DDN November 2016

screen-shot-2016-11-07-at-10-56-20Welcome to our latest issue…

There is an absolute moral imperative on all of us to tackle the ‘outrageous discrimination’ against people with mental health problems, said Norman Lamb MP at a recent conference. I don’t think any of us would disagree with that – the question is, how? As our article shows, the problems are magnified for people from minority groups, and when you add the stigma of a drug or alcohol problem, it’s not surprising that people are not presenting for help. Dual diagnosis has been much talked about in recent years, but are we addressing it logically?

The conference itself was an extremely positive experience, with ideas flying around throughout the day. Participants pledged to network beyond the event, and there was plenty of support for integrating mental health, substance misuse and social care. But it also highlighted the need to reach beyond our sector – it was seen as crucial to engage people at a much earlier stage, which means joint planning with health services and education to catch them before they are at crisis point. Yet who has the time and money to think beyond a day job that’s full to capacity?

We have to talk about this, or it renders our good intentions meaningless. It requires a different way of working and a different level of investment that has to be underpinned by political support – and not just that of our free-speaking shadow ministers. If you have experience of working with dual diagnosis, please share it with us.

Virtual mag / PDF version


Legal cannabis tax could be worth £1bn

A ‘root and branch’ reform of UK cannabis policy is ‘long overdue’, says a new report from Volteface and free market think tank the Adam Smith Institute. A legal cannabis market in the UK could be worth £6.8bn a year and produce annual benefits to the government of up to around £1bn in tax revenue and reduced criminal justice costs, says The tide effect: how the world is changing its mind on cannabis legalisation.

Current policy is a ‘messy patchwork’ of legislation – with enforcement intermittent and dependent on each regional police force – and the government ‘must acknowledge’ that legalisation is the only workable solution, states the document.

The report, which has the backing of cross-party MPs including Caroline Lucas, Nick Clegg, Paul Flynn, Peter Lilley and Michael Fabricant, comes after more US states, including California, have voted to legalise the use, sale and consumption of recreational cannabis. A regulation model is ‘substantially more desirable’ than either decrimi­nalisation or unregulated legalisation as it is the only way to ensure that the product meets acceptable standards of quality and purity, as well as removing criminal gangs from the equation ‘as far as possible’, it says, raising revenue for the Treasury through point-of-sale taxation and protecting pub­lic health.

The document also echoes previous calls for the responsibility for cannabis policy to be moved to the Department of Health, with the Home Office’s role changing from ‘enforcement of prohibition to enforcement of regulation and licensing’. Jailing people for cannabis-related offences in England and Wales costs around £50m per year, the document adds.

‘The global movement towards legalisation, regulation and taxation of cannabis is now inexorable,’ said Volteface’s director, Steve Moore.

‘Today in the UK there is capricious policing of cannabis and no regulation of its sales and distribution. This quasi-decriminalisation of cannabis leaves criminals running a multi-billion dollar racket and exposes teenage kids to criminality. The evidence is now clear that regulated markets for cannabis cut crime and protect vulnerable children. The government’s current policy vacuum is untenable in the face of this evidence.’

Report available at www.adamsmith.orgimg_5519

Ground-breaking recovery research focuses on families

‘What does recovery from addiction look like for families?’ is the subject of a ground-breaking research project from Adfam and Sheffield Hallam University’s Helena Kennedy Centre for International Justice, funded by Alcohol Research UK.

The Family Life in Recovery project is the first of its kind in the UK and will be conducted through a series of workshops followed by a detailed survey to map the recovery journey of family members of those suffering from addiction.

The survey will ask: ‘What is the recovery journey for the family member (and the remainder of the family)?’ and ‘What is the family member’s experience of an addict’s recovery journey and its impact on them?’ Results of the survey are expected to be published next summer.

The work follows on from Sheffield Hallam University’s first national UK survey of addiction recovery addiction experiences in 2015, which showed clear improvements in wellbeing in the transition from addiction to recovery. These related to health, employment, offending, risk and substance use, families and social relationships.

‘The Family Life in Recovery survey provides us with a rare chance to build an understanding of what the experience of living with and through addiction recovery is like and what impact it has on a range of family members,’ said project lead David Best, head of criminology at Sheffield Hallam University.

‘This research will help understand the needs that this population has and what can be done to support them in living with addiction and in supporting people to overcome the many challenges of an addicted lifestyle. We have previously shed light on personal addiction stories and now it is the turn of the families.’

‘We know that the journey of recovery has a large impact on the lives of family members,’ added Vivienne Evans OBE, chief executive of Adfam, the charity working with families affected by substance misuse for more than 30 years.

‘We are looking forward to the findings from this research to see how we can better support and advocate on behalf of families dealing with issues surrounding addiction and recovery.’

Service users search for the ‘wow factor’

Service users in London have been discovering their ‘wow factor’ – ways of wellbeing – at a conference coproduced with Central and NorthWest London NHS Foundation Trust (CNWL) and the charity Build on Belief (BoB).

This year’s Engage Conference focused on the simple steps anyone can take each day to improve their quality of life and included a look at dual diagnosis and common physical health problems. The Outside Edge theatre group inspired the audience with their drama, and entertainers were accompanied by a troupe of BoB musicians.

The day also featured awards to service users, recognising their efforts to overcome substance misuse problems and give back to their services and community.

‘Hearing people speaking about their recovery journey to a big audience takes courage and I was humbled and thankful to these people for sharing their personal journeys,’ said Lorna Payne, CNWL divisional director, who presented the awards.cnwl-pic

Industrial strength: Where next for alcohol policy?

screen-shot-2016-11-04-at-16-09-07The 2012 alcohol strategy (DDN, April 2012, page 4) had set the policy direction that local areas were still following, head of public services and welfare for cross-party think tank Demos, Ian Wybron, told last month’s What now for alcohol policy? event. The significant exception, of course, was minimum unit pricing, the strategy’s commitment to which was later shelved (DDN, August 2013, page 4). ‘Binge drinking across the UK is in decline and has been for ten years, particularly among 16 to 24-year-olds,’ he told delegates. However, alcohol-related hospital admissions were increasing, and alcohol-related violent crime remained a major issue.

The strategy had contained a great deal on local area partnerships, he said, but the government appeared to have gone ‘very quiet’ on the controversial public health responsibility deal – a ‘very interesting engagement’ between itself, the industry and the voluntary sector. Other elements of a changing policy landscape included the newly revised chief medical officer guidelines (DDN, February, page 4) and the potential implications of Brexit – ‘it feels like there’s an awful lot of uncertainty around alcohol policy there,’ he said. According to Demos’s own research, there were a number of factors that could explain declining rates of binge drinking among young people, he told the event. ‘There seem to have been successes in terms of the health messaging around alcohol, with lots of young people taking those messages on board and moderating their consumption. There’s also a big role for social media, and the sheer amount of time that young people spend on it when perhaps they might otherwise be out drinking. Working with the statistics is always difficult, but one thing they do indicate is that while fewer people are drinking, the ones who are, are drinking more. So what’s needed is a much more targeted approach.’

The think tank’s interviewing had found that young people still did not use units to calculate or moderate their drinking, however. ‘They don’t really understand them, so we do need a new language in terms of consumption – one that makes sense to young people – as well as more emphasis on developing preventative programmes in schools.’ While there had been ‘a lot of effort’ around unit awareness, clearly more was needed, acknowledged the British Beer and Pub Association’s director of public affairs, David Wilson.

The binge drinking figures, however, showed that some policy measures were working, he said. ‘So we need to learn what works and do more of it. The more we can do together – as policy makers and industry – the more effective we can become, rather than having all our debates pitched as stand-offs between the two.’ The industry would continue to develop, and promote, greater choice in areas such as lower-strength products, he said, but this had to be combined with more government help in terms of things like tax policy and advertising rules.

‘We believe that policy – fiscal and otherwise – should encourage and promote low-strength products,’ he said, while one possible opportunity in terms of Brexit was the chance it offered to review beer, wine and cider duties, which are calculated according to alcohol by volume (ABV). In terms of the retailer role in helping to reduce harm, alcohol remained an ‘incredibly important’ category for shopkeepers, said public affairs executive at the Association of Convenience Stores, Julie Byers. ‘Our members have a huge responsibility when it comes to things like ensuring there are no under-age sales.’

Around 70 per cent of convenience store retailers had an age-verification scheme like ‘Challenge 25’ in place, with more than a quarter refusing under-age sales around ten times a week – something that was not always easy for staff working alone in the shop and facing aggression. Her organisation also distributed information to raise awareness of things like proxy purchases – when children persuade older siblings, friends or even parents to buy alcohol on their behalf – and many local authorities and community alcohol partnerships now had campaigns explaining to parents that proxy purchasing was illegal.

‘When people think of the drinks industry they tend to think of huge multinationals, but 90 per cent of it is small and medium sized enterprises – something that’s hugely import­ant to bear in mind when looking at policy,’ chief executive officer of the Association of Licensed Multiple Retailers, Kate Nicholls, told the event. ‘The night-time economy is worth £66bn – it’s big business for UK PLC.’ Her organisation’s members had a vested interest in tackling alcohol-related harm, she told delegates – ‘it’s not good for business if we don’t have a safe night-time economy’ – and partnership was key. Two thirds of alcohol was now sold and consumed away from the on-trade, she said, which meant that ‘top-down policy approaches’ targeting clubs, pubs and bars were not going to achieve the desired results.

‘You can obtain the same end objectives working in partnership,’ she said. Initiatives like promoting lower-strength products and smaller measures would always be more effective than bureaucracy or ‘finger-wagging and lecturing’. ‘We do need to recognise success as well,’ she said, ‘which means we need a clear benchmark of where we start from to work together’. Her members were frustrated, however, that ‘the goalposts seem to keep moving,’ she stated. ‘You need to give the trade the credit where it’s deserved, and you also need to make sure there’s joined-up thinking across government. In our own dealings with government we’ll say “people are drinking less” and they’ll say “ah yes, but now they’re drinking all those nasty soft drinks that are full of sugar instead”.’

‘It’s worth saying that, in any social policy area, to have these sorts of trends in things like reductions in binge drinking is very significant,’ said Portman Group chief executive Henry Ashworth. ‘But we really need to make the effort together to tackle things like the rise in alcohol-related hospital admissions.’ One of the main tasks was to see how local challenges related to the bigger picture, he said – for example binge drinking rates in Newcastle or alcohol-related hospital admissions in Blackpool, both of which were way above national averages. The ‘negative’ attitudes towards the alcohol responsibility deal had also not been helpful, he argued. ‘The drinks industry committed to, and delivered, 80 per cent of alcohol products on the shelves carrying unit and health information and pregnancy warnings – voluntarily.’ Things were now ‘in a different place’ when it came to labelling, however, as, ‘having achieved that 80 per cent figure, the CMO’s guidelines have changed’. There was a ‘plethora of fantastic’ local alcohol partnerships and schemes that were addressing the challenges in a coordinated way, he said. ‘We need to continue to robustly evaluate these partnerships to understand what’s working well. That way we can build more trust between the public and private sectors, the industry and the public health community, and identify and overcome the barriers to effective partnership working.’

When it came to a policy area that was nearly as controversial as the responsibility deal – advertising regulation – the last three years had seen a ‘sharp decline’ in the number of complaints about alcohol adverts, said regulatory policy manager at the Advertising Standards Authority (ASA), Malcolm Phillips. There had also been a smaller decline in the number of alcohol cases his organisation – which enforces the UK’s advertising codes – had decided to formally investigate, he explained. However, the authority knew it could not ‘rely on complaints alone to tell us what we need to know’, and was committed to maintaining a proactive approach towards the issue. ‘A claim often made by critics of advertising self-regulation is that the codes have no teeth, and there’s no incentives for companies to not bend the rules,’ said Diageo GB’s head of alcohol in society, Mark Baird. ‘This is not true. ‘If you spend hundreds of thousands of pounds making an advert and buying advertising slots only to find out you can’t use it – that has an impact, believe me.’

Advertising self-regulation served to complement national laws, he said, and ‘always went beyond’ the legal requirements. ‘Alcohol advertising comes under regular government scrutiny, but it’s very difficult to isolate a single factor – advertising – from all the other factors that influence alcohol con­sumption,’ he argued. Denmark, for example, had liberalised advertising regulations and seen consumption decline, he said, while the introduction of the Loi Évin – designed to restrict children’s exposure to alcohol marketing – in France in the early ’90s had had limited impact on consumption levels. ‘It’s very, very tight regulation, but under-age drinking is actually on the increase in France, at the same time as it’s declining here.’

In a ‘mature market’, advertising did not increase overall demand, he maintained. ‘So that brings us to the question people always come back with – “If you say alcohol advertis­ing doesn’t work, why do companies spend so much money on it?” Well, of course it works, it just doesn’t work in the way critics and commentators say it does – does Andrex think it can grow the market for toilet paper? The purpose of advertising is to raise aware­ness of your product, and to steal market share from your competitors. We want people to buy our product, rather than someone else’s.’

A round-up of national news: November 2016

Afghan opium production has soared by 43 per cent compared to 2015 levels, according to UNODC’s latest Afghanistan opium survey. The increase – to 4,800 metric tons – was ‘worrying’, said UNODC executive director Yury Fedotov. While the area under opium cultivation has also risen by 10 per cent, the most important driver in the increased production is higher yield per hectare, the document explains. The country’s western and southern regions – which together account for 84 per cent of total poppy cultivation – have recorded increases in yield per hectare of 37 and 36 per cent respectively.
Document at www.unodc.org

Prisons are failing to rehabilitate offenders and should be radically restructured, according to the final report of the RSA’s ‘Future prison’ project (DDN, September, page 10, and June, page 7). Inconsistent political leadership has created a system that ‘puts public safety at risk’ says A matter of conviction: a blueprint for community-based prisons. Among a range of recommendations in the document is that a new ‘rehabilitation duty’ be legislated requiring prisons and probation services to track individual and institutional progress towards rehabilitation. Report at www.thersa.org

Getting people back into work is a key way to tackle health inequalities in the North East, according to a report from NECA (North East Combined Authority). Last year the region recorded the highest number of drug-related deaths in the country for the third year running (DDN, October, page 4) and it also experiences high rates of alcohol-related harm. The document calls for a ‘radical shift’ to close the health and wealth gaps with the rest of the country, including better joint working, shifting the spending focus towards prevention and developing training for primary care staff on helping people with mental health conditions back into the workplace. ‘The entire system needs to shift its priority towards preventing poor health,’ said PHE chief executive Duncan Selbie.
Health and wealth: closing the gap in the North East at www.northeastca.gov.uk

Enforcing America’s drug laws has caused ‘devastating’ and ‘unjustifiable’ harm to individuals and communities, says a report by Human Rights Watch and the American Civil Liberties Union. The document is calling for personal use and possession to be decriminalised for all drugs, as well as increased funding to improve and expand harm reduction services.
Every 25 seconds: the human toll of criminalizing drug use in the US at www.hrw.org

The impact of the government’s flagship ‘troubled families’ programme has been negligible, according to an evaluation report from the Department for Communities and Local Government. Although the programme ‘clearly raised the profile of family intervention country-wide’ and transformed service development in some areas, these achievements did not ‘translate into the range and size of impacts’ that might have been anticipated based on the programme’s original aspirations, it says. In terms of outcome measures like use of drugs and alcohol in the previous three months, there was ‘no statistically significant evidence of any impacts of the programme’.
National evaluation of the troubled families programme: final synthesis report at www.gov.uk

Products containing the active cannabinoid cannabidiol (CBD) for medical purposes ‘meet the definition of a medicinal product’, according to a review by the government’s Medicines and Healthcare products Regulatory Agency (MHRA), but anyone selling CBD products will now need to apply for a licence. Co-author of the recent All-Party Parliamentary report on medical cannabis, Professor Mike Barnes, called the decision ‘confused’. ‘If the MHRA and the UK government now consider that cannabis-derived CBD is a medicine, this is incompatible with the continuing schedule 1 status of cannabis under the Misuse of Drugs Act that clearly states that cannabis has no medicinal value,’ he said.
MHRA statement on products containing cannabidiol at www.gov.uk

A coalition of emergency services organisations, road safety charities and health bodies is calling for the drink driving limit in England and Wales to be reduced in order to save lives. Around 240 people die each year as a result drink driving, a figure that has remained unchanged since the start of the decade, while the 80mg alcohol per 100ml blood limit has been in place since 1965 and is higher than almost anywhere else in Europe. ‘With hundreds of lives lost each year, we can’t afford to let England and Wales fall behind our neighbours in road safety standards,’ said director of the Institute of Alcohol Studies (IAS), Katherine Brown. ‘It’s time the government looked at the evidence and what other countries are doing to save lives and make roads safer.’
IAS drink drive video at www.ias.org.uk

family-focusFAMILY FOCUS
A joint research project into what recovery means for the families of those with substance problems has been launched by Adfam and Sheffield Hallam University. The ‘Family life recovery project’ aims to map the recovery journey of family members through an in-depth survey and a series of workshops, with the results published next summer. The work would give ‘a voice to a group who are poorly understood and rarely listened to – those who bear much of the burden of addiction and who themselves are affected by the experience’, said project lead, Professor David Best. www.adfam.org.uk


westminster-worriesAlmost a quarter of the homeless people staying in hostels in the central London borough of Westminster are using synthetic cannabinoids like ‘spice’, the local authority has said – a figure that would ‘have been closer to zero just two years ago’. The drugs pose a risk to both rough sleepers and frontline staff, said cabinet member for public protection, Nickie Aiken, and the council is calling for the police to be given increased powers to confiscate them.

Leeds launches ‘Like My Limit’ alcohol campaign

Forward Leeds is among local services launching initiatives for Alcohol Awareness Week, 14-20 November. Their Like My Limit campaign aims to reach 17,000 dependent drinkers in the city and tackle more than £26m a year lost to the local economy through hangovers.

Through arranging for its workers to appear at various locations, and an accompanying social media campaign, the service will ask people to keep an eye on how much they are drinking.

‘The amount of alcohol a person drinks can have a significant impact on their health and happiness,’ said Dr Ian Cameron, Leeds City Council director of public health. ‘Our Like My Limit campaign encourages people to keep an eye on their intake and consider making one small change so that they can still enjoy drinking in moderation but feel happier knowing they are not risking their health.’

‘We’re trying to hit people who may not access formal treatment and just help them to become aware of the risks, give them some skills and show them what they can do to prevent drinking too much,’ added Jane Doyle of Forward Leeds. ‘We want to make sure people have an informed choice.’

The campaign was originally launched in 2014 to tackle the rise in the number of adults regularly drinking alcohol at home and putting their longer term health at risk. Top tips include having two alcohol-free days a week, using smaller wine glasses and switching to low alcohol drinks.

To see the Forward Leeds list of events for Alcohol Awareness Week, visit: http://www.forwardleeds.co.uk/2016/11/11/health-issues-highlighted-alcohol-awareness-campaign/lml-guidlines1

Mental health is in crisis – time to act

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.screen-shot-2016-11-04-at-16-19-04

‘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?’

screen-shot-2016-11-04-at-16-18-54 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’. screen-shot-2016-11-04-at-16-19-40

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.

screen-shot-2016-11-04-at-16-19-20The ‘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 is steeped in controversy

mike-ashton-20161031_123530_resizedNew 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

Legal eye: ‘Can we challenge negative online reviews?’

screen-shot-2016-11-04-at-15-50-18Joanna Sharr of Ridouts answers your legal questions.

Our residential rehab has a good reputation but is the target of a negative online campaign by a disgruntled resident. How can we challenge this?

The advent of social media and the ability of individuals to make online reviews has placed significant power into the hands of those who may wish to damage a service’s reputation. Even if your contract with the service user has regard to the use of social media while resident, engaging contractual provisions does not remedy the underlying issue.

This is a sensitive issue and should be handled with care; if dealt with in a heavy-handed manner, not only could the service be perceived to be unreasonable, but the online campaign could easily escalate to cause further damage to the service’s reputation.

For whatever reason, the resident did not seek to raise their concerns with the service directly but went to social media to vent their concerns. Perhaps the resident did not feel that their issues would be taken seriously, but they should be reassured by the service that they are. We would therefore treat the online campaign as a complaint.

A service’s formal complaint procedure should involve particularising the concerns and recording them, exploring the issues and possible resolutions and ultimately responding to the complaint. It may be helpful to include the resident’s family (or advocate if there is any capacity issue) in any discussions to ensure that the resident feels supported throughout the process. The service should discuss the outcome of the matter with the resident and ensure that the situation is resolved to the resident’s satisfaction. This will also help evidence CQC’s key questions, ‘well-led’ and ‘responsive’ in any future CQC inspections.

The resident should be encouraged to raise any future concerns or complaints with the service directly. The service could request the resident removes their negative comments from social media and ask that the resident desists from using social media to vent any future concerns about the service, particularly if the matter had been resolved to their satisfaction.

There will always be cases where, no matter what a service does, a resident will simply be unhappy and will seek to maintain their damaging course of action online. If that happens, and all conciliatory routes are exhausted, the service may wish to consider its contractual options to serve notice to the resident. This course of action will not necessarily quell the negative social media campaign and may lead to an increase in posts. We would advise taking specific legal advice regarding contractual remedies and the implications and subsequent actions that could be required if the matter cannot be resolved amicably.

Joanna Sharr is a solicitor at Ridouts LLP, a practice of health and social care lawyers, www.ridout-law.com