TYSABRI: 'I'm so glad I was a guinea pig for the MS wonder drug....
"IT STARTED in a laboratory in southern San Francisco in the early nineties. Paralysed laboratory mice were suddenly able to walk when given a drug. Around the same time, thousands of miles away in Dublin, 14-year-old Carol Brennan noticed something wrong with her sight.

She had blurred vision for over a month. Then she felt a numbness in her legs and arms. Her balance started to go.

'When I was 14, I was brought in to the Eye and Ear and they thought it was an inflammation of the optic nerve - which happens to people who are in their nineties, not young people,' she recalls. 'So they sent me for an MRI scan and lesions came up.

'My Dad is one of the rare people in the world who has never lied in this life. And I remember we were getting the results after the MRI. We were driving home and Dad had very tearful eyes and I asked him, "What's wrong with me?" and he said, " Nothing, nothing, you'll be grand. They have to do more tests," and I said, "Dad, you're lying".

'When we got home he was speaking to Mam and she came downstairs bawling her eyes out and I went to Dad and said, "Please tell me". They probably wouldn't have told me at such a young age but I kind of made them - I had Multiple Sclerosis.' Carol, the youngest child of six, had little idea of what this bizarresounding condition actually meant.

'I knew people who had MS but they had died quite old. I think at that stage it was just like "oh my God I'm different". And as a teenager you just want to conform.

'And then I would read up in the medical journals on MS and just think: "Oh my God". My mam worked with older people so she was very aware of MS. She was aware of the implications and the severity of it.' There were no treatments worth the name available to the 7,000 or so Irish people with MS.

'They were generally told to go home and live their life as best they could because there was nothing that could be done for them,' says the chairman of MS Ireland, Louise Wardell.

Carol was put on self-injecting drugs called interferons which had limited effect on her condition.

'When I was on the interferons I was getting night-sweats and wasn't sleeping properly,' she says. But that was not the worst of it, the greater problem was administering the doses.

'I just couldn't do it,' she says. 'I hate needles. It was more depressing than anything else. I would get up in the morning and think, "God, I have only eight hours to go and I will have to do it again".' Her fear of self-injection became so great that she had to come off interferons. The result was a string of what MS sufferers call 'relapses' - agonising episodes of dizziness, weakness and pain that can leave them unable even to pick up a pen and write.

'I was on no drugs and getting a lot of relapses,' says Carol. 'After a relapse you get all your steroids and drugs, but you are never back 100 per cent. My doctor was saying: "You have to take something".

'But it was unfair on my mother and my family to ask them to [inject me]. My mother was upset about my health like any mother would be,' she says.

Then came news which seemed, at first, like a miracle. The drug which almost a decade earlier had helped paralysed mice walk again was being put forward for its first human trial under the brand name Tysabri.

Its maker, Elan, was Ireland's biggest pharmaceutical firm and was looking for volunteers here.

Carol needed absolutely no persuasion. When offered the chance to participate in the Tysabri trial, she accepted immediately.

It meant being administered the drug via an intravenous drip once a month.

There was no more selfinjecting.

The impact on her illness, even in the trial stage, was immediate. 'With MS you never know. Everyone is affected differently. But I have a very active life. I probably wouldn't have been able to be so active without it.

I did get a lot of relapses before I started the trial and it really reduces relapses. I think by 70 per cent. So in the space of five years, normally I would have had 10 relapses but I only had three. That's brilliant,' she says.

'In relapse, my legs get weak and my walking is impaired. And I am touching walls walking down a corridor, afraid I will fall. My arms get weak and my writing gets bad. I remember years ago I lost my wallet and when I got my cards back, because my hands were so sore, I couldn't write my name on the new credit card.' In November 2004, the U.S. Food and Drug Administration approved the drug. Initial trial results were spectacular across the board.

Tysabri was shown to reduce relapses by 66 per cent and slow progression of disability by 44 per cent.

This was the silver bullet that MS sufferers had been waiting for.

But Elan was a not a firm that had enjoyed a trouble-free life. Only two years earlier, in 2002, analysts were predicting that the company would collapse, when in the fallout from the Enron scandal in the U.S., the Securities Exchange Commission launched an investigating into Elan's accounting practices. The share price collapsed.

In July 2002, with mounting fears the company would run out of cash, chief executive Donal Geaney resigned.

Geaney had joined Elan in 1987 and presided over its transition from a E1.6million company to one with a share valuation of E20billion.

ANEW CEO sold more than E1.2billion in assets to pay off debts. Geaney, the man who had made the firm and who had developed Tysabri, was broken. He died in 2005, aged just 54.

And while none of Tysabri's earlier financial woes mattered to Carol, it gave the firm a brittle reputation.

And in February 2005, with the trial still continuing, Elan announced that one fatal and one nonfatal case of a rare brain disease known as PML were found in patients given Tysabri in combination with another drug Avonex.

Elan's share price fell off a cliff again. And Carol was caught up in the maelstrom.

'It was a disaster,' she recalls. 'I was actually in the hospital that morning and one of the doctors said, "We're after getting a phone call from Elan. You have to come off Tysabri". I said, "What happened?

What's wrong with me?" And they said, "No, it's not just you, it's everyone." I asked, "Is everything ok?"

and they said, "It's grand, they have to go back to data and so on".' Then in March 2005, a second PML death was attributed to Tysabri.

With the trials suspended, Carol's symptoms returned.

'The year I was off Tysabri I was on steroids five or six times. At Christmas I was quite unwell. And I just had this massive fear that this is it.

I'm not going to get better.

'I was on steroids four times in the space of two months and I noticed I was awful tired. My legs were weak.

My walking was terrible. My balance was terrible. I was put on steroids and they weren't working and I was pushing the doctors for more. My brother is a pharmacist and he was telling me you are only supposed to be on these steroids three times in your life - and I have been on them 15 times. They damage your whole immune system and the next time you take them they won't be as effective.' Carol's personal life was also in turmoil.

'I was going out with a guy for ages but we broke up three months before Christmas last year. I was going out with him for a year which is a long time for me! I knew before we broke up I was going to get sick, so the relapses weren't because of the break-up.

'Although stress wouldn't help it.

If you are really down and stuff, that doesn't help.' Meanwhile, Elan's share price continued to fall. It became a worldwide news story.

Carol recalls the horror of watching the TV news: 'I am doing this interview because I want people to be more aware of what Tysabri is.

When I was looking at the Elan shares dropping and on TV they had pictures of tablets and Tysabri is not even a tablet. And all the focus was on the shares. But I was thinking "but what about the people who are actually on it?"

'It was horrible to think that it was all to do with money. It was just typical of our society - it wasn't about the dampener for people who had MS, it was about money.

People like me who had been on the trial, their lives were on hold.

And it was such a disaster.

'You know people were tracking the thing though trials and all the hopes and the feeling that it would be the best thing ever and then it was nothing, full stop. Finished.

'I wouldn't have gone back to injecting myself. I probably would have stayed taking nothing. I just hate needles.

'I think from the day I was diagnosed I wanted something like Tysabri that I wouldn't have to inject myself.' Carol believes the PML cases were over-hyped: 'All the focus in the media was on the rare examples of people getting PML and not on the positives. I think if you ask anyone with MS if they are prepared to take the risk they will say "of course".' Carol thought of all the sacrifices she had made just to take part in the trials. It had meant leaving the job she was in.

'I worked in insurance for years, but they were very discriminating when I started the trials. My boss told me I would have to take an annual leave day each month so I just got fed up with that.' THE effect on her emotionally was also harrowing. 'The year off Tysabri was weird. I was reading up on stem cell therapy and things. Then I was thinking because I love kids, maybe I should think about having kids now.

'Tysabri was never tried on pregnant women so you would never know what effect it would have on kids in the long term. You wouldn't do it to another human being. So then I thought "no I don't want kids yet".

'And then I thought "well it's a year of my life, just live it" because my life had been on hold for so long.

'So I travelled to Asia and Thailand-and Australia. But I was still thinking if Tysabri comes back again I will need to be back for the trial.' Aware of the effect its suspension was having on MS sufferers, the FDA (and its EU counterpart) fasttracked Tysabri back to market as fast as they felt able to.

Finally, in June this year, came the news Carol had been praying for. The drug was re-approved, with certain restrictions.

Carol is back on Tysabri. The only MS symptoms she has now are a numbness in parts of her legs and some problems with balance.

She is delighted other MS sufferers may get their chance to take it.

'You just wish for a drug like this.

It's not a cure, but it's the nearest thing to it.' She has a new boyfriend and the future is looking bright.

'I broke it to him [about MS] the first night I met him because his sister knew me and she knew.

When I'm seeing someone I would rather they hear it from me. He was a real funny chap. He still is. He makes me laugh.' She thinks about the future and having children. 'I know I'd have to come off Tysabri. And I do want to have kids in the next few years. A lot of women with MS are in remission while they're pregnant and then when they have the kid they go into relapse.

'That's scary......"