Doctors in 'uncharted waters'

2006-03-16 22:53

London - Doctors in Britain admitted on Thursday that they were in uncharted waters as they tried to save the lives of six young men who became violently ill from clinical trials of a new drug.

The drug's manufacturer, TeGenero AG of Germany, has sent staff to try to help at Northwick Park Hospital in northwest London, where the men were admitted on Tuesday with inflammation which eventually affected their internal organs.

Two of the patients, reported to be horrifically bloated, remained critically ill, while the four others were seriously ill, but showing signs of improvement, doctors said.

Doctor Ganesh Suntharalingam said the men were now being treated with anti-inflammatory drugs such as steroids, but he was unable to say why some of the men had begun to recover while two remained critically ill.

Experts from around the world

Suntharalingam, clinical director of intensive care at the hospital, said his team was consulting experts from around the world on the best way to deal with the inflammation, although staff knew well how to deal with organ failure.

Doctors had seen similar symptoms before, but the experience was entirely new, he said.

"Some of the features such as the need for a large amount of fluid and unstable organs are things that happen with other disorders, but the exact sequence of what's happening here is unique," said Suntharalingam.

"No one has had this agent before and no one has had this reaction before, but some aspects are familiar to us," he said.

The men, who had all been healthy, were admitted after falling ill while taking part in the trial at the independent research unit in the hospital compound operated by Parexel, a United States drug research company.

Paid volunteers

Two other men also took part in the clinical trial - all eight men were paid volunteers - but escaped unscathed after being given a placebo.

Raste Khan, a 23-year-old who received a placebo, described to British media the violent reaction from the six who took the drug: sweating, severe pain, the need to use the toilet, fainting, and vomiting.

"First they began tearing their shirts off, complaining of fever, then some screamed out that their heads felt like they were going to explode," Khan told the Sun mass-circulation newspaper.

In its home city of Boston, Parexel International said in a statement that it did "everything possible" after the men fell ill, while TeGenero's chief executive Benedikte Hatz said the trial had conformed to best practices.

"These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies which enabled us to progress investigations into human volunteers," Hatz said.

Guidelines

"The clinical trial performed by Parexel adhered to standard clinical research guidelines," she said.

"Such an adverse reaction occurs extremely rarely and this is an unfortunate and unusual situation," said Herman Scholtz, head of clinical pharmacology at Parexel.

"When the adverse reaction occurred, the Parexel clinical pharmacology medical team responded swiftly to stop the study procedures immediately and notified authorities," he said.

"We worked in co-operation with the hospital intensive-care doctors and the sponsor (TeGenero) to have the volunteers given the best possible care, and to explore all possible treatment options."

The medicine, identified by TeGenero as TGN1412, has been under development since 2000 for immunological diseases such as multiple sclerosis, rheumatoid arthritis and certain cancers.

- AFP