NZ drugs volunteers undeterred by London trial disaster

Fifteen volunteers who began a drugs trial in Christchurch on Friday were committed to going through with it, despite the TGN1412 disaster in London.

The volunteers are taking part in a phase-one trial of a cholesterol-lowering drug conducted by the Christchurch Clinical Studies Trust.

Trust manager Nicola Forrest-McLernon told a national Sunday newspaper that all the volunteers were given the chance to pull out, but that none was put off by the London tragedy in which six volunteers, including a New Zealander, became critically ill after being injected with the drug TGN1412.

The type of drug they were given, a monoclonal antibody, could stay in their bodies for months, doctors said yesterday.

The Christchurch Clinical Studies Trust is the only organisation conducting phase-one trials in New Zealand and has run about 60 trials since it was set up by Dr Richard Robson in 1999.

Last year, the trust used more than 200 healthy volunteers in clinical trials, which included tests of treatments for diabetes, rheumatoid arthritis, asthma, osteoporosis, hepatitis C and cholesterol.

In the past year, the Health Ministry's regulator of therapeutic products, Medsafe, had 21 applications for phase-one clinical trials, involving 623 volunteers.

The ministry said no deaths had occurred in New Zealand as a result of the trials.

Ms Forrest-McLernon said trust volunteers were paid between $1000 and $5000, and spent at least 48 hours in the trust's wards while tests monitored how the medicines were absorbed, distributed and excreted.

She said participants in any such trial should have contracts giving insurance cover for any injuries which might result.

- NZPA