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America's Most Admired Lawbreaker: Chapter 5, "Three Card Monte"

A Convenient Re-Analysis

Six days before Austin Pledger swallowed his first Risperdal, Janssen scientists and marketing executives met with an advisory board of doctors in a luxury hotel suite in New York. The group wrestled with problems concerning the prolactin and gynecomastia data that had come in from the clinical study Gorsky and his team had ordered up, hoping to put the issue to rest.

This new study was actually a study of studies. It pooled the one study called “INT-41”—which had the largest number of participants and the worst results and had devoted what those who conducted it called “special attention to prolactin”—with four smaller, more general studies that had produced less troubling numbers.

Although this approach diluted the bad news for Janssen, there were still two problems.

First, the gynecomastia rates remained high.

Second, one table showed a statistically significant relationship between elevated prolactin and breasts among boys who had been taking the drug for eight weeks. In other words, it looked like causation had been established.

According to later testimony, at that meeting, the doctor advisors and the Janssen team came up with a solution that, they decided, could remove many of the gynecomastia cases but in a way that was scientifically legitimate.

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To read Chapter 5 in its entirety and view the accompanying materials online, visit The Huffington Post: Highline website:

#clinical #Risperdal #results #retroactive #labels #children #adolescents #elderly #dementia #FDA #sales #doctors #puberty

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