Lives in danger as drug trial goes horribly wrong

Mar 16 2006

In a drug trial which went horribly wrong two men are critically ill in a London hospital and four others are seriously ill, after suffering violent reactions to a new drug they took as part of a clinical trial.

The Medicines and Healthcare products Regulatory Agency (MHRA) says the drug is being developed for a German company to treat chronic inflammatory conditions and leukemia.

Reports say the head and neck of one of the men has swollen to three times normal size and another's head had swollen and was wider than his waist while all his internal organs had failed.

The MHRA says the eight healthy men took part in the trial, two of whom were given a placebo; the six who took the real drug all became ill.

The men were reportedly paid 2,000 pounds ($3,500) to take part in the trial which was in its first phase, when a drug is tested on healthy humans.

According to spokeswoman for the Northwick Park Hospital in northwest London where they are being treated all six are young men and two are critically ill, while four were seriously ill but had shown signs of improving.

Richard Ley, spokesman for the Association of the British Pharmaceutical Industry (ABPI), says he cannot remember anything comparable and it is an absolutely exceptional occurrence.

Inspectors are attempting to clarify what exactly the event was that caused the disaster.

MHRA Chief Executive Officer Professor Kent Woods has said there are several possibilities as to what might have gone wrong; a manufacturing problem, an issue of contamination, a dosing error or some completely unanticipated side effect of the drug in humans, which is specific to humans.

The trial was set up by U.S. drug research company Parexel International Corp. on behalf of German pharmaceutical company TeGenero AG.

Parexel has described the incident as "unfortunate and unusual," adding that it assumed the volunteers had suffered an adverse reaction to the drug, known as TGN 1412.

The MHRA suspended the trial as soon as the men became ill and has notified other European regulatory bodies about it.

Professor Woods says the immediate priority has been to ensure that no further patients are harmed and an exhaustive investigation to determine the cause and ensure all appropriate actions are taken is being carried out.