From the WUSTL Newsroom...
From reading and hearing news accounts, the general public has a vague impression that some things are amiss with the pharmaceutical industry — one word: EpiPens. But few might consider it an industry in a state of collapse.
Michael Kinch tries to convince otherwise in “A Prescription for Change,” his history and review of the industry. Kinch is the associate vice chancellor and director of the Center for Research Innovation in Biotechnology at Washington University in St. Louis, and he brings to this book (University of North Carolina Press) many decades of research and harrowing personal experience with pharma.
The book starts with some classic tales of the struggle to make sure drugs weren’t poisons and actually did what they were said to do. One early antibiotic, for example, was mixed in a sweet syrup whose main ingredient was antifreeze: 106 died, mostly children.
The pace quickens as the struggle between innovation and regulation becomes fiercer. The industry spins off, Kinch notes, into new territories, such as patent extensions, me-too drugs, generics, pay-for-delay, orphan drugs and compendium expansion.
Companies found ways to game the system by gaining FDA approval for an orphan drug under favorable terms and then conducting a small clinical trial that would allow the drug to be approved for another indication, called “compendium expansion.” This was lucrative, Kinch explains, because orphan drugs could command high “price points” without insurance companies squealing, but the expansion drugs made up for the small number of patients with orphan indications.
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