What the study authors did was manipulate data to make it seem like Risperdal had an 0.8% risk of causing gynecomastia when in fact the number was closer to 4.5%.
The unusual math was discovered by Priscilla Brandon, who was reviewing documents when she noticed a study called INT-41 that looked at prolactin levels in children. Prolactin is a pregnancy hormone that stimulates breast growth.
She found three drafts and a final version of what would later be known as the Findling study. The drafts appeared to show different numbers in different drafts. After digging further, she found internal emails about “re-analyzing” the data to “reassure doctors.”
According to Stephen Sheller, the attorney who led the Risperdal litigation against Johnson & Johnson:
“We had discovered what this case was all about and what these people had done. This wasn’t just selling off-label; it was knowing that the drug caused gynecomastia and covering that up.”
The published study showed a very low rate of gynecomastia — just eight-tenths of 1 percent. However, the rate was a mathematical sleight of hand. In a study of 592 children (boys and girls under 18 years old), five boys under 10 years old developed breasts — 0.8%.
However, only 358 of all children were under 10 years old, so the rate of gynecomastia should have been 1.4%. Furthermore, another 17 boys over age 10 developed gynecomastia, bringing the total number of cases to 22. After eliminating girls in the study, the actual rate of boys with gynecomastia was 22 out of 489 — 4.5%.
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