Pf magazine February 2017 by E4H Ltd

PHARMA&NHS: Solving the puzzle together

February 2017 PHARMAFI E LD.CO.U K

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EDITOR

John Pinching john@pharmafield.co.uk A S S I S TA N T E D I T O R

Amy Schofield amy@pharmafield.co.uk ART DIRECTOR

Emma Warfield emma@pharmafield.co.uk COMMERCIAL DIRECTOR

Hazel Lodge hazel@pharmafield.co.uk MARKETING MANAGER

Rachel Cresswell rachel@pharmafield.co.uk FINANCIAL CONTROLLER

Fiona Beard finance@events4healthcare.com P f AWA R D S

Melanie Hamer melanie@events4healthcare.com PUBLISHER

Karl Hamer karl@events4healthcare.com pharmafield.co.uk events4healthcare.com @pharmafield @pharmajobsuk HEAD OFFICE

Spirella Building Bridge Road Letchworth Garden City Hertfordshire SG6 4ET United Kingdom Cover illustration by Alex Buccheri alexbuccheri.com The content of and information contained in this magazine are the opinions of the contributors and/or the authors of such content and/or information. Events 4 Healthcare accepts no responsibility or liability for any loss, cost, claim or expense arising from any reliance on such content or information. Users should independently verify such content or information before relying on it. The Publisher (Events 4 Healthcare) and its Directors shall not be responsible for any errors, omissions or inaccuracies within the publication, or within other sources that are referred to within the magazine. The Publisher provides the features and advertisements on an ‘as is’ basis, without warranties of any kind, either express or implied, including but not limited to implied warranties of merchantability or fi tness for a particular purpose, other than those warranties that are implied by and capable of exclusion, restriction, or modification under the laws applicable to this agreement. No copying, distribution, adaptation, extraction, reutilisation or other exploitation (whether in electronic or other format and whether for commercial or non-commercial purposes) may take place except with the express permission of the Publisher and the copyright owner (if other than the Publisher).

Letter from the Editor

ndustry transparency is a theme that has emerged repeatedly in the last five years. As with any concept requiring widespread cultural change, it started off as a bold belief system, before stagnating in a vortex of jargon and ‘targets’, as people tried to decipher exactly what was expected. In the last two years, however, we have witnessed a gradual metamorphosis. Our industry has recognised the need to step forward and identify itself but, perhaps most pivotally, it has accepted that the public simply do not know enough about who or what it is. There are a minority of people who are aware that pharma – through a complex set of stages – transforms, extends and saves millions of lives, but there are also a very large number of people who are happy to subscribe to the caricature of mad scientists, with gangster-style money counters. It has been industry’s job to form a positive resistance and Pf Magazine’s role is to champion those endeavours. In this edition, we look at the blossoming partnerships between the NHS and some of our companies – finally these two different animals are recognising that it is actually their differences that represent the key to co-existing. We also talk to healthcare professionals operating in the corridors of the private sector – diligently, professionally and impartially. Do the public or patients even know that industry employs such individuals? In addition, we’ve got the latest on antimicrobial resistance, an entirely unprovoked attack on bacon sandwiches and much more.

We’d also like to welcome our newest Editor’s Assistant, Hunter Pinching, who subscribed on 1 January, 2017

The information contained in this magazine and/or any accompanying brochure is intended for sales and marketing professionals within the healthcare industry, and not the medical profession or the general public.

IN THE NE X T ISSUE: Pf readers go to head-to-head with NHS leaders and we take a look at the most exciting new medicines of our times. Also, a report on the latest ‘Five Year Forward View’ developments...

Pf is published monthly. For subscription details, telephone 01462 476119 or email hello@pharmafield.co.uk.

HAVE AN OPINION ON SOMETHING YOU ' VE RE AD IN P f MAGA ZINE? @Pharmafield

M AG A ZI N E | FEB R UA RY 2017 | 1

MAGAZINE

Contents “By working side by side with healthcare professionals and fully understanding the needs of patients, we can work together to improve the long–term care for patients.” Harriet Lewis, ABPI. Cover story, page 8

3 N E WS

COFFEE BREAK

All the most compelling stories from across our industry, NHS and wider healthcare

JP raises a coffee mug to an orthopaedic research guru who is excited by robots

David Thorne stacks up some numbers while firing a warning flare for pharma

F E AT U R E

The NHS and pharma are arguably closer than they’ve been since about 1948

11 F E AT U R E

Bacon sandwiches are even responsible for our breathing problems, apparently

12 POLITICS

For completely fair medicine access NHS England must take its lead from Scotland

2 | PH A R M A FI EL D.CO. U K

16 F E AT U R E

Healthcare professionals work in industry but, curiously, hardly anybody knows it

20 F E AT U R E

For decades we couldn’t resist antibiotics, but now it seems they are resisting us

OPINION

26 F E AT U R E

Louise Finke had an amazing evening at the Pf Awards and she wasn’t even there!

28 F E AT U R E

The pharma job carousel keeps turning and we’ve got all the movers and shakers

OPINION

P H A R M ATA L E N T

Why are pharmacists facing jail for human error when dealing with prescriptions?

Boehringer Ingelheim’s Director of Sales Lee Gittings shares the secrets of his success

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NHS

PLEASE SCAN YOUR ITEMS NOW Barcode technology used in major industries – such as aerospace and retail – is being introduced to the NHS across England in a bid to revolutionise patient safety. In an initiative spearheaded by the Department of Health, barcodes are being placed on replacement hips, medication and surgical tools. The £12 million Department of Health ‘Scan4Safety’ project enables staff to track each patient through their hospital journey. Used in six pilots across the country, each barcode can be scanned to show exactly

A P P R OVA L S

Blood brothers

which member of staff administers treatment, at what time and where. Everything from a screw used in a knee operation to a breast implant – which may develop a fault years later – can be instantly traced with barcodes. Details, such as when it was used and the surgeon who carried out the procedure, can be tracked. This helps to avoid the risk of patients being administered the wrong drugs, or surgery being performed on the wrong part of the body. Early results from the six pilot sites in Derby, Leeds, Salisbury, Cornwall,

North Tees and Plymouth suggest that the scheme has the potential to save lives, and up to £1 billion for the NHS, over seven years. Tim Wells, Consultant Cardiologist at Salisbury NHS Foundation Trust, said: “Knowledge is power – not only does this provide us with a level of data and insight, it helps us to reduce inefficiencies and improve patient experience and outcomes – more importantly it helps to safeguard our patients from avoidable harm.” Pf View: This is another sublime example of taking mainstream tech and reinventing it in a quite extraordinary, simple and efficient way. Healthcare needs to keep exploring ‘non-medical’ solutions to medical problems.

straZeneca and APT Therapeutics have signed a research collaboration, option and asset deal focused on the development of APT’s lead human recombinant apyrase therapy, APT102, for the treatment of thrombotic diseases. Under the terms of the agreement AstraZeneca will make an undisclosed upfront cash payment to APT, while also being eligible to receive future development milestones. AstraZeneca will carry out all clinical trials with APT102 for the indications of heart attack and stroke. According to APT, studies in animal models of stroke and heart attack have shown that APT102 reduces clot formation – without causing bleeding – and can also reduce bleeding associated with current antithrombotics.Animal studies also indicate that APT102 starts to inhibit platelet activation almost immediately after intravenous administration and continues to work for at least 24 hours after a single injection. Ridong Chen, Ph.D., president and CEO of APT Therapeutics, said: “We have a great opportunity to develop a breakthrough drug that will safely and substantially improve the lives of millions of patients worldwide.”

M AG A ZI N E | FEB R UA RY 2017 | 3

BAC K T WE ET THE WORD ON CYBER STREET SOMETHING TO SAY? @Pharmafield

Jeremy Hunt @Jeremy_Hunt

Congratulations to Sir David Behan @CareQualityComm on his knighthood. Very well deserved #NewYearsHonours

SMOKING.

NO SMOKE WITHOUT PYRE

UK Prime Minister @Number10gov

PM will set out plans for a new approach to mental health support in her speech @ChtyCommission.

Smoking costs the global economy more than $1 trillion a year, and will kill one third more people by 2030 than it does now, according to a study by the World Health Organization (WHO) and the U.S. National Cancer Institute. That cost outweighs global revenues from taxes on tobacco, which the WHO estimated at $269 billion in 2013-2014. The study – peer-reviewed by more than 70 scientific experts – stated that the number of tobacco-related deaths is ‘projected to increase from about six million deaths to about eight million, annually, by 2030. More than 80% of these will occur among low and middle-income countries’. Although smoking prevalence was falling aross the global population, the total number of smokers worldwide is rising, the study said. ‘Government fears that tobacco control will have an adverse economic impact are not justified by the evidence. The science is clear; the time for action is now,’ the report concluded.

OTWO Eben L Britz. @ebenlouis

Thank you, @GeorgeMichael for the charity work and donations you gave in support of HIV/AIDS and the LGBTQI Community. Bayer AG @Bayer

Worldwide, some 415 million are affected by #diabetes today – by 2040, that figure could be 642 million. Pf View: The news that the number of global smokers is increasing comes as a shock and underlines the responsibility of governments, the tobacco industry and even pharma to educate society with stark anti-smoking messages.

Pfizer Inc. @pfizer

4%-7% of smokers who attempt to quit unaided are likely to succeed #StopSmoking #ValueOfMeds You can seek support @quitterscircle Roche @Roche

Most #HPV infections have no symptoms. So tell all the women in your life to get tested! #CervicalHealthMonth Boehringer @ ‫ ‏‬Boehringer

Did you know? Over 70% of infectious #disease outbreaks in humans since the 1940s originated in #animals. #BIAnimalHealth BTGFC HealthCare @btgfchealthcare

NHS England chief executive Simon Stevens has criticised revellers for treating the NHS as the “National Hangover Service.”

4 | PH A R M A FI EL D.CO. U K

BUSINESS.

IT’S NOT ME, IT’S YOU

anofi and its vaccines global business unit Sanofi Pasteur have confirmed the end of their vaccine joint-venture with MSD, Sanofi Pasteur MSD (SPMSD). Sanofi Pasteur and MSD will now pursue their vaccine strategies separately in Europe, integrating their respective European vaccines businesses into their operations. The project has been managed in an open dialogue with the SPMSD employees, unions and relevant external stakeholders, in compliance with the applicable rules and regulations, since its announcement in March 2016. The respective companies will now be able to define their own vaccines strategies. As part of its strategic roadmap 2020, Sanofi announced in November 2015 that it would reshape its portfolio through sustained leadership in vaccines.

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M E D I C A L E D U C AT I O N

Events4Healthcare launches Parallel Learning

vents4Healthcare (E4H) has announced the launch of a unique learning portal at parallellearning.co.uk. This new initiative is the culmination of E4H’s vast experience of delivering medical education. This project has come about in direct response to an industrywide survey taken in 2016. The Pf People Survey measures company perception, motivation and general satisfaction within the pharma industry. One huge gap that was highlighted was the lack of knowledge within pharma of the ever-changing structure of the healthcare environment.

Karl Hamer, E4H director, explained the decision to create Parallel Learning: “We have been delivering medical education to the pharmaceutical sector for 10 years,” he said. “Over time we realised that there was a need to provide insights for both the pharma industry and healthcare professionals on what changes are happening across the NHS – today and tomorrow. We will also examine the impact these factors will have on delivering effective patient care and partnerships between industry and the NHS.” Go to parallellearning.co.uk

Quick doses People with protein in their urine may be more likely to develop problems with thinking and memory skills, or even dementia later in life, according to a study published in the online issue of N E U R O LO GY. The BAY E R C A R E S FO U N DATI O N presented the Aspirin Social Innovation Award and a prize of €20,000 to five international initiatives for new approaches in the areas of healthcare and nutrition. A poll reveals that 61% of GPs and secondary care doctors believe that G P S U R G E R I E S should be placed in A&E departments to deal with patients who turn up to hospital inappropriately. E I S A I has entered into a joint research agreement with K E I O U N I V E R S I T Y, Japan, with the aim of discovering new drugs and therapies for the treatment of dementia. S E RV I E R has partnered with P I E R I S P H A R M AC E U TI C A L S to co-develop Pieris’ preclinical dual-checkpoint inhibitor PRS-332 and up to seven other immunooncology bispecific drug candidates. A B P I reacts to Brexit Committee’s ‘transitional arrangements’: “We welcome its focus on getting medicine regulation right from day one. Regulatory cooperation is in the best interests of the UK Government, EU members and patients.”

ASTHMA

Captain sensible

laxoSmithKline (GSK) and Innoviva have announced the start of a phase III study investigating the effects of once-daily combination therapy, fluticasone, when compared to Relvar/Breo® (FF/VI), as a treatment for patients with asthma. The closed triple combination therapy is comprised of three medicines, delivered once-daily in GSK’s Ellipta® dry powder inhaler. In the phase III study – CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) – the primary endpoint is the change from baseline in trough volume, at 24 weeks of treatment. The key secondary endpoint is the annualised rate of moderate/severe asthma exacerbations, while other endpoints are assessing health-related quality of life and symptom control. Dave Allen, Head of Respiratory R&D at GSK, said: “Despite the availability of treatments, many patients have asthma that is inadequately controlled. While some patients already receive triple therapy in two or more inhalers, we believe there will be real benefits from delivering the dual bronchodilators together.”

M AG A ZI N E | FEB R UA RY 2017 | 5

MERGERS &. AC Q U I S I T I O N S .

SWAP SHOP ZIK A VIRUS

Secret seven Researchers at the University of Maryland School of Medicine (UM SOM) say that they have identified seven key Zika Virus proteins that may cause a range of dangerous health problems. The study was published in the ‘Proceedings of the National Academy of Sciences’. Researchers at UM SOM tested the virus using fission yeast, which was originally used to make beer, and has been used by scientists for many years to identify mechanisms and the behaviour of cells. Lead researcher on the study, Dr Richard Zhao – a professor of pathology at UM SOM – is a pioneer in using the yeast model to study human immunodeficiency virus. For the experiment, Dr. Zhao and his colleagues separated each of the Zika virus’s 14 proteins and small peptides from the overall virus. He then exposed yeast cells to each of the 14 proteins, to see how the cells responded. Seven of the 14 proteins harmed or damaged the yeast cells in some way, inhibiting their growth, damaging them or killing them. Dr Zhao said: “We now have some really valuable clues for future research.” The next step in the research is to understand more about how these seven proteins work in humans. The problems associated with Zika include the birth defect, microcephaly, and neurological problems such as Guillain-Barré syndrome.

6 | PH A R M A FI EL D.CO. U K

N H S E N G L A N D.

COMBINATION THERAPY

Sanofi and Boehringer Ingelheim have confirmed that the strategic transaction signed in June 2016 – consisting of an exchange between Sanofi’s animal health business (Merial) and Boehringer Ingelheim’s consumer healthcare (CHC) business – has been successfully closed in most markets. It marks the successful outcome of business swap negotiations, which started in December 2015. Alan Main, Executive Vice President Consumer Healthcare and a member of Sanofi’s Executive Committee, will steer Sanofi’s CHC business, including the former Boehringer Ingelheim CHC brands. Meanwhile, the Boehringer Ingelheim animal health business unit will be headed by Dr Joachim Hasenmaier, who will remain as Member of the Boehringer Ingelheim Board of Managing Directors. Olivier Brandicourt, Chief Executive Officer of Sanofi, said: “The integration of Boehringer Ingelheim’s highly skilled CHC team, and its well-established products, allows Sanofi to enhance positions in core strategic categories in a promising CHC market.”

HS England (NHSE) has launched a scheme to benefit patients across the country by getting 1500 extra clinical pharmacists into GP surgeries. Clinical pharmacists are highly-trained experts in disease and medicine, and can work as part of the general practice team, providing advice for patients, particularly the elderly and those with multiple conditions. By taking responsibility for patients with chronic diseases, clinical pharmacists can free up GPs for other appointments, thereby reducing the number of people presenting at A&E departments. The clinical pharmacists will work closely with community and hospital pharmacists to provide joined-up NHS pharmacy services for patients. NHSE guidance to help with the next round of applications has been published. This follows a successful pilot in which over 490 more clinical pharmacists worked in approximately 650 GP practices across 90 pilot sites.

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P R O S TAT E C A N C E R .

GREAT LIGHT HOPE

new non-surgical light-based therapy has shown potential in early cases of prostate cancer. The phase III clinical trial of a new technique called vascular-targeted photodynamic therapy – led by researchers at University College London – involves injecting a lightsensitive drug into the bloodstream. It is subsequently activated with a laser, which destroys tumour tissue in the prostate. The method was trialled in 413 patients, and 49% of patients treated went into complete remission, while just 13.5% of the control group went into remission. Radical therapy, such as surgical removal or irradiation of the prostate, is currently the main way of treating prostate cancer. These approaches can lead to problems such as erectile dysfunction or incontinence.

The light-based therapy, however, targets tumours precisely, reducing the risk of side effects and allowing low-risk patients – who would not normally be treated – to benefit from the approach. Lead investigator Professor Mark Emberton, Dean of University College London Medical Sciences, said: “The success of this new tissue-preserving treatment is welcome news indeed.” Pf View: It sounds like something that would be administered on an ailing character in a Star Wars film, but this is just the sort of innovative tech that gets everyone in the galaxy excited about modern treatments.

M E R G E R S & AC Q U I S I T I O N S

Holy alliance

Abbott has completed the acquisition of St Jude Medical, establishing the company in a high position across cardiovascular device markets. Upon completion of the acquisition, St Jude Medical became a wholly-owned subsidiary of Abbott. St Jude Medical has a strong position in fast-growing areas such as atrial fibrillation, heart failure, structural heart and chronic pain, while Abbott occupies a leading position in coronary interventions and mitral valve disease. Abbott will continue to bring numerous new products to market over the coming years, including the EnSite Precision™ cardiac mapping system, and the ConfirmRx™ Implantable Cardiac Monitor and HeartMate 3®, which offers physicians more options for patients with advanced stage heart failure. Miles White, Abbott’s Chairman and Chief Executive Officer, said: “The addition of St Jude Medical creates one of the broadest medical device portfolios in the world and provides a steady stream of new technologies and therapies for many years to come.”

I M M U N OT H E R A PY

FUNDING

Welsh care bit The Association of the British Pharmaceutical Industry (ABPI) has welcomed the Welsh Government’s launch of an £80 million New Treatment Fund aimed at speeding up access to the very latest medicines for Welsh NHS patients. The ABPI advocated the new funding mechanism in the build-up to the 2016 National Assembly for Wales elections, as a way of delivering ‘equitable and consistent patient access to the latest medicines, no matter the disease area’. Annually, it will provide additional support of £16 million to Welsh health boards until 2021. Under the new system – confirmed by Health Secretary Vaughan Gething – all health boards in Wales will be required to make National Institute for Health and Care Excellence, or All Wales Medicines Strategy Group recommended, medicine available no later than two months from the date that guidance is published. Dr Rick Greville, ABPI Director with responsibility for Wales, said: “This announcement is great news for NHS patients in Wales and is the type of progressive policy which can make a real impact on patients’ lives. The people of Wales should look forward to the prospect of benefitting from the right medicines, for all patients, at the earliest time.”

T junction

Researchers at Yale Cancer Center and Yale Medicine have identified the critical target of new immune-checkpoint therapies – subsets of immune cells called tissue resident memory (TRM) T cells. In the same research, scientists found that individual metastatic cancer lesions contain unique sets of TRM cells. Tumour tissue resident memory T cells are different from those T cells circulating in the blood, both at a phenotypic and genomic level. The study’s senior author, Dr Kavita Dhodapkar, Associate Professor of Pediatrics at Yale School of Medicine, said: “Understanding the biology of TRM cells and the factors that control the persistence of these T cells within tumours will allow us to improve upon the current immune therapies.” The results of the study were published in the Journal of Clinical Investigation Insights.

M AG A ZI N E | FEB R UA RY 2017 | 7

PHARMA&NHS: Solving the puzzle

together

WORDS BY

8 | PH A R M A FI EL D.CO.U K

Amy Schofield

COVER STORY

How is industry working with the NHS to deliver the best possible outcomes for patients?

ross-sector joint working initiatives are witnessing the NHS deliver better outcomes for patients, by drawing on the extensive knowledge and expertise of the pharma industry. Joint working ensures that patients receive optimal care and support to help them maximise the benefits of their treatment. The Association of the British Pharmaceutical Industry (ABPI) produced a toolkit in 2012, when the concept was in its infancy. ‘Joint Working – A quick start reference guide for NHS and pharmaceutical industry partners’ describes these inter-sector partnerships as: ‘Situations where, for the benefit of patients, NHS and industry, organisations pool skills, experience and/or resources for the joint development and implementation of patientcentred projects and share a commitment to successful delivery.’ In delivering all that it promises in its ‘Five Year Forward View’, the NHS faces many challenges, including intense financial pressures and an unrelenting drive to improve quality and productivity. Kopano Mukelabai, National Programmes Manager, Roche UK, said that the chance to work together exists despite – or perhaps because of – the challenges facing the health service: “There is real opportunity for this country to be a global leader in healthcare, even at these times when NHS finances are under severe strain.” As a result of these difficulties, NHS organisations are increasingly calling on external expertise to supplement existing skills and resources, helping them rise to the challenges they face. This is where pharma enters the equation.

T WO H E ARTS

he pharmaceutical industry not only develops and supplies medicines that improve patients’ lives, it also brings business and financial expertise and a vast knowledge of therapy areas – essential for joint working initiatives with the NHS. The Department of Health and the ABPI – along with pharmaceutical companies and other key industry bodies – are actively promoting joint working initiatives. Harriet Lewis, NHS Engagement Partner (North) and Medicines Optimisation Lead at the ABPI, explained: “The pharmaceutical industry is wholly committed to working in partnership with NHS providers and commissioners to improve outcomes for patients, both nationally and regionally.” The ABPI has four regional expert networks that focus on partnership working to support the NHS in delivering efficient and transformational services and care for patients. They provide opportunities for collaborations that focus on delivering benefits for patients, ranging from addressing pathway challenges, reducing unwarranted variation in care across regions and service arrangements to improve patient access to innovative treatments. The Greater Manchester Diabetes Partnership – a collaboration between the NHS, ABPI, and a number of pharmaceutical companies – was set up in February 2016 to explore ways to enhance diabetes care. “By establishing a more integrated approach to patient care across Greater Manchester, with support from providers, commissioners, and thirdsector stakeholders, the Partnership is working to improve patient outcomes and reduce unwarranted variation across the area,” reflected Harriet. Collaborative working presents its own challenges, however. “When initiating joint projects between the NHS and industry, they often require more than one company to be involved,” added Harriet. “There can, therefore, be delays and barriers, as each side negotiates its responsibilities and roles to ensure a fair division of work among all involved. We believe, however, that by helping to sustain the NHS for the future, by working side-by-side with healthcare professionals and fully understanding the needs of patients, we can work together to improve the long–term care for patients.”

“Our ultimate goal is to transform the lives of thousands of people in the UK living with, and beyond, devastating conditions.” Kopano Mukelabai, National Programmes Manager, Roche UK

S E E DS O F C HAN G E

epartment of Health guidance encourages NHS organisations and their staff to consider opportunities for joint working with the pharmaceutical industry, where benefits to patient care and the difference it can make to their health are clearly beneficial. In 2008, the Department of Health produced, ‘Best practice guidance for joint working between the NHS and the pharmaceutical industry’. It was designed to encourage NHS organisations and staff to consider joint working as a realistic option, and to advise NHS staff of their main responsibilities when considering such partnerships with the pharma industry. After the publication of the ABPI’s initial toolkit, it released ‘Joint working with the pharmaceutical industry, guide and case studies’, in 2013. This publication shared seven steps to setting up joint projects, as well as providing evidence of successful partnership initiatives.

M AG A ZI N E | FEB R UA RY 2017 | 9

COVER STORY

NHS/PHARMA

G I A NT L E A P S : G S K Joint working projects completed in 2014-2015 included NHS Lanarkshire and GSK working jointly to improve the management of chronic obstructive pulmonary disease (COPD) across North and South Lanarkshire Community Health Partnership Boundaries. Meanwhile, Epilepsy Scotland, Union Chimique Belge Pharma and GSK UK worked jointly to evaluate and subsequently improve the services for epilepsy patients in Dumfries and Galloway Health Board.

S U P P O RT G R O U P: M S D The company says that ‘some of its greatest achievements have come about through collaborative effort’. These include working with NHS North Lancashire, Ely Lilly, Novo Nordisk and Pfizer on the Primary Care Diabetes Facilitator Project to increase management of diabetes in primary care. It also has a partnership with the London Sexual Health Programme (NHS England, London) and Bayer HealthCare on ‘Improving Choices in Contraception through Training’.

S TR E E T W I S E : A S T R A ZEN EC A The company says that it is ‘committed to ensuring that AstraZeneca’s business is aligned with NHS priorities and supports delivery of excellent patient care’. It has duly undertaken over 30 joint working projects since 2009. These include collaborating with Stockport CCG to improve asthma and COPD care and reduce unplanned admissions and unwarranted variation.

B R E ATH E E A SY: T E VA U K Involved in a number of joint working projects with the NHS across the country, Teva has helped with ‘Improving Asthma Outcomes’ in Ashford Clinical Commissioning Group, via a Medicines Use Review (MUR) support programme. This included inhaler technique training, MUR training and reducing asthma hospital admissions across NHS Bristol.

ROCHE SOLID: ROCHE Over the last three years Roche has worked with over 25 NHS organisations on more than 28 projects. These include supporting initiatives to remodel cancer pharmacy services, helping to build whole system integrated care platforms in the South of England and alongside The Christie, in the new setting of a devolved health economy.

HIGH FIVES

FOR THE COM MON G OOD

harma has enthusiastically embraced working in partnership with the NHS, and vice versa. Across industry, projects that support innovation and high-quality patient care have been successfully completed and many more are ongoing, with the common goal of better patient outcomes providing the driving force behind them. Roche’s Kopano Mukelabai sums up the approach of industry to partnering with the NHS: “Our ultimate goal is to transform the lives of thousands of people in the UK, and beyond, living with devastating conditions. Central to this is our promise to do all we can to ensure patients can access the medicines and tests that we are proud to have worked so hard to develop, while at the same time recognising that – for the NHS to remain sustainable – we all need to work together to ensure that every opportunity to capture value is maximised across the whole pathway.”

10 | PH A R M A FI EL D.CO.U K

F E AT U R E WORDS BY

Amy Schofield

Are bacon sandwiches taking our breath away? Don’t believe the hype: health headlines dissected TH E S TO RY

TH E R E S U LT S

Alarming headlines have warned baconlovers that too many risky rashers could lead to a life-threatening asthma attack. A study published by The BMJ suggests that eating four or more portions of processed meats a week could worsen asthma symptoms. We know that processed meat has also been compared to smoking when it comes to carcinogenic risk factors, but is it also responsible for extreme breathlessness?

Participants were analysed for an average of seven years, after which time just over half (53%) showed the same asthma symptom score and 27% demonstrated improved scores. Asthma symptom scores were worse in 20% of study subjects. The data showed that tucking into processed meat at least four times a week increased the risk of worse asthma symptom scores by 76% – though some of this could be explained by the link between cured meat consumption and existing high BMI.

TH E R E S E A RC H Researchers used information from a study of more than two decades on over 2000 people, their close relatives, and a comparison group from five French cities. They were looking for links between worsened asthma symptom scores after levels of consumed cured meat were measured. When the study began, around 40% of the participants had previously been diagnosed with asthma. Meanwhile, the control subjects had no history of the condition. The reported study was based on 971 adults, from whom complete diet information, weight, asthma symptom scores and demographic data were taken. Of the total, 35% were overweight, while 9% were obese. Participants also filled in health and dietary questionnaires, asking them how often they ate 118 foods, including cured meats. Asthma symptoms in the preceding 12 months, such as shortness of breath, chest tightness, and difficulty breathing, were recorded and scored from zero to five. Taking other factors that may influence the asthma symptom score – such as smoking and physical activity – into account, the scientists analysed the data to assess any links between the consumption of processed meats, and body mass index.

TH E D E A L The researchers said: “While the indirect effect mediated through BMI accounted for only 14% of this association, the direct effect explained a greater proportion, suggesting a deleterious role of cured meat independent of BMI”; meaning that a higher intake of cured meat was associated with worsening asthma symptoms over time, though not with doubling the risk, as some headlines claimed. It’s difficult to prove that just one food can cause asthma symptoms, and food is just one factor in the mix of asthma symptoms risk.

W HAT TH E PR E S S SA I D : “Regularly indulging in a bacon sandwich doubles the risk of an asthma attack” The Sun; “Processed meat ‘could be bad for asthma’” BBC News; “Four ham sandwiches a week could almost double risk of asthma attack” The Telegraph

THREE

LITTLE PIGS

The earliest reference to a ‘BACON SANDWICH’

1931

WAS BY GEORGE ORWELL IN

THE ROMAN EMPEROR

CONSTANTINUS I

& THE CATHOLIC CHURCH MADE

SAUSAGE

EATING

a sin in 320AD MORE THAN

44,000 CANS OF SPAM

ARE PRODUCED EVERY HOUR

M AG A ZI N E | FEB R UA RY 2017 | 1 1

SCOTLAND

WORDS BY

Vicky Whitehead

n independent assessment of access to new medicines in Scotland – the Montgomery Review – recently found a marked increase in access to end-of-life, cancer and orphan medicines since 2014. Perhaps even more surprising was that it found high levels of satisfaction across stakeholders in the community – including patient groups, clinicians and industry. This story seems to present a stark contrast to the situation in England, where cancer drugs have required the creation of the notorious Cancer Drugs Fund to ensure patient access, and where specialised services have been threatened with a clampdown. Every day the mainstream media seems to carry another news story about a patient who has been denied the life-saving breast cancer treatment, Kadcyla – representing a recent example in a long-line of NICE rejections. Satisfaction it seems in England is at an all-time low, so can anything be learned from our dear neighbours?

I N FLU E NT E N G LI S H Let’s examine how the English system for access to new end-of-life and orphan medicines is functioning. These products come under the banner of ‘specialised services’ and, in England, the medicines assessment process is slow, complex and unpredictable. To highlight one key way in which the English system is problematic – it is not always clear which organisation is likely to undertake the assessment of a new medicine. This can either fall to NICE or NHS England. Even the respective organisations themselves don’t seem clear on their responsibility. A 2015 review by the Genetic Alliance found at least four medicines for which both NHS England and NICE had made plans to evaluate. When medicines do go through NHS England, the assessment process is opaque and inconsistent. Since 2013, NHS England has used at least three different evaluation processes for new medicines and it has yet to make public the majority of its meeting notes, or board papers, relating to how treatment decisions are made.

PAC E S E T TI N G

OUR FRIENDS in the NORTH When it comes to satisfaction and access NHS England could learn much from Scotland 1 2 | PH A R M A FI EL D.CO.U K

Which brings us to the situation in Scotland. In 2014 they were in a similar position to England. Following long-term concern that a significant proportion of medicines for end-oflife and rare conditions were not being funded, the Scottish Medicines Consortium (SMC) introduced significant changes to its evaluation processes. The feeling in Scotland was that these medicines were predominantly being denied on grounds of cost, despite their effectiveness. Under the new process, orphan, end-of-life and new cancer medicines would be evaluated by the New Drugs Committee (NDC). If it looked like the NDC would pass a negative recommendation, there would be an option for a Patient and Clinician Engagement (PACE) meeting. The aim of PACE is to describe the added benefits of the medicine, from both patient and clinician perspective – benefits that may not have been captured within typical clinical and economic assessment processes. This seems to have caused a cultural shift in the Scottish NHS. The Montgomery Review found that a startling 92% of end-of-life medicines, and 67% of cancer medicines that received supportive PACE statements, went on to be approved. The result for orphan medicines has been less impressive, increasing by only 14%. Overall, however, these show how much increased clinician and patient engagement has impacted on the rate of approval for access to new medicines.

POLITICS

“NHS England should seriously consider the creation of a Patient and Clinician Engagement process, which has been so successful in Scotland and which effectively incorporates the voice of stakeholders.”

ROUTE OF THE PROBLEM

SCOTL AN D TH E B R AVE NHS England can clearly learn a great deal from Scotland’s reinvigorated processes. In Scotland – unlike in England – every single medicine went through the SMC. There is only one assessment body, rather than two, which already halves the complexity of the process. Though recent changes in specialised services have moved to streamline arrangements between NICE and NHS England, it is evident that the two organisations are not going to become one any time soon. NHS England should seriously consider the creation of a PACE process, which has been so successful in Scotland, and which effectively incorporates the voice of stakeholders. Within NHS England, patient and clinician engagement is currently achieved through bodies called Clinical Reference Groups (CRGs). These groups have reported to the National Audit Office that they are unsure of how their advice is actually used. Recently the number of CRGs has been drastically reduced, with some suggesting that those which fought hardest against NHS England decisions were the first to go. It seems that there is a strong need for NHS England to make sure that patients and clinicians are better represented in its processes. It is likely that this feeling of inclusion has contributed as much to the satisfaction of stakeholders, as the actual physical increase in the commissioning of new medicines. Though multiple recent policy documents – including the ‘Accelerated Access Review’ and the ‘Five Year Forward View’, have promised greater patient and clinician empowerment, tangible changes remain to be seen. With an NHS whose funding remains increasingly under pressure, it is all too important that patients and clinicians begin to feel that the right decisions are being made. The first step then, is to ensure that the treatments they would prefer are funded. The answer to this dichotomy is well within reach – indeed, it’s just over the borderline.

s the Genetic Alliance has previously highlighted, ‘without a coordinated, transparent and publicly accountable approach for triaging medicines into each route, inconsistent decisions are at a risk of being made’. Ultimately patients may be denied access to a medicine purely because of the route by which it was assessed. In addition, the complexities of the system have previously resulted in a massive backlog of decisions and, consequently, delays in patient access to treatments. The upshot is that when the National Audit Office interviewed stakeholders last year, they did not find high-levels of satisfaction. Instead they discovered multiple concerns around consistency and transparency.

“Patients may be denied access to a medicine purely because of the route by which it was assessed.”

Vicky Whitehead is Head of Research at Decideum - the views expressed here are entirely her own. Go to Decideum.com

M AG A ZI N E | FEB R UA RY 2017 | 13

DAYDREAM BELIEVER JP boils the kettle in readiness for a quite remarkable story INTERVIEW BY

ravailing the avenues and alleyways of healthcare – in search of the truth – I have encountered some extraordinary individuals. Within the echelons of UK orthopaedic research, there is a doctor who likes to dream. With this considered, it is my pleasure to introduce, Dr Kaveh Memarzadeh. What is Orthopaedic Research UK (ORUK)? It is a prominent London-based medical charity involved in funding bone and joint-related research, and conducting very popular training for professionals. It was founded by pioneering orthopaedic surgeon Mr Ronald Furlong in 1989, and has been active ever since. Dr Arash Angadji is our new Chief Executive and he has introduced a new phase in the charity’s history, aiming to increase our impact on healthcare.

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John Pinching

What is your specific role? My role is unique. It involves considerable creativity, rigour, struggle, enthusiasm and, occasionally, daydreaming. Believe it or not, it helps a lot with the creative process! I’m in charge of the science and research that our organisation funds, while also communicating findings to the public. I’m a great believer in science communication – being honest with your audience is key. People often say ‘you need to dumb it down for average people to understand’. That’s nonsense – I think the concept behind the most complicated research can be understood if scientists take the time to get out there and share it with the public. How have you begun the New Year at ORUK? With a bang! In many ways 2017 is going to be a crucial year for all of us at ORUK, because we will see the implementation of a new five-year strategy which has patients and innovation at its very

core. I’m also excited about the setting up of our new website – designed with patients in mind – which will be launched early this year. What does your research involve? The previous research funded by our charity covered the vast field of orthopaedic subjects. We are now focussing on a much narrower field of research . We’re becoming more focussed on dealing with pain – a major factor affecting the quality of life among millions of patients. Other areas include post-operative complications and – closer to my heart – new innovations in medical devices. This is everything from utilising nanoparticles on device surfaces for antimicrobial purposes, to the exciting field of robotics. What interesting results have emerged from your research in the last few years? We have scientists working on fascinating subjects, such as bone cancer induced pain, to help look for biomarkers that could help

COFFEE BRE AK

“I think the concept behind the most complicated research can be understood if scientists take the time to get out there and share it with the public.”

alleviate pain for those individuals suffering from an already progressed cancer. What are the organisation’s biggest challenges? For an organisation like ours we must stay ahead of the current trend of research and remain open to the new possibilities that technology allows – choosing research projects that are going to have a direct impact on people’s everyday lives and not shying away from new industry opportunities. How far has the understanding of your field progressed in recent years? This is very much an ongoing progress – that’s how science operates. The more you learn about a field, the more you realise how little you know. What are the typical orthopaedic conditions that people live with in Britain? Because we are an increasingly ageing nation, conditions such as osteoporosis and arthritis are going to affect more people. As a nation we’re also suffering from conditions such as obesity, which could put a significant strain on our joints and lead to serious orthopaedic conditions. The good news is that many organisations – ORUK included – are promoting a healthy lifestyle and can direct those seeking help in the right direction.

What are the most effective modern treatments for patients in the orthopaedic realm? While not exactly modern, by far the most effective treatment is the hip replacement procedure. I’m also excited by what I’m seeing from the field of robotics, which can assist otherwise wheelchair-bound and immobile patients to walk again. What milestones would the organisation like to reach over the next five years? To become more public-facing, encourage more patient interaction and always put patients first. Orthopaedic conditions are among the most common around, but because they’re not fatal, they are not perceived as important enough. We want to change this by highlighting a good quality of life for patients. Tell me about your journey to Britain I arrived in London as a 15-year-old immigrant kid from Iran – exactly 17 years ago. I was clueless about the language – apart from saying ‘hello’. I had no idea about the culture and felt extremely stupid and inadequate at times. I remember listening to people speak at first, and saying to myself: “I thought I understood the English language but, no, I don’t”. It was an alien

experience, but I liked the difference – it provided me with a challenge. My mother had decided that it’s important to send her kids to a country which is home to scientists such as Isaac Newton, Charles Darwin and Rosalind Franklin! What has been the most rewarding aspect of working here? The fact that it allows freedom of thought and the culture of making science a priority. The real turning point for me was when I studied at university. Being exposed to people with different backgrounds allowed me to appreciate the diversity of thinking and the ability to question things that you once thought ‘set in stone’. I apply these values to most things in life and they have made me the person I am today. What one record would you choose for the soundtrack of your life? Time by Pink Floyd. It’s all about knowing the value of life and appreciating every second. What is your favourite meal? Spaghetti with meatballs. Nice one. Goodbye Kaveh Bye John. Go to oruk.org.

M AG A ZI N E | FEB R UA RY 2017 | 15

UNMA S

Shaantanu Donde, Pfizer

“You have to stay focused on patient health, without compromising your integrity.”

ome would view a healthcare professional (HCP) taking a job with a pharmaceutical company as akin to an impressionable Jedi being seduced by the dark side of the force. Many more don’t even know that doctors, nurses and a plethora of other medical people even operate within industry.

TH E RO LE

C HA N G I N G LI V E S

I am the Regional Medical Therapeutic Area Lead for the Europe Region. I provide medical support toward driving established drugs, while also launching newer variants into the market. The role entails coordination with national and global colleagues, and collaboration with business, safety and regulatory personnel. I also develop responses to medical queries received from HCPs and provide training to medical and business colleagues on products and therapy areas.

We can touch lives of our patients by addressing their needs through contributing to the development of new medicines and improving disease awareness. We also strive to help HCPs who have direct communication with patients, while ensuring the continued safety of drugs, and releasing safety alerts when adverse events occur in marketed products.

S O U N D A DV I C E We provide strategic inputs regarding the effectiveness and safety of the products. This helps them reach larger and relevant populations through customer insights. As experts in the therapy area, we also give advice based on the unmet needs of disease areas and share competitive intelligence based on recent scientific data and literature.

I N D U S TRY S TR E N GTH I have continued to work in the industry as it offers a very conducive environment where your thoughts are valued and your innovation can influence the development of future strategies.

PATI E NT FO CU S We do not generally get an opportunity to directly work with patients, but we can play a critical role in shaping their health by ensuring that our medicines are effective and safe. We can drive many patient awareness programs by developing appropriate content, but have to be sensitive about not influencing their decisions to adopt our products.

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R E WA R D SYS TE M Satisfaction comes from influencing patients’ health through working on so many good quality drugs. Getting an opportunity to engage with great HCPs, who have immense respect for the company and are willing to lend their expertise for better patient outcomes, is a really gratifying experience.

PU B LI C I MAG E Though there is more visibility about the physicians working in the industry, I do not believe the general public are cognisant of this fact.

AC H I E V I N G BA L A N C E It is very possible to stay unbiased. You have to stay focussed on patient health, without compromising your integrity, and there are checks to ensure you don’t promote your products inappropriately. The interactions with HCPs are critical and you must ensure that accurate information – based on scientific evidence – is shared appropriately. Go to Pfizer.co.uk

SKED

F E AT U R E

Who are the healthcare professionals that don’t work for the NHS? WORDS BY

John Pinching

In reality, HCPs are just as qualified, just as diligent and just as sworn to the ol’ Hippocratic oath as their NHS counterparts. Two HCPs working at two of the biggest pharma companies now reveal how they navigate the private sector terrain, while keeping patients in sharp relief.

TH E RO LE

C HA N G I N G LI V E S

I am a senior medical adviser working in the field of type 2 diabetes. I am principally involved in UK medical affairs, which entails the medical management of a launched product. I advise and interact with colleagues from commercial, legal and health outcomes, as well as NHS clinicians and other public officials. I have held numerous posts in medical affairs and clinical development over the years in several companies and therapeutic areas.

Given that new drugs coming to the market must demonstrate benefit – both from an efficacy, but also a health economic argument – it is clear that in working with such medicines you are making a difference to health. As a medical adviser you can also help educate stakeholders on the benefits of those medicines.

S O U N D A DV I C E I advise on all medical aspects, to support accurate and balanced information about licensed diabetic medicines, as per the ABPI Code of practice. I also advise internally about data and other information on the company’s and competitors’ products.

R E WA R D SYS TE M Reward comes from addressing real unmet need with high-science medicine. I really enjoy cutting-edge innovation and thinking. For example, I was involved with a company that brought a new class of cancer treatment to the market and this has really revolutionised the way that some cancers are now treated.

PU B LI C I MAG E I N D U S TRY S TR E N GTH In the past I have been an NHS GP and an anaesthetist, however, around 25 years ago decided that I would have a more fruitful and exciting career in the pharmaceutical industry. Had I remained as a GP in the NHS, I would now be very disillusioned and looking for early retirement. I do still see patients, as I have a weekly private practice session in London.

PATI E NT FO CU S As I still see patients, I can understand that working solely for industry can blinker views and lead one down a tunnelled path. One is at risk of not seeing the big picture and being lost in the minutiae of data.

The public are not aware of us. Historically, and to this day, pharma is seen as a suspicious industry by the media, and this misconception has been passed on to the public. Although it has not changed in several decades, HCPs within the NHS now hold greater respect for pharmaceutical physicians than they once did.

Duncan Gould, Merck

“The medical role is to put the patient at the heart of all decisions.”

AC H I E V I N G BA L A N C E It is possible to be completely unbiased and it is very important that one is. The medical role, and that of others, is to put the patient at the heart of all decisions. I have only ever experienced this philosophy with the companies I have worked for. Being biased is wrong and will be found out. Go to merck.co.uk

M AG A ZI N E | FEB R UA RY 2017 | 17

How can you maximise your primary care investment when the focus is shifting to specialty?

The market is changing...

he landscape of pharma is clearly changing rapidly – the emergence of the self-managed patient, digital technology and different pressures on our healthcare systems are making an impact. The most successful navigators of the new terrain will be those that release innovative and life-changing therapies into a medicine ecosystem that they fully understand, while also preserving the value of established treatments. It’s not just about what is happening now, it’s about having your finger on the pulse of ‘future pharma’, what it looks like and how to succeed through both cutting-edge science and evolving commercial models. The rise of specialty medicines is a worldwide trend, with their share of global medicine spend rising by 10% in the last decade, and set to increase by another 5% over the next five years.* By 2021, speciality drugs will be approaching half of total medicine spend in the UK. Whilst the highest growth will come from specialty products, established and primary care brands will still generate a large part of pharma revenue.

With sales and marketing budgets decreasing and what remains increasingly shifting towards specialty, the question arises…

How do you focus on specialised portfolios, whilst using available budget to protect and maximise other revenuegenerating brands? A syndicated detail slot offers a compelling way to conduct detailed promotional sales calls for newly launched products, campaign realignment for growing products and simple brand messages for mature products. There is a tactical approach to suit every brand across its lifecycle: · Newly launched · Growing · Mature · Long-listed/loss of exclusivity (LOE)

WHAT IS SYNDICATED?

A FULLY OUTSOURCED SALES TEAM REPRESENTING NON-COMPETING PRODUCTS FROM DIFFERENT COMPANIES

Three brands are promoted PER CALL, EACH WITH A DIFFERENT WEIGHT IN TOTAL DETAILING TIME

WHY SYNDICATED?

A COST EFFECTIVE way to deliver

HIGH QUALITY sales calls and increase

SHARE OF VOICE A flexible approach to align WITH YOUR SPECIFIC GOALS &

MAXIMISE

THE POTENTIAL OF YOUR PORTFOLIO

SOURCE: Outlook for Global Medicines through 2021, QuintilesIMS

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P R O D U C T L I F E C YC L E PROFILE OF PRODUCTS S U I TA B L E FO R S Y N D I C AT E D S A L E S

Newly launched/ post-launch products

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Finding the right syndicated solution There is no one-size-fits-all model. Ashfield consults on your specific goals and context to recommend the best approach: PHARMA SALES FORCE SYNDICATE D TE AM

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Reinforce: A syndicated sales force can work alongside your own in the same territories. This is ideal in a really competitive market where you want to increase frequency and quickly gain a greater share of voice. Expand: If your coverage requirement is too large for in-house teams and you would like to target a larger percentage of the market potential, use a syndicated team to access additional customer segments. Refocus: You allow a syndicated team to promote an older brand, taking sole responsibility for sales activities, this provides you with the opportunity to refocus internal efforts behind a new growth product. This cost-effectively protects the revenue of the existing brand.

Long-listed/ LOE products

Increase frequency and quickly gain a greater share of voice W H Y A S H F I E L D? Clients trust the Ashfield syndicated model and their 20 years of experience. With the largest number of syndicated sales teams in the industry, clients benefit from flexibility, choice of team size and security. Ashfield ensures a fully compliant service and high quality sales calls, with performance measured by structured detail follow up (DFU) reports and intelligent analytics. Ashfield can help you achieve your goals: · Increase competitive share of voice at a lower cost than a dedicated sales force · Grow and protect product sales from erosion and competition · A lign promotional activity to the product’s maturity and needs · Increase flexibility by adjusting promotion efforts to product seasonality · Enable existing sales force to focus on core products and/or key targets

To see case studies that have reinforced, expanded and refocussed our clients’ brands, or for more information, contact us on 01530 562300 or commercial@ashfieldhealthcare.com ashfieldhealthcare.com/commercial

M AG A ZI N E | FEB R UA RY 2017 | 19

APOCALYPSE

NOW

The advance of drugresistant bacteria threatens global health – what’s being done to protect us? WORDS BY

Amy Schofield

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magine a world where simple surgeries carry the risk of death. Where common infectious diseases – which previously posed no threat – could kill you, and where giving birth becomes life-threatening. Before the invention of antibiotics, this was the perilous existence of our ancestors. We could, however, be returning to those dark ages, as the overuse of antibiotics brings with it the very real worldwide scourge of antimicrobial resistance (AMR). “The threat is very serious,” said microbiologist Dr Jessica Blair PhD, of the Institute of Microbiology and Infection at the University of Birmingham. “Multi–drug resistant infections currently kill 700,000 people annually and this figure is rising every year. If this rise continues at current rates then it is predicted that by 2050 there will be 10 million deaths every year due to multi-drug resistant infections.” The lack of novel drugs in development to replace those we can no longer use, due to resistance, means that Chief Medical Officer for England Professor Dame Sally Davies’ warning of an “antibiotic apocalypse” was no exaggeration. “The use of antimicrobials underpins modern medicine,” added Dr Blair. “Without

action now many simple infections will once again become untreatable.” AMR threatens the effective prevention and treatment of a continually expanding range of infections caused by microorganisms such as bacteria, parasites, viruses and fungi.

“It is predicted that by 2050 there will be 10 million deaths every year due to multi-drug resistant infections.” AMR occurs when these microorganisms alter after being exposed to antimicrobial drugs including antibiotics, antifungals, antivirals and antimalarials. Sometimes referred to as ‘superbugs’, microorganisms that develop AMR are rendering antimicrobial medicines ineffective, meaning that infections persist, increasing the risk of an infection – with nothing to fight it. New resistance mechanisms are now emerging all the time and spreading across the world, threatening global public health.

F E AT U R E

ANTI B I OTI C G UAR D IAN CAM PAI G N

The Antibiotic Guardian campaign from Public Health England is asking the public, students, educators, farmers, the veterinary and medical communities and professional organisations to choose ‘one simple pledge’ about how they will make better use of antibiotics to slow resistance. Go to antibioticguardian.com

N I G HTMARE

MR is compromising the fight against diseases including tuberculosis (TB), HIV and malaria and – without antibiotics that work – the successful outcomes of minor and major surgery, and cancer chemotherapy will be seriously compromised. Figures from the World Health Organisation (WHO) show that 480,000 people develop multi-drug resistant TB each year. According to Dame Sally’s foreword to a report on AMR, from Lord Jim O’Neill and the Institute and Faculty of Actuaries, 50,000 people are dying every year in Europe and the US from infections that antibiotics have simply lost the power to treat. She warned that the death toll could increase worldwide and that our ever-increasing life spans may end up falling. “The projected figures are much more worrying. It is quite possible – and perhaps even likely – that the recent era of material mortality improvements will give way to many years of material mortality worsening,” Dame Sally warned. One study concluded that 70% of bacteria around the world have already developed resistance to antibiotics, including colistin, which is described as the last resort of antibiotics, due to its side effects. It’s not just the over–use and misuse of antibiotics by humans which has contributed to the crisis; the growth of factory farming is linked with the development of AMR bacteria. Indeed, two-thirds of antibiotic consumption in the EU occurs in animal farming. The human – as well as the economic cost – of AMR is massive, and until new medicines are developed, it can only grow. But there are exciting new developments afoot, giving hope to a world currently under considerable threat.

AC TI O N STATI O NS

n September 2016, 193 countries signed a landmark UN Declaration agreeing to combat AMR. Signed at the United Nations General Assembly in New York, the agreement followed a worldwide campaign led by Dame Sally and Health Secretary Jeremy Hunt to highlight the threat posed by resistance to antibiotics. The nations duly committed to tackling drug-resistant infections as a priority, and agreed to develop surveillance and regulatory systems on the use and sales of antimicrobial medicines for humans and animals, encourage innovative ways to develop new antibiotics and improve rapid diagnostics. They will also carry out awareness-raising activities to educate healthcare professionals and the public on how to prevent drug resistant infections. At the time, Dame Sally said: “We need governments, the pharmaceutical industry, health professionals and the agricultural sector to follow through on their commitments to save modern medicine.” The UN Secretary General is to report back on progress within two years. Meanwhile, Dr Blair is spearheading a national campaign – Antibiotic Action. It is a public awareness initiative of the British Society for Antimicrobial Chemotherapy (BSAC) and works to inform everyone about drug resistance – including members of the public, scientists, HCPs and politicians. “We need to make people aware of the issue of antibiotic resistance and try to help people understand the threat,” said Dr Blair. “The main messages are to urge everyone to use existing antibiotics wisely and promote the importance of infection prevention and control.” Go to antibioticaction.com

“We need governments, the pharmaceutical industry, health professionals and the agricultural sector to follow through on their commitments to save modern medicine.” Professor Dame Sally Davies, Chief Medical Officer for England

M AG A ZI N E | FEB R UA RY 2017 | 2 1

F E AT U R E

DISCOVERIES

IN 2016

The European Commission (EC) granted marketing authorisation for A S TR A Z E N E C A’s new combination antibiotic Zavicefta (ceftazidimeavibactam), developed for the treatment of patients with serious gram-negative bacterial infections, which require hospitalisation.

Scientists at Germany’s U N I V E R S IT Y O F T U B I N G E N discovered that people with the bug Staphylococcus lugdunensis (S. lugdunensis), present in their nostrils, were less likely to also have Staphylococcus aureus (S.auresus), including the superbug strain MRSA. Researchers identified the single gene that contained the instructions for building a new antibiotic which could treat superbug infections and named it lugdunin. Tests on mice showed that it could treat MRSA, as well as Enterococcus infections.

Life scientists at U C L A discovered that combinations of three different antibiotics from a group of 14 drugs can often overcome bacteria’s resistance to antibiotics, even if they are ineffective on their own or when combined with one other.

SY M C E L partnered with CO L Z Y X to test 25 different new collagen VI derived antimicrobial peptides, analysing their capability to kill bacterial growth in different ways.

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WAKE U P CALL

he ‘golden era’ of antibiotics research and development – when new medicines were being discovered – is toast. The old model, where pharma companies developed a new drug, then sold as much as possible of it, is no longer working, as old medicines lose their ability to fight infection. New products, therefore, must be used sparingly to avoid a repeat. In his report, Lord O’Neill proposed a new way of repaying pharma companies for new antimicrobial medicines, through a ‘market entry reward’ payment of around $1.3bn (£890m) to the company that develops an effective new antibiotic for an ‘unmet need’. Dr Jessica Blair is currently undertaking research to gain an understanding of the mechanisms of drug resistance in gram-negative bacteria. “By understanding the mechanisms we are better placed to target them with new drugs,” she said. Dr Blair’s research involves efflux pumps – molecular pumps in the membrane of bacterial cells. “Efflux pumps are able to pump the antibiotic molecules straight back out of the cells allowing bacteria to survive the antibiotic treatment,” she explained. “Through this research we hope to be able to develop inhibitor molecules against these pumps that could be administered with existing antibiotics to restore sensitivity to these drugs.” Dr Bjorn Herpers, clinical microbiologist at the Regional Public Health Laboratory in Haarlem in the Netherlands, said: “As all traditional antibiotics have eventually led to resistance, developing ‘new’ antibiotics of the traditional type isn’t the answer.” The use of endolysins presents another new strategy. These are special enzymes that cleave the bacterial cell wall – a mechanism with no risk of generating resistance. “This resolves the doctor’s dilemma of not wanting to withhold a potential beneficial treatment to an individual patient, but having to be restrictive with antibiotics because of the risk of resistance induction,” added Dr Herpers. Together with the Technical University of Zurich and the Dutch biotech company Micreos, he has successfully tested Staphefekt, the first endolysin available to the public for use against the bacteria Staphylococcus aureus, including the resistant type MRSA. In further developments, Dame Sally Davies launched a new initiative at the London School of Hygiene and Tropical Medicine (LSHTM), in December 2016, to address the challenge of AMR. Giving the keynote speech at the launch of the School’s new Antimicrobial Resistance Centre, Dame Sally said: “We have a duty of solidarity to sort this, we cannot step back and watch it happen – we have to work out how to make a difference.” The exciting research and development currently underway – along with action at local, national and international level – presents new hope that this potential global disaster can be averted.

OPINION

P Error and trial After a pharmacist is convicted Niamh demands parity WORDS BY

Niamh McMillan

“Pharmacists spend their days clinically, legally and sometimes accuracy-checking prescriptions, which can themselves contain prescribing mistakes.”

harmacists are currently the only healthcare professionals who risk criminal charges and conviction for making an honest mistake. This has been highlighted again through the tragic case of Martin White – a Northern Irish pharmacist, who has been handed a fourmonth suspended sentence for a dispensing error, which has been linked to a patient’s death. Mr White was sentenced at Antrim Crown Court in December 2016 after he pleaded guilty to supplying a “medicinal product…which was not of the nature or quality specified in the prescription”. Mr White had made a SALAD (sound alike, look alike drug) error – dispensing propranolol for a prescription of prednisolone. This may, in turn, have contributed to the death of an elderly patient. The consequences of this mistake were undoubtedly terrible, and my heart goes out to the deceased patient’s family, however, I feel very uncomfortable about this kind of ruling. As a pharmacist – and a human – I have made dispensing errors over the years. Luckily, none of my errors have led to patient harm, but they could have. I genuinely feel for Mr White, and it’s not hard to imagine myself in his shoes. Pharmacists spend their days clinically, legally and sometimes accuracy-checking prescriptions, which can themselves contain prescribing mistakes. Indeed, if those errors had not been rectified by the pharmacist they could also have harmed the patient. We work hard to prevent errors reaching patients, and yet we are the only profession who can be prosecuted for them. A literature review in The International Journal of Pharmacy Practice (2009) into the incidence of dispensing errors suggests community pharmacists make a dispensing error with up to 3.32% of medicines dispensed, while doctors have a prescribing error rate of 5% in general practice, and 7% in hospitals. I do wonder if the discrepancy in reporting levels are due to fear of consequences, such as criminal prosecution. As a profession it is essential to commend active reporting of incidents and near misses. At Superdrug, for instance, we strive towards an open and honest ‘no blame’ culture where pharmacists and pharmacy professionals can share their mistakes without fear. I’d love to see a time where we are treated no differently from other healthcare professionals, with the decriminalisation of dispensing errors – although I don’t see that happening any time soon. Until parity is reached, I hope that through increased openness in reporting we can reduce patient harm. Provided we are not negligent, and using all opportunities to learn and develop safer practices, we should be free from the risk of a criminal conviction. Niamh is Clinical Development Manager at Superdrug. Please note, these are Niamh’s personal views and do not necessarily reflect those of the Superdrug business.

M AG A ZI N E | FEB R UA RY 2017 | 2 3

OPINION

“The variation of funding explains many things about local NHS services and performance against key indicators, but does pharma understand it?”

Money talks David’s back and he’s got the abacus out WORDS BY

David Thorne

2 4 | PH A R M A FI EL D.CO.U K

et’s talk about something that few people understand, despite its significance and public sensitivity. Indeed, it’s the best kept NHS secret. Both GP federations I work with are rapidly moving to unified ‘Team NHS’ budgets as Accountable Care Organisations, and away from internal NHS market transactions. One will operate as an MCP (multispecialty community provider) and the other as a PCT (Primary and Acute Care System). Like many others we’re designing pathways and programmes around patients and communities, using ‘capitation-based budgets’, not ‘payment by results’. I now find myself as the Programme Director for a new collaboration between our York GP practice alliance and the local hospital and community services foundation trust. That means we can design services across an integrated system based on one NHS ‘virtual merged budget’. My new role means I need to become fascinated with NHS finance! In York the budget is £1,112 per patient but, if I were doing the same role through our federation in Sunderland, it would be £1,573 per patient. That is a difference of 41% and equates to £46m a year extra to spend across 100,000 patients. Furthermore, these two cities aren’t the most extreme examples. Each CCG is funded on the basis of the number of patients registered with its GP practices, multiplied by a complex weighted formula. This was previously used for Primary Care Trusts and Health Authorities, but has been regularly amended in response to methodological debates. Broadly, the economically poorer areas get higher funding, but more affluent areas are currently getting higher annual incremental increases to offset that. It is a prime reason why CCGs will consolidate, as fusing their budgets evens out local variations. It is also a reason why northern cities prefer their large universities – and I am sure you can work out why! The variation in funding explains many things about local NHS services and performance against key indicators, but does pharma understand it? I have never met a field-based person who knows their weighted capitation figures for their territory, let alone their relationship to product. But, do head office sales targets and marketing plans ever take its features into account? If a medicine has an acquisition price of £300 a year, then it surely has a greater proportionate financial impact upon the NHS in – for example – York, than in Sunderland, and its costeffective value also varies. A Medical and Educational Goods and Services offer has a different context and, in fact, the entire value proposition and budget impact is different for the two cities. The complex formula variables that set the variation also reveal a useful story that could be linked to product value, not least as prescribing is included. So, what does weighted capitation mean for you and your customers? David Thorne is Chair, Washington Community Healthcare and Non-Executive Director, City and Vale GP Alliance. Go to blueriverconsulting.co.uk

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2 7 M A R C H 2 017

Accountable Care Organisations: Are these the future of healthcare? Join David Thorne as he discusses how ACOs are shaping the future of healthcare in England.

ADVANCE YOUR THINKING ACOs are a response to growing financial and service pressures as they integrate once separate services. They take many different forms, ranging from fully integrated systems to looser alliances and networks of hospitals, medical groups and other providers.

This webinar introduces the key ideas around ACOs, which are currently under active development in several areas in England and reviews the risks, challenges and opportunities for pharma companies.

Book your place to gain expert insight into how ACOs are currently being implemented and how they might have an impact on your organisation or role. Pf Magazine readers can claim an extra 20% discount with the code PfMag20.

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Where are they now? Louise Finke remembers little about the ceremony, because she wasn’t there, but it was still a life-changing evening

ho were you working for at the time? I had recently joined Shire and was looking for a challenge that would benchmark me against my peers.

towards it – but success can be contagious; it’s the sum collection of all your efforts that makes you successful. The award has certainly helped to highlight my successdriven approach.

What award did you win? I won Experienced Hospital Sales rep of the year in 2010.

Would you recommend entering the Pf Awards? I really recognise the importance and significance of these awards and, to be honest, I strongly feel that more people should put themselves forward for them.

What are your recollections of that evening? I was lucky enough to have also won an internal award at Shire – one of their Ambassador awards – and this involved a trip away. The news arrived while I was on the trip. A colleague sent me a text to say I had won in my category – I was absolutely thrilled. How did you celebrate? We were all enjoying the last night of our magical trip when I received the news, so I celebrated with my colleagues. It was brilliant to be recognised and completed a great year for me! Were you more ambitious? Yes, it did motivate me to put myself forward for more challenges. I sought out new roles and opportunities, developed myself and entered more awards for different programmes I have worked on over the years. How did it impact on your career? I moved into an International Training Role within Shire and then progressed into Marketing, which is where I am currently employed at Shire.

“I believe you drive your own destiny and you drive your own successes. Success isn’t something that just happens to you.”

Where are you now and what are you doing? I’m currently working as a Brand Manager for Shire, responsible for four products within the Internal Medicine Portfolio. It’s a great place to be as I manage mature brands, orphan drugs and am also working on a new launch. It’s a busy and varied role, which I like, and it feels as though we are paving a new course. I can genuinely say no two days are ever the same!

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John Pinching

2 6 | PH A R M A FI EL D.CO.U K

Do you still look back fondly on your win? I remember the night before the assessment centre feeling rather nervous. I had a lot on at the time, and I remember thinking “why did I think this was a good idea?” But that morning I woke up feeling fresh and thought, “I’m here now, so I might as well just go for it.” I’m glad I stayed and didn’t get back in the car to drive home, and I’m glad the story played out for me the way it did. Go to pfawards.co.uk

Do you think winning an award was a trigger for further success? I believe you drive your own destiny and you drive your own successes. Success isn’t something that just happens to you, you move

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