A large pharmaceutical company was litigated against after they allegedly covered up the potential harmful side effects of the antidepressant Risperdal. The case claimed that the company had obscured evidence that the risperidone in Risperdal increased prolactin and caused gynecomastia in many of its patients. The case hinged on an early version of a company-run study that traced a link between increased prolactin levels and the onset of gynecomastia. These findings were allegedly obscured from the final paper, and an expert in statistics was needed to review the original report and re-analyze the data to determine whether or not the company should retract its research paper.
Question(s) For Expert Witness
- 1. Please describe any experience you may have conducting statistical analysis for drug trials or biomedical research.
Expert Witness Response E-035914
I am a biostatistician with over thirty years of experience designing, reviewing, and analyzing nearly five hundred clinical trials. I am well-versed in issues associated with biostatistics, data management, statistical programming, and regulatory affairs; my professional experience spans various therapeutics areas including psychiatry, neurology, oncology, endocrinology, infectious disease, cardiology, rheumatology, urology, and anesthesia. As a former Vice President of Biometrics at large pharmaceutical companies and contract research organizations, I have managed biostatisticians and statistical programmers in the pre-clinical, non-clinical, and clinical areas. I also led initiatives of implementing adaptive designs of clinical trials to improve clinical drug development.
Expert Witness Response E-035865
I have over twenty years of experience as the lead statistician on numerous clinical trials and observational studies of HIV and other infectious diseases. These include studies of HIV and CMV transmission, microbicides for the prevention of STDs, HIV disease progression, correlates of HIV risk and acquisition, HIV treatment adherence and Tuberculosis. Through my involvement with these studies I have gained extensive experience in designing studies, preparing statistical analysis and interim monitoring plans, preparing and presenting Data and Safety Monitoring Board reports, and the statistical analyses of data.