The diabetes threat is still very real

by Amy Schofield 25. June 2017 10:08

 

Crisis averted?

 

Diabetes still dominates the news. People in their thousands are being diagnosed with the type 2 version and public bodies warn of a healthcare crisis.

Indeed, type 2 diabetes has become the de facto disease of modern times; a punishment for our descent into procrastination, screen-gazing and an insatiable appetite for junk food.

Meanwhile, the number of people with the much less common type 1 are growing, but mainly through better diagnosis. Nonetheless, the UK has one of the highest rates of type 1 diabetes on the planet.

In both cases, proactive self-management of the diseases has been key to greater survival. Pharma has had to react to the societal shift, creating new products that engage patients and urge them to take control. Meanwhile, diabetes prevention programmes are being rolled out by the NHS following recommendations in the Five Year Forward View.

 

View from the expert

Jenny Hirst MBE, Co-Chair of the InDependent Diabetes Trust

The treatment and care people receive varies from one area to another, ranging from excellent to poor care. This is clearly demonstrated in the National Diabetes Audit 2015/16. For people with type 1 diabetes, the targets achieved for HbA1c levels, blood pressure and cholesterol varied from 11%, in some Clinical Commissioning Groups, to 34% in others.

While people with type 2 diabetes fared better, there was still a wide variation from 33% to 49%. Diabetes care should not depend on where you live!

A major problem is the rationing of glucose test strips to people with type 1 diabetes for unacceptable reasons, from ‘you are only allowed one tub of test strips a month’, to the number of test strips ‘dropping off’ repeat prescriptions. In doing this, GPs and CCGs are in breach of NICE guidelines, which state that ‘support should be offered to adults with type 1 diabetes to test at least four times a day, and up to 10 times a day’ in certain circumstances.

From 2009 to 2014 the number of people with type 2 diabetes, who were offered structured education within a year of diagnosis, increased to 82%, but for those with type 1 diabetes, the increase was only 5% to 39% during the same period.

In the UK, 130 amputations take place each week. Shockingly, 80% of these are preventable, if people are told of the risks, given advice on looking after their feet and receive the correct treatment at the correct time. Sadly, for many people this is not the case, as the figures clearly show.

How can people with diabetes be expected to meet targets for their long-term health, if they’re denied education and tools? They only spend two to three hours a year with a healthcare professional, so they need the knowledge and skills to manage their diabetes through education.

 

Case in point: Keith MacBrayne

Diagnosis

It happened in 1986. I was 43 and a Captain with Britannia Airways, on the Boeing 737 200. With another 17 years to go until retirement, it wasn’t work, it was play. Then I went to the doctors with a rash, and they tested my blood sugar – it was 19. They said, “you can’t fly with that”, and I thought they meant for a couple of weeks, but it was the end of my flying career. I went home from work one day and never went back. 

Reaction

It was a bit of a shock. I had health and flying license insurance, so wasn’t short of money, but I needed something to do for the next 20 years. I had been a trustee with the Britannia Airways Pension Scheme, so went to work with Equitable Life, but didn’t enjoy selling life insurance, so I quit and, for the next 20 years, did all the things people normally do as teenagers.

Reality

I realised I was neglecting my diabetes – I was just drifting. I used to use a disposable syringe and, British culture being what it was, would go to the toilet to inject. On one occasion, at Cliff Richard’s anniversary concert, at Wembley, I went down to the toilets and thought, “I could catch something here”. After that, I kept a pre-filled syringe in my pocket – I could just open my shirt and stick it in my stomach.

Stability

Life was fine, but my stability wasn’t – I was having a few hypos (hypoglycaemia reactions) and one night my wife found me white and twitching. When the paramedics brought me round my blood sugar was 1; caused by lipohypertrophy (lipo). Insulin is a growth hormone and if you puncture a fat cell you eventually get a lump or lipo, and I have several of these. If the insulin enters one, it just sits there, so you need to rotate the site. When you’re doing it five times a day, that’s difficult.

Knowledge

After my near-death experience, I became passionate about staying alive. I did the DAPHNE (diet adjustment for normal eating) course, at Bedford hospital; one of the best diabetes centres around. My knowledge grew, and I met specialist Claire Springall, who introduced me to Becton Dickinson – the needle manufacturers. The company wanted me to help promote correct injection technique, so they used me for demonstrations. 

Change

I have been wearing a remote-controlled Omnipod for three years. It’s amazing, available on the NHS and doesn’t have tubes. It administers the insulin through a capillary under the skin, throughout the day. I also self-fund an Abbott Freestyle Libre – a wearable, which reads your sugar level. It’s more effective than finger pricking, but the challenge is working out how much insulin to deliver, because the two devices do not ‘talk’ to each other.

Progress

It’s been an exponential curve in diabetes and the last 15 years have witnessed incredible progress. In America they are trialling an artificial pancreas – and I’d love to be on that. In terms of dietary information there is only one restaurant chain I know of that provides the carbohydrate content of every single item on the menu – McDonald’s.

Freestyle

If we gave the Libre to everyone with type 1, we would save a huge portion of the 10% health budget that goes on diabetes. It provides much better insulin control and would be less painful, particularly for children. There are other pumps, but they have half-a-metre of tube attached. I trialled one and they are a pain in the backside – you don’t want to be untangling tubes every time you use the toilet!

Frustration

The DVLA recently changed its policy, so that all drivers with type 1 diabetes have to test their blood an hour before driving and every two hours during. Finger-pricking only tells you the score at that very moment, while the Libre records the last eight hours. NICE needs to get its finger out and make it available on the NHS.

Future

I did have a reading of 8.9, but since being on the Omnipod, it’s 7.3. Normal is 3.5, so I’m pretty close to that zone – my goal is to get it down to under 7 within the next year. The more knowledge that is devolved to patients, the better we can look after ourselves!

 

Established Diabetes treatments:

Companies making a difference

GSK: Eperzan (injection T2) Tanzeum (injection T2) 

Eli Lilly: Bydureon (injection T2) Humulin (injection T1/T2) Tradjenta (pill T2)

Novo Nordisk: Tresiba (injection T1/T2) Victoza (injection T2) PRANDIN (pill T2)

Abbott: FreeStyle InsuLinx (monitor T1/T2) FreeStyle Libre (wearable injection, as used by Keith, T1/2)

Bayer: Contour XT (glucose meter T1/T2) Contour (test strips T1/T2) NEXT USB (blood data transfer T1/T2)

 

 

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Features

Could dragon blood slay MRSA?

by Amy Schofield 19. June 2017 11:00

 

 

Don’t believe the hype: health headlines dissected

 

THE STORY

Reaching a length of up to 10 feet and weighing in at 300 lbs, Komodo dragons are the largest living lizards on earth. These fearsome predators are also hard as nails when it comes to recovering from wounds sustained in battles with other dragons, thanks to their astonishingly robust immune systems. Previous research has shown that they can harbour as many as 57 pathogenic bacteria in their mouths without even getting a sore throat. A team of researchers from Virginia in the US set out to find out more about the Komodo dragon’s secret defence against these bacteria, and discovered that proteins in its blood plasma could hold the answer. In an age of growing antimicrobial resistance, could this remarkable beast hold the key to slaying deadly hospital superbugs in humans?

 

THE RESEARCH

The team from George (naturally) Mason University extracted blood from Komodo dragons, and analysed it for traces of cationic antimicrobial peptides (CAMPs) – protein fragments that show antimicrobial activity. CAMPs, found in almost all living creatures, are an essential part of a healthy immune system and the team had previously discovered these proteins in alligator blood. The scientists isolated peptides from the dragon’s plasma samples with a technique using negatively-charged nanoparticles made from hydrogel to capture them. Analysis of the samples identified 48 peptides, 47 of which were derived from histone proteins and are known to have antimicrobial properties. They then synthesised eight of these peptides and tested them for their antimicrobial properties.

 

THE RESULTS

Methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa (P. aeruginosa) are two superbugs that kill thousands of people every year. In tests using the eight synthesised peptides on mice infected with these bugs, seven were effective at killing both bacteria in lab-grown cultures, while only one was effective against P. aeruginosa, suggesting that Komodo dragon blood plasma contains a host of potentially viable antimicrobial peptides.

 

THE DEAL

Though these findings are a promising step forward in the development of new antibiotics and the fight against antimicrobial resistance, there is more work to be done in establishing the mechanisms by which the peptides are produced. The team concluded: “Future efforts will focus on determining whether peptides are constitutively produced or the result of pathogen detection, as well as whether this phenomenon is limited to Komodo dragons or if it occurs in other species, including humans.”

 

What the press said:

“Is Komodo dragon blood the key to new antibiotics?” bbc.co.uk; “Dragon’s blood could hold the key to wiping out deadly superbugs” mirror.co.uk; “Dragon blood could provide a cure for antibiotic resistance” mnn.com    

 

 

 

 

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Features

Marketing Focus: helping modern marketeers to thrive

by Amy Schofield 13. June 2017 09:15

 


PART ONE: Setting the scene

 

Introducing a new series of ‘Marketing Focus’ articles, helping modern marketeers to thrive in the changing healthcare environment.

 

In the first of the series, Dr Graham Leask and Stewart Adkins set the scene with the first of a two-part feature addressing the changes facing pharma professionals today.

From a global perspective, the key drivers of change within the pharma marketplace have existed for some years. The shift in product mix towards more expensive, low volume, speciality medicines continues apace. This situation meets increasing resistance from payers, as these drugs concentrate the pharmaceutical budget on fewer patients.

Pharmacoeconomic arguments rage on, but the reality is that governments seem unprepared to cancel out future cost savings from current costs in its societal calculus. As a consequence, the rise in Health Technology Assessment groups, for example the UK’s National Institute for Clinical Excellence (NICE), is a way for payers to contract out the difficult decisions of market access and effective rationing.

In the meantime, payers have forced prescribers to follow more restricted prescribing guidelines in an effort to control today’s budget. The concentration of decision-making in the hands of opinion-leaders and pharmacy committees changes the role of commercial organisations, encouraging more peer-to-peer medical liaison at the top of the ecosystem, and fewer ‘face-to-face’ calls with GPs at the bottom. This is a necessary change with specialty drugs, but means a big reduction in contact time between pharma corporations and primary care physicians.

Strategically the shift in product mix has encouraged pipeline realignment, with more emphasis on in-licensing of biotech drugs or straight acquisition of the license-holder. This has left traditional ‘white pill’ companies struggling to generate reasonable growth, whereas relative late-comers, such as Shire Pharmaceuticals or Celgene, have shown strong expansion. There is little expectation, however, that these newcomers will solve continuing problems in the world of primary care. For that, we may have to await a resurgence of chronic diseases that do not yield to today’s generics.

 

A marketing & sales model fit for the 21st century

The application of modern analytical methods to sales and marketing data should enable each company to develop a mix of promotional activities that form part of a feedback loop, each component of which can be optimised for best effect. Currently such processes are impeded by a reticence to use the new sophisticated statistical methods that are required to analyse pharmaceutical data accurately. Reliance on inadequate tools such as Excel and visualisation tools like ‘Tableau’, that incorporate an Excel-type analytics capability, is a major cause of this problem.

Accurate timely adjustment of activity and sales response, guided by these ‘appropriate sophisticated tools’, will allow campaigns to be finely tuned throughout each promotional cycle, thus minimising waste and boosting sales and margins. Figures 1 and 2 illustrate this point and show the considerable benefit of moving away from Victorian techniques and embracing modern methods.

The trialling of novel campaigns in mutually exclusive geographic areas and the rapid feedback that modern analytics can produce will allow more selective or targeted approaches. The result? More accurate targeting, and less wasteful campaigns tailored to the local environment.

 

The impact of digital

Currently, few companies are monitoring the true impact of digital. They simply throw it into the promotional mix and watch the ripples in the pool. A pick up in sales is regarded as positive whereas the true cause may be elsewhere. Only a true isolation of the impact of all the promotional puzzle pieces, including digital, can lead to strong conclusions about digital, one way or the other. Unsophisticated blanket use of digital is equivalent to a pollutant, as indiscriminate use is likely to blunt doctors’ responsiveness to contemporary channels rather than encourage new productive forms of interaction.

In contrast, clever use of digital to cover uneconomic surgeries, or move the call frequency achieved on a customer into an effective band, is likely to sharply improve productivity. Thoughtful blending of promotion with sophisticated analytics can produce tailored campaigns that are a win–win for company and healthcare professional alike.

 

About the authors

Stewart Adkins was a Pharmaceutical Analyst at Lehman Brothers for 23 years and now writes independently.

Dr Graham Leask worked in industry for over 20 years and now works with Warwick University as a writer and researcher on pharma strategy.

 

Next month, in part 2, Graham and Stewart look at the shift from treatment to prevention, and outline what the healthcare landscape of the future will look like.

 

 

 

 

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Features

Top 5 R&D hubs in the UK

by Amy Schofield 3. June 2017 09:58

Read this cover story in the June issue of Pf Magazine here. 

 

Join us on a tour of inspirational research and development centres. 

As the host to leading global universities and the finest scientific talent, the UK is a world–leading location for diverse and innovative research and development (R&D). The UK life sciences sector currently encompasses around 5000 companies, supports over 220,000 jobs, and generates an annual turnover of over £60 billion*.

 

1. ‘The Golden Triangle’

The South East of England has long been a thriving hub for R&D activity in the UK, and is home to the ‘Golden Triangle’ of London, Oxford and Cambridge.

 

Oxford

Oxford has developed an impressive reputation in the biotechnology space, witnessing more than £1.2bn of investment in biomedical research over the last five years. The city is host to the Oxford Biotech cluster, one of the most mature life science clusters in Europe, as well as business, science and technology facility, Milton Park, home to around 250 businesses.

Oxford BioTrans, an Oxford University spinout, opened an R&D facility at Milton Park in 2016, while Adaptimmune, one of the UK’s leading cancer research companies, is steadily expanding. Ipsen has moved in, while Oxitec are in situ and working with the World Health Organisation to create a genetically modified mosquito. The aim is
to decimate local mosquito populations, after it proved effective against Zika in small scale field trials.

The Oxford biotech cluster, supported by the Oxford Biotech Network (OBN), conducts a wide range of activities from traditional drug discovery and development to medical technology innovation. The University’s influence is significant, and its spin-out companies include Oxford BioMedica, Oxford Gene Technology and Celleron Therapeutics.

 

Cambridge

Cambridge has been described by MP Daniel Zeichner as “the beating heart of research and science in the UK today”. In April this year, AstraZeneca marked a key milestone with the ‘topping out’ of its new state-of-the-art, strategic R&D centre and global corporate headquarters at the heart of the Cambridge Biomedical Campus (CBC).

The company, including its biologics research and development arm, MedImmune, already has 2000 employees working in Cambridge among the city’s lively scientific, academic, clinical and business community. There is a high concentration of leading scientific organisations at the CBC, across Cambridge and the region, all sharing knowledge, skills and expertise.

Pascal Soriot, CEO of AstraZeneca, said: “We believe Cambridge offers a tremendously vibrant academic and life-sciences ecosystem that can truly catalyse discovery and innovation.”

 

London and the greater South East

MedCity is a collaboration between the Mayor of London, Imperial College Academic Health Science Centre, King’s Health Partners, UCL Partners, Cambridge Health Partners and Oxford Academic Health Science Centre. It was launched in April 2014 to promote and grow the world-leading life sciences cluster of the South East of England.

The greater South East region is home to five out of the UK’s six Academic Health Science Centres and has four universities regularly placed in the global top 10.

Just north of London, in Hertfordshire, are the Stevenage Bioscience Catalyst (SBC), and Roche’s global R&D hub, in Welwyn Garden City. Roche invested almost half a billion pounds in UK R&D in 2016 and registered more clinical trials than any other company.

SBC is the UK’s first Open Innovation campus, created to bring academia, biotech and pharma companies together to advance healthcare research more effectively. SBC is jointly funded to the tune of £38m by BEIS, GSK, Wellcome and Innovate UK (TSB).

The University of Cambridge has located an innovation centre at SBC, where it can develop academic drug assets with access to relevant expertise at SBC and GSK. This will lead to the development of relationships with other leading universities, while UCL also has a presence on the site.

Outgoing CEO Martino Picardo says that it is the quality of scientific research in the UK that makes it a serious player on the global R&D stage. “We are world–leading in drug discovery and development across academia, small companies and corporates like GSK and Astra Zeneca, both of which have R&D sites in the UK,” he explained. “We are considered to rank alongside the Boston and California hubs and we must strive to stay at that level. The quality of the science is unquestionable and how we translate that science in new therapies and for patient benefit is good and will get better.”

 

2. The Northern Powerhouse

When George Osbourne launched his plan to build a ‘Northern Powerhouse’ in 2014, his aim was to close the historical economic gap between north and south. It is now home to over 1000 life sciences and healthcare companies operating across a wide range of specialisations. There are 45,000 people working in life sciences and healthcare-associated industries across the region, which covers the North East, North West and Yorkshire.

Global companies including Allergan, AstraZeneca, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, MSD, Recipharm and Shire serve UK and global markets from their key manufacturing and R&D operations based in the area.

 

The North East

The North East produces 33% of the UK’s GDP in pharmaceutical manufacturing with 95% of finished product exported to global markets, while MSD, in Cramlington, Northumberland, is one of the most advanced pharmaceutical manufacturing and packaging facilities in the world and employs over 400 people. The UK’s Centre for Process Innovation (CPI) opened its £38m National Biologics Manufacturing Centre (NBMC) in Darlington, Co. Durham, in 2015, to help companies develop, prove and commercialise new processes and technologies for the manufacture of biologics.

 

The North West

Big pharma has made the North West its home, with several global pharmaceutical companies including Eli Lilly, AstraZeneca’s biologics arm, Medimmune, and Novartis Vaccines operating manufacturing facilities in Speke, Liverpool, as part of the largest cluster of biologic manufacturing in Europe.

Drug discovery and development firm RedX Pharma has established a 74,000 sq. ft. development facility at Alderley Park, Cheshire for Redx Oncology, which develops anti–cancer drugs. Additional investment in the region includes £4m for a drug discovery catapult, and £4m for the Antimicrobial Resistance Centre, both also at Alderley Park.

 

 Yorkshire and the Humber

The region is home to one of the largest clusters of orthopaedic, medical device and surgical companies in the UK, including Smith and Nephew and Reckitt Benckiser. WELMEC Centre of Excellence in Medical Engineering (which researches and develops new types of intervention for musculoskeletal and cardiovascular systems), EPSRC Centre for Innovative Manufacturing in Medical Devices (Leeds, Bradford and  Sheffield) and the Leeds Innovation and Knowledge Centre (IKC), also operate in the area.

 

3. Scotland

Edinburgh’s BioQuarter site is a leading European destination for translational medical research. The site is home to institutions and companies including Queens Medical Research Institute, which brings together over 650 researchers with strengths in cardiovascular disease, reproductive health and inflammatory and respiratory research, and Fios Genomics, which provides bioinformatics data analysis services to pharma, CROs and academia for drug discovery and development and applied research. The world–leading Scottish Centre for Regenerative Medicine, which studies stem cells, disease and tissue repair to advance human health, has also made its home here.

 

4. Wales

Launched in 2014, Life Sciences Hub Wales, based in Cardiff Bay, brings together Wales’ life sciences ‘eco system’ and honours the Welsh Government’s commitment to establishing the country as one of the foremost environments in the world for lifes sciences innovation, delivering at least £1 billion of extra value within the sector in Wales by 2022. Members of the hub include medical technologies and services company GE Healthcare, Johnson & Johnson Innovation, Novartis and MSD.

 

5. Northern Ireland

There are more than 150 native firms in Northern Ireland’s life sciences space, employing 7500 people and exporting over £1bn.

The Almac Group, a contract development and manufacturing organisation which provides services to companies in the pharmaceutical and biotech sectors all over the world, is headquartered in Craigavon, Northern Ireland. Services encompass R&D and biomarker discovery and development. Almac is expanding in Craigavon by building a new lab and offices, and last year announced plans to expand into Dundalk, in the Republic of Ireland, to ensure access to the single market in the wake of Brexit uncertainty.   

 

 

 

 

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Features

Remarkable era of treating HIV/AIDS and hep C

by J Pinching 30. May 2017 09:09

 

Death sentence revoked

The last few decades have witnessed remarkable milestones in treating HIV/AIDS and hepatitis C.

Not so long ago, being informed you were HIV positive, or had contracted hepatitis C, meant your entire future was thrown into grave doubt – if you had a future at all.

Over the last 35 years, however, AIDS has gone from a virtual death sentence to a perfectly manageable condition. Indeed, my Uncle – Professor of Immunology, Anthony Pinching – reflected that “the HIV/AIDS model of research had become the standard bearer for other diseases”.

Meanwhile, Hepatitis C treatments have reached new highs, with thousands given renewed optimism and even a cure.

Now we hear exclusively from Jane Anderson – a uniquely-placed expert who has been involved in HIV/AIDS for 30 years – and Mykie Leong Chadwick, an award-winning hepatitis C Service Development Manager, from MSD.

 

Chance of a lifetime

Jane Anderson Director at the Centre for the Study of Sexual Health and HIV, and Chair of the National AIDS Trust

I have been privileged to work in one of the most interesting and fast moving areas of medicine; to have worked with some of the most inspiring and committed clinicians, patients and activists, and to have witnessed enormous progress during the course of my medical career.

I started work over 32 years ago as a newly qualified houseman at St. Mary’s Hospital Medical School, which saw the arrival of the very first patients with AIDS in the early 1980s. In those early days almost everyone died, there was a great deal of fear and an intense period of learning about AIDS and HIV.  

By the time I became a consultant at St Bartholomew’s Hospital in 1990, although medications were being developed they were often unpleasant to take and not particularly efficacious. It was the use of drugs in combination and - in 1995 - the introduction of the protease inhibitors, which made the difference. We began to see fewer deaths and better outcomes.

Working in East London with a very diverse population I became increasingly interested in the impact of HIV among migrant and ethnic minority communities, and the particular needs of women and families. This lead to the establishment of the Centre for the Study of Sexual Health and HIV, at Homerton Hospital in Hackney. I have also been privileged to Chair the British HIV Association and work with both Public Health England and NHS England and, in 2015, I became the Chair of the National AIDS Trust - our main policy and campaigning charity for HIV in the UK.

More people than ever before – about 105,000 – are living with HIV in England, as effective therapy increases longevity and new infections continue. For those diagnosed in time and who have lifelong access to antiretroviral medications, HIV has changed from a universally fatal infection into a manageable condition for the long-term, with clinical and virological outcomes that are world leading.

Virological suppression is key, both to avoiding HIV related ill-health and to prevention, as those with completely supressed viral activity are not infectious to other people. More people with HIV are now living into old age, often with added complications. Late and undiagnosed infection is a major challenge – more advanced infection being associated, not only with increased morbidity and mortality, but also with the risks of unwitting onward transmission.

Estimates suggest that about 17,000 people with HIV are as yet undiagnosed and at least a third of people newly diagnosed have advanced infection, making expanded HIV testing a crucial intervention.

Despite enormous clinical advances HIV continues to take a significant toll on people’s lives. For example, quality of life for people with HIV is below that of the general population, poor mental health is common and HIV-associated stigma and discrimination is unrelenting. Knowledge and awareness about HIV within the general population is dispiritingly low.

We now have the wherewithal to ensure long life for people with HIV but, as economic constraints deepen we must not allow the phenomenal progress of the past 30 years to stall. The next few years are crucial in ensuring that treatment evolves to effectively meet the changing needs of an increasing and ageing population. Measures that improve quality of life in particular, through reducing stigma and discrimination, need to be implemented.

Following the 2012 health reforms all three commissioning bodies have responsibility for some aspects of the prevention and care pathway. Ensuring a joined up approach that delivers seamless care to people is a challenge that must be overcome. Making sure new information is translated into action on the ground – for example, securing access to Pre-Exposure Prophylaxis for all those at high risk of acquiring HIV – must be a key priority.

 

Cure in the community

Mykie Leong Chadwick Service Development Manager, Hepatitis C, at MSD

For the 214,000 estimated people chronically infected with the hepatitis C virus (HCV) in the UK[1], there are more treatment options available than ever before.

Over the last decade, mortality – due to hepatitis C-related cirrhosis or liver cancer – in the UK had been increasing at an alarming rate; over twice as many people died of HCV-related illnesses in 2014 than in 2005[2]; but, in 2015, there was an 8% reduction in the number of deaths related to HCV compared with the previous year[2].

In recent years more people are becoming aware of their HCV status and seeking treatment. As HCV is usually asymptomatic, however, it can be a challenge to identify infected people – the number of people in England diagnosed was five times greater in 2015 than in 1996[2], but half of HCV patients are estimated to be undiagnosed[3].

Treatments available for HCV have improved dramatically in the last few years, with the introduction of direct-acting antiviral (DAA) treatments. Historically, treatment used to be 48 weeks long, involved injectable and oral dosing, and was effective in only 56% of patients[4]. DAA treatments can now be taken as a single pill per day, are well tolerated and have cure rates exceeding 90%[5].

The majority of HCV patients are from marginalised groups in society, including people who inject drugs[6], however, infection could occur through unprotected sex, infected blood transfusions – received before September 1991[7] – or sharing toothbrushes, razors and tattooing or body piercing equipment.

The HCV team at MSD has a vision – achieving a future free of hepatitis C; for patients and the NHS. We believe that each person in the UK living with chronic HCV infection deserves to be cured.

As treatment is only a part of the solution to eliminate HCV, we are also committed to collaborating with organisations to promote awareness and prevention, especially among the populations most at risk for chronic HCV.

Curing a patient of HCV is an amazing achievement, but it is also about developing holistic treatment strategies and reducing risk of re-infection that gets me up and ready to go every day.

 

References

1: Public Health England. Hepatitis C in the UK 2016 report. Available online (last accessed – April 2017): https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/565459/Hepatitis_C_in_the_UK_2016_report.pdf.

2: Public Health England. Hepatitis C in the UK 2017 report. Available online (last accessed – April 2017): http://hcvaction.org.uk/resource/hepatitis-c-england-2017-report

3: National Institute for Health and Care Excellence. Costing template: Implementing the NICE guidance on ledipasvir-sofosbuvir (TA363), daclatasvir (TA364) and ombitasvir-paritaprevir-ritonavir with dasabuvir (3D) or without dasabuvir (2D) for treating chronic hepatitis C (TA365)

4: National Institute for Health and Care Excellence.  Technology appraisal guidance [TA75]: Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C

5: World Health Organization, Hepatitis C, July 2015. Available online (last accessed – April 2017): http://www.who.int/mediacentre/factsheets/fs164/en/]

6: Public Health England, Hepatitis C in the UK 2015 report, 2015. Available online (last accessed – April 2017): https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/448710/NEW_FINAL_HCV_2015_IN_THE_UK_REPORT_28072015_v2.pdf

7: NHS Choices, Hepatitis C – causes. Available online (last accessed – April 2017): http://www.nhs.uk/conditions/hepatitis-c/pages/causes.aspx/]

 

 

 

 

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Features

What really goes on at the science end of treatment discovery?

by John Pinching 22. May 2017 09:57

 

At the business end of pharma it is all too easy to forget the trials (quite literally) and tribulations of the science that precedes it.  

The currency – beyond pounds, dollars and euros – of research and development is what pharma ultimately trades in. It is the gauge with which a company can judge itself and it is the platform upon which employees, stakeholders and, yes, patients can build – whether it is commercial reputation or improved health. 

Having a clear understanding of the exhaustive process involved in bringing a drug to market is essential. While defeat at any stage of the cycle often comes with severe implications, overcoming each hurdle and reaching the mecca of approval has far-reaching benefits, often with a global impact.

Here, Claire Bale from Parkinson's UK takes us through each vital step on the journey.

 

Hit selection

To develop treatments that can tackle the underlying causes of Parkinson’s we need to change the way brain cells work. The key is finding small molecules that target the process that has gone wrong in the cell. Up to half a million drug-like molecules are screened, quickly identifying any that may have potential. 

 

Hit to lead

To discover more about the chosen molecules, they are tested to identify those with the most promise. Any that fail, or cause problems in other organs, or are known to produce serious side effects, are discarded. Each molecule is tested for strength and it must be soluble in water. Biotech company Oncodesign is currently developing a class of compounds in the Hit to Lead phase that prevent the enzyme LRRK2 from activating. LRRK2 is often found in genes that are associated with Parkinson’s.

 

Lead optimisation

Now the group has been whittled down to molecules with genuine promise, it’s time to start developing them into drugs – this step needs skilled scientists who are specialists in drug design. They painstakingly tweak the structure of the remaining molecules to achieve the best possible effects, while minimising any negative reactions. Throughout this process, molecules are refined and then tested repeatedly – this can go on for years.

 

Candidate nomination

After all the lab testing, tweaking and modifying, scientists will finally look at the best possible candidates to create a new drug, and select the best contender. After years of research, if successful, the compound will be taken forward and moved into preclinical drug development.

 

Preclinical studies

Before any new experimental treatment can be used on people, it first needs to be rigorously lab-tested. At the preclinical development stage, pharmacologists and toxicologists test the new drug under experimental conditions. Firstly, the scientists will use computer programmes – in silico – before testing the active compounds in test tubes or petri dishes – in vitro. Finally, animal experiments – in vivo – help scientists understand the complex effects of the drug.

 

Clinical Trials: Phase 1

The new drug is ready for clinical trials on a small number of people, testing for safety, side effects and best dose. Studies involve a small group who may be healthy volunteers or people with the condition. Two different Parkinson’s vaccines are currently being tested in early stage trials  – one developed by US firm Prothena, and the other by Austrian company Affiris.

 

Clinical Trials: Phase 2

These studies include a comparison group who receive a placebo, allowing researchers to see whether people who receive the treatment do better than those that ‘imagine’ they have taken it. Exenatide, a drug that is currently used to treat type 2 diabetes, has shown potential for slowing the course of Parkinson’s. A phase 2 trial of the drug is now complete and results are expected in 2017.

 

Clinical Trials: Phase 3

Later clinical trials often take place across many countries, involve hundreds of participants and run for several years. Apomorphine is already used by many people with Parkinson’s to help control symptoms. Phase 3 trials are now underway in the US and UK to test a new way of delivering that involves placing a special strip under the tongue. Results are expected in 2017.  

 

A new frontier in development

The pathway to creating new drugs is a long, expensive and difficult journey. Each step in the process is vital, and a drug can fail at any stage along the way. For every potential therapy that enters the process, perhaps only one in a thousand will end up being approved for use.

Over the years, investment that would push forward promising early-stage research for Parkinson’s into drug development has gradually dried up – leading to a bottleneck in the drug development pathway and less research making it through to clinical trials.

Now, Parkinson’s UK is embarking on a radical new programme of work to shake-up the drug development process. Funded by a new campaign, ‘We Won’t Wait’, Parkinson’s UK will act as a biotech company to highlight important research and develop it for further investment.

Without building labs, employing teams of scientists or buying expensive equipment, the charity will work ‘virtually’ in partnership with a range of other organisations – companies, universities or other charities – that have the facilities to carry out scientific work. Parkinson’s UK will be able to rapidly invest in promising research projects and make early-stage research more attractive to investors.

While we can’t know exactly what will happen next in terms of treatments, we can be optimistic about ongoing research. We’re confident a cure is there – it just needs to be developed.

 

Claire Bale is Head of Research Communications at Parkinson’s UK. Go to wewontwait.parkinsons.org.uk

 

 

 

 

 

 

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Features

Could spider venom be an antidote to stroke-incurred brain damage?

by Amy Schofield 22. May 2017 09:41

 

Don’t believe the hype: health headlines dissected

 

THE STORY

Most of us would insist on a safe distance from massive poisonous spiders, but not our intrepid scientist friends ‘down under’, who not only got close, but secured their venom as well. In the process, they might have stumbled across a protective therapy for people who have suffered a stroke.

While studying venom from the deadly funnel-web spider, researchers at the University of Queensland (UQ) and Monash University happened upon a compound which they say could protect the cells of the brain from damage, even hours after a stroke.

 

THE RESEARCH

While sequencing the DNA from three of the lethal arachnids – which were reportedly “milked exhaustively” of their venom – the scientists discovered a protein, Hi1a, that resembled two copies of another chemical known to be capable of protecting brain cells.

Professor Glenn King, Group Leader, Chemistry and Structural Biology Division Investigator at the UQ Institute for Molecular Bioscience– whose research ‘harnesses the chemistry of venoms’ from arthropod predators, such as spiders, scorpions and centipedes, to develop novel pharmaceuticals – said that Hi1a “proved to be even more potent” than the other protective chemical.

In a series of studies on rats, Prof. King and his team demonstrated that a small single dose of the spider venom molecule protected neurons in the brain from strokes.

 

THE RESULTS

Not only did administering Hi1a two hours after stroke reduce the extent of brain damage by 80%, but the compound remained effective eight hours after a stroke, reducing the amount of brain damage by around 65% when compared with untreated animals.

The researchers concluded that Hi1a is “a powerful pharmacological tool and a promising lead for the development of therapeutics to protect the brain from ischemic injury”.

 

THE DEAL

“We believe that we have, for the first time, found a way to minimise the effects of brain damage after a stroke,” Prof. King enthused.

The Australian team hope to start human trials of the compound in the next two years, however, further trials must be carried out first. If these trials are successful, treatment of stroke patients could potentially be transformed.

 

What the press said:

“Deadly spider venom could ward off stroke brain damage, say doctors” The Guardian

“Spider venom may offer stroke therapy” BBC News

“Can spider venom protect brain cells after a stroke?” Spectator Health.  

 

 

 

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Features

Ask the ABPI - your most important questions answered

by J Pinching 21. May 2017 09:51

 

Regulation questions:

Our readers take the opportunity to ask ABPI leaders questions about the industry landscape, the regulatory environment, the future and much more.  

 

Andreas Knight, Senior Recruitment Consultant, CHASE: 

With the impending exit from the EU, how does the ABPI think UK pharma will be impacted and are there immediate plans in place?

 

Rebecca Lumsden, ABPI Head of Science Policy:

As part of the UK/EU ‘Life Sciences Transition Programme’, the ABPI is working alongside our members at the BioIndustry Association to engage the life sciences sector and outline the work needed to create a world-leading life sciences environment in the UK, outside the EU.

We have welcomed the Government’s commitment to our industry and the broader Life Sciences ecosystem so far. ‘Making the UK the best place for science and innovation’ is one of the Prime Minister’s 12 Brexit negotiation priorities and a core pillar of the new industrial strategy, with new funding made available by the Chancellor for science.

Research and development, however, is a global endeavour. To ensure the UK continues to ‘punch above its weight’ we need to continue welcoming highly-skilled talent and maintain access to international scientific networks. Access to international collaborations, such as the Innovative Medicines Initiative, are highly valuable for both academic and industry researchers.

 

 

Polly Appleby, Account Manager, Star Medical: 

What has most impressed the ABPI about UK pharma’s recent digital initiatives?

 

Aileen Thompson, ABPI Executive Director, Communications:

Digital campaigns allow us to celebrate the scientific advances our industry is making and share these with new audiences, including the patients and public. Earlier this year we launched ‘Only Just Begun’ – a major digital campaign focussing on the value of the pharmaceutical industry in the UK, and the commitment and passion of the people who work within it.

From the £4.2 billion we spend in the UK on R&D, to the £30.7bn contributed to UK GDP in 2015, we are promoting our achievements now, more than ever, by sharing content. We’re also seeing an uptake in activity and engagement across our social media channels, including Twitter and LinkedIn. It’s great to see the interest growing in our industry through digital platforms.

 

 

Lucy Pohling, Account Executive, GCI Health: 

How will the ABPI continue to drive joint working, transparency and innovation in the future?

 

Harriet Lewis, ABPI NHS Engagement Partner (North):

Our industry already works in partnership with the NHS, charities and other healthcare organisations for the benefit of patients. This year, we have made the first steps towards a unique new partnership with the NHS in Manchester. The agreement will allow Greater Manchester to explore new ways of paying for medicines based on patient outcomes – enabling the £1 billion spent on medicines in the region to be as beneficial to the local population as possible.

The partnership will also enable companies to work with Greater Manchester Health and Social Care Partnership to improve the utilisation of medicines and the adoption of innovative medicines, using the unique data capabilities of Greater Manchester.

The Salford Lung Study – effectively a real time clinical trial for chronic obstructive pulmonary disorder – is another example of how collaborative joint working is helping develop a new swathe of medicines. Initiatives like this show that when the NHS embraces innovation, patients benefit, while industry expertise is recognised and welcomed across the country in a growing number of collaborations.

 

 

John Pinching, Editor, Pf Magazine: 

The ABPI has had some high-profile gains in terms of members in recent times – what are the organisation’s immediate aims for 2017?

 

Sam Ogden, ABPI Chief of Staff:

The ABPI welcomed seven new innovative, research-based large, medium and small biopharmaceutical members companies in 2016. Together our members provide 80% of branded medicine to the NHS. This is an exciting new era of biosciences in the UK and we are sure that 2017 will be a seminal year for the life sciences sector, and the country as a whole.

Our focus this year is to continue demonstrating the story of our science, innovation and value to healthcare, patients and the economy. This focus is consistent with our priorities, which include enhancing our industry reputation, delivering the current PPRS, improving access and uptake of new medicines and building our relationship with the NHS.

We want to continue to identify opportunities and make the UK domestic landscape attractive for clinical development and the manufacturing of medicines. We would say to any prospective new members – come and join us and help to shape this.

 

Hannah O’Neill, Operations Director, Virgo Health: 

Patient groups’ perception of pharma has declined in every area – what does the ABPI make of this and what action must UK pharma take?

 

Karen Borrer, ABPI Head of Reputation:

The pharmaceutical industry is on the brink of a golden age of innovation, with some 7000 medicines in the pipeline. As medicines development becomes increasingly complex and we enter an era of ever more personalised medicines, it is critical that we engage with and use the knowledge of patients by involving them at every step.

Industry works with patients through the European Patients’ Academy, for example, which focuses on increasing the capacity and capability of patients to understand and contribute to medicines research and development through education.

We also continue to work on improving the pharmaceutical industry’s reputation. Disclosure UK makes the transfer of value between the pharmaceutical industry and healthcare professionals more transparent than ever before, with payments or benefits made in kind to health professionals and healthcare organisations in the UK, publicly accessible on a searchable database.

Initiatives like this help us to assure patients and members of the public that we are committed to open-working with colleagues in the NHS and charities. We cannot make the medical advancements needed without working together with patients, health professionals, academics and other experts and we must find ways to do this in a transparent and open way. We have made good progress on this and will continue to look for ways to improve further.

 

Julian Given, Chief Officer, Washington Community Health Care: 

How do you view the proposal document – published in January – about changing the arrangements for NICE appraisals?

 

Paul Catchpole, ABPI Value & Access Director:

The ABPI is clear – we believe changes, which have now been put in place by NICE/NHS England and will introduce a £20m budget test for innovative new treatments, break the Conservative Party’s 2015 Manifesto promise to speed up the introduction of cost-effective medicines into the NHS.

In a recent member survey – when asked about the impact of the Budget Test – 71% of respondents said they believed it meant their companies would prioritise launching new medicines in European countries over the UK; and 89% said they believed it will mean patient access to cost-effective medicines in the UK will decrease.

Thousands of patients may have to wait longer for treatment for conditions like cancer, heart disease and diabetes, while those medicines which will often stand to benefit the most people are caught up in the system. If the NHS became more effective in its planning it could manage the introduction of new medicines in a more coherent way.

Use of new medicines in the UK is already low, with patients seven times more likely to get a newly launched medicine in places like Germany or France. While Scotland and Wales are both making some helpful strides in improving the use of new medicines, English patients appear to be facing more barriers than ever before. As we head towards Brexit, we should be catching up with Europe, not falling further behind. Ultimately, we would like to see these plans paused while better solutions are found. 

 

Go to abpi.org.uk

 

 

 


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Features

Astellas partnership helps to raise awareness of childbirth injury

by Amy Schofield 8. May 2017 10:10

 

 

Astellas is working with the Fistula Foundation to raise money and awareness of a little known but life-shattering childbirth injury.

 

Obstetric fistula is a problem that you may not have heard of, but this devastating childbirth injury and the stigma surrounding it ravages the lives of a million women worldwide.

As Kate Grant, CEO of the Fistula Foundation, says: “Fistula is not an issue that most people know or care about – the predominant injury is a hole in the vagina; there’s not many things that are tougher to talk about than that.”

Thanks to Astellas’ involvement in the three-year corporate giving program ‘Action on Fistula’, and the overwhelming generosity of its employees, however, this little known issue is receiving much-needed funding and support – transforming women’s lives in the process.

Kate was first contacted by Astellas three and a half years ago. The company was interested in doing something to address the problem of obstetric fistula in Kenya. The representative asked Kate and her small team to submit a proposal about how they would tackle it. It was a competitive process, but Astellas chose the Fistula Foundation’s plan, and the Action on Fistula programme kicked off in May 2014.

 

All in

Kate says that working with Astellas hasn’t simply been a case of them providing the cash – there is true engagement on a corporate and employee level. “The Fistula Foundation has what I would truly term a partnership with Astellas – they’ve been with us every step of the way,” reflects Kate. “It wasn’t a situation where they gave us the money and we never heard from them again. We have the financial and moral support of the company, but Astellas has always been more than a ‘cheque writer’, they’ve been a cheerleader.”

Astellas’ employees also raised money for the Foundation, demonstrating their true commitment to the cause. The company works with a number of charities, and the employees also nominated the Foundation to receive an additional $100,000 of funding. “The employees chose us. That commitment goes to demonstrate the ‘all in’ phenomenon there,” Kate enthused. “The more subtle benefit is that Astellas is getting behind fistula, not only as an issue, but also backing the Fistula Foundation – those things are important too.”

 

Unlimited need

There are many bigger charities than the Fistula Foundation, but this is one that punches above its weight. Despite its small size, the Foundation raised just over $10m last year – up by a factor of five in the last decade – and did more fistula surgeries than the U.S. Government.

Together, they get money to over 30 countries. It’s deliberately run by a small team to keep operations as swift and efficient as possible: “We ask, ‘Is that going to help women get treated?’ If the answer is no, we’re not going to do it,” explained Kate. “We try to get eight out of 10 dollars to those who need them.” It’s still a drop in a vast ocean, however, and there is almost an unlimited need for funds.

The Fistula Foundation says that to successfully treat fistula, three elements are needed: a patient, a trained surgeon and a properly equipped facility.

The women suffering from obstetric fistula often feel ashamed and suffer in silence for years, concealing their condition, not knowing that it is treatable. This makes them hard to find. There are not enough surgeons available to treat the growing numbers of women in need, and some facilities lack even basic equipment.

The statistics show that one million women worldwide, in low–resource countries, suffer from obstetric fistula as a result of giving birth without access to medical help. Out of these, one in 50 get treatment – around 15,000 per year on average* – and thousands more cases develop each year. “It’s relentless,” says Kate. That’s why the committed support of organisations such as Astellas, which is providing funds of €1.5m over three years for the programme in Kenya, is so vitally important. *globalfistulamap.org

 

International awareness

The International Day to End Obstetric Fistula, held on 23 May, and approved at the UN four years ago, is an essential tool to leverage awareness of the problem facing so many voiceless women. “There’s a camaraderie around it, even if there aren’t New York Times headlines,” insistes Kate. “We try to leverage opportunities as much as we can, but it’s a challenge.”

Back when Kate was first working on the Action on Fistula plan with Astellas, she identified her dream, which was to get a network of treatment centres, train doctors, create a community of practice, and form a centre of excellence for surgery excellence.

“Astellas bought it,” says Kate. “I thought it could work, but it is gratifying to see how incredibly well it does. It’s exciting.”   

Go to fistulafoundation.org

 

 

 

 

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Features

5YFV next steps - what they mean for commissioners

by John Pinching 8. May 2017 09:54

 

Step change: ‘Next Steps on Five Year Forward View’ is here, but what does it mean for commissioners?

 

The Five Year Forward View (5YFV) was Simon Stevens long, imploring, ultimately optimistic love letter to NHS England. That original manifesto, with its neo-healthcare, Atlantic-crossing ideas and crusade against the old order, promised a fresh perspective.

Now that it’s half way towards the original vision – or two and a half years into the five at any rate – the whole country watches and waits for the green shoots of change. Meanwhile, ‘Next Steps on the Five Year Forward View’ has been duly published, with new targets in some key areas – notably commissioning.

In order to shed some light on what this means we’ve got an expert who could not be closer to the action.

 

Julie Wood, NHS Clinical Commissioners Chief Executive

View from the expert:

Long before the publication of ‘Next Steps on the Five Year Forward View’ it was clear that the commissioning landscape was evolving. Clinical Commissioning Groups (CCGs) have been playing key roles as architects of this changing landscape and I’m pleased that the Next Steps document has the potential to support the vision that we and our members called for in our ‘future of commissioning’ paper, published last year.

Next Steps recognises just how far clinical commissioning has come since the ‘Five Year Forward View’ (5YFV) was published. Having local clinical leadership at the heart of healthcare commissioning has had immense benefits for patients. While, going forward, we are unlikely to see a single model of commissioning, it is evident that the local clinically-led element must remain, or the NHS will be poorer for it.

 

Facing up to the challenges

The delivery plan didn’t ignore the challenges. There was a welcome focus on improving primary care, urgent care, cancer and mental health, all of which are priorities for our members. The willingness to relax the 18-week waiting time was an important recognition that the NHS can’t deliver everything that is being asked of it within the resources provided by Government.

That said, the plan won’t solve every problem. The NHS is still being asked to deliver an awful lot with finite funding. CCGs are certainly up for the challenge of working with what they have and creating a sustainable health and care system – but this involves making tough decisions. That means working with those who provide care to establish how best to spend the NHS pounds – they can only be spent once.

 

Effective prioritisation

There must be recognition that sustainability needs to involve transformation and doing things differently. The NHS provides high-quality cost-effective care, but its ability to continue will be restricted if we can’t prioritise areas which get the best outcomes for patients, while also getting the best value for our limited budget.

Part of this relates to the work that NHSCC are carrying out on medicines spend, referred to in the delivery plan. We’ve worked with our members to produce a list of items that could be considered low priority for NHS funding , either because they offer no or minimal clinical value – because cheaper and equally effective alternatives are available – or are otherwise low priority.

We’re not calling for a blanket ban – there must be flexibility to allow individual patient needs to be met. Through NHSCC our members will work with NHS England, the professions and patient groups on the best way to implement this, ensuring we are taking these needs into account, while making the most effective use of NHS funds.

This work forms only one part of what will be needed to transform the NHS. Clinical commissioners are ready and able to play their part. They continue to work with partners – through Sustainability and Transformation Partnerships, as well as other local arrangements – to deliver a health and care system fit for the future.

Next Steps has the potential to help and drive forward the transformation agenda. It is vital that we work together across the system to make sure its vision becomes a reality, especially if we are to close the gaps laid out in the 5YFV – not in finance and efficiency but, critically, in health and wellbeing, and care and quality.

 

The Stevens Legacy

Words by John Pinching

 

In spite of a long cross-party, intercontinental career at the higher echelons of healthcare change management, Simon Stevens remains an enigma – a man on a journey where the destination has not come into sharp focus. Even so, his determination to navigate the chaotic landscape feels very real and there is no doubt that this NHS explorer has gained some very useful traction.

It is perhaps his lack of allegiance to a party (he has worked successfully under Labour and Conservative), and a seemingly stealth-like will to fundamentally and positively change the NHS, which have allowed him to avoid the extremities of political bun fighting. Indeed, Simon Stevens is not an unpopular operator and, when you compare that with Jeremy Hunt’s beleaguered public image, you realise that even a mild approachability in the hostile terrain of public health, is a remarkable achievement.

There have been elements of his conduct which provide clues to his modus operandi. When he told people in Britain to lose weight – he lost weight. He is passionate about reducing sugar from the diets of British citizens, and particularly children – he clearly worries about the same things we do. Furthermore, he hasn’t been afraid to bring elements of what he learnt during his spell in America at United Health, such as Accountable Care Organisations, into an antiquarian NHS. This raises the possibility that the public – contrary to popular belief – don’t reject change to our 1948 institution. We simply respect an honest approach and Stevens has adhered to that.

The targets laid out in the 5YFV and, in particular, his determination to integrate fragmented services – attaching GP surgeries to hospitals – use resources more efficiently and place an emphasis on public responsibility, could represent his lasting legacy.

Ultimately, Simon Stevens’s magic bullet could be a combination of political impartiality, an ‘I’m a user too’ mentality and a ‘Stateside’ perspective, but if the journey ends with an NHS that is both ‘beloved’ and functioning within its means, the appointment of Simon Stevens could just be the greatest decision David Cameron ever made.  

 

 

 

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