Drug trial nightmare - two still critically ill

In the drug trial nightmare which has left six men very ill in a London Hospital two remain in intensive care and are not expected to make any early improvement, according to their doctor Ganesh Suntharalingham, Northwick Park Hospital's Clinical Director of Intensive Care.

Dr. Suntharalingham says they are still treating the inflammatory response following the drug trial and are providing full supportive care for the organs affected by this process.

The two are classed as critically ill while the other four are in a serious condition but have shown signs of improvement.

The experimental drug TGN1412 administered in the trial aims to combat immunological diseases and chronic conditions such as 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.

Suntharalingham said the six men could make a full recovery but it is too early to make predictions. He said he did now know what had caused the violent reaction.

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

Relatives and friends of the two men have said the volunteers' features have become severely swollen.

Distressed relatives have been given some comfort from Dr.Suntharalingam who says such patients sometimes need a lot of fluid, and one result of that is severe but temporary swelling.

He says although this is distressing for relatives to see, it does go away on recovery and it has no long-term effects.

On Thursday, one of two men given a harmless placebo,apparently watched in horror as minutes after taking the drug, the six around him collapsed, writhing in agony, vomiting and screaming about the pain in their heads.

Britain's Medicines and Healthcare products Regulatory Agency (MHRA) have said they are working with police and the Department of Health to investigate what went wrong but the inquiry is expected to take weeks.

German firm TeGenero which makes the drug had contracted American firm Parexel to carry out the first human trials for the new therapy in Britain.

The company has apologised to the men's families.

TeGenero insists the drug was developed in accordance with all regulatory and clinical guidelines and standards;Parexel works as a contractor trialing new drugs and agrees that all guidelines had been followed. Its testing programmes entice financially challenged young students with offers of easy money.

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

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 that the cost of compensation for non-negligent harm falls upon the injured patients themselves.

As soon as the men fell ill, the MHRA suspended the trial and notified other European regulatory bodies.

It is unclear at this stage if there will be any kind of compensation pay out.

One of the men apparently has a lawyer already.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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