Clinical Trial Men's Families Told To Pray For A Miracle

Featured Article
Main Category: Clinical Trials / Drug Trials
Also Included In: Public Health
Article Date: 16 Mar 2006 - 15:00 PDT


The families of two men who had volunteered to take part in a clinical trial that went tragically wrong have been told by doctors to 'Pray For A Miracle'. The two men are still critically ill, their doctors say the probability that they make an early improvement is very remote.

Another four men who took part in the trial are still in a serious condition, but starting to recover.

Ganesh Suntharalingham, Northwick Park Hospital's Clinical Director of Intensive Care, said "The two men remain critical and it could be a while until they show significant change. The four who are seriously unwell are continuing to show signs of improvement but it is still early days. We are still treating their inflammatory response following the drug trial, and are providing full supportive care for the organs affected by this process."

Relatives and friends of the men were shocked at seeing how their features had become so severely swollen. However, patients in intensive care generally require a great deal of fluid - this results in severe swelling. As soon as the patient starts making a recovery the swelling goes down.

Nobody knows yet what made this clinical trial go so badly wrong.

Parexel International (USA) was running the trial on behalf of TeGenero AG (Germany). The experimental drug is called TGN 1412.

Parexel says it has worked within regulatory guidelines. Chief Scientific Officer of TeGenero, Thomas Hanke, says he and his colleagues were 'shocked' by what happened. He added that his company has apologised, after being asked by reporters.

Eight men were involved in the trial. Two were given a placebo (dummy drug), the other six were given TGN 1412.

In an interview with Sky News, one of the volunteers who was given the placebo said he watched horrified when he saw the other six collapse around him. He said they were screaming, vomiting and writhing in excruciating pain - they were screaming about the unbearable pain they felt in their heads. He said it was like Russian Roulette, with two of them being spared the hell.

A girlfriend of one of the men said he looked like Elephant Man, with his head wider than his waist. She was told to pray for a miracle as doctors told her all his internal organs had failed.

Three bodies are working together to try to find out what went wrong.

1. The Healthcare Products Regulatory Agency (MHRA).
2. The Police.
3. The Department of Health.

The moment it was clear something had gone badly wrong, the MHRA informed other agencies in Europe where similar trials were going to take place.

Each volunteer was given £2000 ($3600) to take part in the trial. It was a Phase I Trial. This means it was being carried out on healthy volunteers.

(Placebo = Dummy Drug. This looks like a medicine but has no 'active ingredient'. It has no effect at all. A placebo is given to some volunteers along with others who are given the active ingredient to see if there is a difference at the end of treatment between the ones who took the placebo and those who took the active ingredient).

Written by: Christian Nordqvist
Editor: Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

• Additional
• References
• Citations