Mental health is in crisis – more so for people from minority groups. How do we reach them before they drown? DDN reports from the Minority Mental Health conference

‘There is outrageous discrimination against people with mental health problems… there is an absolute moral imperative on all of us to do something about the situation,’ said Norman Lamb MP.

The shadow Liberal Democrat spokesperson on health was addressing the Minority Mental Health conference, Ending discrimination in mental health: turning the crisis tap off, held in London last month. The event brought together professionals from all areas of health and social care to look at ‘one of the deepest and most discriminatory social failures of our education, social, health and criminal justice services’.

In many cases substance misuse was identified as playing a crucial part in developing mental health problems, while others used substances to self-medicate their mental health issues. In all cases, people were being failed by a complete lack of coordinated care and a health and social care system in crisis.

‘People need diversion [into the appropriate support] when entering the system – but we need to do more than this,’ said Lamb. ‘We need to address the underlying causes of mental health problems, and we need to stop the dreadful flow into the criminal justice system.’

Among the headline statistics, Black African Caribbean men were up to 6.6 times as likely to be admitted as inpatients or detained under the Mental Health Act as the average population. While attending a recent event organised by the charity Black Mental Health UK, Lamb – who has long campaigned for better treatment and understanding of people with mental illness – said ‘the degree of anger, frustration and disadvantage I came across shocked me to the core. I came away feeling something had to be done to address the anger from people in that situation.’

The aim of this latest event was ‘not to call for more research, but to look at what we can do together to turn the crisis tap off,’ said Gill Arukpe, chief executive of the Social Interest Group, created by Penrose and Equinox to support people with a range of needs, including mental ill health and alcohol/drug dependence. ‘Why do so many black people end up in mental health services or prison?’ she asked. ‘Why do so many end up in a crisis situation?’

Ending discrimination needed a change of approach, to look at how we can make a difference to individuals’ lives, said Antony Miller, Penrose’s director of operations. Early intervention was important; The Sainsbury’s Centre for Mental Health said counselling should always be available, but people were having to wait six to nine months for access to talking therapies.

‘What do we do to make people feel they can access services and engage?’ he asked. ‘Early intervention has to be better than dealing with problems when they are fully entrenched.’

We also needed to be much more responsive. ‘It’s not about saying to people, “this is your journey, this is your pathway”. It’s about listening.’

At workshop discussions on ‘the service user’s voice’, a delegate from Camden and Islington Mental Health Trust commented, ‘We need to start listening to the service users who are the experts – take from them what works and go back to them. They are the ones who are feeling it… Just because people have mental health issues or substance misuse issues doesn’t mean they don’t have hope too. We need to catch these issues before it becomes a crisis.’ A director from Norfolk and Suffolk Foundation Trust added: ‘It’s about unity… people can’t afford to be little monoliths, doing things on their own.’

‘We need to understand what’s in front of us – there are people who are not mad, not bad, but need support,’ said Commander Christine Jones, the National Police Chiefs’ Council lead for mental health, address­ing the conference on ‘the imperative for change’. 

With the prospect of less money in the system, our joint health needs analysis needed to be a lot more sophisticated, instead of applying a ‘sticking plaster approach’ to people in crisis.

We were missing vital opportunities to coach young people ‘at the point when they’re most malleable, most recoverable,’ she said. ‘Damage caused by entry into the criminal justice system at the age of 14 means they’ll be involved into their 30s. Things are easy to spot at an early stage and intervention points can change a life.’

Police had a ‘huge part’ to play in this, as they were often the first contact point, ‘and if they don’t know how to respond, it can escalate’. There were many reasons why people hadn’t come into services before crisis point, including stigma, fear and embarrassment.

Going forward, we needed to think about more efficient options, she said. ‘We need to make decisions at the right place and the right time, to deal with a problem that’s been misunderstood and under-resourced for too long.’

‘It’s about joint working and joint training,’ commented a head of social care at question time. ‘The criminal justice system doesn’t work with local authorities and health as well as it could. If police and health colleagues had more joint understanding, we could move the agenda forward.’

The afternoon sessions were dedicated to ‘solutions’ and Luciana Berger MP offered insights from her visits to mental health projects across the country.

‘It’s worth reflecting that we have made some progress in the last three years, particularly on stigma’ she said, mentioning the recent World Mental Health Day. ‘Mental health is not a sign of weakness – we all have mental health.’

However, the BME community was disproportionately represented in our mental health wards, and the fact that you’re more likely to be sectioned or end up in prison if you’re black was ‘one of the most glaring examples of inequality in our society’. There was a gap in data from both physical and mental health services that was needed to collate a national picture, she said, and government was shirking its responsibility to know ‘so much more’ about BME mental health, to properly develop services.

The financial implications of not helping people early on were showing in mental health costs to the NHS of £105bn every year. Furthermore, Berger’s FOI request to every clinical commissioning group in the country had showed disinvestment in mental health.

The ‘fragmentation of our system’ needed to change to ‘seamless integration of mental health and social care,’ she said, and this relied on everyone working together: ‘If we’re thinking about these mental health issues through the prism of the NHS, we’re thinking about them too late. Our local auth­orities should be supported in keeping services going.’

Dr Geraldine Strathdee of the Mental Health Intelligence Networks said that there was plenty of data and ‘fantastic analysts working across the system’, but a lack of representative leaders from the target population – the best way to find out about the needs of each area.

‘We need to use data much more effectively and intelligently,’ said Cllr Jacqui Dyer of the Mental Health Taskforce. Everyday discrimination was ‘a great source of stress’, but there was ‘nothing as powerful as true commitment and collaborative work… solutions are possible in every level of the system, but what it takes is collaborative effort.’

And this effort needed to be made at a much earlier stage, according to Maria Kane, chief executive of Barnet, Enfield and Haringey Mental Health

NHS Trust.

‘We need to do services cradle to grave, sperm to worm!’ she said. ‘Turning the crisis tap off is about introducing services much earlier – perinatal services. Those first 1,000 days are key to your mental wellbeing.’

Mental health relied on having ‘somewhere to live, someone to love, something to do,’ she said. ‘We need to line up our services and outcomes to make sure this is what we’re giving to people’.

There were ‘fantastic’ projects going on in many areas, but they depended on short-term funding and needed ‘mainstreaming’.

In the Q&A session at the end of the day, there were questions relating to many aspects of discussion, from recruitment of the right staff to better integration and communication. Asked about the poor experience of many people with substance issues within services, Leo Downey, Equinox director of operations, said referral to the right services could be difficult when mental health and substance misuse were so separate, and suggested that many mental health staff needed more training on substance misuse issues.

‘We need to make sure we don’t keep this con­versation to ourselves,’ commented one delegate – a point underlined by the panel’s chair, Antony Miller.

‘It’s about sharing the work now,’ he said. ‘We’ve heard of at least ten projects today that are making a change. We need to stop talking about this and start moving it forward.’ DDN

New alcohol medication Selincro has had a controversial route to market, as Mike Ashton explains.

In 2013 Danish pharmaceutical company Lundbeck was authorised by the European Medicines Agency (EMA) to market Selincro – their trade name for the opiate-blocking drug nalmefene – to reduce consumption among dependent (but not physically dependent) drinkers.

Authorisation paved the way for nalmefene to tackle the bulk of dependent drinking lying below the iceberg-tip of physically dependent drinkers aiming for abstinence – and opened up for its manufacturer a large and potentially lucrative market, provoking accusations of an expensive and inappropriate medicalisation of lesser degrees of dependence based on unproven effectiveness.

To grasp the essence of the controversy, first we have to understand the dubious world of the post hoc sub-sample analysis, the type of analysis on which authorisation was based.

Imagine you have carefully levelled the playing field in a study by randomly allocating patients to a medication or to an identical but inactive placebo. Then eliminating any further bias, you check how the patients do. It can be likened to randomly loading coins with medication or placebo, then tossing them in the air and leaving them to fall – a process over which you have no control once the coins leave your hand.

If the medication worked, you would expect to see, not an even split of heads (healthy outcome) and tails (not so good), but the medication-loaded coins tending to fall on the healthier side. That might happen, but not consistently enough to meet conventional criteria for a significant effect. However, now you have a great advantage: you can actually see how the coins have fallen. You can check the one-pences, the two-pences, the five-pences, the ten-pence coins, the 20-pences, the pounds and the two-pounds. Maybe in one of these subsets there is such an excess of heads that you can pronounce the medication effective, at least among (say) the ten-pence patients. Had you said in advance you would focus on the ten-pence patients, you would have risked another negative finding. But with the data in, now you can see what the outcome actually was.

The conventional criterion for a significant effect is that the difference between the outcomes of medication and placebo patients would have happened less than one in 20 times by chance – a result considered so unlikely that something more must have been involved. Everything else having been equalised, that ‘something’ could only have been the medication.

Now we can see that researchers have an almost sure-fire way to generate a statistically significant finding: slice up the sample in lots of ways until in one subset the magical ‘less than one in 20 by chance’ result emerges. Try more than 20 slices, and a significant finding becomes more likely than not, even if in reality the medication is ineffective.

It is not enough to back-engineer good reasons for after-the-event (or post hoc) sub-sampling, and to deny trawling the data until a ‘significant’ pattern of excess heads was found. The possibility that this could have happened has to be eliminated. Otherwise the analysis can merely suggest the medication might be found effective in another trial limited to these patients, or at least where sub-sampling was planned in advance. Without this, it remains of unproven efficacy.

Authorisation to market Selincro rested on just such an analysis, undertaken in response to unconvincing initial findings in Lundbeck’s trials. Most ways of assessing the primary drinking outcomes had left nalmefene with no significant advantage over a placebo. When it was assumed patients not followed up were drinking at their pre-trial levels, none of the comparisons with a placebo reached statistical significance.

Faced with these results, Lundbeck and their research associates conducted sub-sample analyses which excluded medium-risk drinkers, and those at higher risk who had rapidly remitted even before treatment started – drinkers who tended to stay remitted, leaving Selincro little to improve on. What remained was a higher risk sub-sample who remained at high risk when treatment started. Among these patients, nalmefene had greater scope to reduce drinking, and the results were more consistently positive – but in the process, scientific credibility had been sacrificed.

The EMA’s scientific advisers admitted it was ‘not ideal’, but shrugged off post hoc sub-sampling as common in psychiatric trials due to high dropout. But in this case, high dropout was not the rationale. Instead, sub-sampling had been ‘proposed’ by Lundbeck ‘in order to define a population where the benefit of Selincro would be greatest’. Not just the effect, but the intention it seems was to find a slicing strategy which favoured Selincro. Sub-sampling also helped exclude about half the randomised patients, leaving a small and probably atypical remainder to supply the critical data. Together with multiple reasons for excluding trial applicants, it meant the results could not be relied on as an indication of nalmefene’s likely impact among the generality of drinkers.

Once made, the EMA’s decision initiated a chain leading to its approval for the NHS in Britain. In self-justifying loops, during European authorisation Lundbeck conducted the sub-sampling analysis in order to maximise nalmefene’s apparent impact, which in turn justified authorisation for these kinds of drinkers. This justified a published analysis focused on these drinkers and led to cost-effectiveness analyses based on the sub-sample, leading the National Institute for Health and Care Excellence (NICE) to say the NHS must make the product available for these types of drinkers.

Each link in the chain retained the original analysis’s vulnerability to bias and its questionable applicability to patients in general. To this, NICE added acceptance of the company’s argument that it was neither appropriate nor possible to compare nalmefene with naltrexone, its cheaper parent drug. One strand in the argument (justified by the unreliable sub-sample analysis) was that nalmefene was licensed to reduce drinking, but naltrexone to promote abstinence. In fact, naltrexone usually promotes reduced drinking, and does so among the same types of drinkers.

The other argument which led NICE to discount naltrexone was the company’s assertion that required data was lacking from trials, and that these were so different from the nalmefene trials that comparison would have been invalid. Contradicting their own case, Lundbeck later sponsored and co-authored just such a comparison. Its findings were broadly but not always significantly in favour of nalmefene, but were undermined by the sub-sampling decision. In the three largest of the four nalmefene trials, this gifted the drug an advantage not replicated for naltrexone. The dice were stacked against naltrexone, but only a reader familiar with the source studies would have known.

Eliminating naltrexone from Selincro’s therapeutic ball-park or finding it less effective was vital to Lundbeck. Financially, the company had suffered from the expiring of patent protection, leaving its medications open to competition from cheaper, non-branded, ‘generic’ equivalents. Selincro was meant to help plug the resulting revenue gap, but this would not happen if it too faced competition from generic naltrexone. An indication of how crucial this kind of issue was, in 2013 Lundbeck had paid a 93.8m euro fine imposed by the European Commission after being found to have paid rivals manufacturing generic antidepressants to ‘stay out of its market and delay the entry of cheaper medicines’.

Beyond naltrexone – and beyond this abridged version of the story – is whether any medication is appropriate for the kinds of drinkers at whom nalmefene is targeted. Full story and supporting citations at http://findings.org.uk/PHP/dl.php?file=Palpacuer_C_1.txt&s=dd

Mike Ashton is editor of Drug and Alcohol Findings, http://findings.org.uk

Trends come and go and nowhere more so than in the shifting world of addiction management, says Dr Julia Lewis.

The pendulum seems to swing from one paradigm to another with the supporters of each frequently baying for the blood of their opponents. Some support abstinence as the only sensible goal, and berate the so-called ‘medical model’ with its alleged transfer of dependence to state-endorsed substances, while others shout loudly in support of what they claim is a more inclusive harm reduction approach. But what if there was a model that encompassed all these laudable ideas and then took things a stage further?

In 2007 the World Health Organization called the management of chronic disease (such as asthma, diabetes and hypertension) ‘one of the greatest challenges facing healthcare systems throughout the world’. Out of these concerns developed the chronic disease management (CDM) Model defined by the Disease Management Association of America as ‘a system of coordinated healthcare interventions and communications for populations with conditions in which patient self-care efforts are significant’.

Various researchers have argued that this model can be applied to the management of addiction, as evidence suggests that addiction has a similar profile to other chronic diseases. For instance, more than half of patients entering publicly funded addiction services in the USA achieve and sustain recovery after multiple episodes of treatment over several years, and addiction is associated with chronic physiological changes; a relapsing, remitting course; comorbidity; a need for ongoing care but with variable adherence to that care; and the absence of a ‘cure’.

Current models of addiction treatment provision in the UK frequently follow an acute care model, concentrating on the management of complications of use as opposed to the underlying condition, and lacking essential coordination of care across health and social care systems. However, managing addiction solely through these acute episodes of brief stabilisation and detoxification can contribute to the frustration of service users, their families and the public regarding prospects for permanent recovery.

Also, as a chronic disease with biological, genetic and physiological elements, addiction should be addressed via a case-managed combination of treatment modalities, personalised to the assessed needs of the service user, providing an integrated pharmacopsychosocial approach to treatment.

In contrast, the CDM model bases care on the service user’s needs, values and decisions, rather than reacting to problems. Nevertheless, transferring the CDM approach to the management of addiction requires a move into a recovery-oriented system and the recovery management (RM) model has been developed to combine these two treatment paradigms. So, what are the essential features of an RM model of addiction treatment?

The model is easy to access and geared to developing motivation. The care planning process focuses on the whole life of the service user, not just the problems caused by their use, and supports their right to manage their own condition. The clinician is seen as an educator, providing long-term support, and a comprehensive care plan brings together services best placed to address their needs. Interventions are evidence-based and include all relevant modalities, and the emphasis going forward is on self-management, with links to recovery resources in the community and easy access to re-intervention if needed.

It is possible that the RM model provides us with an integrated system of tried and tested addiction treatments but in a way that wraps the management plan around the service user, connects them effectively to other relevant parts of the health and social care system and draws on recovery resources in their community.

Accepting the chronic disease nature of addiction may be a difficult mindset shift for some, but to continue to attempt to address it via a model of acute, ‘one-size-fits-all’, circumscribed treatment not only does a disservice to our service users but also flies in the face of the evidence. It’s time to adopt the new paradigm.

Creating a shift in thinking from the traditional acute care models to the RM model is underpinned by the following concepts:

Addiction exists in transient and chronic forms. Transient forms may resolve spontaneously or with brief interventions alone. Chronic forms are associated with greater complications, more comorbidity and more obstacles to recovery.

Evidence shows us that, although recovery is an achievable goal, it takes around three to four treatment episodes over a period of eight years for this to occur.

If we see addiction as a chronic disease, we should not see previous treatment as a poor prognostic indicator, convey to service users the expectation of complete recovery after one treatment episode and punitively discharge service users who relapse.

Many people discharged from addiction treatment find themselves caught between recovery and relapse for weeks, months or even years, strongly supporting the need for ongoing post-treatment monitoring and support.

Multiple episodes of treatment, if integrated into a recovery management plan, can lead to cumulative effects and multidisciplinary interventions may have synergy.

Dr Julia Lewis is consultant addiction psychiatrist for Aneurin Bevan University Health Board. This article is based on her talk to the SMTPC event, The post-war dream, held in Newport, Gwent.

Kevin Stow, an ex-drug user and previous hepatitis C sufferer shares his experiences and talks about how being cleared of hepatitis C helped give him the momentum to overcome his drug addiction.

Kevin is an ambassador for the recently launched I’m Worth… campaign, which aims to address the stigma that many people with hepatitis C face, encouraging and empowering people living with hepatitis C to access care and services no matter how they were infected.

‘I contracted hepatitis C during a period of my life when I was frequently sharing pins and cooking spoons with other people. I was diagnosed during a visit to the doctor. He took a sample of my blood and later I found out I tested positive for hepatitis C.

‘All I really knew when I was diagnosed was that it was some kind of liver disease, but I didn’t know much more than that. At that time, I didn’t want to know more. I wasn’t interested in getting treatment.

‘I would often wake up in the morning and feel tired and lethargic. I was never sure whether those feelings were as a result of my drug withdrawal, or my hepatitis.

‘There were times when I felt there was no point trying to overcome hepatitis C. To me, my life was already over. I felt that I had no other choice, other than to keep using. It all felt too much for me to handle.

‘The turning point for me was when a team from the local hospital hepatology unit came into the drugs clinic and I started speaking to more people about my hepatitis C. When I was ready to consider treatment and drug recovery, the support I received was fantastic. My key workers played a very important role in helping me understand hepatitis C treatment options and some of the consequences of living with untreated hepatitis C. I believe this information and support is what saved my life.

‘After treatment, my hepatitis C was cured and I felt like I had one less burden in my life. Getting cured was an important step in my recovery journey. I felt beating hepatitis C gave me the motivation to face other challenges, including becoming drug free.

‘Being cured of hepatitis C completely changed my outlook. When I stopped using and was in drug recovery, I became a volunteer hepatitis peer mentor. Now I have a full-time job in Southampton drugs clinic. I’m very passionate about educating people about the importance of considering hepatitis C treatment. I know what a difference it has made in my life. I hope that if I can play a role in helping someone else know more, they can take the right steps to try and clear hepatitis C.

‘It doesn’t matter how you got hepatitis C, no one deserves to live with a potentially life threatening disease.’

Kevin Stow is an ambassador of the I’m Worth… campaign. You can view his story, alongside others at imworth.co.uk/ambassadors

Despite effective medicines that can cure the majority of people with hepatitis C now available on the NHS, most people diagnosed with hepatitis C in England remain untreated – one of the lowest treatment rates among northern European countries.^2,3

Choosing whether or not to start treatment is not always an easy decision. Drug support services can play a vital role in providing current and previous drug users with hepatitis C information and support, educating clients that hepatitis C is treatable and, in the majority of patients, can be cured, can help them make important decisions about their health.

For more information on the campaign and to access materials designed to support people living with hepatitis C please visit www.imworth.co.uk

1             PHE. Improving access to, and completion of, hepatitis C treatment. 2015

2             PHE. Hepatitis C in the UK. 2015/2014

3            Hawkes, N. Confronting the silent epidemic: a critical review of hepatitis C management in the UK. www.hepctrust.org.uk/Resources/HepC%20New/Hep%20C%20Resources/Reports/HALO _Media_Report_FINAL. pdf

(Last accessed August 2016)

The I’m Worth… campaign is a disease awareness programme, that has been developed and paid for by Gilead Sciences Ltd, a science-based pharmaceutical company. Content development has been supported by input from numerous patient groups with an interest in hepatitis C in the UK.

August 2016, HCV/UK/16-08/CI/2138