The NHS spent £1.68 billion on medicines in Scotland in 2015/16, nearly 14% of its total budget. Is this too much? Well it’s a large figure, but difficult to say whether it is too much, or not enough. Partly it depends on how well we think the drugs work. If they help people recover from illnesses, or can alleviate pain and suffering, then they may be worth it, and indeed, save money if it means people get back to work quicker or other expensive treatments are not needed.
Comparisons with other healthcare systems are difficult, but according to the OECD (Organisation for Economic Co-operation and Development) spending in the UK as a whole on medicines, as a percentage of healthcare spending, is lower than most other developed countries, but all systems are facing the same problem of rising cost pressures as a result of expensive new medicines coming onto the market. In Scotland this means that as costs of medicines continue to increase ‘they will absorb an increasing proportion of health boards budgets , which means in turn that tough decisions will need to be made about reducing spend in other areas of provision.
And despite the existence of standards and measures for testing the effectiveness of new medicines, there continue to be doubts about just how good some of the new drugs are.
A recent report in the British Medical Journal argues that “Most cancer drugs recently entering the European market do so without clear evidence of extending or improving quality of life” and the research suggests that the majority of cancer drugs approved from 2009 to 2013 were “without evidence of a survival or quality of life benefit. Even when drugs did show survival gains over available treatment options, most of these were not clinically meaningful.”
There are, naturally, high public and political expectations of regulators, and there is difficulty in saying ‘no’ when a drug could be of potential benefit. In many ways, regulatory organisations are in a ‘no win’ situation. If they say no to a new, and potentially life saving drug, they will be seen as denying treatment to people who need it. However saying yes may mean that drugs which deliver toxic side effects as well as costing significant money are prescribed to patients who derive no benefit, but whose hopes have been needlessly raised. Quite often in practice, the ‘evidence’ for whether a new drug works can be less than straightforward, and waiting until full definitive evidence is available may also result in needless suffering as well as strong pressure from patient groups and politicians.
Even if expensive drugs are of benefit, it may be that there is an ‘opportunity cost’ and that more benefit could have come from spending that money on something else. Inequity in spending on healthcare has long been a potent issue, as Dr Brian Montgomery recognised in his recent review on access to new medicines where he notes concerns that “medicines were not being treated equitably when compared with other healthcare treatments and technologies.” And recently, a member of the Scottish Parliament Health and Sport Committee called for “a national conversation about some of the very expensive drugs that are coming along that deliver marginal benefits…”
There are many complex ethical issues involved in this. Is it right that one patient can get access to expensive drugs when others who require other interventions have to go without? In trying to make comparisons, is it right to purely look at ‘health benefit’ (even assuming this comparison can be done fairly and accurately) without also understanding other societal values, like the ‘rule of rescue’, which refers to a widespread view that we should prioritise resources on ‘saving’ people at risk. A strict utilitarian ‘outcomes’ approach for example, is not applied to whether we should spend money rescuing people from natural disasters, or people who are lost on mountains, even though we could probably spend this money more effectively on achieving other outcomes. People expect the NHS to come to our aid when we are severely ill, and its ability to do that forms an important part of our societal expectations when paying taxes to support it.
The issue is much wider than medicines, and all healthcare resources are finite and have to be managed and delivered effectively and in a way that is seen to be fair. In practice, many prioritisation decisions will be taken at the ‘micro’ level i.e. where patients/users meet on an individual basis with professionals and service providers. For example GPs act as ‘gatekeepers’ in terms of referring people onward to services, and waiting lists are one way of restricting services in practice.
Most prioritisation decisions are made ‘implicitly’ rather than ‘explicitly’. The requirement for flexible, person-centred care, and the need to take into account emotions, aspirations and preferences means that decisions about the most effective treatments for particular patients/users should be shared decisions between those receiving and providing treatment, rather than being made by formal committees meeting in public.
Explicit decision making is best restricted to setting frameworks, establishing limits to resources, and producing formulas for fairly distributing healthcare, as the academic David Mechanic argues in his paper ‘Muddling through elegantly’. However, this leaves a vast area for deliberation and dispute.
In Scotland there is guidance on prioritisation for the NHS at local level but at both local and national level ‘cost effectiveness’ can often serve as a proxy for prioritisation decisions.
Organisations such as the Scottish Medicines Consortium, the Scottish Health Technologies Group, and SIGN (the Scottish Intercollegiate Guidelines Network) make evidence based decisions on what treatments and approaches should be used by the NHS. However, this doesn’t necessarily mean that these organisations find it easy to make difficult decisions. Attempts around the world in having transparent and explicit prioritisation seem to demonstrate that in fact the more public and transparent the process is, the less easy it becomes to prioritise particular treatments or to say ‘no’. This is because public and political awareness is raised and focused on the areas where someone may be denied treatment, rather than on the more complex ‘trade off’ or opportunity cost issues which have system wide consequences. One study looking at approaches in eight countries found little evidence that having explicit processes had led to changes in practice or savings, and that in fact “the more that rationing decisions are made public and explicit, the less likely that a public insurance system is able to ration services.” This is known as ‘the political paradox of rationing’.
On the one hand it is clearly in everyone’s interest to have a transparent, open and fair system for allocating healthcare resources, and indeed natural justice and democratic principles of accountability seem to demand it. But in practice this can lead to conflict and an avoidance of, rather than engagement with, difficult decisions. Those with the loudest or most influential voices, or the most easily measured ‘need’ may prevail regardless of whether that is fair. There is currently no settled view about how we get the right balance, but with developments in personal medicine, genomics and artificial intelligence likely to bring new challenges, not just in terms of cost but also in how we define healthcare, we have to continue questioning what the best system for making choices looks like. We will need to develop new and innovative ways of involving the public and understanding societal views if the NHS is to continue to maintain public confidence and distribute healthcare resources fairly. In a future blog I will explore what some of these methods may be.
What do you think? I would be interested to hear your views. Please email me at Richard.Norris@ed.ac.uk
This is a well written and carefully considered blog and I commend Richard Norris for raising such a difficult area. This issue is very much in the realms of the Chief Medical Officer’s “Realistic Medicine” initiative.
One of my areas of interest is in over-medicalization and the harms that this can cause, not least inverse-care (services stretched so far that those most in need cannot access them). I believe that this has happened with dementia.
Following Sir Harry Burn’s recent review on Targets I have put together a perspective of the decade that has almost passed since incentivised dementia Targets were introduced by the Scottish Government:
Richard Norris mentions SIGN Guidelines but the Dementia Guideline – SIGN 86 – was withdrawn as being out-of-date. My research for a Sunshine Act concluded that this Guideline may have been heavily influenced by the Pharmaceutical Industry. In my view this facilitated over-medicalization and the introduction off HEAT target 4. Ethics were side-lined and transparency was not to be found.
In terms of other areas of what some have termed as “mass prescribing” we now have 1 in 7 Scots now on long-term antidepressants. Is this “realistic”? What is the cost? Who has gained most? We are also now learning from patient experience that many patients are struggling with dependence and withdrawal from psychotropics (there is a petition on this being considered in the Scottish Parliament at present).
It was 2 years ago that the Scottish Health Council facilitated a public consultation on a Sunshine Act. In majority, those consulted, wished all financial payments from the pharmaceutical industry and device makers to be mandatorily declared on an open public register.
2 years on and all the public have heard from the Scottish Government is that it is “scoping” a “range of options”. There has been no openness about what is happening. The Scottish Government has NOT listened to the Scottish public. I would go as far as to say this is shameful. Patient harm may result and prescribing of psychotropics will continue to rise, year-on-year as they have done for the last decade.
I am disappointed that neither Healthcare Improvement Scotland nor the Chief Medical Officer has publicly supported Sunshine legislation. One can only speculate reasons why they have not. Is the lack of such support realistic?
The Polypropylene Mesh scandal is today being debated in the Chamber of the Scottish Parliament. One of the central issues relates to “fully informed consent”. This applies across the board for any medical intervention such as prescribing.
I would welcome a response to these open questions from Healthcare Improvement Scotland and their working partners the Scottish Government.
Again, thanks to Richard Norris for inviting comments to his excellent blog.
Dr Peter J Gordon
I very much welcome the opportunity to comment on this issue. As a member of the online prescribed harmed community, I am now aware of the immense harm being caused to patients by benzodiazepines, antidepressants and other psychiatric drugs. Benzodiazepines were launched on the market in the 1960s and were said to be non-addictive. Antidepressants were promoted as a means of alleviating depression said to be caused by a “chemical imbalance” in the brain. This was a marketing tactic by the drugs companies and has never been scientifically proven. There is considerable evidence now that antidepressants and other psychiatric drugs do more harm than good. Many patients are finding it extremely difficult to taper off these drugs and are therefore congregating online in self-help support groups, unable to find appropriate support from their prescribing doctors, many of whom do not even recognise the withdrawal symptoms for what they are. Instead, more drugs are offered and patents end up poly-drugged or on even higher doses. So my question is “How much harm is being done by prescription drugs?” And why are doctors so uneducated in drugs of dependence and the difficulties of withdrawal? The NICE guidelines on antidepressant withdrawal are based on short term studies of patients. The drugs were never tested long term yet they are being prescribed for decades and patients are sustaining neurological damage, some permanent.
It isn’t just the cost of the drugs which may in fact be relatively cheap, it is the cost in terms of human suffering, unemployment, underemployment, disability, repeat medical consultations, more drugs for side effects, referrals and investigations in case something else is wrong etc etc. SSRIs are known to increase the risk of suicide, but more often than not the role of the drugs are not recognised when patients take their own lives. Patients in the online community have lost 10, 20, 30, 40 years to drugs of dependence. I have lost over 40 years and am now brain damaged due to withdrawal. It is only now I am off the drugs that I know that the drugs have caused a lifetime of disability and illness. I am by no means unique and I wish it was a historical problem, but it isn’t. Younger people are coming up behind me in considerable numbers. There are now 875,000 patients on antidepressants in Scotland and the number keeps rising. Why? How long have patients been on these drugs? How many were previously on benzodiazepines and were simply transferred? How many cannot taper off these drugs and are going to be stuck on them for the rest of their lives with unknown consequences? And of course we now have a problem with opioid painkillers.
Petition No PE01651,Prescribed drug dependence and withdrawal, will be discussed tomorrow by the Petitions Committee at Holyrood. I have contributed to this petition as have other affected patients. A similar petition has now been submitted to the Welsh Assembly by an affected patients. The BMA has called for a helpline and specialist services but no UK Government is willing to fund. Patients are advised that drug and alcohol addiction services are provided. These are entirely inappropriate. And so patients, most of whom are very sick, are trying very hard to seek a different way forward. Most of us were never informed that the drugs were addictive. We were never informed of the risks of irreversible damage. And now for those of us who are irreparably damaged, we have to fight tooth and nail simply to get an acknowledgement that the drugs were responsible. I do not think patients in future will tolerate any of this. Doctors do not explain to patients that the drugs they prescribe may in fact be of very limited benefit and that they may cause considerable harm. Phrases like “all drugs have side effects’ lull patients into a false sense of security. Antidepressants are promoted as “safe and effective” which also serves to falsely reassure unsuspecting patients. If I go into hospital for an operation, I am advised there is a risk I might die. Why should prescription drugs be any different?
The power and influence of the pharmaceutical industry is such that patients’ health is at considerable risk from their products. The drug regulatory processes are inadequate. Leading doctors often have financial ties to the drug companies. Medical research fraud is now prevalent. Clinical guidelines can be completely flawed due to these and other factors. There needs to be much more emphasis on preventing ill health and promoting well being. Fewer harmful prescription drugs would help improve the health of the nation. Money should be spent on those drugs which really do benefit patients more than they cause harm. Something needs to change. I often hear that the public want to consume drugs, that is most certainly not my experience. Most of us did not want to consume drugs. We have been misled into thinking that the drugs would benefit us. We simply asked for medical advice and assumed that that advice would be to our benefit but we were sadly very mistaken.