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carbar
03-15-2006, 06:16 AM
Six men were in intensive care in a north London hospital last night after a pharmaceutical company's trial went wrong. Regulatory authorities have suspended the drug trial and are investigating in collaboration with the police.
The six were healthy volunteers, paid to take part in the earliest stage of human testing of a potential new medicine for inflammatory diseases such as rheumatoid arthritis and leukaemia. The volunteers were needed to establish whether there were any side effects or obvious problems with the drug before it was tested on people who have the conditions.

But on Monday, the first day of the trial, the Medicines and Healthcare Products Regulatory Authority (MHRA) said yesterday all six men became ill at the commercially run clinical trials unit at Northwick Park hospital, Harrow. One of the men reportedly had extreme breathing difficulties within three hours of taking the drug and his family was told his legs had turned purple, according to the Sun newspaper.
Two other men at the unit were enrolled in the trial but had been given a placebo and are unaffected.

Because the unit was in the hospital building, the sick men were rapidly given medical help and transferred to intensive care that evening. A spokeswoman for the MHRA said it was "very concerning" but "almost unheard of". The drug company, the German firm Te Genero, had submitted the results from animal safety tests, as it must do under the regulations, to get permission to run a trial on human beings. There had been no irregularities in the animal tests, the MHRA said. Investigators at the site will be looking at whether human error played a part in the incident, whether the product was contaminated or something went wrong with its storage.

http://www.guardian.co.uk/medicine/story/0,,1731230,00.html

metronycguy
03-15-2006, 11:07 AM
now that is scary!

carbar
03-15-2006, 12:17 PM
http://news.bbc.co.uk/1/hi/health/4808614.stm

Two men are critically ill and another four are seriously ill in the intensive care unit of Northwick Park hospital after taking an anti-inflammatory drug as part of a drug trial.
Myfanwy Marshall's boyfriend is one of those whose condition is critical. Doctors have warned he can die at any time.

She says he decided to take part in the trial - which paid around £2,000 - because he needed some money to pay his bills.

"He saw the ad, he told me it was for a leukaemia drug. He'd taken part in trials before and been fine.

"I didn't want him to do it, but he said he was helping mankind, helping scientific knowledge."

"I went in expecting to see his smiley face and curly black hair.

"But he was completely lifeless. He's like a shell of who he is.

"He can't even move his eyelids.

"This machine is pumping out his lungs. His chest is puffed out, his face is puffed out like the elephant man.

"A day ago I was talking to him and he was fine and now they are saying he could die at any moment."

She said his friends cannot bear to see him. His parents, who live abroad, are currently trying to get over to the UK.

Myfanwy added: "I can't hold his hand because of the tubes. But I have to stay there because I can see beyond the wires. I know he's in there.

"I sit and talk into his ear and tell his body to heal itself."

Myfanwy said doctors were working round the clock to treat the affected men, and were talking to scientists in the US and Germany who had worked on the development of the drug.

But she added: "The doctors say they are in the dark. They don't know the drug or what it can do.

carbar
03-16-2006, 09:21 AM
A volunteer who escaped a disastrous medical trial unscathed because he received a dummy drug today described how six other men collapsed writhing in agony minutes after being given experimental medication.
Raste Khan, 23, said he was terrified as the six men, all previously healthy, "went down like dominoes" screaming that their heads felt like they were going to explode as the anti-inflammatory drug, never before tested on humans, began to have a devastating effect.

Mr Khan, one of two volunteers given a placebo in the clinical trial, told The Sun: "First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were going to explode. It was terrifying because I kept expecting it to happen to me at any moment. But I felt fine and I didn't know why."

http://society.guardian.co.uk/health/news/0,,1732358,00.html

carbar
03-18-2006, 10:45 AM
Animal tests on the kind of drug given to the six men ill in a London hospital may not be the best way of evaluating the effects in people, an expert warns.
The drug they took stimulates a protein only found in humans.

Dr David Glover, an expert in drug testing, said this meant animal tests of medicines of this sort might give falsely reassuring results.

He said it might be better to look at innovative ways of testing small amounts of such drugs on people.

The drug, TGN 1412, which the six men took belongs to a class called monoclonal antibodies.

It is hoped they could combat a wide range diseases, including cancer.

They are created in the lab by fusing or merging a cell that produces antibodies - the foot soldiers of the immune system - with a cancer cell.

People's lives have been saved, and the quality of people's lives has improved dramatically over the last 25 years, thanks to monoclonal antibodies such as Herceptin, hailed as a significant breast cancer drug.
Most monoclonal antibodies prevent something happening in the body - they are "antagonists".
For example, Herceptin works by blocking the action of the Her2 protein, which can fuel the growth of breast cancers.
But TGN 1412 is an "agonist" - which boosts a particular action.
It boosts the activity of human immune system protein called CD28 which is present on the surface of white blood cells.

There have been concerns it might have been inappropriate to test such drugs on healthy volunteers, whose immune systems are already working effectively, as a further boost might push their systems into over-drive.

At this stage, there is no hard evidence to suggest this is what happened in the study that left six men seriously ill.

The problem might equally be due to a fault with the manufacturing process, or simply a unique reaction to the drug in humans that could not have been predicted.

http://news.bbc.co.uk/2/hi/health/4817178.stm

LaMemChose
03-18-2006, 11:10 AM
I saw this on Dateline last night. It's very troubling.

What was interesting is that only 3% of cancer patients actually sign up for clinical trials, according to the report. After this turn of events, possibly fewer still will even consider it.

If these trials had been performed on subjects other than the healthiest would they have survived? As sick as the six have been, I have my doubts.