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The Ineffective Cure Hepatitis C and the Drug That Never Got Its Chance

Description

Hepatitis C is an infectious disease that affects 71 million people worldwide and causes liver failure and death if untreated. In 2013, a direct acting antiviral drug, sofosbuvir, revolutionized treatment

Hepatitis C is an infectious disease that affects 71 million people worldwide and causes liver failure and death if untreated. In 2013, a direct acting antiviral drug, sofosbuvir, revolutionized treatment of the disease. Sofosbuvir showed immense promise, but the high price point at which it was launched created access barriers that prevented it from reaching its full public health potential. By 2016, fewer than 1% of Hepatitis C patients worldwide had received treatment. In the United States (US), concerns about the cost of the drug led public and private payers to implement rationing and treatment restrictions that prevented some of the most vulnerable populations from accessing Hepatitis C treatment at all. Through interviews with researchers, patients and providers, and a literature review of grants, patents, papers, court documents, and news articles, I examine the history of sofosbuvir with attention to the ways in which federal funding practices and intellectual property law encouraged the high initial pricing of the drug. I then examine the impact of this drug on healthcare systems in the United States and abroad, and discuss how the fragmented nature of the United States healthcare system has exacerbated price-based barriers to access. Finally, I discuss intellectual property laws as potential mechanisms to increase access. My study underscores how the political reluctance to use well-established federal funding and intellectual property laws has resulted in a drug development system that delivers medications that are so highly priced that the fragmented US healthcare system cannot compensate for the expense. This leads to low access and poor public health outcomes, and a continued failure to contain or control diseases for which effective therapies exist.

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Created

Date Created
  • 2020

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Atrial fibrillation ablation: history, practice, and innovation

Description

Atrial fibrillation (AF) is the most common abnormal heart rhythm, affecting

nearly 2% of the world’s population at a cost of $26 Billion in the United States annually, and incalculable costs

Atrial fibrillation (AF) is the most common abnormal heart rhythm, affecting

nearly 2% of the world’s population at a cost of $26 Billion in the United States annually, and incalculable costs worldwide. AF causes no symptoms for some people. However, others with AF experience uncomfortable symptoms including palpitations, breathlessness, dizziness, and fatigue. AF can severely diminish quality of life for both AF sufferers and their loved ones. Beyond uncomfortable symptoms, AF is also linked to congestive heart failure and stroke, both of which can cause premature death. Medications often fail to control AF, leading patients and healthcare providers to seek other cures, including catheter ablation. To date, catheter ablation has yielded uneven results, but garners much attention in research and innovation in pursuit of a cure for AF. This dissertation examines the historical development and contemporary practices of AF ablation to identify opportunities to improve the innovation system for the disease. First, I trace the history of AF and AF ablation knowledge from the 2nd century B.C.E. through the present. This historical look identifies patterns of knowledge co-development between science, technology, and technique, as well as publication patterns impacting knowledge dissemination. Second, I examine the current practices of AF ablation knowledge translation from the perspective of clinical practitioners to characterize the demand-side of knowledge translation in real-world practice. Demand-side knowledge translation occurs in nested patterns, and requires data, experience, and trust in order to incorporate knowledge into a practice paradigm. Third, I use social network mapping and analysis to represent the full AF ablation knowledge-practice system and identify

opportunities to modify research and innovation practice in AF ablation based on i

measures of centrality and power. Finally, I outline six linked recommendations using raw data capture during ablation procedures and open big data analytics, coupled with multi-stakeholder social networking approaches, to maximize innovation potential in AF ablation research and practice.

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Created

Date Created
  • 2016