HC Deb 03 March 2004 vol 418 cc282-303WH

2 pm

Dr. Vincent Cable (Twickenham) (LD)

I am grateful for the opportunity to introduce the debate, which I have secured for several reasons. Like a great many Members, I have received lots of letters and cards in connection with a recent campaign by the National Osteoporosis Society about the recommendations of the National institute for Clinical Excellence. Several of the moving and affecting letters that I have received led to complicated casework, which has highlighted some of the difficulties of the matter.

The issue affects many people in the House. I note that 161 Members signed the early-day motion in the name of the chairman of the all-party group on osteoporosis, the hon. Member for Erith and Thamesmead (John Austin), and that another 72 signed a virtually identical early-day motion in the name of the hon. Member for Westbury (Dr. Murrison). I am not sure why there should be any tribalism on the subject, which is fundamentally non-controversial. However, as a result of those two initiatives, more than 235 Members have expressed their support for the society and its work, and their concerns about the problems that the widespread illness presents.

Another reason why I have a personal interest in the matter is that one of the first initiatives that I took after entering the House in 1997 was to introduce a ten-minute Bill on the role of the elderly more generally in the national health service. I tried, as one does, to introduce provisions on non-discrimination in the health service as it affects elderly patients. However, a lot has happened since then: the national service framework has been introduced, and there is now much greater sensitivity toward osteoporosis, which has become a pretty central issue. Much progress has been made, but there are serious problems.

The osteoporosis arguments are very much at the heart of bigger debates on the health service and how we shift the emphasis from dealing with disease to prevention. Although that is an attractive slogan, it is difficult to realise in practice, as this case makes all too clear. I want to focus on the issue too because it raises some challenging questions about the role of the National Institute for Clinical Excellence. Most of us accepted that the underlying philosophy behind NICE was right. We thought it important to have an independent body to make professional, objective assessments of drug; rather than to rely on lobbying by companies, fashion, doctors or press campaigns. The aim was to have an objective, detached institution that was separate from Ministers to make such judgments.

Although the role of NICE has been vindicated, what has happened with osteoporosis is alarming: in many ways, the initial ruling—the technical assessment— appeared to cut the ground from under the argument in favour of prevention One is left with two potentially alarming explanations. One is that the methodology employed by NICE is flawed. If the health economics that underlie it are unsound, that raises wider questions. The second explanation, which is even more alarming, is that the case that most of us made for placing much more emphasis on prevention rather than dealing with disease may be flawed. The first explanation is likely to be the issue. Therefore, the case of osteoporosis raises not only specific issues but more fundamental questions about what NICE is doing and about its reputation, which has been somewhat damaged by this episode.

All that means that we are in a worrying position: many people, particularly won't have been left stranded, because they have been advised by doctors and the media not to take hormone replacement therapy. Some 1.7 million women use HRT; they have been advised that it enhances the risk of cancer. Indeed, if they read this morning's Daily Mail, they will also have been advised that it enhances the risk of stroke. Many of them are ceasing to use it, but they are in a kind of limbo in which alternative drug treatments appear uncertain and NICE is unwilling to make positive recommendations—certainly on newer drugs. Therefore, such women have been left in what has been called NICE blight—an unsatisfactory situation that is unlikely to be resolved until June 2005, when a revised version of the NICE report will be published.

I want to set out a few of the basic facts, with which the Minister and many hon. Members will be familiar, although it does no harm to rehearse them. Osteoporosis is an extensive illness that affects one in three women over the age of 50 and one in 12 men—3 million people altogether, of whom probably 250,000 have an acute form. It almost certainly leads to about 300,000 fractures a year. There is a much uncertainty about the specifics, because in many cases the disease is difficult to define precisely, but probably between 70,000 and 85,000 are hip fractures and another 50,000 are wrist fractures. I have seen quite wide variations in the estimates, but there are probably 100,000—perhaps fewer—spinal fractures a year. The literature suggests that the position is not static, but that the incidence of the disease and of fractures is growing rapidly, and for simple demographic reasons: the population is getting older, and there are more frail and elderly people, particularly frail and elderly women, who are prone to the illness.

The consequences of osteoporosis are not simply the obvious ones. Once a fracture has occurred, not only is the probability of a repeat fracture considerably enhanced, many people become crippled, with the attendant consequences of immobility, care costs and so on. Moreover, the illness gives rise to enhanced rates of mortality, as apparently 20 per cent. of those who have hip fractures die within a year. There may be other reasons for that; it may not be a direct cause and effect, but it is a rather worrying link.

The impact on the NHS is substantial. It has been calculated that the cost to the NHS of hip fractures alone is about £1. 7 billion—so it is much higher for osteoporosis in general. Osteoporosis also makes a heavy demand on orthopaedic beds, accounting for an estimated 800,000 bed nights. Probably at any one time, 20 to 25 per cent. of beds in orthopaedic wards are blocked—I know that that is a pejorative term and we should perhaps be careful with it—mainly by elderly people with osteoporosis.

I want to touch on two issues relating to the policy response. The first is the role of the national service framework, in which the Government have been central. Secondly, I want to say something further about NICE, its recommendations and their consequences. I believe that there is general acknowledgement among those involved with the disease that standard 6—the step forward taken in 2001—was positive. Tribute has been paid to those who campaigned for that and to the Government's role in delivering it. It was a big step forward, and I have no criticism of it. It had several positive outcomes. It led to awareness of the need for osteoporosis work at primary and secondary care level; to the need to deal with falls and their prevention; and to greater concern about prevention and risk assessment.

Mr. David Drew (Stroud) (Lab/Co-op)

I apologise for missing the hon. Gentleman's first words. I want to raise a problem with the issue of falls and osteoporosis. A retired general practitioner, Dr. Jonathan Bayly, who produced a report for the National Osteoporosis Society, did some valuable work on fall prevention. Of course, it involves trying to prove a negative. The local primary care trust has been unwilling to widen the scheme beyond one practice, where it tries to pinpoint women who are likely to suffer from osteoporosis. Is that not a particular problem? It is difficult at present to prove how valuable preventive work is. What does the hon. Gentleman feel about that?

Dr. Cable

That is a thoughtful and appropriate intervention. Concern about the problem that the hon. Gentleman describes is quite widely shared. When NICE published its report on falls and how to prevent them, the National Osteoporosis Society described its work as muddled and lacking in cohesion. Even the experts have had the same difficulty in linking the various elements as he and the GP whom he mentioned have had, so the point is perfectly valid.

Although the national service framework has been launched with the positive objectives that I described, those who have been following the issue most closely have several concerns. Despite the creation of the framework, there is, for example, little evidence that many PCTs are taking the issue very seriously. I think that only 20 per cent. of PCTs even mention the framework in their local plans. Also, very little monitoring is being done. Clearly, one does not want to argue for a large bureaucracy and monitoring for its own sake, but there appears to be little monitoring other than that which the society conducts.

The skeletal evidence that exists suggests that Britain still lags way behind other European countries in the extent of scanning. Large numbers of people with fractures are still released from hospitals without having been scanned. There is also a lack of linkage between the genuinely pioneering preventive work in primary care and that in the secondary care sector, where such standards are not matched. The national service framework standard 6 is an important step forward, but the big question is how we put more energy into it and take it forward.

The other policy question arises in connection with NICE and its technical studies, particularly those on three contentious drugs that required evaluation, of the five drugs that were studied. Those drugs were—I am not a scientist, so I shall have to read their names to ensure that I do not get them wrong—bisphosphonates, raloxifene and teriparatide. Three major conclusions were derived from that technical work, which have rather worrying implications for osteoporosis sufferers.

First, NICE strongly advised in its initial draft that there should not be preventive use of drugs by people who do not have a fracture. In other words, NICE questioned the principle of using drugs for prevention. Secondly, even for people who have fractures, there is a tight definition of risk that excludes many of the variables that people in the field recognise as important predictors, thereby considerably narrowing the range of drug use. Thirdly, the lack of confidence in raloxifene and teriparatide prevents the use of drugs for dealing with spinal vertebrae osteoporosis and fractures resulting from it.

The society and many people who have written to us were alarmed by those outcomes for several reasons—one of which was that they appeared totally to contradict the work in the national service framework and to undermine the current preventive work, let alone its expansion. The findings have also opened up the possibility that people who cannot use bisphosphonates—the established drugs—because of their side effects will have no other drug treatment open to them.

As a consequence of the objections that were raised, NICE is having a fresh look and a report will appear in just over a year's time. The result of the whole exercise, however, has been to raise doubts about the methodology. Again, I am not a specialist or scientist in the field, but critics of the process made some rather obvious points that question the basic scientific rigour.

For example, it was noted that the studies failed to establish the connection between the use of such drugs for osteoporosis and their value in other fields such as cancer prevention. They appeared to assume that each fracture had equal value for health economics, when in fact repeat fractures increase the probability of a return. Simple mistakes seem to have been made—a serious consequence of which is that the lives of large numbers of people, particularly women, are blighted because they cannot progress with drug therapy and it is uncertain which treatment is appropriate.

An unintended consequence of the uncertainty surrounding the subject has been that it has drawn attention to one area in which prevention can be improved: people's lifestyles and diets. We all pay lip service to lifestyle and diet, but they are becoming the first line of defence in the absence of a satisfactory agreement on drug treatment. Some of the conclusions that emerged from the dietary research underline much of what we say about other diseases: smoking and alcohol add to the risk; plenty of exercise reduces risk; and fruit and vegetables are good preventers. All those good messages are reinforced in the case of osteoporosis.

In addition, there is a large body of evidence on the importance of calcium in milk drunk at early stages of growth and of vitamins D and K. Milk is important. Some 30 years ago, I was part of the campaign to try to stop the withdrawal of milk from schools. It was a major political issue more than a generation ago, but the battle was lost. The rationale for withdrawing milk was that it was originally provided to deal with rickets, and that as rickets was disappearing, we might not need to worry too much about it in future. However, evidence is emerging that lack of milk in early years is a major factor in increasing the risk of osteoporosis later in life. The National Dairy Council is quite properly putting the issue back on the agenda. I am not suggesting that the spending commitments of the Government or the Liberal Democrats should include free school milk; as the Liberal Democrat Treasury spokesman, I would not be very popular with my colleagues if I suggested that. None the less, reintroducing milk as central to preventive care is an important theme.

Dr. Andrew Murrison (Westbury) (Con)

I was one of the primary school children who were affected by the withdrawal of milk. My childhood memory is of leftover crates of milk, because the milk was invariably of poor quality, it had usually gone off, and was rarely drunk. Does the hon. Gentleman accept that bone mineral density is certainly increased by diet and by milk, but that the evidence relating to the incidence of fractures and their prevention is less clear-cut?

Dr. Cable

The hon. Gentleman speaks with medical authority. His conclusions, which I read in the literature, are straightforward, and I accept his point.

Another finding concerns acidity and relates—I believe—to the risk of fracture rather than to bone density. The hon. Gentleman has not yet referred to that finding, but it is quite interesting, and perhaps he will comment on it later. A conclusion that is emerging about diet is that all that sparkling water in this Chamber is extremely helpful in preventing osteoporosis fractures. There is, however, a negative side to the story: Coca-Cola and Pepsi-Cola are risky substances that appear to be very damaging to our hone structure. I do not know whether the Minister intends to campaign against those companies, but if he reads the literature, he will probably conclude that he should.

I draw my thoughts together by asking the Minister a few questions. This is not a highly polemic subject, let alone a party political one, but there are issues that we need to address. First, how do we bring energy and life into national service framework standard 6, given the somewhat negative and even cynical comments about its effectiveness at grass-roots level? What can be done to reinvigorate it?

Secondly, what happens when what NICE says diametrically opposes the national service framework? Will Ministers express a view, or will they let the process of professional comment and interaction between bureaucracies work itself out? There is clearly a problem. Thirdly, w hat happens about blight? We are in a difficult position because women, in particular, are highly uncertain al out what preventive measures to take, given that all such measures are unapproved or risky. What advice is given? How does one reduce blight?

Fourthly, is the Department monitoring hormone replacement therapy? Are there numbers to show how rapidly it is tailing off? Given the frequent changes in clinical assessment, what advice is now being given? Lastly. the importance of lifestyle choices is growing, although some are controversial, while others are not. What role do the Government have in ensuring that lifestyle choices are improved, particularly as regards osteoporosis?

2.21 pm
Mr. Russell Brown (Dumfries) (Lab)

I congratulate the hon. Member for Twickenham (Dr. Cable) on selecting this subject for debate. I also apologise to you, Mr. Deputy Speaker, to the Minister and to others in the Chamber, as I must leave just before 3 o'clock for another engagement.

I must declare an interest as a patron of the Dumfriesshire osteoporosis support group, which has been in existence for about six years. The group's chairman, Mrs. Margery Wilkins, is a trustee of the National Osteoporosis Society. As such, she represents all sufferers and support groups in the United Kingdom.

The hon. Gentleman mentioned NICE, to which I shall return later. I fully appreciate that it covers only England and Wales, and not Scotland. When I spoke to the Minister, he assured me that NICE's recommendations on a host of issues were recognised throughout the world, but not in Scotland. I am sure that he will enlighten us about that.

Sandra Gidley (Romsey) (LD)

I believe that Scotland has a separate system called SIGN, or the Scottish intercollegiate guidelines network. When the Select Committee on Health examined the phenomenon—I hesitate to say problem—that is NICE, it was supportive of the Scottish system, which seemed to be quicker and to provide more practical advice.

Mr. Brown

I thank the hon. Lady for her comments. She is right. Although we have devolution in the UK, practice on either side of the border is not completely at odds.

As I said, my local group has been in existence for about six years, and I want to give colleagues an indication of some of the good work that it is doing. The group produced the National Osteoporosis Society healthy bones packs and, with a grant from the Lloyds TSB Foundation for Scotland, it distributed them to all the primary schools in Dumfries and Galloway 10 months ago. That goes back to the point about prevention in the early years, when people can take on board issues that will help in later life.

In my area, people initially went to West Cumberland hospital in Whitehaven for DXA scans. If necessary, that was followed by a meeting with the bone nurse. Given the pressure in the area, we purchased a DXA scanner through public subscription. However, even after many months, it was receiving little usage. People were still going to Whitehaven, and those who know the geography of the area will know that getting there and back is a significant journey. I added my support to the local osteoporosis group and we were able to put pressure on the local health trust to develop a strategy to enable better use of the DXA scanner. I am delighted to report that an expanding service is now being provided to sufferers and that the group is now well established at Dumfries and Galloway royal infirmary.

The chairperson of my local group contacted me in early January because NICE had published on its website the consultation document prepared by the technology appraisal committee. She was considerably concerned as the document was in draft form. I want to give hon. Members a flavour of the concerns that arose from that initial posting, although I appreciate that the consultation period finished on 23 January, that we have moved on and that the Minister will update us. The chairperson wrote:

To deny a DXA scan to those over 65 with a broken bone is to deny them and their doctor a base line from which to assess whether their bisphosphonate treatment is effective or not". In her case, the scan results showed that the bisphosphonate drug Fosamax alone was not proving effective, and until Fosamax was combined with HRT, calcium and vitamin D, her bone density continued to decline. Had she been denied a scan, none of that would have been discovered.

She went on to say: For those under 65 to have to wait for treatment until their T score is as low as stated by the NICE proposals, is counterproductive in terms of fracture risk and positively cruel. Many people with T scores less severe than this do suffer pain from wedged vertebrae. The big question was: were they being denied the basic human right to have the disease arrested and further fractures prevented? All in all, the draft proposals that were posted caused concern. I am delighted that that letter allowed me to take the opportunity to write to Lord Warner, the Minister with responsibility for NICE, who got back to me and fully explained what was happening.

I said that I would keep my comments brief, and that is basically as much as I want to say. Again, I congratulate the hon. Member for Twickenham. As he has said, this is a debilitating illness. Early intervention is vital. I have given the example of my local group, which believes that the starting point should be in schools. Those who suffer need to be listened to, and I hope and pray that they are. The National Osteoporosis Society, an extremely well-organised national body, needs to be listened to. The real test will be whether we see a dramatic fall in the number of sufferers over the years on the back of NICE's recommendations. I apologise again that I have to leave the debate early, but I will read the Minister's response in Hansard tomorrow with great interest.

2.28 pm
Linda Gilroy (Plymouth. Sutton) (Lab/Co-op)

It is a pleasure to follow my hon. Friend the Member for Dumfries (Mr. Brown); I always want to call him the hon. Member for Moffat, where I was born, but he is the hon. Member for Dumfries. It is also a pleasure to share his experience. There must have been a drive six years ago to set up local osteoporosis societies, when I became a patron of my local society. I remember the inaugural meeting at which well over 100 people—there could have been more than 200—turned up. That was an early lesson to me about the impact that osteoporosis can have on people's lives.

We have probably all been active members of the all-party group on osteoporosis, which has been ably supported by the National Osteoporosis Society. I wish to take this opportunity to pay tribute to the former director of the society, Linda Edwards, who sadly died an untimely death at an early age last year. On a nice sunny day such as today—well, it was a nice sunny day—I well recollect some of the events that were organised. We were invited to take our bones for a walk and to have our photograph taken with Oscar the skeleton. I have still have a photo up in my office of me shaking hands with the skeleton.

I congratulate the hon. Member for Twickenham (Dr. Cable) on initiating this timely debate. He has already referred to the NICE appraisal. As that appraisal continues, it is important not only for the individuals concerned but for Government policy that we make robust representations. As he mentioned, the NHS currently spends £1.7 billion a year on mending fractures. We are talking about 86,000 hip fractures and 310,000 osteoporotic fractures. That is a huge cost on the health service and it is largely preventable. That is one of the reasons why the work of the all-party group on osteoporosis and the National Osteoporosis Society is important. When working out how one spends one's time, this is an area in which Members should try to ensure that a programme that addresses the issues is carried forward.

The NICE technology appraisal on drug treatments is in progress. The preliminary recommendations that it was considering caused significant consternation. It is important that patients and carers get clear, authoritative advice on the sort of care that might be appropriate and what can be expected from the NHS. That consternation was largely well founded. The hon. Gentleman has already referred to some of the concerns expressed by individual patients suffering from osteoporosis and also to the concerns of the National Osteoporosis Society, which I recently met. It is important that the final appraisal determination reflects those concerns. Some signs that that is the case might already be emanating from the recent meeting of the appraisal committee. I hope that the Minister will assure us that he is putting his weight behind ensuring that the many representations that were made in the early parts of the process are taken heed of.

It is difficult to believe some of the grounds on which the initial recommendations were made. Take the example of women over 65 with fragility fractures receiving treatment without a DXA scan. That could immediately have an impact on women with old traumatic deformities, Scheuermann's disease or osteoarthritis of the lumbar spine, who could wrongly receive treatment if the decision is based solely on an apparent vertebral fracture. The apparent proposed treatment restrictions in the case of post-menopausal women below 65 would mean that, unless there was a T-scan or other risk factors, they would be excluded. In reality, it is difficult to use an absolute cut-off of the type that is proposed. I know that both NICE and the World Health Organisation are considering more sophisticated approaches, and I understand that there may be further reflection on that issue in future stages of the appraisal process.

On restrictions on treatment, there is the idea that no treatment should be given until a woman has a fracture, and the proposal that we should move away from the sort of primary prevention that we have all been working hard to encourage in our local primary care trusts among those at highest risk. Women are at much greater risk of subsequent fractures following the first fracture. As the National Osteoporosis Society said in its representation to NICE:

just as high blood pressure and raised cholesterol are treated to prevent heart attack and stroke, so osteoporosis should be treated in those at high risk". The National Osteoporosis Society expressed a number of other concerns to me about the restrictive criteria being proposed for the use of teriparatide, and the way in which it was proposed that calcium and vitamin D supplements should be used. It was also concerned that raloxifene would no longer be available to prevent fractures in those at higher risk, especially as it reduces the risk of breast cancer and is an alternative to HRT, which has been the subject of much topical concern. That needs to be looked at far more closely. Women who are at risk of vertebral fracture often cannot tolerate the side effects caused by biophosphonates or cope with complex treatment regimes. Several other concerns were expressed alongside those.

As an illustration, I wish to refer to a letter from a local constituent, as it shows how some of the issues that I have described can impact on and worry some of our constituents. The lady in question writes: I was diagnosed with osteoporosis in 1992 after suffering excruciating back pain, clay and night. The rheumatologist arranged a bone density scan. That density scan revealed that her bones were indeed in a bad state, and she continues: I was unable to take Didronel because of quite severe side effects, so I was treated with HRT patches. Over the ensuing months and years, the pain decreased dramatically and mobility was restored. After five years, she had another scan that showed a great improvement in her bone density and HRT was continued for another five and a half years. However, from time to time she developed painful cysts in her breasts that had to be aspirated.

A year ago, although the breast clinic was of the opinion that to protect my constituent's bones, it would be good on balance for her to remain on HRT and to keep the situation monitored, her GP and rheumatologist—presumably against the background of concern about HRT and breast cancer that I have described—thought that it might be better to give her different medication, at least for a while. She has been trying different regimes of medication, such as Evista, which did not suit her, and Actonel—both the one-a-day and one-a-week versions—but that caused her considerable pain. She has now settled with the one-a-week version, but that will have to be reviewed in a year's time. She also writes: It needs no stretch of the imagination to envisage my despair when I read that it was being proposed that this drug 'should not be available to post-menopausal women with osteoporosis and at high-risk of fracture until they have fractured already'. In that one case alone, we can see almost all the points of concern that the National Osteoporosis Society raised in its representation to NICE on the initial proposals.

I hope that the Minister will be able to offer us some reassurance that he will be encouraging NICE to continue to listen to representations such as those from my constituent. Indeed, that lady did in fact submit her views to the NICE committee. I hope that he will give that reassurance not only for all the reasons of personal distress and anxiety that the letter illustrates, but also because of the contribution that getting the correct balance between prevention and secondary care can bring to reducing the £1.7 billion bill that I mentioned at the beginning of my remarks.

I hope that the Minister will take a close interest and encourage the more strategic and flexible approach that appears to be beginning to emerge, and that he will not hinder implementation on falls and fracture prevention in standard 6 of the national service framework. Extending the appraisal period as NICE now intends to do will be a noteworthy effort to evaluate primary and secondary treatment. It will give a chance to do that evaluation and to create the best guidelines for both pre and post-menopausal women.

If the draft had stood as it was originally presented, there would have been an increase in falls that would have had disastrous effects on the health and lives of many women. There is no logical sense in creating guidelines that are so strict that they overlook the needs of patients. Patients should definitely come before guidelines. Patient needs must be assessed in a more flexible approach that allows treatment to ensure that that first preventable fracture never occurs.

2.40 pm
Sandra Gidley (Romsey) (LD)

I congratulate my hon. Friend the Member for Twickenham (Dr. Cable) on securing the debate. I am a little surprised that there are not more Members present, because I for one have received a large number of cards on this subject. We all know how easy it is to arrange a postcard campaign, but what struck me particularly was the number of people who also took the time to write to me to tell me how the recommendations would affect them if they were implemented. That is powerful; people do not lightly write to an MP.

Osteoporosis is a prevalent issue, but I sometimes cynically ask myself whether it is so ignored and underestimated because it mainly affects women. If it were a male disease, would more research be devoted to the subject? That is probably a little churlish. The answer is that I do not know why there is not more research or why something that affects such a large number of the population—affects their mobility and the way in which they can look after themselves when elderly—does not receive the attention that is given to other matters.

Linda Gilroy

Will the hon. Lady concede that the disease not only affects women but is prevalent in older age? It is only in recent times that we have begun to take it much more seriously and not just to put it down to something that is inevitable in old age.

Sandra Gidley

Sadly, despite some of the Government's best efforts, there is all too often an institutional ageism in the NHS. If one looks closely at the NICE guidelines, one sees that if somebody is much older—over 80 years old, for example—the cost benefit of treating them is much better. Any Figures that showed such cost benefit across the age range would suggest that such people should receive treatment So, I wonder whether there is almost an element or ageism in some of the NICE conclusions.

Clearly, there is a big problem. Many statistics have been mentioned today, but the one that I was particularly taken by is that every three minutes somebody has a fracture owing to osteoporosis. More seriously, 14,000 people die as a result of an osteoporotic hip fracture. It has already been mentioned that if one has one fracture, another is between half a likely and twice as likely to occur. I did some work on the matter—I think that it was with the National Osteoporosis Society—a couple of years ago. I was not sure what part I was meant to play, as there was a very young, glamorous model, a very small old lady and me in the middle. I think that I was there in my capacity as an MP, but the age range was quite stark. We were posing with dummies in a shop window. Members could make a lot of political capital out of that should they be so cruel.

The dummies were in various stages of disrepair, and the point that we were trying to get across was that, as a young woman one was unlikely to suffer breakages. The first break is often of the wrist or a lower arm fracture, which should be treated as a sign that the case should be investigated and, perhaps, that treatment for osteoporosis should begin. Sadly, not everybody has a less serious fracture first. Many women—and some men—who suffer from osteoporosis, first know of it when they have a more serious fracture.

The point of that campaign was to try to encourage young women, in particular, to exercise. It is with dismay that, in reading for this debate, I discovered that the jury is still out on whether exercise is a good thing. Clearly, exercise provides other health benefits, but from the point of view of osteoporosis, it is not as clearly beneficial as it might be.

Dr. Morrison

Perhaps I can help the hon. Lady. I think that it is proven that bone mineral density increases on exercise. The question is whether the incidence of fracture goes up or down.

Sandra Gidley

The hon. Gentleman is correct. It must be pointed out that not just any old exercise will help; it has to be weight-bearing exercise to have a beneficial effect.

Sadly, some of the women who wrote in—my hon. Friend the Member for Twickenham referred to this point—felt a double whammy. HRT had been taken away from them as a recommended treatment. Many women were taking HRT and thought that it was doing them good. There seemed to be evidence that it was helping with osteoporosis, but the problem was that the benefits did not appear to outweigh the risks.

There is some interesting research that suggests that it might not be the hormones in themselves that have a beneficial effect. One effect of taking such hormones is to alter the acid-alkali balance in the body; the body becomes less acidic. That has been shown to have a positive effect on bone density and—possibly—on whether someone gets osteoporosis. We should be investing in research around food and Coca-Cola. Incidentally, I have switched to drinking sparkling water. It would be interesting if the Minister could tell us exactly what research is going on. Setting aside the recommendations for a moment, I found it particularly interesting that NICE recommended further research. It struck me again, most powerfully, that we simply do not have all the answers that we need in order to come to an informed decision.

NICE has arrived at a different decision from a number of other bodies. I mentioned the Scottish intercollegiate guidelines network—SIGN—in an intervention. It has come to a different conclusion: Postmenopausal women who have had low BMD confirmed by DXA scanning should be considered for one of the following options", and it goes on to name some treatments. The Scottish Medicines Consortium appraised teriparatide in 2003 and recommended that it be used by osteoporosis specialists following assessment of fracture risk and bone mineral density. I think that assessment of fracture risk is important. An action plan on osteoporosis in the European Community published in November stated: Many interventions, such as bisphosphonates and raloxifene are cost-effective if targeted at individuals at high-risk of osteoporotic fractures. We have to develop a much more robust way of identifying who is at high risk than merely saying, "Well, you've had a fracture, clearly you must be high-risk." That needs looking into.

Some of those comments bear out the NICE proposals for further research. NICE can make proposals for prescribing that must be adopted, but I am not clear whether if it proposes further research there is an onus on anybody to conduct it. How can the Government and drug companies work together to make sure that we have the answers sooner rather than later?

I do not want to dwell too much on quality-adjusted life years, which NICE uses to measure whether a drug is cost-effective. I have alluded to the fact that that changes according to the age of the patient. However, when the Select Committee on Health looked into NICE, it was clear that the science around health economics, health benefits, quality-adjusted life years and the like was very new and inexact. Sometimes figures must be treated with a little caution; one must find out exactly what criteria were used in order to ensure that the figures were not blurred. In fairness to NICE, it is improving in that regard, but I am still not sure that its systems are state-of-the-art.

I turn to the link with falls and the standard in the national service framework for older people. NICE is producing clinical guidelines on falls in August 2004, and it is producing a separate set of clinical guidelines on osteoporosis in June 2005. It seems that there is scope for overlap, so is there not a case for amalgamating the studies or at least for ensuring that enough account is taken of the former? It would clearly be ridiculous—it has not happened yet, and there are no signs of it happening, but it may happen—for different groups within NICE to produce guidelines that are slightly at odds with each other. The thinking should be joined up more efficiently.

There has been little evidence of progress or of joined-up thinking on the matter. In January, I asked the Minister this question: What estimates the Department has made of the potential savings to be made by preventing osteoporosic fractures rather than treating them? Sadly, the reply said: The Department has made no estimate of the potential savings to be made" —[ Official Report, 5 January 2004; Vol. 416, c. 203W.] It then went on to refer to NICE. Clearly, NICE does not feel that it has the right answer. The preliminary revised statement was very welcome, in that— hopefully—there will be a review of cases to examine how high-risk patients can be assessed and whether there is any way in which they can be treated before they suffer a fracture, but I must admit that I found the reply a little disappointing.

I started to think about the slightly wider implications. It may have been t he hon. Member for Dumfries (Mr. Brown) who mentioned bed blocking; my hon. Friend the Member for Twickenham may also have done so. I tabled another question: What assessment has been made of the link between osteoporosis and bed-blocking? Clearly, a large number of patients with osteoporotic fractures are, because of their age group, unable to rehabilitate easily at home. It would be useful to try to get a grip on the scale of the problem—but no. The answer stated: The Department of Health does not collect data on the precise medical conditions of patients delayed in hospital". It does not mention falls or osteoporosis.

The National Osteoporosis Society has discovered that osteoporosis is still not sufficiently prioritised and that services are not established in line with the national service framework. Although falls have been included in primary care trust local delivery plans, very few plans contain direct references to such measures. I asked for the Minister's assessment of whether identifying osteoporosis had become a priority in primary care as suggested in the national service framework for older people. I do not propose to read out the full answer, which is quite long, but it ends: The most recent reports we have from strategic health authorities indicate that all but a few of the primary care trust local delivery plans include actions to achieve the 2005 falls milestone. We have collected no systematic information on what local plans cover."—[Official Report, 12 January 2004; Vol. 416, c. 618–9W.] I am not quite sure who has got it right. Perhaps the Minister needs to talk to the National Osteoporosis Society. Clearly, there is a great difference in perception between the answer to my parliamentary question and the survey by people on the ground. If he can elaborate on that, it will be useful.

I wondered whether the Government had a good initiative on falls, and became excited on finding a press release stating that falls had been halved. Sadly, the small print revealed that that was not for the whole country, but in one primary care trust area that had issued gripper slippers to older people at risk. Although that is a welcome initiative, it is disingenuous to put a bold headline on the website claiming that the problem is well on the way to being reduced, when close inspection does not bear that out. I hope that the Minister will assure me that that measure is not the only one that is to be introduced. He may want to announce a roll-out of the slipper scheme today, so that the number of people in hospital can be reduced. Any progress on that initiative will be welcome.

The National Osteoporosis Society said that there is still a long way to go in implementing Standard Six, particularly with respect to better co-ordination between primary and secondary care services. Its audit also highlighted a lack of progress towards implementation and focused on several cases. I have been doing a preliminary survey of my own, and my findings are closer to those of the National Osteoporosis Society than to the Minister's.

The subject is an important one. I look forward with interest to the Minister's reply—particularly with regard to whether the Government will help to fund any of the research projects identified by NICE. We would, I think, all agree that preventing an accident, or preventing the deterioration of osteoporosis, is in everyone's best interest.

2.58 pm
Dr. Andrew Murrison (Westbury) (Con)

There have been some thoughtful contributions today. It is a pity that there have not been more of them. That may be the case because of the trade justice debate that is happening under the auspices of the official Opposition on the Floor of the House, but it is a pity nevertheless, because the subject is important.

I pay tribute to the National Osteoporosis Society for its hard work in highlighting a subject that is one of the forgotten areas of medicine. I am mindful of my time about 20 years ago as a house surgeon in Bristol in orthopaedics, dealing with orthopaedic fractures, including hip fractures. At that time, the condition was pretty well ignored. If someone had a fracture, they had their hips repaired and either got better or did not. By and large, no real thought was given to the treatment of their underlying osteoporosis.

I wonder whether, 20 years on, a great deal has changed. I suspect that it probably has, although perhaps not quite as much as one might have liked it to change over two decades. In so far as there has been change and improvement, a great deal of it has been down to groups that have brought the condition into the public arena. Of those groups, I would obviously single out the National Osteoporosis Society.

I congratulate the hon. Member for Twickenham (Dr. Cable) on initiating the debate, which is very timely. We have recently heard a great deal about NICE and its consideration of osteoporosis. White I would hope to avoid the temptation to use the present occasion as an opportunity to criticise NICE, it is right to highlight the fact that that episode has perhaps not been the most glorious in its history, and it may wish to reflect upon that.

The impact of osteoporosis on people's health and its economic impact on the national health service are underestimated. I recall broken hips and vertebrae, wedge fractures and the classic dowager's hump. Osteoporosis is often passed off as part of the natural ageing process when it can be treated quite satisfactorily. It is a great pity that even now, in the 21st century, we are prepared to pass it off as a normal facet of ageing. It is also a great pity that many radiologists will not comment on wedge fractures, in an elderly chest X-ray, for example, and that they will not be recorded in notes, even less subjected to any formal assessment of treatment. There is a long way to go in raising awareness among the public and professionals.

The NICE appraisal consultation document has been subject to criticism both by the National Osteoporosis Society and the public, as is evidenced by the mailbag that NICE has received. It has been criticised by the industry, and in particular by Lilly, which is responsible for producing two of the products, in question—the selective oestrogen receptor modulator, raloxifene, and teriparatide, which is better known as parathyroid hormone. We must welcome last month's announcement that there will be a separate appraisal of primary and secondary prevention, which probably follows criticism of NICE and its work to date on osteoporosis. The announcement is welcome because the two forms of prevention are quite different and need to be addressed, and the work to date has not been as comprehensive or forensic as one might have liked.

There have been big problems with the consultation document. Its ethos appears to conflict with the national service framework for older people of 2001, of which standard 6 has been cited. It seems to be preoccupied with treatment rather than prevention of fractures. It is a pity that it should simply deal with the situation after somebody has sustained a fracture. We hear a great deal about public health, and we have had a Minister with responsibility for public health since 1997. Osteoporosis is a public health problem, as it applies to the population, and we could have done more over many years in this area of public health.

There are several conflicts with the NICE guidelines and those issued by the Royal College of Physicians in 1999, which are the trade standard for treatment of osteoporosis. They are exceptionally good. considering that it is sometimes difficult to make head or tail of some of the college's paperwork: they clearly set out what works, what does not and what might, and they give reasonably clear guidance to professionals working in the field. The NICE guidelines appear to row back from many of those recommendations, which is why the National Osteoporosis Society said that they are a retrograde step. It is a great pity when NICE is cast in the guise of an organisation that is removing rather than promoting that which is good.

It is true to say that the guidelines produced by the Royal College of Physicians and the remarks of the National Osteoporosis Society reflect the importance of compliance. One or two hon. Members, including the hon. Member for Plymouth, Sutton (Linda Gilroy) in particular, mentioned compliance in relation to fragility fractures involving the spine, and alluded to the fact that it can cause digestive problems. That becomes a particular problem with biphosphonates. People are often unable to cope with biphosphonates because of gastric upset. We are then left asking what on earth they are going to use for their treatment because they are left with calcium and vitamin supplements—and the answer is not a great deal.

It is important to note that, if someone feels unhappy with a treatment and if it upsets them, they are probably not going to take it. We find that that is the case with high blood pressure and the treatment of hypercholesterolemia—conditions that do not cause great problems from day to day. We do not go around complaining about high blood pressure or about high cholesterol because they hurt, but we have them treated because we fear the long-term consequences. It is difficult to insist on compliance in those circumstances, and we know from studies that it can be poor.

I suspect that if we do not give people a treatment with which they can cope in this field, they will not take it. That is why it is important that, as the national osteoporosis society is right to insist, we give people a range of treatment options. If one option does not agree with them, there is a possibility that they can have another.

It is also probably true to say that affordability has not been adequately assessed by NICE in connection with selective oestrogen receptive modulators. We know that raloxifene protects against breast cancer, but there is a bit of a paradox here, because HRT was associated at the tail end of last year with stories about a possible risk of breast cancer. Here we have a treatment for the same condition that appears to protect against it. We do not see any evidence in the recent NICE information about the protective effect in respect of breast cancer. If we are going to make a serious economic appraisal, we need to factor in such possibilities. Apparently, there is a protective effect on the heart, but we see no evidence of that. It is probably true to say that we need to have a bit of a rethink. To that extent, I welcome the recent announcement by NICE that it is going to look at the issue again.

NICE seems to be relying on the lack of evidence for a reduction in the incidence of hip fracture in respect of raloxifene in making its conclusions about whether the treatment can be recommended. That is a pity, because such an approach underplays the importance of fragility fractures in the spine. The inference is that there is no evidence that the treatment can be used effectively to prevent hip fractures, which are, by implication, more important than vertebral fractures. I am not sure that that is right. Surely, we cannot be saying that we cannot recommend that treatment purely on the basis that there is no evidence that it will be any good for treating one particular subset of the range of conditions that can be provoked by osteoporosis. That is a non-sequitur.

Equally, we must recognise that there are some good things about the NICE appraisal; it would be remarkable if there were not. A consensus is emerging, and the Royal College of Physicians and the society certainly appear to believe that there is no reason to go for population screening, attractive though such options often are. A more selective approach is required, involving so-called case finding.

We need to make provision for the possibility that there may be technology in future enabling us to embark on screening the population, possibly using ultrasound scanning or indeed bone-turnover markers. I agree with the hon. Member for Romsey (Sandra Gidley) in her assessment of the need for further research in this area. As an aside, I shall comment on her suggestion that the condition has not been given the attention that it deserves because it predominantly affects females. It crossed my mind that if one were to compare the incidence of research on breast cancer and prostate cancer and the money spent on such research, a parallel could be drawn. The situation may not be as straightforward as she suggests.

It will be interesting to see in August what I hope will be NICE's formal recognition of the importance of a fall-prevention strategy. One or two hon. Members have touched upon that subject. Again, I think that we shall see a consensus among NICE, the Royal College of Physicians and the society on the need to prevent falls. The issue is not only about dishing out pills for the condition; at the end of the day, it is okay to have osteoporosis provided that one does not have fractures. One prevents fractures by not falling—or by not coming into contact with immovable objects. We may want to think about how to reduce that risk, particularly among the at-risk elderly population. I look forward to seeing the guidelines, which I understand will be published in August.

Exercise will help it certainly increases bone-mineral density. A little more controversial is the question whether it prevents fractures. We could say that more exercise means a greater possibility of falling and a greater chance of fractures, but the matter may not be as straightforward as it seems. Equally, tobacco and alcohol increase the risk of osteoporosis. That is a particular concern for women, because we know that they drink and smoke more than previously; their habits have come to approximate those traditionally associated with men. We may be storing up problems for the future.

In our public health strategy—I know that the Government are keen on it—we should focus on the reduction of osteoporosis not only in the elderly, but in the younger population, by ensuring that attitudes to exercise, alcohol and smoking are changed at an early stage. We can then ensure that bone structure is enhanced at that formative stage and that attitudes are developed that will promote long-term skeletal health.

Osteoporosis has, been ignored over the years for several reasons. One is its lack of ownership by a medical specialty. In my earlier experience as a junior orthopaedic surgeon, it seemed that no one was particularly worried about osteoporosis as a medical condition. It seemed to fall between specialties. In my day, surgeons were by and large concerned with fixing people's fractures. I suspect that a residue of that attitude remains, arid that osteoporosis has suffered as a result. Its treatment is multi-disciplinary. It is a pity that people who suffer from fragility fractures do not get the gold standard treatment of physiotherapy, hydrotherapy, pain management and so on that they really ought to receive. I genuinely feel that that is a reflection of the fact that no specialty has gripped the illness or taken ownership of it.

It is a sad fact that the UK ranks behind almost all European countries in its provision of dual-energy X-ray absorptiometry. That is a great pity, because we know that existing treatment is best targeted at those who are at high risk. That is a reflection of their bone-mineral density, and the only way to assess it accurately is by DXA scanning. We also know that poor intra-centre comparison of the results of DXA scans is a problem for screening. One of the reasons why we could not screen the population, even if it were possible to do so, is that it would be difficult to compare the results from one centre with those from others. We clearly need to work on that. It would be interesting to hear from the Minister whether any of the £3 million that his right hon. Friend the Secretary of State announced last week for radiology will be devoted to that area.

Self-help has been somewhat neglected. Many constituents feel strongly about the use of food additives for treating chronic conditions such as osteoporosis. I could cite others. In that connection, the European food supplements directive has caused a great deal of distress to many people, as it appears that many of the remedies that they think help their condition will be harmonised out. That leads to a conflict: as a science-based person, I believe that evidence must sustain any backing of a treatment, but if I were honest, I would say that that was an arrogant view. Many people insist that additives and supplements make them feel better, and that really is the bottom line. It is not for any of us to say otherwise if people believe that what they buy in the shops helps them. Many of the products in question have been used perfectly safely in this country for many years, and people feel that the EU is doing them down by removing them. I am pleased that the Alliance for Natural Health has taken a case to the European Court of Justice in connection with the European food supplements directive, and I await the outcome with interest.

The Minister would be somewhat disappointed if I did not take this opportunity to point out that the Government's obsession with targets, predominantly for acute conditions, has, in our finite system, inevitably impacted adversely on long-term and chronic conditions. We can more or less take that as read. I am pleased that he and his colleagues have decided at this rather late stage to change tack somewhat. I welcome the implications that that may have for the management of chronic conditions.

Twenty years on from my own rather unsatisfactory experience of dealing with osteoporosis in hospital orthopaedics, I ask myself whether things have improved much. I have to admit that they probably have done so, but not really as much as I would have hoped them to do in two decades. I look forward to the NICE reappraisal of its draft proposals and hope that they will at least be a step in the right direction.

3.17 pm
The Parliamentary Under-Secretary of State for Health (Dr. Stephen Ladyman)

I begin by thanking the hon. Member for Twickenham (Dr. Cable) for initiating this debate on this important issue, which is of great concern to many of our constituents and which affects many people in Britain today. I share his concern and that of other hon. Members about reducing the suffering of those who have osteoporosis and about putting in place prevention strategies.

As has been said, osteoporosis an important subject. Why? One in three women and one in 12 men over the age of 50 will develop the disease. Almost half of all women experience an osteoporotic fracture by the time they reach 70. Some 90 per cent of osteoporotic hip fractures result from a simple fall from standing height or less. After an osteoporotic hip fracture, some 50 per cent. of patients lose the ability to live independently, and 20 per cent. die within a year. As those figures suggest, the disease is a terrible burden to individuals, their family and friends, the national health service and their community. That is why the Department of Health, the NHS and others have put in place a programme of work to help minimise the harm done by the disease.

The Department of Health and the Welsh Assembly have asked the National Institute for Clinical Excellence to develop two clinical guidelines and a technology appraisal to provide the best available evidence covering falls, fractures and drug treatments, and to assess that evidence. It is probably appropriate that I stress that at this point.

The response to some of the comments that have been made during the debate—I highlight the difficult case outlined by my hon. Friend the Member for Plymouth,

Sutton (Linda Gilroy) and cases mentioned by other hon. Members—is that the issues are complex. If they were easy, if some fact were crying out "You do this, and people will get better", it would not be necessary to have bodies such as NICE, because doctors themselves would be able to make such assessments. NICE must look at the available evidence, balance the complexities and give us guidance about the most appropriate treatment for the most appropriate people.

I caution hon. Members that, when they are communicating with their constituents on these matters, what will obviously be right for one constituent will not be right for every other constituent who presents at a doctor. NICE must ensure that the information is available to allow doctors to make those difficult decisions.

The hon. Member for Twickenham referred to NICE blight. It is true that while NICE is considering these complex issues, there is a period of what may appear to some to be limbo. During that time, and even when the NICE guidance is published, it is up to doctors to make their own judgment for the care of the individual patient. Therefore, nobody should delay making recommendations—

Sandra Gidley

rose—

Dr. Ladyman

I shall not give way to the hon. Lady. I have only nine minutes and hon. Members have asked me a lot of questions. I want to deal with as many of them as possible.

The perception of NICE blight should be rejected. People should press their clinicians to make their own judgments in the absence of firmer NICE guidance.

The clinical guideline on the assessment and prevention of falls in older people is currently out for consultation. Falls are a major cause of disability and the leading cause of mortality resulting from injury in people aged over 75 in the UK. One third to one half of those aged over 65 fall each year. Up to 14,000 people die annually in the UK as a result of an osteoporotic hip fracture. Falling, therefore, has a considerable impact on quality of life, health and health care costs. Although osteoporosis does not cause falls, it significantly increases the likelihood of a fracture when a fall occurs. The falls guideline will provide recommendations for good practice based on the best available evidence of clinical and cost-effectiveness and is due to be completed in August.

A second clinical guideline has been commissioned to assess fracture risk and consider the prevention of osteoporotic fractures in individuals at high risk. Osteoporotic fractures can lead to pain, disability, greatly reduced quality of life and premature death. The guideline will look at all high-risk groups and will examine interventions used to prevent an initial fracture and those used to prevent subsequent fractures where one has already occurred. The guideline is due in June 2005.

NICE is also conducting a technology appraisal of the drugs used in the prevention and treatment of osteoporosis. The initial findings have recently been out to consultation and, as several hon. Members have said, have elicited a large response and considerable controversy. However, I want to assure hon. Members that this consultation document does not constitute the institute's formal guidance. Recommendations of this type are preliminary and may change after consultation. It would have been nice if one or two hon. Members in the Chamber had given NICE a pat on the back for listening to the consultation and for announcing that it intends to amend its work as a result.

The institute has accepted the independent appraisal committee's recommendation to separate the appraisal into two parts. The first will address the treatment of existing osteoporotic fractures in post-menopausal women—so-called secondary prevention. Further analytical work will be done on that before the appraisal progresses to the next stage, as several hon. Members requested. A new timetable for the work will be published shortly.

The second part of the appraisal will address the prevention of fractures in post-menopausal women who have not yet had a fracture—primary prevention. To inform recommendations on the clinical and cost-effectiveness of treatments for primary prevention, more data are needed that will assess the contribution of risk factors in the development of fractures. The data will be informed by work being done by the World Health Organisation and the NICE guideline development group on osteoporosis. The data are expected towards the end of the year and the institute will publish a separate timetable for that part of the appraisal.

I should like to thank all who have responded to the consultation, including the National Osteoporosis Society. Those individuals and groups have highlighted the need for additional information and analysis, which is being built into NICE's work. I regard that as a good example of what consultation is about. NICE has listened to the views that other experts and members of the public have expressed and has adapted its work to take account of their concerns. That shows that the process of consultation is working. The National Osteoporosis Society has welcomed that development.

The hon. Member for Romsey (Sandra Gidley) asked several questions about research that might have been identified as necessary during the process. The Department of Health funds the NHS research and development programme, which aims to identify NHS needs for research and to commission research to meet those needs. Commissioning is undertaken through national programmes of research, such as the health technology assessment programme, through which three projects have been funded, two of which have now ended. The topics include treatment of osteoporosis—a systematic review and cost-utility analysis—and selective oestrogen receptor modulators for osteoporosis. Research on the cost-effectiveness of different strategies for the management of steroid-induced osteoporosis is due for completion in the middle of this year.

The main Government agency is of course the Medical Research Council. In the financial year 2001–02, the MRC spent an estimated £6.9 million on research into osteoporosis, which included a randomised trial of vitamin D and calcium for secondary prevention of osteoporosis-related fractures in the elderly. It was therefore a little churlish of the hon. Member for Romsey to say what she did. [Interruption.]I do not know why the hon. Lady is looking aghast—she suggested herself that she was perhaps being churlish when she implied that there were restrictions on research in such fields. It is important to remember that we are not the only country in the world conducting such research. Research is conducted all around the world, as well as in the UK, but the work done here is extensive. The MRC welcomes good quality research proposals at any time, so I encourage anyone who has such ideas to put them to the council.

Falls services, incorporating those for osteoporosis, are covered in the national service framework for older people. I am grateful to the hon. Member for Twickenham, who said some nice things about the framework. It is important to recognise that the framework has been well received and is doing some good work. However, I should point out to the hon. Gentleman that the framework is a 10-year programme and that we are only three years into it. He asked what I was going to do to put energy into the programme. The answer is that, as the implementation of the national service framework for older people falls within my portfolio, I welcome any suggestions that he has for sustaining the rapid pace of reform. However, given the time since the rational service framework was published, it is making stupendous progress. I do not say for one second that I here are not huge areas in the health service or our social services that we cannot improve. Demonstrably, much work remains to be done in many areas; however, the national service framework is making huge inroads in those areas. The people who are involved in it and who drive it forward should be congratulated on their work.

The NSF sets clear milestones for the planning and development of integrated falls services and provides the basis for a service model that will deliver the improvements in prevention, care, treatment and rehabilitation that many hon. Members have mentioned. The framework aims to reduce the number of falls that result in serious injury and to ensure effective treatment and rehabilitation for those who have fallen. The Department is undertaking detailed work in conjunction with professional and voluntary bodies to support time delivery of the NSF's integrated fall service. For example, we have worked with Help the Aged on its "Avoiding Slips, Trips and Broken Hips" campaign. I cannot promise that we shall announce a national gripper slipper campaign—

Mr. Deputy Speaker (Mr. John McWilliam)

Order. Time is up. I should point out that the Minister had only 13 minutes in which to reply. Even after only an hour and a half of debate, a Minister should have the opportunity to reply effectively to the hon. Member who introduced the subject. The Minister was so constrained in this case because Opposition Front Benchers took 37 minutes.