Pf Magazine July 2016

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SMOKE AND MIRRORS

July 2016 PHARMAFI E LD.CO.U K


INT R ODUC I N G

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WELCOME

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 SALES & MARKETING DIRECTOR

Hazel Lodge hazel@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.co.uk @newpfmag @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.

B

Letter from the Editor

y working in pharma, sometimes we feel like rebels, but not because we’re rebelling against the dying light (which, in a way, we are). It’s the feeling that is thrust upon us by external forces. The idea that you are operating on the fringes of society often comes from the reaction we encounter when the industry in which we work is revealed to people, for the first time. This will usually trigger one of two responses. Either the ‘double eyebrow raise’ of barely-veiled horror or – most unsettlingly – the slow ‘single brow raise’ of suspicion – the one that suggests you are in league with the devil, or worse, that you are no better than tobacco industry pimps. King of rock and chips Elvis Presley famously said, ‘we can’t go on together with suspicious minds’ but, in spite of that certainty, pharma does carry on, and always will. Indeed, once your friends and family have got off their high horses, it’s fun to go through all the times pharma has probably saved their lives and watch those smug brows make a rapid descent. This kind of resistance can make a difference to perception, but in the last decade social media campaigns from big pharma and data transparency have also begun a genuine cultural shift. In roughly 500 years’ time, pharma will finally be judged on its achievements and when it is, Pf Magazine will be there – that’s my pledge to you.

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). 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. 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? @NewPfMag

M AG A ZI N E | J U LY 2016 | 1


MAGAZINE

Contents If the government refuses to ban smoking then they must restrict it to nicotine prisons, into which smokers can climb, but out of which smoke cannot escape. Cover story, page 8

03

14

21

The biggest stories emerging from our industry are ready and waiting

Claudia takes an intriguing look at mental health through the NHS prism

Do funky mushrooms hold the magic key to lifting depression?

N E WS

08

POLITICS

16

F E AT U R E

22

F E AT U R E

COFFEE BREAK

EVENTS & CONFERENCES

Society’s relationship with cigarettes is at a critical point – it’s do or die

Carly explains why pharma should embrace the human touch

All the action, opinions and debate from the GSK Rheumatology Conference

11 OPINION

The inimitable Henry is back with sound advice on exhibiting

12 F E AT U R E

Our gut instinct is that microbiome may be the next big thing

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18

24

F E AT U R E

P H A R M A TA L E N T

What US patient groups really think about the prospect of NICE

For the latest Pharma personnel news and updates

20 OPINION

Lucy and a new screening kit are on a crusade against bowel cancer


NEWS

NHS

MOBILE ROAM

DRUGS.

Diabetes drug could help breast cancer patients

Health teams will take mobile testing labs out into communities in a bid to reduce premature deaths from undiagnosed conditions – such as diabetes and cardiovascular disease – among people with mental illness. Dr Martin Myers, Consultant Clinical Scientist and Director of Clinical Biochemistry at Lancashire Teaching Hospital, is developing the new service. Teams will take kits out to pop-up clinics across the North West, with the aim of bringing tests to individuals who have difficulty attending their GP or hospital appointments. Eventually, people could be tested in their homes. The NHS’s Five Year Forward View for mental health states that those with mental health problems are dying, on average, 15 to 20 years earlier.

A

new study shows that metformin – commonly used as the front-line treatment for type 2 diabetes – improves survival for some breast cancer patients. The study is the first to examine the effect of metformin in this area and involved the examination of clinical outcomes for 1215 people. These particular patients were already diagnosed and had undergone surgical treatment for breast cancer between 1997 and 2013. Data indicated that 97 patients reported using metformin before their diagnosis, and 97 reported use of the drug after diagnosis. Results of the study showed that patients who used metformin before being diagnosed with breast cancer were more than twice as likely to die than patients who never used the drug, while patients who began using metformin after their cancer diagnosis were almost 50% more likely to survive than non-users. The results of the study were presented by researchers from the Perelman School of Medicine, at the University of Pennsylvania, during the American Society of Clinical Oncology (ASCO) Annual Meeting.

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

Zinn O))) @ZJemptv

I have trans friends who’ve waited for months to see a therapist or doctor for HRT. The Orlando shooter acquired a rifle in less than a week

ASTHMA

Benralizumab breathes life into asthma options

Edwin Lee @mayoredlee

#PrEP is an important tool in our fight to get to zero new #HIV infections. distant @ItsJackD

The school system taught me algebra but never once educated me on mental health Pfizer Inc. @pfizer

EU label for Pfizer #smoking cessation treatment updated w/ new safety & efficacy data following #CHMP endorsement Goddess Queen ‫@‏‬PromiseRW

If I’d just prayed & nothing else, I’d be dying right now. Science, incl “Big Pharma” saved my life. GSK @GSK

Imagine a future where electricity is harnessed to treat disease. It could be closer than you think #leadingscience

AstraZeneca’s benralizumab has achieved positive top-line results in two pivotal phase III registrational trials involving its asthma drug. Benralizumab – a potential new medicine and anti-eosinophil monoclonal antibody – was well tolerated and achieved the primary endpoint in the trials (SIROCCO and CALIMA), demonstrating significant reductions in the annual asthma exacerbation rate, compared to placebo. The trials evaluated the efficacy and safety of benralizumab during two dose regimens. It was tested as an add-on

therapy for severe uncontrolled asthma, with eosinophilic inflammation, in adults and adolescents 12 years of age and above. The safety and tolerability findings for benralizumab were generally consistent with those reported in previous trials. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “We are pleased with the results from these pivotal trials as they demonstrate the potential for benralizumab to improve outcomes for patients with severe asthma.”

Boehringer @Boehringer

People with #T2D and declining #kidney function are also at greater risk of #CVD #2016ADA Heidi Alexander @heidi_mp

Important urgent question from @GwynneMP on #PrEP – ministers must find a way to sort this out. Critical to tackling rising rates of HIV. Dr Christian Jessen ‫@‏‬DoctorChristian

The Vatican calls for abstinence to end HIV? America has proven this to be a total disaster: it fails on all levels.

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DRUGS

A

Dupilumab shows efficacy

one-year Phase 3 study evaluating Sanofi and Regeneron Pharmaceuticals’ dupilumab has met its primary and key secondary endpoints. Dupilumab, taken with topical corticosteroids (TCS), was compared to TCS alone, in moderate-to-severe atopic dermatitis (AD) adult patients. Those who were inadequately controlled by TCS – with or without a topical calcineurin inhibitor (TCI) – were enrolled in the study. Dupilumab with TCS significantly improved measures of overall disease severity at 16 and 52 weeks, when compared to placebo.

Meanwhile, the combination was superior to topical corticosteroids alone – and provided sustained efficacy – significantly improving measures of overall disease severity, skin clearing, itching and qualityof life through one year of treatment. Dr George D. Yancopoulos, Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, said: “Our collective clinical data demonstrate that this pathway is a root cause in atopic dermatitis, asthma and nasal polyposis, and we continue to evaluate the potential.” The first regulatory submission is planned in the US for the third quarter of this year.


NEWS

DRUGS.

Key to cancer care is closer chemo

Thousands of cancer patients in need of chemotherapy could receive treatment closer to home under new plans revealed by the NHS. An NHS England programme led by specialist pharmacists reduces variation in drug doses and is expected to create substantial savings. The NHS plans to reinvest these in patient care over the coming years. Chemotherapy accounts for an estimated £1.4 billion a year – almost a tenth of the entire central budget – and represents the single biggest spend within NHS England’s Specialised Commissioning.

NHS England now hopes to reduce variation and wastage in chemotherapy by implementing a national system of ‘dose banding’, where patients will receive optimised doses of drugs, rather than individually calculated measures. Cally Palmer CBE, NHS England’s National Cancer Director, said: “By embracing this approach, providers can support patients to receive chemo at appropriate times and in places which are more convenient for them.”

DRUGS

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Roche’s bladder cancer therapy Tecentriq® (atezolizumab).

DRUGS.

FDA APPROVAL FOR ROCHE’S NEAT TECENTRIQ

The drug treats people with locally advanced or metastatic urothelial carcinoma (mUC) who have experienced disease progression during, or following, platinum-based chemotherapy. It is also used by patients whose disease has worsened within 12 months of receiving platinum-based chemotherapy, before or after surgery. The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence that suggests clinical benefit. Tecentriq gained approval based on tumour response rate and duration of response. Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra. Roche is also evaluating Tecentriq in a confirmatory phase III study (IMvigor 211), which compares Tecentriq with chemotherapy in people whose bladder cancer has progressed on at least one prior platinum-containing regimen.

Faslodex trumps alternative AstraZeneca has announced positive results from the Phase III FALCON trial comparing Faslodex 500mg (fulvestrant) to Arimidex 1mg (anastrozole) for the treatment of locally-advanced or metastatic breast cancer. The treatment met its primary endpoint of extended progression-free survival in a trial of post-menopausal women who have not had prior hormonal treatment for hormonereceptor-positive (HR+) breast cancer. It also demonstrated superiority compared with Arimidex 1mg in FALCON. Sean Bohen, AstraZeneca’s Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “The potential to delay disease progression is important for these patients as there is currently no cure.”

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ZIK A VIRUS

Zika destined for Southern Europe

The established Aedes-mosquito population could spread the Zika virus in Europe this summer, according to Swedish researchers. An analysis of temperatures, vectorial capacity, basic reproductive number and air traveller flows indicate that parts of Southern Europe may witness outbreaks of Zika between June and August. The study, led by Umeå University researchers in Sweden and published in the journal, EBioMedicine, could help European public health officials to identify locations and times where the risk of Zika is heightened. Joacim Rocklöv, researcher at Umeå University’s Unit for Epidemiology and Global Health, and co-author of the article, said: “The presence of established Aedes mosquito populations, the warmer climate and the coinciding peak flow of air travellers into Europe is a triage, making Southern Europe fertile ground for Zika.”

CROHN’S DISEASE

CROHN’S STUDY REVEALS REMISSION RATES

J

anssen Research & Development Phase 3 data presented for the first time at Digestive Disease Week® 2016 showed that a significantly greater proportion of adult patients with moderate to severe Crohn’s disease – receiving STELARA® (ustekinumab) subcutaneous (SC) maintenance therapy – were in clinical remission at one year.

Ustekinumab, approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in a number of countries, is a novel biologic therapy that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, including Crohn’s disease. The Phase 3 IM-UNITI maintenance study evaluated 388 patients who achieved clinical response eight weeks after a single intravenous infusion of ustekinumab. Applications seeking approval of ustekinumab for the treatment of moderately to severely active Crohn’s disease are currently under review in the United States and Europe.

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DRUGS

NHS GETS RECORD NO ONE WANTS NHS England has announced that the 12 months to March 2016 were the busiest in the health service’s history. Almost 23 million people visited A&E over the period – up half a million on the previous year. TH E F I G U R E S R E V E A L : 87.3% of were patients admitted, transferred or discharged from A&E departments within four hours of arrival, against the target of 95%. The number of days patients were delayed before being discharged from hospital, despite being fit enough to leave, rose by 11.4%, between 2014/15 and 2015/16. Ambulances responded to two out of three calls – considered the most serious – in the target time of eight minutes. 8.5% of patients waiting for operations longer than the target period of 18 weeks – the worst since records began. Targets for routine operations and cancer were also missed. NHS England blamed increased waiting times for operations on the impact of the junior doctors’ strike. Shadow Health Secretary Heidi Alexander said that the figures “show an NHS in constant crisis.”


NEWS

A

P H A R M AC I E S

Chemists closing time Thousands of local pharmacies in England could be at risk of closure due to Department of Health cuts, according to campaign group Pharmacy Voice. The pharmacists’ group states that a quarter of patients will visit their local GP instead, if access to their community pharmacist is no longer possible. The government proposes giving more people access to community pharmacies, but points out that in some areas they are too close together – 40% of pharmacies are located in clusters of three or more, within a 10-minute walk of each other. The average community pharmacy receives around £220,000 in NHS funding each year – 80 – 90% of its total. The government proposes cutting the amount of funding that some receive, saving £170m in the process. According to the group, the proposals would mean the closure of up to 3000 community pharmacies. The impact would be felt mostly in deprived areas, where need is greatest. Prof Rob Darracott, chief executive of Pharmacy Voice, said: “Losing a local pharmacy in these areas is simply not an option.”

ANTIMICROBIAL . R E S I S TA N C E .

PR AC TI CE PI LLO RI E S POI NTLE SS PI LL PO PPI N G

Hertfordshire GP practice has been awarded £10,000 of funding to help develop blood tests that prevent the unnecessary prescribing of antibiotics. The Challenge Prize ‘acorn’ funding was awarded to Attenborough Surgery in Bushey, Hertfordshire, as part of the 2015/16 NHS Innovation Challenge Prizes. The money will be invested in further developing its point-of-care fingerprick blood tests, which assist doctors in deciding whether antibiotics are really necessary for patients who visit with respiratory infections. Spearheaded by Advanced Nurse Practitioner, Liz Cross, all patients visiting the surgery with chesty coughs in winter 2015/16 were given the simple blood test, which shows levels of C-reactive Protein (CRP), a biomedical marker of bacterial infections. This allowed nurse practitioners to reduce antibiotics prescribed by 23%. The surgery also saw a fall of more than 50% in unscheduled follow-up visits by patients who had taken the test. Almost three quarters of all antibiotics are prescribed in primary care, many of which are inappropriate, as evidenced by Attenborough Surgery. Liz Cross said: “The test gives us the confidence we need to sensibly restrict antimicrobial prescribing, while making sure those who really do have an established bacterial infection get the antibiotics they need.” The Challenge Prize funding will allow the tests to be rolled out to 10 further practices this winter.

DRUGS

Schizophrenia jab injects hope The European Commission (EC) has approved the use of Janssen’s TREVICTA® – a three monthly paliperidone palmitate injection – for the maintenance treatment of schizophrenia. The injection will provide the longest dosing interval available for an antipsychotic medication in the European Union, compared to currently available antipsychotic treatments. The three-monthly injection is indicated for the maintenance treatment of schizophrenia in adult patients who have been stabilised on once-monthly paliperidone palmitate, preferably for four months or more. Dr Rozlyn Bekker, Medical Director, Janssen UK & Ireland, said: “This approval is a significant step forward for people living with schizophrenia in Europe.”

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I L L U S T R AT I O N B Y

A filthy habit and a grizzly killer

that reflects our most

WORDS BY

unpleasant yearnings.

John Pinching

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Alex Buccheri


COVER STORY

SMOKE AND MIRRORS

S

ir Walter Raleigh has got a lot to answer for. This lauded chap from the olden days brought us potatoes and tobacco – fags and chips. Two of Britain’s biggest health burdens. Thanks for that, Walt. It is cigarettes that have wreaked most havoc, however, and they continue to reek to this day. Relationships, marriages, friendships have all gone up in smoke. Meanwhile, smoking has been keeping the NHS and pharma busy for decades, as cancer, heart disease, strokes and emphysema have discarded millions of people into the ash tray of oblivion. Industry continues to plough billions into researching and delivering treatments for those with smoking-related diseases, while increasingly concentrating on areas of prevention – but shouldn’t pharma’s focus be on making life better for people who do have disease, but don’t smoke?

H E A RT O F DA R K N E S S When I was growing up in the 1980s, iconic images, such as James Dean – squinting into an uncertain future, made smoking irresistibly exotic, while the striking packages were an early example of how mesmerising graphic design can be. My generation, however, were the first to have some seriously disturbing information to contend with, as doubts crept in about how ‘cool’ smoking actually was. Public information films warned of the ‘natural born smoker,’ born with an addiction to nicotine. People also started to die from cancer, as a result of starting in the ‘30s and ‘40s. The impact was negligible, as children were seduced into a habit that was flaunted by their parents. Smoking was in offices, pubs, streets, in advertising and in our homes.

Smoking is also a notorious passion killer. I once told a former girlfriend that she had to choose between her & I, and Benson & Hedges. To this day, if I need to summon contempt for a smoker, I channel the feeling of being metaphorically stubbed out after issuing what was a very reasonable ultimatum. The entitlement and the self-righteousness of the smoker is the real burden on the NHS and pharma’s priorities, because it guarantees a long succession of tumours. There is no such thing as a considerate smoker. Smoke, by its very nature, goes where it pleases, regardless of explicit signage. I do believe in the basic human right to indulge, as long as it doesn’t kill me. People can drink and abuse drugs at their own risk, because it’s not mine. But each and every time someone ignites a cigarette they are making a conscious decision to kill, not only themselves, but me – us – as well. With this considered, it seems utterly preposterous that in 2016 smoking is still legal – we are still subjected to the grey-faced dystopian tribe of doorway chokers making an enemy of their own future, and many willing to do so in a phony war they can’t possibly win; their principles as thin as the paper around their tobacco. The people who fail to see the misery that their habit is weaving, end up as the half-ghosts, outside hospitals, pulling along their drip trollies with one hand, and nursing a smouldering dog end with the other – the last days burning away in a grotesque plume. The final insult. Our sympathy must cease – why should anyone in a modern, civilised world tolerate smoking? I have seen the new plain cigarette packages and, yes, graphic illustrations

of disfigurements and cancerous decay are hideous, but is it enough? If the government refuses to ban smoking then they must restrict it to nicotine prisons, into which smokers can climb, but out of which smoke cannot escape. In the final analysis, you wouldn’t invite Jack the Ripper to a hen night and expect him to be back by seven, so why would you expect a smoker to act responsibly in the presence of passive bystanders. I can draw little distinction between a serial killer and someone who insists on smoking.

Q U IT TE R S For smokers who have seen the utter futility of what they are doing, help is at hand. Healthcare professionals are only too willing to help them, when it seems the will to live isn’t strong enough. Here are the thoughts of key sympathisers.

Smoking cessation medicines have been shown to be one of the most effective methods to stop smoking, when combined with support from a healthcare professional. As pharmacists, we are often the point of contact for smokers, many of whom get stuck in a cycle of trying to quit with no NHS support, and not succeeding on other therapies, like NRT. Pharmacists in the community or hospital are in ideal locations to offer evidencebased advice to help smokers make an informed decision. Darush Attar-Zadeh, Respiratory Lead Pharmacist Barnet CCG

As nurses, we are often one of the first points of contact for people looking to quit smoking – whether in a GP surgery or at a smoking cessation clinic. The findings from the EAGLES study highlight the benefits of smoking cessation medication and provides us with key information to help us have informed conversations with our patients who are looking to stop smoking. Tracy Kirk, respiratory nurse consultant and primary health care educator CONTINUED

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COVER STORY

MURDER MOST FOUL

WHEN IT COMES TO DESTROYING LIVES AND, ULTIMATELY, ENDING THEM – NOTHING GETS CLOSE TO SMOKING.

6,000,000 10,000,000 GLOBAL YEARLY DEATH TOLL

YEARLY DEATHS ACROSS THE WORLD BY 2030

ONE BILLION deaths by end of the century

IN 2012-13

460,900 hospital admissions WERE ATTRIBUTED TO SMOKING IN THE 35+ AGE GROUP – ACCOUNTING FOR 5% OF ALL ADMISSIONS.

APPROX.

LEAGUE TABLE OF PREVENTABLE DEATHS IN THE UK*

Smoking 100,000

OBESITY 34,100 | ALCOHOL 6,592 ROAD TRAFFIC ACCIDENTS 1,775 ILLEGAL DRUGS 1,605 | HIV INFECTION 530 Data provided by ash – action on smoking and health * Figures for England except HIV which is for UK and traffic accidents for Great Britain

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E AG LE S HA S L A N D E D Pfizer has flown into the smoking den by releasing its EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) data. The study is the largest placebo-controlled trial to compare the neuropsychiatric safety and efficacy of ‘varenicline’ and ‘bupropion’ with placebo and nicotine patches. The results demonstrated that the use of varenicline or buproprion in patients, with or without a history of psychiatric disorder, is not associated with an increased risk of serious neuropsychiatric adverse events. In addition, patients taking varenicline showed superior continuous abstinence rates at weeks 9–12, and 9–24, than patients treated with placebo, bupropion or nicotine patch. Furthermore, patients treated with each of the medications had higher abstinence rates than those treated with placebo. Robert West, Professor of Health Psychology, University College London and co-author of the EAGLES study commented: “This study should reassure regulatory authorities, doctors and patients about the safety and effectiveness of medicines to help smokers stop. Every smoker should receive the offer of evidence-based support to stop at least once a year – currently most do not.” EAGLES also included an efficacy objective to determine smoking abstinence rates in patients. The results showed that patients with and without a history of psychiatric disorders, taking varenicline, had significantly higher continuous abstinence rates than patients treated with bupropion or nicotine patch. Those treated with each of the medications had higher abstinence rates than those treated with placebo during both time periods. Dr. Berkeley Phillips, UK Medical Director, Pfizer, commented, “EAGLES adds a significant, additional body of important safety and efficacy data for varenicline in a large population of smokers. At Pfizer, we remain committed to effectively supporting smokers throughout their journey to stop smoking.”


H Raging exhibitionism Henry’s back with a masterclass in conference stand survival WORDS BY

Henry Rubinstein

elp! It’s that time of the year again. The point in the calendar when we seem to be inundated with conferences – those which we ‘must’ attend, lest we fall behind the general zeitgeist of the industry. I’m so inundated that I barely have time to sup a reflective pint with the editor of this fine publication! Even worse, walking around the show floor, I am often the victim of the dreaded ‘cold sale’. I can easily sympathise with representatives who loyally man their stalls hour after hour, as – in a previous existence – I hawked paraphernalia at political party conferences. The crushing production line of insincere smiles from delegates can, indeed, be exhausting. With this considered, here are my survival tips for those planning to do battle for their companies on an expo stand. Knowing your audience is key. For older exhibition stand hacks this is a given, but I have come across many younger specimens who totally misjudge the vibe and, as such, miss the opportunity of snaring an interested visitor. At one Labour Party Conference, I tried to distribute a decidedly Conservative tome to left-wing MPs and prominent trade unionists. I wish I could say it was calculated,

OPINION but it was pure ignorance, and they didn’t come back. Always remember what you’re selling and who you’re selling it to. One of the best aspects of a show is the opportunity to meet new people. I recall at one conference I struck up a great friendship with the Countryside Alliance team, who occupied the opposite stand. It’s essential to take a stroll into unchartered pastures. Wallflowers are more common than not at these affairs, and many go through a whole show without striding outside their own comfort zone. There are actually few better opportunities to establish connections, than at these events. To make it even easier, most have specific receptions and networking periods for these purposes, so there is no excuse. I often laugh when I think back to some of the absurd situations I have found myself in at exhibitions. Whether it be trying to find duct tape at one in the morning in order to patch up loose panels, or frantically sourcing last-minute replacement speakers from an exhibition floor. In the face of adversity, however, the absolute golden rule is to keep a broad sense of humour. It would be wholly justified to fly into a rage, but it serves no purpose. Keep your cool, be personable, and you’ll be surprised how effective you can be! Henry Rubinstein is planning manager at Triggerfish Communications. Go to triggerfish.co.uk

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WORDS BY

Amy Schofield

Human league The mystery of the microbiome might be a magic moment for healthcare

Y

ou’re all human, right? Wrong. You are merely host to a 100 trillion microbial cells that make up the majority of your earthly form, primarily housed in your gut. These microscopic microbial life forms – known as the microbiota – outnumber our own cells by about 10 to 1, and the genes within these cells are collectively known as the ‘human microbiome’. The microbes’ role in the gut is the focus for a growing body of research that is exploring the profound influence on our health caused by the composition of these curious imposters. What we put into our bodies – from food to antibiotics – could create conflict between gut microbes and the humans they interact with, leading to disease. A holistic understanding of the microbiome in human health is emerging as the key to tackling many challenges facing humanity in the twenty-first century, including the prevention and treatment of disease and infection.

What we put into our bodies could create conflict between gut microbes and the humans they interact with.

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S U PE R NATU R A L The concept of the human microbiome was first introduced to the scientific community by Joshua Lederberg. He defined it as ‘the ecological community of commensal, symbiotic and pathogenic microorganisms that literally share our body space and have been all but ignored as determinants of health and disease’.* There are millions more microbial genes than human genes in the human/ microbiome superorganism and this vast array of microbes first colonises the human body at birth. It is the way in which the genes within these microbes interact with you – their genial host – that define their ultimate role in our existence, whether it be nurturing good health or taking on disease.

B R A I N FO O D We have a symbiotic relationship with our gut bacteria – providing them with a protected, nutrientrich habitat. They break down the food we eat to produce energy, make essential vitamins and act as the first line of defence to fight off marauding pathogens. Scientists are just beginning to understand our relationship with microbes, and research is recognising the microbiome as a newly-discovered organ, about which there is much to learn. Currently, a number of conditions are associated with an imbalance of gut microbes, including inflammatory conditions, food allergies and cardiovascular diseases. Food choices, antibiotics and the regular use of antibacterial lotions and soaps are thought to kill the ‘good’ bacteria, and allow the ‘bad’ bacteria to thrive. This then disturbs the balance of the microbiome, which can lead to immune reactions and digestive issues. Potential treatments are aimed at addressing these imbalances and restoring health.


F E AT U R E

YA K CU LT Nobel laureate Elie Metchnikoff introduced the concept of probiotics to the scientific community, publishing a seminal report linking the longevity of Bulgarians with consuming fermented milk products containing viable Lactobacilli.** This suggested that certain microbes, when ingested, could actually be beneficial for human health. Shann Jones owns a goat farm in Wales, where her family business produces ‘kefir’ – a live culture-fermented goats milk product – which acts as a powerful probiotic. It is thought that probiotics can heal a plethora of health problems, including eczema, asthma and infection. Shann and her husband, Rich, have joined forces with the Institute of Biological, Rural and Environmental Sciences (IBERS) at Aberystwyth University. IBERS’ Director of Research and Professor of Animal Science, Prof. Jamie Newbold, has a research interest that focuses on the effect of probiotics on the structure of microbial populations in the gut, and he genetically strained and tested their kefir. The research demonstrated that the product was found to be effective within the human microbiome, as well as the equivalent in dogs and horses.

Unlocking the role that these myriad microbes play could mean a revolution in how we prevent and treat disease.

CO M E TO G E TH E R Although research into this exciting area is increasing, a lack of coordination is concerning those involved. The authors of a report published in Nature – ‘Microbiology: Create a global microbiome effort’ – are calling for a cohesive government-led microbiome research programme to get past “national silos” and “gain universal insights that will benefit all humankind.” In May, the White House revealed that it was launching the $121 million Microbiome Initiative, a nationwide project to coordinate and fund microbiome research. Meanwhile, research into the human microbiome continues apace around the world. Unlocking the role that these myriad microbes play could mean a revolution in how we prevent and treat disease.

WA R A N D PE AC E As with any host/guest arrangement, sometimes things go awry and conflict breaks out. When the needs of microbes and humans are at odds – due, for instance, to a poor diet – gut microbiota may contribute to chronic conditions, or use nutrients intended for the host, causing inflammation and other negative health effects. Recent research published in Annals of the New York Academy of Sciences examines the role of microbes in the gut. The study – led by Athena Aktipis – researcher at Arizona State University’s Biodesign Institute, explores how the food we choose to eat either promotes cooperation or fuels conflict between gut microbes and their human hosts, leading to health or disease. “There are certain foods that lead to resource-sharing between us and our microbes, while other foods can lead to conflict and resource competition between our bodies and our microbes,” Aktipis says. “This cooperation and conflict framework can help us understand certain aspects of why we get sick and how we can stay healthy.”

THE STATS

10 to 1 MICROBES OUTNUMBER HUMAN CELLS

Human microbiome =

8 MILLION GENES

300

IT’S

TIMES LARGER THAN THE GENE SET IN THE HUMAN GENOME Lederberg and McCray, 2001 Metchnikoff and Mitchell, 1907

* **

M AG A ZI N E | J U LY 2016 | 13


MIND MATTERS T Claudia considers one of the greatest challenges of the modern age WORDS BY

Claudia Rubin

1 4 | PH A R M A FI EL D.CO. U K

here are some things we all know – healthcare costs rising, is one of them. Total healthcare expenditure in the UK from public and private sectors was £150.6 billion in 2013, having been only £54.9 billion in 1997. This equates to a ‘per person’ spend of £2,350 in 2013, more than two and a half times the level in 1997, when £941 was spent for each UK resident, according to ONS data. Obvious explanations for these rises – like the ageing population, medical advances and patients’ greater expectation of their health – are not offset by technological change which, unlike in manufacturing for example, can only marginally reduce health costs. It’s not often that a whole new area of health emerges that has the potential to impact healthcare services, and shape the thinking of policy-makers, across the board. The focus, however, that is now given to mental health is markedly greater than just five years ago, and has the potential to disrupt established healthcare norms. As an indicator of its growing political capital, the term ‘mental health’ was mentioned 162 times in House of Commons debates from June 2005 to June 2010, compared to 847 times from June 2011 to June 2016. A massive achievement for those campaigning to get recognition and critical exposure for mental health sufferers. It is also delivering results. There has been a near-universal acknowledgment of some basic requirements and a commitment to increasing services.

In 2011, the government set an ambition that mental health would be valued as much as physical health. In October 2014, the Department of Health and NHS England set out standards for access to mental health services that people should expect, and how long they should have to wait for treatment. The government has also committed £1bn extra a year by 2020, which should help one million extra people a year to receive treatment. Despite government pledges to establish parity with physical health, however, the amount actually spent on mental health by the NHS last year, was just 11.9% of overall NHS spending. It is also the case that, although standards have been set, and a plethora of policy goals delivered from the highest level, not least the ‘Five Year Forward View for Mental Health’ earlier this year, the full cost of meeting these standards is not well understood. This is why parliament’s Public Accounts Committee (PAC) – chaired by Labour MP Meg Hillier – has opened a new inquiry into the funding of mental health services. They note that full data does not exist to measure how far the NHS is from meeting the new access and waiting time standards, but it is clear that achieving the standards will be a very significant challenge. Despite seemingly never ending increases in funding for healthcare, there are massive gaps in funding at almost every level. The Kings Fund offers a good explanation; “Between 2009/10 and 2020/21, spending


POLITICS

D UAL CO M PLI CATI O N S

T

on the NHS in England will rise by nearly £35 billion in cash terms – an increase of 35%. But much of this increase will be swallowed by rising prices. In fact, around £24 billion will be absorbed by inflation, leaving a real increase of just £11 billion [a 10% rise over eleven years; equivalent to an average annual increase of just 0.9 %].” So we can see how significantly this new, quite proper, commitment to treating mental health may increase the pressure on budgets. One in four adults reports being diagnosed with a mental illness at some point in their lives. Government has committed to providing additional money, but there will be competition for this funding. CCGs will have impossible decisions in terms of delivering mental health commitments without sacrificing other services. This is where the developing field will impact upon everyone invested in healthcare delivery in this country. Since the Commons PAC inquiry opened in May, almost 100,000 testimonies have been submitted by the public, emphatically highlighting the lack of NHS services. Where cancer funding once had to compete with heart disease, and then with huge levels of spending on dementia, into the mix comes the realisation that mental disorders are not restricted to the ageing population, but of critical importance through school years and beyond.

THE STATS 2009/10 – 2020/21 NHS SPENDING UP BY

£35BN Increase of 35% LESS £24 BN IN INFLATION

=

‘real’ increase of

£11 BILLION

0.9% AN AVERAGE ANNUAL INCREASE OF JUST

1 billion extra a year on mental health =

1 MILLION PEOPLE HELPED

here is no mutual exclusivity at play with mental health. Chronic pain, illness or weight problems; these physical conditions may be complicated by associated mental health concerns, and successful treatment of the former can be impossible without addressing the latter. In 2014-15, 3.3 million people were known to be suffering from depression. Building the mental health workforce is a challenge, and an expensive one. Evidence from past initiatives indicates that it takes years to embed change successfully across the health system. Typically the pharmaceutical industry has had a smaller stake in mental than physical health, though there are a range of medications available for its treatment, such as anti-psychotic drugs, antidepressants and mood stabilisers. Many of these have attracted controversy for prescribers and manufacturers, with growing levels of addiction to opiates and benzodiazepines adding another dimension for policy-makers. As the government pushes the NHS to deliver higher standards, the Prescribing Observatory for Mental Health (POMH-UK) – which aims to help specialist mental health Trusts improve their prescribing practice – will also grow in importance. It is likely that the pressure on NHS funding will necessitate greater engagement with mental health from across industry and its partners. Though the ABPI’s Pharmaceutical Mental Health Initiative (PMHI) currently comprises just three companies, its description as “a group of ABPI member companies with an interest in mental health” suggests it ought to be larger. Policymaking in the health sector must increasingly take a holistic view from across health and social care, and it is advisable that we all engage better with how the NHS delivers vastly improved mental health outcomes.

Claudia Rubin is a Government Affairs Strategist at Decideum. Go to decideum.com

M AG A ZI N E | J U LY 2016 | 15


CARLY IN VOGUE JP downs Americanos with the epitome of a modern marketing maestro INTERVIEW BY

A

ccording to a mystical prediction I was about meet someone with an inspirational story and, for once, my horoscope was accurate. The star is Carly Stringer, and her sign is Virgo. JP Were you kept awake at night by dreams of working in the health arena? Yes and no! When I was younger I wanted to be a vet, but the thought of putting down animals wasn something I couldn’t handle. I only have to watch Marley and Me and I’m crying like a mad woman! Biology was always my favourite subject and I wanted

John Pinching

a career that helped people. When I was researching universities I came across pharmacology – it wasn’t something I had thought about before, but working in a lab on drug development sounded like a fascinating job. It was a four-year course, including a year working in industry. JP Where did you study? I studied at the University of Bath. I loved every minute – from being thrown into a house with twelve other students, on my first day, to graduating in Bath Abbey. I also met my husband there and we now have two beautiful children.

Healthcare is an industry with people at its heart.

JP Wow! Tell me about your initial experience of pharma I spent my placement at Novartis’s Horsham Research facility and this involved working in the lab. Although I loved the idea of my research transforming lives, I realised that spending the rest of my days in a white coat wasn’t for me. It was very lonely work sometimes and I’m a people person! JP Tell me about your career prior to joining Virgo Before joining Virgo, I spent some time at a healthcare market research agency in Central London. I worked with pharmaceutical clients, developing questionnaires, conducting interviews with healthcare professionals, analysing results and presenting recommendations regarding wider marketing and communication strategies. JP How did Virgo come into your life? I’ve worked at Virgo for seven years and seen the company grow to meet the needs of a changing industry – it’s been really amazing to witness. For example, we now do much more corporate reputation and employee engagement work, while our offering covers the entire lifespan of the drug development process, from clinical trials to market access. JP What has happened during those seven glorious years? My career here has been very varied – which suits me perfectly! I started out as a Senior Account Executive, working on ethical PR campaigns. As the company grew, we opened a Medical Education Division and I wanted to be

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


COFFEE BRE AK involved, because I had missed the hard science. I started working as an Associate Medical Writer, and was later promoted to Medical Writer. I loved travelling extensively, working with leading experts and getting to grips with the science behind medicines. JP When did you make the move into marketing? After having my little girl, I wanted more flexibility, so I took on a marketing role, which plays to all my strengths. I have now had a second child and moved a considerable distance from our office, but Virgo has been very supportive, by allowing me to work from home. I now have the ultimate work-life balance and couldn’t be happier! JP What is the Virgo company ethos? Healthcare is an industry with people at its heart and everything Virgo does, through communication and medical education, is designed to help people make better decisions about health. ‘Being Human’ is the ethos we live by – we strive to recognise what people really think, believe and do, and use this information to communicate in a personalised way. JP What do you dig most about working at Virgo? It is definitely the people that make our agency what it is. Everyone is supremely talented, passionate and committed – we have a culture which empowers us to be creative. We push our clients to be bold, but because our ideas are grounded in human insight they trust us to deliver, while navigating regulatory and industry challenges. Our team is inherently curious and the company ensures we’re at the cutting edge of trends and developments that impact us and the industry. From healthcare policy debates to digital health summits, the people at Virgo always want to learn and I find that very inspiring. JP What have been the most memorable projects you have been involved with? I was recently involved in creating video content to showcase what my colleagues love about working at Virgo, as part of the communications around our Great Places to Work® submission. I really enjoy working on video and digital content and it was great to see how passionate my team are about impacting positively on society’s health. JP What would you say are the biggest challenges of working with pharma clients? Hesitance to adopt a ‘human

thinking’ approach. The healthcare industry can easily become bogged down in communicating scientific messages and therefore lose perspective on how to communicate in a personalised and compelling way. With increasing scrutiny, in a highly-regulated industry, pharma clients understandably tend to be much slower to use new multi-format communication channels and advances in technology, than the consumer industry. We try to help our clients realise the potential of putting more of a human touch into healthcare. JP Is technology playing an increasing part in what you do? Yes, new technological advances are happening all the time – be it a new social media channel or an advance in the way we can deliver information at a conference. As a communications agency it’s critical that we stay on top of the latest developments and make the appropriate recommendations to our clients. Through the ‘Virgo Pharmacy’ – our internal creative hub – we explore and share new ways of thinking with our clients, and encourage them to step out of their comfort zone, push the boundaries of their communication programmes and ultimately be more relevant.

The healthcare industry can easily become bogged down in communicating scientific messages.

JP What ambitions are you harbouring for the next few years? I thrive on learning new things, so I will continue to say ‘yes’ to opportunities that take my career in a direction that interests me and excel in the job I love doing. JP How do you escape the madness? I’m not sure I do! As soon as I switch off my computer for the day I’m moments away from toddler tantrums and dirty nappies – at work I at least get to drink my tea while it’s hot! JP What one record would you choose for the soundtrack of your life? Monty Python’s Always look on the bright side of life. JP What are you doing this evening? After getting the kids to bed, I’ll be going for a run. Ten weeks ago I couldn’t run for one minute, but I’ve been doing the ‘couch to 10K’ programme, in preparation for a Race for Life in July. Wish me luck! JP Good luck and good bye, Carly, Bye John. Go to virgohealth.com

M AG A ZI N E | J U LY 2016 | 17


F E AT U R E

ASCO is trying to address the problem of the patient involvement – but are they a significant part of the discussion? No.

Not nice T Kevin Grogan is in Chicago as delegates launch fierce attacks on their drug pricing systems while kicking ours straight out of the park WORDS BY

Kevin Grogan

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

he American Society of Clinical Oncology (ASCO) meeting in Chicago once again provided a fascinating insight into the leading research being carried out into tackling cancer but, unsurprisingly, the price of drugs was a debate that rang around the halls of McCormick Place. ASCO itself presented a modified version of its ‘Value Framework’ – originally published in June last year – which represents an attempt by the Society’s ‘Value in Cancer Care Task Force’ to develop a methodology which defines the currency of treatment within the context of rising costs, when applied to new and novel therapies. Development of a software tool to aid cancer therapy decision-making will continue toward a pilot study by the end of the year, with the aim of conjuring up something much simpler for doctors to use while in conversation with patients. Ah yes, patients. Fair play to ASCO, it is trying to address the problem of patient involvement – but are they a significant part of the discussion? No, I don’t think so. With this in mind, I ventured out of the congress centre to actually speak to some American patients, and gauge their views on the cost of medicines. They have much to say and about one group in particular – the Institute for Clinical and Economic Research (ICER). ICER is a Boston, USA-headquartered group, which describes itself as “a trusted non-profit organisation”, and has been in the headlines for a number of analyses. These studies have concluded that drugs

are too highly priced and, in May, it focussed on myeloma treatments, stating that the price of some should be cut by as much as 94% to justify their true value. The methodology used by ICER uses the quality adjusted life year (QALY) measure, which has some similarity to the equation used by the National Institute for Health and Care Excellence (NICE) in England and Wales. In terms of myeloma, its methodology has been slammed by Amgen and Bristol-Myers Squibb and the latter has said that its limitations could set up “arbitrary barriers to patient access.” B-MS acknowledges that while “assessments of cost-effectiveness may prove useful in comparing treatments, they have significant limitations”. It added that ICER’s assessments should “not be used for decision-making that determines access to innovative medicines”. The problem is that they are being used for decision-making, according to Bob Goldberg of the Center for Medicine in the Public Interest. He told Pf Magazine that the NICE comparison is not particularly accurate, as the process in the UK is open and involves robust science-based dialogue. “What ICER wants to do is limit the spending on medicines to pay for roads, bridges and police. I find that to be offensive – I can’t get my mind around it”. He also stresses that the headline list prices of products give a false picture, and further negates ICER’s flawed models. Discounts of 30%–50% are commonplace, because of rebates that drug companies provide. These rebates, however, worth billions of dollars, and are arguably being


P f AWA R DS trousered by insurers and pharmacy benefit managers. Meanwhile, patients in the USA are being forced to pay 30% of the list price out of their own pockets. Mr Goldberg believes that ICER sees healthcare in terms of cost – he essentially sees it as an investment. He acknowledges that cancer costs are increasing, but that is mainly because people are living longer, thanks to increased survival rates. Is ICER therefore saying that survival is a problem? Quite the opposite, as it means that more people are alive to pay taxes. At an event held at the home of the Chicago Symphony – concurrent with the ASCO conference – Jonathan Wilcox, co-founder and policy director of Patients Rising, said “the so-called ‘valueframeworks’ by ICER, and others, could re-shape the future of healthcare”. He added that they “use complicated mathematical formulas to put arbitrary limits on the cost of new treatments.” “The proposals could potentially harm the health and well-being of the millions of Americans with cancer and other lifethreatening diseases,” he concluded.

Priority in the UK has changed from providing healthcare to all consumers, to distributing it equitably, regardless of individual needs. Stacey Worthy, director of public policy for the Aimed Alliance

WE ARE N OT WO RTHY

W

ould following the example of NICE be better for our friends across the Atlantic? No thanks, says the brilliantly-named Stacey Worthy, director of public policy for the Aimed Alliance, who was also at the Chicago Symphony event. She has authored a report claiming that under NICE’s model, “priority in the UK has changed from providing healthcare to all consumers, to dividing up the care that is available, and distributing it equitably, regardless of individual circumstances and needs – the institutional rationing of healthcare. The same can be expected in the USA if insurers implement ICER’s price controls”. Worthy believes NICE has led to “decreased quality of care, delays in treatment, increased mortality rates and a stifling of innovation”. Arguing that NICE has not approved a single breast cancer drug in the last seven years, she said, “England is a decade behind the other countries in Europe in terms of cancer survival rates”. At present, England’s cancer survival rates are 15% lower than the USA’s rates. “We cannot afford that to happen here”, she added. Worthy thinks that if the US healthcare system moves closer to the model on our side of the Atlantic, it will lead to higher mortality rates and poorer quality of care for patients. This may yield a short-term budget impact, but the long-term cost would be terrible for patients, Worthy insists. Scorching words, but one thing is clear, the patient’s voice in the USA is getting louder and resistance to drug rationing will be ferocious.

The largest sales awards in the UK pharma industry The Pf Awards 2016 postawards brochure is out now! Head to our website to see winners, judges’ comments, and pictures from the night. Be part of it in 2017 Take your talent, show your style, change your life. Jump online to see key dates and entry criteria. Are you a past winner? We’d like to talk to you! Give us a call on 01462 476120 or email enquiries@pfawards.co.uk P FAWA R D S .C O.U K

M AG A ZI N E | J U LY 2016 | 19


OPINION

Screen saver Newer, easier and more accurate bowel cancer home testing kit to be rolled out across England WORDS BY

Lucy Morton

B

owel cancer is the fourth most common cancer in the UK and currently the second biggest cancer killer in England. If it is detected at an early stage – before symptoms appear – it’s easier to treat and there’s a better chance of surviving. We have a National Bowel Screening Program already in place, but tests only have a 58% completion rate, when sent to people’s homes. This is why there is much excitement about the new Faecal Immonochemical Test (FIT) which, it is estimated, will lead to more uptake in testing – thus quicker diagnosis. The new kit is easier to use, as it only requires the person to provide one stool sample – rather than two samples from three separate stools – and results are sent in two weeks. It will also encourage those who are reluctant to visit their GP. The FIT test looks for hidden blood in stool samples, which can be an early sign of bowel cancer. It will be rolled out across England, and automatically sent to men and women aged 60 to 74, every two years. Early diagnosis is crucial to saving lives and, if diagnosed early, more than 90% of bowel cancer cases can be treated successfully. Furthermore, if the cancer is detected before it spreads to other areas, there is a greater chance it will be cured. Every half an hour someone dies of the disease and it is hoped the new screening test will make a real difference.

2 0 | PH A R M A FI EL D.CO. U K

Those over the age of 74 years are not excluded from the FIT test, however, it will not be sent to them atomically. If any patients over 74 years of age want to have a free test sent, they can call Public Health England Contact number: 0800 707 6060. It is so important to know what public health campaigns are happening, both nationally and locally, as community pharmacists speak directly to the public on a daily basis. They have a pivotal role in helping raise the profile of campaigns and improve test usage. The FIT test should increase screening uptake by around 10%, resulting in 200,000 more people being tested every year, potentially saving hundreds of lives. Could you and your teams improve the visibility of the National Bowel Screening Program? Let’s play our part in making this screening program a success. Lucy is Clinical Governance Manager at Superdrug. Please note, these are Lucy’s personal views and do not necessarily reflect those of the Superdrug business.

Early diagnosis is crucial to saving lives and, if diagnosed early, more than 90% of bowel cancer cases can be treated successfully.


F E AT U R E WORDS BY

Amy Schofield

Could it be magic?

THE FACTS LIBERTY CAP MUSHROOMS ARE THE MOST COMMON TYPE OF

MAGIC

MUSHROOM Don’t believe the hype: health headlines dissected

A

small group of volunteers suffering from resistant depression were given psilocybin – the active substance in magic mushrooms – to explore the possibility that it could relieve their long-term depression. The Sun took the medal for the most facile, not to mention insensitive, headline: “Magic mushrooms make you a fun guy”. Meanwhile, other media outlets at least gave it more gravity.

TH E S TO RY Psilocybin was given to volunteers in whom at least two other anti-depressant treatments hadn’t worked. All of them reported a lightening in their mood for weeks afterwards. The researchers weren’t sure if the effect of psilocybin was due to chemical changes in the participants’ brains, or whether the ‘trip’ instead helped them to see things from a new perspective. A previous study by John Hopkins University looked into the effects of psilocybin on 36 subjects. Of these, 79% reported increased well-being for months after the trial.

TH E S TU DY The trial was carried out by scientists from Imperial College London and published in the Lancet Psychiatry Journal. Number of participants: 12 What the researchers did: Setting the scene

for a calming experience in a safe room, with relaxing music playing, and two psychiatrists on hand to talk to, the researchers gave the volunteers a low dose of psilocybin to check for adverse reactions. The following week a higher dose was administered. The psychedelic experience lasted up to five hours and one participant described it as “sometimes beautiful”. What the press said: ‘Magic mushrooms could be the future of antidepressants’ (Vice.com); ‘Magic mushrooms make you a fun guy’ (The Sun); ‘Psychedelics could be a new class of antidepressant’ (The Guardian).

TH E R E S U LT S

in the UK

THE AZTECS CALLED THEM TEONANACATL OR

‘FLESH of the

GODS

Magic mushrooms aren’t addictive THEY ARE

CLASS A CATEGORY DRUGS

They were once discovered in the Queen’s gardens AT BUCKINGHAM PALACE

The substance lifted the depressed mood of all the trial participants for three weeks, and some felt better for up to three months.

TH E D E A L All the participants experienced an alleviation of their depression after taking psilocybin, with the effects lasting for months in five of the subjects. There was no placebo involved, so the results were only a ‘proof of principle’. They did show, however, that under controlled conditions, a positive effect was felt by people whose depression had not responded to previous treatments.

M AG A ZI N E | J U LY 2016 | 2 1


D E AR D IARY UP-AND-COMING PHARMA EVENTS FOR YOUR DIARY 1 J U LY 2 0 16

A one day update on Gynaecology WHERE: Nottingham WHO: Events 4 Healthcare INFO: events4healthcare.com/naps CONTACT: 01462 476 120 or

enquiries@events4healthcare.com

RHEUM WITH A VIEW

21 S E P T E M B E R 2 0 16

NHS Improvement – where it's going, drivers and policies WHERE: Durham WHO: Morph Consultancy INFO: morphconsultancy.co.uk CONTACT: 07581358272 or

claire@morphconsultancy.co.uk 2 3 S E P T E M B E R 2 0 16

WHERE: Birmingham WHO: Morph Consultancy INFO: morphconsultancy.co.uk CONTACT: 07581358272 or

claire@morphconsultancy.co.uk 2 5 - 2 6 S E P T E M B E R 2 0 16

The Pharmacy Show 2016 WHERE: NEC Birmingham WHO: CloserStill Media INFO: thepharmacyshow.co.uk CONTACT: 0207 013 4976 or

m.patel@closerstillmedia.com 2 6 - 2 9 O C T O B E R 2 0 16

47th Union World Conference on Lung Health WHERE: Liverpool WHO: The Union INFO: liverpool.worldlunghealth.org CONTACT: union@theunion.org

U P CO M I N G E V E N T W E S H O U L D K N OW A B O U T ? H A Z E L @ P H A R M A F I E L D . CO . U K

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

The EULAR Congress 2016 provides hope, inspiration and unity WORDS BY

T

Amy Schofield

he cavernous halls of ExCel London played host to the 17th European League Against Rheumatism Annual Congress (EULAR). Doctors, scientists, health professionals, representatives from the pharmaceutical industry and patient organisations from across the world convened to share the latest scientific and clinical information that is changing the treatment of rheumatic and musculoskeletal diseases (RMDs), and transforming the lives of patients. Pharmaceutical companies large and small showcased their latest treatments through innovative, engaging and, occasionally, spectacular means. Interactive displays, show-stopping spectacles, a vast poster exhibition of latest trial results and eager pharma professionals on every stand made the congress a truly collaborative affair.

Delegates were spoilt for choice when it came to scientific sessions and satellite symposia. Across the congress, a wide range of topics were covered, from clinical, translational and basic science to the diagnosis and general management of rheumatic patients. New patient-focussed initiatives were also unveiled, highlighting the importance of the patient perspective. Indeed, pharma had clearly encouraged patient participation in innovative ways. Lilly’s inventive ‘Room of Discovery’ was an exhibition of everyday rooms – including a lounge and a baby’s bedroom – in which quotes from patients adorned the walls and a TV showed patient facts and stats. Meanwhile, companies invited us to explore their pipeline information through interactive displays. AstraZeneca and MedImmune featured big touch screens and impressive graphic displays,

PHOTOGRAPH COURTESY OF EXCEL LONDON WWW.EXCEL.LONDON

Vanguard Orthopaedic Alliance


E VENTS & CONFERENCES

P f MAG A Z I N E S PE A K S W ITH PAU L- PE TE R TA K

It’s a very patient-centric approach – we need people to see that we are really in it for the long term.

and Hospira (a Pfizer company) presented us with life-size interactive skeletons. Meanwhile, Janssen encouraged us to use the interactive differential diagnosis tool – which highlighted the different clinical features and pathopsychologies of common rheumatic diseases – and MedImmune urged delegates to get truly interactive and ‘explore gout from the inside out’ with the opportunity to discover your serum uric acid level. Show-stopping structures, such as Sandoz’s giant bookcase, Novartis’ Cosentyx’s giant man on a scooter, Biogen’s enormous atom and Celgene’s Otezla’s life-sized bus added theatrical dressing to the biggest rheumatology event in Europe. Everywhere, attendees were deep in conversation; sharing and collaborating with one common aim – to make life better for patients with RMDs.

GSK is marking the 20th anniversary since the discovery of B lymphocyte stimulator on SLE understanding and research. At EULAR the company announced the results of Phase III data showing greater treatment response with GSK’s Benlysta® (belimumab), vs placebo, in patients with highly active systemic lupus erythematosus (SLE). Pf Magazine spoke to GSK’s Chief Immunologist and Senior Vice President R&D Pipeline, Paul-Peter Tak, about what the data means for future treatment of the disease, GSK’s celebration of two decades of discovery, development and innovation in lupus, and where the future of rheumatology treatment lies. Q What was the response at EULAR to the Benlysta data announcement? Very positive. SLE is a difficult disease and, even if you give optimal standard of care you can still have statistically significant additional benefit in patients who receive Benlysta, compared to placebo. It is important because it may help to reduce progressive tissue damage; ultimately the most important effect in terms of outcome. It may also reduce the need for corticosteroids – we’re looking at new studies in real detail to see if there’s evidence of that. From a patient perspective that’s very relevant. People in the scientific and clinical community are really starting to understand how Benlysta can be used. This medicine consistently delivers in SLE. You can reduce tissue damage, you can change the course of the disease and you can reduce the number of flares. We’ve been very interested in exploring the effects of Benlysta in other inflammatory disorders and we’ve been testing it in other diseases as well. Q Have you seen an increase in inflammatory disorders over the last few years? Yes. There is a prevalence of 6 – 7% and this is expected to increase because of the ageing population in the rest of the world. These are conditions that we cannot cure yet, so if you get it you will live with it for a long time. I’ve done a lot of clinical work and research in the field of osteoarthritis and there’s always an inflammatory component. We’re testing the same medicines in these different populations – it’s a very big field.

Q Where will you take your research next? I want to take it to the next level. It’s always good to check what the latest information is. It’s also important for us to present ourselves, because GSK has not been a big immuno-inflammation company, but we are building a very strong immunology portfolio. We have very encouraging data in the field of quality of life as well, which illustrates the holistic approach that I try to take. It’s a very patient-centric approach and it’s very important that we present it here – we need people to see that we are really in it for the long term. It’s a serious commitment to the field of rheumatology.

THE STATS

14,000

DELEGATES FROM 120+ COUNTRIES

4300 abstracts submitted

190

OVER

SESSIONS AND POSTER TOURS

M AG A ZI N E | J U LY 2016 | 2 3


P H A R M A TA L E N T

MOVERS & SHAKERS

JAMAL RUSHDY

JEREMY HAIGH

The Board of Collagen Solutions plc – developer and manufacturer of medical grade collagen components for use in regenerative medicine, medical devices and in-vitro diagnostics – has appointed director Jamal Rushdy as CEO.

Proteome Sciences has recruited Jeremy Haigh as CEO, furthering expansion of the executive team. A strong advocate of precision medicine, Haigh has three decades of experience in clinical and operational research and development.

VIVIENNE COX

Dr Cox CBE has joined GlaxoSmithKline's Board as Non-Executive Director, and also takes up a role as a member of the Corporate Responsibility Committee. She has extensive experience of business in the energy, natural resources and publishing sectors.

DR HAROLD VARMUS

Non-profit organisation the International Biomedical Research Alliance has recruited Dr Harold Varmus to its board of directors. Dr Varmus – corecipient of the Nobel Prize in Physiology or Medicine – stepped down as director of the National Cancer Institute (NCI) in 2015. LUCY CHURCH AND GREG KANE

DAVID LAWRENCE

WHO’S GOING WHERE AND WHY THEY’RE GOING THERE. WORDS BY

Amy Schofield

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Redx Pharma has appointed David Lawrence as Non-Executive Director. He succeeds Derek Lindsay, who has stepped down from the Board. Lawrence has over 25 years’ experience in the biotech and pharmaceutical industries where he worked at Chiron Vaccines, Acambis plc and GSK.

Cormis Partnership have welcomed Lucy Church and Greg Kane into their expanding Client Services team. Lucy – an accomplished organiser of Healthcare Events – brings a wealth of experience to her new role of Account Manager. Greg, having taught English for a year in Madrid, now applies his passion for customer service and communication as an Account Executive. Greg’s mother, Helen Kane, is the Medical Associate for Cormis Partnership.


ADVERTORIAL

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IT AIN’T WORKING – REPLACE OR FIX IT? By Ian Close, Partner, Cormis Partnership

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SANOFI COMMITTEE CHANGES

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Chief Executive Officer and Executive Committee Chair, Olivier Brandicourt (1), has announced a number of changes to Sanofi’s Committee in support of the company’s recently announced 2020 Strategic Roadmap. Olivier Charmeil (2), Executive Vice President and General Manager, General Medicines and Emerging Markets*; Jérôme Contamine (3), Executive Vice President, finance; Peter Guenter (4), Executive Vice President and General Manager, diabetes & cardiovascular *; Carsten Hellmann, Executive Vice President and General Manager of Merial; Karen Linehan (5), Executive Vice President, legal affairs and general counsel; David Loew, Executive Vice President and General Manager of Sanofi Pasteur; Philippe Luscan (6), Executive Vice President, global industrial affairs; Muzammil Mansuri, Ph.D., Executive Vice President, strategy & business development; David Meeker, MD, Executive Vice President and General Manager of Sanofi Genzyme; Ameet Nathwani, MD, Executive Vice President, medical affairs; Roberto Pucci, Executive Vice President, human resources; Elias Zerhouni, MD, President, global research & development.

Pharmaceutical companies dedicate a lot of resources to create communication frameworks that support their marketing strategies. New models are frequently launched but not always maintained. Do you recognise the following sequence?

Some managers don’t engage with the new approach They may not know what good looks like or how to coach for improvement so teams continue doing what feels familiar No change is observed The company decides the approach doesn’t work They rip it up and start again It doesn’t have to be this way. Typically, the problem is not the new approach being implemented, but the implementation process itself. At Cormis, we immerse ourselves in the problem to really understand what’s working and what’s not. We don’t throw the baby out with the bath water but work with the organisation to allow their own processes to improve by engaging managers to support the approach and coach against clearly defined standards of excellence, thus transforming their own and their teams’ potential, and achieving success. We only implement new processes when the current model cannot be adapted to become fit for purpose. Tailored solutions are frequently promised, but how often do they truly reflect your company essence? If you want expert solutions that feel like your own, then contact Cormis Partnership on 01932 903060, email contact@cormispartnership.com or visit cormispartnership.com to find out more.

* Denotes change in position for existing Executive Committee member.

M AG A ZI N E | J U LY 2016 | 2 5


P H A R M A TA L E N T Q How do you get the best out of people? We have a strong commitment to take care of our employees. We truly believe that having an engaged workforce is our best competitive advantage and that’s why we always try to find the right balance between setting ambitious goals and having fun at work. Q What does loyalty engender at the company? By putting people first in everything we do, we generate sustainable results and experience a very high level of commitment among our colleagues. Here you will not only change your professional life, by working with challenging tasks and inspiring colleagues, you will also be part of making a real difference to the world we live in.

HR Director Antonio MarínBlázquez explains why Novo Nordisk is a great place to work.

INTERVIEW BY

Amy Schofield

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ovo Nordisk is a pharma employer that takes corporate social responsibility to a new level. It gives back – to its employees, and to the wider community. The company has created a workplace culture that engages, enriches and enhances. HR Director, Antonio Marín-Blázquez, explains how Novo Nordisk attracts and keeps talent.

Q What’s the culture like at Novo Nordisk? People like to do exciting things. They like to be part of the journey, during which we’re saving people’s lives. So we bring patients in to see our employees. We illuminate the big difference we’re making. Without our medication, 24 million people would suffer. There is nothing more motivating for people than going to work and saving people’s lives.

Q How does history influence what you do? At Novo Nordisk, you are part of a unique company culture and heritage, dating back to when co-founder August Krogh brought insulin production to Denmark in 1923. It is a values-based way of doing business, anchored in what we call the ‘Novo Nordisk Way’. Novo Nordisk has earned a reputation as a very attractive workplace, both in Denmark and abroad. Internally, anonymous surveys show consistently high engagement ratings. Our employees are not only committed to changing diabetes and the rest of the therapy areas in which we work. In the spirit of our Triple Bottom Line – we are socially, environmentally and financially responsible – they also care about what happens in the community and the environment in which they live and work. Q What does the future hold? The future could not look brighter for the Company. Our shares continue to be very attractive for investors due to our current outstanding portfolio of best in class products, which will continue to increase in the next few years. We are actually expecting to launch one new product per year, if not more. As a consequence of it, one of our main focus areas right now is to strengthen our Market Access capabilities to make sure that patients have access to our products as soon as possible and in the best conditions possible. Go to novonordisk.co.uk

Looking for a life-changing career? Join us and make the most of your talent www.novonordisk.com/careers 2 6 | PH A R M A FI EL D.CO. U K


NOVO NORDISK’S EMPLOYEE INITIATIVES NOVO NORDISK HAS CREATED A WORKPLACE CULTURE THAT ENGAGES, ENRICHES AND ENHANCES THE LIVES OF ITS EMPLOYEES. HERE’S HOW.

ADVERTORIAL NovoHealth is a global programme seeking to develop a workplace culture that promotes and supports healthy living for all employees. Driven by Sophie Wood, Performance Management and Organisational Design Manager, it presents an opportunity for Novo Nordisk to practise what it preaches as a means of preventing type 2 diabetes, among other lifestyle-driven diseases. Talent Attraction & Retention Specialist Gemma Sawyer says: “NovoHealth gives us an exciting opportunity to bring the organisation together across the globe, support our colleagues, address our social responsibility as an employer and improve business performance in accordance with our Triple Bottom Line principle.” Many affiliates have access to free healthy food every day and gym facilities on-site, to support employees in making healthy choices. “At the start of this year, we challenged every employee in the UK and Ireland to make some positive changes to their lifestyle,” explains Gemma. “We issued every employee with a Fitbit, in line with our NovoHealth commitment to support colleagues in being physically active.” To see how employees are progressing, and celebrate positive milestones, all employees are invited once a quarter to nominate themselves, their colleagues or whole teams who have been taking steps (often by the thousands) to increase their activity, and set a great example to their peers. “We collected nominations of activity and lifestyle changes throughout Q1,” says Gemma. “From those nominations we were able to shortlist three finalists. They were each awarded a prize and we ensured that we shared their stories in order to highlight their great efforts and inspire the rest of the organisation. We are looking forward to seeing who the winners are for Q2!”

R E AC H I N G R I O In the lead up to the 2016 Rio Olympics, Novo Nordisk are encouraging employees to take part in a virtual race from London to the Rio Olympics, run by West Sussex County Council. Teams of five compete against each other and log their activity in the battle to reach Rio first, winning prizes along the way. “Novo Nordisk employees have over 20 teams signed up and they are riding high in the leader boards against a number of other local organisations,” reveals Gemma.

TA K E AC TI O N TakeAction is Novo Nordisk’s global employee volunteer programme, driven by Sophie Wood, it gives employees flexible ways to make a difference. This could be as an individual or part of a team, during working hours or outside, and focuses on a diabetes related cause or one in the local community. Novo Nordisk UK and Ireland took part in a whole company TakeAction event, where employees were tasked with building bikes, which were donated to children via the JDRF and Great Ormond Street Hospital. “As well as being very aware that we were giving something great back to the diabetes community, it was a great team-building exercise, as people from all different parts of the organisation worked together to do something they had never done before,” enthuses Gemma. “Sophie and the Take Action team are really looking forward to handing over the bikes and seeing our efforts put a smile on the faces of 48 children.”

M AG A ZI N E | J U LY 2016 | 2 7


ADVERTORIAL

KIE TO SUCCESS ANDREW WAITON EXPLAINS WHY GOOD HABITS START FROM THE INSIDE Words by Andy Waiton

Key Opinion Leaders, Thought Leaders and Key External Experts (KEE) have – for years – led best practice and influenced disease management among their peers. Clearly, if that person is an advocate of your brands, a relationship between the pharmaceutical company and the KEE is mutually beneficial. So beneficial that some have questioned the impartiality of the relationship, no matter how impeccably they have conducted themselves. The ultimate response has been to stop any sponsored advocacy by KEEs, and companies are now looking to create their own Key Internal Experts (KIE) – fully employed clinicians, pharmacists or scientists who are experts in therapy areas. The challenge is how to transform a company therapeutic expert into somebody that healthcare professionals will trust, believe in and relate to. This requires far more than just knowledge, it needs the right skills and attitude. Imagine a KIE being represented by a library. To be effective you need content, books and a comprehensive knowledge. But a library also needs to be accessible.

ROI – Now we can help you measure the return on your training investment with your KIEs. Excel Evaluate is an online tool that empowers organisations to easily and cost-effectively measure the behavioural impact of your internal training, or the expert training provided by the Excel Communications group of companies.

Excel SciMed is a highly specialised division of Excel Communications. It recognises the vital importance of the pharmaceutical industry’s Field Medical and Medical Affairs professionals, offering unique, engaging and tailored communication skills training. Today Excel Communications has over 50 trainers delivering global training programmes in every corner of the globe, across 22 languages.

C R E ATI N G A N E X PE RT KIEs must have unparalleled knowledge of their field, the relevant therapy area, product and clinical data. A greater challenge, however, is to develop the three communication skills that are required to unlock the doors to a wealth of knowledge. 1) KIEs must be able to create trusting one-to-one relationships if they are to debate, challenge and inform. 2) They must take confidence into Advisory Boards and disease management meetings 3) They need to command an audience so that data comes to life. The thing that truly differentiates a KIE is their attitude and this is less easy to train. Recruit people with the right attitude and it follows that skills and knowledge can easily be trained.

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For more information and to download a free copy of our White Paper – 'Building the Future of Field Medical', please visit our website at excel-communications.com or call the office on +44 (0) 1628 488 854.


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