September 30, 2015 — The story of how Johnson & Johnson used creative math to downplay the risk of gynecomastia from Risperdal has been revealed in Steven Brill’s expose America’s Most Admired Lawbreaker.
It takes only a third-grader’s math level to understand how the drug-maker fudged the numbers to make it seem like Risperdal had only a 0.8% risk of causing gynecomastia, when in fact the number was closer to 4.5% of boys.
The cover-up was discovered by Priscilla Brandon, a lawyer in charge of reviewing millions of pages of documents produced by Johnson & Johnson. What she found was four versions of a study called INT-41 which would later be known as the Findling study.
Tables appeared to show different numbers in different drafts. Accompanying these documents were internal emails from researchers who were “nauseated” with the results and looking to “re-analyze” the data to “reassure doctors.”
Stephen Sheller, the attorney who led the litigation, concluded:
“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 re-analysis used a simple mathematical sleight-of-hand that downplayed the risk of gynecomastia — making it appear as low as 0.8%, when the original study had found a 4.5% risk.
The study involved 592 children, including boys and girls. A total of 22 boys on Risperdal developed gynecomastia out of 489 on the drug — 4.5%.
However, the number in the final total eliminated teenage boys who developed gynecomastia and added girls to the denominator. The 0.8% figure was calculated using only five boys under the age of 10 who developed gynecomastia out of a total of 592 children, girls included.