Epidemiology Expert Evaluates Peripheral Neuropathy from Fluoroquinolone Antibiotic

Case Overview

This case involves a number of incidents related to the administration and long-term use of a particular type of antibiotic therapy. The antibiotic in question belongs to a class of drugs referred to as fluoroquinolones, and is used to treat a number of different infections within the skin, kidneys, bladder, sinuses, and prostate. However, some patients have experienced permanent damage to their peripheral nervous system, even after using the drug for a limited amount of time. As a result of this damage, patients have experienced pain, numbness, burning, and reduced motor capacity. Patients continue to experience symptoms well after ceasing the drug, and show little improvement after a year. It was alleged that the pharmaceutical companies that developed the drugs had a responsibility to vigilantly report and address the negative side effects of the antibiotic, and that they failed to shield patients from potential neurological damage.

Questions to the Pharmacy expert and their responses

Are you well versed in pharmaceutical epidemiological studies and Biostatistics?

I have conducted several pharmacoepidemiological studies and teach pharmacoepidemiology at my position at a major university medical center. I have training in medicine and epidemiology, with a focus on pharmacoepidemiology.

Please explain why you are qualified to review this case.

I have conducted several studies in this area and am aware of the medico legal implications of this particular situation. I have published extensively on similar scenarios and other drugs and side effects. I have a history of collaborative work with the US FDA where I primarily conduct projects focused on advanced methods for benefit and risk assessment or advising companies on emerging issues in drug safety.

Is it the responsibility of the drug company to make sure that there is proper pharmacovigilance analyses of their product?

The drug company does have a certain responsibility to make sure that the FDA approved product is safe. However, other factors may also modify this scenario.

About the expert

This Epidemiologist earned his MPH from the highly-regarded Johns Hopkins Bloomberg School of Public Health. He also has an MD that he earned from Patna Medical College in India and he later completed his Internal Medicine Residency at Strong Memorial Hospital in New York. He is active in his field as a member of the International Society of Pharmacoeconomic Outcomes Research. He was formerly a Clinical Research Scholar at the NIH and has published over 100 peer-reviewed journal articles in Epidemiology. He is a prolific researcher, with more than $1M in active grant funding. In his previous position at Johns Hopkins, where he was until recently, he held various clinical and research leadership roles. At Hopkins, he was on faculty at the Bloomberg School of Public Health in the Center for Public Health and Human Rights and the Center for Health Sciences and Outcomes Research. He was also the Associate Director of the Center for Drug Safety and Effectiveness. Currently, he is a Clinician-Researcher and a Professor of Family Medicine and Community Health at a Major New England Medical University.