Ghp May 2015 new

ghp May 2015

Sandoz Receives FDA Approval for GlatopaTM as the First Generic Competitor to MS Therapy Copaxone® 20mg

www.ghp-magazine.com

global health & pharma

How Social Proof Is Transforming the Laser Eye Industry

Simply Irresistible – How Cranberry Could Help in the Fight to Defeat Antibiotic Resistance

Could Reusable Needles be a Thing of the Past?

One man’s 30-year battle to prevent iatrogenic infection by dirty needles

ghp editor’s note

global health & pharma

this month’s features

inside this issue

Welcome to the latest issue of Global Health & Pharma Magazine.

04 News

In this month’s issue, we take a look at Sandoz, a company making waves after announcing the US approval of GlatopaTM, the first generic version of a one-time-daily multiple sclerosis therapy.

10 Global Vaccination Targets

We also find out how social proof and the rise of the internet is casting a positive light on the laser eye industry’s previously negative reputation and, as we reach a potential crisis point with bacteria becoming ever more resistant, we discover why cranberry could be the unlikely answer.

We also spoke to Peter Utterström, Senior Counsel at Hellström Advokatbyrå KB law firm, who gave us his insight into how the pharmaceutical industry is performing, and the challenges that lie ahead.

Sandoz Receives FDA Approval

Sandoz, a Novartis company, has announced the US approval of GlatopaTM, the first generic version of Teva’s Copaxone® (glatiramer acetate injection) 20 mg/ml one-timedaily multiple sclerosis therapy.

Page 8

We hope you enjoy the issue.

Mark Toon, Editor

How Social Proof Is Transforming the Laser Eye Industry

To date the laser eye industry has had a largely negative reputation. The media frequently report horror stories that have left prospective patients feeling confused and scared about the clinics, procedures and surgeons on offer.

Page 12

“While the election has prompted considerable discussion over the NHS – particularly in the recent health debate - whenever I turn on election coverage or look at a newspaper everything is reduced to ‘doctors and nurses’. It’s about time that allied health professionals were given a similar level of focus.”

Andrew Anastasiou, Managing Director, Medicare

‘Off-Track’ Warns WHO

Progress towards global vaccination targets for 2015 is far off-track with 1 in 5 children still missing out on routine life-saving immunisations

14 Could Reusable Nee

And, as the WHO announces its third global policy on needle safety, we find learn more about one man’s 30-year battle to help eradicate iatrogenic infection by dirty needles through the development of a revolutionary single-use needle.

And as always, we’ll be keeping you up to speed with all the latest news and developments taking place across the pharmaceutical world.

The latest news from across the global healthcare and pharmaceutical industries

dles Finally Be a Thing of the Past?

In February of this year, Dr Margaret Chan, DG of the World Health Organisation announced their third-ever global policy on Needle Safety

16 Simply Irresistible

How Cranberry Could Help in the Fight to Defeat Antibiotic Resistance

Global Health & Pharma 39A Birmingham Road Blakedown Worcestershire DY10 3JW Tel: +44 (0) 1234 567 890 Email: info@ghp-magazine.com Web: www.ghp-magazine.com

news

Political Healthcare Debate Fails to Recognise Allied Health Contractors The allied health arena deserves significantly more public recognition from political parties in their manifestos, according to Medicare First.

Specialist healthcare recruiter, Medicare First, has spoken out about how professionals in the field who provide a valued service to the NHS are rarely publically factored into political plans for the National Health Service.

haul in the way the public views the health service.

With an ageing population the allied health arena is only going to grow in importance and I think it’s about time we did more to promote its role.”

Andrew Anastasiou, managing director of Medicare First, commented. “Allied health professionals, such as physiotherapists and prosthetists, are the backbone of the NHS and I think it’s about time they were given more recognition. At a time when the health service is looking to cut costs it seems surprising that more isn’t being done to promote the value of the field.

“Allied health is a relatively cost-effective resource and one particular focus is to help patients move towards independence, rather than – often expensive – clinical interventions, which is exactly what the health service is trying to drive. Getting patients out of hospitals and back into their homes as quickly as possible is of paramount importance, not least because it can halt the spread of hospital-acquired infections and reduce blockages at the back door.

“While the election has prompted considerable discussion over the NHS – particularly in the recent health debate - whenever I turn on election coverage or look at a newspaper everything is reduced to ‘doctors and nurses’. It’s about time that allied health professionals were given a similar level of focus.

“The arena is huge and has grown by a third since 2002; however it’s rarely spoken about in the media or in the political field. What’s really needed is an over-

4 | ghp May 2015

news

Proton Partners and Global Leaders to Equip UK’s First Proton Beam Therapy Centres Proton Partners International Limited, which is planning to build three Proton Beam Therapy cancer treatment centres in the UK, has announced the appointment of global partners to provide state of the art clinical equipment and innovative technology solutions to the company.

Proton Partners International Ltd is to open treatment centres in Cardiff, London and Northumbria by 2017 and the first – Cardiff – will be operational next year. The establishment of the centres will mark a significant breakthrough in the provision of cancer treatment in the UK. The lack of access to the latest treatment options in radiotherapy in the UK has been highlighted in a flood of patient dramas in the press.

Mike Moran, managing director of Proton Partners International Limited, commented: “We are very pleased to announce that we will be working with world class providers who will equip our centres to the highest specifications. We are excited about the opportunity to work with our partners in the NHS, universities and the Life Sciences community to help support the research effort in the wider use of proton beam therapy.”

Proton therapy hit the headlines when the delay in provision of machines in the NHS led to many patients, acknowledged to need Proton therapy, being transported to the USA and elsewhere for treatment, which unsurprisingly is much more costly than could be available in the UK. IBA (Ion Beam Applications), the world’s leading provider of proton therapy solutions for the treatment of cancer, has been selected by Proton Partners to install its single-room proton therapy system, Proteus®ONE, in each of the three UK centres.

Appointments PARTNERS+simons President and CEO Named CEO of Myelin Health PARTNERS+simons, a 25-year old brand communications and integrated marketing services firm specializing in the healthcare and financial services industries, announced today that President and CEO Rich Levy has added responsibilities as the new CEO of Myelin Health. Rich will operate both as CEO of Myelin Health and president & CEO of PARTNERS+simons.

Myelin Health, parent company of PARTNERS+simons, is a growing network of communications firms linked by their experience and capabilities in the healthcare and financial services sectors. Myelin Health is comprised of agencies with expertise in digital and traditional marketing solutions, strategy and branding, integrated marketing, research, data analytics, mobile engagement, design and more.

In his new role as CEO, Levy will drive growth and change within the Myelin Health network and will also be responsible for identifying, evaluating and integrating new acquisitions.

“With his deep healthcare and marketing experience and strong leadership of P+s, Rich was the natural choice for CEO of Myelin Health,” said Randall Mehl, partner at Baird Capital, founder of Myelin Health. “This is an exciting time for Myelin Health, and we look forward to the network’s continued growth under Rich’s capable guidance.”

Prior to joining PARTNERS+simons, Rich served as president of iHC Communications, inventive Health Communications’ largest North American agency. In that role, he built and managed the newly formed Global Strategic Corporate Accounts Group, which comprise more than $1 billion of inVentiv Health’s business.

“Our healthcare system is undergoing massive transformation and reform, and Myelin Health is positioned to provide superior marketing experience and capabilities to companies in that space,” said Levy, president & CEO of PARTNERS+simons, CEO of Myelin Health.

“Just as healthcare organizations are focused on outcomes, Myelin’s success is based on generating superior business outcomes for clients. I look forward to helping the Myelin Health network continue to strengthen and grow.”

Philips has been appointed to deliver software and technology tools including Philips’ Pinnacle Treatment Planning which delivers an intuitive planning environment that simplifies workflow. Philips will also provide big bore CT scanners at each centre and a PET CT in the Cardiff centre.

Before appointing its suppliers, Proton Partners International conducted an exhaustive selection process across two continents, including visiting the Willis Knighton Hospital in Shreeveport, Louisianna to see an IBA treatment room in operation. Final selection was made on technical and commercial merit.

Rich’s professional experience also includes serving as president at Ferguson/CommonHealth, HealthStar Advertising and president/ CEO of Adair Green, Inc. At Adair Greene, he oversaw agency growth from $9 million to more than $150 million, and led the sale of the agency to IPG/McCann Erickson.

Professor Gordon McVie, Senior Consultant at the European Institute of Oncology and chairman of Proton Partners International, said: “These appointments are a significant milestone along the pathway to establishing the first proton beam therapy centres in the UK and reflect the quality and strength of our commitment to improve cancer treatment.”

Rich received a Bachelor of Science in Marketing and Finance from Syracuse University.

ghp May 2015 | 5

news

Antithrombotic Drugs: World Industry and Market Prospects 2015-2025 A new report by visiongain forecasts the overall world market for antithrombotic drugs will reach $22.4bn in 2019. That revenue forecast and others appear in Antithrombotic Drugs: World Industry and Market Prospects 2015-2025, published in March 2015.

The purpose of that investigation is to provide forecasts and qualitative analyses of the antithrombotic drugs market. Visiongain is a business information publisher and consultancy in London, UK. It produces analyses to help organisations understand potentials of industries and markets.

That new study analyses the antithrombotic drugs market in 2013 and 2014, as well as forecasting its prospects for revenue growth from 2015 to 2025. In particular, the work examines 14 leading products on the market in 2014, providing revenue forecasts for each as well as the overarching market and its segments.

Visiongain predicts the antithrombotic drugs market will recover from the sharp decline following patent expiries for Plavix and Lovenox in 2012. Although the market may not reach the same heights as it did in 2011 when Plavix revenue totalled $9.6bn, the patient population for antithrombotic drugs expands. The study finds the market will expand following its prior decline, until it faces patent expiries for other leading drugs in the second half of the forecasted period.

Alyscia Curtis, a pharmaceutical industry analyst in visiongain, said: “The world market for antithrombotic drugs generated $20.2bn in 2014. Although the loss of patent protection for Plavix and Lovenox has severely impacted the market, there is still potential for growth in the 2015-2025 period. The industry is changing, and novel anticoagulants are becoming the market leaders. The warfarin replacement market is large and with several compounds now vying for position. As antidotes become available for these novel anticoagulants, the market will grow.

However, in the latter half of the forecast period, the antithrombotics market will decline as a result of patent expiries, generic competition and a limited pipeline. However, with a growing

number of people suffering from cardiovascular diseases, and with aging populations, the antithrombotic drugs market retains promise for developments and revenue generation.”

Visiongain’s updated analysis shows revenue forecasts to 2025 at overall world market, submarket, product (brand) and national level. First it gives revenue predictions to 2025 for therapeutic submarkets at world level: •

• •

Anticoagulants, also with sub-forecasts for direct factor Xa inhibitors, heparins, direct thrombin inhibitors and vitamin K antagonists Antiplatelet agents Fibrinolytics.

That study then predicts revenues of 14 leading drugs to 2025.

Medicines forecasted and discussed include Plavix, Lovenox, Xarelto, Pradaxa, Activase, Effient, Aspirin Cardio and Pletal.

Research, data and analyses cover activities of Sanofi, Boehringer Ingelheim, Bayer, Johnson & Johnson, Genentech, The Medicines Company, Eli Lilly, Pfizer and other developers, manufacturers and marketers of antithrombotic drugs.

That new study also discusses R&D and commercial news, shows two research interviews and predicts revenues to 2025 in 11 leading national markets. The work analyses the United States (US), Western Europe (Italy, Spain, Germany, the UK and France), Japan and BRIC countries (Brazil, Russia, India and China).

Antithrombotic Drugs: World Industry and Market Prospects 20152025 adds to visiongain’s analyses on industries and markets in healthcare. Together those studies cover pharmaceuticals, diagnostics, medical devices, outsourced services and biotechnologies.

6 | ghp May 2015

news

Antibody Production Market Worth $2.572 Billion by 2019 According to a new market research report “Antibody Production Market by Product (Equipment, Consumables), by Type (Monoclonal, Polyclonal), by Technology (Hybridoma), by End-User (Biopharmaceutical Companies, Diagnostic Labs, Research Institutes) - Analysis & Global Forecast to 2019”, published by MarketsandMarkets, the report studies the global Antibody Production Market for the forecast period of 2014 to 2019. This market is expected to reach $2.572 Billion by 2019 from $1.425 Billion in 2014, and is poised to grow at a CAGR of 12.5% during the forecast period.

The global Antibody Production Market is segmented on the basis of products, types, technologies, end users, and regions.

Based on products, the Antibody Production Market is categorized into equipment and consumables. In 2014, the consumables segment accounted for a major share of the antibody production market.

On the basis of types, this market is segmented into monoclonal and polyclonal antibodies. In 2014, the monoclonal antibodies segment accounted for a major share of the antibody production market.

Based on technologies, the market is segmented into hybridoma and hybridoma-free technologies. In 2014, the hybridoma technology segment accounted for a major share of the antibody production market.

companies. Moreover, emerging markets of India and China, rising demand for protein therapeutics, and increasing risk of pandemics and infectious diseases are likely to increase the demand for equipment and consumables used in antibody production. However, high cost of primary antibodies is likely to restrain the growth of this market.

Some of the major players in the global Antibody Production Market include GE Healthcare (U.K.), Thermo Fisher Scientific, Inc. (U.S.), Sigma-Aldrich Corporation (U.S.), Sartorius AG (Germany), Merck Millipore (U.S.), Abcam plc (U.K.), Amgen (U.S.), Sanofi S.A. (France), Rockland Immunochemicals, Inc. (U.S.), and Roche Applied Science (Germany).

On the basis of end users, the market is segmented into biotechnology and pharmaceutical companies, diagnostic laboratories, and research institutes. In 2014, the biotechnology and pharmaceutical companies segment accounted for a major share of the antibody production market.

On the basis of regions, the market is divided into North America, Europe, Asia, and the Rest of the World (RoW). The Rest of the World region comprises Latin America, Pacific countries, and Middle East and Africa. In 2014, North America accounted for the largest share of the antibody production market, followed by Europe and Asia. However, the Asian market is slated to grow at the highest CAGR in the coming five years and serves as a revenue pocket for the companies offering antibody productions.

Over the years, the demand for production of antibodies is likely to increase owing to the rising demand for monoclonal antibodies globally and rising R&D expenditure of pharmaceutical and biotechnology

ghp May 2015 | 7

Appointments Hospital for Special Surgery Names Frank Schwab, M.D., as the New Spine Service Chief Hospital for Special Surgery (HSS), the topranked orthopedic hospital in the nation, has announced the appointment of Frank Schwab, M.D., to be its new Spine Service Chief, effective August 1.

“Spine care is a top and growing population health need, and we are committed to providing the very best,” said Dr. Albert. “There is no one better than Dr. Schwab to build on the great work of Dr. Frank Cammisa and lead the finest spine team in the world to a new level of excellence in patient care.”

Dr. Schwab succeeds Frank Cammisa, M.D., as Spine Service Chief. He comes to HSS from New York University’s Hospital for Joint Diseases, where he has served as Chief of Spine Deformity since 2007. A California native, Dr. Schwab earned his undergraduate degree at Princeton and his medical degree at Columbia University, where he also performed his Residency. Over the past 20 years his extensive research has originated more than 180 published articles, six major awards and honors including from the NIH and NATO, eight grants, and other notable recognition.

“In all that they do, HSS continues to prove that focus drives excellence,” said Dr. Schwab.

“This is the ultimate opportunity for me to focus my abilities on leading the most focused and excellent spine service in the world.”

“In the changing healthcare landscape, HSS is committed to demonstrating that value is a factor of excellence, and excellence is a factor of talent, experience, and quality,” said HSS president and CEO Louis A. Shapiro. “Dr. Schwab’s proven track record in both spine surgery and strategic development means continued strength in the great tradition of musculoskeletal care at Hospital for Special Surgery.”

r&d

Sandoz Receives FDA Approval for GlatopaTM as the First Generic Competitor to MS Therapy Copaxone® 20mg Sandoz, a Novartis company, has announced the US approval of GlatopaTM, the first generic version of Teva’s Copaxone® (glatiramer acetate injection) 20 mg/ ml one-time-daily multiple sclerosis therapy.

“Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy,” said Peter Goldschmidt, President of Sandoz US. “The approval of Glatopa reinforces Sandoz leadership in complex, differentiated generic products and further demonstrates our commitment to offer patients and payors a full range of therapeutic options.”

MS is a debilitating disease affecting about half a million individuals in the US alone; only half of those diagnosed are currently treated.

Glatopa, developed in collaboration with Momenta and produced entirely in the US, is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS. Sandoz is the global leader in complex differentiated generics, which represent more than 40% of its global portfolio, and one of the top two global generics companies by net sales.

Fighting MS, together with other CNS disorders, is central to the Novartis mission, and Sandoz’s Glatopa joins a broad MS portfolio including two approved therapies and one late-stage development compound.

Important Safety Information Glatiramer acetate is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

Approximately 16% of glatiramer acetate patients vs.

4% of those on placebo experienced a constellation of symptoms immediately after injection that included at least 2 of the following: flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and urticaria. These symptoms generally have their onset several months after the initiation of treatment, although they may occur ear-

lier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.

Transient chest pain was noted in 13% of glatiramer acetate patients vs. 6% of placebo patients. While some episodes of chest pain occurred in the context of the immediate post-injection reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known.

The pain was transient, often unassociated with other symptoms, and appeared to have no clinical sequelae.

Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment.

At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy.

Because glatiramer acetate can modify immune response, it may interfere with immune functions. For example, treatment with glatiramer acetate may interfere with recognition of foreign antigens in a way that would undermine the body’s tumor surveillance and its defenses against infection. There is no evidence that glatiramer acetate does this, but there has not been a systematic evaluation of this risk.

The most common adverse reactions with glatiramer acetate vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%). ISRs were one of the most common adverse reactions leading to discontinuation of glatiramer acetate. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with glatiramer acetate than placebo.

8 | ghp May 2015

ghp May 2015 | 9

industry insight

Global Vaccination Targets ‘Off-Track’ Warns WHO Progress towards global vaccination targets for 2015 is far off-track with 1 in 5 children still missing out on routine life-saving immunisations that could avert 1.5 million deaths each year from preventable diseases.

In 2013 nearly 22 million infants missed out on the required three doses of diphtheria-tetanus-pertussis-containing vaccines (DTP3), many of them living in the world’s poorest countries. WHO is calling for an end to the unnecessary disability and death caused by failure to vaccinate.

“World Immunization Week creates a focused global platform to reinvigorate our collective efforts to ensure vaccination for every child, whoever they are and wherever they live,” said Dr Flavia Bustreo, WHO Assistant Director-General, Family, Women’s and Children’s Health. “It is critical that the global community now makes a collective and cohesive effort to put progress towards our 6 targets back on track.”

In 2012, all 194 WHO Member States at the World Health Assembly endorsed the Global Vaccine Action Plan (GVAP), a commitment to ensure that no one misses out on vital immunization. However, a recent independent assessment report on GVAP progress rings an alarm bell, warning that vaccines are not being delivered equitably or reliably and that only 1 of the 6 key vaccination targets for 2015 is currently on track – the introduction of under-utilized vaccines.

Many countries worldwide have experienced large measles outbreaks in the past year, threatening efforts to achieve the GVAP target of eliminating measles in 3 WHO Regions by end-2015.

Actions to get back on track A global collaborative drive for immunization, begun in the mid-1970s — with the establishment of the Expanded Programme on Immunization in all countries — achieved dramatic results, raising vaccination levels from as low as 5% to more than 80% in many countries by 2013. WHO estimates that today immunizations prevent between 2 and 3 million deaths annually and protect many more people from illness and disability.

Although progress has stalled in recent years, this early success demonstrates the potential of vaccines, which are increasingly being extended from children to adolescents and adults, providing protection against diseases such as influenza, meningitis and cervical and liver cancers.

The GVAP recommends three key steps for closing the immunization gap: • Integrating immunization with other health services, such as postnatal care for mothers and babies; • Strengthening health systems so that vaccines continue to be given even in times of crisis; and

•

Ensuring that everyone can access vaccines and afford to pay for them.

Dr Jean-Marie Okwo-Belé, Director of Immunization, Vaccines and Biologicals at WHO, says the Organization will work to increase its support to all countries that are lagging behind in meeting immunization targets. In May this year, WHO will bring together high-level representatives of 34 countries with routine vaccination (three doses of DTP3) coverage of less than 80% to discuss the challenges faced by countries and to explore solutions to overcome them.

Although many countries are already vaccinating four out of five children with DTP3, a full one-third of countries are still struggling to reach the ‘fifth child’, meaning millions of children remain at risk of illness, disability or death because they are not getting the immunizations they need.

“There is no one centralized approach that can ensure vaccines are delivered and administered to each child.

Vaccination plans on the ground need to be adapted not just to countries, but to districts and communities,” said Dr Okwo-Belé.“What is required is a truly concerted effort and much stronger accountability so that each one of the key players involved fulfills its mandate and helps close the immunization gap.”

Critical operational needs to ensure wider vaccination and delivery on the ground, include: • finding ways to simplify vaccination procedures in the field • improving vaccination delivery to reach every last child, especially those living in remote and inaccessible areas • Ensuring vaccine affordability and strengthening vaccine supply chains • Training more health workers, skilled managers and providing supportive supervision • Improving the quality of data collected by countries and using this to improve immunization operations • Overcoming challenges posed by conflict, natural disasters and other crises • Increasing awareness and demand for immunization by communities • Greater accountability linked to micro-planning of vaccination operations and clear lines of responsibility.

Earlier this year, donor countries and institutions pledged to meet the funding needs of Gavi, the Vaccine Alliance that brings together public and private sectors to create equal access to new and underused vaccines for children living in the world’s poorest countries.

10 | ghp May 2015

industry insight

Global Pandemic of Fake Medicines Poses Urgent Risk Poor quality medicines are a real and urgent threat that could undermine decades of successful efforts to combat HIV/AIDS, malaria and tuberculosis, according to the editors of a collection of recently published journal articles. Scientists report up to 41% of specimens failed to meet quality standards in global studies of about 17,000 drug samples.

Among the collection is an article describing the discovery of falsified and substandard malaria drugs that caused an estimated 122,350 deaths in African children in 2013. Other studies identified poor quality antibiotics, which may harm health and increase antimicrobial resistance. However, new methodologies are being developed to detect problem drugs at the point of purchase and show some promise, scientists say.

Seventeen articles in all, detailing various aspects of the issue and proposing possible solutions, are included in a special journal supplement “The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives,” published online ahead of print by The American Journal of Tropical Medicine and Hygiene. Several articles suggest policy interventions, including an international framework and the adoption of stricter national laws against drug counterfeiting.

“This problem continues to spread globally, creating an even greater challenge to cooperation among stakeholders, many with limited resources,” noted the supplement’s co-editor, Joel Breman, M.D., M.P.H., senior scientist emeritus at the National Institutes of Health’s Fogarty International Center. “The need is urgent for collaboration among those with expertise in policy, science, technology, surveillance, epidemiology and logistics, in order to secure global supply chains.”

In an introductory essay, former U.S. Food and Drug Administration Commissioner Margaret Hamburg, M.D., says globalization has added layers of complexity to the drug supply chain that require greater oversight. “Today’s medical-product landscape blurs the line between domestic and foreign production, drawing attention to the need for global quality and safety oversight to prevent patient exposure to falsified products,” wrote Dr. Hamburg, who was recently named foreign secretary of the Institute of Medicine.

Scientists inspected the quality of about 16,800 samples of anti-malarials, anti-tuberculosis medicines, antibiotics and anti-leishmaniasis drugs and reported from 9 to 41 percent failed to meet the specifications. Seven separate studies were carried out, primarily in low-resource settings, and included samples from public and private sources.

“The pandemic of falsified and substandard medicines is pervasive and underestimated, particularly in low- and middle-income countries where drug regulatory systems are weak or non-existent, as shown by field studies in the supplement,” says Jim Herrington, Ph.D., M.P.H., co-editor of the supplement and director of the University of North Carolina’s Gillings

Global Gateway at Chapel Hill. Until recently, Herrington was director of Fogarty’s international relations division.

New methodologies to test drug quality are emerging and scientists reported the results of four investigations. Simple paper-based test cards proved to be an economical and portable method to identify very low quality anti-malarials. More sophisticated approaches using fluorescent and luminescent techniques or other novel technologies can measure with greater precision, but may be difficult to use in remote settings.

All of these promising tools require further testing to provide a greater evidence base to guide policymakers, the authors say.

An urgent and coordinated international response is required to address the pandemic of poor quality drugs, the scientists maintain. Policy proposals include a global agreement, similar to the Framework Convention on Tobacco Control , and stricter national laws to prosecute those who knowingly sell counterfeit medicines.

In addition to Fogarty, the supplement is sponsored by the Bill and Melinda Gates Foundation and the New Venture Fund.

The individual articles will be published online at: www.ajtmh. org/content/early/recent The Fogarty International Center addresses global health challenges through innovative and collaborative research and training programs and supports and advances the NIH mission through international partnerships. For more information, visit http://www.fic.nih.gov.

About the National Institutes of Health (NIH) NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

ghp May 2015 | 11

industry insight

How Social Proof Is Transforming the Laser Eye Industry To date the laser eye industry has had a largely negative reputation. The media frequently report horror stories that have left prospective patients feeling confused and scared about the clinics, procedures and surgeons on offer.

The rise of the internet, apps and social media sites has transformed the way people research the options available to them. Prospective patients are now equipped with the most powerful and valuable tool prior to making a decision: testimonials.

Now exposed to the experiences of others, patients are able to head to sites like Lasik Eyes to make a fully informed decision without having to rely solely on the sales efforts of the clinics themselves. So what do reviews mean for practitioners and why are they transforming standards within the laser eye industry?

The Rise of the Savvy Consumer-Patient Today’s consumer has a lot more information at their disposal prior to making any purchase. They are increasingly turning to online resources that offer a comparison service coupled with testimonials from people who have already bought and used the product.

Websites like TripAdvisor and AirBnB are becoming the most reliable source for gauging which products and services have disappointed, matched or exceeded consumer expectations.

This concept has extended into the elective healthcare sector.

With hundreds of clinics and surgeons available, prospective patients can be far more selective about the option they decide to proceed with. This has resulted in a significant shift in the relationship dynamic between surgeons and patients, where the latter are increasingly being viewed as consumers.

Similar to people researching the best Italian restaurants in London or the most cost efficient hotels in Bruges, laser eye patients too want to learn about how others have perceived the service they received from clinics around the world.

Why is this important for laser eye professionals?

Word of mouth advocacy is the most valuable tools for customer prospects and this is even more important when it comes to a health related matter. Whilst Laser Eye surgery is a relatively minor procedure with few complications, the thought of any surgical procedure is still unnerving. Positive referrals help alleviate a lot of the uncertainty for prospective patients and gives reassurance about the procedure, but most importantly the surgeon carrying it out.

The abundance of patient horror stories reporting inexperienced surgeons performing poor quality laser eye surgery with life-changing results has led to the industry suffering a long history of bad press.

With no official regulatory body in place safeguarding the public, testimonials are one of the few reliable resources future patients can use to make a confident decision. Reviews validate the reputations of clinics and surgeons, which helps filter out the highly skilled from the incompetent. Positive endorsements add a human element to the research and selection process, which helps filter through the noise of the hundreds of clinics trying to sell their services.

Whilst every clinic promises outstanding results, the proof ultimately lies in the experiences of previous patients. As such, testimonials are raising the standards of the laser eye industry as future patients are being increasingly guided towards companies and surgeons that have a proven success rate with ex patients.

Research by Software Advice reveals that patients use reviews as the first step in finding a new doctor and evaluating their online reputation.

As such, positive recommendations improve clinic and surgeon search rankings, which means future laser eye surgery prospects will always first find practitioners that have a developed a highly credible online reputation.

Alexander Ionides, a leading eye surgeon at Moorfields Eye Hospital discusses the importance of recommendations in helping patients find him: “Testimonials are an excellent resource for potential patients in that they help them make a truly informed decision based on the experiences of others.

“Whether ex-patients have had a really positive or negative experience, their stories help future patients save time and energy when researching for their own procedure as they are able to quickly identify the leading surgeons that have built a strong reputation for providing an excellent service.”

12 | ghp April 2015

industry insight

ghp April 2015 | 13

innovation

After One Man’s 30-Year Campaign, Could Reusable Needles Finally Be a Thing of the Past?

In February of this year, Dr Margaret Chan, DG of the World Health Organisation announced their third-ever global policy, on Needle Safety. The launch had been postponed several times due to the growing crisis of Ebola in West Africa – a sad irony being that Ebola itself was spread by the re-use of dirty needles during its first recorded outbreak in Zaire 1976.

World health often seems a case of politely focussing on a better future, rather than attaching responsibility to a flawed past. The tragedy that remains is how long it can take to progress a simple proven solution to successful scalability and global uptake.

Thirty-one years ago, Marc Koska OBE read a newspaper article that reported that the re-use of hypodermic syringes could be a major source of transmission for HIV and other viruses, causing widespread illness and loss of life. No one would suggest that health workers wilfully cross infect their patients, but it has been self-evident for over 30 years that re-usable syringes would indeed be re-used, especially in developing countries, and that doing so can cause cross infection and death.

A further cruel irony is that even today people continue to die at the hands of those who are trying to help them. Since 1984, at least 20 million people are likely to have died due to cross-infection. For example, the village of Rokha in North Cambodia has just been decimated by an unlicensed doctor, using dirty re-usable needles, and infecting over 250 villagers - including his own family - with HIV. If there was no solution, or the solution was expensive, difficult to make or unreliable, one might consider that the continued production and sale of re–usable syringes could be justified. However, Marc pioneered an inexpensive, reliable solution that is straightforward to make and use, and low–cost enough to be a scalable solution around the world.

Marc’s solution became known as the “K1” syringe.

The concept was simple: a syringe plunger that is designed to be used normally but cannot be withdrawn after use without snapping at its head. He designed the K1 to be produced and used within the existing supply chain, using available machinery with very little modification with no increase in production costs.

syringes continue to dominate the market. In 1999, the World Health Organisation (WHO), UNICEF, the Red Cross and the UNFPA issued a policy statement that all immunisations had to be delivered with an auto-disable syringe. Since that date, all UNICEF immunisation programs have been delivered using auto-disable syringes.

This accounts for 5% of the 40 billion syringes produced each year. The other 95% (used predominantly for curative or therapeutic purposes) continue to pose risks to life and health if multiple use syringes are used.

Now, finally, the ridiculous position of permitting iatrogenic infection by dirty needles is going to be ending in both markets, curative and immunisation.

The WHO Global Policy is now in place, with a deadline set at 2020 for near universal AD up-take.

The challenge will be to ensure sufficient capacity of Auto-Disable and Needle-stick Prevention devices is supplied by the manufacturers to meet the policy-stipulated growth in demand around the world – and not just in the developing world.

There are multiple levers at hand – building the economic case to ministries around the world of the enormous cost effectiveness of spending on AD syringes – calculated by the WHO at an average of over $14 saved for every $1 spent; building a global health-care and consumer education campaign to demand a safe “LifeSaver” syringe every time; and even considering the legal position of a pharmaceutical or manufacturing company, a ministry or a hospital for allowing a treatment to be made on equipment that was not safe.

Marc set up Star Syringe Limited to exploit the invention and has since licensed the manufacture of over 4.5 billion self-disabling syringes through several licensees. But that 4.5 billion represents just a small fraction of global syringe production, and multiple use

14 | ghp May 2015

innovation

ghp May 2015 | 15

innovation

Simply Irresistible – How Cranberry Could Help in the Fight to Defeat Antibiotic Resistance

By Sonia Job

It’s a day that the father of antibiotics foresaw. Sir Alexander Fleming suggested in his 1945 Nobel Prize lecture that “The time may come when penicillin can be bought by anyone in the shops.

Then there is the danger that the ignorant man may easily under-dose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.”

Now it is generally accepted that we are approaching crisis point as bacteria – Escherichia coli especially – become ever more anti-biotic resistant, and new effective antibiotics are alarmingly difficult (if not altogether impossible) to find or develop.

The World Health Organisation repeatedly and increasingly warns that most countries are not doing enough to protect the antibiotics we do have, and the Chief Medical Officer for England Professor Dame Sally Davies describes a “ticking time bomb” in which common infections could potentially reemerge as killers if the antimicrobial arsenal is not strengthened soon.

To help curb antibiotic overuse in primary care, specific government recommendations for limiting prescriptions in coughs and colds, sore throats, middle ear infections and urinary tract infections (UTIs) are in place, yet research has found the national guidelines in UK primary care has had “mixed success1”, with results suggesting “there is significant scope to improve prescribing, particularly for coughs/ colds and for UTIs1”.

All is not entirely lost, however, as the failure rates of individual antibiotics vary within the infection classes.

One of the most frequently prescribed antimicrobials for urine infections – trimethoprim – is cited as having failed 25% of the time in 1991, spiralling to 56% in 20122, but this was when it was prescribed for an upper respiratory tract infection. Amoxicillin, on the other hand, remains highly prescribed for the same condition, yet had a relatively low failure rate of 12.2% in 20122.

Essex-based NHS GP Dr Rory McCrea is keenly aware of the problem, and is concerned that the scale of antimicrobial resistance is not being fully grasped in primary care, which is where the challenges begin. Treatment of UTIs provides a fine example, he suggests. After respiratory tract infections, they are the most common infectious diseases seen by GPs and in hospitals. “Anything that can be done to reduce UTIs is good,” he says, “particularly in older people, where UTI is all too often associated with impaired cognitive function. When I see patients showing signs of delirium and or confusion is reigning, I wonder what the urine’s doing. Typically a UTI is

all-too-often an underlying problem to the point that once the UTI is controlled the cognitive function is restored, but never to quite the same level as before.

Clearly the more often the individual experiences a UTI, the more marked the cognitive deterioration will progressively become.”

Prophylaxis to prevent recurrent UTI is not ideal with antibiotics because people are likely to end up resistant to treatment, especially if they have been prescribed trimethoprim. “Typically a patient begins with a UTI and the more entrenched the infection becomes, the more difficult it becomes to treat,” explains Dr McCrea. Eventually patients may be admitted to hospital and required to take antibiotics intravenously.

“If hospitals are going to reduce their admissions of elderly people suffering from UTI, nursing and residential homes need to be considering ways to reduce the incidence of UTI in the first place,” he says, “Non-antibiotic prophylaxis has got to help, if it’s available.”

Could it be that a cheery berry holds the answer?

Certainly a growing contingent of scientists and urologists think so. While it’s not new news that cranberry juice and cranberry extracts appear to help in the relief and prevention of recurrent UTI, the discovery that using Vaccinium macrocarpon Aiton is unlikely to trigger bacterial resistance is making ripples in the urology community.

The key to cranberry’s potential lies in its mode of action. “The accumulation, growth and biofilm-like attachment of uropathogenic P-fimbriated E. coli in the lower urinary tract is the first step in the genesis of a urinary tract infection3,” writes Gunter Haesaerts, president of French supplement manufacturer Pharmatoka, whose Urell cranberry capsules and syrup have been the subject of a number of promising in vitro and in vivo studies. Juice and powdered extracts containing active constituents Proanthocyanidins (PACs) from the American cranberry have been found to inhibit the adherence of P-fimbriated E. coli to uropepithelial cells, effectively preventing the bacteria from growing and causing infection as they are flushed out in the urine stream.

16 | ghp May 2015

innovation As the bacteria are not killed by the mechanism of cranberry PACs upon them, they do not mutate to develop resistance. And because a population of resistant bacteria has not had the chance to build, the bacteria should remain sensitive to antibiotic treatment in the event that an infection is not entirely eliminated by the cranberry initially.

Moreover, it is thought that uropathogenic E. coli propel themselves upwards in the urinary tract by using their flagella (or ‘legs’). The authors of a study investigating the mode of action of cranberry on E. coli strain CFT073 successfully demonstrated that cranberry PACs can disable the bacteria to prevent them swarming or swimming. They and other researchers suggest that applying cranberry extracts to catheters, for example, could be useful in slowing the movement of bacterial pathogens as they bid to reach the kidneys.

But what of cranberry’s role in the prevention of simple urinary tract infections like cystitis? The Cochrane Review by Jepson et al in 2012 indicated that both cranberry and low-dose antibiotic prophylaxes were more-or-less as effective, while a randomised control in 137 older women by McMurdo and others4 concluded that “Trimethoprim had a very limited advantage over cranberry extract in the prevention of recurrent UTIs in older women and had more adverse effects.”

UTI has led to competition and debate over which is the most powerful extract, and how this potency is measured. Unfortunately for the purposes of meaningful scientific evaluation, this is largely unhelpful as direct comparisons are difficult to achieve. The general consensus in the scientific community is however that a cranberry product must provide at least 36mg PACs per dose, as measured by the BL-DMAC. Nonetheless the important message is, as Dr Amy Howell, associate research scientist at the Marucci Center for Blueberry Cranberry Research at Rutgers University puts it, that cranberry could decrease the recurrence of UTIs and that “this nutritional approach could lower the use of low-dose antibiotics for prevention.” Even more tantalising perhaps is the likelihood that cranberry, as well as reducing “the overall need for antibiotics for treatment” could thereby reduce “the consequent development of resistance to these drugs.” In effect, it may have the ability to make some antimicrobials almost irresistible to certain uropathogenic bacteria.

“Cranberry is a truly complementary therapy,” concludes Dr McCrea, “and one that could be of great interest in primary care.”

1

Hawker JI, Smith S, Smith GE et al. Trends in antibiotic prescribing in primary care

for clinical syndromes subject to national recommendations to reduce antibiotic resistance. UK 1995-2011. Journal of Antimicrobial Chemotherapy. Published online August 4 2014

The elderly are of course not the only group at risk of UTI. It is estimated that more than 50% of women will experience a UTI in their lifetime, of which as many as 30% will suffer two or more recurrences.

Children, pregnant women, catheterized patients, and those with spinal cord injuries, or chronic and/ or diseases that compromise immunity are all populations susceptible to urinary tract infections. In none of these cases is over-prescription of antibiotics desirable as microbial resistance will almost certainly develop – and this may be irreversible.

2

Currie CJ, Berni E, Jenkins-Jones S, et al. Antibiotic treatment failure in four com-

mon infections in UK primary care 1991-2012: longitudinal analysis. BMJ. Published online September 23 2014 3

Haesaerts G. Urell by Pharmatoka: The pioneer of bacterial anti-adhesion against

uropathogenic p-fimbriated E. coli in the urinary tract. Bol. SPAO 2010; 4(2) 4

McMurdo MET, Argo I, Phillips G, Daly F, Davey P Cranberry or trimethoprim for the

prevention of recurrent urinary tract infections? A randomized controlled trial in older women Journal of Antimocrobial Chemotherapy, 2009. 63(2): p. 389-95

In the community setting, further advantages of cranberry extracts include next to no drug interaction and the fact that they can be readily and safely taken alongside prescribed medication - including antibiotics. Haesaerts is keen to stress that cranberry products should never be seen as an alternative to antimicrobial medication, however, as they could not, he says “be considered to cure UTIs, which actually means replace antibiotics.” He believes that such suggestions are “dangerous and false”.

Dr McCrea agrees: “Cranberry is never going to be the whole story in the fight against antibiotic resistance – but anything – even a 10% reduction - in preventing the infections in the first place has got to be beneficial.”

The cranberry product to be used should be chosen with care. Under current legislation in most of the world, all cranberry products – including juices, cordials, supplements, and dried extracts – are classified as food or dietary supplements, and are therefore governed under food laws. Unlike in herbal medicine, there is no requirement for the products to be standardised and claims for their benefits can vary wildly from country to country: in Europe, EFSA has not approved any claims for the fruit whatsoever. Inevitably as cranberry’s potential as a non-antibiotic prophylaxis for recurrent

ghp May 2015 | 17

products

Review of Liquid Biopsy and the Role of PointMan™ PointMan is an easy to use and highly sensitive and selective tool offering the ability to enrich mutations from limited sample material. This is a vital characteristic for a companion diagnostic particularly in the field of oncology, where the availability of the tumour biopsy is limited or where a liquid biopsy is preferred because multiple biopsies are required in order to monitor the effectiveness of the chosen therapy and the early detection of resistance to that therapy.

In studies the ability of PointMan kits to enrich specific mutant DNA from a blood based sample has been established and is working reliably at the levels of sensitivity required for it to become a standard usable system to follow the course of treatment once the appropriate regimen has been established.

Cancer, after heart disease is the second-leading cause of death in the United States. Major advances have been made in diagnosis using solid tumour biopsies that have fundamentally changed how various types of cancer are targeted and treated. The completion of mapping the human genome and subsequent technological advances in genomic medicine have led to the development of solid tumour diagnostics that use individualised tumour information to personalise treatments which can ultimately prolong life and sometimes even cure patients with cancer.

Molecular testing of tumours using high-throughput genomic technologies, such as next generation sequencing (NGS), has further expanded our knowledge of oncogenic pathways.

Access to NGS enables the genomic profiling of tumours and facilitates individualized approaches to cancer treatment by sub-classifying cancer types based on genomics.

Physicians can use an in-depth understanding of cancer at a molecular level to optimise therapy by selecting the most appropriate drugs based on known targets.

Health care is just now starting to effectively use the information from the human genome to diagnose and treat disease. Nowhere is this more crucial than in the treatment of cancer, from which 7.6 million people in the U.S alone die each year despite spending some $87 billion a year on treatment.

One of the reasons cancer is so difficult to treat is that current testing methods often don’t help doctors match specific cancers with effective drug treatments.

And it’s a moving target — cancer cells are constantly changing, mutating.

The detection and molecular characterisation of circulating tumour cells (CTCs) are one of the most active areas of translational cancer research, with more 400 clinical studies using CTCs as a biomarker. The aims of research on CTCs include the estimation of the risk for metastatic relapse or metastatic progression (prognostic information), the stratification and real-time monitoring of therapies, the identification of therapeutic targets and resistance mechanisms, and the real-time understanding metastasis development in cancer patients.

Historically, physical biopsy tests were crucial for showing the look and makeup of a tumour, but less good at giving doctors clues about which drugs the cancer might respond to. Biopsies are usually performed at the initial diagnosis, then often abandoned because of risk of infection and cost.

The Medical Solution Tumour genome sequencing to generate informed treatment decisions is already central to the management of many patients with cancer. Tailored therapy relies on the identification of the correct molecular tumour target. Currently, tumour biopsy tissue, generally from the primary tumour, is used to determine molecular targets at a single time point, before treatment commences. These biopsies carry some risks for patients, they are painful, they are costly and, importantly, the process takes time. Also, given the complexities of tumour heterogeneity, both within a tumour and between a primary tumour and metastases, a tissue sample may not be a true representation of the molecular profile.

A liquid biopsy, on the other hand, may capture the entire heterogeneity of the disease. What is more, tumour genotypes are notoriously unstable and prone to changes under selection pressure. In this regard, liquid biopsies offer what tissue biopsies cannot, due to risks to the patients and cost; the opportunity to take serial samples in order to monitor tumour genomic changes in real time.

This allows clinicians to ensure that the therapy they have selected, based on a particular molecular target, remains relevant and observe the emergence of any resistance.

As a result, instead of waiting for information from scans it is possible to identify at an earlier stage if a treatment is not working and to spare the patient the unnecessary toxicity of a drug that no longer provides any benefit. At the same time it is possible to observe if any new molecular targets appear that could be suitable for treatment. All this could help to provide patients with the right treatment for the right target without delay.

18 | ghp April 2015

products Numerous genomic alterations have been transformed into diagnostic markers for treatment with targeted therapeutics, and several anti-cancer drug labels require that pharmacogenomic information is obtained.

Examples of oncology diagnostic tests that comprise the new standard of care include ER and HER2 in breast cancer, bcr-abl in chronic myeloid leukemia, c-Kit in gastrointestinal stromal tumours, BRAF in melanoma, and EGFR and ALK in lung cancers.

With increasing development of targeted biological therapeutic agents in oncology comes a corresponding need for personalised treatment strategies.

These strategies will facilitate the selection of patients who are most likely to benefit from a particular therapy, while simultaneously avoiding the cost and morbidity of futile interventions.

Today, for a tissue biopsy, sensitivity rates reach approximately 1:20–1:1,000 at best. Therefore, the shift in sensitivity from tissue biopsy to a liquid biopsy requires significant advances in lab-based technological platforms.

This reality does not address the various informatics hurdles that come from managing the wealth of data that is produced from a single biopsy sample. Cutting-edge platforms to extrapolate tumour information from bloodbased samples must also be implemented in a manner that proves to be scalable, cost-effective, and reproducible.

Although relatively abundant in late-stage diseases, the amount of tumour burden found in the blood is not close to the number of cells obtainable via tissue biopsy.

Most key predictive biomarker tests would need sensitivities at the single-cell level in order to successfully be detected in blood. In a best-case scenario, detection of expression, amplification, and mutation changes requires sensitivities of one tumour cell in 100,000 nucleated blood cells. However, tumour cells are more likely to occur at only 1:1,000,000, or even down to 1:100,000,000 in the total nucleated cell population.

How Does PointMan Match Up? PointMan is a highly sensitive and selective tool offering the ability to enrich mutations from limited sample material. This is vital for a companion diagnostic particularly in the field of oncology, where the availability of the tumour biopsy is limited and a liquid biopsy is preferred for all of the reasons above.

In studies (refs and data on file) the ability of PointMan kits to enrich mutant DNA from a blood based sample without the need for further biopsy has been established working at the levels rerequired for it to be as usable system to follow the course of treatment once the appropriate regimen has been established.

Liquid biopsy material may contain very low level and variable quantities of mutated DNA sequences that are difficult to resolve from the wild type. With a sensitivity of 0.001%, PointMan is ideally placed to be the technology of choice that can significantly enrich low level mutations for downstream sequencing analysis.

based systems for extracting DNA and the whole test in real-time is rapid taking less than 2 hours from a minimally prepared sample.

Because of the sensitivity of PointMan only a minimal amount of sample is required for analysis which makes it a strong candidate for routine blood based testing for CTC’s. The ultra-sensitive nature of the system means that specific mutations can be detected down to 0.001% in a background of wild type Medical Evidence Where does PointMan fit in with liquid biopsy options?

To find out how well each of the two most significant markers – cancer cells or tumour DNA reflected what was happening within the body, scientists compared the results of the blood tests with CT scan data from 20 women who were followed for up to ten years, which revealed how many tumours they had and how big they were.

For women who had a reasonably large number of escapee cancer cells in their blood, the number of these cells mirrored their response to treatment reasonably well – the number of cells fell after chemotherapy, and slowly climbed back up again as the cancer returned.

But for women who only had a relatively small number of cancer cells in their blood to start with (reflecting the fact that they have fewer and/or smaller tumours) there was no match.

But measuring the levels of tumour DNA in the blood provided an even better match in most of the women, tracking the changes in their cancer through several cycles of treatment. Measuring tumour DNA can reveal how a patient’s cancer is changing and evolving on the genetic level – something which is vital if there is to be progress in ‘personalising’ treatment.

This is where PointMan wins out against other liquid biopsy methods available.

It was possible to show faults in specific genes in some patients’ cancers that developed during treatment that were not there when the tumour was first biopsied up to a decade before.

This shows that measuring levels of tumour DNA in a patient’s blood could be the most powerful way to track the way the genetic landscape of an individual’s cancer shifts and evolves during treatment.

In terms of measuring the DNA in circulating blood, serum or urine it must be possible to efficiently enrich and recover minute amounts of small, fragmented nucleic acids from these fluids, which is exactly what PointMan is capable of doing on a routine, predictable basis and reliable basis.

PointMan works by enriching the DNA sample for the point-mutated sequence, using a simple reagent set that combines with standard DNA extracts and runs on a real time thermos-cycle platform. The product of the PointMan enrichment assay can then be used in combination with standard detection methodologies such as PCR, Pyrosequencing and Sanger sequencing. PointMan works with all industry standard instrumentation and laboratory

ghp April 2015 | 19

regulation

How Do You Solve a Problem Like Non-Adherence?

Recent research from the World Health Organisation and the Mayo Clinic on the impact of (and influences on) a patient’s ability to adhere to their treatment regime has shown that an astounding amount of patients do not follow or complete their treatment as prescribed.

The drugs don’t work Although patients know that the medications prescribed are effective at curing or controlling their medical conditions and diseases; depending on the therapeutic area, the percentage of patients who do not adhere to their treatment can range from 25% to 78%. This behaviour can drastically reduce the efficacy of treatment, which in turn leads to increased medical emergencies, increased morbidity and, in the worst case scenario, death. There are many factors that influence a patient’s ability to follow their treatment as prescribed. Just the fact that there are many different reasons, and that a single patient can be dealing with a combination of factors that influence their behaviour, makes the identification of a single solution to non-adherence almost impossible.

The known factors that affect adherence can be derived from the attributes of the patient, issues with HCPs, the healthcare system or pharma products. More specific reasons for non-adherence can include: low health literacy, poor patient-HCP relationship, lack of communication or continuity of care, having an asymptomatic chronic disease, physical impairments, the mode of administration, treatment complexity and length, side effects, or poor social support. It is obvious from this long list why a ‘one-size fits all’ solution is not possible.

Several factors have a direct influence on adherence A major concern for healthcare practitioners is the lack of time they get to spend with patients so they can properly communicate to patients what to expect with regard to their condition, treatment options, potential adverse effects from medication, and any issues surrounding poly-pharmacy or co-morbidity. For the patient this type of information can be difficult to fully digest. The information is not always presented in a way that is understandable and there usually is a great deal of it, presented at a time when the patient may be under high levels of stress. Patients also need to often cope with not only with masses of information, but also conflicting information from multiple HCPs. This can result in patients not having a full understanding of their condition, how their treatment works, or the importance of adherence.

Ultimately patients want to be well, however, for many patients this requires behaviour support and education to ensure that not only do they understand the importance of adherence, but also have the tools to tackle any barriers that they face. A simple solution would be providing a patient more time with their HCP, but this is unlikely to be a practical one.

For common prescriptions such as antibiotics it has been assumed that the importance of adherence is recognised, instructions may not be as prescriptive or informative as they should be. For a patient to be told “ensure you complete the entire course” is not enough, especially if a patients symptoms disappear and they think they are cured. Information on consuming alcohol whilst taking antibiotics is a common concern, and it’s worrying that patients are satisfied with the

20 | ghp May 2015

knowledge that (depending on the type of antibiotic) the treatment will simply cease to work. This is a misconception however, symptoms of consuming alcohol whilst on an antibiotic treatment can cause a number of quite unpleasant symptoms, not to mention the reduction in or a delay in the effect of the medication, contributing to poor efficacy.

Understanding the effect on the patient (and the greater population) of not completing the treatment as prescribed could provide both the rational and emotional reasons for adherence.

Influencing the patient is the responsibility of all The healthcare system can also influence patients’ ability to adhere to their treatment regime. By ensuring that the information provided to patients is appropriate and covers the issues that concern both the patient, the HCP, the healthcare system and the pharmaceutical company (that is written at a level that is informative, yet digestible by someone without a medical background) this will allow the patient to become more knowledgeable about their prescribed treatment, and more confident in self-administering, resulting in them being fully engaged with their treatment.

Poor adherence is costly for the wider healthcare system as prolonged or unsuccessful treatments can lead to secondary issues, such as increased morbidity in patients, as well as the potential for emergency or institutional care. This ultimately leads to an increased cost in care and a greater financial burden on the healthcare or social system, and perhaps the patient or their carer.

Pharma also want to see their products being used successfully to control chronic conditions and treat diseases. Supporting patients to adhere to their treatment regime with relevant and suitable information, products, tools, or services that help patients to deal with barriers can lead to better outcomes. Providing additional services can not only support the patient, but will also help the HCP in their efforts to elicit adherence behaviour.

Services that go ‘beyond the pill’ help patients to not only remember to take their medication, but also help them to understand their treatment at times when an HCP may not be available. Well-designed services can provide the motivation and behavioural change to make adherence easier and create a habit that elicits adherence behaviour. In order to do this, services, tools and products must focus on addressing the causes or problems that lead to non-adherence- not only the symptom.

Additionally, we see pharma products that can increase adherence by addressing some of the barriers or pain points that patients’ experience. Drugs that can be taken once a month as opposed to every day, or that can be done at home as opposed to a long and sometimes difficult visit to a clinic, can be beneficial for adherence and ultimately patient outcomes.

Lastly, another contributing factor is the type of condition. Advances in healthcare have evolved, and in a relatively short amount of time. This means that many of the conditions that previously lead to mortality are now classified as long-term chronic conditions. The treatment of chronic diseases is long term and often complex. Typically, complex and long-term treatments contribute greatly to non-adherence statistics. The complexity and length of a treatment and understanding where a treatment may be controlling a condition as opposed to curing, can influence a patient’s ability to adhere, especially when the results are not immediately obvious.

Not adhering to treatment is costly personally to the patient, financially to the healthcare system and pharmaceutical companies. In order to effecting address the issues that cause non-adherence, the content – patient attributes, therapeutic area, the healthcare system, the treatment and the relationship with HCPs much be taken into account.

Solutions must be tailored to the context of the patient.

No matter how effective a treatment, patients must take it for it to work as intended by their physician.

ghp May 2015 | 21

training, education & skills

Science Industry Partnership (Sip) Marks One Year of Science Employers Addressing Skills Development in Life Sciences The science industries’ £52m skills and talent initiative, the Science Industry Partnership (SIP) – facilitated by Cogent Skills – has surpassed 2,000 new people being trained as the initiative reaches its first anniversary this month.

That includes a range of employers in the life sciences sector now benefiting from Government investment for people development and training designed by and for employers in the sector.

Indeed 45 per cent of these learners are working in the Life Sciences sector – which includes pharmaceuticals, biotechnology, medical technology and consumer healthcare and 55 per cent are working in Industrial Sciences including chemicals, industrial biotechnology, polymers and advanced materials and coatings.

The total investment is made up of a Government contribution of £32.6 million, with £20 million from employers, alongside £31 million employer in-kind contributions – including time and resources.

The SIP board – led by GlaxoSmithKline (GSK), along with representatives from other leading science sector companies – are now urging organisations not yet participating in the employer-led skills initiative to start the process in this new financial year, as co-funding available via the SIP pilot will end in March 2016.

More than 260 companies have engaged with the SIP, undertaking recruitment, training and new talent development programmes co-funded through the partnership and delivered through Cogent Skills’ range of delivery services including Apprenticeships, Placements and Training Courses.

Malcolm Skingle, Director, GSK and chair of the SIP board said: “With more than 2,000 science sector employees accessing Apprenticeships, Placements as well as training and development within its first year, the SIP has made significant progress in transforming skills across the UK’s science-based, world-leading industries which are essential to the country’s economic prosperity.

“The combination of Government funding and employer contributions for the £52m investment pot – alongside employer designed training courses and new talent services delivered by Cogent Skills – is addressing the current skills gaps and shortages across the sector and enabling businesses to innovate for the future of the UK’s science economy.”

Linda Millett, Head of HR at Takeda Cambridge, said: “Being part of the SIP enables us to engage with other like-minded organisations to exchange ideas, lobby key decision-makers and develop important programmes to deliver the skills and workforce we actually need as employers.

“It has provided valuable funding towards our training needs and enabled us to offer a broader training curriculum to a larger number of employees here at Takeda Cambridge, leading to an increased take-up of training internally and better awareness of the benefits of Higher Apprenticeships.

The long term benefits include provision of quality-assured training to more employees, raising awareness of different career pathways and encouraging more people into a career in science.”

“The SIP offers an excellent opportunity for employers both large and small to get involved on a practical and strategic level to shape the skills landscape, ensuring the future of science-based industries here in the UK.” According to the latest figures the SIP has so far achieved: • • • • • • • • •

260 companies engaging with the SIP 32 traineeships started 372 apprenticeships started 1,652 people training through Workforce Development 16 Modular Masters started 41 Industry Degrees 10,066 people accessing careers advice 52 training providers quality assured 65 SIP ambassadors trained

Cogent Skills – the strategic skills partner to science sector employers – has heralded the SIP’s first-year success as a significant step in its own “2020 vision” for the UK to attain world-leading capabilities in science sector innovation and growth in the next five years.

Cogent Skills CEO Joanna Woolf added: “The joint-funding and access to quality-assured training providers

22 | ghp May 2015

training, education & skills companies is enabling employers to develop skills excellence and ensure that the science industry sector is a world leader fit to meet the healthcare and industrial challenges of the 21st century.

Kate described the process, “to act as the provider means the apprentices are trained by subject matter experts currently within the industry to the current expectations of the employer.”

“In particular, the increasing emphasis on research and development in biologics requires the development of new skills and capabilities to build a modern workforce that is well-versed in new and rapidly advancing biopharmaceutical techniques. Indeed biotechnology and bioprocesses in engineering, technology, medicine and other fields is requiring new skills right across the Sector.”

INDUSTRY CASE STUDY 2: Maiher-Un-Nisa Khan, GlaxoSmithKline, Operational Quality Officer becomes SIP Ambassador (pharma)

Companies that get involved with the SIP are able to obtain a range of different funding options to invest in people and skills development. For more information contact kate.hutchins@cogentskills.com or visit http://www. scienceindustrypartnership.com/home/ INDUSTRY CASE STUDY 1: Pfizer takes on apprentices through the SIP (pharma) Pfizer, one of the world’s premier innovative biopharmaceutical companies, has taken on its first ten trailblazer apprentices through the SIP on the new Manufacturing and Laboratory Scientist frameworks. Kate Barclay, Director of Drug Product Supply said, “so far the benefits have been around being able to select what elements we deliver on against the Standard. We are able to choose the knowledge-based qualification suitable for candidates with varying entry levels, select relevant external environmental health and safety certification and also provide internal training with current expertise. This all gives credibility and benchmarking for the Apprenticeship across our industry.”

The new standards have also enabled Pfizer to act as a provider and deliver some of their own training on product quality, good laboratory practices and continuous improvement elements.

“From a very early age I have been intrigued and fascinated by what things are made up of. After graduating with a degree in Chemistry, I wanted to enter a career where I could help people get better and so decided to work in the pharmaceutical industry at GSK. “I decided to become a SIP ambassador to help break the stereotypes associated with working in science and show people young and old that working in science is not just white lab coats and safety glasses and to encourage more people to take up a career in science, proving that science is fun and very rewarding!

“I have found it very rewarding talking to young people about science and seeing first hand some of the stereotypes in their minds being broken. I have now become aware of how to influence and encourage people who don’t necessary agree with you. My company has also benefitted from me and my colleagues becoming SIP ambassadors. Each year GSK has a large intake of summer placements, work experience, industrial placement and graduate students. Many of those who apply have had some interaction with SIP ambassadors and have been encouraged to apply due their experience.

“I think other companies should nominate their employees to become SIP ambassadors so that they can tell people of all ages, truly what science in industry means and engage and inspire young minds at an early age. Application of science in the real world is so vast and the true diversity of this can only be shown by the different types of SIP ambassadors.”

ghp May 2015 | 23

public sector

Eastern Oregon Coordinated Care Organization Partners with Health Integrated to Improve Health of Medicaid Recipients with Complex Medical Issues Innovators Join Forces to Address 3X Higher-than-Average Healthcare Spend of Vulnerable Population With rapid Medicaid expansion in more than 20 states under new federal rules, health plans are eagerly looking for innovative solutions to improve care and contain costs with vulnerable beneficiaries. To help improve the health of their recipients with complex medical issues, Eastern Oregon Coordinated Care Organization (EOCCO), serving 47,000 Oregon Health Plan beneficiaries in 12 rural Oregon counties, has partnered with Health Integrated®, a leader in precision care management, to provide a targeted chronic condition management program. The program, Synergy Targeted Population Management®, is designed to improve patient health and reduce healthcare costs.

Health Integrated’s Synergy program identifies and engages high-risk patients with multiple chronic conditions combined with diagnosed, undiagnosed or untreated psychological and social barriers such as lack of family support or adequate housing. Typical psychosocial issues include depression, anxiety and substance abuse disorders. These patients have been shown to make repeated emergency room visits and have higher rates of hospitalizations that drive up costs for health plans. Health Integrated’s Synergy program has been shown to reduce this kind of usage by 10 percent to 20 percent with similar populations while assisting them in accessing the right care at the right time to assure better health.

communities to support them in their efforts to achieve the triple aim; better health, better care, and lower cost.”

Bringing on new clients like Eastern Oregon Coordinated Care Organization has led to explosive growth for Health Integrated.

“Since November 2014, we have hired 140 people and now have more than 400 employees,” said Health Integrated chief executive officer Shan Padda. “Much of our growth is attributed to bringing on highly skilled and trained clinicians, as well as informatics professionals and data analysts, to serve our growing client base.

We look forward to working closely with EOCCO and helping their most vulnerable members improve their health status.”

About EOCCO Eastern Oregon Coordinated Care Organization (EOCCO) is a Coordinated Care Organization (CCO). The CCO is a group of all types of healthcare providers who work together for people on the Oregon Health Plan (OHP) in Baker, Gilliam, Grant, Harney, Lake, Malheur, Morrow, Sherman, Umatilla, Union, Wallowa, and Wheeler Counties. EOCCO is administered by Greater Oregon Behavioral Health, Inc. (GOBHI) and Moda Health. For more information, visit www.eocco.com.

About Health Integrated

“The State of Oregon has long been an innovator in delivering strategic, cost-effective care in the public sector,” said Robin Richardson, EOCCO chief operating officer. “Research has consistently shown that Medicaid beneficiaries with chronic conditions impacted by psychosocial issues can lead to three-timeshigher-per-enrollee spending than the average beneficiary. Our aim is to deliver the very best care to our members but also to contain costs. We feel strongly that Health Integrated’s unique approach to serving this population will help us to continue to meet this goal.”

Health Integrated enables health plans to effectively manage its members and control costs through its highly scalable precision care management delivery model. By integrating actionable big data with its unique Dynamic Somato-Social Theory™, it addresses the biopsychosocial drivers impacting member outcomes and plan performance. As a result, Health Integrated helps plans gain a competitive advantage and stronger financial returns, while enhancing quality and increasing compliance. For more information, visit www.healthintegrated.com.

In the program, master’s-prepared personal clinicians, who are licensed psychotherapists cross-trained in chronic condition management, deliver specialized interventions to educate and motivate individuals to long-term changes in behavior impacting their health. The ultimate goal is to facilitate self-efficacy and mitigate the use of avoidable and costly healthcare services. The clinicians also serve as advocates for the members, facilitating and coordinating multiple needs with providers, community resources and caregivers.

“Reaching a vulnerable population in rural areas calls for a very proactive and targeted approach,” said EOCCO chief executive officer Kevin Campbell. “We are excited to bring the clinical expertise and technology offered by Health Integrated to our rural

24 | ghp April 2015

public sector

ghp April 2015 | 25