The New Medicines: How Drugs are Created, Approved, Marketed, and Sold

(Hardback)

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Today, most people use prescription medications. Every year, the multi-billion dollar pharmaceutical industry produces new medicines that treat everything from arthritis to AIDS, from high cholesterol to depression. But, despite recent controversies regarding the safety of drugs, consumers know little about the medications that they ingest and inject. How are these new medicines invented How do consumers know that drugs are safe and effective How are they tested Who regulates their production - and who watches the regulators How do drug companies produce the vast quantities needed for the marketplace, and why do they market their drugs as they do The New Medicines leads the reader through the maze of the modern drug industry - from bench to bedside - and provides consumers with a step-by-step understanding of how new medicines are created, approved, marketed, and sold. 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

Reviews

"The author does all the heavy lifting, laying out the important points and context in a coherent narrative that maximizes reader comprehension. Given the broad scope of the topic and the moderate length of the book, the chapters on clinical research are remarkably informative. The book is ideal for clinical research professionals who want to see the forest through the trees of study and case report forms."-Journal of Clinical Research Best Practices
"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

Author Bio

Bernice Schacter Ph.D., has over 25 years of biomedical research experience in both academia and industry. She served on the faculty of the School of Medicine of Case Western Reserve University and conducted immunology research at Bristol-Myers Squibb Company. She also served as Vice President of Research at BioTransplant, Inc., a biotechnology startup company in Boston, MA. She has published over 50 papers in peer-reviewed journals and is a co-inventor on four issued patents. Since 1994 she has been a biomedical consultant and writer. She has taught immunology to undergraduate, graduate, and medical students and has developed and offered biotechnology courses for liberal studies students at Wesleyan University in Connecticut and at the University of Delaware.