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Bottle of Lies: The inside story of the generic drug boom By Katherine Eban; Ecco Once you start reading Bottle of Lies, you won't be able to put it down. Investigative journalist Katherine Eban has crafted a gripping account of the global multibil- lion-dollar generic drug industry as she examines the process of making generic drugs, the shockingly deceptive practices of some generic drug manufacturers, the Food and Drug Administration's (FDA) fraught role in regulating and investigat- ing the safety of prescription drugs, and the dangerously flawed drugs that make their way to markets all over the world. In her author's note, Eban says that the "book grew out of a puzzle I couldn't solve." In 2008, Eban had already been covering the drug industry for a decade when she set out to find out why some "generic drugs either didn't work or caused devasting side effects." She spent the next 10 years on the project trying to find out what was wrong with the drugs, interviewing more than 240 people across four continents and looking at thousands of pages of internal FDA documents, including filing 16 Freedom of Information Act requests. It was time well spent as Eban does an excellent job recreating pivotal moments and discov- ering background details that bring scenes to life in the book. At times Bottle of Lies reads like fiction, with intersecting plotlines, suspense, and drama as the stories unfold, and a wide cast of characters, including intrepid (as well as lax) FDA investigators, conscience-stricken whistle-blowers, concerned doctors, lawyers, and unethical pharmaceu- tical executives willing to deceive the FDA in their relentless pursuit of profits—even if they put people's lives in danger. Billions of dollars are at stake and millions of lives are at risk if the drugs aren't safe. Eban makes potentially mind-numbing topics, such as a pharma- ceutical drug plant inspection or filing a new drug application into compelling, informative page-turners. Here's a scene from Chapter 2 when an executive from Indian generic drug manufacturer Ranbaxy Laboratories is about to catch a 16-hour flight in 2002 to the com- pany's U.S. headquarters in New Jersey: "His mission was top secret. In his luggage were five binders, each about three inches thick, con- taining reams of data. The documents comprised key portions of what would become an Abbreviated New Drug Application or ANDA, to be filed with the FDA. The application, once completed, would become known in industry parlance as a "jacket." But this was no run-of-the-mill jacket. The executive carried the most potentially lucrative dossier ever compiled in the generic drug world: the data the company would use in its application to make the first U.S. generic version of the world's best-selling drug of all time: Lipitor." Bottle of Lies exposes the cesspool of greed underlying the generic drug industry and the FDA's tangle of bureaucracy and political pressures that make it difficult and sometimes impossible for the agency to do its job. Ninety percent of the U.S. pharmaceutical mar- ket is made up of generic drugs, a low-cost alternative to the brand-name versions. Generics are required to be bioequivalent to the brand-name drugs and have the same "dosage form, safety, strength, route of administration, quality, performance characteris- tics, and intended use," according to the FDA. But sometimes the active pharmaceutical ingredient (API) in a generic drug is not the same as the brand-name drug. This is why Cleveland Clinic's phar- macists examine the bioequivalence data from generic drug makers and even research where APIs are made and do their own manufac- turing plant visits to create a confidential list of drugs the hospital should use or avoid (On the blacklist in 2013: a generic version of tacrolimus, a drug for transplant patients that helps prevent organ rejection, made by Indian company Dr. Reddy's Laboratories). Ranbaxy has a prominent role in the book as a prime example of what's wrong with the generic drug industry. Eban documents Ran- baxy employees' unabashed willingness to cut corners in drug production, falsify data, and lie to regulators to expand its drug portfolio and increase profits at the expense of patients. Ranbaxy didn't destroy drugs they knew wouldn't mass muster in the United States. Instead, they sold their defective drugs to vulnerable patients in markets with few, if any, drug regulations: Africa, Eastern Europe, Asia, and South America. Ranbaxy's drug portfolio also included antiretroviral drugs for the U.S. AIDS relief program. Who knows how many people died from Ranbaxy's pharmaceuti- cals? This is not an area the book explores, but Eban includes a scene that perfectly illustrates the company's attitude when a new employee asked about the quality of Ranbaxy's AIDs medications for Africa. The executive's shocking response: "Who cares? It's just blacks dying." The disturbing reality is that fraud is prevalent in the generic drug industry; the FDA does not have the resources to regularly inspect pharmaceutical plants for drug safety; and the political pres- sure to approve generic drugs can outstrip the FDA's responsibility to protect patients from dangerous drugs. To be sure, the FDA has a huge regulatory role, overseeing the safety of food, drugs, medical devices, dietary supplements, pet food, and cosmetics. Eban notes that from 2001 to 2008, drug imports into the U.S. market had doubled and that the FDA had "more drug plants to inspect abroad than it did within U.S. borders." And there are FDA investigators who take their job very seriously. Eban highlights a few who were relentlessly thorough in their inspections of drug manufac- turing in India and China and had an uncanny ability to root out fraud. Bottle of Lies is an unsettling examination of the generic drug industry that will make you question whether any generic drug is safe. The book illustrates the fact that profits have no place in health care. —Chuleenan Svetvilas Eyes to the Wind: A memoir of love and death, hope and resistance By Ady Barkan; Simon & Schuster Eyes to the Wind, a memoir by activist and ALS patient Ady Barkan, tells the riveting true story of a young man, father, husband, and activist faced sud- denly with terminal illness. The memoir is a story of determina- tion, selflessness, and courage. Barkan details the psychological and emotional roller coaster of coming to terms with death at a young age. But he also describes how that very struggle drove him to dive even deeper into his activ- ism. Knowing he may only have a few years left on earth, Barkan became determined to make his mark. 18 N A T I O N A L N U R S E W W W . N A T I O N A L N U R S E S U N I T E D . O R G O C T O B E R | N O V E M B E R | D E C E M B E R 2 0 1 9