§ Motion made, and Question proposed, That this House do now adjourn.—[Mr. Patnick.]
10.28 pm§ Mr. Paul Flynn (Newport, West)This is a remarkable story. It is about a scandal at the heart of the national health service, leading to a wanton waste of millions of pounds and to an immeasurable and unnecessary amount of human suffering. Forty thousand hip operations take place in Britain every year. They provide renewed mobility and an end to acute suffering for the great majority of those who receive them. In part, it is a great success story. However, there is another side to it.
Many senior surgeons have expressed deep anxieties about the Government's policy. Earlier this year, the British Orthopaedic Association withdrew from discussions with the Government over best practice guidelines. The main charge is that there has been a deterioration in the quality of operations, possibly as a result of over-emphasis on the quantity of operations.
The number of failed operations has mushroomed. In the 1980s, the number of failures trebled to 12 per cent and it is feared that that rate will rise to 33 per cent. In an article in the British Medical Journal in March this year, Dr. Bulstrode, a former orthopaedic surgeon at the John Radcliffe Hospital, Oxford, described what he called "designer hips". They are newly developed implants that are expensively designed. Factories are tooled up and the product is developed and marketed at great cost. Most designer hips are indistinguishable from the traditional hips that have existed for a long time. Some of the new ones are successful, but others fail—they usually quietly disappear from the scene without leaving a trace because there is no register of failures.
The standard traditional hip replacement—mainly the Charnley, which was designed about 30 years ago—can be sold for as little as £100 and has a failure rate of less than 1 per cent. per year. The newer "designer" implants can cost up to £1,500. Most are untested and unproven and some are failing within four to five years.
I would like to present precise figures of what has been happening in the United Kingdom, but that is impossible—not because I have not diligently prepared for this debate, but because the figures are simply not known. On 14 February, the Parliamentary Under-Secretary of State for Health told me that the Government have no record of the success and failure rates of hip prostheses used in this country. Luckily, one country has done the work. Sweden has conducted detailed research on 93,000 hip replacements. Among many other useful bits of information, it was discovered that one implant—the Christensen hip—has an atrocious record. It was used in more than 5,000 operations and virtually not one of them lasted four years.
The cost of that designer hip is an estimated $20 million in the revision operations required, plus the anguish of the thousands of victims. Do we know if there has been a similar mass failure here? There has almost certainly been such a mass failure, but we have no knowledge of it because so many of the prostheses that have been introduced in the past 20 years have quietly disappeared without any national record.
1088 In 1971, there was only one type of implant—the Charnley. There are at least 34 on the market now. Dr. Bulstrode said:
There is now more money in design than in success rates. Every year there is a new colour, a new shape, a new coating.He estimates that if every surgeon used the most reliable model, the annual cost of revision operations would be £200 million. If we continue to use unproven implants, the cost will rise to about £600 million in the next 10 years.In July 1992, the Drug and Therapeutics Bulletin had this to say:
There are no formal controls for new joint designs nor for their marketing. The newer hips should be considered experimental and this should be made explicit when seeking the patient's informed consent to surgery.How can clinicians, let alone patients, exercise choice? How can they make informed decisions? There are no statutory tests that hip replacements must satisfy before they can be marketed, nor is there any centrally held information. I recently asked the Secretary of State for Health what plans she had to introduce a national register. She told me that she had no such plans. The manufacturing registration scheme of the Department of Health is voluntary and has in no way deterred manufacturers from launching suspect and unproven designs. The Government lack the courage to compel manufacturers to meet statutory standards and to subject them to the kind of close monitoring that takes place in the United States and in many other countries.A point strongly made in the report by the Select Committee on Welsh Affairs in 1991 on elective surgery was why it was that drugs had to undergo rigorous tests before they could be introduced and prescribed when implants were treated differently. The dangers are just as great. The damage caused by an inadequate hip implant is not easily rectified. Dr. Michael Wroblewski—Charnley's successor in Wigan, where the technique was pioneered—says:
The first time is the best time. After that it is salvage.When the first operation is carried out, a great deal of the good, healthy bone has to be sacrificed. In perhaps his most stark comment, Dr. Bulstrode said:I could go home tonight, knock up a hip in the garden shed, bring it in tomorrow, sterilise it and just whack it into a patient and there's no law in the land to stop me.Revision operations drain NHS resources and lengthen waiting lists. They take nearly twice as long as primary operations and require longer hospital stays. One revision means that two primary operations have to be cancelled.The Government have long been obsessed with the methods and the language of the market. Increasingly, they apply their ideology to everything, including health care. Understandable concern about waiting times has spurred the Government into precipitate action. The Government have maximised bed throughput by minimising standards. The modern health service manager is subjected to performance-related pay and has one overriding objective—to treat as many patients as possible. That is the measure of successful management and, in isolation, it is extremely dangerous and damaging. Higher productivity cannot be the sole criterion when the raw material is a human patient. The value of an operation cannot be measured by knocking one number off the waiting list. It must be assessed carefully over months and years.
Specialist orthopaedic surgeons have a high success rate. It is surprising to know that in Britain we have the 1089 lowest percentage of specialist orthopaedic surgeons of any western country. What is happening with the conveyor-belt surgery that is being cranked up to maximum productivity is that more and more nonspecialists are being employed. The specialist hip or orthopaediecentres are losing patients to general hospitals simply because they happen to have a surgeon available. A short-term reduction in waiting lists is followed by an influx of patients requiring revision. A report in The Guardian quotes one specialist, Mr. Khalid Drabu, a consultant surgeon at East Surrey hospital, as saying:
An artificial hip can and should last 15 to 20 years, but we've got a tidal wave of patients returning within four to eight years and many sooner.What do the Government offer? Answers to parliamentary questions reveal that the Government have no register of revisions, no statistics on which implants fail, no database to explain what is happening and no study—there is one study of Trent—as comprehensive as the Swedish one which would identify the rogue prostheses. They have no plan and they have no strategy, except perhaps the lame excuse that was given to me in a letter—that the European Community would come galloping to their rescue.In a letter to me, the Minister says that a European CE marking will apply to hip implants, and that it is intended to come into force
on I January 1995 with a transitional period that will extend to about mid 1998.That is five long years away, whereas the misery, the tragedy and the waste is happening now, and is still evolving—a great medical scandal. We need action from the Minister now. We need him to say tonight that he will commit himself to setting up a national register of hip replacements which will identify the rogue prostheses and the least competent surgeons, both of which are formidable elements in the scandal that we are discussing.We want immediate short-term studies on new operations. These can be done easily. It is possible to measure accurately through minute X-rays the tiny migrations that take place in the first six months after an operation. That can be plotted to show what will happen over the next five or, indeed, 20 years. The technology is there. We must do that now.
We need a thorough investigation into the selling and marketing of prostheses by manufacturers. We hear odd stories of inducements being offered. We know of cases in which improper commercial pressures are being put on surgeons and others in the health service. We need more professionally trained orthopaedic surgeons. We need a system of audit that rewards NHS managers and medical staff for the quality, not the quantity, of their work.
These are not new concerns. This letter was written by Mr. Michael Freeman, the present president of the British Orthopaedic Association. He demands that we take steps to prevent
the unlimited proliferation of indistinguishably different or bad prostheses".That letter was written on 13 November 1973. Some 20 years later another distinguished orthopaedic surgeon wrote to Mr. Freeman, pointing out that that 1973 letter probably initiated the interest of orthopaedic surgeons in the field. He said: 1090For all these years we have been struggling to get some scheme off the ground. The sadness is that even when it had been accepted by all the various bodies, even the Minister himself, absolutely nothing happened.That letter was written on 25 March thi s year.There have been 20 years of vain struggle. The legacy of Government inactivity is now exacerbated by market forces coming into the health service. Inducements are offered by greedy profiteers. The tradition of care, high science and best quality medicine is being corrupted by the Government's devotion to market forces.
§ Mr. Rhodri Morgan (Cardiff, West)I congratulate my hon. Friend the Member for Newport, West (Mr. Flynn) on obtaining an Adjournment debate on this important topic. The debate is timely and I know that he has a long-standing, close personal interest in the topic. Not many people would give up the chance of representing Britain in the 400 metre hurdles in next year's Olympic games just to have an Adjournment debate on hip and knee joint replacement surgery.
My hon. Friend rightly referred to the topic of the debate as yet another scandal story about how the health service operates. I am pleased that, although I am speaking as Labour's Front-Bench health spokesman in Wales, it is the Government's English Under-Secretary of State for Health who will respond, because that will avoid any possible problems in relation to the quasi-judicial functions that the Secretaries of State for Wales and for Health occasionally have.
I intend to add some local interest and to refer to the Yellow Ribbon story in relation to knee and hip joint replacements that are carried out at the Prince of Wales orthopaedic hospital. It is in my constituency, but it serves virtually the whole of Wales for replacements if the waiting time has exceeded the patients charter guideline. That waiting time was 18 months, though an attempt is being made to reduce it to 12 months now. I do not criticise the unique method used by the Welsh Office under this Government of having specialist "treatment centres", which do not exist in England, simply to treat those who have been on the waiting list for a long time. The centres treat cataracts and there is one in my constituency at the Prince of Wales orthopaedic hospital, Rhydlafar, for knee and hip joint replacements.
I applaud the treatment centre phenomenon, but the surgeon in charge of the Rhydlafar centre has experienced considerable difficulties and has now been suspended on full pay pending disciplinary hearings. Those hearings will obviously take their course in the usual way, but I raise the matter in the House because I suspect that there is a strong connection between the point raised by my hon. Friend and the treatment centre.
A specialist treatment centre for patients on the waiting list for knee and hip joint replacements takes bread out of the mouths of the orthopaedic consultants who, to a man—they are all men—also operate at BUPA and other private hospitals in Cardiff and Newport. I believe that there is one private centre in Newport at a Catholic foundation hospital and there is a BUPA hospital in Cardiff. Most orthopaedic surgeons tend to share their time between the two.
If a treatment centre is set up with the specific aim of taking all the patients from anywhere in Wales who have been waiting for 18 months—I think that it is now 12 1091 months—since first seeing a consultant for treatment, free to the purchasing health authority, that obviously takes bread out of the mouths of the private consultants who would love to be treating them at £3,000 or £4,000 a time at a BUPA hospital.
To make matters worse, on 1 April 1993 at the Prince of Wales hospital, Rhydlafar, a third operating theatre was opened. The triple suite there now means that the work can be dealt with rapidly and, in theory, the waiting list could be removed altogether. That, in turn, takes the bread out of the mouth of the BUPA and other private hospitals with orthopaedic facilities.
That places enormous pressure on orthopaedic consultants' income from private work. The more work that is done under the NHS and the more the waiting lists for hip and knee joint operations under the NHS shrink, the more one removes the incentive for private operations at BUPA and other hospitals. That sets up enormous tensions between the surgeons who are best at cutting the waiting lists and the surgeons who make most of their money from private work.
A surgeon can either be one of the boys, take it slowly and not work too fast in order to leave plenty of work to be done privately, or he can be as committed to the NHS as it is possible to be and thereby upset his colleagues. Attitudes to patient care and the functions of the NHS must be borne in mind when specific treatment centres are set up as part of Government policy.
At the Prince of Wales hospital, Rhydlafar, the top orthopaedic surgeon involved in knee and hip joint replacement, who is in charge of the contract from the Welsh Office, has been told to cut the waiting list. Patients waiting longer than the maximum time allowed by the patients charter, whether they are from north, mid or south Wales, have to be treated free, at no cost to the patient or the purchasing health authority from which the patient originates. They can be dealt with immediately at the Prince of Wales hospital. That is what should, in principle, be done.
But that has probably led to a climate of jealousy and tension between professionals which may well, in turn, have led to the suspension of the director of the treatment centre, Ian Mackie, on 17 June pending disciplinary proceedings for a series of charges of gross misconduct, professional misconduct, and so on.
Whether the charges have been trumped up, as many people believe, I am not in a position to say, but the tension between the various professionals in knee and hip joint replacement surgery has been building up for a long time. The treatment centre has been putting pressure on the private income of those who have been largely dependent on performing knee and hip joint work at BUPA and other private facility hospitals in south Wales. It is, therefore, fortunate that the Under-Secretary of State for Health, the hon. Member for Bolton, West (Mr. Sackville), will be dealing with the issue, because the Welsh Office Minister might at some time in the future have to deal with quasi-judicial appeals. The Minister here tonight will not have to, so he will not be embarrassed by my referring to the issue.
Since Mr. Ian Mackie has been suspended from duty, members of staff, patients and others have been wearing yellow ribbons to show their support for him. I was told of an incident only today when the acting unit manager visited the hospital to get members of staff to remove "Back Mackie" stickers from their cars while they are on 1092 hospital premises. That is getting heavy; people should be free to express their opinions about the surgeon but they are clearly not able to do so because of the health authority's sensitivity and the fact that the authority is undertaking disciplinary proceedings.
My hon. Friend the Member for Newport, West made an extremely important point about the lack of guidelines. Biomet and Zimmer are the two companies which are in dispute and are behind the present incident that led to the suspension. They are or were American owned. Nobody knows how far such companies can go in encouraging consultants to be demonstrators or lecturers at international conferences. Are they supposed to ask consultants to demonstrate their equipment, or is it a breach of disciplinary procedures? We do not know, because there are no guidelines laid down by the British Medical Association or the hospital service. In the absence of any satisfactory guidelines from the NHS, I am pleased that my hon. Friend has raised the matter tonight so that the Minister can tell us what the Government's position is in a matter on which they do not appear to have any policy.
§ The Parliamentary Under-Secretary of State for Health (Mr. Tom Sackville)I congratulate the hon. Member for Newport, West (Mr. Flynn) on raising this important subject. I know of his strong interest in hip replacement operations.
The medical development of the prosthetic replacement of joints culminated in the 1960s in the first hip replacements for patients. The development of the early hip prostheses owes much to the ingenuity of Sir John Charnley in Manchester and the pioneering work carried out by Mckee and Watson-Ferrar in Norwich. In less than 30 years, other joint prostheses have been added, but the one that meets the greatest need of people all over the world remains the hip joint replacement.
Many problems have been recognised in the use of prostheses, such as that of operating on elderly patients. In the first 15 years or so, it was the elderly lady with the fractured neck or femur and those suffering from the degenerative condition of osteoarthritis who were the natural priorities. In the 1960s, however, doctors and patients immediately recognised that a hip replacement offered effective treatment for debilitating or depressing health problems. From the wheelchair or from confinement to the house and dependence on others for simple activities, people could become free of the pain of osteoarthritis and able to lead more independent lives.
The numbers of hip replacements rose rapidly. In England in 1969—
§ Mr. SackvilleIf I do, I shall not be able to get through what I am trying to say, so I would rather not.
In England in 1969, there were 10,869 operations. By 1979, the number had risen to 28,788. Recently published data show that more than 50,000 operations were carried out in 1989–90. Total hip replacements have been one of the outstanding success stories of the national health service. Through this operation, skilled surgeons are making a major contribution to improving the quality of life for many thousands of people every year.
1093 As the hon. Gentleman said, many prostheses have been brought into the market since the early days of Charnley, and the majority of the 800-plus orthopaedic surgeons are performing this operation every week in the national health service. The success of the operation has brought new developments in its wake. Surgeons are now extending the range of patients for whom it is considered beneficial to provide prostheses—younger, fitter, more active people who expect to return not only to domestic activities in comfort but to the energetic pursuits they enjoyed before joint disease slowed them down. We can justifiably take pride in the achievements of the national health service in providing such a large number of operations and in extending hip prostheses—
§ Mr. Jon Owen Jones (Cardiff, Central)Will the Minister give way?
§ Mr. SackvilleI have only four minutes left.
§ Mr. SackvilleWe must also recognise that there is an implication for the design and long-term performance of the prostheses themselves, subjected to much greater wear and tear over the longer lifespan of those younger patients. Much research and development worldwide is concentrating on the problems that this presents to patients and their doctors. The sorts of areas of research aimed at reducing the effects of wear include the materials prostheses are made of, the precise design and, thus, the distribution of stresses during movement, and the value of the use of various types of cement to fix the prostheses in place and whether cement is needed at all.
Of course, there is not consensus among clinicians about individual prostheses. Indeed, as has been said, we have insufficient knowledge in many areas. However, we know that the life expectancy of a hip prosthesis is reckoned to be between 10 and 15 years. We also know that 9.5 per cent. of all hip replacement operations in 1990–91 were revisions. Of course, this does not give us a 1094 true percentage revision rate. Estimates of revisions vary considerably. Many experts would agree on about 10 per cent. Revisions are an important load on the national health service resources, and we are all—patients, doctors and everyone involved in the service—concerned to reduce that burden of distress and to maximise the use of resources so that more patients may have a satisfactory outcome and more money may be available for providing treatment.
In the United Kingdom, total hip replacements are classified as medical devices and, as yet, are not subject to specific legislation. Voluntary controls have, however, been applied for many years by the Department of Health, under the manufacturer registration scheme, which has been in operation since 1986. This involves the assessment of the manufacturer's facilities to ensure they meet the Department's requirements for quality assurance, including control of product design. The requirements for total hip replacements are included in "Quality Systems for Orthopaedic Implants", which was published in 1990. This calls for compliance with BS 5750, as well as specific materials and product standards.
The list of approved manufacturers is supplied to the NHS and the private sector, which are strongly recommended to buy only from registered companies.
§ Mr. SackvilleAnother important control is the Department's—
§ Mr. Deputy SpeakerIs it a point of order for the Chair?
§ Mr. FlynnIt is, Sir. I appeal to you, as the defender of the rights of Back Benchers. My speech tonight was my first Back-Bench speech in the Chamber for more than 12 months. The Minister is abusing his position by ignoring all the—
§ The motion having been made after Ten o'clock and the debate having continued for half an hour, MR. DEPUTY SPEAKER adjourned the House without Question put, pursuant to the Standing Order.
§ Adjourned at two minutes to Eleven o'clock.