Company 'held back' data on drug for children

[Guest guest]

Company 'held back' data on drug for children

http://www.guardian.co.uk/uk_news/story/0,3604,1137542,00.html

Antidepressant had no effect, leak reveals

Boseley, health editor

Tuesday February 3, 2004

The Guardian

The British manufacturers of an antidepressant drug that was last

year banned from use in children knew as long ago as 1998 that it

did not work and deliberately avoided publishing the full data

because of the risk to their lucrative adult market, according to a

leaked internal document.

A position paper dated October 1998 shows that managers at

Kline Beecham - now GlaxoKline - were concerned at the

commercial implications of two clinical trials in which their drug

Seroxat was given to children and adolescents with major depression.

The results of both trials, known as protocols 329 and 377, showed

that the drug was no better than a placebo - an inert pill - in

alleviating the children's depression. An internal unit at the drug

company called the Central Medical Affairs team prepared a strategy.

The target, says the document - leaked to the BBC's Panorama team,

which has made two programmes on Seroxat - was " to effectively

manage the dissemination of these data in order to minimise any

potential negative commercial impact " . About 500,000 adults were at

the time taking the drug in the UK. Seroxat was licensed for their

use, but not for use in children. Even so, some 8,000 to 10,000

children were also on it because doctors can prescribe an unlicensed

drug on their own responsibility.

The paper says that following consultations within the company,

Kline Beecham would not submit any data to the regulators to

get a statement on the efficacy or the safety of the drug. It

says: " It would be commercially unacceptable to include a statement

that efficacy had not been demonstrated, as this would undermine the

profile of paroxetine [seroxat]. " It adds, however, that " positive

data " from the first and bigger study, protocol 329, would be

published in abstract form at a psychiatric meeting the following

month and that a full manuscript of the trial " will be progressed " .

It was eventually published in July 2001 with the

conclusion: " Paroxetine is generally well tolerated and effective

for major depression in adolescents. "

It was only last spring, after Glaxo submitted the full data from

protocols 329 and 377, together with a third study of depressed

children on Seroxat and data from trials of the drug in children

with obsessive compulsive disorder and social anxiety disorder, that

the UK regulator, the Medicines and Healthcare Products Regulatory

Agency (MHRA), realised that not only was Seroxat ineffective in

children but that a bigger proportion of those taking it in the

trials thought about killing themselves than among those on placebo.

The drug was then banned.

Yesterday Alastair Benbow, GSK's head of European clinical

psychiatry, said the document " draws inappropriate conclusions and

it is inconsistent with the facts " .

He insisted that there was no sign of a suicide problem until all

the trials were put together.

Brook, the chief executive of Mind, the UK organisation for

mental health and a member of the Seroxat review panel convened by

the MHRA, said he was appalled by the revelations in the leaked

document. To allow the drug to be given to children when there were

known side-effects and it could not be proven to work was " morally

and ethically bankrupt " , he said.

[Guest guest]

Company 'held back' data on drug for children

http://www.guardian.co.uk/uk_news/story/0,3604,1137542,00.html

Antidepressant had no effect, leak reveals

Boseley, health editor

Tuesday February 3, 2004

The Guardian

The British manufacturers of an antidepressant drug that was last

year banned from use in children knew as long ago as 1998 that it

did not work and deliberately avoided publishing the full data

because of the risk to their lucrative adult market, according to a

leaked internal document.

A position paper dated October 1998 shows that managers at

Kline Beecham - now GlaxoKline - were concerned at the

commercial implications of two clinical trials in which their drug

Seroxat was given to children and adolescents with major depression.

The results of both trials, known as protocols 329 and 377, showed

that the drug was no better than a placebo - an inert pill - in

alleviating the children's depression. An internal unit at the drug

company called the Central Medical Affairs team prepared a strategy.

The target, says the document - leaked to the BBC's Panorama team,

which has made two programmes on Seroxat - was " to effectively

manage the dissemination of these data in order to minimise any

potential negative commercial impact " . About 500,000 adults were at

the time taking the drug in the UK. Seroxat was licensed for their

use, but not for use in children. Even so, some 8,000 to 10,000

children were also on it because doctors can prescribe an unlicensed

drug on their own responsibility.

The paper says that following consultations within the company,

Kline Beecham would not submit any data to the regulators to

get a statement on the efficacy or the safety of the drug. It

says: " It would be commercially unacceptable to include a statement

that efficacy had not been demonstrated, as this would undermine the

profile of paroxetine [seroxat]. " It adds, however, that " positive

data " from the first and bigger study, protocol 329, would be

published in abstract form at a psychiatric meeting the following

month and that a full manuscript of the trial " will be progressed " .

It was eventually published in July 2001 with the

conclusion: " Paroxetine is generally well tolerated and effective

for major depression in adolescents. "

It was only last spring, after Glaxo submitted the full data from

protocols 329 and 377, together with a third study of depressed

children on Seroxat and data from trials of the drug in children

with obsessive compulsive disorder and social anxiety disorder, that

the UK regulator, the Medicines and Healthcare Products Regulatory

Agency (MHRA), realised that not only was Seroxat ineffective in

children but that a bigger proportion of those taking it in the

trials thought about killing themselves than among those on placebo.

The drug was then banned.

Yesterday Alastair Benbow, GSK's head of European clinical

psychiatry, said the document " draws inappropriate conclusions and

it is inconsistent with the facts " .

He insisted that there was no sign of a suicide problem until all

the trials were put together.

Brook, the chief executive of Mind, the UK organisation for

mental health and a member of the Seroxat review panel convened by

the MHRA, said he was appalled by the revelations in the leaked

document. To allow the drug to be given to children when there were

known side-effects and it could not be proven to work was " morally

and ethically bankrupt " , he said.

[Guest guest]

Company 'held back' data on drug for children

http://www.guardian.co.uk/uk_news/story/0,3604,1137542,00.html

Antidepressant had no effect, leak reveals

Boseley, health editor

Tuesday February 3, 2004

The Guardian

The British manufacturers of an antidepressant drug that was last

year banned from use in children knew as long ago as 1998 that it

did not work and deliberately avoided publishing the full data

because of the risk to their lucrative adult market, according to a

leaked internal document.

A position paper dated October 1998 shows that managers at

Kline Beecham - now GlaxoKline - were concerned at the

commercial implications of two clinical trials in which their drug

Seroxat was given to children and adolescents with major depression.

The results of both trials, known as protocols 329 and 377, showed

that the drug was no better than a placebo - an inert pill - in

alleviating the children's depression. An internal unit at the drug

company called the Central Medical Affairs team prepared a strategy.

The target, says the document - leaked to the BBC's Panorama team,

which has made two programmes on Seroxat - was " to effectively

manage the dissemination of these data in order to minimise any

potential negative commercial impact " . About 500,000 adults were at

the time taking the drug in the UK. Seroxat was licensed for their

use, but not for use in children. Even so, some 8,000 to 10,000

children were also on it because doctors can prescribe an unlicensed

drug on their own responsibility.

The paper says that following consultations within the company,

Kline Beecham would not submit any data to the regulators to

get a statement on the efficacy or the safety of the drug. It

says: " It would be commercially unacceptable to include a statement

that efficacy had not been demonstrated, as this would undermine the

profile of paroxetine [seroxat]. " It adds, however, that " positive

data " from the first and bigger study, protocol 329, would be

published in abstract form at a psychiatric meeting the following

month and that a full manuscript of the trial " will be progressed " .

It was eventually published in July 2001 with the

conclusion: " Paroxetine is generally well tolerated and effective

for major depression in adolescents. "

It was only last spring, after Glaxo submitted the full data from

protocols 329 and 377, together with a third study of depressed

children on Seroxat and data from trials of the drug in children

with obsessive compulsive disorder and social anxiety disorder, that

the UK regulator, the Medicines and Healthcare Products Regulatory

Agency (MHRA), realised that not only was Seroxat ineffective in

children but that a bigger proportion of those taking it in the

trials thought about killing themselves than among those on placebo.

The drug was then banned.

Yesterday Alastair Benbow, GSK's head of European clinical

psychiatry, said the document " draws inappropriate conclusions and

it is inconsistent with the facts " .

He insisted that there was no sign of a suicide problem until all

the trials were put together.

Brook, the chief executive of Mind, the UK organisation for

mental health and a member of the Seroxat review panel convened by

the MHRA, said he was appalled by the revelations in the leaked

document. To allow the drug to be given to children when there were

known side-effects and it could not be proven to work was " morally

and ethically bankrupt " , he said.

[Guest guest]

Company 'held back' data on drug for children

http://www.guardian.co.uk/uk_news/story/0,3604,1137542,00.html

Antidepressant had no effect, leak reveals

Boseley, health editor

Tuesday February 3, 2004

The Guardian

The British manufacturers of an antidepressant drug that was last

year banned from use in children knew as long ago as 1998 that it

did not work and deliberately avoided publishing the full data

because of the risk to their lucrative adult market, according to a

leaked internal document.

A position paper dated October 1998 shows that managers at

Kline Beecham - now GlaxoKline - were concerned at the

commercial implications of two clinical trials in which their drug

Seroxat was given to children and adolescents with major depression.

The results of both trials, known as protocols 329 and 377, showed

that the drug was no better than a placebo - an inert pill - in

alleviating the children's depression. An internal unit at the drug

company called the Central Medical Affairs team prepared a strategy.

The target, says the document - leaked to the BBC's Panorama team,

which has made two programmes on Seroxat - was " to effectively

manage the dissemination of these data in order to minimise any

potential negative commercial impact " . About 500,000 adults were at

the time taking the drug in the UK. Seroxat was licensed for their

use, but not for use in children. Even so, some 8,000 to 10,000

children were also on it because doctors can prescribe an unlicensed

drug on their own responsibility.

The paper says that following consultations within the company,

Kline Beecham would not submit any data to the regulators to

get a statement on the efficacy or the safety of the drug. It

says: " It would be commercially unacceptable to include a statement

that efficacy had not been demonstrated, as this would undermine the

profile of paroxetine [seroxat]. " It adds, however, that " positive

data " from the first and bigger study, protocol 329, would be

published in abstract form at a psychiatric meeting the following

month and that a full manuscript of the trial " will be progressed " .

It was eventually published in July 2001 with the

conclusion: " Paroxetine is generally well tolerated and effective

for major depression in adolescents. "

It was only last spring, after Glaxo submitted the full data from

protocols 329 and 377, together with a third study of depressed

children on Seroxat and data from trials of the drug in children

with obsessive compulsive disorder and social anxiety disorder, that

the UK regulator, the Medicines and Healthcare Products Regulatory

Agency (MHRA), realised that not only was Seroxat ineffective in

children but that a bigger proportion of those taking it in the

trials thought about killing themselves than among those on placebo.

The drug was then banned.

Yesterday Alastair Benbow, GSK's head of European clinical

psychiatry, said the document " draws inappropriate conclusions and

it is inconsistent with the facts " .

He insisted that there was no sign of a suicide problem until all

the trials were put together.

Brook, the chief executive of Mind, the UK organisation for

mental health and a member of the Seroxat review panel convened by

the MHRA, said he was appalled by the revelations in the leaked

document. To allow the drug to be given to children when there were

known side-effects and it could not be proven to work was " morally

and ethically bankrupt " , he said.