Erin L. Rubenstein, JD, MPH, George Washington University, 1646 Park Road N.W., Washington, DC 20010, 202.360.7644, lawguy@gwu.edu and Susan G. Rose, MPH, JD, Dept. of Environmental & Occup. Health, School of Public Health and Health Services, George Washington University, 2100 M Street, NW, Suite 203, Washington, DC 20052.

In the 1970’s, the Walter Reed Army Institute of Research (WRAIR) launched a program to find a chemoprophylaxis for Chloroquine-resistant malaria. After years of research, WRAIR sold mefloquine (Lariam) to Hoffmann-LaRoche to develop for the commercial market. After navigating the FDA drug approval process, Lariam was granted a license by the FDA in 1989. Reports of neuropsychiatric side effects of varying severity began to emerge in the medical literature. Reported side effects included depression, acute anxiety, mania, psychosis and suicidal ideation. In 1996 a new study challenged the accepted view of Lariam’s low incidence of side effects. Since then, studies were conducted that have shed new light on what adverse events Lariam can cause; the incidence of the adverse events; and why these undiscovered risks, if any, were not found during the initial trials and early studies reporting low incidence of side effects. This presentation is a cogent review of the data available so public health professionals have access to the seminal work that has been done and can come to an informed opinion about how safe Lariam really is. Because Lariam is given to people who are not sick and business travelers are on the average healthier than the general population, a different calculus should be applied in assessing the risks and benefits of Lariam as an appropriate malaria chemoprophylaxis. The presentation concludes by examining the role of industry bias, poor testing during development, and industry sponsored studies that were not reasonably calculated to find the suspected adverse events.

Learning Objectives: At the conclussion of this session, the audience will

• Be able to define the international business traveler as a cohort and understand the risk of malaria contraction;
• Evaluate the seminal studies that have purported to address the issue of neuropsychiatric adverse events among those who have taken Lariam and;
• Understand how industry bias, testing on populations that differed from the eventual consumer, and failure to actively seek neuropsychiatric adverse events have prevented acknowledging and remedying the problem.

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.