Man tells of drug trial horror

2006-04-03 16:48

London - One of six men who became seriously ill while participating in a clinical drug trial said he was warned to expect nothing worse than headaches and nausea as side effects of the medication.

"The risk they mentioned was some headache and nausea. And they didn't mention any other risk apart from that," Navneet Modi, 24, said in an interview on Monday.

The six healthy volunteers had convulsions and organ failure last month after being given trial doses of TGN1412, a drug being tested for treatment of leukaemia and autoimmune and inflammatory diseases. It was the first time the drug had been tested on humans.

The trial of the monoclonal antibody developed by TeGenero AG of Wuerzburg, Germany was being run at a London hospital by Waltham, Massachusetts-based Parexel International.

One of the men remains in critical condition, but the others are making a good recovery, the hospital said.

Modi, a recent MBA graduate and part-time pharmacy worker, told ITV television's "Tonight with Trevor McDonald" programme in a pre-recorded interview he planned to use the £2 000 ($3 500) fee from the trial to buy a laptop computer. He said he had still not told his parents, who live in India, about what had happened.

Modi said he had participated in two previous trials run by Parexel. In both cases, he said, "whatever side effects they mentioned and if there were any side effects, those were the ones. If they mentioned there wasn't any side effect, then definitely there wasn't any side effect."

'No side effects in monkeys'

Modi said a doctor told the volunteers "there had been no side effects in monkeys when the drug was given. 'The only side effects we can think of is headaches and nausea.' That's what he said."

TeGenero initially said there had been no "drug-related adverse events" in tests on animals, but later acknowledged the drug had left monkeys with swollen glands.

Modi said that about an hour after receiving the drug he felt a headache like "a huge bolt upon my head."

"And it was like a huge amount of pressure being put on my head and I started moaning to the doctor," he said.

'I am going to die'

Modi said the headache was followed by shortness of breath and severe back pain.

"I was crying of pain. I really started crying. I said: 'Doctor, please do something. I am going to die,"' he said.

A friend who visited Modi in hospital told newspapers his head and body were so swollen he looked like "the Elephant Man."

Modi said he recovered after several days in an intensive care unit, and was released from hospital last week. But he said he still suffered weakness, pain in his limbs and an inability to concentrate, and planned to seek compensation from Parexel.

"I am a bit angry with Paraxel ... they can't pay me back," he said. "I mean, they can't give me back my joys, they can't give me back my health, they can't give me back my mental condition."

- AP