A New Book Argues That Generic Drugs Are Poisoning Us – New York Times – By David Dobbs – May 13, 2019
This is a review of a recently published book exposing the seamy side of the “profit above all else” generic drug industry:
The Inside Story of the Generic Drug Boom
By Katherine Eban
I’ve always been suspicious of generic drugs because I’ve noticed that my body sometimes reacts slightly differently to a new batch, and often reacts very differently to a switch from brand-name medications to generic. This book validates my concerns and even adds new ones.
I knew that generics are manufactured overseas in Third World countries where corruption is a problem, but I assumed that the FDA was monitoring foreign facilities to assure our drug supply was at least safe, even though these drugs often seem ineffective.
I’m horrified at what this book exposes. And it’s not just about pain medication, which is actually a very straightforward chemical compound. I’m more worried about things like anti-depressants and hormones which I take.
I’ve tried stopping all my drugs at various times, But then I feel even worse, so I know they’re helping at least a little bit.
But as I hear about this atrocity, I might pay more attention to which generic drugs from which manufacturers I’m currently taking, so that when the pharmacy switches their suppliers I will know why the medication is causing weird side-effects or isn’t working anymore.
There he is, early in Katherine Eban’s “Bottle of Lies,” barefoot in his Ahmedabad ashram, urging the chemist Khwaja Abdul Hamied (a fellow Indian nationalist) to copy Western drugs as a way to bring affordable medicine to India’s masses. Thus the generic drug industry began.
At first, things went nicely. Hamied’s business, Cipla, founded in 1935, quickly grew adept at reverse-engineering drug formulas, and by midcentury it was supplying India and other countries with low-cost versions of important Western medicine
In the 1980s, when the United States began allowing the import of such generics, Cipla and other generic makers became heroes to critics of Big Pharma.
Cipla, almost a tenth the size of Merck, has kept its nose clean. But much of the wider generics industry is harming and sometimes killing patients by making drugs quick and dirty and erecting facades of legitimacy to fool regulators.
This booming industry, with most production coming out of lightly regulated plants in India and China, is pumping bad medicine into unsuspecting patients in every corner of the globe.
Eban’s gripping book lays bare how Gandhi’s well-intentioned local action became hellish global fraud.
The book’s central thread is a David and Goliath whistle-blower story, as a young engineer and executive named Dinesh Thakur tries to stop Ranbaxy Laboratories, the Indian generics giant that employs him, from continuing (and covering up) its careless drug manufacture.
Eban skillfully unspools the slow, intricate, cat-and-mouse investigation that follows, as well as an armed raid of corporate headquarters (“Step away from your desk”), the discovery of astounding levels of deceit and damage, and finally a three-front legal battle, as Ranbaxy fights the F.D.A., the United States attorney Rod Rosenstein and the lawyer Thakur retains so he won’t get skinned alive
Thakur’s story stuns with how utterly corrupt an entire company can become. Both his and the book’s broader account of the industry, meanwhile, show how a quieter sort of corruption — an erosion of will and mission — has neutralized the industry’s overseers.
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.
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.
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.
Author: David Dobbs is the author of “My Mother’s Lover,” a memoir of his mother’s long-secret wartime affair.