I would refer you to my letter of November 20, 1997 regarding your audit of the Health Protection Branch (HPB) of the Department of Health. In my letter I expressed concern about HPB's decision making and compliance with the requirements of the Food and Drug Act with respect to the anti-malarial drug mefloquine, specifically pre-market evaluation, mechanisms for monitoring adverse reactions, and post-approval surveillance.

Today I want to bring to your attention evidence of the failure of the HPB to oversee the Lariam Safety Monitoring Study so as to ensure compliance consistent with the Food and Drug Act. Furthermore, the HPB licensed mefloquine even though it was fully aware that the safety data was incomplete and thus unreliable.

An August 24, 1992 "Review of Safety Report Update For the Lariam Safety Monitoring Study" by the Infection and Immunology Division of HPB revealed "investigators [were] not returning their completed case record forms...This indicate[d] that the safety data from the Canadian study [was] incomplete."

Even the incomplete safety data revealed that most reported adverse events were neuropsychiatric, both central nervous system and psychiatric, not unlike the adverse events that occurred in Somalia. If HPB had given effective oversight to the Safety Monitoring Study, the manufacturer would have been forced to comply with the law and as such the matter of the misuse of mefloquine by the CF in the Somalia deployment would not have arisen.

The HPB proceeded with the licensing of mefloquine even though it was aware that the safety data from the Safety Monitoring Study was incomplete. It therefore proceeded with the licensing of the drug without any reliable safety data on its adverse effects on Canadians.