Searching for Magic Bullets: Orphan Drugs, Consumer Activism, and Pharmaceutical Development

By Lisa Ruby Basara

Searching for Magic Bullets reveals the quest of consumers, health professionals, and drug developers to find safer and faster methods of bringing new medications to the marketplace. Authors Basara and Montagne explore the current drug development and approval processes, their strengths and weaknesses, and the mechanisms by which patients and organizations evade these processes. Readers learn about the fundamentals of traditional and nontraditional drug discovery and development as they occur in the U.S., as well as the views of consumers, patients, and health professionals. Specific case studies of non-traditional drug development and acquisition strategies are highlighted, including AIDS medications, orphan drugs, and patient importation of medications. Basara and Montagne establish the differences in both knowledge and opinions of health consumers and health professionals regarding drug development, as well as how these differences often lead to frustration, dissatisfaction, and misappropriation of resources. The authors pinpoint the need for consumers and patients to know much more about the discovery and development of medicines, and for health professionals and students to understand patients'concerns, needs and beliefs, including their reasons for considering alternative methods of drug development and acquisition. Searching for Magic Bullets is a springboard from which consumers, health professionals, and students can discuss, debate, and resolve these issues and begin to develop more capable drug development and approval systems. This groundbreaking new book enlightens health professionals about patients'views regarding medication discovery and development and informs consumers and patients about the sometimes conflicting views of health professionals. It is divided into three sections: drug development and approval in the U.S., a case study of orphan drugs, and risky and sometimes illegal ways in which consumers evade the traditional drug development and approval systems. An Overview of the Chapters: A Review of the Drug Development Process of the Pharmaceutical Industry: Presents the steps that must be taken when researching and developing a new medication. The Food and Drug Administration and the Drug Approval Process: Describes the history and scope of the FDA, the steps involved in acquiring drug approval, and the various stages of clinical testing. Orphan Drug Legislation: A review of the Orphan Drug Act of 1983 and the changes that have recently been proposed by Congress. The impact of the Act is highlighted through a description of products that have been made available since the legislation was enacted. Issues of controversy are also highlighted. Non-traditional Methods of Drug Development: The role of patients and consumers in drug development and evaluation is discussed, with an emphasis on the perceived shortcomings of the formal system. Patient Influence on Drug Development and Regulation: The influence of patient advocacy groups and consumers is discussed in relation to the development and approval of orphan drugs, the fast-tracking of specific medications, and the use of unapproved and alternative therapies. Prescription Drug Importation: Clarifies the current drug importation regulations, as well as provides specific directions for patients wishing to receive such products or learn more about FDA importation laws. The final chapter summarizes safe and rational techniques that empower consumers in their search for beneficial drug therapies. Resources and strategies for obtaining and using information are provided as a reference for readers. A glossary of terms, acronyms, and a directory of supplemental information sources strengthens the reader's understanding of the information presented. Who Benefits From This Book? Consumers and patients can use Searching for Magic Bullets as an accurate source of infor

• Format: Paperback
• Language: English
• ISBN: 1560248599
• ISBN13: 9781560248590
• Release Date: June 1994
• Publisher: CRC Press
• Length: 266 Pages
• Weight: 1.00 lbs.
• Dimensions: 8.5" x 0.8" x 6.3"