Research on Type 2 Diabetes: The George Washington University Receives Record U$S 134 Million Grant

Effectiveness of glucose-lowering drugs in treating type 2 diabetes is the focus of the multiyear research project to be coordinated by Biostatistics Center.

John Lachin, professor of biostatistics, epidemiology and statistics at the George Washington University, has been awarded a five-year, $134 million grant from the National Institute of Health’s National Institute of Diabetes and Digestive and Kidney Diseases to conduct a clinical trial examining the long-term effectiveness of several glucose-lowering medications for treatment of people with type 2 diabetes. The grant sets a record as the largest sum award GW has ever received.

Dr. Lachin, who is also the interim director of GW’s Biostatistics Center in Rockville, Md., is principal investigator for the grant with David M. Nathan, director of the Diabetes Center at the Massachusetts General Hospital and professor of medicine at Harvard Medical School, both in Boston. The pair, working jointly with investigators at GW and Massachusetts General Hospital, recruited a network of more than 40 clinical centers nationwide to participate in the study.

“This funding is tremendously important to health care as it could result in more effective treatment of diabetes,” said Leo Chalupa, vice president for research at GW. “The award of this grant signifies that the Biostatistics Center is a premier facility of its type and that Dr. Lachin and the project team deserve tremendous credit for putting together this successful investigator-initiated grant application. An award of this magnitude will increase the future ranking of GW among the country’s research universities and bring us closer to the goal set by President Knapp of becoming a top-tier research institution.”

Titled “Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study,” the clinical trial will directly compare the most commonly used medications to treat type 2 diabetes.

“Type 2 diabetes is an epidemic that threatens to become the century’s major public health problem and poses enormous human and economic challenges in the U.S. and worldwide,” said Dr. Nathan.

Dr. Nathan is the senior medical and scientific investigator for the project and chairs the GRADE Research Group. The director of the Coordinating Center, Dr. Lachin, is the senior biostatistician for the project and is responsible for the coordination of all study research activities. Together, they will provide the scientific leadership for the project and oversee all study activities.

The study will address the challenges of type 2 diabetes in a randomized, clinical trial of 6,000 patients with recent onset of type 2 diabetes. The GRADE study will compare the effects of four glucose-lowering medications - the sulfonylurea glimepiride, DPP-4 inhibitor sitagliptin GLP-1 agonist liraglutide and basal insulin glargine, added to metformin – over about four years and track their success in combating the disease. Each of the drugs will be used in combination with metformin, the widely accepted first-line medication for treatment of type 2 diabetes.

“For people with type 2 diabetes, this is a compelling need because numerous competing treatments are available,” said Dr. Lachin. “While each agent was found to safely and effectively reduce blood glucose for relatively short periods such as six months to a year, type 2 diabetes will usually require continued treatment over a lifetime. GRADE’s primary objective is a direct comparison of the commonly used drugs over a more realistic period of time with regard to glucose lowering, side effects, tolerability, other effects and costs.”

Glucose management is important in diabetes patients because sustained elevated levels of blood glucose can lead to extensive damage to the circulatory system, which then can lead to a host of diabetic complications. Damage to the nerves can lead to amputations of the extremities, particularly feet; damage to the kidneys can lead to end-stage renal disease requiring dialysis or transplantation; and damage to the eyes can lead to impaired vision or blindness.

“The goal of therapy should be to maintain a blood glucose level as close to the non-diabetes range as possible to prevent or slow the progression of these complications,” said Dr. Lachin. “The principal study objective is to determine which of these therapies most effectively and safely reaches and maintains such near normal levels of blood glucose.”

More than 40 participating clinical centers each plan to recruit at least 150 eligible patients who have consented to be randomly assigned to one of the four therapies under study. Funds from the grant to GW will be dispersed to these centers to support their activities in the GRADE study.

GW’s Biostatistics Center will coordinate all research and operational activities at all sites for the study.

The initial steps of the project will begin Oct. 1. The present grant supports the first five years of the project, with the opportunity for renewal for an additional three years. The total project duration is scheduled to be eight years.

GEORGE WASHINGTON TODAY

Rice Hall
Division of External Relations
2121 Eye Street, NW
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Phone: (202) 994-1000
gwtoday@gwu.edu

Joint Commission Annual Report names 620 Hospitals as "Top Performers on Key Quality Measures"

Report Summarizes Performance of More Than 3,300 U.S. Hospitals

by Elizabeth Eaken Zhani, Media Relations Manager

(OAKBROOK TERRACE, Ill. – September 19, 2012) "Improving America’s Hospitals: The Joint Commission Annual Report on Quality and Safety 2012," includes 620 hospitals that are leading the way nationally in using evidence-based care processes closely linked to positive patient outcomes. The hospitals identified as attaining and sustaining excellence in accountability performance in 2011 represent approximately 18 percent of Joint Commission-accredited hospitals reporting core measure performance data.

The annual report also summarizes the performance of more than 3,300 Joint Commission accredited hospitals on 45 accountability measures of evidence-based care processes closely linked to positive patient outcomes. While the data show impressive gains in hospital quality performance, improvements can still be made. Some hospitals perform better than others in treating particular conditions.

The list of Top Performers on Key Quality Measures™ increased more than 50 percent to 620 hospitals from its debut last year, and 244 of the hospitals named in the new report are appearing on the list for the second year in a row. The designation is based on performance related to accountability measures for heart attack, heart failure, pneumonia, surgical care, children’s asthma care, inpatient psychiatric services, venous thromboembolism (VTE) care, and stroke care.

Each of the Top Performersmet two 95 percent (95/95) performance thresholds on 2011 accountability measure data. First, each hospital achieved performance of 95 percent or above on a single, composite score that includes all the accountability measures for which it reports data to The Joint Commission, including measures that had fewer than 30 eligible cases or patients. Second, each hospital met or exceeded 95 percent performance on every accountability measure for which it reports data to The Joint Commission, excluding any measures with fewer than 30 eligible cases or patients. The list of Top Performers on Key Quality Measures and the measure set or sets for which the hospital was recognized are available online at http://www.jointcommission.org/accreditation/top_performers.aspx. Additional quality, safety and patient satisfaction results for specific hospitals can be found at www.qualitycheck.org.

"The Joint Commission began releasing this information as a way to shine a light on and encourage excellence on accountability measures. The significant increase in the number of hospitals achieving Top Performers status demonstrates that these organizations are intently focused on delivering high quality care within their communities," says Mark R. Chassin, M.D., FACP, M.P.P., M.P.H., president, The Joint Commission. "Making the Top Performers list is no easy feat. I salute these organizations for their hard work in attaining excellence. By consistently using evidence-based treatments, their patients are getting better hospital care."

Overall, The Joint Commission annual report shows 88.8 percent of hospitals achieved a composite accountability measure performance of 90 percent in 2011, compared to 20.4 percent of hospitals in 2002. For the first time, measures in the inpatient psychiatric services, VTE care and stroke care measure sets were included in this calculation.  Including these newer measures resulted in a decrease from the 91.7 percent composite score reported last year. This composite includes all 2011 accountability measures except for two inpatient services measures – hours of seclusion and hours of physical restraint. On these measures, a lower score is preferred.

The newest data show:

• In addition to the 620 hospitals achieving Top Performers status, another 583 hospitals (17 percent of hospitals reporting measures) fell slightly short by missing 95 percent performance on only one measure. To help these 583 hospitals potentially achieve Top Performers status next year, The Joint Commission is encouraging use of the Core Measure Solution Exchange that allows health care professionals from accredited organizations to freely exchange quality improvement practices, as well as the Leading Practices Library and the Strategic Surveillance System (S3)™, a tool that provides a series of risk assessments and comparative reports to assist in the development of improvement plans.
• All measures tracked over at least two years showed improvement from the year of inception to 2011.
• The heart attack care result is up 9.9 percentage points, from 88.6 percent in 2002 to 98.5 percent in 2011. A 98.5 percent score means that hospitals provided an evidence-based heart attack treatment 985 times for every 1,000 opportunities to do so. This composite includes aspirin at arrival, aspirin at discharge, ACEI or ARB at discharge, beta-blocker at discharge, fibrinolytic therapy within 30 minutes, PCI therapy within 90 minutes, and statin prescribed at discharge.
• The 2011 pneumonia care result is 96.2 percent, up from 72.4 percent in 2002 – an improvement of 23.8 percentage points. This composite includes pneumococcal vaccination, blood cultures in the intensive care unit (ICU), blood cultures in emergency department, antibiotics to ICU patients, antibiotics to non-ICU patients and influenza vaccination.
• The surgical care result has improved to 97.6 percent in 2011 from 82.1 percent in 2005 an improvement of 15.5 percentage points. This composite includes antibiotics within one hour before the first surgical cut, appropriate prophylactic antibiotics, stopping antibiotics within 24 hours, cardiac patients with 9 a.m. postoperative blood glucose, patients with appropriate hair removal, beta-blocker patients who received beta-blocker perioperatively, prescribing VTE  medicine/treatment, receiving VTE medicine/treatment, and urinary catheter removed.
• The 2011 children’s asthma care result is 94.7 percent, up from 79.8 in 2008 – an improvement of 14.9 percentage points. This composite includes relievers for inpatient asthma, systemic corticosteroids for inpatient asthma, and home management plan of care.
• The 2011 inpatient psychiatric services result is 87.3 percent, up from 80.5 percent in 2009 – an improvement of 6.8 percentage points. The composite includes multiple antipsychotic medications, justification for multiple antipsychotic medications, continuing care plan created, and continuing care plan transmitted.
• The 2011 venous thromboembolism (VTE) care result is 89.9 percent, up from 82.7 in 2010 – an improvement of 7.2 percentage points. This composite includes VTE medicine/treatment, VTE medicine/treatment in ICU, VTE patients with overlap therapy, VTE patients with UFH monitoring, and VTE warfarin discharge instructions.
• The 2011 stroke care result is 94.9 percent, up from 92.7 percent in 2010 – an improvement of 2.2 percentage points. The composite includes VTE medicine/treatment, discharged on antithrombotic therapy, anticoagulation therapy for atrial fibrillation/flutter, thrombolytic therapy, antithrombotic therapy by end of hospital day two, discharged on statin medication, stroke education and assessed for rehabilitation.

Although hospitals achieved 90 percent or better performance on most individual process of care measures, the report contends that more improvement is needed. For example, only 60.2 percent of eligible heart attack patients receiving fibrinolytic therapy within 30 minutes of arrival at the hospital.

Fuente: The Joint Commission

Key Lessons on Pharmaceutical & Biotechnology Royalties, too often learned the Hard Way...

by Nigel Borshell, Director of Consultancy, PharmaVentures Ltd, Oxford UK

As the patent cliff looms the pharmaceutical and biotechnology industry is undergoing considerable change requiring greater innovation and a strong need for successful partnering. Royalties can represent the most valuable component of a deal but are often couched in remote and desensitized terms whereas the upfront and milestone values often grab the headlines in the deal announcement. Understanding the true value of your asset and how royalties are inextricably linked with overall deal value can help you negotiate on the things that really deliver value. You stand to lose more of your hard earned value through royalty percentages and tier adjustments than any other component of the deal.

The pharmaceutical and biotechnology industry is undergoing considerable change as the patent cliff looms, fostering invention and change, and a strong need for successful partnering. There are also new opportunities to develop in emerging and emerged new markets. What impact are these changes having on companies as they seek to partner, to strike the best deal? How can companies be sure that the deal terms they achieve, and associated royalties, are the best possible? Does the often quoted 25% rule of thumb really work? And what are "Effective Royalty Rates" anyway? 

While much of the methodology and context on royalty rates is available, there are key lessons to be learned by the aspiring deal maker in the smallest biotech to the largest pharma company. 

Deal making is as much an art as it is a science 

If you are tempted to flip through a royalty rate report to find the bar charts and data tables holding "standard" royalty rates that you dearly wish and need to discover so that you can define your own deal term limits and expectations, then go right ahead, a fool and his money are easily parted. However, if you invest your time in understanding royalties, you will come away with a better understanding of what royalties are, and how and why they are inextricably linked with overall deal value. Context is everything. Without a full understanding of the value in your product and of other contributions to deal value, you cannot determine a suitable royalty rate, no matter how many tables you read. 

It's as much about 'what you can live with' as about meeting specific industry norms 

Deal making is as much about "what you can live with" as it is about meeting specific industry norms. If either one party feels - or both parties feel - that the terms set out do not meet expectations, then there is no rosy future, even if the terms that you propose meet the industry norms. Only by an in-depth analysis of a programme’s value, and of the split of that value among deal components (upfront payments, development milestones, sales milestones, royalties) will you be able to answer that ‘what can I live with?’ question. 

"Living with" involves envisioning the future in both the short and long term. Can we afford it? It could seem like a blindingly good deal long term from a business development perspective, but the short-term impact on the licensee’s bottom line or company cash flow from the CFO’s (and shareholders’) perspective might just be the deal breaker.

More can be gained through effective knowledge-backed negotiation

The third lesson is that there is more to be gained through effective knowledge-backed negotiation skills than there is from reading tables of royalty data or calculating value on a spreadsheet. Beyond the obvious impact of prevailing market conditions, actual value is fundamentally a function of a product’s net present value enhanced by a licensee’s strategic need for that product. Understanding the estimated ‘actual’ value that a product may have does not automatically translate into knowing how big a share of it you will get. 

That share comes from a skill-based activity called negotiation, and, unsurprisingly, it is a professional activity that is built on information, not on anecdote. 

A great deal of time and effort is spent in negotiating deal terms, but is the time spent on the various value components in line with their relative values? Negotiate hardest on the things that really deliver value! 

You stand to lose more of your hard earned value through royalty percentages and tier "adjustments" than on any other component of the deal. Small changes in small numbers can represent millions in dollar values. 

Apart from royalties, deal components tend to be described in absolute cash terms, millions of US Dollars or Euros, whereas royalties are couched in somewhat remote and desensitized percentage terms. The difference between $125M proposed and $100M offered is perceived by all as $25M, money at least when expressed in currency terms, talks. The human brain would recognize the value of $25M with recourse to convert it into a percentage of the original $125M. But what is the difference between 12.5% and 10%? 

Just a couple of percent of sales! Or for that matter what value might a royalty difference of just 0.5% constitute when the decimal place disappears in the counter term sheet? 

Keeping a clear and informed head and an eye on maximising the deal value, while living with any consequences, is the fine line trodden by deal makers today. And when this all happens across cultural and language divides, it makes for interesting times.

Fuente: PharmaDeals Review

La Dra. Mirta Roses consideró imprescindible luchar por la equidad en salud y trabajar por la reducción de las disparidades (OPS)

Durante la presentación de su informe quinquenal de gestión, la directora de la Organización Panamericana de la Salud (OPS), doctora Mirta Roses Periago, afirmó que “es imprescindible e impostergable luchar sin descanso en favor de la equidad y la igualdad en la salud pública” para lograr una vida más larga y de mejor calidad en las Américas.

“La reducción de las disparidades entre los países y dentro de ellos es, sin duda, el mayor reto en materia de salud pública para la Región y es, además, condición indispensable para su desarrollo pacífico y sostenible y su protagonismo mundial”, consideró.

La doctora Roses Periago sostuvo que como resultado de nuevas constituciones y marcos jurídicos en algunos países –que incorporaron el derecho a la salud–, millones de personas y familias accedieron a cobertura sanitaria por primera vez.

“Muchos Estados lograron ampliar la protección sanitaria al incorporar grupos anteriormente excluidos de los sistemas existentes, crear nuevos mecanismos de cobertura, reducir los gastos de bolsillo de los pacientes o implantar medidas sociales como las transferencias en dinero, las asignaciones por hijo y escolaridad, las pensiones a la invalidez y vejez, y otras combinaciones de estas medidas”, destacó al referirse a la consolidación del concepto de salud como un derecho humano en las agendas políticas de casi todos los países de las Américas.

Asimismo, las delegaciones de los países de las Américas iniciaron el debate sobre la estrategia y el plan de acción sobre gestión del conocimiento y comunicaciones, durante la 28ª Conferencia Sanitaria Panamericana.

Esta estrategia y plan de acción busca guiar a los países miembros en la adopción de normas, políticas y procedimientos en materia de gestión del conocimiento y comunicaciones, al asegurar la convergencia de proyectos, iniciativas, productos y servicios de la región en estos temas en beneficio de la salud.

Según la estrategia y el plan de acción, el acceso a la información confiable y el intercambio de conocimientos sobre salud, mediante el uso de las tecnologías de la información y comunicaciones, se ha considerado esencial para el desarrollo de la salud en la región. Para la OPS/OMS, la gestión del conocimiento y las comunicaciones son herramientas y metodologías importantes para tomar decisiones fundamentadas, y para promover cambios que conduzcan a mejorar la salud en las Américas.

Fuente: Organización Panamericana de la Salud

En la última década el Gasto en Salud en Argentina aumentó 800%

La noticia se conoce en medio del conflicto con las clínicas, sanatorios y hospitales de comunidad
Qué harán las prepagas para garantizar los servicios

En medio de la polémica entre clínicas y sanatorios, y prepagas, la Asociación civil de Actividades Médicas Integradas (ACAMI) advirtió esta mañana que el gasto en salud aumentó 800% en la última década, según un sondeo encargado a Poliarquía.

ACAMI reúne a prestadores como los hospitales Alemán, Británico, Italiano y Cemic y financiadores como OSDE, William Hope y Mita, todos “sin fines de lucro”, y en estos días se está desarrollando su decimoquinto congreso anual.

Las entidades mencionadas prestan servicios a sus afiliados con normalidad, se aclaró desde ACAMI, a pesar de que la Asociación de Clínicas y Sanatorios advirtió que desde el lunes los afiliados a prepagas serán relegados en la atención porque esos financiadores se niegan a incrementar los fondos.

“En los últimos 10 años el gasto en salud a aumentado casi un 800%. La inflación de la salud es mucho mayor que el costo de  vida, el gasto en salud se compone de múltiples sectores”, se explicó desde ACAMI.

En este período, el gasto total en salud aumentó 782%, el salario de una enfermera de piso subió 1.011%, medicamentos ambulatorios 555% y prótesis 1508%”, señaló el presidente de la entidad, Hugo Magonza.

En tanto, las prepagas que se vean afectadas por las limitaciones de los servicios médicos resolvieron derivar las consultas a sus propias clínicas o bien reintegrar copagos.

Las prepagas van a garantizar la continuidad de las prestacionesincluso reintegrando el costo que cobren las clínicas que limiten los servicios”, le dijo Jorge Piva, directivo de CIMARA (Cámara de Instituciones Médicas Asistenciales de la República Argentina) que nuclea a la mayoría de las prepagas, como Medicus, Galeno, Medifé y Omint, entre otras.

Fuente: Fortunaweb

Global Pharma Market will expand by 5% to 7% in 2016 (Part 2)

IMS Study Forecasts Rebound in Global Spending on Medicines, Reaching Nearly U$S 1.2 Trillion By 2016

Spending in Pharmerging Markets to Nearly Double while Health Systems in Developed Countries Benefit from Historically Low Spending Growth

PARSIPPANY, NJ, July 12, 2012 – Following several years of slowing growth, the global market for medicines is poised to rebound from an expected low point of 3-4 percent growth in 2012 to 5-7 percent in 2016, according to a new forecast issued by the IMS Institute for Healthcare Informatics.

The report, The Global Use of Medicines: Outlook through 2016, found that annual global spending on medicines will rise from $956 billion in 2011 to nearly $1.2 trillion in 2016, representing a compound annual growth rate of 3-6 percent. Growth in annual global spending is forecast to more than double by 2016 to as much as $70 billion, up from a $30 billion pace this year, driven by volume increases in the pharmerging markets and an uptick in spending in developed nations.

Additionally, patent expiries, which will peak in 2012, as well as increased cost-containment actions by payers, will constrain branded medicine spending growth through 2016, at 0-3 percent. Developed markets are expected to experience their lowest annual growth this year, at less than 1 percent or $3 billion, and then rebound to $18-20 billion in annual growth in the 2014-16 period.

“As health systems around the world grapple with macroeconomic pressures and the demand for expanded access and improved outcomes, medicines will play an even more vital role in patient care over the next five years,” says Murray Aitken, executive director, IMS Institute for Healthcare Informatics. “The trillion-dollar spending on medicines we forecast for 2016 represents a rebound in growth that will accentuate the challenges of access and affordability facing those who consume and pay for healthcare around the world.”

In its latest analysis, the IMS Institute identifies the following dynamics:

• Health systems in developed economies will experience slow growth in medicine spending.Spending on medicines in developed nations will increase by a total of $60-70 billion from 2011 to 2016, following an increase of $104 billion between 2006 and 2011. Despite the highest number of patent expiries in history, spending in the U.S. will grow by $35-45 billion over the next five years, representing an average annual growth rate of 1-4 percent, as newer medicines that address unmet needs are introduced and patient access expands in 2014 due to implementation of the Affordable Care Act. In Europe, growth will be in the -1 to 2 percent range due to significant austerity programs and healthcare cost-containment initiatives. The Japanese market for medicines is forecast to grow 1-4 percent annually through 2016, slightly lower than the rate during the prior five years and reflecting biennial price cuts scheduled for 2012, 2014 and 2016. Overall, patent expiries in developed markets will yield a five-year “patent dividend” of $106 billion, reflecting reduced brand spending of $127 billion offset by $21 billion in higher generics spending
• Health systems in pharmerging markets will nearly double their medicine spending in five years. Annual spending on medicines in the pharmerging markets will increase from $194 billion last year to $345-375 billion by 2016, or $91 in drug spending per capita. The increase will be driven by rising incomes, continued low cost for drugs, and government-sponsored programs designed to increase access to treatments – by limiting patients’ exposure to costs and encouraging greater use of medicines. Generics and other products, including over-the-counter medicines, diagnostics and non-therapeutics, will account for approximately 83 percent of the increase.
• Pharma manufacturers will see minimal growth in their branded products through 2016. The market for branded medicines will experience flat to 3 percent annual growth through 2016 to $615-645 billion, up from $596 billion in 2011. In the major developed markets, branded medicine growth will be severely constrained at only $10 billion over the five-year period due to patent expiries, increased cost-containment actions by payers and modest spending on newly launched products. The pharmerging markets are expected to contribute $25-30 billion in branded product growth over the same period. Off-invoice discounts and rebates will offset about $5 billion of global branded medicine growth.
• Manufacturers of small molecule generics will experience accelerating growth. Global generic spending is expected to increase from $242 billion in 2011 to $400-430 billion by 2016, fueled by volume growth in pharmerging markets and the ongoing transition to generics in developed nations. The impact of patent expiries primarily will be felt in the U.S. In Europe, limited savings from expiring patents are prompting policy shifts to encourage greater use of generics and lower reimbursement for these products.
• Providers will have more treatment options due to additional new medicines being launched. Global launches for New Molecular Entities (NMEs) will rebound during the next five years, as 32-37 NMEs are expected to be launched per year through 2016. Between 2011-16, 160-185 NMEs are expected to launch, compared with 142 between 2007-11. Innovative therapies to extend or improve patients’ quality of life are anticipated for treatment of Alzheimer’s, autoimmune diseases, diabetes, and a number of cancer and orphan diseases. Treatments for global priority diseases, such as malaria, tuberculosis and neglected diseases, are expected to improve, although gaps will remain.
• Biologics manufacturers will benefit from expanding market opportunity. Biologics are expected to account for about 17 percent of total global spending on medicines by 2016, as important clinical advances continue to emerge from research. Seven of the top ten global medicines by spending will be a biologic within five years. Adoption of biosimilars as low-cost alternatives to the original biologic medicines will remain limited, as biologics remain protected by patents or market exclusivity in many countries.

The IMS Institute report, The Global Use of Medicines: Outlook through 2016, including additional findings and details on methodology, is available at www.theimsinstitute.org.

Analyses conducted for The Global Use of Medicines: Outlook through 2016 report are based on IMS audits and include all types of biopharmaceuticals, including biologics, OTC, and traditional medicines distributed and administered through regulated delivery systems such as pharmacies, hospitals, clinics, physician offices, and mail order, where applicable. Spending figures are derived from IMS Market Prognosis™ and are reported at ex-manufacturer estimated prices that do not reflect off-invoice discounts and rebates. IMS MIDAS™, Lifecycle™ R&D Focus, Lifecycle™ New Product Focus, PharmaQuery™, Market Prognosis™ and Therapy Forecaster™ were also used for assessing worldwide healthcare markets, therapy class and product dynamics and country-level pricing and reimbursement complexities. More detail on information sources is included in the report. Developed markets are defined as the U.S., Japan, Top 5 Europe countries (Germany, France, Italy, Spain, U.K.), Canada and South Korea. Pharmerging countries are defined as those with greater than $1 billion in absolute spending growth over 2012-16 and that have GDP per capita of less than $25,000 at purchasing power parity: China, Brazil, India, Russia, Mexico, Turkey, Poland, Venezuela, Argentina, Indonesia, South Africa, Thailand, Romania, Egypt, Ukraine, Pakistan and Vietnam.

About the IMS Institute for Healthcare Informatics

The IMS Institute for Healthcare Informatics provides key policy setters and decision makers in the global health sector with unique and transformational insights into healthcare dynamics derived from granular analysis of information. It is a research-driven entity with a worldwide reach that collaborates with external healthcare experts from across academia and the public and private sectors to objectively apply IMS’s proprietary global information and analytical assets. More information about the IMS Institute can be found at www.theimsinstitute.org.

About IMS Health

IMS Health is a leading provider of information, services and technology for the healthcare industry around the world. The company draws on its global technology infrastructure and unique combination of in-depth, sophisticated analytics, on-shore and off-shore commercial services, and software platforms to help clients better understand the performance and dynamics of healthcare systems. With a presence in 100+ countries and more than 55 years of industry experience, IMS serves leading decision makers in healthcare, including pharmaceutical manufacturers and distributors, providers, payers, government agencies, policymakers, researchers and the financial community. Additional information is available at www.imshealth.com.

Fuente:  IMS Health Incorporated

Global Pharma Market will expand by 5% to 7% in 2016 (Part 1)

Why Big Pharma won't get its piece of the 
U$S 1.2 Trillion Global Drug Market
by Matthew Herper, Forbes Staff

The global market for prescription drugs will grow from $950 billion now to $1.2 trillion in 2016, according to a new report released today. But Big Pharma may sit out much of the growth as patents on big-selling drugs expire and people fast-growing markets such as China, Russia, and Brazil buy generic drugs from local manufacturers.

That’s the forecast from the IMS Institute for Healthcare Informatics, a unit of health information company IMS Health, which tracks prescription data and provides consulting services to drug makers and to Wall Street. All the charts are from this report, which serves as not only a forecast but as an annual opportunity to take the drug industry’s temperature.

First, as the overall market grows, the United States will command a smaller piece of the pie while still being the largest single drug market. It’s good that we’re controlling the cost of prescription drugs, but this does mean that the U.S., which a fifteen years ago seemed to be pulling European drug makers such as Novartis, Sanofi, GlaxoSmithKline, and Novo-Nordisk to amp up their presence here, will be less of a lure.

Here’s a country by country look at what’s really happening. The U.S. still spends more per capita on medicine than any other nation. But in the emerging markets, costs and volumes are going up. According to Michael Kleinrock, director, Research Development for the IMS Institute, the reason for this transformation is pretty simple. As per-capita income increases, say, from $500 to $5,000, a medicine’s cost as a percent of that income drops by an order of magnitude. Many of these countries are just reaching a point where people will be able to afford some medicines they need and want out of pocket.

For the record, when we talk about emerging markets in pharma, we’re talking about: Brazil, India, Russia, Argentina, Egypt, Indonesia, Mexico, Pakistan, Poland, Romania, South Africa, Thailand, Turkey, Ukraine, Venezuela, and Vietnam. In these markets, the products are not just generic companies, like Teva or Mylan, they’re often small and local, too. And that’s where much of the growth will be – although every big drug maker is fighting to get some of this growth.

In these markets, the reports says, 65% of about $360 million in sales will be from generics. In the developed world, only 18% of $675 million in sales will be from generics. That leaves branded drugs with just $680 million in sales, a bit more than half the market, with cheaper generics taking the rest.

In the U.S. and Europe, though, growth will be harder to come by, as these countries try to control cost. The drug industry will actually pull out of its research drought, IMS says, bringing 35 new medicines to market each year, on average – than it has in any of the previous five years. These might include medicines against’ Alzheimer’s being developed by Eli Lilly and Pfizer, and a likely new drug for multiple sclerosis from Biogen Idec.

But more than anything else, the drug business in Europe, the U.S., and Japan will be focused on cancer and diabetes. Want an explanation for why AstraZeneca and Bristol-Myers Squibb bid for Amylin Pharmaceuticals? Look no further.

That may not be enough to make up for the massive waves of patent expirations that are still going to be buffeting the drug business, though. Over this period, more than $127 billion in annual sales will be lost as drugs go generic. Here, to end, is a list of all the brands that will go off patent in big markets over the next five years. It is a list of many of the biggest products on the market today.

Patient Care: Spirituality at Work

by Terry Sheridan

If you’re a nurse, you know about the importance of stress reduction, mindfulness and holistic treatment in helping your patients. But have you considered their spirituality?

Dr. Christina Puchalski, director of the George Washington University Institute for Spirituality and Health (GWISH) in Washington, D.C., is convinced that you and every healthcare provider should.

“There is a tremendous dissatisfaction among patients, and people in general, with the healthcare system,” says Puchalski, who also is a professor in the George Washington University School of Medicine’s Department of Medicine and Health Sciences. “People feel disillusioned by medical procedures, a lack of compassion and the efficacy of procedures. And the complexity of the system makes choices very, very difficult.”

Post 9/11

More people, especially since Sept.11, 2001, increasingly are reflective – asking deep spiritual questions, she says. When they are ill or facing loss, those questions are even more prominent.

Nurses and other providers can incorporate spirituality into their work in several ways. The GWISH website offers a link to its spiritual assessment guide that caregivers can use for study.

“The model is that everyone who is caring for patients, everyone on the team, offers spiritual care,” Puchalski says. “The question comes, who does what?”

“Board-certified chaplains are the experts who can diagnose spiritual issues,” she says. Nurses and other caregivers would provide that care in a more “generalist way,” as Puchalski puts it. At the same time, she recognizes that spirituality is becoming a healthcare specialty.

It’s why she wrote what’s considered the first reference textbook on the topic, the “Oxford Textbook of Spirituality and Healthcare.” According to the university’s July 2012 announcement about the text, it’s intended to guide multidisciplinary practitioners.

Employer policies

In addition to patients’ spiritual care, during an interview, you might want to find out whether a potential employer respects the right of employees to practice their belief system. Other than traditional days off, would you be allowed to have a day for cultural time off?

“We advocate for employment to focus on wellness and an environment where people can be their authentic self,” Puchalski says.

But Puchalski wants to aim for what she calls deeper and broader benefits. GWISH is working to develop wellness initiatives, including focusing on what makes a company a good place to work.

“One of those reasons has to be that an employer allows employees to find their own sense of balance,” she says. “If that means meditating or running or having a moment of silence, does the employer allow that?”

You may even broach the topic of developing a spiritual care model.

GWISH developed the “Whole-Person Clinic” that emphasizes “the focus of care should be on health and healing rather than just eradication of disease,” according to the institute’s website. It means that healing, as differentiated from cure, can occur any time.

The model is based on recommendations for spiritual care from the 2009 National Consensus Conference in Palliative Care. That care includes a physician, psychiatrist, board-certified chaplain and social worker who interview the patient during intake. The team, and the patient, develop a treatment plan.

You won’t want to bring up your first vacation right away in a job interview. But if you really want to delve into the topic for an intensive week, GWISH offers a retreat for healthcare providers and practitioners every August in Assisi, Italy.

Fuente: GW School of Medicine and Health Sciences - AllHealthcareJobs.com

FDA may speed Approval of "Breakthrough" Drugs

Experimental drugs that show a big effect early in development for treating serious or life-threatening diseases would get a faster and cheaper path to U.S. approval, under a proposal likely to become law this year.

The U.S. Food and Drug Administration has said it supports the proposal, which is included in both versions of an FDA "must-pass" funding bill currently working its way through Congress and set to be passed by the end of the summer.U.S. drug regulators would be able to label such treatments "breakthrough" therapies, and work with companies to speed up clinical trials, for example by testing the drugs for a shorter time or enrolling fewer patients.

The plan fits with President Barack Obama's aim to foster innovation as a means of spurring job creation, and may pacify some critics who say the FDA lags European countries in approving new medicines or medical devices.

Dr. Janet Woodcock, head of the FDA's drugs center, has said the FDA needs more flexibility to bypass "business as usual" when it sees unexpected effects, or when a new medicine can greatly help patients.

"What happens when you have a breakthrough drug that shows an effect that's never been seen before?" she told reporters in March, discussing the proposal.

"If we'd done business as usual during the AIDS epidemic, we would have never controlled that epidemic," Woodcock said.

Jeff Allen, executive director of Friends of Cancer Research, said the time was right for another avenue to speed innovative treatments to patients.During a spike in new cases of AIDS in the early 1990s, the FDA created an "accelerated approval" process to get new AIDS drugs to the market more quickly by allowing companies to show indirect measures of how the drug helped people.

Allen said new understanding of human biology and of diseases meant companies could create more effective drugs, but with fewer side effects, because they would be more targeted to specific patients or disease types.

He said a good example was Roche Holding AG's skin cancer drug Zelboraf, approved last year; people taking the pill were 63 percent less likely to die from melanoma than people on standard chemotherapy.

There was also Pfizer Inc's targeted lung cancer drug Xalkori, which could shrink or eliminate tumors in 10 to 12 months for people with a specific genetic mutation.

"The most promising drugs show an effect early," Allen said. "(But) there's a mentality among drug developers or FDA reviewers that you have to go through this multi-step approach" to get a drug to market.

"We're hoping to encourage getting away from that," he said.

Allen said the FDA would retain its power to require companies to do post-approval studies, or withdraw drugs from the market if initial evidence of benefit was not shown in follow-up trials.

Fuente: Thomson Reuters

GW Receives Record U$S 24.5 Million for Research

Grants from National Institutes of Health, Robert Wood Johnson Foundation will fund health and medical research

The George Washington University today announced that it has received two grants totaling nearly $24.5 million dollars, the largest grant allocation the university has received in recent history.

“Receiving these grants, specifically on the same day, reaffirms that GW is making a serious and sustained impact in the research community,” said Leo Chalupa, vice president for research. “Our growing profile in the science and research arena not only reflects positively on the institution but also on the caliber of our faculty and other resources.”

The National Institute of Diabetes and Digestive and Kidney Diseases has awarded John Lachin, professor of epidemiology and biostatistics in the School of Public Health and Health Services (SPHHS), almost $14 million for GW’s Biostatistics Center. The institute is within the Department of Health and Health Services’ National Institutes of Health.

The funding is for the continuation of the Epidemiology of Diabetes Interventions and its Complications study (EDIC) project that is the long-term follow up to a diabetes and control complications trial in which the epidemiology of diabetes interventions and complications are studied. The goal for the next five years is to accurately describe the long-term effects of glycemia and other risk factors on diabetes complications.

“This grant will allow for the continued follow up of a cohort of subjects with type 1 diabetes to evaluate the factors that contribute to the long-term development of microvascular outcomes such as eye and kidney diseases and cardiovascular outcomes such as heart attacks in type 1 diabetes,” said Dr. Lachin. “We hope that this will provide further insights into the role that high blood glucose levels plays in these complications.”

The second grant, for almost $10.5 million, was awarded to George Washington University for the continuation of Aligning Forces for Quality (AF4Q), the Robert Wood Johnson Foundation’s (RWJF) signature effort to lift the overall quality of health care in targeted communities, reduce racial and ethnic disparities and provide models for national reform. The foundation has made the commitment to improve health care in 16 geographically, demographically and economically diverse communities that together cover 12.5 percent of the U.S. population.

“We are pleased to continue the important work of AF4Q, which asks the people who get care, give care and pay for care to work together toward common, fundamental objectives to lead to better care,” said Robert Graham, AF4Q’s project director and a research professor of health policy with SPHHS. “After six years, AF4Q communities have built transformative partnerships, often where none existed before. In these 16 communities, data on quality, cost and patient experience measures are being collected and publicly reported, hospitals are improving care from the emergency department to the bedside, patients are playing a crucial part in transforming health care, and new models for care delivery and organization are being implemented.”

SPHHS’ Department of Health Policy serves as the national program office for the project.

Earlier this year, the National Science Foundation ranked GW as one of the nation’s top 100 colleges and universities in terms of funding spent on research and development projects.

GEORGE WASHINGTON TODAY

Rice Hall
Division of External Relations
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Washington, DC 20052
Phone: (202) 994-1000
gwtoday@gwu.edu

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