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   Human Drug Testing - When Things Go Wrong

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Topic: Human Drug Testing - When Things Go Wrong (Read 261 times)

Rhune
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Human Drug Testing - When Things Go Wrong
« on: Mar 17^th, 2006, 2:17am »

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http://www.theregister.com/2006/03/16/drug_trial_latest/

Details continue to emerge of the London drug test that put six volunteers in a critical condition.

Speaking to the Mirror, Dolores Flanagan, aunt of 21-year-old Ryan Wilson, one of the men that reacted badly to the drug, said: "The family are in pieces. He's in the hands of God now."

The Sun got hold of one of the more fortunate participants in the trial, who seems to have been given a placebo. Raste Khan said: "Some screamed out that their heads felt like they were going to explode."

Late this afternoon, authorities at Northwick Park Hospital in London said the condition of four of the men is showing signs of improvement. A statement said: "The other two men remain critical and it could be a while until they show significant change."

Student David O'Donnell, 19, was due to take part in the next stage of testing of the drug in April at a higher dose. A friend of his took part in the trial and is seriously ill. O'Donnel told the BBC: "I am very worried about him indeed, but I had a message from my friends to say they have managed to get in contact with him."

The distressed girlfriend of one of the men said yesterday that he looked like "the Elephant Man". Northwick Park intensive care clinical director Ganesh Suntharalingam tried to calm fears: "These patients sometimes need a lot of fluid, and one result of that is severe but temporary swelling. This is distressing for relatives to see, but it does go away on recovery and it has no long-term effects."

The experimental drug TGN1412 administered to the six was aimed at combatting immunological diseases - chronic conditions like rheumatoid arthritis, multiple sclerosis and leukaemia. German firm Tegenero had contracted American firm Parexel to carry out the first human trials for the new therapy in Britain.

TGN1412 is designed to target rogue T-cells which cause these illnesses. In the trial it triggered a massive inflammatory response in the healthy human volunteers, despite passing animal testing without problems.

TeGenero says it has apologised to the sick men's families.

A TeGenero statement says: "The drug was developed in accordance with all regulatory and clinical guidelines and standards."

Parexel works as a contractor running testing of many new drugs. It agreed that all guidelines had been followed. Its testing programmes draw in cash-strapped students with offers of easy money. Parexel's website trumpets: "Paid time to yourself."

It's unclear if there will be any kind of compensation pay out.

In an open letter to the British Medical Journal back in February, University of London Professor Desmond Laurence criticised the unclear arrangements for compensation when drug trials go wrong.

He said documents covering drug trials were not written in plain language and therefore did not meet the legal requirement of fairness and openness under consumer law. He observed: "The cost of compensation for non-negligent harm falls upon the injured patients themselves."Ž

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yesteach
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Re: Human Drug Testing - When Things Go Wrong
« Reply #1 on: Mar 19^th, 2006, 3:39pm »

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From BBC:
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Three of the six men left seriously ill by a drugs trial have been taken off organ support, doctors have said.

Doctors at Northwick Park Hospital, in north-west London, said on Sunday they were encouraged by the progress of four of the men, who were fully conscious.

Another two volunteers remain in a critical condition and under sedation, but have also made improvements.

The men were taken ill on Monday after taking part in a drugs trial at a facility next to the hospital.

Dr Ganesh Suntharalingam, head of intensive care at Northwick Park, said: "We are continuing to make advances with treating the four seriously ill patients, and we are encouraged by their progress and recovery to date.

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"All four are improving and we have now been able to remove artificial organ support from three of them.

"The two other men are still in a critical condition.

"They are under sedation for their own comfort while they receive organ support."

Four of the men suffered multiple organ failure within hours of taking the drug TGN1412.

The case is being investigated by the Medicines and Healthcare products Regulatory Agency (MHRA), which has seized documents and sealed off offices.

Scotland Yard said officers were talking to the MHRA and doctors.

Staff from Parexel, the firm carrying out the trial, insist the right procedures were followed.

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