The perils of clinical trials

On Offer:

£150 per day for 11 days.


The Condition:

Young, healthy, adult males – all under 40 - to take part in the early stages of a trial for a drug to treat conditions such as rheumatoid arthritis and leukaemia.


The Volunteers:

Eight took part. Two given dummy pills while six others were given the drug TGN1412 during the trial at a research unit based in a London hospital on Monday. It was the first time the drug, designed to treat conditions such as rheumatoid arthritis, leukaemia and multiple sclerosis, had been tested on humans.


The Status:

The six men have been in intensive care since falling ill, suffering multiple organ failure, immediately after taking the drug. Two of them remain in a critical condition. They have been given several blood transfusions to try to rid their bodies of toxins. Four were said to be showing signs of improvement but doctors said it was still early days.


The Symptoms:

A volunteer’s girlfriend said he was "completely gorgeous, a beautiful person, really buoyant, oozing with charm and really muscly."

And now,

"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."

The Problem:

The growing resistance to animal testing in Britain and the effect this might be having on drugs trials.


Those Responsible:

American company Parexel, which ran the trial, said it had followed recommended guidelines.

TeGenero, which manufactures the anti-inflammatory drug, apologised to the sick men's families and said the medicine had showed no signs of problems in earlier tests.

TeGenero said TGN1412 had been tested extensively in laboratories and on rabbits and monkeys for safety with no adverse effects and no drug-related deaths.


Possible Outcome:

Medicines and Healthcare products Regulatory Agency (MHRA) and the police are investigating. The MHRA is investigating whether the reaction suffered by the men was caused by a manufacturing problem, contamination, a dosing error or whether it was some completely unanticipated side-effect of the drug in humans.


The Miracle:

That’s what the doctors are saying the six volunteers now need.


Read more:

Q&A: Drug trials
Making a career out of drug tests
Ryan's drug test anguish