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News Article | April 13, 2016
Site: www.nature.com

Epidemiologist Thomas Sellers thought that he had discovered a treasure trove of data that could help to shed light on the heredity of breast cancer. When he took a post at the University of Minnesota in Minneapolis in 1989, he had heard about archived records of a multi-generation family study of the disease that were mouldering in the basement of the botany department. The study had been completed in 1952, and no one had kept track of the families that had been involved. Excited by the prospect of data that spanned decades and generations, Sellers sifted through index cards that listed the names of people with breast cancer, and their relatives. He started to track down descendants of the patients to ask about their health and medical histories. “We ended up with four- or five-generation pedigrees,” he says. “It was a really powerful resource.” But about seven years into his work, Sellers hit a major snag: in 1996, the US government passed the Health Insurance Portability and Accountability Act (HIPAA), a law that, among other things, established strict protections for the health information of individuals. His efforts to contact the relatives had to cease. “We were revealing information about people's cancer history to others who might not be allowed to know,” says Sellers, now director and an executive vice-president of the Moffitt Cancer Center in Tampa, Florida. “It is a study that could not be done today.” Privacy laws have complicated research that involves people in many fields. Early-career investigators must navigate an ever-changing maze of regulations, but they do not have to face the challenge alone. Institutional review boards and compliance offices of universities and research centres can provide guidance on each step, from obtaining patient consent to handling and storing human tissue and data. Working closely with colleagues who are familiar with the issues — both within and beyond their institution — can also help researchers to get the data that they need without falling foul of the law. An important first step in many areas of biomedical research is for scientists to become familiar with the privacy laws that affect their work. In the United States, human-tissue research is governed mainly by two wide-ranging laws: the HIPAA and the Federal Policy for the Protection of Human Subjects, which is also known as the Common Rule. These laws dictate how researchers can obtain and use tissue and how they may store and protect the personal information that they collect. Regulations vary widely between US states, and some state laws are tighter than federal laws; California, for example, has set a higher standard for medical privacy. And most institutions will also have their own policies and procedures, which can create a bewildering patchwork of requirements, especially for researchers who are part of multi-institution collaborations. “Cancer research in the United States is a fragmented effort,” says Melissa Markey, a lawyer with Hall, Render, Killian, Heath and Lyman in Troy, Michigan, who specializes in technology, privacy and human-subject research. “This is the reason that researchers run screaming from explanations of how these laws fit together, because it is very confusing. It's like Alice in Wonderland.” Rules and responsibilities also vary from nation to nation. In the United Kingdom, the Data Protection Act controls the use of personal information, and the Human Tissue Act (and its counterpart in Scotland) regulates the use of human organs and tissues. The National Health Service (NHS) helps to direct how personal medical information can be shared. Senior members of staff in the NHS act as 'Caldicott guardians' who work to ensure that those data stay secure. “That seems like a lot of regulations, and it is,” says Stefan Symeonides, a clinical oncologist at the University of Edinburgh. “My advice is to not be daunted. It's a lot of process, but the underlying principle is to enable research and maximize use of data in a safe way.” In Europe, harmonized laws facilitate the flow of tissues and data between EU member countries and beyond. It can be a challenge to navigate the acquisition of health data. Large institutions and academic health-science centres in the United States and the United Kingdom typically employ or retain individuals who have expertise in privacy law and can offer comprehensive support to researchers. Madhu Purewal, a senior legal officer at the University of Texas MD Anderson Cancer Center in Houston, earlier this year helped an investigator to procure patient data from a handful of institutions that had different protocols. She guided the researcher in crafting individualized agreements for each. “As a faculty member, this is not your area of expertise,” she says. “But I can help you figure out what is needed.” Carlos Caldas, an oncologist at the University of Cambridge, UK, says that he and his colleagues rely heavily on their institutions' clinical-research coordinators and data-security staff to steer them through the regulatory requirements. His advice? “Join places that have a critical mass of expertise.” Caldas also says that large cancer-research facilities tend to have the infrastructure — tissue and tumour banks and encrypted databases — to accept and process samples without putting materials or data at risk. Launching a research programme at an institution with no affiliation to a hospital can be a trickier matter. The lack of access to patients created cumbersome obstacles for biomedical engineer Michael Fenn, who works on cancer diagnostics. As a new member of faculty in 2013 at the Florida Institute of Technology in Melbourne, Fenn's research stalled when he tried to get patient samples and data from other research centres. The institute had no formal partnerships with cancer hospitals or research institutes, so he was uncertain about whom to contact at those organizations or how to comply with their privacy requirements. “I'm asking them, 'May I have some tissue from a particular type of patient?'” he says. “But the process was so convoluted and I wasn't even sure how to initiate it.” Fenn smoothed the way by establishing relationships with key researchers, surgeons and pathologists at the centres who helped him to navigate the process of accessing tissue and data. He now advises early-career researchers to establish informal alliances before they even think about getting their first samples. “You'll get the access you need, and the scientists and physicians there will help you to move beyond the bureaucracy,” he says. Even investigators at large cancer-research centres are likely to encounter bureaucratic knots, particularly when participating in large collaborations that span institutions. “In an era of team science, that can be really difficult,” Sellers says. “There might be 30 institutional review boards involved for one study, each with their own agreements. It takes time, money and effort, and it's not helping to accelerate academic health-related research.” Individual researchers can be frustrated by restrictions. Katerina Politi, a pathologist at the Yale Cancer Center in New Haven, Connecticut, has obtained consent from patients that allows her to collect their tissue for immediate analysis. But patients must provide further consent if another sample is needed from them. “We can do this biopsy, but if they have another in the future, they have to reconsent,” says Politi. “If you could streamline the consent of patients and acquisition of materials, you might not miss opportunities to learn more about diseases.” Some institutions are trying to smooth the process. In 2014, oncologist Michael Caligiuri, who directs the Ohio State University Comprehensive Cancer Center in Columbus, in 2014 co-founded the Oncology Research Information Exchange Network, a federation of 11 cancer-research centres across the United States. Member organizations share an institutional review board and follow a uniform protocol for interacting with patients and requesting and collecting tissue and data. Caligiuri says that studies performed within the network can move more quickly and require less paperwork because members can share data and samples from patients. Ultimately, joining forces with peers and colleagues is the best way to untangle the knotty problems of privacy, say seasoned researchers. “The rules are always changing,” says Sellers. “One needs to be paying attention to the literature and what's coming out there from the government. Find people in your network who are dealing with the same challenges. We're always happy to share our recipes for obtaining the data and consent.”


Months after a severe earthquake devastated Haiti in 2010, UN peacekeeping troops exacerbated Haitians’ suffering by introducing cholera to the country, via waste that leaked from a UN housing base into the Artibonite river. The disease sickened 800,000 people and killed more than 9,000 – although a study at four sites in northern Haiti found the actual death toll could be substantially higher than the official count. In August 2016, UN Secretary General Ban Ki-Moon acknowledged the UN’s role in Haiti’s cholera epidemic, accepting moral but not legal responsibility. The UN was working to secure funding for water and sanitation improvements and direct assistance to Haitian communities affected by cholera when Hurricane Matthew struck in early October. The country’s southwestern region bore the worst of the storm damage, which included destruction of water-distribution systems and flooding. Those conditions allowed cholera to spread rapidly – and with difficult travel conditions and 40 of the country’s 74 cholera and acute diarrhea treatment facilities damaged, many cholera patients have struggled to get the oral or intravenous rehydration they need. UNICEF and its partners are providing safe water and distributing cholera prevention kits with water purification tablets, soap, and oral rehydration salts. With help from the Pan-American Health Organization/World Health Organization, the Haitian Ministry of Health plans to vaccinate 820,000 people in the affected areas, with a campaign beginning November 8th. While vaccination can blunt the impact of the disease, the main long-term solution is assuring clean water and appropriate sanitation. In an interview with The Verge’s Alessandra Potenza, UN cholera response leader David Nabarro explained what an imposing task this is: We are not going to be able to provide the resources required for sanitation of the whole of Haiti to get it up to the standards that it’s appropriate, because only 25 percent of people in Haiti have got proper lavatories and actually only 50 percent have got access to drinking water. But on the other hand, what we do plan to do is to work with a number of partners who already quite active on water and sanitation. These include the Inter-American Development Bank, the World Bank. Other partners include a number of governments like the United States and Spain and also there’s some private sector groups who would like to be involved in water and sanitation. It needs to be quite a long-term approach because, as you’re implying, plumbing is not straightforward and we’re anticipating that it might take until 2030 to get everybody in Haiti having a properly functioning lavatory and of course water supplies that you need if your lavatory is going to work. The UN aims to raise $400 million to fight cholera in Haiti, though it’s currently far short of that amount. Some suggest it’s too little, too late. Somini Sengupta and Jonathan M. Katz report in The New York Times: [Independent UN human rights adviser Philip] Alston has already criticized the package, saying that one-time payments do not let victims have their day in court. “It will be a travesty of justice if, having moved so far in such a short time, the United Nations finds itself at the last moment unable to accept the principle of accountability, the avoidance of which has motivated the long years of total denial, and if it is similarly unable to embrace the principle of respect for the rights of victims to compensation as opposed to charitable payments,” he wrote to [UN Deputy Secretary General Jan] Eliasson on Oct. 5. … “Cholera is now endemic to Haiti,” said Louise Ivers, the senior health policy adviser at Partners in Health, a medical aid group that has worked in Haiti for years. “If there had been massive influx of resources in the first year, the first two years, the first three years, it certainly would have been a lot easier to address.” There had been widespread expectations that Mr. Ban would make a statement about the United Nations’ responsibility for the cholera crisis in his recent trip to Haiti in the aftermath of Hurricane Matthew. Instead he spoke more generally about the organization’s cholera eradication plan, which is grossly underfunded. Epidemiologist Renaud Piarroux of Aix Marseille University offers this prescription in a New York Times op-ed: To rid Haiti of cholera, the United Nations needs to help reduce the vulnerability of the populations where the disease is rooted. In these areas, priority should be given to projects aimed specifically at improving access to clean drinking water. Only a little more than half of Haitians use a safe water source. The United Nations must also help Haiti strengthen its ability to detect and control outbreaks. Field teams must respond immediately to cholera alerts, investigate the cause of the outbreak, educate the affected people, and secure clean drinking water through chlorination. The cholera response teams set up three years ago do extraordinary work, but they are too few and poorly equipped, and their funding is not guaranteed. By admitting that it was involved in the outbreak, the United Nations made only a first and timid step toward a full assessment of its responsibility. The United Nations must continue to open up about what happened in Haiti, rectify the damage, and establish policies that prevent such disasters in the future. Its credibility is still on the line. At its annual meeting in Denver last week, the American Public Health Association adopted a policy statement on accountability for the Haiti cholera epidemic: Citing the role of the United Nations’ inadequate sewage precautions in the 2010 Haitian cholera outbreak, which has since killed more than 9,000 people and sickened nearly 790,000, calls on the UN, in coordination with the World Health Organization, the World Bank and other partners, to take responsibility for raising funds and implementing the National Plan for the Elimination of Cholera in Haiti in its entirety. Urges that Haitian workers be hired and paid fairly to build water and sanitation infrastructure in accordance with the national cholera plan, and encourages UN officials to ensure that a diversity of stakeholders oversee the plan’s implementation, including those from Haitian civil society organizations and international nongovernmental organizations that have built up trust with people in Haiti. Also calls on the UN to ensure fair and transparent systems for remedying any harms it may inflict on people and environments during future peacekeeping missions. It’s the beginning of Haiti’s rainy season, which makes it easier for cholera to spread.  I hope the domestic and international response to cholera in Haiti will not only save lives now, but allow for better health in the future. Some of our past posts on cholera in Haiti A 10-year plan to eliminate cholera transmission in Haiti (March 2013) Cholera, sanitation, and suspicion in Haiti (April 2012) Clean water and education could outperform vaccines at reducing Haiti cholera epidemic (February 2011) Vaccination Considered in Haiti as Cholera’s Spread Slows (January 2011)


SHAPE, the Society for Heart Attack Prevention and Eradication (http://www.shapesociety.org), a nonprofit grassroots organization dedicated to the mission of eradicating heart attacks, today announced the agenda of its first focus group meeting on prediction of near-future heart attacks using artificial intelligence. The meeting is led by Dr. Morteza Naghavi the founder and executive director of SHAPE and features leading cardiovascular researchers from around the world.. This will be the 20th scientific meeting held by SHAPE since 2001. Detailed agenda of the meeting is shown below. The First Machine Learning Vulnerable Patient Symposium A Focus Group Meeting on Developing an Artificial Intelligence-based Forecast System A Satellite Event in Conjunction with 2016 Annual Scientific Sessions of American Heart Association This event is open to public. Participation via GoToMeeting can be requested. Dinner will be served 7:30 PM. This is the 20th Vulnerable Plaque & Vulnerable Patient Symposium held by SHAPE since 2001. Welcome: Morteza Naghavi, M.D. Founder of SHAPE and Executive Chairman of the SHAPE Task Force Opening Remarks: Valentin Fuster, M.D., Ph.D. Professor of Medicine and Physician-in-Chief, Mount Sinai Hospital and Icahn School of Medicine Jagat Narula M.D., Ph.D. Chief of Cardiology, Mount Sinai West & St. Luke’s Hospitals Associate, Dean, Arnhold Institute for Global Health at Mount Sinai Icahn School of Medicine Ioannis Kakadiaris, Ph.D. Professor of Computer Science and Biomedical Engineering, Director of Machine Learning Laboratory University of Houston Topic: What is Machine Learning and How Can It Shape the Future of Healthcare? Invited Online Presentations: Two Examples of Machine Learning Studies in CVD Risk Assessment (10 minutes each) CVD prediction using support vector machine in a large Australian cohort. Dinesh Kumar, Ph.D. and Sridhar Arjunan, Ph.D. Biosignals Lab, School of Electrical and Computer Engineering, RMIT University, Melbourne, Australia (2) Prediction of revascularization after myocardial perfusion SPECT by machine learning in a large clinical population Piotr Slomka, Ph.D. Chief Scientist, Artificial Intelligence in Medicine Program, Department of Imaging Cedars-Sinai Medical Center, Professor, UCLA School of Medicine, Los Angeles, CA Moderated Discussions on the Vulnerable Patient Project Machine Learning for Prediction of Near-Term CHD Events All investigators will be asked to give a very brief introduction of their study and how it can fit in Background: Imagine instead of the existing daily weather forecasts and hurricane alerts we were told the probability of a storm within the next 10 years! This is how heart attacks are predicted today. We teach our physicians to calculate the 10-year probability of a heart attack and sudden cardiac death based on their patients’ risk factors. Long term predictions do not trigger immediate preventive actions. Although some people develop warning symptoms, half of men and two-thirds of women who die suddenly of coronary heart disease (CHD) have no previous symptoms. Imagine if we could alert people months, weeks, or even days before a heart attack and trigger immediate preventive actions. The Idea: Use machine learning to create new algorithms to detect who will experience a CHD event within a year (The Vulnerable Patient). Algorithms will be based on banked biospecimen and information collected days up to 12 months prior to the event. We will utilize existing cohorts such as MESA, Heinz Nixdorf Recall Study, Framingham Heart Study, BioImage Study and the Dallas Heart Study. External validation to test for discrimination and calibration will be conducted using other longitudinal observational studies that provide adjudicated cardiovascular event information such as the MiHeart, JHS, DANRISK and ROBINSCA. Additionally, we will use machine learning to characterize individuals who, despite high conventional risk, have lived over 80 years with no CHD events (The Invulnerable ). We expect to discover new targets for drug and possibly vaccine development. We will make the algorithms available as an open source tool to collect additional data over time and increase its predictive value. Organizers: SHAPE as the originating and organizing center for the entire project, recruiting new studies and biobanks, conducting workshops with researchers from each study, fundraising, creating an open source platform community for future enhancement and collaborations. Stanford as the coordinating center for collecting data and samples, and basic science labs. Mount Sinai as the data review and publication center. Machine Learning Lab to be decided, either Google, Apple, IBM, Facebook, Amazon or wherever we find a strong industry partner or sponsor. Director, Cardiac Computed Tomography, Associate Professor of Medicine, Johns Hopkins University Division of Cardiology, The Johns Hopkins Hospital Imagine the new machine learning Vulnerable Patient detection algorithm (heart attack forecaster) is created and validated. If studies confirm the algorithm is able to detect the Vulnerable Patient with 50% or more certainty. In other words, 1 out of 2 patients classified as Vulnerable Patient goes to have an ASCVD event in the following 12 months. Now the questions are: A)    What preventive actions would you take if your asymptomatic patient tested positive as a Vulnerable Patient? B)    What preventive actions would you take if the patient was you?! (This question is meant to circumvent regulatory and financial limitations that may apply to your patients but may not hold you back). Moderators will invite comments from all participants in the meeting. Invited Key Opinion Leaders (Alphabetic Order) Arthur Agatston, M.D. Founder of South Beach Diet, Director of Wellness at Baptist Hospital and Professor of Medicine at University of Miami, FL Daniel Berman, M.D. Professor of Medicine at UCLA, Director of Cardiac Imaging and Nuclear Cardiology at Cedars-Sinai, Los Angeles, CA Michael Blaha, M.D., M.P.H., Director of Clinical Research, Ciccarone Center for the Prevention of Heart Disease, Johns Hopkins University, Baltimore, MD Mathew Budoff, M.D. Professor of Medicine and Director of Preventive Cardiology, UCLA Harbor, Los Angeles, CA Adolfo Correa, M.D., Ph.D. Chief Science Officer, Jackson Heart Study, Professor of Medicine and Pediatrics, University of Mississippi, Jackson, MS Rahul Deo, M.D., Ph.D. Assistant Professor of Medicine, Division of Cardiology, University of California, San Francisco, CA Raimund Erbel, M.D. Professor of Medicine, Chief of Cardiology and Director of West German Heart Centre, University Essen, Germany Sergio Fazio, M.D., Ph.D. Chair of Preventive Cardiology and Professor of Medicine, Oregon Health and Science University, Portland, OR Zahi Fayad, M.D. Professor of Radiology and Medicine (Cardiology), Director of the Translational and Molecular Imaging Institute, Mount Sinai Hospital, New York, NY Philip Greenland, M.D., Professor of Cardiology, Director, Institute for Public Health and Medicine, Center for Population Health Sciences, Chicago, IL Robert Harrington, M.D. Chair of the Department of Medicine, Professor of Medicine, Stanford University School of Medicine, Stanford, CA Harvey Hecht, M.D., Director of Cardiac CT Imaging Laboratory, Mount Sinai School of Medicine, New York, NY Karl-Heinz Jöckel, Ph.D. Institute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Germany Ioannis Kakadiaris, Ph.D. Professor of Computer Science and Biomedical Engineering, University of Houston, Houston, TX Stanley Kleis, Ph.D. Professor of Mechanical Engineering and Biomedical Engineering, University of Houston, Houston, TX Tatiana Kuznetsova, M.D. Professor and Director, Hypertension and Cardiovascular Epidemiology, University of Leuven, Leuven, Belgium Daniel Levy, M.D. Director of Framingham Heart Study, and Intramural Investigator, National Institute of Health, Bethesda, MD Roxana Mehran, M.D. Professor of Medicine and Director of Interventional Clinical Trials, Mount Sinai School of Medicine, New York, NY Ralph Metcalfe, Ph.D. Professor of Mechanical and Biomedical Engineering, University of Houston, Houston, TX Susanne Moebus, Ph.D., M.P.H. Biologist & Epidemiologist, Head of the Centre for Urban Epidemiology, University Essen, Germany Morteza Naghavi, M.D. Founder and Executive Chairman of the SHAPE Task Force, President of MEDITEX, Houston, TX Tasneem Z. Naqvi, M.D. Professor of Medicine and Director of Echocardiography, College of Medicine, May Clinic, Scottsdale, AZ Jagat Narula, M.D., Ph.D. Associate Dean for Global Affairs, Professor of Medicine (Cardiology), Mount Sinai Hospital and School of Medicine, New York, NY Ulla Roggenbuck, Ph.D. Institute for Medical Informatics, Biometry and Epidemiology, University Hospital of Essen, Germany Henrik Sillesen, M.D. Professor and Head of Dept. of Vascular Surgery, Rigs Hospitalet, University of Copenhagen, Copenhagen, Denmark Robert Superko, M.D. Professor of Medicine and President at Cholesterol, Genetics, and Heart Disease Institute, Carmel, CA Pierre-Jean Touboul, M.D. Professor of Neurology, Department of Neurology and Stroke Center, AP-HP Bichat University Hospital, Neurology and Stroke Center, Paris, France Nathan Wong, M.P.H., Ph.D. Professor of Epidemiology and Director, Heart Disease Prevention Program, University of California, Irvine, CA Symposium Registration http://shapesociety.org/the-first-machine-learning-heart-attack-forecast-symposium/ About SHAPE The Society for Heart Attack Prevention and Eradication (SHAPE) is a non-profit organization that promotes education and research related to prevention, detection, and treatment of heart attacks. SHAPE is committed to raising public awareness about revolutionary discoveries that are opening exciting avenues that can lead to the eradication of heart attacks. SHAPE's mission is to eradicate heart attacks in the 21st century. SHAPE has recently embarked on “Machine Learning Heart Attack Forecast System (Vulnerable Patient Project)” Project which is a collaborative effort between world’s leading cardiovascular researchers to develop a new Heart Attack Forecast System empowered by artificial intelligence. Additional information on this innovative project will be announced soon. To learn more about SHAPE visit http://www.shapesociety.org. Contact information: 1-877-SHAPE11 and info(at)shapesociety(dot)org. Learn more about the Vulnerable Patient http://shapesociety.org/the-first-machine-learning-heart-attack-forecast-symposium About SHAPE Task Force The SHAPE Task Force, an international group of leading cardiovascular physicians and researchers, has created the SHAPE Guidelines, which educates physicians on how to identify asymptomatic atherosclerosis (hidden plaques) and implement proper therapies to prevent a future heart attack. According to the SHAPE Guidelines, men 45-75 and women 55-75 need to be tested for hidden plaques in coronary or carotid arteries. Individuals with high risk atherosclerosis (high plaque score) should be treated even if their cholesterol level is within statistical “normal range.” If they have plaques, the so-called normal is not normal for them. The higher the amount of plaque burden in the arteries the higher the risk and the more vulnerable to heart attack. SHAPE Guideline aims to identify the asymptomatic “Vulnerable Patient” and offer them intensive preventive therapy to prevent a future heart attack. Knowing one's plaque score can be a matter of life and death. The SHAPE Task Force includes the following: Click below to learn about SHAPE Centers of Excellence http://shapesociety.org/centers-of-excellence/ Drs Naghavi, PK Shah, Daniel Berman, and Mathew Budoff members of the SHAPE Task Force explain how hospitals and community clinics can become a SHAPE Center of Excellence and establish themselves a leader in preventive health.


Dublin, Dec. 20, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Epilepsy: Epidemiology and Patient-Based Market Forecasts, Treatment Algorithm, and Marketed and Pipeline Drug Analysis" report to their offering. Refractory patients, niche indication expansions, and geographical reach offer room for growth in an otherwise crowded epilepsy market. This report addresses the following questions: - Why do leading antiepileptic drugs retain a large amount of brand loyalty, despite loss of exclusivity and cheap direct competition? - Who are the future market leaders in the treatment of epilepsy? - Which patient subgroups will have the largest impact on epilepsy sales? - What are the drug companies' strategies when penetrating a highly crowded market to achieve profitability? - What are epilepsy's unmet needs that could be addressed by drug companies? Key Topics Covered: FORECAST: EPILEPSY - Executive Summary - Market Overview and Trends - Market Definition and Methodology - Aptiom/Zebinix (eslicarbazepine) - Fycompa (perampanel) - Lyrica (pregabalin) - Potiga/Trobalt (ezogabine/retigabine) - Rikelta (brivaracetam) - Vimpat (lacosamide) - Primary Research Methodology TREATMENT: EPILEPSY - Executive Summary - Primary Research Methodology - Disease Definition and Diagnosis - Patient Segmentation - Current Treatment Options - Treatment Dynamics - Unmet Needs in Epilepsy EPIDEMIOLOGY: EPILEPSY - Executive Summary - Disease Background - Sources and Methodology - Forecast - Epidemiologist Insight - Strengths and Limitations - Appendix MARKETED DRUGS: EPILEPSY - Executive Summary - Product Overview - Other Marketed Drugs - Product profile: Aptiom - Product profile: Banzel - Product profile: Briviact - Product profile: Fycompa - Product profile: Keppra and Keppra XR - Product profile: Lamictal and Lamictal XR - Product profile: Lyrica - Product profile: Onfi - Product profile: Potiga - Product profile: Vimpat PIPELINE: EPILEPSY - Executive Summary - Clinical Pipeline Overview - Product profile (late stage): Epidiolex - Product profile (late stage): ganaxolone For more information about this report visit http://www.researchandmarkets.com/research/57rnrg/epilepsy


News Article | February 15, 2017
Site: www.npr.org

From Vector To Zoonotic: A Glossary For Infectious Diseases The world is in a hyperinfectious era. And that means there are a lot of words being tossed around that you might not be familiar with. Or maybe you have a general idea of what they mean but wish you knew more. Here are some key terms and definitions. And yes, there will be a quiz (coming in March so you have time to study). Epidemic: A sudden increase in the number of cases of a disease in a particular geographic area, beyond the number health officials typically expect. An increase that occurs in a relatively small geographic area or among a small group of people may be called an "outbreak." For example, the Centers for Disease Control and Prevention calls HIV/AIDS, which affects 1.2 million people in the United States, an "epidemic." By contrast, the CDC called two cases of sickness from drinking raw milk (listeriosis) in the United States an "outbreak." Pandemic: An epidemic spanning many countries and/or several continents. The difference between an outbreak, an epidemic and a pandemic can be murky and depends on the opinions of scientists and health officials. Emerging disease: A disease that occurs in the population of a certain geographic region for the first time, or a disease that's been present at low levels in a region but then rapidly reaches new peaks in the number of cases reported. Animal-human interface: The points of contact between animals and humans — when people cut down forests and set up dwellings where forest animals are still prevalent, for example. Some types of diseases spread from animals to humans at this interface. (Note: In all these definitions "animal" refers to nonhuman animals.) Reservoir: An animal, plant or environment in which a disease can persist for long periods of time. For example, some bats serve as a reservoir for rabies and can spread the disease by biting humans. But the bats — and other reservoir species — may not experience symptoms because of built-in immunity. A disease reservoir is analogous to a water reservoir. But instead of supplying water, a disease reservoir serves as a supply for a virus or other pathogen. Vector: Any living creature that can pass an infection to another living creature. Humans are technically vectors, but the term is more commonly applied to nonhuman organisms. Spillover: The transmission of a disease from one species to another. Sometimes a disease may reside in a plant or animal or even in soil, and then spread to humans. This spread of disease is called a "spillover event." Index case: The first case of a disease known to health officials. Some epidemiologists may refer to an index case as "patient zero." Zoonotic: Any disease that spreads from animals to people. The animals can range from tiny ticks to lumbering cattle. One Health: This two-word phrase embodies the view that there's no such thing as just human health or just animal health or just the health of the environment — they're all part of One Health. That's because the health of humans is closely linked to the health of the environment and other animals. Proponents of One Health believe medical doctors, ecologists, veterinarians and other specialists should work together to improve a community's health. Microbe: A living thing too small for the eye to see, such as bacteria, fungi or viruses. Many microbes are harmless and may even benefit other living things. But some can cause disease among humans, other animals and plants. Microbes that cause disease are called "pathogens" and are informally referred to as "germs." Epidemiologist Peter Krause of the Yale School of Public Health provided invaluable input for these definitions. What do you want to know about pandemics? Share your questions by submitting them in our special tool here. Our global health team will answer some of them in an upcoming story.


News Article | February 15, 2017
Site: www.npr.org

From Vector To Zoonotic: A Glossary For Infectious Diseases The world is in a hyperinfectious era. And that means there are a lot of words being tossed around that you might not be familiar with. Or maybe you have a general idea of what they mean but wish you knew more. Here are some key terms and definitions. And yes, there will be a quiz (coming in March so you have time to study). Epidemic: A sudden increase in the number of cases of a disease in a particular geographic area, beyond the number health officials typically expect. An increase that occurs in a relatively small geographic area or among a small group of people may be called an "outbreak." For example, the Centers for Disease Control and Prevention calls HIV/AIDS, which affects 1.2 million people in the United States, an "epidemic." By contrast, the CDC called two cases of sickness from drinking raw milk (listeriosis) in the United States an "outbreak." Pandemic: An epidemic spanning many countries and/or several continents. The difference between an outbreak, an epidemic and a pandemic can be murky and depends on the opinions of scientists and health officials. Emerging disease: A disease that occurs in the population of a certain geographic region for the first time, or a disease that's been present at low levels in a region but then rapidly reaches new peaks in the number of cases reported. Animal-human interface: The points of contact between animals and humans — when people cut down forests and set up dwellings where forest animals are still prevalent, for example. Some types of diseases spread from animals to humans at this interface. (Note: In all these definitions "animal" refers to nonhuman animals.) Reservoir: An animal, plant or environment in which a disease can persist for long periods of time. For example, some bats serve as a reservoir for rabies and can spread the disease by biting humans. But the bats — and other reservoir species — may not experience symptoms because of built-in immunity. A disease reservoir is analogous to a water reservoir. But instead of supplying water, a disease reservoir serves as a supply for a virus or other pathogen. Vector: Any living creature that can pass an infection to another living creature. Humans are technically vectors, but the term is more commonly applied to nonhuman organisms. Spillover: The transmission of a disease from one species to another. Sometimes a disease may reside in a plant or animal or even in soil, and then spread to humans. This spread of disease is called a "spillover event." Index case: The first case of a disease known to health officials. Some epidemiologists may refer to an index case as "patient zero." Zoonotic: Any disease that spreads from animals to people. The animals can range from tiny ticks to lumbering cattle. One Health: This two-word phrase embodies the view that there's no such thing as just human health or just animal health or just the health of the environment — they're all part of One Health. That's because the health of humans is closely linked to the health of the environment and other animals. Proponents of One Health believe medical doctors, ecologists, veterinarians and other specialists should work together to improve a community's health. Microbe: A living thing too small for the eye to see, such as bacteria, fungi or viruses. Many microbes are harmless and may even benefit other living things. But some can cause disease among humans, other animals and plants. Microbes that cause disease are called "pathogens" and are informally referred to as "germs." Epidemiologist Peter Krause of the Yale School of Public Health provided invaluable input for these definitions. What do you want to know about pandemics? Share your questions by submitting them in our special tool here. Our global health team will answer some of them in an upcoming story.


News Article | February 28, 2017
Site: www.npr.org

Why Are More Young Americans Getting Colon Cancer? One of the great treats of following an Agatha Christie mystery (my favorite being Hercule Poirot) is that you know there will be an "Aha!" moment at the end. The fastidious, mustachioed detective will pull together all the disparate facts and present a compelling answer. I'm frequently reminded that science doesn't work that way. The latest case in point is an article published Tuesday in the Journal of the National Cancer Institute that sets out to explore a trend in colorectal cancer among younger Americans. More than a decade ago, scientists noticed an odd quirk in the data: While overall rates of colorectal cancer have been falling dramatically since the mid-1980s, there's been a steady uptick of this disease among people younger than 50. The numbers are small. Cancer incidence is creeping up by 1 or 2 cases per 100,000 people under 50. By way of comparison, the disease rate among older Americans has plummeted by more than 100 cases per 100,000 people. And the vast majority of colorectal cancer cases are among people over 50: These older Americans are 16 times more likely to get colon cancer, compared with adults who are younger. That's why a small trend in younger adults is far outweighed by the dramatic decrease of disease among people over 50. Still, the under-50s will eventually grow older. What will happen to their risk then? Will the trends that started in their 20s and 30s continue? If that's the case, overall colorectal cancer rates might ultimately end their steady decline, and could start to rise. Another possibility is that, once people turn 50, they will follow the current medical guidance and get colonoscopies or other recommended screening tests, which can actually prevent colorectal cancer by finding and removing precancerous polyps. And their risk profile could end up looking much like it does today. Here's where even Poirot would be stumped. There simply isn't enough information to know what will happen. Epidemiologist Rebecca Siegel and her colleagues at the American Cancer Society have published their take in the JNCI. In their study, they break down the population into generational cohorts, focusing on millennials and members of Generation X. By breaking down the cases by age group, Siegel says, it's easier to disentangle generational changes such as differences in diet from trends in medical diagnosis and treatment, which vary less by age. Still, she and her colleagues can only say so much. "[T]he results do not provide any direct evidence about the role of specific exposures or interventions," they note in the study. Even so, the researchers say, because trends in the young "could be a bellwether of the future disease burden, our results are sobering." Siegel tells Shots, "It appears that under the surface, the underlying risk for this disease is actually increasing in the population." What's driving that is hard to say. Obesity is more common among younger than it used to be, so perhaps it's partly to blame. Or it may not be obesity itself; it could be that poor diet and lack of exercise, which contribute to obesity, are also influencing colon cancer rates. One study found that people from Africa who were suddenly switched to an American diet had signs of inflammation in their colons within just two weeks, Siegel notes, "so this change can happen fairly rapidly." But that's far from a complete explanation. A large British study published a few years ago suggested that only 11 percent of colon cancer cases could be tied to trends in obesity. There's also a scenario in which this seemingly glum cancer trend is in fact good news. Dr. H. Gilbert Welch, a professor of medicine at the Dartmouth Institute for Health Policy & Clinical Practice, says what look like additional cancers in people under 50 may simply be cases that are being diagnosed earlier than they would have been. Some people are getting colonoscopies for reasons other than cancer screening these days, and doctors are surely coming upon early cases of colon cancer they might not have turned up so soon. There's some evidence to back that claim: While the rate of new cases of colorectal cancer has been climbing in under-50 Americans since the mid-1990s, the death rate among that group has remained remarkably flat. And death rates may be the more telling statistic. Something similar happened with breast cancer in the 1980s — there was a temporary spike in the number of breast cancers diagnosed, as large numbers of women went in for mammography screening for the first time. But death rates didn't rise, and incidence rates of breast cancers fell again after that uptick. Welch notes that we're seeing that again with the rates of thyroid cancer, which are skyrocketing due to intensive screening and diagnosis; but, again, there's been no increase in mortality from thyroid tumors. Welch offers yet another possibility: Maybe the apparent rise in colon cancer among young people is real, but it won't affect them as they age. "The biology of the disease may be different between the young and the old," he says. Welch himself has explored the much larger trend of declining colorectal cancer rates. Some of it is no doubt caused by vastly increased screening for colorectal cancer, though he notes that the decline was well under way before colonoscopies became routine. There's no question that diet and other factors can also have a profound effect on cancer rates. "One of the most dramatic cases of that is stomach cancer, which used to be a very common cause of cancer and has now virtually disappeared, at least in the United States," Welch tells Shots. On one point there is broad agreement among doctors and researchers treating and studying this disease: The increased screening for colorectal cancer, which can involve removing polyps before they become cancer, has been a significant factor in reducing the burden of this illness. Another point of agreement: If the Trump administration eliminates the current insurance benefit for colon cancer screening as it does away with the Affordable Care Act, fewer people are likely to get screened for this deadly malignancy. And the likely impact of that is not a mystery. You can contact Richard Harris at rharris@npr.org.


News Article | February 28, 2017
Site: www.npr.org

Why Are More Young Americans Getting Colon Cancer? One of the great treats of following an Agatha Christie mystery (my favorite being Hercule Poirot) is that you know there will be an "Aha!" moment at the end. The fastidious, mustachioed detective will pull together all the disparate facts and present a compelling answer. I'm frequently reminded that science doesn't work that way. The latest case in point is an article published Tuesday in the Journal of the National Cancer Institute that sets out to explore a trend in colorectal cancer among younger Americans. More than a decade ago, scientists noticed an odd quirk in the data: While overall rates of colorectal cancer have been falling dramatically since the mid-1980s, there's been a steady uptick of this disease among people younger than 50. The numbers are small. Cancer incidence is creeping up by 1 or 2 cases per 100,000 people under 50. By way of comparison, the disease rate among older Americans has plummeted by more than 100 cases per 100,000 people. And the vast majority of colorectal cancer cases are among people over 50: These older Americans are 16 times more likely to get colon cancer, compared with adults who are younger. That's why a small trend in younger adults is far outweighed by the dramatic decrease of disease among people over 50. Still, the under-50s will eventually grow older. What will happen to their risk then? Will the trends that started in their 20s and 30s continue? If that's the case, overall colorectal cancer rates might ultimately end their steady decline, and could start to rise. Another possibility is that, once people turn 50, they will follow the current medical guidance and get colonoscopies or other recommended screening tests, which can actually prevent colorectal cancer by finding and removing precancerous polyps. And their risk profile could end up looking much like it does today. Here's where even Poirot would be stumped. There simply isn't enough information to know what will happen. Epidemiologist Rebecca Siegel and her colleagues at the American Cancer Society have published their take in the JNCI. In their study, they break down the population into generational cohorts, focusing on millennials and members of Generation X. By breaking down the cases by age group, Siegel says, it's easier to disentangle generational changes such as differences in diet from trends in medical diagnosis and treatment, which vary less by age. Still, she and her colleagues can only say so much. "[T]he results do not provide any direct evidence about the role of specific exposures or interventions," they note in the study. Even so, the researchers say, because trends in the young "could be a bellwether of the future disease burden, our results are sobering." Siegel tells Shots, "It appears that under the surface, the underlying risk for this disease is actually increasing in the population." What's driving that is hard to say. Obesity is more common among younger than it used to be, so perhaps it's partly to blame. Or it may not be obesity itself; it could be that poor diet and lack of exercise, which contribute to obesity, are also influencing colon cancer rates. One study found that people from Africa who were suddenly switched to an American diet had signs of inflammation in their colons within just two weeks, Siegel notes, "so this change can happen fairly rapidly." But that's far from a complete explanation. A large British study published a few years ago suggested that only 11 percent of colon cancer cases could be tied to trends in obesity. There's also a scenario in which this seemingly glum cancer trend is in fact good news. Dr. H. Gilbert Welch, a professor of medicine at the Dartmouth Institute for Health Policy & Clinical Practice, says what look like additional cancers in people under 50 may simply be cases that are being diagnosed earlier than they would have been. Some people are getting colonoscopies for reasons other than cancer screening these days, and doctors are surely coming upon early cases of colon cancer they might not have turned up so soon. There's some evidence to back that claim: While the rate of new cases of colorectal cancer has been climbing in under-50 Americans since the mid-1990s, the death rate among that group has remained remarkably flat. And death rates may be the more telling statistic. Something similar happened with breast cancer in the 1980s — there was a temporary spike in the number of breast cancers diagnosed, as large numbers of women went in for mammography screening for the first time. But death rates didn't rise, and incidence rates of breast cancers fell again after that uptick. Welch notes that we're seeing that again with the rates of thyroid cancer, which are skyrocketing due to intensive screening and diagnosis; but, again, there's been no increase in mortality from thyroid tumors. Welch offers yet another possibility: Maybe the apparent rise in colon cancer among young people is real, but it won't affect them as they age. "The biology of the disease may be different between the young and the old," he says. Welch himself has explored the much larger trend of declining colorectal cancer rates. Some of it is no doubt caused by vastly increased screening for colorectal cancer, though he notes that the decline was well under way before colonoscopies became routine. There's no question that diet and other factors can also have a profound effect on cancer rates. "One of the most dramatic cases of that is stomach cancer, which used to be a very common cause of cancer and has now virtually disappeared, at least in the United States," Welch tells Shots. On one point there is broad agreement among doctors and researchers treating and studying this disease: The increased screening for colorectal cancer, which can involve removing polyps before they become cancer, has been a significant factor in reducing the burden of this illness. Another point of agreement: If the Trump administration eliminates the current insurance benefit for colon cancer screening as it does away with the Affordable Care Act, fewer people are likely to get screened for this deadly malignancy. And the likely impact of that is not a mystery. You can contact Richard Harris at rharris@npr.org.


Dublin, Dec. 20, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Gastric Cancer: Epidemiology and Patient-Based Market Forecasts, Treatment Algorithm, and Marketed and Pipeline Drug Analysis" report to their offering. Pipeline therapies will look to fulfil many areas of high unmet need left by the lack of targeted therapies approved for the treatment of gastric cancer. This report addresses the following questions: - What impact will the PD-1/PD-L1 inhibitor class of drugs have on the gastric cancer market? - How will pipeline immunotherapies be positioned in the gastric cancer treatment space? - Which targeted therapies are expected to experience the greatest growth over the forecast period? - How will Eli Lilly look to maintain Cyramza's first-to-market advantage? - What are the key drivers of the rapidly expanding gastric cancer market? Key Topics Covered: FORECAST: GASTRIC CANCER - Executive Summary - Market Overview and Trends - Market Definition and Methodology - Avelumab - BBI - (napabucasin) - Cyramza (ramucirumab) - GS-57 - Herceptin (trastuzumab) - Keytruda (pembrolizumab) - Lynparza (olaparib) - Nimotuzumab - Opdivo (nivolumab) - Perjeta (pertuzumab) - Primary Research Methodology TREATMENT: GASTRIC CANCER - Executive Summary - Primary Research Methodology - Disease Definition and Diagnosis - Patient Segmentation - Country Treatment Trees - Current Treatment Options - Prescribing Trends EPIDEMIOLOGY: GASTRIC CANCER IN THE US, JAPAN, AND 5EU - Executive Summary - Sources and Methodology - Forecast - Epidemiologist Insight - Strengths and Limitations MARKETED DRUGS: GASTRIC CANCER - Executive Summary - Product Overview - Product profile: Cyramza - Product profile: Herceptin PIPELINE: GASTRIC CANCER - Executive Summary - Clinical Pipeline Overview - Product profile (late stage): BBI6 - Product profile (late stage): GS-57 - Product profile (late stage): Keytruda - Product profile (late stage): Lynparza - Product profile (late stage): Opdivo - Product profile (late stage): Perjeta - Product profile (late stage): avelumab - Product profile (late stage): nimotuzumab For more information about this report visit http://www.researchandmarkets.com/research/m6cxm5/gastric_cancer


Dublin, Nov. 23, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Bipolar Disorder: Epidemiology and Patient-Based Market Forecasts, Treatment Algorithm, and Marketed and Pipeline Drug Analysis" report to their offering. Generic dominance will prevent the growth of the bipolar disorder market, and few pipeline candidates show promise to completely reverse this trend. This report addresses the following questions: - What are the key events shaping the bipolar disorder market dynamics over 2014-23? - Which segments of the market provide opportunities for growth? - How does the bipolar disorder pipeline compare to other psychiatric indications, and what are the candidates to look out for? - How do currently available bipolar disorder drugs compare to one another? - What is the standard of care in bipolar disorder, and which are the key unmet needs in treatment? Key Topics Covered: FORECAST: BIPOLAR DISORDER - Executive Summary - Market Overview and Trends - Market Definition and Methodology - Abilify (aripiprazole) - Abilify Maintena (aripiprazole) - Latuda (lurasidone) - Risperdal Consta (risperidone) - Saphris (asenapine) - Seroquel/Seroquel XR (quetiapine fumarate) - Vraylar (cariprazine) - Primary Research Methodology TREATMENT: BIPOLAR DISORDER - Executive Summary - Primary Research Methodology, - Disease Definition and Diagnosis - Patient Segmentation - Country Treatment Trees - Current Treatment Options - Prescribing Trends - Unmet Needs in Bipolar Disorder EPIDEMIOLOGY: BIPOLAR DISORDER IN THE US, JAPAN, AND 5EU - Executive Summary - Disease Definition - Global Variation - Risk Factors - Co-Morbidities - Sources and Methodology - Forecast - Forecast: Bipolar Disorder I - Forecast: Bipolar Disorder II - Epidemiologist Insight - Strengths and Limitations - Bibliography MARKETED DRUGS: BIPOLAR DISORDER - Executive Summary - Product Overview - Other Marketed Drugs - Product profile: Abilify - Product profile: Geodon - Product profile: Lamictal - Product profile: Latuda - Product profile: Risperdal/Risperdal Consta - Product profile: Saphris - Product profile: Seroquel/Seroquel XR - Product profile: Vraylar - Product profile: Zyprexa PIPELINE: BIPOLAR DISORDER - Executive Summary - Clinical Pipeline Overview - Target Product Profile - Clinical Trial Design - The Future of Treatment - Recently Discontinued Drugs - Product profile (late stage): ITI-007 For more information about this report visit http://www.researchandmarkets.com/research/d2fd69/bipolar_disorder

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