SIX men are in intensive care in a British hospital after suffering violent reactions to a new drug they took as part of a clinical trial.

 

One man's head had swollen up to three times its normal size, a newspaper reported today.

The volunteers fell ill after taking the drug, being developed for a German company to treat chronic inflammatory conditions and leukaemia.

 

Student Ryan Flanagan, 21, of Highbury, north London, was taken to intensive care three hours after taking the drug, The Sun newspaper reported.

 

His family were told he could not breathe and his head and neck had swollen to three times normal size.

 

Family friend Sarah Brown, 27, told the paper: "Ryan was a healthy young man and he saw the trial advertised on the internet.

 

"He is at college and was doing it to make a bit of extra money.

 

"He told us he would be paid STG2,000 ($4,750) and did not think there would be any problems.

 

"His mother got a call to say his head and neck were swelling up and his legs were purple."

 

The Medicines and Healthcare Products Regulatory Agency (MHRA) said eight men took part in the trial, two of whom were given a placebo. The six who took the drug all became ill.

 

"An event like this is quite unprecedented," the MHRA's chief executive officer Kent Woods said.

 

"There are several possibilities as to what might have gone wrong," he told BBC radio today.

 

"We've had inspectors on site since yesterday trying to clarify what exactly the event was that caused this disaster.

 

"Has there been some manufacturing problem? Has there been some issue of contamination? Has there been a dosing error or is this indeed some completely unanticipated side effect of the drug in humans, which is specific to humans?"

 

The trial was set up by US drug research company Parexel International Corp on behalf of German pharmaceutical company TeGenero.

 

Parexel described the incident as "unfortunate and unusual", adding that it assumed the volunteers had suffered an adverse reaction to the drug, known as TGN 1412.

 

"Such an adverse drug reaction occurs extremely rarely," Professor Herman Scholtz, head of Parexel International Clinical Pharmacology, said in a statement.

 

This was the first human test of the drug, designed to treat illnesses like cancer and rheumatoid arthritis.

 

As soon as the men fell ill, the MHRA suspended the trial and notified other European regulatory bodies about it.

 

The unnamed patients are being treated at Northwick Park Hospital in northwest London.

 

"They are in a serious condition," said Ganesh Suntharalingam, the hospital's Clinical Director of Intensive Care. "Their families are very concerned, and we are keeping them closely informed about their relatives' progress."

 

:stunned:

:stunned: Woah, that's scary.

 

The dude's head went three times it's normal size?! :shocked: Holy shiz!

That is crazy! Apparently his skin turned purple or something. How strange. £2000 for days of agony...not really worth it I reckon. Few hundred thousand maybe...

Its quite horrific, those poor guys have really suffered from some nasty side effects.

 

You know what's really bugging me about this? The word compensation was used in the newspapers this morning. Now correct me if i'm wrong, but if you put yourself forward for a drug trial you have to sign that you agree to various things. One of which is going to be that this is the first trial on human beings, and that the reason for the trial is to ensure there are no side effects. So, you are agreeing to be paid £2000 for this as their is a risk of side effects. So how can you then claim compensation, when you knew in advance that the reason you were agreeing to the test is because they don't know if there are any side effects in humans?

And surely, anyone who puts themselves through drug trials is doing it for altruistic reasons and not for the money?

Where this world is heading..for God sake..

I've seen that in the evening news during the halftime of an UEFA-Cup match... That "medicament" was developed in Würzburg (Germany) to treat leukaemia and chronic inflammatory conditions. The people there were shocked after they heard about it. It's scary that one man's head had swollen up to three times its normal size. Hope he's getting better now... :(

As sad as it is, doctors and scientists can only learn from their mistakes :blank: