BMJ Editorial

BMJ No. 7046 Volume 312 Saturday 22 June 1996

Rationing health care: moving the debate forward

Groups in Britain are encouraging the debate that the government won't lead

When governments and politicians do not act, the people may. In Britain neither the government nor the main opposition party will openly acknowledge the inevitability of rationing health care. Instead, they talk of increasing the effectiveness of health care, spending more on the health service, and setting priorities locally.

Their implication to the public is that nobody will be denied potentially beneficial treatments. But almost all of those who spend any time studying this subject recognise that people have always been denied potentially beneficial treatments, and they always will be no matter how much is spent on health services. These commentators believe that governments should come clean with the public and lead a debate on how best to ration health care. Because British political leaders will not accept this challenge, various organisations and ad hoc groups have begun to try to find ways to include the public in the debate on rationing health care. Some of these initiatives are covered in this Week's and last week's BMJ.

Most commentators accept that rationing is inevitable, but the debate keeps returning to this point because the politicians refase to acknowledge it.Yet many health authorities in Britain are explicitly excluding beneficial treatments.(1) Some sorts of care that were once available on the NHS-adult dental care and long term care of elderly people are falling away. Britain's mental and geriatric health services are threadbare. Doctors' time and attention-which are effective in themselves for many conditions - always have been and always will be rationed. New and expensive treatments, like interferon beta for some sorts of multiple sclerosis, are not available to many people who might benefit from them.(2) The British government likes to suggest that the drive for effectiveness will obviate the need for rationing.

No doubt substantial sums can eventually be saved by stopping ineffective interventions, but there are increasing examples of treatments that have been proved effective but which are hugely expensive when given to certain sorts of patients. Thus statins have been proved beyond doubt to reduce deaths in patients with coronary artery disease and raised serum cholesterol concentrations. But the cost of a life year saved in women aged 45-54 years with angina and a cholesterol concentration of 5.5-6.0 mmol/l is £361 000 ($541 500).(3) The same story-of proved effectiveness but impossibly high costs for some patients-is true for treating patients with hypertension with angiotensin converting enzyme inhibitors, screening for cardiovascular disease,(4) and many other interventions. The last drops of effectiveness are available at unaffordable costs, which means that decisions must be made to deny some people effective treatments.

The debate over rationing should not be confused with debates over effectiveness and funding of the health service. Few people disagree with the need to increase effectiveness, and there is little controversy about denying ineffective treatments. Many people in the health service think that more funds should be available for health care, and many members of the public support such a proposal. But these are separate debates. More effectiveness and more money will not remove the need to deny effective treatments.

In other countries, governments or state legislatures have taken the lead in the debate on rationing health care. The well known Oregon experiment is almost a decade old, (5) and the governments in Sweden, (6) Norway,(7) New Zealand,(8)and the Netherlands(9)are all active in continuing projects to involve the public in rationing health care. In Britain several local health authorities have consulted the public on the subject, (10) various researchers have sought the public's views, (11,12) the BMA has passed motions at its annual meeting calling for a national debate on rationing, (13) the Royal College of Physicians has called for a national council for health care priorities, (14) and the media keep returning to the issue as cases of "rationing" are uncovered.

The public's role
Last week, we published an account of a fundholding practice trying to involve its patients in rationing decisions.(15) This week we publish a draft agenda for the debate we have to have on rationing (p 1593),(16) an account of using citizens' juries to consider rationing 91591),(17) further clarification from the Royal College of Physicians on its proposals (p1609), (18) and a detailed analysis of how the press covered the case of child B (who was initially denied further treatment for her leukaemia by her health authority) (p 1587).(19) Some general messages seem to emerge from all this work. Firstly, many members of the British public do recoguise the need for rationing. Secondly, most people seem to think that the public does have a part to play in rationing health care. Thirdly, many people are deeply uneasy about rationing happening locally without national debate and guidance.

All this amounts to Britain "muddling through" in a way that is very British. But we need to do better. Rudolf Klein, one of Britain's best informed and most acute observers of the health service, has called this British pragmatism "half baked."(20) We need, in the words of the Royal College of Physicians, "to identify all the relevant issues, analyse them publicly and comprehensively, and satisfy all interested parties that their views are being considered."(14) The Rationing Agenda Group has made a first stab at identifyng all the issues to be considered (p 1593)(16 )But government needs to take the lead and to institutionalise what will have to be a continuing debate.(20) The major parties are not likely to acknowledge this before the general election, but sanity will return once the votes have been counted: Britain's next government must take a lead on health care rationing.

RICHARD SMITH
Editor BMJ, London WClH 9JR

References

Clinical guidelines in the independent health care sector

An opportunity for the NHS to observe managed care in action

Ever since Aneurin Bevan "stuffed the consultants' mouths with gold" the place of private medicine in the provision of health care in the United Kingdom has been much debated. With over six million lives insured-dver 10% of the population-and with numbers forecast to rise,(1) the independent sector is an increasingly important provider of health care. The activities of the private sector have the potential to influence the NHS and cannot be ignored. Indeed, the private sector might act as a test bed for measures, such as clinical guidelines, that the NHS would like to see widely implemented.

Eighty per cent of private health care bought in Britain is funded by insurance. To keep premiums low, insurers must contain costs, and one perceived mechanism is evidence based medicine. Some of the larger insurers are therefore introducing clinical practice guidelines into their business. BUPA, for example, has set up clinical consensus panels to develop professionally led guidelines that will "encourage the delivery of the very best health care...both in terms of appropriateness and quality of outcome."(2) The clinical guidelines being developed or in use cover mainly high cost, high volume elective surgery, which constitutes the bulk of private medical insurers' business, but psychiatric and medical guidelines are also being developed.

Implicit in this activity is the belief that guidelines will eliminate inappropriate treatments, improve quality, reduce costs, free up resources, and avoid the need for rationing - a concept not usually associated with private medicine. Insurers see quality and long term cost control as closely linked. Thus the agendas of the private sector and the NHS are not so different. What is different is the approach to the implementation of guidelines. Whereas the NHS encourages the use of evidence based medicine in general and guidelines in particular to promote best practice, the independent sector will increasingly be using guidelines to authorise care before it is given or to contract with preferred providers. This guideline activity is thus a springboard for the introduction of the American concept of managed care. Defined as "a variety of methods of financing and organising the delivery of comprehensive health care in which an attempt is made to control costs by controlling the provision of services,"(3) managed care is increasingly being discussed as a possible part of future British health policy. Yet there has been little real debate on how, or indeed whether, the concept of managed care might be applied in the NHS. Its introduction and evolution in the private sector may well have lessons for the NHS.

Influencing doctors' practice towards high quality, cost effective care is critical to the success of evidence based medicine but not always easy to achieve. The contracting process has been suggested as having the potential to support the implementation of guidelines, (4, 5) though doubts have been expressed about this approach. (6) By contracting with preferred providers to work within guidelines through managed care, private insurers could be "purchasing guidelines" to a greater extent than is currently the practice in the NHS. Will this achieve, firstly, a change in practice and, secondly, better clinical and financial outcomes?

Managed care works by modifying the practice of doctors by using clinical guidelines, by financial incentives, by restricting access to specific doctors (preferred providers), or by a combination of all three measures. If insurers are successful in using managed care to change practice nationally, in volume and across specialties, then the NHS must take note. On the other hand, if the private sector, with its strong financial levers, is unsuccessful what chance has the NHS? Just as doctors value their clinical freedom, insured patients value freedom of choice and expect a luxury product at a competitive price. They will not pay to be rationed when they can be rationed on the NHS for free. Therefore, how insurers market guidelines and managed care to both clinicians and their subscribers will be central to their success-and of great interest to the NHS.

Although a claims driven system allows insurers to evaluate use and cost, long term clinical outcome data are presently lacking. Insurers are developing increasingly sophisticated information systems which may help to overcome this problem. In addition BUPA has recently announced that it will provide some primary care services. An ektension of this and other possible initiatives by some insurers, such as the establishment of health maintenance organisations, may also help to provide long term outcome data.

In the short term, cooperation with the NHS to provide data is one possibility. Some insurers are willing to cooperate with the NHS by sharing skills and information or by contributing to a clearing house for guidelines.(7) Thus the NHS and private sector have an opportunity to cooperate by sharing information to see if guidelines can not only change practice but also realise better outcomes for less cost: in other words, to determine if all the current activity on guidelines is justified. The opportunities should not be missed.

Managed care is in its infancy in the private sector, and its evolution could go several ways. Disease management could become a reality with clinician-manager relationships becoming cooperative rather than adversarial and clinical practice guidelines resulting in high quality, cost effective care. Alternatively, managed care systems might set medical fees, decide budgets for hospitals, and set standards of practice: use of services might be controlled but clinicians and patients could be left dissatisfied. The costs of administration could outweigh any savings, and quality might not be guaranteed. As the American experience tells us, the reality is likely to be somewhere in the middle, with insurers striving to get the best from managed care while eliminating the worst.

By whatever path managed care evolves, one thing is certain: unless the independent sector, like the NHS, can deliver high quality care at an acceptable cost it will not survive in its present form. Guidelines implemented through managed care may be one answer. Whether the private sector has lessons for the NHS depends on its future development, its willingness to collaborate, and the willingness of those in the NHS to seize the opportunities. Whatever the outcome, we have an opportunity to observe managed care at work in a British setting.

GILLIAN FAIRFIELD Senior registrar in public health medicine
RHYS WILLIAMS Professor of epidemiology and public health Nuffield Institute for Health, University of Leeds, Leeds LS2 9PL

References

Contraceptive implants

Users lose out when misleading information limits choice No single contraceptive method exists that meets all preferences, and a wide choice is therefore important in maintaining contraceptive cover and continuation. (1) This is reflected in NHS advice that family planning outlets should provide all methods,(2 )as well as in public interest in research leading to new methods.(3) Unfortunately, incomplete or inaccurate information from any source may contribute to negative impressions of a method and thereby limit choices further. Norplant, a slow release progestogen implant that offers many advantages to users, is one method of contraception currently at risk of such treatment.

Norplant contains levonorgestrel, a synthetic progestogen prescribed to millions of women over two decades; 15 preparations are currently licensed for contraception and hormone replacement in Britain. Daily dosages of 75-250 microg occur in combined oral contraceptive pills and 30-75 microg in progestogen only pills. Users achieve peak blood concentrations in excess of 2.5 nmol/l.(4 )If there were major problems with this compound they would have become apparent by now, but none have been reported. Indeed, a recent letter to prescribers from the Committee on Safety of Medicines (18 October 1995) encouraged greater utilisation of combined pills containing levonorgestrel because of apparently lower risks of venous thromboembolism.

None the less, within three weeks of that letter being sent, the television programme Horizon reported that undisclosed risks were associated with the newer levonorgestrel contraceptive, Norplant. This product releases approximately 30 microg of the drug daily, maintaining blood concentrations around 1.0 nmol/l.(4 )It therefore seems biologically implausible that significant new systemic effects would come to light with this delivery system.

Norplant is, of course, not free from problems; problems already familiar to most prescribers and users (up to 95% of the 50 000 British women currently using Norplant have previously used other hormonal methods).(5)Norplant has, like all progestogen only contraceptives, a variable impact on the menstrual pattern, particularly in the first months of use, when irregular bleeding may occur. Interventions to improve this pattern have been suggested. These include oestrogens or non-steroidal anti-inflammatory drugs, and where needed, these are preferable to premature discontinuation. (6) As with all hormonal methods, including combined pills, 5-10% of users report changes, sometimes in a beneficial direction, in their weight, hair and skin consistency, headaches, and mood.(4)

Another problem relates to reported difficulties in removing the subdermal capsules. Experience in other countries has shown that correct subdermal placenient of the Norplant capsules is vital.7 Because of this, the British distributors established a free traIning programme for doctors before the product was launched, (8) and its impact is reflected in the generally positive experience of British women and their doctors with regard to removal.(9) In our clinic, average removal time, including removal by trainees under supervision, is now less than eight minutes.

The overall success of Norplant in Britain is apparent from high one year continuation rates - 85% from one study of patients treated predominantly by trained general practitioners,'(9) and more than 90% in some larger centres (L Mascarerthas; J Davie, personal communications). Where direct comparisons have been completed, Norplant continuation rates exceed those for the combined pill.(10) Users report that ease of complying with this "fit and forget" contraceptive method is one of its attractions.(5,10) From the providers' point of view, long acting methods are recognisably more cost effective, (11) especially when providers are also responsible for the cost of unplanned pregnancies. This is likely to become increasingly important with the extension of general practitioner fundholding. Although the "medicalisation" of removal is a disadvantage of Norplant use, it helps avoid the situation where users discontinue contraception without arranging an alternative method, a risk common in women using the pill at the time of "scares." When scares about newer methods proliferate, in the face of objective evidence and biological plausibility, it is reasonable to ask whose advantage is served. (12) Certainly not that of the vast majority of users. "Trial by media" has major disadvantages for them encouraging discontinuation, discouraging provision and uptake, jeopardising continuing research into new methods, and potentially halting further expansion of the contraceptive "menu." It is hoped that newer implants such as Norplant 2 and Implanon will soon become available. These are suitable for further groups of users and their progression from research, through development and licensing, to general availability has been painstakingly and carefully overseen. It would be a pity if misleading information prevented appropriate uptake and further expansion of user choice.

DAVID R BROMHAM Senior lecturer in obstetrics and gynaecology St James's University Hospital, Leeds LS9 7TF

David Broniham receives fees from Norplant as a trainer.

References

Health workers and the baby food industry

World Health Organisation acts to end conflict of interest and promote breast feeding

Recent reports about phthalates in infant formulas in Britain have revived interest in the possible dangers of breast milk substitutes and the need to promote breast feeding.(1) While the British government tried to calm public fears, the World Health Organisation's governing body, the World Health Assembly, passed a resolution urging health institutions, professionals, and ministries in all member states to prevent the baby food industry from providing financial or other support for health workers.(2 )This resolution is likely to provide added strength to those committed to protecting, promoting, and supporting breast feeding. But what does it mean for the funding of health care and training; will it remove conflicts of interest; and can it be implemented?

Breast feeding is important for infant health, for rich people as well as poor people. (3, 4 ) But poor people are especially at risk from inappropriate marketing of breast milk substitutes; as well as adding to infant mortality and morbidity, these products add further strain to the economy of already marginalised families and resource poor nations.

Breast milk substitutes are big business. The global market in 1983 was estimated to be $3.3bn (£2200m) (5) and in 1991 over $6bn (A Chetley, personal communication). For India, Prakash quoted a figure of £180m, growing at 6% per year.(6)

That companies strive to use health professionals to promote their product is no secret. Describing Abbott Topics, a medical magazine sent to health workers, the company says "As the voice of Abbott, Abbott Topics can be a positive force in moulding the physician's opinion of Abbott. In effect we are striving to make the physician a low-pressure salesman of Abbott."(7) Jelliffe wrote, "The medical and nursing profession can sometimes be very naive in their interactions with commercial companies, so that mixtures of 'manipulation by assistance' (free samples; assistance with research funds; hospitality at meetings) and 'endorsement by association' (advertisements in newsletters and journals of professional associations; sponsorships of conferences) are very frequently and successfully used promotional methods, usually unperceived, minimised, or tolerated as such by the physicians, nurses, and nutritionists concerned."(8) Some professional b6dies have already taken action. Since 1980, despite opposition from some quarters,(9) the Indian Academy of Pediatrics has been moving towards independence from the baby food industry. The government set up a committee to draft a code for marketing of baby foods. Nestle offered a donation to an academy official on the committee. The academy saw conflict of interest and voted overwhelmingly to refuse the donation.(5) Since then, the academy has held workshops on consumer protection and lactation management with support from Unicef and without aid from the baby food industry.

For several years Nestle, followed by Wipro, had conducted a paediatric quiz for undergraduate medical students along with the academy. The academy decided to end that association and will now run the quiz independently. In 1994 a brand leader among multinational formula companies in India offered to pay all the expenses for the academy's sponsored 8th Asian congress of paediatrics, estimated by its president at about 10-15m rupees ($0.5 million) (R D Potdar, personal communication). The academy refused the offer.

The Indian Medical Association (with 100,000 members) has also decided not to take any support from the baby food industry. The Pakistan Paediatric Association did not allow formula companies to participate in its recent 13th international conference. Such examples frQm resource poor countries, along with the World Health Association's resolution, may act as a shot in the arm for those paediatricians in Britain who have been pressing for the British Paediatric Association to refuse industry funding.

In its provision for monitoring the marketing practices of baby food manufacturers, India's law is unique;(10) as well as authorising government inspectors to take baby food companies to court if they violate the ban on promotion of bottle feeding and advertising of breast milk substitutes and feeding bottles, it has also given similar authority to selected voluntary organisations engaged in child welfare and nutrition. Four such organisations have now been given this power, and the Assocation for Consumers Action on Safety and Health has brought criminal charges against Johnson and Johnson and Nestle. Johnson and Johnson is charged with promoting bottle feeding. According to the association, the company was selling feeding bottles to the public at a discount and giving retailers one bottle free for every dozen sold. Nestle is charged with encouraging too early use of complementary foods. Since 1994, the World Health Organisation advises that these foods should be introduced from about six months of age, not four to six months as was previously recommended. Indian law clearly advises that they be started after the age of four months. Nestle's promotional slogan in Hindi, "Chouthe Mahine Se," literally means "from the beginning of the fourth month." The assocation also says that Nestle was failing to place the words, "mother's milk is best for your baby" in Hindi as well as English on the front of baby food packaging. The charges are still pending, but Johnson and Johnson has now decided to withdraw completely from the feeding bottle market in India by November l996 (Gohnson and Johnson, personal communication).

Important questions must now be faced: who will fund research and conferences; who will provide health workers with information; and who will monitor the marketing practices of industry? Professional and voluntary bodies that believe in complete independence from the baby food industry, even if it means acute shortage of resources, must either raise money from their own members or through publications. Governments, international organisations, and nongovernmental organisations (including independent charitable trusts and other appropriate sources that do not create conflict of interest) will need to step into the breach. In India, the Indian Council of Medical Research, the Department of Science and Technology, the Ministry of Health, and the Department ofWomen and Child Development, several charitable trusts, and Unicef have been meeting such needs.

Organisations such as the British Paediatric Association, which have apparently yet to realise that the interests ofmanufacturers may conflict with those of breast feeding mothers and their children, should be guided by three thinkers who well understood human nature. In his book Raja-Yoga, Swami Vivekananda remarked that when one man receives a gift from another, he loses his independence.(11) Milton Friedman said, "There's no such thing as a free lunch." And Aesop wrote, "Better starve free than be a fat slave."

RK ANAND Senior paediatrician Jaslok Hospital and Research Centre, 15 Dr G Deshmukh Marg, Mumbai 400 026, India

References

Is the human testis still an organ at risk?

Regional differences in sperm counts and fertility may provide a clue

Although several lines of circumstantial evidence suggest that we may be seeing adverse changes in male reproductive health, it is the possibility that semen quality may have declined that has attracted most attention. In a meta-analysis Carlsen et al examined data from 61 papers published between 1938 and 1991 on the quality of semen in normal men.(1) Using linear regression analysis, they identified statistically significant decreases over time in mean ejaculate volume and a fall in sperm concentration from 113x10 to the 6/ml in 1940 to 66x10 to the 6/ml in 1990. This report has aroused continuing debate.(2) Subsequently, Auger et al published data on 1351 healthy fertile candidates for sperm donation who attended one centre between 1973 and 1992.(3) Correcting for sexual abstinence, they observed a significant decline in sperm concentration, the percentage of motile spermatozoa, and the percentage of morphologically normal spermatozoa both as a function of year of birth and age at donation.

Several workers have since examined secular trends in semen quality, some apparently showing a trend downwards,(4,5 )while others have found no such trend.(6 ,7) Most recently, two groups of workers from the Urnted States have published data suggesting no changes in semen quality with time.(8,9) Paulsen et al examined the semen quality of 510 men in Seattle, selected on the basis of endocrine and physical normality to participate in clinical research studies, and found no evidence of any change in semen quality with time. (8) Fisch et al reported on 1283 men banking semen prior to vasectomy between 1970 and 1994 at three different sperm banks.(9) Although they found no evidence of changes with time in semen quality, they did observe significant and unexplained differences in semen quality in the three locations~the average sperm concentration was 131.5x10 to the 6/ml in New York, 100.8x10 to the 6/ml in Minnesota, and 72.7x10to the 6/ml in California.

These regional differences reflect similar differences observed in Europe, most notably between Finland and Denmark, (6 10) and are at least as intriguing as the difficult and controversial issue of secular trends. Whether these regional differences are due to ethnic, environmental, or lifestyle factors remains to be explored.

The question of whether these apparent differences are relevant to fertility has recently been addressed by Joffe in a careful and thought provoking comparison of "time to pregnancy" in Finland and Britain.(11) Couples in Finland conceived more quickly than their British counterparts, suggesting that semen in Finland is of higher quality.

If real, changes in semen quality are not happening in isolation. There is evidence that the incidence of testicular cancer is changing, with unexplained increases being observed in Europe (12 ) and in the United States.(13) In the west of Scotland, for example, the number of testicular germ cell tumours registered more than doubled between 1960 and 1990, (14) while a recent study from Norway reported that the age standardised incidence for testis cancer increased from 2.7 per 100 000 in 1955 to 8.5 per 100 000 in 1992.(15) It is of interest that there is also a substantial geographical variation in both the incidence of testis cancer and in the observed rate of increase.(12) This geographical variation may be linked with that seen in semen quality - testis cancer is four times more common in Denmark, where some studies have revealed rather low sperm counts,(12) than in Finland, where semen quality is better. (8)

Rise in incidence of congenital malformations
It has also been suggested that the incidence of congenital malformations of the male genital tract is changing, with observed increases in the prevalence of cryptorchidism and hypospadias.(16 )Rates of cryptorchidism, for example, are reported to have increased by as much as 65%-77% over recent decades in Britain. (17 )Regional differences were also found, although these results are perhaps less robust. In a multicentre study of 8122 boys from seven malformation surveillance systems around the world, Kallen et al concluded that, even when differences in ascertainment were taken into account, true geographical differences existed in the prevalence of hypospadias at birth. (18) Intriguingly, they also concluded that there seemed to be an inverse correlation between fertility in a population (estimated from mean parity in control women) and the prevalence of isolated hypospadias at birth.

The question of causation remains open. The provocative "oestrogen hypothesis"(19) remains a hypothesis, albeit one which is gathering biological weight, (20 ,21) and clinical data are scarce. Taken together, the available data on semen quality and other aspects of male reproductive health, at the very least, raise concerns that should be addressed by properly designed, coordinated, and funded research. Prospective multicentre studies with attention to possible confounding factors and appropriate quality control are required, together with more reliable methods of assessing semen quality. To paraphrase a recent BMJ editorial, (22) delay may compromise the reproductive health of future generations.

STEWART IRVINE Consultant MRC Reproductive Biology Unit, Centre for Reproductive Biology, Edinburgh EH3 9EW

References

A treasured treasurer

BMA treasurer steps dewn with BMA 's finances strong

Next week Alistair Riddell, treasurer of the BMA since 1987, will come to the end of his term of office. He will step down amidst universal agreement that he has done an excellent job and is a fine fellow. These are both considerable achievements in these financially turbulent times many major professional institutions are financially weak, and treasurers are often unpopular because they must regularly resist the urges of their political colleagues to spend money.

When Dr Riddell became treasurer the BMA's reserves stood at £14m. Now they have grown to £38m. During this time members of the BMA have seen many developments in the services they are offered-such as enhanced regional services and access to Medline. In addition, the number of members who pay less than the real cost of serving them has increased: student membership, for example, has grown from under 6000 in 1987 to almost 11 000. Dr Riddell and his team have achieved the kind of "economic miracle" that governments seek but rarely find through careful day to day financial management, growth, skilled political guidance of subscription rates, and inspired management of the association's investments. The annual turnover of the association (including BMA Services) has grown from £27m in 1987 to £52m in 1996, while the market value of the association's investments were £13m in 1987 and are now £45m. Dr Riddell has been cautious when he needed to be cautious and daring when he needed to be daring.

The achievements of treasurers are often unsung. BMA members who are actively involved in medicopolitics know Dr Riddell; many other members will not. But they have enormous reason to be grateful to him for his hard and successful work. The BMJ thanks him on behalf of all BMA members.
RICHARD SMITH Editor BMJ, LondonWC1H 9JR

Correction