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Drug trial creates 'Elephant Man'


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Medical Research

LONDON, England -- Two men are in critical condition in a London hospital and four others are in serious condition after taking part in a clinical trial for a new drug.

One victim, whose head and neck were reported to have increased to three times normal size, was described by a friend as resembling "the Elephant Man."

The men were admitted late Monday to the intensive care unit from an independent medical research unit at Northwick Park Hospital after reacting badly to the drug, which is intended to treat chronic inflammatory conditions and leukemia.

The volunteers suffered extreme reactions while participating in a drug trial run by clinical research company Parexel International, based in Boston, Massachusetts.

"My 20-year-old came in here a healthy boy," the mother of one of the volunteers told CNN. "He doesn't smoke, not a big drinker, fit is a fiddle and they destroyed my son's life."

His girlfriend added: "He's in a bad way. His immune system is all gone."

The UK's Sun newspaper said one of the men had been taken to intensive care after his head and neck increased to three times normal size.

It quoted a friend as saying the 21-year-old was a student and had taken part in the trial to make money after seeing an advertisement on the Internet.

The girlfriend of another volunteer told the BBC her partner looked like the "Elephant Man" -- a freak show figure in Victorian Britain whose head ballooned outwards until his skull was wider than his waist.

She said all his internal organs were failing.

"Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation," Dr. Herman Scholtz, head of Parexel International Clinical Pharmacology, said in a statement.

Scholtz said Parexel had acted within regulatory, medical and clinical research guidelines during the study.

"We use standardized procedures for testing a drug in humans for the first time, based on a well-defined protocol, designed by the sponsor company and approved by ethics committees and regulatory authorities," he said.

Parexel said the drug, TGN1412, was an antibody developed by TeGenero of Wuerzburg, Germany.

"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," TeGenero's chief executive Dr. Benedikte Hatz said in a statement.

The UK medicines watchdog -- the Medicines and Healthcare products Regulatory Agency (MHRA) -- immediately started an investigation.

Professor Kent Woods, Chief Executive Officer at MHRA, told the UK Press Association: "Our immediate priority has been to ensure that no further patients are harmed.

"We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."

Eight men had all volunteered to take part in the trial. Two were given a placebo and were unharmed.

"Two patients remain critical and four patients are serious but showing some signs of improvement," Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital, said in a statement Wednesday.

"The drug, which is untested and therefore unused by doctors, has caused an inflammatory response which affects some organs of the body," he said.

"The critical care team has been doing everything possible to treat the patients successfully in this unique set of circumstances. We are also collaborating closely with colleagues in the UK and overseas to draw on the skills of other specialists."

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