A Johnson & Johnson biochemist recently gave testimony indicating that the pharmaceutical and medical equipment manufacturing giant may have hidden incriminating study results from the U.S. Food and Drug Administration (FDA).

The study results showed a link between the company’s popular antipsychotic drug Risperdal and dangerous hormonal levels.

The omission came to light after an Alabama man was awarded $2.5 million in a Risperdal lawsuit in February. A article published after the award made testimony from the trial public. The testimony revealed that evidence from a study conducted by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, was allegedly concealed in the published version of the study, and never made it to the FDA.

Janssen’s Risperdal Study

Janssen Pharmaceuticals funded a study in 2003 on Risperdal (risperidone). Risperdal has been used since it was approved by the FDA in 2006 to treat disorders on the autism spectrum, as well as bipolar disorder and schizophrenia. Ultimately, the published study concluded that it found no link between heightened prolactin levels and long-term risperidone usage.

Interestingly, Janssen Pharmaceuticals itself employed three of the study’s authors. The study did have independent authors as well, but two of them have since asked for the study’s findings to be reanalyzed.

This desire for reevaluation may be due to the fact that, in February’s Risperdal trial, a manuscript used in the testimony showed a link between Risperdal use and elevated prolactin levels. Elevated prolactin levels can cause gynecomastia, or the development of female-like breasts in young men and boys, as well as other serious side effects.

These results, while presented at the Risperdal trial, were never officially published, and so had not been revealed to the FDA.

Scientific misconduct is a serious problem in the medical and scientific community. Oftentimes, misconduct consists of making up results to cut corners or show a more favorable outcome in a study. However, scientists say there is not much difference between making up results and purposefully leaving them out – both are serious cases of scientific misconduct.

The version of the Risperdal study published in 2003 concluded that prolactin levels rose and then stabilized after five months. However, it went on to conclude that there could be no positive correlation made between these high prolactin levels and side effects potentially linked with Risperdal. The tables left out of this study, and used in February’s Risperdal lawsuit as testimony, indicated that Risperdal was likely linked with side effects.

The FDA approved Risperdal in 2006, a full three years after the now controversial study’s results were published. While gynecomastia is now listed as a potential side effect on Risperdal’s warning label, many men bringing Risperdal lawsuits claim that they suffered side effects of the drug, such as gynecomastia, during the time period when that side effect was not included on the label.

The February Risperdal lawsuit against Johnson & Johnson was the first of thousands like it to face a jury. If you have suffered serious side effects of Risperdal such as gynecomastia, you may be able to file a lawsuit.