
Industry history covering J&J's opioid marketing and its regulatory politics.
Gerald Posner wrote a history of the American pharmaceutical industry from the nineteenth century patent medicine trade to the opioid epidemic, with the Sackler family and Purdue Pharma at the centre of the later chapters.
The historical material covers the origins of the industry, the passage of the Pure Food and Drug Act and the later Kefauver-Harris amendments requiring proof of efficacy, the amphetamine and barbiturate booms, the development of the modern regulatory regime, and the growth of direct-to-consumer advertising after the rules were relaxed in 1997. Posner treats Arthur Sackler as the figure who invented modern pharmaceutical marketing, through medical advertising agencies, controlled medical journals, and the recruitment of physicians as promotional agents, using Valium as the case.
The opioid chapters cover Purdue's development of OxyContin, the claim that its formulation made addiction unlikely, the sales practices, the 2007 guilty plea by the company and three executives, and the litigation and bankruptcy that followed. Posner also covers the Food and Drug Administration's dependence on industry user fees since 1992 and the movement of personnel between the agency and the companies it regulates. The book is long, journalistic, and organised as accumulated indictment rather than as analysis; it does not seriously address the industry's actual therapeutic achievements. The reporting on the Sacklers and on FDA funding is well documented.
Investors in pharmaceuticals and readers of regulatory capture who want a long history of industry marketing practice and its regulatory context.
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