Ethical Issues In Drug Testing Approval And Pricing

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Ethical Issues in Drug Testing, Approval, and Pricing

Although most developed countries have extensive regulations governing the testing, approval and marketing of new drugs, there are major gaps in these regulations. In this compelling new volume, Dr. Brody uses the example of the development of thrombolytic drugs to identify several such gaps. Issues addressed include the use of placebo control groups in clinical trials, the importance of determining the type of consent that should be obtained for emergency research, and ways to avoid conflicts of interest in clinical trials. He also discusses topics such as deciding to continue clinical trials or to approve a drug quickly, maintaining a proper balance between efficacy and safety in drug approval, the pricing of new drugs and considering prices when ordering drugs. Dr. Brody offers a series of solutions based upon philosophical principles such as respect for individual differences in a liberal society. An insightful critique of the current process of approving drugs by the FDA in the United States is also provided. The book offers a new way to deal with questions about the cost of drugs. And it gives a complete history of a major medical development that saves thousands of lives each year, the use of clot-dissolving drugs for patients with heart attacks. This illuminating work offers the first comprehensive analysis from an ethical perspective of the entire drug development process, and it does so while comparing American and European approaches to the process.
Ethical Issues in Health Care on the Frontiers of the Twenty-First Century

Author: S. Wear
language: en
Publisher: Springer Science & Business Media
Release Date: 2006-04-11
of UB’s medical school, that UB developed its School of Arts and Sciences, and thus, assumed its place among the other institutions of higher education. Had Fillmore lived throughout UB’s first seventy years, he would probably have been elated by the success of his university, and he should have been satisfied and pleased that UB remained intrinsically bonded to its community while at the same time engrafting the values and standards important to higher education’s mission in the region. UB and its medical school have undergone many challenging transitions since 1846. Included among them were: (1) the completion of an academic campus in the far northeast comer of the City of Buffalo while leaving its medical, dental and law schools firmly situated in the core of downtown Buffalo; (2) the eventual relocation, after the second world war, of the law school to the newer campus in Amherst, and the medical and dental school to the original academic campus: and (3) the merger with the State University of New York System in 1962. Despite these significant transitions, any one of which could have changed the intrinsic integrity of UB and disrupted the bonding between community and university, that did not happen. To this day, the ties between community and academe persist. Fillmore and White should celebrate their success and important contribution to Buffalo and Western New York.
Ethics and the Business of Bioscience

Author: Margaret L. Eaton
language: en
Publisher: Stanford University Press
Release Date: 2004
Businesses that produce bioscience productsgene tests and therapies, pharmaceuticals, vaccines, and medical devicesare regularly confronted with ethical issues concerning these technologies. Conflicts exist between those who support advancements in bioscience and those who fear the consequences of unfettered scientific license. As the debate surrounding bioscience grows, it will be increasingly important for business managers to consider the larger consequences of their work. This groundbreaking book follows industry research, development, and marketing of medical and bioscience products across a variety of fields, including biotechnology, pharmaceuticals, and bio-agriculture. Compelling and current case studies highlight the ethical decisions business managers frequently face. With the increasing visibility and public expectation placed on businesses in this sector, managers need to understand the ethical and social issues. This book addresses that need and provides a framework for incorporating ethical analysis in business decision making.