To combat this “bad press” Risperdal had been receiving in the scientific literature, J&J helped publish a paper, “Prolactin levels during long-term Risperidone treatment in children and adolescents,” in the Journal of Clinical Psychology (Nov 2003). Clinicians examined five trials — three long-term and two short-term — that covered 700 subjects.
Their conclusion made a splash in the field, since it seemed to contradict the conventional wisdom at the time: risperidone did cause high prolactin levels and related side effects. However, the authors concluded: “With long-term risperidone treatment in children and adolescents, serum prolactin levels tended to rise and peak within the first 1 to 2 months and then steadily decline to values within or very close to the normal range by 3 to 5 months.”
In other words, the high prolactin levels did not last!
At first blush, the paper seemed like a big victory for J&J.
However, critics quickly pointed out a variety of glaring problems with the research:
- The title suggests that researchers analyzed “long-term” treatment with the drug. But two out of the five studies used were only short-term.
- Researchers didn’t measure prolactin levels from over 100 subjects.
- The paper’s abstract did not accurately report the findings in the paper itself! For instance, the research found that 30 children (out of 592 whose prolactin levels were studied) had one or more side effects that were possibly caused by prolactin — for a grand total of 5+ percent. But the abstract purposefully excluded boys 10 years or older, who had experienced gynecomastia. Include those cases, and the numbers were much worse.
Emboldened by this sneaky “science,” in 2005, Janssen applied again for FDA approval to use Risperdal in children and adolescents. Again the FDA turned the drug maker down.
Risperdal’s label at the time had the following warning: “the clinical significance of elevated serum prolactin levels is unknown for most patients.” The label also admitted that “safety and effectiveness in children have not been established.” The side effect of gynecomastia was rated as “rare,” meaning that it occurred in fewer than one out of a thousand patients.
But where on earth did Janssen get that number? Even per the company’s own [highly flawed] research paper from 2003, 4.5% of boys suffered the side effect — or 45 in 1,000. In other words, even going by the company’s own, highly biased study, the drug’s warning labeldownplayed the risk of gynecomastia in boys by at least a factor of 40.
For insight into your Risperdal case, call the Davis & Crump team now at 800-277-0300.
