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Six violently ill after drug trial

15mar06

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

Parexel described the incident as "unfortunate and unusual"

minir wrote:Hi Pie



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How callous a statement is that by Parexel

That ought to help their future recruiting for Test Bodies...Not!

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minir

minir wrote: How callous a statement is that by Parexel

That ought to help their future recruiting for Test Bodies...Not!

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minir

YARDofSTUF wrote:SURPRISE! Untested drugs aren't safe. Sucks for the guys doing it, healthy people should, people that have the disease or illness teh drug is being tested to help or cure should be doing it. And either way stuff like this is always a possiblilty.

Until a drug is tested on humans we can't know exactly how it will react.

YARDofSTUF wrote:I don't see a problem with the statement, and I bet they will always get test subjects when they put ads out for them.

thepieman wrote:Actually it probably should have been tested on animals a little more first, but we all know Animal rights come before humans nowadays. God forbid testing a drug on a monkey and its head swells. Pamela Anderson would have a hissy fit.

BlindPilot wrote:Well it was tested on animals to an extent, but obviously theres only so much testing drugs on animals and not humans can tell you.

They will all have signed a contract saying they can bring no action in the case that any harm came to them through taking the drugs, i've looked into drug testing in the past when being broke at uni.

Ofcoarse i only ever looked at the cases where a few £, say 100, was offered, the stuff being paid in the 1000's always seemed too dodgy..

thepieman wrote:Actually it probably should have been tested on animals a little more first, but we all know Animal rights come before humans nowadays. God forbid testing a drug on a monkey and its head swells. Pamela Anderson would have a hissy fit.

ghettoside wrote:Are there any details yet on what testing was done prior to human testing?

YARDofSTUF wrote:A couple different articles mention that Parexel followed the correct steps. The questions seem to be in manufacturing and contamination, or esle just a side effect.

Animal testing can only do so much. First test on humans, I wouldnt expect it to go well.

THis is Britian, they dont have "our" PETA to deal with.

thepieman wrote:They did mention animal testing but I've seen videos on some of the Animal Rights groups and they really put pressure on these companies to stop using animals to test drugs and cosmetics on. The cosmetics I can understand but drugs are extremely important. These kind of things could save human lives and can avoid things like this from happening. 21 years old and just looking to make some money..it really is a shame if they are handicapped for life or they die. I hope they pull through.


Pie

thepieman wrote:Nah just a sad situation man. Could be you or any one of the young guys/girls here strapped for cash going to school. I know you say you wouldn't do it but....they either hadda be pretty desperate or maybe they didn't advertise it to be as dangerous as it could have been.

Parexel described the incident as "unfortunate and unusual"

minir wrote:----


Paid or not. Warned or not. Waivers or not. Proper procedures followed or not? They were human beings and had hopes and futures, as well as Families that are now left wondering Why!

To call their condition or possible demise "Unfortunate" is an insult imho.

One would at least hope that their spokesperson would have had the common decency to show some concern and empathy at what has happened to those involved as well as their Family members and loved ones.

"Unfortunate" to me at least, simply doesn't cover it.

Yes there will always be volunteers, however perhaps not quite so many if this is the kind of callous treatment offered by the Drug Companies.

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minir

``occurs extremely rarely and this is an unfortunate and unusual situation,'' Herman Scholtz, head of clinical pharmacology at Parexel, said in an e-mailed statement. ``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.''

YARDofSTUF wrote:Well theres some more Minir, but I don't see why you should be so upset over a short public statement. Who cares how long and drawn out they say sorry for on the news?

minir wrote:--

Hi YARDofSTUF

I for one care & would think the Families and friends of those whose lives maybe lost or lessened would as well.

Its not like someone dinged a car in the parking lot and "Unfortunate" might cover the situation. These are flesh & blood human beings involved and whatever their motives, altruistic or financial they deserve to be shown due respect imho.

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regards

minir

YARDofSTUF wrote:What they say to the public and families are probably different. Parexel publicly saying its unfortunate is enough, explains there thoughts on it. Now if some guy from teh company walked up, said that, and left, thats something else.

minir wrote:--

Hi YARDofSTUF

I guess we'll have to agree to disagree on this one YARDofSTUF. I find their response inappropriate for the situation and lacking in compassion for those involved.

No matter what motives these Men had in being used as guinea pigs for the drugs involved they where in their own way helping humanity and deserve better imho.

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regards

minir

Burke wrote:Work some overtime or get a second job or cut out some expenses if you need money. Something tells me these people would volunteer to be crash test dummies if the pay was good enough.

YARDofSTUF wrote:Sign up now, $5000 for eacher person to test bullet impacts!

knightmare wrote:Classy reply Minir, as always.
Most on this forum regard another human being's suffering as tough cookies*, or the victim's own stupidity.

Prey521 wrote:@ 5K per bullet, I'd do it

Izzo wrote:You assume this risk when you sign at the dotted line.

Ken wrote:Why are you bringing marriage into this thread?

Izzo wrote:She made you sign a pre-nup?



*points n laffs*

YARDofSTUF wrote:Nah hes BSin' ya, no man thats married has their head swell up 3x its size!