(drug trial UK) .Health secretary Hewitt said: It is a shocking event

[Guest guest]

The six are being treated at Northwick Park hospital

Six men remain in intensive care after they were taken ill during a

clinical drugs test in north-west London.

The healthy volunteers had been given an anti-inflammatory drug at a

private research unit based at Northwick Park Hospital when they

suffered a reaction.

http://news.bbc.co.uk/1/hi/england/london/4808836.stm

Myfanwy Marshall told BBC News her boyfriend's body was badly

swollen and his organs were failing.

An investigation has begun at the unit, run by Parexel, which said

it followed recommended guidelines in its trial.

The young men were being paid to take part in the early stages of a

trial for the drug TGN1412 which is designed to treat conditions

such as rheumatoid arthritis and leukaemia.

But within hours of taking it on Monday, six volunteers had to be

admitted to intensive care - a further two had been given a placebo.

This is not leukaemia, this is not pneumonia, this is not something

they know how to deal with

Myfanwy Marshall

'He needs a miracle'

Northwick Park Hospital's intensive care director Ganesh

Suntharalingam said two were in a critical condition, and the other

four were serious but showing some signs of improvement.

He added his team had been doing everything possible in this " unique

set of circumstances " .

" The drug, which is untested and therefore unused by doctors, has

caused an inflammatory response which affects some organs of the

body, " he said.

Ms Marshall, 35, whose boyfriend is critically ill, said the

normally healthy 28-year-old barman's face was so puffed, he " looks

like the Elephant Man " .

She said: " His friends cannot even face seeing him. I have to stay

there because I'm looking beyond all the wires and the puffiness.

" This is not leukaemia, this is not pneumonia, this is not something

they know how to deal with. "

Such an adverse drug reaction occurs extremely rarely and this is

an unfortunate and unusual situation

Professor Herman Scholtz, Parexel

Q & A: Drug trials

Send us your experiences

The Medicines and Healthcare products Regulatory Agency (MHRA)

immediately withdrew authorisation for the trial and an

international warning was sent out to prevent the drug from being

tested abroad.

MHRA inspectors have visited the independent research unit and are

in talks with the local strategic health authority, the Department

of Health and police about the cases.

Its chief executive Professor Kent Woods said: " Our immediate

priority has been to ensure that no further patients are harmed.

" We will now undertake an exhaustive investigation to determine the

cause and ensure all appropriate actions are taken. "

It had approved the trial and the drug had already been tested on

animals.

Volunteers are paid up to £150 a day to take part in clinical

trials.

'Swift response'

Parexel, which was running the trial, said it had followed

guidelines and such cases were extremely rare.

The Medical Research Council said that while it was " an unfortunate

and extremely rare event " , such clinical trials were essential for

the development of new and better treatments.

Professor Herman Scholtz, from Parexel, said: " When the adverse drug

reaction occurred, the Parexel clinical pharmacology medical team

responded swiftly to stop the study procedures immediately.

" Such an adverse drug reaction occurs extremely rarely and this is

an unfortunate and unusual situation. We did everything possible to

get the patients treated as quickly as possible. "

TeGenero, the Germany-based manufacturers of the drug, said the

events were completely unexpected and did not reflect results from

initial laboratory studies.

Health secretary Hewitt said: " It is a shocking event and

obviously our thoughts are with those young people and with their

families. "

---------------------------------------------------------------------

-----------

Have you taken part in a drug trial? How did you find the

experience? Would you consider taking part in one? Have you

conducted a drug trial? Send us your comments and experiences.

Click here to send us your comments

[Guest guest]

The six are being treated at Northwick Park hospital

Six men remain in intensive care after they were taken ill during a

clinical drugs test in north-west London.

The healthy volunteers had been given an anti-inflammatory drug at a

private research unit based at Northwick Park Hospital when they

suffered a reaction.

http://news.bbc.co.uk/1/hi/england/london/4808836.stm

Myfanwy Marshall told BBC News her boyfriend's body was badly

swollen and his organs were failing.

An investigation has begun at the unit, run by Parexel, which said

it followed recommended guidelines in its trial.

The young men were being paid to take part in the early stages of a

trial for the drug TGN1412 which is designed to treat conditions

such as rheumatoid arthritis and leukaemia.

But within hours of taking it on Monday, six volunteers had to be

admitted to intensive care - a further two had been given a placebo.

This is not leukaemia, this is not pneumonia, this is not something

they know how to deal with

Myfanwy Marshall

'He needs a miracle'

Northwick Park Hospital's intensive care director Ganesh

Suntharalingam said two were in a critical condition, and the other

four were serious but showing some signs of improvement.

He added his team had been doing everything possible in this " unique

set of circumstances " .

" The drug, which is untested and therefore unused by doctors, has

caused an inflammatory response which affects some organs of the

body, " he said.

Ms Marshall, 35, whose boyfriend is critically ill, said the

normally healthy 28-year-old barman's face was so puffed, he " looks

like the Elephant Man " .

She said: " His friends cannot even face seeing him. I have to stay

there because I'm looking beyond all the wires and the puffiness.

" This is not leukaemia, this is not pneumonia, this is not something

they know how to deal with. "

Such an adverse drug reaction occurs extremely rarely and this is

an unfortunate and unusual situation

Professor Herman Scholtz, Parexel

Q & A: Drug trials

Send us your experiences

The Medicines and Healthcare products Regulatory Agency (MHRA)

immediately withdrew authorisation for the trial and an

international warning was sent out to prevent the drug from being

tested abroad.

MHRA inspectors have visited the independent research unit and are

in talks with the local strategic health authority, the Department

of Health and police about the cases.

Its chief executive Professor Kent Woods said: " Our immediate

priority has been to ensure that no further patients are harmed.

" We will now undertake an exhaustive investigation to determine the

cause and ensure all appropriate actions are taken. "

It had approved the trial and the drug had already been tested on

animals.

Volunteers are paid up to £150 a day to take part in clinical

trials.

'Swift response'

Parexel, which was running the trial, said it had followed

guidelines and such cases were extremely rare.

The Medical Research Council said that while it was " an unfortunate

and extremely rare event " , such clinical trials were essential for

the development of new and better treatments.

Professor Herman Scholtz, from Parexel, said: " When the adverse drug

reaction occurred, the Parexel clinical pharmacology medical team

responded swiftly to stop the study procedures immediately.

" Such an adverse drug reaction occurs extremely rarely and this is

an unfortunate and unusual situation. We did everything possible to

get the patients treated as quickly as possible. "

TeGenero, the Germany-based manufacturers of the drug, said the

events were completely unexpected and did not reflect results from

initial laboratory studies.

Health secretary Hewitt said: " It is a shocking event and

obviously our thoughts are with those young people and with their

families. "

---------------------------------------------------------------------

-----------

Have you taken part in a drug trial? How did you find the

experience? Would you consider taking part in one? Have you

conducted a drug trial? Send us your comments and experiences.

Click here to send us your comments

[Guest guest]

The six are being treated at Northwick Park hospital

Six men remain in intensive care after they were taken ill during a

clinical drugs test in north-west London.

The healthy volunteers had been given an anti-inflammatory drug at a

private research unit based at Northwick Park Hospital when they

suffered a reaction.

http://news.bbc.co.uk/1/hi/england/london/4808836.stm

Myfanwy Marshall told BBC News her boyfriend's body was badly

swollen and his organs were failing.

An investigation has begun at the unit, run by Parexel, which said

it followed recommended guidelines in its trial.

The young men were being paid to take part in the early stages of a

trial for the drug TGN1412 which is designed to treat conditions

such as rheumatoid arthritis and leukaemia.

But within hours of taking it on Monday, six volunteers had to be

admitted to intensive care - a further two had been given a placebo.

This is not leukaemia, this is not pneumonia, this is not something

they know how to deal with

Myfanwy Marshall

'He needs a miracle'

Northwick Park Hospital's intensive care director Ganesh

Suntharalingam said two were in a critical condition, and the other

four were serious but showing some signs of improvement.

He added his team had been doing everything possible in this " unique

set of circumstances " .

" The drug, which is untested and therefore unused by doctors, has

caused an inflammatory response which affects some organs of the

body, " he said.

Ms Marshall, 35, whose boyfriend is critically ill, said the

normally healthy 28-year-old barman's face was so puffed, he " looks

like the Elephant Man " .

She said: " His friends cannot even face seeing him. I have to stay

there because I'm looking beyond all the wires and the puffiness.

" This is not leukaemia, this is not pneumonia, this is not something

they know how to deal with. "

Such an adverse drug reaction occurs extremely rarely and this is

an unfortunate and unusual situation

Professor Herman Scholtz, Parexel

Q & A: Drug trials

Send us your experiences

The Medicines and Healthcare products Regulatory Agency (MHRA)

immediately withdrew authorisation for the trial and an

international warning was sent out to prevent the drug from being

tested abroad.

MHRA inspectors have visited the independent research unit and are

in talks with the local strategic health authority, the Department

of Health and police about the cases.

Its chief executive Professor Kent Woods said: " Our immediate

priority has been to ensure that no further patients are harmed.

" We will now undertake an exhaustive investigation to determine the

cause and ensure all appropriate actions are taken. "

It had approved the trial and the drug had already been tested on

animals.

Volunteers are paid up to £150 a day to take part in clinical

trials.

'Swift response'

Parexel, which was running the trial, said it had followed

guidelines and such cases were extremely rare.

The Medical Research Council said that while it was " an unfortunate

and extremely rare event " , such clinical trials were essential for

the development of new and better treatments.

Professor Herman Scholtz, from Parexel, said: " When the adverse drug

reaction occurred, the Parexel clinical pharmacology medical team

responded swiftly to stop the study procedures immediately.

" Such an adverse drug reaction occurs extremely rarely and this is

an unfortunate and unusual situation. We did everything possible to

get the patients treated as quickly as possible. "

TeGenero, the Germany-based manufacturers of the drug, said the

events were completely unexpected and did not reflect results from

initial laboratory studies.

Health secretary Hewitt said: " It is a shocking event and

obviously our thoughts are with those young people and with their

families. "

---------------------------------------------------------------------

-----------

Have you taken part in a drug trial? How did you find the

experience? Would you consider taking part in one? Have you

conducted a drug trial? Send us your comments and experiences.

Click here to send us your comments

[Guest guest]

The six are being treated at Northwick Park hospital

Six men remain in intensive care after they were taken ill during a

clinical drugs test in north-west London.

The healthy volunteers had been given an anti-inflammatory drug at a

private research unit based at Northwick Park Hospital when they

suffered a reaction.

http://news.bbc.co.uk/1/hi/england/london/4808836.stm

Myfanwy Marshall told BBC News her boyfriend's body was badly

swollen and his organs were failing.

An investigation has begun at the unit, run by Parexel, which said

it followed recommended guidelines in its trial.

The young men were being paid to take part in the early stages of a

trial for the drug TGN1412 which is designed to treat conditions

such as rheumatoid arthritis and leukaemia.

But within hours of taking it on Monday, six volunteers had to be

admitted to intensive care - a further two had been given a placebo.

This is not leukaemia, this is not pneumonia, this is not something

they know how to deal with

Myfanwy Marshall

'He needs a miracle'

Northwick Park Hospital's intensive care director Ganesh

Suntharalingam said two were in a critical condition, and the other

four were serious but showing some signs of improvement.

He added his team had been doing everything possible in this " unique

set of circumstances " .

" The drug, which is untested and therefore unused by doctors, has

caused an inflammatory response which affects some organs of the

body, " he said.

Ms Marshall, 35, whose boyfriend is critically ill, said the

normally healthy 28-year-old barman's face was so puffed, he " looks

like the Elephant Man " .

She said: " His friends cannot even face seeing him. I have to stay

there because I'm looking beyond all the wires and the puffiness.

" This is not leukaemia, this is not pneumonia, this is not something

they know how to deal with. "

Such an adverse drug reaction occurs extremely rarely and this is

an unfortunate and unusual situation

Professor Herman Scholtz, Parexel

Q & A: Drug trials

Send us your experiences

The Medicines and Healthcare products Regulatory Agency (MHRA)

immediately withdrew authorisation for the trial and an

international warning was sent out to prevent the drug from being

tested abroad.

MHRA inspectors have visited the independent research unit and are

in talks with the local strategic health authority, the Department

of Health and police about the cases.

Its chief executive Professor Kent Woods said: " Our immediate

priority has been to ensure that no further patients are harmed.

" We will now undertake an exhaustive investigation to determine the

cause and ensure all appropriate actions are taken. "

It had approved the trial and the drug had already been tested on

animals.

Volunteers are paid up to £150 a day to take part in clinical

trials.

'Swift response'

Parexel, which was running the trial, said it had followed

guidelines and such cases were extremely rare.

The Medical Research Council said that while it was " an unfortunate

and extremely rare event " , such clinical trials were essential for

the development of new and better treatments.

Professor Herman Scholtz, from Parexel, said: " When the adverse drug

reaction occurred, the Parexel clinical pharmacology medical team

responded swiftly to stop the study procedures immediately.

" Such an adverse drug reaction occurs extremely rarely and this is

an unfortunate and unusual situation. We did everything possible to

get the patients treated as quickly as possible. "

TeGenero, the Germany-based manufacturers of the drug, said the

events were completely unexpected and did not reflect results from

initial laboratory studies.

Health secretary Hewitt said: " It is a shocking event and

obviously our thoughts are with those young people and with their

families. "

---------------------------------------------------------------------

-----------

Have you taken part in a drug trial? How did you find the

experience? Would you consider taking part in one? Have you

conducted a drug trial? Send us your comments and experiences.

Click here to send us your comments