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

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

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

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

Synopsis

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?

Excerpt

Do we have the pharmaceutical industry we need and
want? Perhaps not, but it is the industry that our innova
tive and entrepreneurial society and responsive regulatory
system has given us. And knowing how it works may
allow us to make better decisions as patients, caregivers,
and citizens.

The seed for this book began in 1984 when, with little forethought, I landed in the midst of an industrial effort, the fruits of which had benefited me but the workings of which were pretty much unknown to me. After serving in an academic position where I did research, taught immunology to medical students, and ran a laboratory that matched people for organ transplants, I moved to a research scientist position at what was then Bristol-Myers, where I was quickly exposed to the steps of drug discovery and development. With no wall separating the research and development work, department and division review meetings provided ample opportunities for a glimpse of what it took to morph an idea into a drug in a bottle. It did not hurt that my spouse was immersed in the same process on the clinical side. [Phases,] [the Agency,] and [project status] became my jargon . . .

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