US biopharma company Intra-Cellular Therapies, Inc. (ITI) has appointed former NICE Chairman Professor Sir Michael Rawlins to its Board of Directors.

Rawlins’ experience in the field of drug assessment, from both clinical and economic perspectives, will be of value to ITI’s ambitious programme of drug development to treat psychiatric and neurological disorders.

As Chairman of NICE from its inception in 1999 to March 2013, Rawlins had a complex relationship with the pharmaceutical industry, which respected his expertise but sometimes challenged his priorities.

With a background in medical practice and clinical pharmacology, Rawlins recently became President of the Royal Society of Medicine, and has received numerous medical awards.

Sharon Mates, CEO of ICT, said: “We are excited to have Sir Michael Rawlins join our board. His expertise in the cost-effectiveness of new pharmaceuticals and other issues in health economics will be invaluable to Intra-Cellular Therapies.

“I look forward to working closely with Michael as we transition our clinical programs through late-stage development and commercial approval.”

Rawlins commented: “ITI has set itself on a course to develop outstanding new pharmaceuticals to treat CNS diseases, surely an ambitious task, but one in which I am pleased to join and help.”

Based in New York, ITI aims to develop drugs for the treatment of dementia and major psychiatric disorders. Its novel antipsychotic ITI-007 is currently undergoing phase II clinical trials as a treatment for schizophrenia.

London-based pharma company Dainippon Sumitomo Pharma Europe (DSP Europe) has changed its name to Sunovion Europe.

The new name reflects the development of DSP’s European subsidiary into a more active commercial organisation, shortly to launch a new schizophrenia drug.

Sunovion Europe will focus on products to treat mental health and neurological disorders – including the atypical antipsychotic lurasidone hydrochloride, which it plans to launch in Europe shortly.

The company will also develop and market specialised drugs for disease areas where there is unmet medical need.

Lurasidone hydrochloride, a generic drug, has been submitted to the European Medicines Agency (EMA) for treatment of schizophrenia by DSP’s European partner, Takeda.

Dr Mike Taylor, Managing Director of Sunovion Europe, said: “This represents a significant landmark in the evolution of our European business as we prepare to commercialise our first drug in the UK.

“At Sunovion Europe we focus on the development and introduction of innovative medicines that improve people’s health and well-being. We will continue to focus on psychiatry and neurology, and over time will grow the European business to include other areas.”

Dainippon Sumitomo Pharma (DSP) is a multi-billion dollar company based in Japan. It was formed by the merger in 2005 of Dainippon Pharmaceutical Co. and Sumitomo Pharmaceuticals Co.

With a growing product portfolio and pipeline, DSP aims to become a major supplier of innovative treatments in psychiatry, neurology and oncology.

NHS Dudley CCG has spent £60,000 on an online service to help adults with common mental health and wellbeing issues.

Commissioners have agreed a one-year deal with the Big White Wall, an interactive online counselling service for those in emotional or psychological distress to get support and self-manage their condition.

Dr Mona Mahfouz, NHS Dudley CCG, said the agreement made “good sense, particularly in today’s socially networked generation.”

The web-based facility provides users with a safe and anonymous service where people can access peer support, wellbeing tests and additional online resources to aid self-care and creative art and writing therapies. Counsellors are also available at all times to provide any additional support.

The Big White Wall initially launched in 2008. After its pilot year it had attracted more than 3,000 users that backed its value in improving mental wellbeing. It has since partnered with the Department of Health, the Ministry of Defence and the charity Help for Heroes to provide support to troops returning from conflict.

“When mental and psychological distress arise, getting the right sort of help and getting it early is key to recovery,” said Dr Mahfouz. “Having access to The Big White Wall is yet another tool that will provide help to those in need of it.”

The service, which is available free of charge 24/7, can be accessed by registered patients within the Dudley borough by visiting www.bigwhitewall.com.

To read more local NHS stories visit www.pfdiscovery.com.

Staff at Surrey-based company Vifor Pharma UK (VPUK) have given a day of their time to assist three charities in meeting the needs of the local community.

One VPUK volunteer team helped the Oakleaf charity, which provides training for people with mental health problems, to renovate its premises.

Another team assisted the renovation of the Lighthouse Project in Woking, a community facility for underprivileged people.

A third team organised carol singing and other activities with elderly residents living with dementia at Heathside residential home in Woking.

Derek Williams, General Manager of VPUK, said: “We remain committed to our social and environmental responsibility, despite a busy couple of years in which we have grown as a company.

“This charity day allowed us to give back to the community and all three of the charity projects were genuinely touched by team Vifor Pharma’s enthusiastic support and we will be aiming to organise another such volunteering day next year.”

Based in Switzerland, Vifor Pharma specialises in discovering, developing, manufacturing and marketing drugs to treat iron deficiency, including both prescription and OTC medicines.

The new NHS Mandate, presented to Parliament by Health Secretary Jeremy Hunt, has replaced the draft version’s outcome targets with requirements for “measurable progress”.

The final Mandate, which establishes the strategic objectives for the NHS Commissioning Board (NHS CB), maintains the broad goals of the draft version but is lighter on specific commitments.

Positive responses from the NHS CB and the BMA suggest that criticisms of the draft version as being over-prescriptive have been addressed.

Significant changes include the loss of definite overarching commitments to reduce premature death and increase quality of life for the chronically ill.

More generally, where quantitative outcome targets were set with the numbers pending consultation, there is now only a requirement to improve.

The Mandate states that improvements should be measurable by March 2015, the end of the Board’s first term of office.

As before, it notes the duty of the Board and the DH to promote “the autonomy of local clinical commissioners”, and identifies this is the means by which outcomes will be improved.

Key priorities for improvement include: standards of treatment for older patients; diagnosis, treatment and care of people with dementia; support for people with multiple physical and mental long-term conditions; and preventing premature deaths from major diseases.

The section on premature deaths notes the importance of “tackling risk factors such as high blood pressure and cholesterol”, as well as ensuring that patients have access to NICE-approved drugs.

The section on long-term conditions places emphasis on integration of care and on patient choice. Personalised care plans and personal health budgets are promised, as well as online access for patients to their care records and the means to book appointments and repeat prescriptions.

Dementia is highlighted as a priority, with progress towards “timely diagnosis and the best available treatment” set as an objective. A further aim is “to put mental health on a par with physical health” and address poor access to healthcare among the mentally ill.

A section on innovation repeats the previous commitment to introducing the controversial “quality premium” for GPs, as well as establishing a “fair playing field” for competing providers from all sectors.

The Mandate stresses the need for “redesigning services, open procurement and contracting for outcomes” – which reaffirms the Government’s commitment to the NHS innovation agenda as well as the role of the private sector.

Sir David Nicholson, Chief Executive of the NHS CB, commented: “The Mandate avoids the danger of excessively prescribing the actions of health professionals. Our role will be to work closely with local clinical leaders and provide the support they need. Our role is not to tell them what to do.”

Dr Mark Porter, Chair of BMA Council, praised the “welcome reduction in targets, objectives and micromanaging” from the draft Mandate, but noted: “If the NHSCB’s strategic vision is to be delivered, ministers must ensure there is genuine clinical involvement and adequate resourcing.”

Commenting on the Government’s innovation agenda, ABPI Chief Executive Stephen Whitehead said: “The NHS Mandate must work hand-in-hand with Innovation, Health and Wealth to help break down barriers to innovation in the NHS and to ensure that new medicines reach patients.”

The train ride towards a new commissioning landscape will reach its final destination next April, but is already encountering leaves on the track along the way.

It’s been another eventful few weeks as the commissioning structure continues to take shape. On Monday 1 October, the NHS Commissioning Board (NHS CB) was finally formally established as an independent body with executive powers and exceptional responsibilities. But it will have to wait until April 2013 to take on its full range of responsibilities.

Professor Malcolm Grant, NHS Commissioning Board Chair, said the formal establishment was a “new phase
in the history of the NHS”. Sir David Nicholson, Chief Executive of the Board, called the new responsibilities the Board now holds a “once in a lifetime opportunity to do things differently”.

The transition completes a hectic twelve months for the Board. Having only been established at the end of October last year, it has played a fundamental role in the Government’s vision to modernise the health service as outlined in the Health and Social Care Act. Arguably its main and most important task, before it takes on full statutory responsibilities next April, has been to assist in the development and authorisation of more than 200 evolving clinical commissioning groups.

As you would expect, this has not been an easy process. Alongside the introduction of clinical commissioning, it has also been given the responsibility for authorising Commissioning Support Units
(CSUs), who will assist clinicians in the procurement of certain services. While this may seem a routine task compared with the authorisation of a raft of CCGs, the Board has been criticised for the time it has taken them to appoint managing directors for the CSUs when clinicians are finally in a position to tender services.

The Board has also issued its response to the Government on the draft mandate for its NHS care objectives. Professor Malcolm Grant agrees the mandate is “fundamental” to the Government’s vision of a ‘liberated NHS’. However, he urged David Cameron and Health Secretary Jeremy Hunt to be “ambitious” in searching for new opportunities to focus on the “outcomes that matter to patients and the public.”

Professor Grant said that the “critical tests” of the mandate will be whether newly empowered CCG leaders can address and analyse the mandate and then say ‘‘Yes, this gives me the necessary freedom to address the needs of my local population.” Grant added that the mandate “provides a unique opportunity to make this happen.”

The Commissioning Board has also been informed by the Department of Health of an initial set of specialist
services it will be expected to commission nationally. Although the central powers for commissioning have now been transferred locally, the NHS CB will still retain responsibility for certain services which are defined as treating rare and uncommon conditions and illnesses. The 38 specialist services, which were selected by the Clinical Advisory Group for Prescribed Services, include:

• Specialised Cancer Services (adults)
• Haemophilia and related bleeding disorders (all ages)
• Cystic Fibrosis services (all ages)
• HIV/AIDS treatment and care services (adults)
• Specialised Mental Health Services (all ages)
• Morbid Obesity Services (all ages).

A final set of regulations will be established later in the year on which services will be commissioned nationally – following a consultation between the DH and the NHS CB on the initial recommendations.

Board under fire
But it hasn’t all been clear sailing for the NHS CB. Alongside being accused of delaying the authorisation of certain CCGs because of its stuttering CSU MD recruitment drive, the Board has admitted that it has failed to recruit a significant number of individuals from ethnic minority backgrounds. Jo-Anne Wass, HR Director, admitted the Board’s recruitment data did “not make easy reading”.

Questions have also been raised about the huge variation between clinical commissioning groups’ internal staff levels when compared to support service organisations. Critics have argued that CCGs will be forced to rely heavily on support units after analysis showed huge variations in staffing levels. Recent estimates from the DH show there are 4,200–6,300 staff employed by CCGs. Commissioning support units are expected to employ around 8,000 people.

Dame Barbara Hakin, National Director for Commissioning Development, has also been put under the spotlight by the General Medical Council. The GMC has commenced an investigation after a complaint against the commissioning director, who allegedly placed United Lincolnshire Hospital Trust under unnecessary pressure in 2009 when she was Chief Executive of the now disbanded East Midlands Strategic Health Authority. It’s claimed that waiting times and A&E targets were prioritised ahead of patient safety, despite warnings the trust was over capacity. Depending on the outcome of the investigation, the GMC may decide to take no action, issue a warning, refer Dame Barbara to a fitness to practise panel where she may be ‘struck off’, or decide on undertakings to allow her to keep her registration.

Commissioning Groups
Yet despite the disparity in numbers, evolving CCGs appear to be in good shape. Following the successful scheduling of all of the wave one applications, the NHS CB confirmed that all 67 CCGs in the second authorisation wave had submitted their applications on time. In fact, every proposed CCG is now involved in an aspect of authorisation with the Board – be it a 360° stakeholder survey, a desk-top review, a case study or a site visit.

However, the authorisation process has been delayed. Initially the Board moved the ‘waves’ back by a month each. It subsequently moved the waves back by an additional month, meaning all CCGs will now be authorised by March 2013.

CCGs have also learnt when their final commissioning budgets will be confirmed. Commissioning Groups will have to wait until December to find out how much money they have been allocated to organise local services to meet the needs of their residents. The budgets will be decided using a system called the Fair Shares formula, which analyses the unique circumstances practices face and the health and wellbeing
of local populations.

Commissioners have aired frustration about the amount of ‘red tape’ they face when trying to organise new local health services. NHS Clinical Commissioners, who represent CCGs across the country, say bureaucracy is hindering doctors in their attempts to redesign new services. Dr Charles Alessi, Chair of the National Association of Primary Care, said there was an “overwhelming number of rules and regulations” which were having a significant impact on commissioners.

Supporting units
But it seems the frustration many commissioners have aired at the slow rate at which CSUs are being established may soon be coming to an end. David Stout has left the NHS Confederation to lead CSUs in Essex and Hertfordshire; Tim Andrews has also been given joint responsibilities at Cheshire, Warrington and Wirral CSU and at Merseyside CSU; Derek Kitchen will lead Staffordshire CSU and Lancashire CSU. Dr Leigh Griffin has also been appointed as the MD of Greater Manchester CSU – meaning only two of the 23 CSUs are still awaiting a permanent managing director.

While the NHS Commissioning Board is readily completing the authorisation process for CSUs it has recently been distanced from employing their support staff. The NHS Business Services Authority has agreed to employ some 8,000 staff during the hosting period up to 2016. The move means that although the NHS
CB will provide oversight and direction to CSUs it will not be the legal employer of CSU employees to avoid conflicts of interest. The new distancing arrangements were welcomed by the Board, who said it would help CSUs “develop appropriately as organisations in their own right.”

After confirming four lead CSUs to provide communications and engagement services around the country last month, the Commissioning Board will now focus on assisting support units to provide services and help to CCGs through the authorisation process, to ensure they are as individually autonomous as possible, to
help CSUs develop to become specialist suppliers and to ensure units seize opportunities open to them.

As the NHS reforms continue to evolve it would seem the commissioning landscape is far from being complete. It’s going to be a busy few months.

Incivo, Victrelis and Mepact win recognition at the 2012 UK Prix Galien Awards.

Two new medicines for the treatment of Hepatitis C have won the 2012 UK Prix Galien Innovative Product
Award. Incivo (Janssen) and Victrelis (MSD) fought of stiff competition to win the prestigious prize at London’s House of Commons. The chairman of the judging panel, Professor Sir Michael Rawlins, said the treatments provided a perfect example of how the pharmaceutical industry can “demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world.”

The ceremony also saw Takeda become only the third winners of a Prix Galien Award for orphan drug development. Mepact – for the treatment of osteosarcoma, a rare malignant bone tumour – won the Orphan Drug Award.

UK Prix Galien 2012
The UK Prix Galien, organised and managed by the specialist market access consultancy WG Consulting – which owns the UK franchise – is held every two years. The 2012 awards were hosted by former shadow Minister for Health Kevin Barron MP, who was the event’s Parliamentary Sponsor. Barron, who is currently co-Chair of the Associate Parliamentary Health Group, said: “It’s a privilege to be able to witness, at first hand, just a glimpse of the deep volumes of medical innovations being developed here in the UK. As an MP, I’ve had a long-standing professional acquaintance with UK pharma. I know and recognise the many
benefits UK medicines have brought – and continue to bring – to patients all over the world. The sector’s continued commitment to the development of medicines to tackle disease, improve health outcomes and extend life is both remarkable and humbling.”

Barron said there was political consensus that driving improvements in health outcomes across all major diseases is a key priority for the NHS – and this focus had been reflected in the 2012 finalists. “It’s interesting to note that the shortlisted entrants for the 2012 UK Prix Galien show that pharmaceutical innovation is aligned with many of the priority needs identified in the NHS Outcomes Framework. Finalists include innovations for the treatment of diseases in cardiovascular, hepatology, mental health, neurology, gastroenterology and oncology. In addition, Prix Galien’s recognition of the industry’s attempts to treat rare, orphan diseases, once again underlines the very human value of R&D.”

Value-based message
The architect of the NHS Outcomes Framework, former Health Secretary Andrew Lansley, also addressed the audience. Attending his fourth consecutive UK Prix Galien, Lansley said: “Every time I come to this event I hear about fascinating innovations that I know are going to be at the heart of the health service for years to come. I’ve met – and continue to meet – patients that have benefited directly from innovations that I’ve previously heard about at Prix Galien. The HPV vaccination programme we have been able to roll out is just one example of that. So it’s a privilege to be here.”

Lansley said that recognising and rewarding innovation is a key Government priority – and that the publication of Innovation Health and Wealth last December was part of a consistent value-based message
it wanted to send to the NHS. “That message is that as you, the pharmaceutical industry, bring forward new treatments that will clearly add value and improve the quality of healthcare for patients then the NHS should be at the forefront, internationally, of demonstrating that value. Our health service can be an exemplar and inspiration to people around the world because of its capacity to demonstrate the effectiveness of new treatments when they are used within the NHS.”

Lansley praised the UK pharma industry, highlighting the value its innovations bring both to the economy and to patients worldwide. “What you are doing is part of how this country will pay its way in the future,” he said. “And it has the added value of knowing that, in the process, we can give patients in this country access to the very best healthcare anywhere in the world.”

The recognition of innovation that can lead to improved health outcomes is a core aim of Prix Galien, as outlined by Professor Sir Michael Rawlins, who announced the winners. “Prix Galien is about honouring excellence in pharmaceutical research and development,” said Professor Sir Michael. “It is about recognising the contribution that new medicines can make to the lives of people with life-threatening conditions. It is about celebrating the achievements of all those individuals – working as teams – upon whom we rely for the discovery and development of new medicines. Most will be unknown to us – but we all owe them a huge debt of gratitude.”

Innovative Product Award
The prestigious Prix Galien medal for innovation was jointly awarded to Janssen and MSD for their respective hepatitis C treatments Incivo and Victrelis. In the UK, it is estimated that there are between 200,000 and 400,000 people chronically infected with hepatitis C virus. This may lead to liver cancer as well as other serious liver diseases. Infection with the hepatitis C virus poses a substantial global health burden, and is responsible for 40% of all cases of end-stage cirrhosis, 60% of hepatocellular carcinoma and 30% of liver transplants.

Professor Sir Michael Rawlins said: “Hepatitis C virus has become an enormous area of need globally, with many patients unaware that they are infected. The consequences of this virus are considerable and burdensome to both patients and the healthcare system; current treatments remain ineffective in a significant number of cases whilst being unpleasant and poorly tolerated by patients themselves.

“Hepatitis C infection is a perfect example of where the pharmaceutical industry can demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world. It is for this reason that the panel felt that both Janssen and MSD should be celebrated and congratulated for their part in addressing the ongoing challenge in managing HCV and its associated complications.”

Brilique (AZ) and Resolor (Shire) both received commendations. Gilenya (Novartis), Xarelto (Bayer), Xeplion (Janssen), Xgeva (Amgen), Yervoy (Bristol-Myers Squibb), Zelboraf (Roche) and Zytiga (Janssen) were all shortlisted.

Orphan Drug Award
The Orphan Drug Award was introduced as a dedicated category at 2008 UK Prix Galien. There had previously been a special award for orphan products in 2006. The term ‘orphan condition’ is used to describe conditions that affect a very small number of patients in a given population – many of which are either untreatable or treated very inadequately. It is estimated that there are 6,000 orphan diseases – which, in total, affect about 30 million EU citizens.

“For orphan diseases that are potentially treatable with medicines, pharmaceutical manufacturers face a number of hurdles – including concerns about the size of the market and difficulties because of the small numbers of patients – in their development,” said Professor Sir Michael.

The 2012 Orphan Drug Award was won by Mepact from Takeda. Mepact (mifamurtide) is for the treatment of osteosarcoma, a rare malignant bone tumour – mainly of children and adolescents – that affects fewer than 1 per 10,000 individuals in the EU. This is equivalent to 150 children and young adults each year in the UK. Tumours most frequently occur in the long bones and are highly aggressive with a propensity to metastasise, particularly to the lung. If left untreated, the primary tumour will undergo local and systemic progression, leading to death within months.

“To investigate the role of this immune modulator in osteosarcoma required extensive and complex trial design with careful implementation of the study programme,” said Professor Sir Michael. “Apart from its novel mechanism of action – and clear evidence of its clinical effectiveness – the jury were also extremely impressed that such an advance in the management of osteosarcoma represents the first significant change in outcomes in 10–20 years of managing this disease. That Takeda managed to undertake the clinical development of this product – in such a niche indication – is hugely to their credit.”

US researchers have defined and tested new criteria for ‘hypersexual disorder’ as a distinct type of mental illness.

The diagnostic criteria identify a pattern of compulsive sexual thoughts and behaviours that impact harmfully on the patient’s life.

Hypersexual disorder (HSD) or sex addiction often develops in adolescence and young adulthood, making early medical intervention possible.

A team of mental health specialists and other experts led by UCLA psychologist Rory Reid have proposed the criteria with a view to inclusion in the Diagnostic and Statistical Manual of Mental Disorders.

The recognition of HSD as a distinct mental health condition would open up a new field for medical interventions.

The proposed criteria were shown in a test of 207 patients to be 88% accurate in positive identification and 93% accurate in negative identification, taking negative life consequences as evidence.

Such a low (7%) rate of misdiagnosis compares favourably with other categories of mental disorder.

The diagnostic criteria include: a persistent pattern of sexual thoughts and urges; a pattern of sexual activity in response to stress or negative mood states; failure to reduce or stop problematic sexual behaviours; and personal distress caused by the impact of these behaviours on relationships.

The study reported that 54% of hypersexual patients traced the problems back before the age of 18 and another 30% to the age period 18–25. This pattern, Reid noted, “has ramifications for early intervention and prevention strategies”.

Characteristic problem behaviours included heavy reliance on pornography, cybersex, bought sex or high-risk sex.

Reid noted that such behaviours are common – “but for these patients, it’s a constant pattern that escalates until their desire for sex is controlling every aspect of their lives and they feel powerless in their efforts to change.”

Thomas Szasz, a leading advocate of ‘patient power’ in psychiatry and critic of forced treatment and psychoactive medication, has died aged 92.

The author of The Myth of Mental Illness (1961) had a significant influence on mental health treatment in the UK, where his championing of psychiatric patients’ right to determine their own treatment pathway had many supporters.

While most psychiatrists did not accept his view that mental illness had no physical basis, Szasz was instrumental in developing a more flexible attitude towards diagnosis and treatment.

In addition, his promotion of community-based psychiatric care helped to influence the mental health strategies of recent decades.

Born in Hungary in 1920, Szasz migrated to the US in 1938. From 1956, he lectured in psychiatry at Upstate Medical University in Syracuse, New York.

As a practising psychiatrist, academic lecturer and writer, Szasz showed a lifelong concern with the dignity and freedom of the individual.

Pointing to the use of psychiatry as punishment in totalitarian societies, he argued that using forced treatment to resolve “problems in living” was a violation of patients’ rights.

According to his colleague Mantosh Dewan, Szasz forced the psychiatric profession to confront “the arbitrariness of psychiatric diagnoses” and helped to bring about the “de-institutionalisation” of many patients.

In 2010, Szasz gave a keynote address to the Royal College of Psychiatrists in the UK – but the RCP’s American counterpart had not given him a platform in almost 50 years.

More than half of intensive care patients suffer mental health problems shortly afterwards, a UK study has shown.

The psychological after-effects, which include depression, anxiety and post-traumatic stress disorder (PTSD), are thought to be partly due to certain drugs.

Sedatives and anti-hypertensive drugs are highlighted as risk factors by the study when used in the intensive care environment.

Of 157 patients at University College Hospital, London, 55% were found to be suffering from psychological illness three months after intensive care treatment.

Depression was the most common disorder (46%), followed by anxiety (44%) and PTSD (27%).

The risk of such problems increased with time spent in intensive care, as well as certain types of medication – including diazepam, a widely used sedative.

Psychologist Dr Dorothy Wade said that patients who regain consciousness in an intensive care unit, surrounded by machines, can be “in a terrified state”.

She commented on the study findings: “As well as looking at modifying our drug treatments, we may need to invest more time in the psychological care of a patient and find ways to prevent psychological suffering in the intensive care unit.”

Bob Winter, President of the Intensive Care Society, said the study had implications for specialists in the field: “The association of benzodiazepine use with subsequent psychological symptoms has important implications for sedative practice in intensive care.

“There are also implications for how we make our interventions tolerable in terms of how we can reduce the duration of sedation.”