Poisonous generic drugs

Mahatma Gandhi helped start the generic drug industry by urging his friend—a chemist—to copy Western drugs as a way to bring affordable medicine to India’s masses. Thus, the friend, Khwaja Abdul Hamied, reverse-engineered drug formulas and founded a company, Cipla, in 1935. The company prospered and, in the early 2000s, for example, provided HIV drugs to millions of people in Africa at a cost that was about 4 percent of Big Pharma’s price. Cipla is still a (mostly) trustworthy manufacturer of generic drugs, but many others are not. In fact, many manufacturers are producing drugs that are harming and sometimes killing patients. For example, in 2007 scores of kidney patients across the United States died from allergic reactions to the blood thinner, heparin. The heparin, which was manufactured in China, was contaminated.

In the US, imports from India make up 40 percent of all the generics we use; 80 percent of the active ingredients in both generic and brand-name medications come from India and China. In other words, they’ve merged with Big Pharma. I suppose this wouldn’t be so bad if the drugs were pure. But they’re not.

The FDA is supposed to regulate the industry by inspecting production and testing facilities and by exhaustively checking records. But inspection visits are rare and, until recently, the manufacturers are given plenty of notice before inspectors arrive, giving corporate officers time to destroy failed quality test results and fabricate documents that show successful tests. Some plants have even built fake production and testing areas that are kept pristine just for inspection purposes.

FDA inspectors avoid taking drugs made overseas. As a Ghanian creator of a drug verification program noted, “All medicines are poisonous. It’s only under the most controlled conditions that they do good.” Ack.

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