“Part memoir, part scientific account of the way the FDA approves new medications… Mills tracks the rise of Scios and its eventual demise… (Those who) have either an educational or professional interest in understanding how Big Pharma operates from the inside will glean the most from Mills’ book. He weaves a compelling narrative and introduces dynamic players (that) keep what could have been a dry narrative fresh and engaging. A lively, well-told, thoroughly researched look at how drugs are brought to market.”
– Kirkus Reviews
This is the true story of the rise and fall of nesiritide, a prescription drug for heart failure, and the company that brought it to market, Scios. It’s a revealing look at what it really takes to develop a drug and then take it to market… and all the things that can go wrong.
When Roger Mills, a medical school professor, made a late-career move from academic cardiology to the pharmaceutical industry, he had no idea what the next decade would bring as VP of Medical Affairs at Scios. Nesiritide was the biotechnology company’s only product in clinical development, and Mills was deeply involved in questions of drug safety and efficacy along the way. After a stunning turn of events at a Food and Drug Administration meeting in 1999, company leadership rallied to reverse its fortunes. Johnson & Johnson eventually acquired the company in 2003 for $2.4 billion, but then had to deal with safety concerns raised about the drug after two scientific publications claimed it could cause kidney failure and death.
Mills tells the story in a way that is accessible to non-clinicians and those not familiar with drug trials and the pharmaceutical industry. Readers walk step-by-step through the development of a new drug – through its successes and subsequent decline. With humor and humility, Mills shares a cautionary tale about influences still impacting the industry today so that others might not make the same mistake.
“This remarkably insightful book gives true meaning to the apocryphal moan from the pharmaceutical CEO as he travels home after an FDA slap down: ‘Drug development ain’t for sissies.’” Peter Kowey, MD, author of Lethal Rhythm, Deadly Rhythm, and The Empty Net.
“This book is a must read for everyone, not just medical professionals.”
“Dr. Mills has managed to make this story from his time in the pharmaceutical industry dramatic, funny, and informative…. Recommended as an insider story of cardiac medicine, big pharma, drug regulation, and the trials of getting a new medicine approved.”
“This is a story of science, marketing, hyperbole, data, and failure… The lingering influences of this saga impact the field today. I was there. This is the story as it happened.”
“Recommended for those in the pharmaceutical research and development industry and for those who are not. It gives enlightening insight to the internal processes of drug development. It’s informative, factual, humorous: a very good read.”