Drug trial victim is like Elephant Man, says girlfriend

London Telegraph
Mar. 16, 2006

The girlfriend of one of the most critically ill victims of a drugs trial mishap said last night that he looked like "the Elephant Man" and could die at any moment.

Myfanwy Marshall's boyfriend and another man were fighting for their lives but yesterday the four other trial participants were beginning to recover. Miss Marshall, a BBC producer, was in tears as she described her boyfriend, a 28-year-old bar manager from London.

"He is largely lifeless," she said. "I can't even get an eyelid movement or a squeeze from his hand. He is a shell of who he is. He is completely puffed up, his face, his body: he is like the Elephant Man.

"When I walked in there, I expected to see his small face and curly black hair but he looks like a monster. He has tubes up his nose, in his heart, liver, lungs, neck and hands. They told me he could be like this for six months to a year.

"They tried to pump the drug out of his system but all his internal organs are infected. They said he could die at any moment. He needs a miracle."

All the men suffered "multi-organ inflammation" after volunteering to test a new treatment for immunological diseases and some cancers, including types of leukaemia.
It was the first time the drug, TGN1412, had been given to humans and the men's doctors are effectively dealing with an unknown condition.

The men were taken into intensive care at Northwick Park Hospital, north-west London, on Monday night and early on Tuesday from an independent research centre at the hospital run by Parexel, an international trials company.

One victim was named as Ryan Flanagan, 21, a student from Highbury, north London. His family was told that he could not breathe and that his head had swollen to three times its normal size.

A man who said he was next of kin to one of the four men in a serious condition told reporters: "We have been told they could all end up with possible scarring on their organs.
They don't know if it will take months for recovery or longer. When you go to a hospital every drug you take has been tested on a human. They are heroes but they did not expect that they were possibly going to die."

TGN1412, a monoclonal antibody made by a German biopharmaceutical company, Tegenero AG, has been in development since 1997.

The Medicines and Healthcare Products Regulatory Agency (MHRA) suspended the trial and began an immediate investigation. The specialist crimes directorate of the Metropolitan Police in west London is watching the incident because of the severity of the men's condition.

Relatives of each man met representatives from Parexel, TeGenero and doctors to discuss the situation.

Inspectors from the MHRA were interviewing Parexel staff, reviewing documents and taking samples.

Ganesh Suntharalingham, the clinical director of intensive care at the hospital, said they were liaising with other hospitals. "The drug is untested and therefore unused by doctors. We are treating the inflammatory disorder triggered by the drug and the effects."

The victims may be eligible for compensation and the hospital may seek payment for the treatment given as a result of Parexel's trial.

Thomas Hanke, the chief scientific officer of TeGenero, said: "Our first concern is for the patients and that they get all treatment possible."

He said the drug was an "innovative new treatment" for leukaemia, rheumatoid arthritis and multiple sclerosis that had showed no safety problems in testing.

Last night, Ann Alexander, a solicitor representing the family of Miss Marshall's boyfriend, said the men had complained of receiving "mixed messages" in two meetings with the drugs company.

In the first, she said they were told that TGN1412 had been tested on monkeys and dogs and that one of the dogs had died.

In a second, they were told it had been tested on monkeys and rabbits.