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America's Most Admired Lawbreaker: Chapter 2, Blowing Past the Label

'Otherwise The Sky Would Be The Limit'

In 1961, newspapers around the world ran stories (accompanied by horrific images) of deformed babies whose mothers had taken a drug to curb nausea during pregnancy called thalidomide. A vigilant FDA inspector had refused to approve thalidomide for sale in the United States because she was worried about its safety. But the thalidomide story, along with persistent new reports about other drug company abuses, were highlighted in hearings convened by Senator Estes Kefauver, a Tennessee Democrat. This created a political climate for clamping down on the emerging pharmaceutical industry, and in 1962, President John F. Kennedy strengthened the landmark Federal Food and Drugs Act of 1906.

A key provision of the new law made it a crime for drug companies to promote drugs to doctors for patients with illnesses for which the drug, according to its FDA-approved label, was not intended and approved for use.

Kefauver explained his concern about tight labeling and the need to police off-label sales this way: Once a drug was approved for any initial purpose, “the sky would be the limit and extreme claims of any kind could be made” about the safety and effectiveness of selling that drug for other uses without the FDA vetting it. That would undermine the benefit-risk analysis that the new law required the FDA to weigh. A drug might be worth the risk of certain significant side effects if it helped alleviate a schizophrenic’s hallucinations or urge to commit suicide. But it might not be worth those risks if it was used to treat a restless nursing home patient or a child acting up in school.

For Risperdal the risks were substantial. Even in the earliest trials, the data showed significant rates of side effects. These included involuntary twitches, somnolence, diabetes and, most frequently, significant weight gain. In the elderly there was a particularly high risk of strokes and other heart-related diseases. In children, Johnson & Johnson’s own data would ultimately count somnolence (51 percent of the time), headaches (29 percent), vomiting (20 percent) and bloating, nausea or other stomach ailments (15 percent), among other side effects.

Moreover, if the drug companies were not required to get a labeling change from the FDA before selling a product more widely, there would be little incentive to undertake the clinical studies necessary to test the safety of the drug when deployed for those new uses. Why test whether the drug is safe for children if you can market it to children anyway?

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To read Chapter 2 in its entirety and view the accompanying materials online, visit The Huffington Post: Highline website:

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