Drugs trial victim 'left like Elephant Man'

FRIENDS and relatives of six men left seriously ill after a clinical drug trial went wrong yesterday spoke of their horror.

The girlfriend of one of the victims said he looked "like the Elephant Man" after he and the five other medical guinea pigs had a violent reaction to the drug on Monday.

One of two medical test volunteers who escaped unscathed after being given a placebo also described the horror of watching those given the real drug go "down like dominoes".

Two of the men remain critically ill and the other four are still in a "serious" condition in the intensive care unit of Northwick Park Hospital, Harrow, north-west London, following the leukaemia treatment trial.

Fellow volunteer Raste Khan, 23, said: "First they began tearing their shirts off complaining of fever, then some screamed that their heads felt like they were going to explode.

"It was terrifying, because I kept expecting it to happen to me at any moment."

Last night the drugs company involved apologised to the families of the six men who developed potentially life-threatening side-effects while taking part in the trial.

But questions were raised as to whether all six victims had been given the experimental TGN1412 drug at the same time - against guidance in the Textbook of Pharmaceutical Medicine, which says such practices can be "difficult to manage" and "put subjects at unnecessary risk".

Professor Gary Slapper, of the Open University law programme, said that even though the drug-trial participants had probably completed consent forms, that did not mean they had signed away their rights to sue if there had been negligence.

The six men were admitted to the ward from an independent medical research unit on the hospital's campus after taking part in the trial, for which they were reportedly to be paid 2,000.

The drug, known as TGN1412, is made by pharmaceutical company TeGenero AG, based in Wurzburg, Germany. It is intended to fight leukaemia, rheumatoid arthritis and multiple sclerosis.

TeGenero AG's chief scientific officer, Thomas Hanke, said the firm was "devastated" at the "shocking developments" in tests of a medicine which had shown no previous safety problems.

One victim was named yesterday as student Ryan Flanagan, 21, of Highbury, north London. His family were told he could not breathe and his head and neck had swollen to three times their normal size.

Dr Hanke said the testing had been done to regulatory standards, emphasising that testing drugs on volunteers was normal.

Initial research into the medicine started in 1997 and it has been in development since 2000 but testing has now been halted, he added.

Lawyer Ann Alexander, who is representing a 29-year-old man on a life-support machine after taking the drug, said his prognosis remained unclear.

She went on: "The family are very distraught and scared because they do not know what the future is going to hold.

The solicitor said it was unclear what legal action might be taken.

She added that she believed the drugs firm had pledged to give the young man's family all the financial support they required.

Distraught Myfanwy Marshall, 35, said her boyfriend, one of the six patients, fell ill 80 or 90 minutes after being given an oral or injected dose on Monday.

She said: "His chest is puffed out. He is already a big kind of guy but his face is like Elephant Man, it's completely puffed.

"This is a drug they have never tested on humans before so they don't know what they are dealing with. It's completely messed up their vital organs."

Her boyfriend, a bar manager in London, had decided to join the trial on impulse because he needed money.

He told her the testing was for a cure for leukaemia and said: "I am helping mankind."

She said she had been told he needed a miracle, adding: "They are saying he could be lying there in six months ."

Scotland Yard confirmed it was talking to the UK medicines watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), about the incident.

Professor Sheila McLean, a professor of medical law at Glasgow University, said there was always an unknown risk in drug trials. "These people do an incredible service for the rest of us," she added.

Long road from the laboratory to the chemists

BRINGING drugs from the lab to the bedside takes a decade or more to complete and even then they will continue to be evaluated for safety and effectiveness.

First, drug formulations are developed and tested in the lab to decide whether they might be effective in targeting particular diseases or conditions. They will then progress to trials in animals, which may last four years. This data must be submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) before moving to human trials. If no major problems occur, the trials then move on to people with the disease that the drug is designed to treat.

Up to 6,000 people could have tested the drug by the end, when the MHRA decides if it is safe for the market.

Scarred for life

PAULINE Walkingshaw said she would not take part in another trial after being left permanently scarred when she volunteered to test omega-3 oil supplements.

The 36-year-old, from Edinburgh, said she thought little of agreeing to take part in the ten-week trial, for which she was paid 300.

But two skin biopsies left scars on her arm - which Mrs Walkingshaw said she was not warned about. "I thought it would not be any hassle," she said. "It was an easy way to get 300. But in terms of the hours I spent going to the clinic, it is not a lot at all."

Mrs Walkingshaw said she had to read and sign "reams and reams of paper" before starting the trial.

Volunteers had to provide skin and hair samples, but the skin biopsy was more invasive than expected. "I had to have my arm bandaged for three days as it would not stop bleeding."

Mrs Walkingshaw said she would not do another trial unless she had a strong reason. "My husband has Crohn's disease and if it was something that could help him, then I would do it."