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27 Nov 2007 : Column 25WH—continued
How do I know all this? The cardiologists at the James Cook university hospital on Teesside, having given me an angiogram, determined that there were three restrictions in my left anterior descending artery: one was at 18 per cent. restriction, another was at 53 per cent. and the other one was at 97 per cent. I did not know that and thought I was fine, but the cardiologists decided that something had to be done about it, so having done an angiogram, they did an angioplasty and placed stents in my left anterior descending artery. That procedure was done about three or four years ago and although it has not cured my problems it has eased them enormously. I am ever grateful to Mark de Belder for doing that for me, at the suggestion of Dr. Shyam Sundar. I am also grateful to Jim Hall, who helped Mark de Belder establish the department in the James Cook university hospital, because they worked night and day for more than three years before establishing it and, as a result, probably saved my life and the lives of many others.
Stents come in two forms: one is a bare metal stent—in other words, stark scaffolding—and others are drug-eluting, being coated with drugs. Some bright character worked out something about restenosis. However, I have not explained what restenosis is, so I had better do so. When a stent is put in place, the platelets and flesh in the inside of the vein start to grow around it. Sometimes too much scarring tissue can grow, causing a restriction again: that is called restenosis. Some bright character thought that, if stents were coated with a drug, it might be possible to inhibit a build-up of such scarring tissue. Would you believe that two drugs were discovered? One is called paclitaxel, which was discovered in 1967 in the stem bark of the Pacific yew tree. The other is called sirolimus, also known as rapamycin, which was found in a soil sample from Easter Island—would you believe? The local name for that island is Rapa Nui, so that is why the drug is called rapamycin.
Not only is the amount of restenosis reduced by using stents coated in drugs—drug-eluting stents—but the need for repeat procedures is reduced. A bare metal stent with the build-up, or restenosis, can sometimes need a repeat procedure done on it. It is sometimes difficult to repeat, some months or years later, a procedure that has already been carried out.
The drug-eluting characteristic has the advantage of reducing the need for a repeat procedure. However, it sometimes causes problems and has been known to give rise to a late thrombosis, which is obviated by a drug called clopidogrel, or Plavix. In America, doctors call Plavix the surgeon’s nightmare, because it is an anti-coagulant: but that is why it is used. I was given Plavix for about 15 months. It is taken regularly on a daily basis so as to ensure that the flow of blood is constant through the stented area and does not tend to wait, pause or clot and cause another problem. Plavix can be advantageous in that sense.
I have so many notes that you would not believe it, Mr. Amess. I am getting phone calls from all over the country giving me ever more information on this subject. People are very concerned about this matter.
Clopidogrel, or Plavix, is the standard treatment for the prevention of clots post-angioplasty. Now, however, details of Plasugrel—an improvement on Plavix
—have been reported in The New England Journal of Medicine. When used in the same circumstances as Plavix to prevent coronary thrombosis and clot formation, Plasugrel reduced the death rate by 19 per cent., and early reports suggest that it will counteract any problems associated with drug-eluting stents.
Am I making progress? I have described what stents are and what drug-eluting stents are, and I come to the issue of cost. There is some argument about cost, and when we discuss it we should be careful to consider every aspect. It is not just the item itself that has a cost; there is a cost in inserting it, and possibly in having to replace it. There is also the cost of time spent in bed in hospital and of recovery time. If we do not use stents, the only other option is open-heart surgery in the form of a bypass, which involves opening the sternum and putting various bits of tubing around wherever the blockage is. That means increased bed, theatre and recovery time, increased need for theatre crew, and lots of pain. When we address cost, therefore, we should consider not only the accountants’ estimates, because you know as well as I, Mr. Amess, that accountants know the cost of everything and the value of nothing. I am thinking about value, rather than cost, which is why I am emphasising the broader assessment.
We should not neglect that broader assessment, because it might be believed that NICE—that body of esteemed worthies whose task is to concentrate on clinical excellence—would ensure that all their assessments are based on sound knowledge and practice. There is a very strange story to tell in relation to that, however, and I wonder whether I have time to tell it all before 12.30 pm.
Initially, an assessment group was established. It was not a national assessment group, however; it was a group based in Liverpool. I have nothing against Liverpool; I was a great fan of Tommy Handley and Ted Ray. I am not very keen on Jimmy Tarbuck, but I appreciate Steve Gerrard and Michael Owen, so I am not down on Liverpool at all. The assessment group was asked by NICE to consider its views on stents, including drug-eluting stents. It formed an opinion, and published it—openly and publicly—well before the closing date for consultation. Having published its views at that point, it seems it was reluctant to withdraw from the position it had adopted, which in my opinion is rather less well informed than that of other agencies that took a broader view.
The fact that the mesh design of stents was being refined in various different places—not just in this country but elsewhere—was not taken into account; neither were the economies of scale—size would be a misleading word, nor the fact that costs are reducing. The initial conclusion that drug-eluting stents would cost something like £600 more than bare metal stents was totally off the wall, completely wrong, and very badly out of date.
I have to say that the opinions of so many different experts—by which I mean consultants—is testimony to the fact that the earlier sums were wrong, and that the opinions need to be reviewed. NICE is currently making its assessment, but has already issued a
statement that it is likely to recommend that drug-eluting stents no longer be used in the national health service. That position is based on the assessments of the Liverpool group, which hardly seems sensible given that those evaluations were based on knowledge that is more than two and half years old. In that period, there have been developments in the forms of stents and in their production and cost of manufacture. It is now generally thought that the cost difference between bare metal stents and drug-eluting stents is something in the region of £320 for a 12-month procedure. If we include in the comparison the fact that the drug-eluting stent causes fewer repeat procedures, the cost saving is even greater.
If we measure the advantages of using stents compared with bypass surgery, there is a colossal saving in theatre time, bed time, healing time and staff time, which holds out the prospect of the Government reaching its 18-week target waiting time, of which they have made so much in the past.
Unfortunately, it seems that there is a bit of an argument between cardiac surgeons and cardiological interventionists. The number of PCIs—stent insertions—used to be the same as the number of open-heart procedures, but there are now three or four insertions for every open-heart operation. Some will immediately say that that is very good, because it reduces waiting lists and improves patient prospects. However, I can understand that if a cardiac surgeon has spent 12 years or so working out how to carve somebody’s sternum into two, open their thoracic cage and get at whatever he finds inside—he would not find much in this place, because not many politicians have a heart—then he will want to protect his professional status and the need for his expertise. Nevertheless, our prime consideration should be the interests of the patients. Even allowing for the vagaries of accountants, we should also consider the cost implications—or rather, the value implications.
I am concerned that NICE’s assessment might well be adversely affected by false logic and misinformed intervention. The fact that we have put our faith in drug-eluting stents in the past is well testified to by Professor Lord Darzi. This morning I spoke to the Secretary of State for Health, although not on this topic. At a certain party conference that I have to say that I did not attend, he said:
“Eight years ago the NHS performed 17,000 angioplasties, a procedure to widen blood vessels for patients suffering from heart problems. Last year the figure was 55,000, a 3-fold increase. This has significantly reduced the length of stay in hospitals for patients who would otherwise have had a much more complicated operation.”
Professor Darzi, in his testimony to the Select Committee on Health, made particular reference to drug-eluting stents, but for the life of me I cannot find the quotation. I apologise for that.
Several studies of drug-eluting stents in routine clinical practice have suggested that those devices may be associated with a reduction in death—the most important of all health outcomes, I would suggest. Studies that confirm that have been conducted in Ontario, Massachusetts, western Denmark, the Carolinas, Pennsylvania, New Jersey, Seoul, Rotterdam—the list goes on. All reported the beneficial impact of drug-eluting stents, but NICE is in danger of announcing that they will no longer be available in the national health service, and all on the
basis of NICE’s quite wrong impression that a drug-eluting stent costs £600 more than a bare metal stent when in fact the cost difference is £320—that is not taking into account the repeat procedures on a bare metal stent.
The other aspect of the issue that makes me feel real anger is that I am told that NICE will announce its decision on 31 December and there will be only a 15-day period in which appeals can be made. You, Mr. Amess, are a very sociable fellow and, like me, you will enjoy a party or two with your family and friends during the yuletide period. That includes 31 December, and festivities usually require a recovery period, which sometimes means a visit to a GP. Fifteen days from 31 December means compiling and submitting an appeal by 14 January. It seems less than sensitive to the needs of the community that things should be decided in that way.
I know that other hon. Members want to speak, but before I conclude let me make it plain that I am not making the case for drug-eluting stents as opposed to bare metal stents. The medical profession has the responsibility to look at each individual patient and assess them and their needs, not in isolation but with a clear focus. The medical profession has to decide what the needs are and whether the best approach is drugs only, which could be the case; bypass surgery, which could be the case depending on what is happening in the person’s plumbing; bare metal stents, which might be the most advantageous approach; or drug-eluting stents. Those are the options, but drug-eluting stents cannot be used if they have been taken out of the list. That would be nonsense.
I am not arguing that it should be drug-eluting stents as opposed to bare metal stents, that it should be stents as opposed to open-heart surgery or that it should be anything as opposed to drugs. I seek an undertaking from the Minister that NICE will be asked to concentrate on its job of assessing fully all the information—not just the information that was gathered two and a half years ago but the information that is being collated as we speak—before it comes up with its decision on 31 December. What has hitherto centred on the question what cost drug-eluting stents has, in my view, crystallised into the question what cost clinical excellence? NICE should concentrate on that.
11.25 am
Dr. Desmond Turner (Brighton, Kemptown) (Lab): It is a pleasure to serve under your chairmanship, Mr. Amess, especially as I know your interest in this area. I congratulate my hon. Friend the Member for Stockton, North (Frank Cook) not only on securing this important debate, but on putting the case so eloquently. I, too, declare an interest. I am of an age when I may need a drug-eluting stent at any time, unlike my hon. Friend, who has first-hand experience and is living proof of the virtue of this piece of technology. Also, among my other activities, I chair the all-party group on medical technology.
Medical technologies have made many important contributions, particularly in the field of cardiology. They include pacemakers and so on, but the drug-eluting stent is one of the outstanding ones. The normal problem that we find with the adoption of medical technologies by the health service is that it is rather bad at taking
them up, for various reasons, which I will not dwell on now. We find that in the UK, compared with our European neighbours and the United States—compared with other medically advanced countries—the use of very helpful, cost-effective medical technologies that have great patient benefits is at a very low level. The galling thing is that, in every case, those technologies have been assessed by NICE and NICE has approved and recommended them, but they still have not been adopted.
The drug-eluting stent was assessed in 2003 by NICE and was recommended, and it has been enthusiastically adopted by cardiologists throughout the land. It is virtually a first choice of treatment. That is entirely consistent with the national service framework for coronary heart disease, which was one of the first NSFs produced by the Government. That was appropriate because coronary heart disease is the country’s biggest killer. It was therefore one of the first NSFs to be developed.
It is still the case that, in that NSF, revascularisation—in other words, angioplasty—as opposed to a bypass is the recommended first line of treatment for coronary artery disease, provided that the patient fulfils the reasonable criteria. In addition, a recent report by Professor Roger Boyle, the national director for heart disease and stroke—the heart tsar, if you like—entitled “Mending hearts and brains—clinical case for change” sets out the case for drug-eluting stents as the appropriate first treatment for a heart attack in appropriate patients. So why is NICE taking the line that it is at this time? Why is it seeking to take out of cardiologists’ toolkit their most treasured and sharpest chisel?
NICE must have a very good case if it is to do that, because with angioplasty we are talking about a procedure that has great advantages. It is much cheaper for the health service than a bypass operation. It is not invasive. The stay in hospital is extremely short and the patient can make a rapid return to normal life. One of the best recent examples is our own much loved Rhodri Morgan, who recently had a coronary event and was given a drug-eluting stent, I am informed. He was back leading the National Assembly of Wales within a few days. That shows the value of that piece of kit and of the procedure.
As my hon. Friend has said, in the last year in which they were counted, 54,000 angioplasties were carried out. The problem with angioplasty and a bare metal stent is restenosis—the reblocking of the vessel. That can occur in 50 per cent. of patients who are given bare metal stents. With the use of drug-eluting stents, that is dramatically reduced by 55 to 60 per cent. The total costs of the procedures are £4,240 for an angioplasty using a bare metal stent and £4,588 for using a drug-eluting stent. The percentage difference is minimal—in the single figures. However, cost-effectiveness should be established by the reduction in the number of repeat procedures alone.
It beggars belief that NICE can come up with a cost-effectiveness calculation that gives the price of £200,000 for a quality year, which is the unit that NICE and other health economists use. I cannot see how NICE has come to that conclusion, given such a small differential between the price of using a drug-eluting stent and a bare metal stent. How does it get that figure? Its information base—derived from the
Liverpool assessment group—is clearly completely different from that of all European cardiologists and the rest of the UK.
The implication of NICE’s calculations is profound: if it proceeds with its draft guidance and withdraws its recommendation of the stent, the number of repeat angioplasties will increase by a degree that is difficult to estimate. That will have a cost through the deterioration of patient quality of life as well as a cost to the health service in repeat procedures. The cost will be enormous. The implication is also that others will not be able to be revascularised and will have to have bypass operations, which cost twice as much. The implication of that misguided guidance, if it is followed through, will be an enormous financial cost to the health service, a considerable cost to patients—including some otherwise avoidable deaths—
Dr. John Pugh (Southport) (LD): I am not sure whether the hon. Gentleman means that NICE guidance was poor because its research base was poor, because the process of appraisal was poor or because both were poor.
Dr. Turner: Both are perceived to be poor in this case. I have observed that in other NICE appraisals in the past. They have come out right in the end, but involved a lot of heartache in the process. We have a narrow patient base that is not representative and a false interpretation in carrying out the calculation.
The consequences are enormous for patients and enormous in cost. The capacity of the NHS will also be threatened, including its capacity to deliver the reduction in waiting times that we are looking for. The implications for the increasing use of beds and for staffing are enormous. NICE’s recommendation is critical.
It is also critical to NICE’s reputation. My hon. Friend the Member for Stockton, North is absolutely right to say that it boils down to NICE meaning clinical excellence. If NICE is to set the standard of clinical excellence, the way in which it does so and the reliability of that standard are critical. I simply ask the Minister—I know that she cannot direct NICE, because we have set it up with a degree of independence—
Frank Cook: Can I alert my hon. Friend to the fact that I felt very concerned that Andrew Dillon, the chairman of NICE, publicly expressed the view—at least, it is printed in The Times—that he wishes NICE to become independent of the NHS? What does my hon. Friend think could be the possible consequences of NICE breaking away from the NHS and then assuming an input on the practices and procedures that the NHS adopts?
Dr. Turner:
My hon. Friend has made an important point. Although NICE needs to be independent, in the sense that we do not want it to be dictated to by Government—we do not want the Government to turn to NICE and say, “The cost of the health service budget is getting out of hand. Can you make sure that your recommendations keep it down for us?”—with
that independence goes a heavy responsibility. NICE must ensure that its scientific and medical assessments are made to the highest standards so that when it says that x is an example of clinical excellence and should be used, or alternatively that x is sort of okay but is not recommended because it is not worth it, we can rely absolutely on that advice.
NICE does not do its own research. It relies on others. Thereby hangs the weakness. Not all the people whom NICE calls on to carry out assessments for it are of the same excellent standard. In this case, one has to question why the Liverpool group is so much at odds with the entire cardiac community.
Frank Cook: I am sorry; I do not want to keep intervening. However, will my hon. Friend consider the fact that the situation may have come about because the group was so keen to publish its initial findings? It would have been much wiser for it to wait and to hear a broader view before crystallising it into a definitive opinion. The group dug itself into a foxhole, but continued to dig further rather than stopping.
Dr. Turner: My hon. Friend raises an interesting point. I would love to know what peer reviewers of the Liverpool publication had to say, assuming that it was peer reviewed. I do not know whether it was. Any peer reviewer considering a publication that is so much at odds with what everyone else thinks would need to look closely to ensure that the methodology is correct. The Minister has every reason to ask NICE, in the nicest possible way, to reconsider very carefully its methodology and to see whether it is sound. The simple logic dictated by the narrow cost difference between bare metal stents and drug-eluting stents is that its cost-effectiveness figures are impossible. If NICE proceeds with them, I fear that its reputation will be fatally damaged. If the figures are right, however—that is a big if, and I put the odds at about 200:1 against—NICE needs to go to great lengths to justify them, otherwise it will not only do patients, the NHS and the cardiac community a great disservice, but it will undermine its own credibility.
11.41 am
Dr. John Pugh (Southport) (LD): It is a pleasure to serve under your cheerful chairmanship, Mr. Amess. I congratulate the hon. Member for Stockton, North (Frank Cook) on introducing this important debate in an informative and extremely knowledgeable way. I must say that neither drug-eluting stents nor cardiology is a specialist subject of mine, although I recently had my heart checked out during an annual health check. They put the blood pressure tourniquet on me, and all was going well, until the phone went—it was my local paper. My blood pressure shot up immediately, and I had to ask them to do it again.
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