Note - this had already been tested on animals

[Guest guest]

..... yet another proof that animal testing has no relevance to how

humans react.

 

Jo

 

Six taken ill after drug trials

 

The six are being treated at Northwick Park hospital

Six men remain in intensive care after being taken ill during a

clinical drugs trial in north-west London.

The volunteers suffered a bad reaction to an anti-inflammatory drug

being tested at a research unit based at Northwick Park Hospital.

 

Relatives are with the patients, who suffered multiple organ failure.

Two men are said to be critically ill.

 

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

followed recommended guidelines in its trial.

 

Our immediate priority has been to ensure that no further patients

are harmed

 

Kent Woods

MHRA

 

The men were volunteers in the early stages of a trial for the drug

to treat conditions such as rheumatoid arthritis and leukaemia, and

were taken ill on Monday within hours of taking it.

 

Eight men had taken part, but two were given a placebo at the unit,

which is on Northwick Park Hospital's grounds, but is run

independently.

 

The hospital's intensive care director Ganesh Suntharalingam said the

patients were admitted very quickly and were receiving " close

monitoring and appropriate treatment " .

 

A Northwick Park Hospital spokesman said two are in a critical

condition, while the other four are " serious but stable " .

 

'Exhaustive investigation'

 

The Medicines and Healthcare products Regulatory Agency (MHRA)

immediately withdrew authorisation for the trial. An international

warning has also gone out, to prevent it being tested abroad.

 

Its inspectors will visit the research unit and it is in contact with

the local strategic health authority, the Department of Health and

police about the cases.

 

Such an adverse drug reaction occurs extremely rarely

 

Herman Scholtz

Parexel

 

Chief executive officer 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 and in a laboratory.

 

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

and such cases were extremely rare.

 

Professor Herman Scholtz, from Parexel, said the clinical research

organisation had followed regulatory, medical and clinical research

guidelines during the study.

 

He said: " When the adverse drug reaction occurred, the Parexel

clinical pharmacology medical team responded swiftly to stop the

study procedures immediately. "

 

He added: " Such an adverse drug reaction occurs extremely rarely and

this is an unfortunate and unusual situation.

 

" Since our unit is located within the hospital, we have immediate

access to world-class medical care and we did everything possible to

get the patients treated as quickly as possible. "

[Guest guest]

Were these poor souls already suffering from RA and luekimia? If so it is even

more tragic

as they may have had emotional blackmail to get hem to try it... like " we have

an exiciting

new drug which may help you " or " there is nothing else we can do for you,

except this

new drug may work " . I am sure this goes on a lot.

 

 

, " heartwerk " <jo.heartwork wrote:

>

> .... yet another proof that animal testing has no relevance to how

> humans react.

>

> Jo

>

> Six taken ill after drug trials

>

> The six are being treated at Northwick Park hospital

> Six men remain in intensive care after being taken ill during a

> clinical drugs trial in north-west London.

> The volunteers suffered a bad reaction to an anti-inflammatory drug

> being tested at a research unit based at Northwick Park Hospital.

>

> Relatives are with the patients, who suffered multiple organ failure.

> Two men are said to be critically ill.

>

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

> followed recommended guidelines in its trial.

>

> Our immediate priority has been to ensure that no further patients

> are harmed

>

> Kent Woods

> MHRA

>

> The men were volunteers in the early stages of a trial for the drug

> to treat conditions such as rheumatoid arthritis and leukaemia, and

> were taken ill on Monday within hours of taking it.

>

> Eight men had taken part, but two were given a placebo at the unit,

> which is on Northwick Park Hospital's grounds, but is run

> independently.

>

> The hospital's intensive care director Ganesh Suntharalingam said the

> patients were admitted very quickly and were receiving " close

> monitoring and appropriate treatment " .

>

> A Northwick Park Hospital spokesman said two are in a critical

> condition, while the other four are " serious but stable " .

>

> 'Exhaustive investigation'

>

> The Medicines and Healthcare products Regulatory Agency (MHRA)

> immediately withdrew authorisation for the trial. An international

> warning has also gone out, to prevent it being tested abroad.

>

> Its inspectors will visit the research unit and it is in contact with

> the local strategic health authority, the Department of Health and

> police about the cases.

>

> Such an adverse drug reaction occurs extremely rarely

>

> Herman Scholtz

> Parexel

>

> Chief executive officer 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 and in a laboratory.

>

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

> and such cases were extremely rare.

>

> Professor Herman Scholtz, from Parexel, said the clinical research

> organisation had followed regulatory, medical and clinical research

> guidelines during the study.

>

> He said: " When the adverse drug reaction occurred, the Parexel

> clinical pharmacology medical team responded swiftly to stop the

> study procedures immediately. "

>

> He added: " Such an adverse drug reaction occurs extremely rarely and

> this is an unfortunate and unusual situation.

>

> " Since our unit is located within the hospital, we have immediate

> access to world-class medical care and we did everything possible to

> get the patients treated as quickly as possible. "

>

[Guest guest]

They were all healthy people. The one I have heard most about needed money

quite urgently, so took the £2000 to be a guinea-pig. I am sure what you

say is true with other trials.

 

Jo

 

-

" herbvalerian " <herbvalerian

 

Wednesday, March 15, 2006 4:18 PM

Re: Note - this had already been tested on animals

 

 

> Were these poor souls already suffering from RA and luekimia? If so it is

even more tragic

> as they may have had emotional blackmail to get hem to try it... like " we

have an exiciting

> new drug which may help you " or " there is nothing else we can do for you,

except this

> new drug may work " . I am sure this goes on a lot.