This case involves several autistic male children who developed gynecomastia after taking the drug risperidone. It was alleged that the pharmaceutical company that marketed this drug hid evidence that would have alerted clinicians and regulatory authorities to the connection between risperidone, increased prolactin, and gynecomastia. An early study on the drug’s side effects allegedly included multiple data sets that reported a direct link between increased prolactin levels and side effects like gynecomastia. These findings were allegedly redacted from the published manuscript and the published version concluded that the drug produced no prolactin-associated side effects. An expert in statistics was sought to review the original drug report and determine whether this paper should be retracted and what data any retraction would cover.
Question(s) For Expert Witness
- 1. Please describe your experience conducting statistical analysis for drug trials or biomedical research.
- 2. Have you lectured or been published in this field?
Expert Witness Response E-035914
I am a biostatistician with 30+ years of experience designing, reviewing, and analyzing over 420 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 20+ 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 TB. 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.