What has 2017 taught us and what hope is there?

by Amy Schofield 11. December 2017 09:17

 

’17 Again

2017 was marked by more political uncertainty, as Theresa May called a snap General Election, which backfired spectacularly. Meanwhile, Brexit ‘negotiations’ rumbled on (and continue to), the NHS buckled further under the strain and every industry – not least the pharmaceutical sector – faced yet more insecurity. So, what challenges faced pharma and the NHS, and what’s next?

 

POLITICS: Where’s the money?

Simon Stevens gave an impassioned speech at the NHS Providers conference, demanding the £350m-a-week promised to the NHS by the Leave campaign, pointing out that: “The NHS wasn’t on the ballot paper, but it was on the battlebus – ‘Vote Leave for a better funded health service – £350m a week’”. At the time of going to press, there was no sign of the cash materialising.

 

 

Pharma & NHS

Reality bites: David Thorne, Managing Director, Blue River Consulting and Pf Magazine columnist

2017 saw the NHS attacking supply and demand. Some blunt weapons are being used – increased waiting times, reduced fixed costs through consolidation, restrictive procurement of material and rationing. The NHS isn’t good at promoting self-care and preventative better health, so it depends on shutting demand valves.

It wouldn’t be so bad if there was a public mandate for any of this but, instead, we have occult measures used to restrict IVF, deny surgery to smokers or the obese, and waiting times gamed to stimulate use of self-pay.

Disruptive change is happening in ways that mean the endpoint of integrated health and care partnerships is being reached through a nebulous maze of temporary organisational acronyms. The NHS reality is driving change via inadequate funding, social care collapse, reduced quality of care and an ageing, inflexible workforce.

For pharma this means a 2018 of focused de-prescribing plans, intense price pressure and coordinated action to minimise uptake of targeted products. There is a real risk of pharma being reduced to a basic commodity market. Ask any CCG Chief to name five medicines and see what happens!

Pharma needs to get ahead of change and find a place in the future system where it can plant its flag of value. The NHS needs help on vaccination and immunisation campaigns, early diagnosis, safety, RightCare and much more. United cross-company work is urgently needed for a positive approach to emphasising the vital place in healthcare of ethical medicines.

 

 

DIGITAL: Remote Renaissance

Andrew Davis, Chairman, neoNavitas

In 2017 the NHS in England became even more complex than ever before. The variables that define a health economy are so many and diverse that we are dealing in segments of one. This heightens the need for local solutions, designed with the customer, that genuinely address patient needs, provider ambition and commissioner goals.

The complexity of differing organisational footprints need not be as challenging to address as it initially seems. The key individuals remain, but their organisations may have changed. Building relationships with these key individuals, deploying teams
with the ability and mandate to engage and deliver on a shared agenda, and engaging head office in a sales enablement drive are strategies that transcend changes in NHS structure and create significant competitive advantage.

2017 also saw the development of remote private and NHS consultations. Could this be the catalyst for the renaissance of primary care? The issue for GPs has been the time required to deliver quality care to those who need it most, and opportunities to create more income. Reducing unnecessary GP consultations would allow GPs to carry out both. 2018 is going to be an exciting year.

 

ABPI: Code breakers 

A 2017 report showed that breaches of the ABPI code of practice have risen sharply. The Prescription Medicines Code of Practice Authority’s (PMCPA) annual report shows that companies in breach of the code, following complaints received in 2016, include Astellas Pharmaceuticals UK, AstraZeneca UK, Eli Lilly, GSK UK, Merck Sharp & Dohme, Novartis Pharmaceuticals UK and Roche Products. According to the PMCPA, the most common cause of complaint is around claims companies make about their products.

 

 

Brexit: the opportunities

Leslie Galloway, Chairman, Ethical Medicines Industry Group (EMIG)

Ongoing Brexit negotiations can be summarised as the greatest uncertainty to face the UK pharma industry and, therefore, our future healthcare and the economy.

This is because ‘no deal’ will mean the UK will likely be relegated in the global sequence of new medicine launches. The implications being that, in future, new medicines would be launched in the EU-27 up to two years before they would in the UK. Such a change would have significant consequences for standard of care, clinical research, the economy and, crucially, patient welfare.

We can lobby as much as we want, but we have little control over how the Commission behaves or how our Government responds, since we are in the midst of exceptional political instability.

We should also remember that the UK does not control its position in global pharmaceuticals. We are 3% of the global market and currently perceived as the English-speaking gateway to the EU. That may well change and the people who will make those decisions are the global pharma decision makers, mostly based in the U.S., Japan and the EU.

How do we compensate for this potential loss of influence over our future?

The answer is: where we have much more control – in the UK and with the Pharmaceutical Price Regulation Scheme, which will be renegotiated in 2018.

It is widely accepted that the current scheme is not working. There are a number of changes we could make, however, which would not only make it work, but create a positive image for the UK as a global centre for innovation.

The most significant change could be the creation of a new medicines fund, underwritten by industry rebates, and aimed at medicines approved by NICE and those with specialised services commissioning policy. Such a scheme could obviate the need for NHS Affordability criteria and the QALY threshold.

These opportunities are within our grasp and could make the UK a global centre, not just an offshore island next to the main market. 

 

HEALTHCARE: Agile response

Samir Paul, Director, Inicio Consulting

2017 has been an interesting year in pharma and healthcare. Maximising the impact of commercial brand strategies in an ever-complex multi-stakeholder environment, efficiencies being driven in the NHS with potential pricing reforms and the increasing voice of the patient, have meant that as an industry we are having to adapt. The ability to show agility and be able to respond to the needs of customers and patients has never been more important.    

 

Therapy breakthroughs 

HIV

Sanofi and NIH researchers have developed genetically engineered ‘three-in-one’ antibodies as a potential breakthrough intervention for HIV/AIDS, which have the highest activity and breadth of coverage yet seen against HIV1.

Cancer

Novartis’ advanced breast cancer drug Kisqali (ribociclib) became the first cancer treatment recommended by NICE under the updated cancer appraisal process, giving women with the most common form of advanced breast cancer the possibility of living an average of two years without their disease progressing.

Diabetes

Trials by University of Leicester researchers on Novo Nordisk’s once-daily pill, semaglutide, show a decrease in blood glucose levels and ‘meaningful’ weight loss in up to 90% of patients over three months, potentially ending the need for insulin injections.

Dementia

In November, billionaire Bill Gates announced a personal $50m investment into the Dementia Discovery Fund to boost research into the underlying causes of the disease. It will also improve dementia diagnosis and participation in trials, bringing new ideas and theories into the field, and use the power of big data to speed up research progress.

 


 

 

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Features

Is porridge better for health than statins?

by Amy Schofield 30. November 2017 10:19

 

 

Don’t believe the hype: health headlines dissected

 

THE STORY

Forget the mass prescription of statins to reduce harmful cholesterol – the nation’s health could be improved by simply eating a bowl of porridge a day. This is according to Chris Seal, Professor of Food and Human Nutrition at Newcastle University, who says the incredible health benefits of the humble bowl of porridge outweigh those gained by taking daily cholesterol-lowering medication. What’s the story morning glory?

 

THE RESEARCH

Porridge is known to have many credentials that contribute to good health; it’s low in fat, high in fibre, low in sugar, and contains minerals and B vitamins. But the thing that gives porridge’s benefits the edge is its high beta glucan content. Beta glucan is a soluble fibre that forms a thick ‘gel’ in the stomach, reducing appetite after eating, while lowering the absorption of low-density lipoprotein (LDL) or ‘bad’ cholesterol.

Prof. Seal says that, according to studies, eating 3g of beta glucan a day, roughly equivalent to the amount found in a 70g bowl of porridge, can reduce levels of LDL cholesterol by approximately 7%. Beta glucan also forms acids including butyric acid, which works on the DNA of cells in the colon and produces an anti-cancer effect.

 

THE RESULTS

The beta glucan found in porridge works by stimulating the excretion of bile salts, made of cholesterol. Therefore, the more cholesterol used to produce bile salts, the less cholesterol found in the blood stream.

“I believe that if everyone started the day with porridge, it would have a significant impact on public health,” says Prof. Seal, who practices what he preaches, eating porridge made with semi-skimmed milk all year round.

 

THE DEAL

Research shows that the cholesterol-reducing powers of the beta glucan in porridge may potentially rival those of statins, with the additional bonus of significantly cutting rates of heart disease and possibly bowel cancer, with no side effects. Commenting on the studies, Dr George Grimble, Principal Research Fellow in the medicine division at University College London, and occasional consumer of porridge, said: “That’s similar to the results you might get from taking a statin.”

 

What the press said:

‘The amazing truth about porridge?’ Dailymail.co.uk

‘THIS 75p breakfast better than drugs to lower cholesterol’ Express.co.uk

‘Here’s why porridge is the healthiest option for breakfast’ Asianage.com    

 

 

 

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Features

Dr Graham Leask on making use of big data

by Amy Schofield 20. November 2017 09:20

 

 

Seize the data

Dr Graham Leask explores how industry can make the most of a modern phenomenon.

 

Listening to a recent talk on ‘big data’ I was reminded that the pharmaceutical industry is awash with data, but devoid of information. What this means in practice is that data – although capable in skilful hands of becoming a useful source of insight – rarely fulfils this role for pharma companies.

 

 

Five sins

There are five reasons. Firstly, over-dependence on CRM systems, combined with the aggregation of inputs that are better separate. Although an important role of the CRM is undoubtedly as custodian of customer records, getting data into your CRM is often a great deal easier than getting useful information out.

Secondly, standard use of smart dashboards produces a set of predetermined charts that display a chosen view of reality and act to distract attention away from the key issues. Thirdly, there is an over-reliance upon Excel-based analysis that is simply not adequate to handle the complexities of modern, highly-correlated pharmaceutical data.

Fourth, there is a lack of training which will equip representatives to use data in clever ways, and direct their efforts, building competitive advantages. Finally, the use of marketing audits aimed at measuring the delivery of marketing messages, the methodology of which corrupts the very essence of what they are trying to measure.

These problems are not universal but common and each weakens the value of our data in its own way. Many CRM systems, for example, dumb down the complex interaction between a representative and a customer to a binary choice of call or meeting. This loses valuable information that disguises the important representative behaviours. (see visual above).

 

Analyse this

Universal use of dashboards may be reminiscent of Soma in Aldous Huxley’s Brave New World. Used selectively they can be valuable, but they are the exception in report form. If a standard deck of charts is routinely circulated, soon they are seen as ‘company wallpaper’ and little notice is paid to them. I once attended a meeting where a large number of charts were presented; the use of so many disguised the one important chart lurking within.

The analytics engine used by many companies is still Excel. This is fine if you want to check your budget, but using these tools to produce linear forecasts can produce the false impression of a robust and statistically significant relationship.

Modern statistics have advanced tremendously since Sir Francis Galton experimented on a packet of seeds in 1875. Linear regression, although undoubtedly useful, relies on four underlying critical assumptions, most commonly violated by complex pharmaceutical data.

This renders many analyses as an unsafe base on which to make decisions. Similarly flawed is the overuse of correlation where, for example, a really interesting 0.992 correlation can be shown between the US spending on science, space, technology and suicides by hanging, strangulation and suffocation.

 

Natural selection

One anecdote perhaps summarises the issue. In one company, having spent vast sums on a new sales force support system, one manager reported to me that trying to use it was “like trying to take a drink from a fire hose”. This is not to say that data is not useful. The key question is – what is the right data?

If we accept the old adage that nothing is sold until someone convinces another person, then the crux of the effective representative’s role is to maximise customer contact on their assigned territory. Here, the key question is; which are the right customers to call upon and what is the optimal frequency of contact?

The first of these is down to a mixture of local knowledge and correct targeting, where the biggest change has been availability of the NHS Prescribing Data. This allows us to precisely tailor our sales argument to focus on relevant competitors.

Call frequency is a specialist analysis that I spent a year working on at Aston University; work that culminated in winning the BOBI Award for commercial analysis. Two findings here are pertinent. Firstly, the effective call frequency corridor is often lower than you may think. Secondly, promotion doesn’t occur in a vacuum - correct alignment to the environment is critical. In conclusion; use selective data well, rather than rely on a house of cards.   

 

Dr Graham Leask is a consultant and writer on the pharma and healthcare industries. He spent 15 years as a member of the faculty of the Economics and Strategy Group, Aston University. To comment on the article, write to grahamleask5@gmail.com

 

 

 

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Features

On the brain: Neurological conditions

by Amy Schofield 13. November 2017 09:12

 

 

Neurological conditions affect the brain, spinal column and nervous system.

 

Here we focus on three of the most prevalent disorders impacting on lives throughout the UK, while taking a look at the treatments and developments which may offer hope for the future.

 

 

Parkinson’s disease

Symptoms

Parkinson’s disease is a complex condition with many physical and mental symptoms, but not every patient will experience all of them, and progression of the disease varies. Physical symptoms include tremors, muscle cramps, slowness of movement, rigidity and restless legs.

Parkinson’s can also cause other distressing symptoms, including anxiety, depression, dementia, hallucinations, delusions and memory problems.

 

Treatments

Parkinson’s disease has no cure, although treatments are available which can help to alleviate symptoms and maintain quality of life.

The main drug used to treat the symptoms of Parkinson’s disease is levodopa. When dopamine levels in the brain become too low, because the dopamine-producing cells are dying or dead, Parkinson’s symptoms develop. Levodopa is a chemical building block that the body converts into dopamine. It can be used at all stages, usually starting with a low dose that is increased gradually until symptoms are controlled.

Dopamine agonists act like dopamine to stimulate nerve cells and come in various forms, such as tablets, capsules, prolonged release tablets, modified release tablets, pre-filled syringes and a skin patch. These treatments include Pramipexole, Ropinirole, Rotigotine, Apomorphine, Bromocriptine, Cabergoline and Pergolide, and can be used alone or alongside Levodopa.

MAO-B inhibitors work by blocking the monoamine oxidase type B (MAO-B) enzyme, which breaks down dopamine in the brain, to help nerve cells make better use of the dopamine that they already have.

 

Latest research

In October, it was reported that researchers at Dundee University had solved the 3D structure of PINK1, a protein that plays a protective role in brain cells. Inherited changes in the PINK1 gene – that stop the protein from working – are known to be one of the most common causes of early-onset Parkinson’s.

The team used x-ray crystallography to make crystals of the protein and then used an x-ray machine to determine the 3D structure of the crystal. The researchers also found that PINK1 has unique control elements that allow it to interact with two other proteins, ubiquitin and Parkin, potentially paving the way to develop drugs that target the protective properties of PINK1.

 

Multiple sclerosis

Multiple sclerosis (MS) is a complex neurological condition with a number of symptoms that vary between patients. Common physical symptoms include vision problems, balance problems, stiffness, spasms, fatigue and dizziness. MS can also affect thinking, memory, emotions and mental health.

 

Treatments

As well as recommendations on using diet, exercise, physiotherapy and complementary therapies to manage the symptoms of MS, disease modifying therapies (DMTs) are recommended for patients. DMTs reduce the number and severity of relapses, as well as slowing down the damage over time caused by relapses. They can’t, however, treat people who have MS without relapses. DMTs, which are taken in tablet or injection form depending on the drug, include: Lemtrada, Tysabri, Zinbryta, Tecfidera, Gilenya, Copaxone, Aubagio. There are five different beta interferons: Avonex, Betaferon, Extavia, Plegridy and Rebif.

Hope is on the horizon for those with progressive MS, as researchers at Roche and Genentech have developed a DMT for people with this form of MS, which it is hoped will be available by 2018. Ocrelizumab (Ocrevus) is the first treatment that can slow the advancement of primary progressive MS, according to the results of phase III trials. In March 2017 ocrelizumab was approved by the US Food and Drug Administration as a treatment for both relapsing and primary progressive MS, and in September Swiss regulatory authorities also approved it for the same indications. It is currently being reviewed by the European Medicines Agency, and a decision is expected in autumn 2017.

 

Cannabis and MS

The pain and muscle spasms associated with MS are exhausting and impact heavily on the sufferer’s quality of life, making daily tasks impossible. There are treatments available on the NHS, but they are ‘not appropriate, available or effective for all people with MS who experience these symptoms’, according to the MS Society. Evidence shows that cannabis for medicinal use can work for some people to relieve pain and muscle spasms in MS.

Bayer’s Sativex is a mouth spray which contains a medicine extracted from cannabis plants which offers relief from spasticity. It is not available on the NHS (apart from in Wales), and is expensive to buy privately. The MS Society is calling for the UK Government to make urgent changes to allow MS patients access to this medicine: ‘We are calling for the pharmaceutical company and the NHS to get back around the negotiating table to explore every possible avenue’, the Society stated in its ‘Cannabis and MS’ report from July 2017.

 

•  72% of people with MS feel that cannabis should be legalised for medicinal purposes

•  22% of people with MS have tried illegal forms of cannabis as they feel it is their only option.

Source: mssociety.org.uk

 

 

Motor neurone disease

The Motor Neurone Disease Association explains MND and the treatments available.

MND is a fatal, rapidly progressing condition that involves the selective degeneration of motor neurones. It has a worldwide incidence of two per 100,000 and a prevalence of five to seven per 100,000. The only treatment currently licensed in the UK is riluzole, which is thought to work by suppressing glutamate activity. Riluzole is generally taken orally as a tablet (now off patent), however it has recently been formulated as a liquid (Teglutik). While the original trials showed that riluzole improved survival by two to three months, its true effects may be greater as its effects are masked by improvements in recent years by multidisciplinary team care and good symptom management (which also extends the lives of people with MND).

In May 2017 edaravone (trade name Radicava) was licensed for ALS (the most common form of MND) in the U.S. Clinical trials of edaravone have been limited to six months duration in a subgroup of patients, where the endpoints have been changes in a symptom management scale (the ‘ALSFRS’) rather than survival.

MND is a heterogeneous disease where the presentation and prognosis are difficult to predict for any one person with the condition. It is likely that a precision medicine approach may be successful in the future, identifying genetic subgroups of patients with specific, targeted treatments. A number of biological markers of progression are emerging which will be invaluable in such an approach.   

 

 

Personal Story

Ian Hatton, 54, lives in Suffolk with his wife Karen and American Cocker Spaniel, Paxton.

 

In March 2016 I was sitting across the desk from my neurology consultant receiving the news that I had MND. I went through the process of asking standard questions about what I could expect and, more importantly, how long I had left.

I was told that most people with MND live two to five years. About 10% survive at least 10 years. A quick calculation told me that in the worst-case scenario it was possible that things could start going downhill very quickly.

It seems just ‘dumb luck’ with MND in terms of which functions and parts of the body are affected first and this obviously dictates how long people survive. I undergo all the standard tests on a regular basis to check physical symptoms and degradation, particularly with respect to breathing, but there is no test that can reliably forecast the rate at which the condition will progress and answer that key question of how much longer someone will be able to lead a relatively normal life. Psychologically I, and my family, find this is the most difficult challenge.

I actually feel very lucky and understand that there are many people much worse off than me. My wife Karen and family are very positive and we’re all determined to make the most of however much time we have together. Karen is a keen runner with several marathons under her belt, while she and friends have been involved with the MND Association to raise funds. The support I have received from this organisation, my consultant and all the specialist nurses and staff I see locally has been fantastic.

There are undoubtedly grim times ahead but to worry about something I cannot control would only have a detrimental effect on the time I have while relatively fit and healthy. 

 

Go to mssociety.org.uk, mndassociation.org, parkinsons.org.uk

 


 

 

 

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Features

Can eating Marmite prevent miscarriages?

by Amy Schofield 30. October 2017 12:20

Can eating Marmite prevent miscarriages and birth defects?

 

Don’t believe the hype: health headlines dissected.

 

THE STORY

‘Cure’ isn’t a word very often bandied around in clinical research. Results from a study by Australian scientists, however, have apparently shown that Vitamin B3 (found in Marmite) can cure deficiencies which cause miscarriages and birth defects. What are the facts behind the hype?

 

THE RESEARCH

Researchers at Sydney’s Victor Chang Cardiac Research Institute, led by Professor Sally Dunwoodie, discovered that deficiency in a vital molecule, nicotinamide adenine dinucleotide (NAD), prevents a baby’s organs from correctly developing in the womb.

Researchers took four families that each had a child with multiple birth defects, and carried out genetic sequencing. After discovering gene mutations that affected production of NAD, they looked at similar disease-causing mutations in mice and the effect that increasing vitamin B3 in the diet had on preventing malformations in developing embryos.

Vitamin B3, also found in meat and green vegetables, is needed by the body to make NAD. Previous studies showed that despite pregnant women taking vitamin supplements, at least a third have insufficient levels of B3 during the critical first trimester of embryonic development. The new findings indicated that pregnant women may need more of the vitamin.

 

THE RESULTS

The researchers studied the effect of vitamin B3 on developing mouse model embryos, with what they called ‘astounding’ results.

Before vitamin B3 was introduced into the mother’s diet, embryos were either lost through miscarriage, or offspring were born with severe birth defects. After the supplements were given, both miscarriages and birth defects were completely prevented, with all offspring born healthy.

 

THE DEAL

The results could indicate that the benefits of vitamin B3 are more broadly applicable to the wider population and are not limited to a rare genetic condition, however, the research does not necessarily translate to reducing miscarriages in human females, as pregnancy outcomes in women were not studied.

Miscarriages and birth defects happen for a range of reasons, not because of one rare genetic mutation. In addition, three of the four children included in the study were the offspring of parents related by blood, which could indicate that the type of genetic mutations studied are more specific to the children of parents who are related.

Clearly, the effect of increases in vitamin B3 consumption would still need to be tested in humans and, love it or hate it, we should conclude that these headlines are hyping.

 

What the press said:

“Why Marmite could prevent miscarriages and birth defects” Telegraph.co.uk

“Why MARMITE could be the secret to a healthy pregnancy” Mirror.co.uk

“Vitamin B3 could prevent birth defects, miscarriages, scientists say” Foxnews.com  

 


 

 

 

 

Inceptua on the scourge of counterfeit medicines

by J Pinching 22. October 2017 09:57

 

 

Fake news

 

A hazy definition of counterfeit medicine, varying degrees of regulation, rising online availability and lenient punishments for traders has led to increased levels of counterfeit drugs.

More recently, there have been more sophisticated counterfeit drugs appearing. Fake versions of Xepilon, a schizophrenia treatment, and Votrient, a cancer therapy, have both been found in Germany, while an imitation of Ominitrope, a human growth hormone, surfaced in France, Denmark and Mexico.

One expert estimates that a $1000 investment in counterfeit drugs can result in a $30,000 return; 10 times the profit of trafficking heroin. Another source reported that selling counterfeit Sildenafil “can be as much as 2000 times more profitable” than selling cocaine.

The risk of being caught is actually lower because detection is so difficult, and penalties are less serious due to a focus on intellectual property rights, rather than human consequences.

The WHO estimates that 30% of the world’s national regulatory agencies can’t function and, in Africa, there are 54 regulatory bodies, many of which are under-resourced. Every country has issues with counterfeit drugs, and while there are countries with robust measures, global harmonisation is lacking.

 

Dr who?

The proliferation of websites has led to easy access to what patients believe are real pharmaceuticals. What purported to be a Canadian pharmacy, for example, was actually 51 websites spread across several countries including China, Malaysia, Taiwan, Russia and Indonesia.

Analysing the IPs of the websites uncovered a further 1005 active domains, 70% hosted in Russia and the remainder in France. In 14 days, 86,276 unique sites worldwide were traced.

When the National Association of Boards of Pharmacy in the US reviewed 11,299 websites offering prescriptions for sale, it discovered that '10,823 (95.8%) were operating out of compliance with state and federal laws'. Staggeringly 4932 global sites selling illicit pharmaceuticals were suspended during an Interpol Operation, Pangea, in 2016.

The Drug Supply Chain Security Act, in the States, came into force in 2015, covering manufacturers, re-packagers and wholesale distributors.

Even in the UK, where regulation and medicine tracking is stringent, The Pharmaceutical Security Institute found that between 2011 and 2015 the global incidence of drug counterfeiting increased by 51%. 

European Council, meanwhile, have released a Falsified Medicines Directive, which aims to improve patient safety by mandating that marketing authorisation holders and manufacturers have a system to prevent falsified medicines from entering the legal supply chain.

In practice, pharmaceutical manufacturers will need to apply a unique identifier and tamper verification feature to the outer package of medicinal products. By February 2019, a European Medicines Verification System will guarantee the verification of medicines throughout the supply chain and at the time of delivery to the patient.

Not only will this allow government bodies to trace the product, but patients will be able to verify their own medication using an app. In 2015, Pedigree had 500 million drug packets coded, and was instrumental in combating a counterfeit antimalarial drug putting thousands of Africans at risk.

The risks are clear; healthcare professionals may be unfamiliar with original products, which could have travelled through several importing markets, increasing risk at every step.

 

Explicit content

The WHO estimates that 16% of counterfeit drugs contain the wrong ingredients. Some contain hazardous elements such as rat poison, boric acid and antifreeze, while others include household items such as floor wax, brick dust, paint and paint thinner. 17% contain the wrong levels of essential ingredients and more than 30% don’t contain any active ingredients.     

 

Copy cats: counterfeit medicine explained 

A counterfeit medicine is one which is deliberately mislabelled with respect to identity and/or source. Products may include correct ingredients or incorrect ingredients, or be without active ingredients, or with insufficient/inadequate quantities of ingredients or with fake packaging.

The WHO recently redefined them as 'substandard and falsified medical products'. This is intended to move the focus away from intellectual property rights rather than the destructive nature of the products.

 

Inceptua Medicines Access prevents falsifed medicines entering the supply chain through its own rigorous quality checks. Go to inceptua.com.

For a complete list of references relating to the article please go to the online version of the magazine at pharmafield.co.uk

 

 

 

 

 

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Features

Market leaders: PM Society Digital Awards

by J Pinching 17. October 2017 09:47

 

Pharma marketing has at last embraced digital.

Although it was the eighth PM Society Digital Awards, this occasion seemed to score its signature in the virtual sand more emphatically than ever before.

For so long our industry has been a polite bystander, as the rest of the universe leapt on the digital super-highway, but in recent years pharma has seized the zeitgeist and invited it to stay on a long-term basis.

Fortunately, PM Society’s Rachel Farrow recognised that this era would come, and created an occasion that specifically celebrated digital wizardry in the brave new pharma marketing world.

Thus, the great, the good and the edgy convened at The Brewery, in London. Not least comedian Russell Kane whose observations of the British character and its relationship with alcohol were chillingly familiar, as the raucous laughter would testify.

As the awards were distributed by Russell and the disembodied tones of Lotto legend, Alan Dedicoat, we witnessed the sizzling innovation, stunning visuals, incredible apps and inspiring patient engagement that has dragged pharma kicking and screaming into the 21st Century.

Jamie Thompson, Associate Creative Director at Saatchi & Saatchi Wellness, reflected on his team’s victory in the Agency Self-Promotion category: “The rebrand involved the whole agency. And to win for something so personal to our people and their feelings is truly special.

“We believe that empathy leads to creativity. That’s why we created the first ever corporate identity that responds to feelings. We captured the emotions of our people using EEG headsets and a bespoke algorithm that turned emotional data into unique individual emoscapes,” he added.

Kosha Vyas, Account Manager at The EarthWorks, which scooped the Healthcare Partnerships title, said: “Our strategy, to be an agency exclusively focused on patient engagement, continues to reap rewards for the patients who benefit from the tailored solutions we develop in partnership with our clients.

“As we have seen from winning this award, our end-to-end capabilities, from strategic consultancy and research, to the development of world-leading health technology, allows us to provide real world value to patients and their HCPs.”  

 

Digital love

Winners from 2017 PM Society Digital Awards

 

Promotional programmes 

Oi Ltd, The Bayer IMCM Lighthouse Project

 

HCP education & support

The Health Hive Group, VR simulation training experience

 

Healthcare partnerships

The EarthWorks, My PAH

 

Patient initiatives

90TEN, Prime – Making HIV history

 

Market access

RFA Advertising & Marketing, Noxafil budget impact model

 

Congress/Meetings

ebee Health, ERS – GSK respiratory

 

Multichannel campaign

90TEN, Prime – Making HIV history

 

Corporate communications

Sandoz International, Sandoz HACk – Healthcare Access Challenge

 

Agency self-promotion

Saatchi & Saatchi Wellness, Saatchi & Saatchi Wellness Rebrand

 

Film

Health Unlimited, Small steps – COPD life is calling

 

Animation

HealthCircle Advertising, It’s hard to see when CAC starts

 

Innovation: New Technology

The Health Hive Group Ltd, VR simulation training experience

 

Innovation: Novel Thinking 

Sudler Milan, Escape Room

 

Inspiration award 

Health iQ, Ground-breaking approach to MPS1

The EarthWorks, MyAsthma app

 

Digital Account Manager 

Doctors.net (Alice Carter)

 

Digital Team

Four Health Media

 

 

 

 

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Features

UK’s biggest killer needs attention

by Amy Schofield 16. October 2017 11:22

 

 

Pathway to promise

It’s international Breast Cancer Awareness Month and the UK’s biggest killer needs attention. 

 

Breast cancer has been the most common cancer in the UK since 1997*, and 1 in 8 women in the UK will develop breast cancer in their lifetime. During Breast Cancer Awareness Month, around 5000 people will be diagnosed with the disease, with one person diagnosed every 10 minutes.

Things are improving, however – in the UK, breast cancer survival has doubled in the last 40 years, while almost 9 in 10 women survive breast cancer for five years or more. Despite this, around 11,400 people die from breast cancer in the UK every year.

 

Treatment developments

Novartis: At the time of going to press, Novartis was waiting for NICE’s decision on whether Kisqali (ribociclib) will be funded by the NHS. Following the drug’s authorisation from the European Commission in August for the treatment of advanced breast cancer, ribociclib is now licensed for use in Europe as a first-line treatment in combination with an aromatase inhibitor in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer.

Roche: After suffering the setback of provisional rejection by NICE in December 2016, Roche’s Kadcyla (trastuzumab emtansine) was the subject of what was dubbed a ‘monumental U-turn’ by the media earlier this year, as the manufacturer agreed a deal with NHS England to make the drug available to around 1200 women per year with advanced aggressive cancer.

Pfizer: In February this year, NICE made the provisional decision that Ibrance (palbociclib) should not be routinely funded on the NHS in England. Its final appraisal was paused for Pfizer to present further clinical data.

Then in May, Pfizer made the unexpected announcement that it would give out palbociclib for free until NICE makes its decision on whether it should be available on the NHS. At the time of going to press, palbociclib was still being given to women with incurable metastatic breast cancer at no cost.

AstraZeneca: Promising trial results for the PARP inhibitor Lynparza (olaparib) were recently revealed. Results from the Phase III OlympiAD trial found a 42% reduction in the risk of the disease spreading in patients taking Lynparza, compared to those undergoing chemotherapy.

 

Expert view

Professor Arnie Purushotham, Cancer Research UK’s senior clinical adviser

 

Recent technological developments have enabled the study of cancer’s molecular and genetic characteristics in unprecedented detail, shifting the view of breast cancer as, not one disease, but a collection of unique diseases with their own challenges. This has ushered in a wave of exciting research into tailoring treatments to each person’s individual cancer, so patients get treatments that are right for their disease.

Coupled with this progress has been finding less invasive techniques to take a detailed snapshot of each person’s tumour, which could help guide therapeutic decisions. Liquid biopsies, blood tests that fish out fragments of tumours for analysis, are increasingly occupying this role. In the future, these innovative methods may have a role in diagnosing the disease earlier.

But just as it’s crucial to ensure patients get treatments that are best for them, it’s essential to prevent harm from giving people treatments that they don’t need. One of Cancer Research UK’s Grand Challenges seeks to address this issue by determining how to distinguish between those who do need treatment and those who don’t in women with a condition called ductal carcinoma in situ (DCIS), which can sometimes develop into breast cancer. This work could spare thousands of women unnecessary treatment.

 

 

Does it add up?

Breast Cancer UK’s ‘You Do the Maths’ campaign shines a light on the relatively small amounts currently spent on understanding and preventing the causes of cancers, and asks whether more can be invested to help prevent breast cancer.

• 75% of breast cancer cases thought to be attributable to environmental and lifestyle causes

• 1% of research funding spent on environmental and lifestyle causes of cancer in 2014

• It is estimated that 20-30% of cases are due to genetic mutations. Of these, 2-3% are associated with BRCA mutations

• £51m is the estimated annual cost savings if the incidence rate for breast cancer was reduced by 10%.

 

 

Personal story

Katy English, 24

 

“It looks like you’ve got cancer,” said the registrar, without warning, or sensitivity. I instantly went numb and completely shut down. My mum, panicking, asked questions: “How are you going to treat it, you’ll be able to sort it out won’t you?” “What, you want me to go through all the treatment options now?” he said with disdain.

We were led away by a breast care nurse, who came to be an invaluable guide throughout. Luckily that first registrar was the only detestable character who played a part in my care; the oncologist, surgeon, chemo nurses and breast care nurses (all women) were outstanding.

At 24-years-old, being told I had cancer was unbelievable, devastating, horrifying. Until then I was a ‘normal’ twenty-something; recently graduated, proud to have moved out of my parents and in with my boyfriend and best friends from school, and even prouder to have just been offered a place to start a PGCE.

I hadn’t been worried when I felt a lump in my breast, they often felt a bit lumpy or bumpy at different times of the month, but I made a doctor’s appointment when I noticed the bottom of one breast looked flatter than the other when I raised my arms. The GP immediately referred me for tests. That was when my whole world turned upside down.

They decided that as the lump was large and my lymph nodes tested positive, I would have six rounds of chemo, to hopefully shrink the lump before surgery to lose less of the breast. Chemo was hard. My family and boyfriend were by my side through everything, I couldn’t have done it without their infinite love and patience.

I wanted a double mastectomy and my surgeon and I both had to appeal for it to be approved, after initially being rejected, but it went ahead on the 22nd of December. I was discharged on Christmas Eve.

I then had three weeks of radiotherapy every day, and now I have to take oestrogen blocking tablets for 10 years, which give me hot flushes and achy joints and muscles, but I have gradually regained energy.

I recently swam 25km in a month and raised £3500 for Bart’s Charity Breast Cancer Research Fund, and I am due to start my PGCE. The last year has been an enormous challenge, but I feel stronger than ever and pray that it never comes back.

 

 

Making an impact

What difference have breast cancer campaigns made?

 

Race for Life

Over the past 20 years, over 8 million women have taken part in Cancer Research UK’s events, from 5k runs to muddy obstacle courses, raising over £547 million to fund research.

 

Wear it pink day

Rock a pink cowboy hat in the boardroom, wear a pink feather boa to walk the dog – it doesn’t matter, as long as you do it in support of Breast Cancer Now on Friday 20 October. The campaign has raised £30.1 million to date for breast cancer research.

 

Coppafeel!

In a mission to educate us that young people get breast cancer too, the charity, headed by the inspirational Kris Hallenga, has launched many campaigns encouraging women (and men) under 30 to regularly check their boobs. These include Check ‘em Tuesday, the Bra Hijack, the Coppafeel! Boob Tour, and #GetItOffYourChest. Read Kris’s remarkable story on p18.

 

 

Men get breast cancer too

Breast cancer is not an exclusively female disease – although it is rare, male breast cancer accounts for 1 in every 100,000 males. According to Cancer Research UK, data shows that male breast cancer mortality is strongly related to age, with the highest mortality rates being in older males. In the UK in 2012-2014, on average each year around 6 in 10 (55%) of deaths were in males aged 75 and over.     

 

If you are concerned about breast cancer, need advice or would like to talk to someone, call 0808 800 6000 or go to breastcancercare.org.uk

 

 

 

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Features

Opposites attract: Pharma & the third sector

by John Pinching 9. October 2017 09:38

 

People generally see industry and specific disease charities as being poles apart; strategically, motivationally and even ethically. 

In reality, common denominators between the two apparently alien factions are manifest. Indeed, even their differences; industry’s expertise in development and manufacturing, in contrast to the skills charities possess in the arena of awareness-raising and patient engagement, make them compelling allies, rather than foreign entities.

Evidence of this co-existence and cooperation comes in the form of several dynamic pharma-charity partnerships. Here are some of the most impressive.

 

Big-C hitters

Dr Nigel Blackburn, Cancer Research UK’s Director of Drug Development

 

Cancer Research UK’s record of developing novel treatments is comparable to any pharmaceutical company.

Industry partnerships have proved hugely valuable in achieving this; they enable us to translate our world-class research into effective treatments for patients.

Commercial partnerships are at the heart of how we interact with industry. Our team works with pharmaceutical companies, who bring the skills, materials and funding necessary to convert promising scientific discoveries into industrial propositions.

Through Cancer Research UK’s Therapeutic Discovery Laboratory, we bring together the best minds in academic cancer research, with the drive of industry. Multi-project alliances include partnerships with AstraZeneca, Merck and Forma.

Our Centre for Drug Development (CDD) has taken over 120 potential cancer drugs into clinical trials and six have made it to market, with others in development. Through our Clinical Development Partnerships scheme, the centre works with leading pharma companies, on a shared ‘risk-reward’ basis, giving promising new drugs the best chance of making it.

Once clinical data is gathered, companies retain intellectual property rights, or transfer them to Cancer Research UK for a share of revenues.

Thanks to our network of Experimental Cancer Medicine Centres we have the specialist infrastructure to bring innovative treatments to patients through clinical trials. The Combinations Alliance is a unique scheme, run through these centres, where we test novel drug combinations using assets from different companies, with a view to improving standard treatments.

Cancer Research UK’s industry interactions have been proven to benefit patients. The first PARP inhibitor, rucaparib (Rubraca), was discovered by our scientists at the Northern Institute for Cancer Research, in collaboration with Agouron and Pfizer. With the help of the CDD, rucaparib entered trials and stimulated interest in PARP inhibitors from other companies. Last year, in the US, the drug was designated a ‘breakthrough therapy’ by the FDA, for patients with advanced ovarian cancer.

We will continue to work closely with industry to accelerate the development of potentially life-saving treatments and beat cancer sooner. Go to cancerresearchuk.org

 

 

Heart strings

Professor Jeremy Pearson, Associate Medical Director at the British Heart Foundation

 

The British Heart Foundation’s (BHF) vision is a world where people do not suffer or die prematurely from heart disease.

A crucial objective of our strategy is to enhance the translation of cardiovascular research into improved patient care. This goal requires strong relationships; academics can bring scientific know-how and years of experience, while pharma provides drug development and commercial expertise, including access to compound libraries and regulatory advice.

To achieve its mission, the BHF funds academic-led projects that involve pharma, where there is clear potential for patient benefit. For example, The Heart Protection Study, led by the University of Oxford, was jointly funded by the BHF, Medical Research Council, Merck and Roche Vitamins Ltd.

This was a 20,000-patient study that showed the benefits of simvastatin in lowering cholesterol, ultimately leading to a reduction in coronary heart disease risk. We have a clear policy outlining the terms of these collaborations, ensuring that universities have intellectual property rights and that if findings result in commercial success, the university and BHF are recognised. This allows revenue to be re-invested into research.

The BHF has a dedicated funding scheme to accelerate the translation of cardiovascular research. The Translational Award provides funding to de-risk promising innovations, enabling them to secure further investment. The committee assessing opportunities has a range of members with differing backgrounds including medicinal chemistry, drug development and venture capital investment expertise.

They help academics translate their work and attract pharma interest by providing advice, identifying commercial hurdles and shaping project design.

The BHF takes an active role in connecting academics with pharma to further stimulate knowledge exchange. Last year, we held a workshop which included speakers from pharma, investment and regulatory organisations, allowing academics to discover exactly what experts look for when assessing potential projects.

Pharma is keen to learn from academia and we play a role in initiating university visits where industry can find out about specific projects and form mutually beneficial collaborations. Go to bhf.org.uk   

 

 

Breathing space

Jason Cater, Director of Fundraising at the British Lung Foundation

 

A positive, lasting impact on the lives of respiratory patients is an essential shared value for any pharmaceutical partnering with the British Lung Foundation. The relationship must be grounded in the charity’s goals of improving the lives of people living with or affected by a lung condition.

An example of such a partnership is a project calling for improved access to treatment for idiopathic pulmonary fibrosis (IPF) patients.

IPF is a condition that causes continuous scarring of the lungs. The scar tissue stops the lungs doing their job of drawing oxygen from the air and passing it into the blood. For those living with the condition, it means breathing gets increasingly difficult. IPF has no known cure or cause, and affects adults of all ages.

Roche was one of two pharmaceutical companies that funded the dissemination of a report by the charity, which made recommendations to improve outcomes for IPF patients. These included establishing the Taskforce for Lung Health in order to produce a five-year strategy for tackling lung disease and improving access to personalised treatments, diagnosis and support.

The project held a half-day seminar with patients, carers and healthcare professionals, to hear directly what they thought the issues are and what, in an ideal world, the care pathway for IPF should look like. This helped identify key principles for good IPF care, including being centred on the patient and their wishes, making all possible treatment options available and ensuring people in all parts of the country access the same standards of care.

The British Lung Foundation then carried out its own research, identifying areas of best practice and finding policy solutions, which would lead to the changes patients want to see.

Roche and other pharmaceutical expertise was essential to the project and its aims.
Go to blf.org.uk

 

 

Force is strong

Professor David Dexter, Deputy Director of Research at Parkinson’s UK

 

Throughout my years of working in Parkinson’s research, a major barrier to the development of new drugs has been the design of clinical trials. Trials are also, of course, an essential part of discovering safe treatments and, ultimately, a cure for the condition.

The most commonly used drug for Parkinson’s, Sinemet, was developed more than 50 years ago. People with Parkinson’s have waited long enough for better treatments, so Parkinson’s UK decided to make clinical trials smarter and faster.

In 2015, we took the bold step of founding the Critical Path for Parkinson’s (CPP) Consortium, in partnership with the Critical Path Institute. Nine major pharmaceutical companies joined the project in its first year, alongside government agencies, academic organisations and other Parkinson’s charities.

Through the consortium, these members work together to garner support from global regulatory agencies for new ways of designing and carrying out clinical trials. Using clinical data from around 8000 people, recently diagnosed with Parkinson’s, the CPP Consortium developed a clinical trials simulation platform.

Clinicians can use the platform to determine the optimum length and size of a trial, as well as predicting the likelihood of success. This will lead to more efficiently designed trials, cutting the cost of drug development – historically, a huge obstacle to making progress.

One of the CPP Consortium’s biggest achievements was in 2016 when the European Medicines Agency issued a public letter of support, backing our campaign for the use of a brain scan that identifies the loss of dopamine brain cells, a symptom of Parkinson’s. This can be used as a selection tool to identify Parkinson’s patients more accurately, ensuring we have the most suitable participants for trials.

 

 

 

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Features

Kris Hallenga used her experience to change the world forever

by John Pinching 9. October 2017 09:25

 

Girl power: When her life changed dramatically Kris Hallenga used her experience to change the world forever.

 

Kris discovered she had breast cancer when she was only 22. Through her pioneering campaign charity CoppaFeel! she has brought confidence, hope and inspiration to countless people across the world. She epitomises the modern patient and, following her own challenging prognosis, has given others the strength to take control. I had the pleasure of chatting to her and this is her remarkable story.

 

What initiatives is CoppaFeel! driving this summer?

It’s funny you should mention driving, we have a big van called Belinda, the ‘boob-mobile’, which goes around festivals. It’s a brilliant education hub, where we give young people temporary tattoos and, as our volunteers are applying them, open up a conversation about boob health. We can also get a bit of data, and they can spread info about breast cancer and CoppaFeel! across social media. We’ve been doing this for years, but it is the first time we’ve had our own vehicle, which is really cool. Those five-minute conversations we’re having in a field are potentially life-saving.

 

Uniquely, the CoppaFeel! website takes something very serious and approaches it in a fun way.

It helps that a bunch of young people started it – we knew how we wanted to be spoken to. Although I am 31 now, I am surrounded by students in the office, so I appreciate the vibe among teenagers and people in their twenties. When we first went into schools we were surprised by how much kids wanted to know. Most people have had an experience, in their family or social group, of cancer. They’re resilient and up for learning new things.

 

You’ve also got some familiar faces on your website.

It’s great to have celebrity endorsements from the likes of Dermot O’Leary and Fearne Cotton, but we’re now moving towards online influencers and ‘youtubers’. Although many of us have not heard of them, young people are watching their output day in, day out.

 

Your messages seem to be about handing control back to patients.

We should never entirely rely on other people when it comes to our own health. Even if our healthcare providers picked up every cancer, we still need to know our own bodies. After my experience, it seems absurd that you would rock up to a GP, let them examine you once and accept the verdict. Knowing your own body and when you need to act on something, gives you a sense of control which is very empowering. If you confidently say that, after 10 years of checking, there is something different about your boobs, they have to refer you.

 

What had your experience with HCPs been?

I was let down badly by two GPs, but had I known myself that the changes happening to my boobs were bad, things could have been very different. People ask me why I didn’t sue, but getting two GPs struck off wasn’t going to make a massive impact. Educating people and promoting better conversations about breast cancer with GPs could. Ultimately, the GPs that ignored my symptoms would have seen my story in the press and I like to think they would not make the same mistakes again.

 

How did you get through the initial period after diagnosis?

I started immediately with a secondary diagnosis and, knowing that it was a disease I was unlikely to get rid of, had to navigate my own route through it. There were days when I was crying a lot, but I had a treatment plan and was focussed on getting better. Waiting to see the impact of my first treatment was most difficult.

 

When did you regroup and decide to do something positive?

Two months after my diagnosis and 10 days before my hair fell out, I was at my mum’s house with some friends and my sisters. I told them there wasn’t really any provision for young people to find out about breast cancer, and asked if they wanted to help me create something. Despite not having any experience they all wanted to give their time.

 

How quickly did you realise you had a hit?

During the first festival we went to, we were positioned beside the mainstage. It was all very amateur; just a gazebo and some stickers! I was going through chemo and injecting myself to ensure my white blood cells were at an acceptable level. We just blagged it, by painting people’s faces, as an excuse to talk about boobs. The tent was full the entire time and we realised right then that if we could convince students, we could be on to something. Following that I had my mastectomy, we got charity status and I won a Pride of Britain Award.

 

What treatments have you been on?

I’m on palbociclib, which was developed by Pfizer, and is doing wonders at the moment. I’m also taking exemestane, the hormone blockers, and monthly injections of denosumab. This is another example of taking control. Oncologists don’t know everything and I did my own research about which drugs were right for me.

 

Is there life before and after cancer diagnosis?

I had been living in Beijing and found out my diagnosis when I returned home for Christmas. When I think about the girl before cancer, I was very different. I was 22, didn’t really have a clue about life and had been through a couple of bad relationships. I wasn’t sure what my purpose was but, oddly enough, when I found out I had cancer, the purpose became clear.

 

What are your plans now?

Somehow eight years have passed since I started CoppaFeel!. At the beginning of last year, I took a step back from being CEO. I stay involved in the campaigns and continue doing the things I love, but now I also have a life in Cornwall.

 

Thoroughly deserved. What is your perfect day?

Discovering a new café that does a delicious brunch, and paddle-boarding on a calm lake.

 

Naturally. What hit record says most about you?

‘Power’ by Little Mix.

 

I’ll check them out. Goodbye Kris.

Bye John.

 

Go to coppafeel.org  

 

 

 

 

 

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