In recent years, pharma companies had become implicated in global politics as never before. Inequitable drug prices, persisting diverences in national regulatory approaches, and debates over how to define safety and e≈cacy for diverse patient populations around the globe now attract an unprecedented degree of attention. The political, financial, and human health stakes have never been higher for patients, manufacturers, government agencies, or the medical profession.
But now a days the regulations wrapped up in seemingly innocuous pharmaceutical drugs and supposedly standardized regimes for verifying their safety and efficacy. Can this Pharmacopolitics be a suitable tool in regulatory aspects in the clinical trials where the regulatory changes of USA, Europe and Japan will keep updating themselves.
Please share your opinion about the Pharmacopolitics and its implimentation in Clinical studies !
Pharmacopolitics
Drug Regulation in the United States and Germany
By Arthur A. Daemmrich
Awards & Distinctions
2006 Edward Kremers Award, American Institute for the History of Pharmacy
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.
About the Author
Arthur Daemmrich is assistant professor of business administration at Harvard Business School.
This book may shed some light on the topic as far as understanding is in question. Mr. Arthur has compared Germany and USA pharmacomedical markets.
Regards,
Bhupesh
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