This book, including all the scenes, dialogue, and assertions in it, is based on extensive interviews, firsthand reporting, and documentation. I interviewed over 240 people, a number of them multiple times, including regulators, drug investigators, criminal investigators, diplomats, prosecutors, scientists, lawyers, public-health experts, doctors, patients, company executives, consultants, and whistleblowers. Primary reporting for this book took place between January 2014 and November 2018, and included on-the-ground reporting trips to India, China, Ghana, England, Ireland, and Mexico and travel throughout the United States. The book also includes material I gathered from 2008 to 2013, while reporting a series of articles about generic drugs in both Self and Fortune magazines.
In every scene with dialogue, I have reconstructed quotes from the recollections of participants as well as documentation, including meeting minutes, handwritten notes, and memoranda of interviews by criminal investigators. The quotes I use from emails and other documents are verbatim, and I have not corrected spelling errors. No names of characters have been changed.
In the course of reporting, I obtained a significant number of confidential documents. These include roughly 20,000 internal documents from the U.S. Food and Drug Administration, including emails, memorandum, meeting minutes, reports, and data; thousands of internal government records related to the investigation of the generic drug company Ranbaxy; and thousands of internal corporate records from several generic drug companies, including emails, reports, strategy documents, correspondence, and sealed court records.
Documentation also came from sixteen Freedom of Information Act requests that I filed with the FDA, as well as from a lawsuit I filed to obtain calendar and meeting records for an FDA official. I also read through years of publicly available FDA inspection records.
Wherever an individual or company has chosen to respond to questions or allegations, relevant portions of their statements can be found incorporated into the book’s endnotes or main text. The endnotes are intended to guide readers to publicly available resources and documentation or to offer more detail on certain topic areas. They do not contain citations for nonpublic material, such as private emails, sealed court records, or other confidential documents.
Funding for this book came only from impartial sources with no stake in the outcome of the events described. These include an advance from HarperCollins and grants from the Carnegie Corporation, the Alfred P. Sloan Foundation, the McGraw Center for Business Journalism at Craig Newmark Graduate School of Journalism, and the George Polk Foundation.