In 2007 Harry Lever, a cardiologist at the Cleveland Clinic, began receiving complaints from patients who were taking generic drugs. They had developed dangerous symptoms—including low platelet counts, excess fluids, cholesterol spikes, and irregular heartbeat and shortness of breath—that their medications were supposed to control or prevent. When Lever switched patients to alternate generics he trusted or to brand-name drugs, the symptoms usually subsided.
The generics Lever first prescribed had cleared the Food and Drug Administration (FDA), as all drugs sold in the US must. He had taken their reliability on faith, yet he came increasingly to think that something must be wrong. He found that all the culprit drugs had either been manufactured in India or China, or else were made in the United States, often by reputable pharmaceutical companies, using ingredients produced in India or China. “In all my innocence,” he recalled, “I stumbled on a mess.”
That mess forms the principal subject of Katherine Eban’s disquieting, often unnerving, and at times infuriating new book. Bottle of Lies ranges across the pharmaceutical industry in several countries, but its chief concern is the generic drug industry in India and the inconsistent vetting by the FDA of the industry’s products for the American market. The FDA’s lack of rigorous, uniform scrutiny of imported pharmaceuticals has put the prescription drug supply in the United States at risk from contaminated, ineffective, and even fraudulent medications—products that not only might fail to control disease but might themselves be life-threatening.
A 1970 reform of the Indian Patents Act legalized the copying of an existing molecule but made it illegal to copy the process by which it was produced. The change gave Indian drug manufacturers a green light to use their own methods to make generic versions of Western brand-name drugs. Operating in an environment of lax oversight, the Indian firms prospered, selling their products not only in India but also in Africa, Latin America, Iran, the Middle East, and Southeast Asia—though for the most part not in the United States, where the pharmaceutical industry resisted generics as both competitive threats and shoddy products. Even in Africa, Eban writes, Indian generic manufacturers were considered “fakers and copycats.”
With the passage of the Hatch-Waxman Act in 1984, however, the US government began explicitly encouraging the manufacture of generics once a brand-name patent expired—formally, twenty years from the date of the patent application but in the actual administration of the act thirteen on average. To gain the approval of the FDA, generics not only had to meet standards of safety and efficacy but also had to approximate closely the composition, activity, and quality of the brand-name prototypes—thus providing a cheap and putatively reliable means of offsetting the high cost of brand-name prescription drugs. Several Indian pharmaceutical companies strengthened their operations to meet FDA standards. The leader was Ranbaxy Laboratories, which had begun in…
This is exclusive content for subscribers only.
Get unlimited access to The New York Review for just $1 an issue!
Continue reading this article, and thousands more from our archive, for the low introductory rate of just $1 an issue. Choose a Print, Digital, or All Access subscription.