Tighter drug trial laws promised .........BBC

[Guest guest]

http://news.bbc.co.uk/2/hi/health/7280798.stm

Tighter drug trial laws promised

Seroxat is the most frequently prescribed antidepressant

Ministers have promised to tighten laws requiring drug firms to

disclose data from clinical trials.

It comes after the drugs regulator announced GlaxoKline would

not face criminal proceedings over claims it withheld information on

Seroxat.

But they warned GSK should have been quicker to raise the alarm on

the risk of suicidal behaviour associated with the antidepressant in

the under-18s.

GSK has rejected claims it improperly withheld drug-trial

information.

The Medicines and Healthcare products Regulatory Agency (MHRA)

received data from clinical trials in May 2003 showing that patients

under 18 had a higher risk of suicidal behaviour if they were treated

with Seroxat than if they received a placebo. We will take

immediate steps to ensure the law is strengthened further, so that

there can be no doubt as to companies' obligations to report safety

issues

Professor Kent Woods, MHRA

Q & A: Seroxat data

Data also showed that Seroxat was not effective for treating

depression in children and adolescents.

The drug was subsequently banned for use in under 18s.

'Responsibility'

But Professor Kent Woods, MHRA chief executive said they were

disappointed GSK had not given them information earlier and that

drugs firms had an " ethical responsibility " .

" I remain concerned that GSK could and should have reported this

information earlier than they did.

" All companies have a responsibility to patients, and should report

any adverse data signals to us as soon as they discover them.

" This investigation has revealed important weaknesses in the drug

safety legislation in force at the time. "

He said subsequent legislation has partially addressed the problem

but more still needed to be done.

The MHRA spent four years looking at over one million pages of

evidence to determine whether GSK had withheld information.

They concluded there was no realistic prospect of a conviction as

legislation in place at the time was not sufficient to require

companies to inform the regulator of safety information when the drug

was being used for, or tested outside its licensed indications.

In common with many drugs, Seroxat was never licensed for the under

18s, but doctors could still prescribe it.

A BBC Panorama investigation last year reported that secret e-mails

showed the drug company distorted trial results, covering up a link

with suicide in teenagers.

The internal documents suggested GSK knew there was a problem with

the effectiveness of Seroxat in children five years before the drug

was banned.

Health minister Dawn Primarolo said the government would take

immediate steps to secure a strengthening of the law in the UK and

Europe.

She also said they wanted to make it clear to all pharmaceutical

companies that, " notwithstanding the limitations that may exist in

the law, they should disclose any information they have that would

have a bearing on the protection of health " .

Dr Alastair Benbow, medical director for GSK Europe said: " We firmly

believe we acted properly and responsibly in first carrying out this

important clinical trials programme and then informing the regulatory

agencies when we identified a potential increased risk of suicidal

thinking and behaviour in patients under 18.

" GSK is committed to working with the government, appropriate

regulatory authorities and other pharmaceutical companies to take

whatever action is necessary to improve legislation and policy in

this area. "

McCulloch, chief executive of the Mental Health Foundation

said it was " totally unacceptable " to hear that young people may have

taken their own lives due to a lack of transparency by a

pharmaceutical company.

[Guest guest]

http://news.bbc.co.uk/2/hi/health/7280798.stm

Tighter drug trial laws promised

Seroxat is the most frequently prescribed antidepressant

Ministers have promised to tighten laws requiring drug firms to

disclose data from clinical trials.

It comes after the drugs regulator announced GlaxoKline would

not face criminal proceedings over claims it withheld information on

Seroxat.

But they warned GSK should have been quicker to raise the alarm on

the risk of suicidal behaviour associated with the antidepressant in

the under-18s.

GSK has rejected claims it improperly withheld drug-trial

information.

The Medicines and Healthcare products Regulatory Agency (MHRA)

received data from clinical trials in May 2003 showing that patients

under 18 had a higher risk of suicidal behaviour if they were treated

with Seroxat than if they received a placebo. We will take

immediate steps to ensure the law is strengthened further, so that

there can be no doubt as to companies' obligations to report safety

issues

Professor Kent Woods, MHRA

Q & A: Seroxat data

Data also showed that Seroxat was not effective for treating

depression in children and adolescents.

The drug was subsequently banned for use in under 18s.

'Responsibility'

But Professor Kent Woods, MHRA chief executive said they were

disappointed GSK had not given them information earlier and that

drugs firms had an " ethical responsibility " .

" I remain concerned that GSK could and should have reported this

information earlier than they did.

" All companies have a responsibility to patients, and should report

any adverse data signals to us as soon as they discover them.

" This investigation has revealed important weaknesses in the drug

safety legislation in force at the time. "

He said subsequent legislation has partially addressed the problem

but more still needed to be done.

The MHRA spent four years looking at over one million pages of

evidence to determine whether GSK had withheld information.

They concluded there was no realistic prospect of a conviction as

legislation in place at the time was not sufficient to require

companies to inform the regulator of safety information when the drug

was being used for, or tested outside its licensed indications.

In common with many drugs, Seroxat was never licensed for the under

18s, but doctors could still prescribe it.

A BBC Panorama investigation last year reported that secret e-mails

showed the drug company distorted trial results, covering up a link

with suicide in teenagers.

The internal documents suggested GSK knew there was a problem with

the effectiveness of Seroxat in children five years before the drug

was banned.

Health minister Dawn Primarolo said the government would take

immediate steps to secure a strengthening of the law in the UK and

Europe.

She also said they wanted to make it clear to all pharmaceutical

companies that, " notwithstanding the limitations that may exist in

the law, they should disclose any information they have that would

have a bearing on the protection of health " .

Dr Alastair Benbow, medical director for GSK Europe said: " We firmly

believe we acted properly and responsibly in first carrying out this

important clinical trials programme and then informing the regulatory

agencies when we identified a potential increased risk of suicidal

thinking and behaviour in patients under 18.

" GSK is committed to working with the government, appropriate

regulatory authorities and other pharmaceutical companies to take

whatever action is necessary to improve legislation and policy in

this area. "

McCulloch, chief executive of the Mental Health Foundation

said it was " totally unacceptable " to hear that young people may have

taken their own lives due to a lack of transparency by a

pharmaceutical company.

[Guest guest]

http://news.bbc.co.uk/2/hi/health/7280798.stm

Tighter drug trial laws promised

Seroxat is the most frequently prescribed antidepressant

Ministers have promised to tighten laws requiring drug firms to

disclose data from clinical trials.

It comes after the drugs regulator announced GlaxoKline would

not face criminal proceedings over claims it withheld information on

Seroxat.

But they warned GSK should have been quicker to raise the alarm on

the risk of suicidal behaviour associated with the antidepressant in

the under-18s.

GSK has rejected claims it improperly withheld drug-trial

information.

The Medicines and Healthcare products Regulatory Agency (MHRA)

received data from clinical trials in May 2003 showing that patients

under 18 had a higher risk of suicidal behaviour if they were treated

with Seroxat than if they received a placebo. We will take

immediate steps to ensure the law is strengthened further, so that

there can be no doubt as to companies' obligations to report safety

issues

Professor Kent Woods, MHRA

Q & A: Seroxat data

Data also showed that Seroxat was not effective for treating

depression in children and adolescents.

The drug was subsequently banned for use in under 18s.

'Responsibility'

But Professor Kent Woods, MHRA chief executive said they were

disappointed GSK had not given them information earlier and that

drugs firms had an " ethical responsibility " .

" I remain concerned that GSK could and should have reported this

information earlier than they did.

" All companies have a responsibility to patients, and should report

any adverse data signals to us as soon as they discover them.

" This investigation has revealed important weaknesses in the drug

safety legislation in force at the time. "

He said subsequent legislation has partially addressed the problem

but more still needed to be done.

The MHRA spent four years looking at over one million pages of

evidence to determine whether GSK had withheld information.

They concluded there was no realistic prospect of a conviction as

legislation in place at the time was not sufficient to require

companies to inform the regulator of safety information when the drug

was being used for, or tested outside its licensed indications.

In common with many drugs, Seroxat was never licensed for the under

18s, but doctors could still prescribe it.

A BBC Panorama investigation last year reported that secret e-mails

showed the drug company distorted trial results, covering up a link

with suicide in teenagers.

The internal documents suggested GSK knew there was a problem with

the effectiveness of Seroxat in children five years before the drug

was banned.

Health minister Dawn Primarolo said the government would take

immediate steps to secure a strengthening of the law in the UK and

Europe.

She also said they wanted to make it clear to all pharmaceutical

companies that, " notwithstanding the limitations that may exist in

the law, they should disclose any information they have that would

have a bearing on the protection of health " .

Dr Alastair Benbow, medical director for GSK Europe said: " We firmly

believe we acted properly and responsibly in first carrying out this

important clinical trials programme and then informing the regulatory

agencies when we identified a potential increased risk of suicidal

thinking and behaviour in patients under 18.

" GSK is committed to working with the government, appropriate

regulatory authorities and other pharmaceutical companies to take

whatever action is necessary to improve legislation and policy in

this area. "

McCulloch, chief executive of the Mental Health Foundation

said it was " totally unacceptable " to hear that young people may have

taken their own lives due to a lack of transparency by a

pharmaceutical company.

[Guest guest]

http://news.bbc.co.uk/2/hi/health/7280798.stm

Tighter drug trial laws promised

Seroxat is the most frequently prescribed antidepressant

Ministers have promised to tighten laws requiring drug firms to

disclose data from clinical trials.

It comes after the drugs regulator announced GlaxoKline would

not face criminal proceedings over claims it withheld information on

Seroxat.

But they warned GSK should have been quicker to raise the alarm on

the risk of suicidal behaviour associated with the antidepressant in

the under-18s.

GSK has rejected claims it improperly withheld drug-trial

information.

The Medicines and Healthcare products Regulatory Agency (MHRA)

received data from clinical trials in May 2003 showing that patients

under 18 had a higher risk of suicidal behaviour if they were treated

with Seroxat than if they received a placebo. We will take

immediate steps to ensure the law is strengthened further, so that

there can be no doubt as to companies' obligations to report safety

issues

Professor Kent Woods, MHRA

Q & A: Seroxat data

Data also showed that Seroxat was not effective for treating

depression in children and adolescents.

The drug was subsequently banned for use in under 18s.

'Responsibility'

But Professor Kent Woods, MHRA chief executive said they were

disappointed GSK had not given them information earlier and that

drugs firms had an " ethical responsibility " .

" I remain concerned that GSK could and should have reported this

information earlier than they did.

" All companies have a responsibility to patients, and should report

any adverse data signals to us as soon as they discover them.

" This investigation has revealed important weaknesses in the drug

safety legislation in force at the time. "

He said subsequent legislation has partially addressed the problem

but more still needed to be done.

The MHRA spent four years looking at over one million pages of

evidence to determine whether GSK had withheld information.

They concluded there was no realistic prospect of a conviction as

legislation in place at the time was not sufficient to require

companies to inform the regulator of safety information when the drug

was being used for, or tested outside its licensed indications.

In common with many drugs, Seroxat was never licensed for the under

18s, but doctors could still prescribe it.

A BBC Panorama investigation last year reported that secret e-mails

showed the drug company distorted trial results, covering up a link

with suicide in teenagers.

The internal documents suggested GSK knew there was a problem with

the effectiveness of Seroxat in children five years before the drug

was banned.

Health minister Dawn Primarolo said the government would take

immediate steps to secure a strengthening of the law in the UK and

Europe.

She also said they wanted to make it clear to all pharmaceutical

companies that, " notwithstanding the limitations that may exist in

the law, they should disclose any information they have that would

have a bearing on the protection of health " .

Dr Alastair Benbow, medical director for GSK Europe said: " We firmly

believe we acted properly and responsibly in first carrying out this

important clinical trials programme and then informing the regulatory

agencies when we identified a potential increased risk of suicidal

thinking and behaviour in patients under 18.

" GSK is committed to working with the government, appropriate

regulatory authorities and other pharmaceutical companies to take

whatever action is necessary to improve legislation and policy in

this area. "

McCulloch, chief executive of the Mental Health Foundation

said it was " totally unacceptable " to hear that young people may have

taken their own lives due to a lack of transparency by a

pharmaceutical company.