
The New Medicines: How Drugs are Created, Approved, Marketed, and Sold
Author(s): Bernice Z. Schacter (Author)
- Publisher: Praeger (UK)
- Publication Date: 30 Dec. 2005
- Edition: Illustrated
- Language: English
- Print length: 280 pages
- ISBN-10: 027598141X
- ISBN-13: 9780275981419
Book Description
In addition to explaining how drugs reach the medicine cabinet, the author – an experienced researcher and teacher – provides the scientific and business background for understanding the current controversial issues surrounding new medicines, such as: The rise and fall of the COX-2 inhibitors, Vioxx and Celebrex, and the process by which they were invented, approved, and re-evaluated. The saga of the cancer drug Erbitux and its creator, the company Imclone, made famous as the centerpiece of the Martha Stewart insider-trading scandal. The strengths and weaknesses of the approval process of the Food and Drug Administration. The controversial new marketing techniques of the pharmaceutical industry. A balanced work that provides readers with an unbiased look at the drug industry,
The New Medicines will answer the questions of anyone who has ever looked at a bottle of their prescription pills and wondered, how did that get here?Editorial Reviews
Review
“This book thoroughly covers the process of how a medication is created, approved, marketed, and sold. Written by an expert in biomedical research with more than 25 years in the field, this book is meant to educate the public on medication development so as informed consumers they can make better decisions….[a] very thorough explanation of how a medication is created, approved, marketed, and sold. I would recommend this book to anyone who wonders why medications cost so much.”-AORN Journal
?Every year the pharmaceutical industry produces new medicines but are they safe? One of the best ways a consumer can find out more about how such new drugs are tested and presented is by reading The New Medicines: How Drugs are Created, Approved, Marketed and Sold, by biomedical researcher and teacher Bernice Schacter. Chapters provide historical and business background around major new drugs which have been controversial news topics, analyze the FDA’s processes, and survey new marketing techniques aimed at consumers rather than physicians. From product launches to unknown factors in drug interactions, THE NEW MEDICINES provides an excellent historical overview.?-Midwest Book Review/California Bookwatch
?Schacter, a biomedical consultant, leads readers through the maze of the modern drug industry, explaining step by step how new medicines are invented, tested, and regulated. Writing in plain language for the general reader, she looks at controversies surrounding the rise and fall of the COX-2 inhibitors, the strengths and weaknesses of the Food and Drug Administration approval process, and the pharmaceutical industry’s new marketing techniques.?-SciTech Book News
?This book thoroughly covers the process of how a medication is created, approved, marketed, and sold. Written by an expert in biomedical research with more than 25 years in the field, this book is meant to educate the public on medication development so as informed consumers they can make better decisions….[a] very thorough explanation of how a medication is created, approved, marketed, and sold. I would recommend this book to anyone who wonders why medications cost so much.?-AORN Journal
?With more people than ever before taking prescription medications and with more drugs having questionable safety records, a wide range of consumers should be interested in this book, which explains how drugs are discovered, tested, approved, and marketed. Biomedical researcher, consultant, and writer Schacter explains the steps involved as new medicines make it to the market in the US. She focuses on two drugs (Celebrex, a pain medication, and Copaxone, used to treat multiple sclerosis) to illustrate the process, stressing that only 10 percent to 25 percent of drugs that begin the human testing process are approved. Schacter describes the different phases of drug testing, including animal testing, and ending with a description of post-approval studies. The text incorporates many statistics and figures; all the information is documented. In the last chapter, “Are We (Well) Served?” the author gives her opinion of the drug approval process, concluding, “We are doing pretty well.” Although the book is geared to consumers, it is detailed and comprehensive enough to appeal to any health professional. Recommended. Public and academic library collections supporting lower-level undergraduates through graduate students, professionals, and general readers.?-Choice
“Every year the pharmaceutical industry produces new medicines but are they safe? One of the best ways a consumer can find out more about how such new drugs are tested and presented is by reading The New Medicines: How Drugs are Created, Approved, Marketed and Sold, by biomedical researcher and teacher Bernice Schacter. Chapters provide historical and business background around major new drugs which have been controversial news topics, analyze the FDA’s processes, and survey new marketing techniques aimed at consumers rather than physicians. From product launches to unknown factors in drug interactions, THE NEW MEDICINES provides an excellent historical overview.”-Midwest Book Review/California Bookwatch
“With more people than ever before taking prescription medications and with more drugs having questionable safety records, a wide range of consumers should be interested in this book, which explains how drugs are discovered, tested, approved, and marketed. Biomedical researcher, consultant, and writer Schacter explains the steps involved as new medicines make it to the market in the US. She focuses on two drugs (Celebrex, a pain medication, and Copaxone, used to treat multiple sclerosis) to illustrate the process, stressing that only 10 percent to 25 percent of drugs that begin the human testing process are approved. Schacter describes the different phases of drug testing, including animal testing, and ending with a description of post-approval studies. The text incorporates many statistics and figures; all the information is documented. In the last chapter, “Are We (Well) Served?” the author gives her opinion of the drug approval process, concluding, “We are doing pretty well.” Although the book is geared to consumers, it is detailed and comprehensive enough to appeal to any health professional. Recommended. Public and academic library collections supporting lower-level undergraduates through graduate students, professionals, and general readers.”-Choice
“Schacter, a biomedical consultant, leads readers through the maze of the modern drug industry, explaining step by step how new medicines are invented, tested, and regulated. Writing in plain language for the general reader, she looks at controversies surrounding the rise and fall of the COX-2 inhibitors, the strengths and weaknesses of the Food and Drug Administration approval process, and the pharmaceutical industry’s new marketing techniques.”-SciTech Book News
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