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Novel Humanitarian Aid Program: The Glivec International Patient Assistance Program-Lessons Learned From Providing Access to Breakthrough Targeted Oncology Treatment in Low- and Middle-Income Countries.

ABSTRACT: Imatinib was the first targeted therapy approved for the treatment of cancer. With its approval, it was immediately clear to Novartis that this breakthrough therapy would require an innovative approach to worldwide access, with special consideration of low- and middle-income countries. Lack of government reimbursement, universal health care, or health insurance coverage, few trained specialty physicians or diagnostic services, and poor health care infrastructure were, and continue to be, contributing barriers to access to treatment in low- and middle-income countries. The Glivec International Patient Assistance Program (GIPAP) is an international drug donation program established by Novartis Pharma AG and implemented in partnership with The Max Foundation, a nonprofit, nongovernmental organization. GIPAP was established in 2001, essentially in parallel with the first approval of imatinib for chronic myeloid leukemia. Since 2001, GIPAP has made imatinib accessible to all medically and financially eligible patients within 80 countries on an ongoing basis as long as their physicians prescribe it and no other means of access exists. To date, more than 49,000 patients have benefited from GIPAP, and 2.3 million monthly doses of imatinib have been approved through the program. GIPAP represents an innovative drug donation model that has set the standard for access programs for other targeted or innovative therapies. The purpose of this article is to describe the structure of GIPAP, as well as important lessons that have contributed to the success of the program. This article may assist other companies with the development of successful and far-reaching patient assistance programs in the future.

SUBMITTER: Garcia-Gonzalez P

PROVIDER: S-EPMC5551649 | biostudies-other | 2015 Oct

REPOSITORIES: biostudies-other

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Project description:Syrian refugees displaced into Turkey have attempted high-risk sea migrations to reach safer destinations in Europe, most often initially arriving on the Greek island of Lesvos. These refugees were often in need of basic humanitarian assistance that has been provided in part by a new category of ad hoc grassroots organizations (AHGOs). The aim of this study was to understand the internal and external operations of these AHGOs and their role on Lesvos.The experiences of AHGOs were investigated through a qualitative research design utilizing semi-structured interviews with organization leaders and spokespersons. AHGOs identified through media and social media sources as new Lesvos-specific organizations were purposively invited to complete an interview over phone, Skype or email. Data analysis of the transcribed interviews was performed by Systematic Text Condensation.Forty-one organizations were contacted and 13 interviews were conducted. Most organizations were formed in autumn 2015 responding to the greater influx of refugees and migrants at that time and reported an absence of professional humanitarian agencies providing aid on Lesvos. Three categories emerged from the material. Features of organizations; Features of volunteers and; Evolution of AHGOs. The organizations perceived themselves capable of evaluating needs, mobilizing resources, funding and providing quick response. The volunteers came with limited humanitarian experience and from a wide variety of nationalities and professional backgrounds, and the organizations developed while on Lesvos.Knowledge from our findings of AHGOs response to this complex disaster on Lesvos could be utilized in future catastrophes. We conclude that AHGOs may prove effective at providing humanitarian aid in a surge response when international non-governmental organizations are unable to respond quickly. In future complex disasters AHGOs should be recognized as new humanitarian actors and conditions should be made favourable for their operations.

Project description:BackgroundThe Diabetes Prevention Program (DPP) and Look AHEAD studies demonstrated that modest weight loss and increased physical activity can significantly reduce the incidence of diabetes among overweight individuals with prediabetes. However, these studies involved costly interventions, all of which are beyond the reach of most real-world settings serving high-risk, low-income populations. Our project, De Por Vida, implemented a diabetes risk-reduction intervention for Hispanic women in a Federally Qualified Health Center and assessed the program's efficacy. This report describes the methodology used to develop and implement De Por Vida, the cultural adaptations made, the community-academic partnership formed to carry out this program, and the barriers and challenges encountered through the implementation process.MethodsOur goal was to translate the DPP and Look AHEAD programs into an intervention to prevent diabetes and reduce diabetes complications among high-risk Hispanic women at a federally qualified health center in Hillsboro, Oregon, where more than half of clinic patients are Spanish-speaking, and nearly all live in poverty. This randomized clinical trial targeted overweight Spanish-speaking women at risk for, or diagnosed with, type 2 diabetes. We developed a 12-month behavioral diabetes risk-reduction intervention that was responsive to the cultural practices of the Hispanic population and that could be implemented in low-income clinical settings. Study planning and implementation involved close collaboration among the clinic leadership, a research team from the Kaiser Permanente Center for Health Research, and Arizona State University.DiscussionCreating a fully informed partnership between research and clinical institutions is the first step in successful cooperative research projects. The adoption of a bidirectional, rather than a top-down, approach to communication between researchers and health-care providers, and between clinic management and the clinic frontline staff, gave the research study team crucial information about barriers, constraints, and needs that clinic staff experienced in implementing the program. This allowed clinic management and front-line clinic staff to play an active role in study implementation, identifying problem areas, and collaborating in finding practical solutions.Clinical trial registrationwww.clinicaltrials.gov, NCT03113916.

Project description:BackgroundScholarly Concentrations programs in U.S. medical schools aim to instill passion for critical thinking and promote careers in academic medicine. The rise of these programs has seen variable goals, structure, and outcomes. Transformation of these programs internationally is in its infancy.MethodsWe describe implementation of the Johns Hopkins School of Medicine Scholarly Concentrations program, offering Basic Science, Clinical Science, Medical Ethics/Healing Arts, History of Medicine, and Public Health/Community Service, at Bezmiâlem Vakif University in Istanbul, Turkey. Over six modules in the preclinical years, students develop a faculty-mentored experience which encourages the acquisition of attitudes and skills for self-directed, lifelong learning and scholarship. This culminates in abstract and project presentation. We report program characteristics (context and logistics) and outcomes (student engagement and experiences).ResultsThe Scholarly Concentrations program at Bezmiâlem began in 2014, with nearly two completed cohorts of students. In comparison to Johns Hopkins, students at Bezmiâlem begin at an earlier age (thus do not have as much prior research experience) and are subsequently evaluated for residency in terms of test scores rather than scholarship and publications, but have a similar level of intellectual curiosity and desire to take ownership of their project. Eighty-two percent of Bezmiâlem students stated the project they pursued was either their own idea or was an idea they formed after meeting with their mentor. Students at Bezmialem were more likely to choose Clinical Science projects (p = 0.009). Only 5% of Bezmiâlem students in end-of-course survey felt dissatisfied with the level of ownership they experienced with their project, a frequency similar to that seen by Johns Hopkins students (2%).ConclusionsScholarly Concentrations programs play an important role in U.S. medical schools, and these programs can be successfully implemented internationally. The Scholarly Concentrations program at Johns Hopkins has been transformed to a program at Bezmiâlem in Istanbul, the first program outside North America or the European Union. When designing these programs, one must consider the context, logistics, student engagement, and outcomes. While long-term outcomes are needed, this can serve as a model for implementation elsewhere.

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Novel Humanitarian Aid Program: The Glivec International Patient Assistance Program-Lessons Learned From Providing Access to Breakthrough Targeted Oncology Treatment in Low- and Middle-Income Countries.

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