/story/0,8150,616291,00.htm

> l

>

>

>

>

>

>

>

> Anti-depressant 'addicts' threaten legal case

>

> Boseley

> Monday December 10, 2001

>

> More than 60 people in Britain who say they have become hooked on

> the anti-depressant Seroxat - a drug in the Prozac class - are

> exploring the possibility of legal action against the

pharmaceutical

> company which they claim failed to warn doctors that that it could

> create dependency.

>

> Two firms of solicitors say they already have between 30 and 40

> cases each. The people have come forward following news of a legal

> case in the US in which 35 people allege they suffered severe side-

> effects when they tried to stop taking the drug.

>

> The Los Angeles law firm Baum, Hedlund, Aristei, Guilford and

> Schiavo - which filed its action against the British manufacturers

> GlaxoKline in September - has since had more than 2,000 calls

> from people to tell of their addiction to the drug, which is known

> in the US as Paxil. The side-effects they suffer when they try to

> stop taking the tablets, include jolting pains in the head,

vertigo,

> loss of coordination, abdominal discomfort, agitation and

confusion.

>

> The US lawyers have asked GSK to set up treatment centres to help

> people attempting to withdraw from Paxil/Seroxat. GSK say there is

> no reliable scientific evidence that the drug causes addiction or

> dependency.

>

> The British solicitors, Ross & Co, based in the Wirral, and Hugh

> Ford Simey of Cardiff, have been receiving calls from people

> who did not realise that others had suffered the same symptoms

when

> they tried to cut down and come off the drug.

>

> " We have been contacted by 30 to 40 people, most of whom have

> startlingly similar tales to tell of being put on the drug and

being

> taken off it, and then going back on, " said Mark Harvey of Hugh

> Ford Simey.

>

> Mr Harvey said most people are told by the doctor that their

> problems are the symptoms of their depression re-appearing and do

> not suspect that the drug might be to blame. " This does have the

> smell of something that is a problem, " he said. " The patient

> information sheet says it is not addictive twice. "

>

> Graham Ross, of Ross & Co, thinks that there is a good potential

> case against the manufacturers. " So far as evidence of dependency

is

> concerned, that is pretty strong, " he said.

>

> " I feel we can prove that. Failure to ensure that GPs are aware of

> that risk and therefore warn patients accordingly - there is

plenty

> of evidence that they are not doing that. "

>

> But group actions face particular problems in Britain. Attempts to

> litigate against the makers of benzodiazapines - including Valium,

> Librium and Ativan, which were also said not to be addictive when

> they were launched - collapsed because the legal aid granted to

the

> claimants was used up in the lengthy investigations of the cases

> demanded by the companies before the action reached court.

[Guest guest]

PREVIOUS; Claims that Cardiff based solicitors Hugh

(Mark Harvey) represent 9000 litigants in a POTENTIAL class action

against GSK has now been " down " reported to 3500 people

???? what happened to the other 5500 people

???? WHY have THOUSANDS of Hugh Clients been dropped??????

http://news.independent.co.uk/uk/health_medical/story.jsp?

story=53028

GSK fights back in battle with Spitzer over Seroxat

Drug giant defends $300m lawsuit by releasing safety studies on

antidepressant

By Foley

11 June 2004

Glaxosmithkline, the UK drugs giant facing a legal onslaught from

the New York state attorney general, yesterday moved to shore up its

reputation for probity by promising to publish research on the

safety of its leading antidepressant which Eliot Spitzer claims has

been illegally kept secret since 1998.

GSK is defending Mr Spitzer's claim for damages of at least $300m

(£163m), but some investors fret that the damage to its reputation

could cost it much more. Meanwhile industry observers believe the

outcome of the case could handicap the pharmaceuticals industry's

ability to discover new drugs.

The company is accused of putting youngsters' lives at risk as

doctors prescribed Seroxat - or Paxil, as the drug is known in the

US - for use by under-18s. GSK, claims Mr Spitzer and others, did

not publish a number of studies which concluded that Seroxat was

ineffective against depression for under-18s, and which, in

aggregate, suggested the drug might increase suicidal thoughts.

The drugs giant took the decision yesterday to publish nine

summaries of clinical trials after a week of internal wrangling over

how to head off the repuational damage unleashed by the intervention

of the combative Mr Spitzer, whose previous assaults have wrung

massive settlements and vicious headlines out of the investment-

banking and fund-management industries.

In a statement, GSK said: " Data have previously been made available

to healthcare professionals through publication in peer-reviewed

journals, poster presentations at scientific meetings and medical

letters to physicians. This approach is accepted standard practice

for making data available. However, to clarify that nature of these

data, GSK will shortly be making available summaries of the safety

and efficacy data from individual reports of the clinical studies

conducted in adolescent and paediatric patients. "

The company - Europe's biggest drug maker and the global number two -

has faced a gathering storm over the side effects and withdrawal

symptoms of Seroxat, and last year had to stop claiming the drug was

not addictive. Exactly a year ago, the UK's medicines regulator

banned doctors from prescribing Seroxat to under-18s, unleashing a

torrent of questions over when GSK first realised the drug was

potentially unsafe.

Jean-Pierre Garnier, the chief executive, has come out fighting,

saying evidence of increased suicidal thoughts emerged only when the

results of several studies were added together, and accusing Mr

Spitzer of bullying and political grandstanding.

The explosive centrepiece of Mr Spitzer's case is a 1998 internal

memo on the first two trials of Seroxat in depressed under-18s. Its

unnamed author argues the company's aim is " to effectively manage

the dissemination of these data in order to minimise any potential

negative commercial impact " .

One City analyst said: " A drug company would be destroying its

reputation by acting in the way that Mr Spitzer is alleging, because

who is going to use their drugs again? "

And executives at other major pharmaceuticals groups are watching

nervously. One said: " I think the reputation of the pharmaceuticals

industry is lower than many in the industry have been prepared to

realise. Dr Garnier's combative response does leave a taste in the

mouth, and we could all suffer because this all affects the

environment in which we operate. "

The apparently damning internal memo was penned by a scientist in

Kline Beecham's clinical medical affairs team, which was set up

to disseminate scientific information internally among the company's

different international businesses. The document - described by Dr

Garnier as one memo among millions - must have been approved by his

superiors, since it was distributed across the organisation, but Dr

Garnier insists its recommendations were not followed. Look at what

we did, he says, not what one employee wrote down.

He also points out that the memo describes the side effects of

Seroxat as being no worse than in adults - supporting the company's

case that it was only later that the suicide risk became apparent.

The memo's author has since quit for another job, and internal

procedures have been changed since the merger of Kline Beecham

with Glaxo Wellcome in 2000. It is unclear whether yesterday's

decision to publish the nine summaries will alleviate or stoke the

controversy, but GSK is acutely aware that it is acting outside the

normal practice of the industry. Regulators do not demand to see all

trial results and do not demand the public dissemination of even all

the information it does see. GSK discussed yesterday's dramatic move

with the US Food and Drug Administration before going ahead with the

publication.

Commercial sensitivity and preventing unjustified health scares are

cited as reasons for the closed dialogue between pharmaceuticals

companies and their regulator. Many in the industry are fearful that

Mr Spitzer's intervention could overturn this system.

ph Baker, the head of pharmaceutical investigations in Mr

Spitzer's office, has said he is investigating further conflicts of

interest across the industry.

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.

Case Study: 'After two days my son tried to stab his brother'

After two days on Seroxat, 17-year-old took a knife and

slashed his arm and wrist, later tried to stab his younger brother

and finally took an overdose of the tablets he had been prescribed

after several years with ME and a low immune system.

" Why did he do that? " asks his mother, Toni. " He only ever

answered, 'I don't know'. I used to think if I hear those words

coming out of this brilliant child again I will scream. "

's violence has fractured relations between Toni's three sons

and she is still haunted by the 11 months she spent nursing him back

to health. " It was 11 months of seeing monsters and me holding him. "

Now 20, is studying for his A-levels, heading to university

and aiming to become a doctor.

Toni and her son are among 3,500 people in the UK hoping to join a

legal action against GlaxoKline over Seroxat. Like the claims

being made in a raft of lawsuits facing GSK in the US, their

solicitor is claiming that Seroxat's side effects make it a

defective drug for adults as well as under-18s.

Toni asks: " What is the difference between my son at 17 years and

364 days and at 18 years and one day? "

PREVIOUS; Claims that Cardiff based solicitors Hugh

(Mark Harvey) represent 9000 litigants in a POTENTIAL class action

against GSK has now been " down " reported to 3500 people

???? what happened to the other 5500 people

???? WHY have THOUSANDS of Hugh Clients been dropped??????

> " But group actions face particular problems in Britain. Attempts

to

> litigate against the makers of benzodiazapines - including Valium,

> Librium and Ativan, which were also said not to be addictive when

> they were launched - collapsed because the legal aid granted to

the

> claimants was used up in the lengthy investigations of the cases

> demanded by the companies before the action reached

court. ........ "

>

>

>

>

>

http://society.guardian.co.uk/mentalhealth/story/0,8150,616291,00.htm

> l

>

>

>

>

>

>

>

> Anti-depressant 'addicts' threaten legal case

>

> Boseley

> Monday December 10, 2001

>

> More than 60 people in Britain who say they have become hooked on

> the anti-depressant Seroxat - a drug in the Prozac class - are

> exploring the possibility of legal action against the

pharmaceutical

> company which they claim failed to warn doctors that that it could

> create dependency.

>

> Two firms of solicitors say they already have between 30 and 40

> cases each. The people have come forward following news of a legal

> case in the US in which 35 people allege they suffered severe side-

> effects when they tried to stop taking the drug.

>

> The Los Angeles law firm Baum, Hedlund, Aristei, Guilford and

> Schiavo - which filed its action against the British manufacturers

> GlaxoKline in September - has since had more than 2,000 calls

> from people to tell of their addiction to the drug, which is known

> in the US as Paxil. The side-effects they suffer when they try to

> stop taking the tablets, include jolting pains in the head,

vertigo,

> loss of coordination, abdominal discomfort, agitation and

confusion.

>

> The US lawyers have asked GSK to set up treatment centres to help

> people attempting to withdraw from Paxil/Seroxat. GSK say there is

> no reliable scientific evidence that the drug causes addiction or

> dependency.

>

> The British solicitors, Ross & Co, based in the Wirral, and Hugh

> Ford Simey of Cardiff, have been receiving calls from people

> who did not realise that others had suffered the same symptoms

when

> they tried to cut down and come off the drug.

>

> " We have been contacted by 30 to 40 people, most of whom have

> startlingly similar tales to tell of being put on the drug and

being

> taken off it, and then going back on, " said Mark Harvey of Hugh

> Ford Simey.

>

> Mr Harvey said most people are told by the doctor that their

> problems are the symptoms of their depression re-appearing and do

> not suspect that the drug might be to blame. " This does have the

> smell of something that is a problem, " he said. " The patient

> information sheet says it is not addictive twice. "

>

> Graham Ross, of Ross & Co, thinks that there is a good potential

> case against the manufacturers. " So far as evidence of dependency

is

> concerned, that is pretty strong, " he said.

>

> " I feel we can prove that. Failure to ensure that GPs are aware of

> that risk and therefore warn patients accordingly - there is

plenty

> of evidence that they are not doing that. "

>

> But group actions face particular problems in Britain. Attempts to

> litigate against the makers of benzodiazapines - including Valium,

> Librium and Ativan, which were also said not to be addictive when

> they were launched - collapsed because the legal aid granted to

the

> claimants was used up in the lengthy investigations of the cases

> demanded by the companies before the action reached court.

[Guest guest]

PREVIOUS; Claims that Cardiff based solicitors Hugh

(Mark Harvey) represent 9000 litigants in a POTENTIAL class action

against GSK has now been " down " reported to 3500 people

???? what happened to the other 5500 people

???? WHY have THOUSANDS of Hugh Clients been dropped??????

http://news.independent.co.uk/uk/health_medical/story.jsp?

story=53028

GSK fights back in battle with Spitzer over Seroxat

Drug giant defends $300m lawsuit by releasing safety studies on

antidepressant

By Foley

11 June 2004

Glaxosmithkline, the UK drugs giant facing a legal onslaught from

the New York state attorney general, yesterday moved to shore up its

reputation for probity by promising to publish research on the

safety of its leading antidepressant which Eliot Spitzer claims has

been illegally kept secret since 1998.

GSK is defending Mr Spitzer's claim for damages of at least $300m

(£163m), but some investors fret that the damage to its reputation

could cost it much more. Meanwhile industry observers believe the

outcome of the case could handicap the pharmaceuticals industry's

ability to discover new drugs.

The company is accused of putting youngsters' lives at risk as

doctors prescribed Seroxat - or Paxil, as the drug is known in the

US - for use by under-18s. GSK, claims Mr Spitzer and others, did

not publish a number of studies which concluded that Seroxat was

ineffective against depression for under-18s, and which, in

aggregate, suggested the drug might increase suicidal thoughts.

The drugs giant took the decision yesterday to publish nine

summaries of clinical trials after a week of internal wrangling over

how to head off the repuational damage unleashed by the intervention

of the combative Mr Spitzer, whose previous assaults have wrung

massive settlements and vicious headlines out of the investment-

banking and fund-management industries.

In a statement, GSK said: " Data have previously been made available

to healthcare professionals through publication in peer-reviewed

journals, poster presentations at scientific meetings and medical

letters to physicians. This approach is accepted standard practice

for making data available. However, to clarify that nature of these

data, GSK will shortly be making available summaries of the safety

and efficacy data from individual reports of the clinical studies

conducted in adolescent and paediatric patients. "

The company - Europe's biggest drug maker and the global number two -

has faced a gathering storm over the side effects and withdrawal

symptoms of Seroxat, and last year had to stop claiming the drug was

not addictive. Exactly a year ago, the UK's medicines regulator

banned doctors from prescribing Seroxat to under-18s, unleashing a

torrent of questions over when GSK first realised the drug was

potentially unsafe.

Jean-Pierre Garnier, the chief executive, has come out fighting,

saying evidence of increased suicidal thoughts emerged only when the

results of several studies were added together, and accusing Mr

Spitzer of bullying and political grandstanding.

The explosive centrepiece of Mr Spitzer's case is a 1998 internal

memo on the first two trials of Seroxat in depressed under-18s. Its

unnamed author argues the company's aim is " to effectively manage

the dissemination of these data in order to minimise any potential

negative commercial impact " .

One City analyst said: " A drug company would be destroying its

reputation by acting in the way that Mr Spitzer is alleging, because

who is going to use their drugs again? "

And executives at other major pharmaceuticals groups are watching

nervously. One said: " I think the reputation of the pharmaceuticals

industry is lower than many in the industry have been prepared to

realise. Dr Garnier's combative response does leave a taste in the

mouth, and we could all suffer because this all affects the

environment in which we operate. "

The apparently damning internal memo was penned by a scientist in

Kline Beecham's clinical medical affairs team, which was set up

to disseminate scientific information internally among the company's

different international businesses. The document - described by Dr

Garnier as one memo among millions - must have been approved by his

superiors, since it was distributed across the organisation, but Dr

Garnier insists its recommendations were not followed. Look at what

we did, he says, not what one employee wrote down.

He also points out that the memo describes the side effects of

Seroxat as being no worse than in adults - supporting the company's

case that it was only later that the suicide risk became apparent.

The memo's author has since quit for another job, and internal

procedures have been changed since the merger of Kline Beecham

with Glaxo Wellcome in 2000. It is unclear whether yesterday's

decision to publish the nine summaries will alleviate or stoke the

controversy, but GSK is acutely aware that it is acting outside the

normal practice of the industry. Regulators do not demand to see all

trial results and do not demand the public dissemination of even all

the information it does see. GSK discussed yesterday's dramatic move

with the US Food and Drug Administration before going ahead with the

publication.

Commercial sensitivity and preventing unjustified health scares are

cited as reasons for the closed dialogue between pharmaceuticals

companies and their regulator. Many in the industry are fearful that

Mr Spitzer's intervention could overturn this system.

ph Baker, the head of pharmaceutical investigations in Mr

Spitzer's office, has said he is investigating further conflicts of

interest across the industry.

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.

Case Study: 'After two days my son tried to stab his brother'

After two days on Seroxat, 17-year-old took a knife and

slashed his arm and wrist, later tried to stab his younger brother

and finally took an overdose of the tablets he had been prescribed

after several years with ME and a low immune system.

" Why did he do that? " asks his mother, Toni. " He only ever

answered, 'I don't know'. I used to think if I hear those words

coming out of this brilliant child again I will scream. "

's violence has fractured relations between Toni's three sons

and she is still haunted by the 11 months she spent nursing him back

to health. " It was 11 months of seeing monsters and me holding him. "

Now 20, is studying for his A-levels, heading to university

and aiming to become a doctor.

Toni and her son are among 3,500 people in the UK hoping to join a

legal action against GlaxoKline over Seroxat. Like the claims

being made in a raft of lawsuits facing GSK in the US, their

solicitor is claiming that Seroxat's side effects make it a

defective drug for adults as well as under-18s.

Toni asks: " What is the difference between my son at 17 years and

364 days and at 18 years and one day? "

PREVIOUS; Claims that Cardiff based solicitors Hugh

(Mark Harvey) represent 9000 litigants in a POTENTIAL class action

against GSK has now been " down " reported to 3500 people

???? what happened to the other 5500 people

???? WHY have THOUSANDS of Hugh Clients been dropped??????

> " But group actions face particular problems in Britain. Attempts

to

> litigate against the makers of benzodiazapines - including Valium,

> Librium and Ativan, which were also said not to be addictive when

> they were launched - collapsed because the legal aid granted to

the

> claimants was used up in the lengthy investigations of the cases

> demanded by the companies before the action reached

court. ........ "

>

>

>

>

>

http://society.guardian.co.uk/mentalhealth/story/0,8150,616291,00.htm

> l

>

>

>

>

>

>

>

> Anti-depressant 'addicts' threaten legal case

>

> Boseley

> Monday December 10, 2001

>

> More than 60 people in Britain who say they have become hooked on

> the anti-depressant Seroxat - a drug in the Prozac class - are

> exploring the possibility of legal action against the

pharmaceutical

> company which they claim failed to warn doctors that that it could

> create dependency.

>

> Two firms of solicitors say they already have between 30 and 40

> cases each. The people have come forward following news of a legal

> case in the US in which 35 people allege they suffered severe side-

> effects when they tried to stop taking the drug.

>

> The Los Angeles law firm Baum, Hedlund, Aristei, Guilford and

> Schiavo - which filed its action against the British manufacturers

> GlaxoKline in September - has since had more than 2,000 calls

> from people to tell of their addiction to the drug, which is known

> in the US as Paxil. The side-effects they suffer when they try to

> stop taking the tablets, include jolting pains in the head,

vertigo,

> loss of coordination, abdominal discomfort, agitation and

confusion.

>

> The US lawyers have asked GSK to set up treatment centres to help

> people attempting to withdraw from Paxil/Seroxat. GSK say there is

> no reliable scientific evidence that the drug causes addiction or

> dependency.

>

> The British solicitors, Ross & Co, based in the Wirral, and Hugh

> Ford Simey of Cardiff, have been receiving calls from people

> who did not realise that others had suffered the same symptoms

when

> they tried to cut down and come off the drug.

>

> " We have been contacted by 30 to 40 people, most of whom have

> startlingly similar tales to tell of being put on the drug and

being

> taken off it, and then going back on, " said Mark Harvey of Hugh

> Ford Simey.

>

> Mr Harvey said most people are told by the doctor that their

> problems are the symptoms of their depression re-appearing and do

> not suspect that the drug might be to blame. " This does have the

> smell of something that is a problem, " he said. " The patient

> information sheet says it is not addictive twice. "

>

> Graham Ross, of Ross & Co, thinks that there is a good potential

> case against the manufacturers. " So far as evidence of dependency

is

> concerned, that is pretty strong, " he said.

>

> " I feel we can prove that. Failure to ensure that GPs are aware of

> that risk and therefore warn patients accordingly - there is

plenty

> of evidence that they are not doing that. "

>

> But group actions face particular problems in Britain. Attempts to

> litigate against the makers of benzodiazapines - including Valium,

> Librium and Ativan, which were also said not to be addictive when

> they were launched - collapsed because the legal aid granted to

the

> claimants was used up in the lengthy investigations of the cases

> demanded by the companies before the action reached court.