"These sorts of trials have to go on. There are 300,000 people out there with MS who have no hope."

THIRTY years ago when Julia Brown was first diagnosed with multiple sclerosis, she and her husband Stuart were offered some words of hope.

"We joined the local MS Society," says Stuart, of Rectory Court in York. "And they said 'there will be a cure around the corner.'"

They have been waiting for that cure ever since - while Julia's condition has gradually become worse and worse.

They are still waiting. And the drugs trial in London which went so tragically wrong - leaving six previously healthy men seriously ill in hospital - could potentially see the wait lasting for even longer.

One of the conditions the drug was intended for was multiple sclerosis.

The worry is that the catastrophic side effects it caused in otherwise healthy people will not only halt this particular drug in its tracks - but that what happened will also put people off volunteering to take part in other trials.

Julia, who can't stand up without help and has the use of only one arm, is sceptical about the use of drugs. "I don't take any medication for my condition," she says. "To be honest the side effects are as bad as the MS - dizziness, sickness, diarrhoea, constipation, all of those."

Stuart, however, can't help hoping that one day scientists will come up with a proper treatment for his wife's condition. He just hopes desperately that what happened at the Northwick Park Hospital in London won't set their efforts back.

"These sorts of trials have to go on," he says. "There are 300,000 people out there with MS who have no hope."

There is very real concern that what happened in London could set back development of new treatments for MS and a range of other medical conditions too.

Researchers are desperate to reassure potential volunteers.

Caroline Mozley, who is the York Hospital-based head of research and development for the North Yorkshire NHS Research and Development Alliance, says what happened in London was a one-off.

Medical trials are extremely closely supervised and monitored, she says - and the risks of anything going wrong are "very small".

"This is a very tragic incident, but it is very important that we don't over-exaggerate it," she says. "It really is an extremely rare occurrence. We have never heard of anything like it."

In particular, she stressed that no patients in York who were taking part in medical trials of new drugs needed to be worried.

The six men who fell ill in London had been taking part in a Phase 1 trial, she says - that is, they were healthy people who were given the drug purely to test whether it was safe to use with people.

Patients in York who are taking part in medical trials of drugs for everything from cancer to heart and breathing problems are in a completely different situation, she says.

They are taking part in Phase 3 or Phase 4 trials, by which stage the drugs have already been rigorously tested for safety.

What they are now being tested for is to see whether they are effective.

Dr Richard Cookson, a health scientist on secondment to the University of York from the University of East Anglia, is a member of the drugs appraisals committee for the National Institute of Clinical Excellence.

He agrees with Caroline Mozley that the risk associated with trials such as that in London is tiny. It is like a major air crash, he says, which causes a big scare and makes people worry about flying when in fact they are much more at risk driving their car to work.

He expects there will to be an initial panic, which will make it difficult for medical researchers to recruit volunteers for six months or a year - but he believes the scare will then die down.

He certainly hopes so. Because the importance of trials such as these to the development of new medicines and treatments - which could one day potentially benefit us all - is huge, he says.

"The information we get from these trials is essential - not only in terms of saving people's lives, but also in terms of improving the quality of people's lives," he says.

He fears the consequences if drug companies were unable to continue with properly controlled and monitored drugs trials in countries such as the UK because of a general panic.

Thalidomide, he points out, is an example of a drug that was introduced without having first been put through a medical trial. About 10,000 babies whose mothers took the sedative during early pregnancy in the late 1950s and early 1960s were born with deformed limbs. "That's what happens when you don't have trials," said Dr Cookson.

Thalidomide couldn't happen today, he says. Instead, if there were problems doing trials here, the pharmaceutical industry would probably go to India "and do drugs trials on the cheap".

Dr Cookson fears that could lead to trials that were not properly conducted or monitored. "And the consequences would be far worse."

Animal testing

ANIMAL rights campaigners are already arguing that the London trial proves that testing drugs on animals first doesn't work.

"Apart from the immorality of animal experiments, the sad case of six healthy young men in a clinical trial suffering severe side effects of the drugs being tested also shows the practical drawbacks to such experiments," says Alan Robertshaw, of York Animal Aid.

"These drugs have been tested on animals without side effects being seen, as was Thalidomide and many other drugs which are quietly withdrawn after human trials fail.

"The reason for such failures is obvious, namely that animals, especially the rats and mice used in most experiments, have a completely different physiology to ours. Also, causing an illness in a healthy animal and then trying to cure it is very different from trying to cure an illness "naturally" acquired by human beings."

Researchers, however, dismiss these claims.

Because drugs are tested on animals first, says Caroline Mozley, the number of cases in which there are harmful effects on human volunteers when the trials move to people is very small. She added that if there were no testing on animals, harmful effects on people "would be much less rare".

More people would end up putting their lives at risk like the volunteers in London, in other words.

The London drugs trial

THE six men taken ill at the Northwick Park Hospital in Harrow, north-west London, were all previously healthy before taking part in the trial.

The drug, known only as TGN1412 and made by German pharmaceutical company TeGenero AG, is intended to fight leukaemia, rheumatoid arthritis and multiple sclerosis.

But one trial volunteer who escaped unscathed because he was put on a placebo said that after his six fellow volunteers took the drug, they began to go down "like dominoes".

Raste Khan, 23, told The Sun newspaper: "First they began tearing their shirts off complaining of fever, then some screamed out 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. But I felt fine and I didn't know why."

The Times reported yesterday that senior doctors were concerned that all six victims had been given the experimental drug at the same time - which it said went against guidance in the Textbook Of Pharmaceutical Medicine which says such practices can be "very difficult to manage" and "put subjects at unnecessary risk."

Chief scientific officer of TeGenero AG, Thomas Hanke, said he was "devastated" at the "shocking developments" in the testing of a new medicine which had showed no safety problems in previous trials.

Asked by reporters whether TeGenero AG had apologised to the men's families, he replied: "Yes."

He said there were no adverse side-effects previously and the testing had been done to regulatory standards. The testing of drugs on volunteers was normal, he emphasised.

Updated: 10:30 Friday, March 17, 2006