Reassurance over drugs trials

RESEARCH staff at Ipswich Hospital have today moved to reassure patients their trials are safe following the disaster in London's Northwick Park Hospital.

Six previously healthy men were critically ill after suffering a severe reaction to a drug designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis.

The case has left health experts baffled but Andrew Poynter, Ipswich Hospital's cancer research lead, said there is no need for people undergoing trials in Ipswich to be worried.

He said: “This was a phase one trial, which means it is the first time the drug has been tested on human beings, and we don't do those kinds of trials at Ipswich. They are usually done in hospitals which have a link with an academic medical laboratory.

“Everything we do here is at least phase three, meaning it has already been rigorously tested on humans.

“This kind of reaction is completely unprecedented in phase one trials. Nobody's ever known anything like it before.”

Mr Poynter said the news has worried some people in the hospital.

He said: “It has definitely worried people, it's bound to. It just raises everybody's awareness of clinical trials.

“There's always going to be an outside chance that something will go wrong in any trial.”

The ill men in London had been given a drug known as TGN1412, made by the German pharmaceutical company TeGenero AG.

Two people are still critically ill in intensive care, four others are also in hospital.

Their doctor said it was too early to say whether the men would make a full recovery, but some were showing signs of improvement.

Have you ever been involved in a clinical trial? Write to Your Letters, Evening Star, 30 Lower Brook Street, Ipswich, IP4 1AN or send us an e-mail to eveningstarletters@eveningstar.co.uk

Weblink: www.ipswichhospital.org.uk

Phase one trials: The drugs are being tested on humans for the first time to see what dosages are safe. They are not looking to see whether it works, just what dosages can be given without adverse reactions - hence the fact that this stage is usually carried out on otherwise healthy people.

Phase two trials: These are slightly bigger trials which are looking to see whether a drug is effective at curing a condition.

Phase three trials: Once a drug has been proven to work for a particular condition, they are tested on a larger number of people so that results can be compared.