New Petitions

During the past six weeks, in excess of 44,000 people have signed the petition. I have brought the latest couple of thousand signatures, which have come in since we handed across the petition 10 days ago.The petition, as you know, calls on the Scottish Parliament to ensure that patients who might benefit from beta interferon and glatiramer acetate—people with MS—should receive them as soon as logistically possible. I do not have MS but I am delighted to be joined this morning by Jackie Doyle, who has MS but is being denied access to beta interferon even though her neurologist has identified her as somebody who might benefit from it, and by Wendy Harris, who also has MS but who has been receiving beta interferon since February. They are here to answer your questions—after I finish my three minutes—in a way that I could not possibly do. During my three minutes I want to touch on two aspects of this complex situation. The first is on the effectiveness of beta interferon and glatiramer acetate, which are similar drugs. The second aspect is the economics of their provision.First, what do we know about how well those drugs work? Beta interferon and glatiramer acetate have been through double-blind, placebo-controlled randomised trials. That is the gold star test for the effectiveness of medications. When we look at the results of that trial—actually, there were at least three trials—we see that the drugs reduce by a third, on average, the number of attacks or relapses that MS sufferers have. An attack or a relapse can mean paralysis or hospitalisation, disruption to one's vision and, frequently, great pain. Multiple sclerosis literally means "many scars", because in MS the body's immune system attacks the brain cells. The trials showed that the drugs can reduce significantly the volume of brain scarring. The trials also showed that the medicines can delay the onset of disability.People with MS are well aware that beta interferon and glatiramer acetate are not miracle cures, but they know the big difference that those drugs can make. They are also aware that if they lived in other parts of Europe or in North America they would routinely be prescribed those medications as the best available.What about the economics and the costs of the medicines? Beta interferon costs around £7,000 per patient per year. The Executive estimates that it would cost around £7 million a year to make those medications available to everybody in Scotland who might benefit from them. To put that in context, that figure is about 0.1 per cent of what the Scottish health service will spend this year. That is a significant but not absolutely unusual price tag. We must think about the costs of not treating MS. We have to think about the benefits that people who have given up work will claim from the state. We have to think about the costs of putting ramps and lifts into people's houses as they become increasingly disabled. We have to think about the informal cost to carers, who perhaps have to give up their employment to look after their daughter, partner or son.In summary, we have a drug whose beneficial impact on individuals has been proven by the most rigorous scientific examination. That drug's price tag to the NHS is likely to be offset significantly by savings to society in a wider context. In the UK, the drug has been licensed for use for more than six years, but most Scots who would potentially benefit from the drug do not have access to it.As the delay in making the drug available continues, we know that a significant number of people's MS will have progressed and their condition will have deteriorated to the extent that they are no longer eligible to benefit from beta interferon and glatiramer acetate. They will have missed forever their chance to benefit. That is why 44,000 people have signed the petition to ask the Scottish Parliament to do what it can to ensure that that injustice is ended as soon as is logistically possible.

There is marked regional variation. Patients are able to get beta interferon in Grampian and, probably, in Fife and Ayrshire and Arran. Elsewhere, new patients are unlikely to be able to get beta interferon.A change since 1996 has been that, after the announcement of the work of the Health Technology Board for Scotland and that of the National Institute for Clinical Excellence south of the border, many of the health boards that were prescribing beta interferon have decided to stop prescribing it pending the ruling of those quangos. On average, it is more difficult to get beta interferon now than it was two or three years ago.

Perhaps the most authoritative document on multiple sclerosis in Scotland was produced by the Scottish Needs Assessment Programme just over a year ago. The programme assessed the societal costs of multiple sclerosis, which are difficult to quantify, and came up with a figure in the order of £120 million a year.

The society is aware of the discussions that have taken place and that, I understand, continue to take place between the Department of Health in England and some of the drug manufacturers. Those discussions came about in part as a result of the proposal of testing as a way forward that one of my colleagues south of the border put to the department. At this stage we do not have any conclusion to those discussions. We are not clear about what drugs might be available, when such an exercise might start and what its duration might be. We do not have a clear picture of the relationship between that exercise and the situation in Scotland. It is an encouraging development, but there is an awful lot of devil in the detail. We are obviously concerned because of the possible delay in establishing such a complicated exercise.

The figure of £10,000 was used for a while. That was based on the manufacturers' prices. The £7,000 figure reflects a change in those prices. One of the manufacturers has brought the price down a little bit and glatiramer acetate—a similar product that I mentioned, which was launched more recently—was launched at about that price.

I clarify that beta interferon is not suitable for all people with MS. It is suitable for those with MS at a relatively early stage, before severe disability sets in, which it does not do in all cases. When we consider other countries, around 20 per cent of the total number of people with MS have the potential to benefit from these drugs. In Scotland, about 2,000 people would have the potential to benefit. There is now quite a few years' experience of its use in clinical practice. Some patients do not respond so well and some cannot tolerate the side effects. Although up to 20 per cent might benefit, the number of patients who receive the medication will be lower than that.

Yes. People try to pay for it themselves. That is another impact of the moving time scales for a decision on the matter. Some people embarked on funding it themselves last year, in the expectation that a decision would be made prior to Christmas last year. They will have had to try to continue funding it themselves or will have had to stop taking the medication because of the further delay that has taken place this year.

I had five relapses last year and was really ill. This year, I have had one relapse and I am going back to work in January. The difference is amazing. I am now fit, whereas last year I was constantly ill. It has made a massive difference to my life.

I do not take the drug at all. Greater Glasgow Health Board indicated that it will not prescribe to anyone. In November 2000, my neurologist diagnosed that I was suitable for treatment. However, in June 2001, I found that my details and those of a number of other people had simply been put in a filing cabinet and forgotten. I wrote to the health board about that. The list has now been forwarded to the health board and there has been correspondence. I have a career as a solicitor, so I have advantages over some people on the list. I am articulate, educated and can work out where my legal rights have been violated. The matter is frustrating. I have had five—possibly six—relapses this year. Some have been mild, but some have been severe. In April, I could not walk. I collapsed while getting out of bed. One morning, I tried to wash my hair and felt the room spinning. I had to hold on to the bath and vomited in the toilet. I had to shout to someone for help. I was helped into bed and had to be looked after for 24 hours a day. I could not eat or drink without help or get to the bathroom on my own. If I wanted to wash, a chair had to be brought to the sink and I had to be put in it. I needed help with brushing my teeth—I could not hold a toothbrush. At that time, I lived in a property with stairs, so I had to be carried upstairs. If I wanted something to eat, I would possibly have to be carried downstairs. That lasted for about a fortnight. There were relapses in March and April. I am in much better health this morning, as members can see. I hold down a full-time job—I am a qualified solicitor. I am educated and have my own firm. I employ six people, whose lives are affected by what I do. I do not want to rely on the state or force other people to rely on it. I employ people and keep them in work.Wendy Harris would have been in a similar situation. There is a sense of total helplessness. Not getting the drug leads to frustration and panic. What will happen to me? Will this be my final relapse? Will I be like this for the rest of my life? I want to contribute to society and want the drug so that I can continue to contribute.

There is less of a difference than some headlines suggest. We handle quite a lot of inquiries from people who have heard that there is a difference. My colleagues carried out work that considered, for example, the costs for people with private funding who are desperately trying to make their money stretch by buying the drug in the US and bringing it over. There are differences in different markets, but those are not as enormous as the press has suggested.One influencing factor is the pharmaceutical price regulation structure in the UK. The structure is extremely complicated and technical but, basically, the Department of Health regulates the overall profitability of an individual company rather than considering the profit margin on an individual product. That is how pharmaceutical pricing is regulated in the UK. The fact that the UK is sometimes used as a benchmark market for setting prices elsewhere also has an influence.

Fife.

In Glasgow, no one receives beta interferon. I have a letter from James Miller of South Glasgow University Hospitals NHS Trust to Harry Burns, the director of public health at Greater Glasgow Health Board. In the letter, James Miller says that he has instructed west of Scotland health boards not to deem anyone suitable for treatment with the drug until funding is identified. That puts the cart before the horse. Funding cannot be identified if a person is unsuitable, but Glasgow is being instructed not to deem anyone suitable before funding is identified. That is even worse than a blanket refusal—that is an instruction not to prescribe.

Yes.

The Minister for Health and Community Care first referred the beta interferon issue to the Health Technology Board in December 1999. We are approaching the second anniversary of that referral. The Health Technology Board did not exist until April 2000. One reason why we ask for the drug to be made available immediately is the long history of delay.NICE has produced its final appraisal determination, which says that the drug should not be available on the NHS. That determination was the subject of an appeal at the beginning of last week. England and Wales await the outcome of that appeal.The Health Technology Board has said that it will not begin its work until NICE publishes its guidance, which it will do once the appeal process has been exhausted. One cannot prejudge the outcome of the appeal at NICE, but the signs are not encouraging.

The appeal is to an appeal panel that is convened by NICE. I think that the chair of the appeal panel is the chair of either NICE or the original appraisals committee that worked on beta interferon.

It was from James Miller, the divisional general manager at South Glasgow University Hospitals NHS Trust.