Pharmacopolitics: Drug Regulation in the United States and GermanyUniv of North Carolina Press, 15 дек. 2005 г. - Всего страниц: 224 Advocates of rapid access to medicines and critics fearful of inadequate testing both argue that globalization will supersede national medical practices and result in the easy transfer of pharmaceuticals around the world. In Pharmacopolitics, Arthur Daemmrich challenges their assumptions by comparing drug laws, clinical trials, and systems for monitoring adverse reactions in the United States and Germany, two countries with similarly advanced systems for medical research, testing, and patient care. Daemmrich proposes that divergent "therapeutic cultures--the interrelationships among governments, patients, the medical profession, and the pharmaceutical industry--underlie national differences and explain variations in pharmaceutical markets and medical care. Daemmrich carries the United States-Germany comparison from 1950 to the present through case studies of Terramycin (an antibiotic), thalidomide (a sedative), propranolol (a heart medication), interleukin-2 (a cancer therapy), and indinavir (an AIDS drug). He points to different political constructions of "the patient" in the United States and Germany to clarify important differences in government policies and in the distribution of power among key social actors. Daemmrich advises that international regulatory harmonization and globalization in medicine must retain flexibility for social and political variation between countries, even as they achieve technical standardization. |
Содержание
Drug Laws and Therapeutic Cultures | |
Clinical Trials from Treatment to Test 19501980 | |
Clinical Trials as Test and Therapy 19802000 | |
Configuring the Market as a Testing Site | |
International Harmonization and the Future of Drug | |
Notes | |
Bibliography | |
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Pharmacopolitics: Drug Regulation in the United States and Germany Arthur A. Daemmrich Полный просмотр - 2004 |
Pharmacopolitics: Drug Regulation in the United States and Germany Arthur A. Daemmrich Ограниченный просмотр - 2004 |
Pharmacopolitics: Drug Regulation in the United States and Germany Arthur A. Daemmrich Недоступно для просмотра - 2004 |
Часто встречающиеся слова и выражения
activists Adverse Drug Reactions adverse reactions advisory committee AIDS AkdÄ American angina angina pectoris antibiotics approved drugs Arzneimittel Arzneimittelkommission der deutschen Bundestag cancer Cetus clinical testing clinical trials committee members Contergan countries criticized Crixivan debates decisions deutschen Ärzteschaft Deutsches Ärzteblatt disease diseasebased organizations Drug Administration drug applications drug approvals Drug Commission drug companies drug laws drug regulation drug safety drug testing drug’s EMEA European evaluation experts FDA Files FDA officials FDA’s Federal Food and Drug German physicians Germany government officials groups Grünenthal indinavir individual institutions Interleukin2 Kelsey kidney cancer longterm manufacturers medical profession medicines Merck patients Pfizer pharmaceutical companies pharmaceutical industry pharmacovigilance Pharmazeutische physicians political postmarket premarket testing production professional Proleukin propranolol regulatory agencies reports of adverse response risks role safety and efficacy side effects standards studies Terramycin testing methods thalidomide therapeutic cultures therapy treatment United