Sunday 10 October 2010

This open letter to Mr Lansley will  be published as a Personal View in the BMJ on 16 October and may be cited as: BMJ 2010;341:c5618




An open letter to the health secretary: how to really save money on the NHS
Peter Lachmann
emeritus Sheila Joan Smith professor of immunology, University of Cambridge


Dear Mr Lansley
Your proposals to transfer the role of purchasing NHS services for patients from primary care trusts to general practitioners is appealing in as much as it promises some reduction in the excessive bureaucracy that resulted from the “low trust” culture introduced by the Thatcher reorganisation of the NHS in the 1980s and never reversed. However, as was so eloquently pointed out by the late Douglas Black—an eminent physician and someone who had much experience in government as well—none of the reorganisations since (and including) those of 1973 have succeeded in improving function by tampering with structure.[1] Indeed they have all done the reverse, essentially, as Sir Douglas also pointed out, because they fail to appreciate that health care should be treated as a service rather than as a business. Business based models have not fared well when it is a service that is required.
However, I imagine that the main aim underlying your proposals is to save money and to provide better healthcare delivery at lower cost. There are, indeed, at least three ways in which very large sums of money could be saved in the delivery of health care, with improvement rather than detriment to the quality of service. However, none of these changes would be universally popular, and they would require time, tenacity, and political courage to bring them about. Nevertheless, without them the future of health care, not just in the United Kingdom but elsewhere, will be imperilled by ever rising costs.
Reducing the cost of drugs
Drugs are a large component of health expenditure. We now live in an environment where the population has been persuaded that medicines have to be absolutely safe and that if anybody comes to harm from taking a drug they should have the ability to seek compensation through the courts. This state of affairs has led to drugs becoming hugely expensive and very slow to bring into use. It is now estimated that to bring a novel drug into use costs several hundred millions of dollars and takes 10 years.
About 60% of drug development is taken up by the late stage, phase III, trials. Phase I trials to ensure safety and phase II trials to demonstrate efficacy require relatively small numbers. Phase III trials involve large numbers and aim both to get more precise information on clinical usefulness and, more importantly, to detect rare side effects. However, even very large phase III trials cannot detect side effects that occur in less than about one in 1000 people.
The details of clinical utility and of rare adverse reactions are detected just as well, or better, by post-marketing surveillance. This is an extremely important aspect of the use of drugs and can be particularly effective in the context of the NHS. There is a strong case for making drugs available after phase II trials and to rely on post-marketing surveillance for detecting uncommon side effects. This would have two big advantages: it would make drugs much cheaper; and it would make drugs available much earlier. Although accurate figures are hard to obtain, it seems likely that phase III trials probably save fewer lives from avoided side effects than they cause deaths from patients having been denied a valuable drug. Certainly the cost per extra life saved will be much in excess of the sums that are allowed in the road traffic industry, which was about £2m per life saved per year, or on the railways, where it was about £3m. Initially, the change to making drugs available at the end of phase II should probably be done on a voluntary basis so that those patients who wish to avail themselves of drugs at this stage would be given them, subject to their signing a legally binding indemnity that they would not look for compensation if they suffered any adverse effects.
The practice of suing drug companies for adverse effects is generally to be deplored. It has become much commoner, and the practice of doing so on a contingency fee basis, imported from the United States, has greatly increased its frequency. It is not sufficiently realised that suing drug companies does not do them any financial harm. The expense is passed on to the consumer and further increases the cost of drugs. The only group that really profits from the process is the lawyers. While those patients who win compensation are better off, the rest of the patient population does badly by paying more for drugs.
Legal redress should really be reserved for cases where there has been negligence or other malfeasance. In many cases this is clearly not the case. Quite recently two examples have been reported. GlaxoSmithKline has settled a large number of claims from people who believe that they had cardiovascular side effects from taking rosiglitazone for diabetes. While rosiglitazone produces such effects slightly more commonly than its competitor pioglitazone,[2] it has nevertheless been a useful treatment for diabetes, and there was no negligence involved in making it available. AstraZeneca has similarly settled claims for $198m from 17,500 patients who developed diabetes after taking quetiapine for mental illness[3]—despite there being no evidence accepted by a court that there is a causal association.
To reverse the litigious compensation culture that has now grown up would obviously not be easy, but it is necessary if drugs are to be available at affordable prices and on a reasonable time scale.
It is also likely that many drugs are never developed because the potential market is regarded as too small for all the risks currently involved in taking a drug to market. There is a less rigorous regime in place for what are known as “orphan drugs” for well characterised rare diseases, but there are many potential drugs that fall between having a sufficient market for commercial development and being for sufficiently rare and well characterised diseases to fall under the orphan drug regulations.
Reforms in this area could save many hundreds of millions of pounds a year and are urgently required. They are rarely even discussed, and the part of the Cooksey report dealing with this problem was simply ignored by the last government.[4]
Making better use of medical facilities
The maintenance of hospitals and their facilities—including operating theatres, radiology departments, with their expensive imaging equipment, and pathology laboratories, with their expensive machines—is all very consuming of capital. It would make much better economic sense to use these facilities much more intensively than they are at the moment. In general, hospital facilities, and indeed most general practices, operate on a five day week, eight hour day basis. This makes neither economic nor medical sense, and it would be much better if many more facilities were used seven days a week, 24 hours a day. This would reduce capital expenditure and, in the longer term, the number of hospitals that need to be built. There are, moreover, other advantages that may be even more important. There has long been convincing evidence that being taken acutely ill on a Friday night carries a worse prognosis than being taken ill on a Monday night, and a recent new report pointed out that babies born “out of hours” face higher risks.[5] The efficiency and quality of the clinical service will therefore benefit, as well as its economics. These changes would involve employing more staff per hospital and getting agreement to rather more unsocial hours of work. Until fairly recently most doctors, particularly in their younger years, did quite a lot of work in antisocial hours; and providing that this was properly remunerated, it should probably not cause huge problems. It would certainly be of great benefit to the NHS.
And perhaps the most important and the most difficult: end of life care
A forbidding statistic produced by the RAND Corporation[6] is that on average between one third and one half of a person’s lifetime healthcare expenditure is spent in the last six months of their life, independent of when this occurs. This is obviously not true of everyone, but it is a general truth, and it leads to the inevitable conclusion that no advance in medicine will make health care cheaper; it just postpones the expenditure. The only answer to this is to reduce heavy expenditure and interventionist methods that are often undignified and painful when there is no prospect of appreciable gain in quality adjusted life years (QALYs). This is to some extent antipathetic to the training of doctors, which is very much based on their duty to the individual patient. Much questionable intervention is carried out on patients where there is no realistic prospect of restoring quality of life or even of extending life span for more than a few months. Although there is no easy solution to this dilemma, medicine does need to adjust to the paradigm that active intervention should be undertaken only in anticipation of improving, or at least maintaining, quality of life and not for prolonging life at all costs. In end of life care the cost per QALY can also not be totally ignored, although the criticism that the National Institute for Health and Clinical Excellence consistently attracts when it makes decisions on this basis shows what a sensitive area this is.
Related to this is the right of patients to have their lives terminated if they so wish. In the UK at present this is legal only if done by withholding treatment or nutrition but is a criminal offence if any active assistance is given. There is a strong argument that people have not only a right to life but also a right to death and that it is also an interference with their human rights to deny them access to ending their life painlessly and with dignity if they are minded so to do. There is a particular problem in this area with patients with depression who may wish to end their lives while they are ill but who after treatment are restored to a normal quality of life. Special arrangements would have to be made to ensure that these patients are protected if arrangements for facilitating a right to death were introduced. On the other hand, the overall resistance to doctor assisted suicide has very unhappy consequences and is, in my view, difficult to justify on medical ethical grounds. There are clearly problems that any such system could be abused, and precautions would have to be put in place. The experience in Oregon and in the Netherlands does not suggest that this has been a major problem there. The religious qualms on these grounds are also particularly difficult to understand, since if one believes that this world is a “sea of troubles” from which one escapes to a better life in the next, it is difficult to see why one should make it so difficult to make this transition, once the quality of this life has become a burden.

Implementing changes in these three areas would allow health expenditure to be contained in a way that would make a real difference, unlike tinkering with management structures which is more like rearranging the deckchairs on the Titanic.
Competing interests: PL has consulted for Novartis and GSK on occasions in the past three years on scientific matters concerning the complement system. He and his wife jointly have shares in Roche and Novartis.
1    Black D. Lessons from nostalgia. Clin Med 2002;2:263-5
2    Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, Ali F, Sholley C, Worrall C, et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA 2010;304:411-8.
3    AstraZeneca. AstraZeneca announces agreements in principle in Seroquel product liability litigation. www.astrazeneca.com/media/latest-press-releases/2010-new/SEROQUEL_Prod_Liability?itemId=10914599.
4    Cooksey D. A review of UK health research funding. HM Treasury, 2006. www.hm-treasury.gov.uk/media/4/A/pbr06_cooksey_final_report_636.pdf
5    Pasupathy D, Wood AM, Pell JP, Fleming M, Smith GCS. Time of birth and risk of neonatal death at term: retrospective cohort study. BMJ 2010;341:c3498.
6  Lynn J, Adamson DA. Living well at the end of life: adapting health care to serious chronic illness in old age. RAND Corporation, 2003.