Nonfiction: A New Book Argues That Generic Drugs Are Poisoning Us

Week

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Unlike American plants, which matured in an environment where constant oversight made shortcuts risky, the Indian industry evolved in a culture in which outwitting inefficient bureaucracies was an essential skill. There the most rational approach was to stress speed and production over accuracy and quality — and deal with the occasional inspector with some sleight of hand and greasing of palm.

The F.D.A. was utterly unprepared for this, and largely blind as well to the implications of both its own and the Indian industry’s cultural assumptions. Lost, it tried to get by, Eban writes, with “a system built on wishful thinking and infrequent scrutiny.” Especially early on, inspections of foreign factories were rare — as few as 100 a year in the 1990s, which worked out to a rate of one inspection per plant every 11 years. These inspections were seldom surprises, because the State Department, valuing good relations over good drugs, asked the F.D.A. to give plants several weeks’ notice. So instead of flashing a badge and roaming at will, inspectors would be fetched from their hotels by drug-company cars and escorted into receptions and plant tours hosted by up to a dozen corporate officers flown in from headquarters. Meanwhile, as more aggressive inspectors eventually learned, a second set of corporate officers would be in back rooms and production areas destroying failed quality test results and fabricating documents showing successful tests. Some plants even built, just for these inspections, fake production and testing areas that were kept pristine while the drugs were made in substandard conditions elsewhere.

These high jinks read like farce but hit like poison, as tainted drugs daily enter patients’ bloodstreams worldwide. In Africa, which the companies consider the safest place to send faulty drugs, doctors regularly find that drugs for AIDS, bacterial infections and other conditions are underpowered. In the United States, imports from India now make up 40 percent of all generics used, and 80 percent of the active ingredients used in both generic and brand-name medications come from India and China. In 2007, when scores of kidney patients across the United States died from allergic reactions after dialysis, experts traced the cause to a contaminant in the blood thinner heparin provided by a Chinese plant contracted by Baxter, the leading American supplier. The F.D.A. had never inspected this plant. Someone there, it seems, had intentionally added a chemical to stretch the drug’s yield and profitability.

The prognosis is grim. The World Health Organization has established, and some plants follow, a definition of “good management practice” for drug manufacture, but no international regulatory body exists to enforce it. The F.D.A. is overmatched and uninspired. And with Big Pharma using saturation advertising to drive demand for its expensive drugs, an overmedicalized society is demanding more and more drugs sooner and cheaper. At the same time, even brand-name companies are increasingly hiring poorly regulated Indian and Asian plants to make their ingredients or formulations — just as the generic industry is being prosecuted for price-fixing. The entire drug supply, as one prominent American cardiologist concluded, is “sick.”

“Bottle of Lies” is an invaluable exposé, a reportorial tour de force and a well-turned epic. Is it news you can use? I can’t give medical advice. Our best medicines are indeed wondrous; many of us owe our lives to them. But I can relate that Eban quotes inspector after inspector saying that they themselves fill only the most essential prescriptions — and will pay anything to avoid taking a drug made overseas. They’ve seen how those drugs are produced, and they live in fear of them.

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