*Katherine Eban. Bottle of Lies. The Inside Story of The Generic Drug Boom. Read by the author. 12 CDs. 14.5 hrs. Harper Audio. 2019. 978-1-9826-5641-6. Bottle of Lies
by investigative journalist Katherine Eban, is a must-listen, shocking investigation into where, how and why generic drugs are made, most of them NOT in the U.S. Eban's reading of her formidable book is compelling. How she maintains her calm as she narrates an increasingly outrageous, frightening, almost unbelievable story is notable.
Eighty percent of all active ingredients in both generic and brand name drugs in the U.S. are manufactured in India and China. Ninety percent of drugs that people take in the US are generic. The Federal Drug Administration (FDA), the government agency responsible for maintaining the safety of these drugs, is supposed to ensure that Generic Drugs are identical to their brand name counterparts. The FDA has not been doing its job to protect Americans for years, even as Americans are taking more and more drugs. Bottle of Lies
meticulously exposes two major themes in the generic drug manufacturing industry: (1) if fraud can happen, it will already have happened. And (2) if people who break laws are not held accountable they will go on to continue to break many many other laws and inspire others to do the same, because they suffer no ill consequences.
In the late 1990s, the National Public Radio's program "The People's Pharmacy" hosted by pharmacologist Joe Graedon and medical anthropologist Terry Graedon began receiving many reports from people taking daily doses of life saving drugs who were experiencing major symptoms, sometimes dangerous symptoms, after being switched to generic drugs supposedly equivalent to the brand names they had been taking. The Graedons shared these reports with the Federal Drug Administration (FDA) for many years. Little was done to help patients who were suffering or to examine the bioequivalency of the drugs. Katherine Eban was intrigued and so she began her investigation to uncover the inadequate regulation by the FDA and scandalous, corrupt, drug production overseas and in the US.
Eban's Bottle of Lies
humanizes the challenges faced by a few very courageous FDA investigators and industry whistleblowers, physicians who put patient health care above profits, and other individuals who would not look the other way in order to go along with the corruption, that is still ongoing. They "chose integrity and paid the price for it." Many actually risked their lives to expose the dangers people all over the world face from generic drugs that are not bioequivalent to their brand name counterpart.
The heart-rending in depth stories of Indian drug industry whistleblower Dinesh Thakur and FDA investigator/whistleblower Peter Baker who worked in both India and China would make a great series on NETFLIX. Both Thakur and Baker found that "Companies routinely adjusted their manufacturing quality depending on the country buying their drugs. They sent their highest-quality drugs to markets with the most vigilant regulators and their worst drugs to countries with the weakest review. In an industry with slim margins, companies slashed costs by using lower-quality ingredients, fewer manufacturing steps, and lower standards, then sold those drugs in poorly regulated countries." Baker wrote reports for the FDA of his findings thus "documenting the tip of a much larger public health crisis" all over the world. Even countries with "vigilant" regulators receive drugs that did not meet bioequivalency tests because there are not enough vigilant investigators, at the FDA for example. Sadly, this continues.
Listeners will need the actual book to check the additional extensive "Notes" at the end of that provides further documentation and a "Glossary" that explains terms, drugs, agencies, initialisms and acronyms, and other important information. Eban's "Acknowledgments" is a valuable list of people and other sources that helped her write the story.
If you don't have time to listen to the book - check out these two interviews with Katherine Eban on DemocracyNow on May 20,2019 about the book and then her recent appearance at the U.S.-China Economic and Security Commission (USCC) hearing on China and Global Health, Part 3, 7/31/2019 on C-Span. After watching you will then definitely want to listen to the entire Bottle of Lies.
Bottle of Lies: How Poor FDA Oversight & Fraud in Generic Drug Industry Threaten Patients' Health
Why Did the FDA Go Easy on Generic Drug Makers After Inspections Exposed Quality & Safety Concerns?
Hearing on China and Global Health, Part 3 Katherine Eban
, an investigative journalist, is a Fortune
magazine contributor and Andrew Carnegie fellow. She has also written for Vanity Fair, the New York Times, Self, The Nation
, the New York Observer
and other publications. She is the author of Dangerous Doses: A True Story of Cops, Counterfeiters, and the Contamination of America's Drug Supply
, and lectures frequently on the topic of pharmaceutical integrity. Educated at Brown University and Oxford, where she was a Rhodes Scholar.