Today I want to bring to your attention another aspect of HPB's "don't ask, don't tell" policy on adverse reactions to mefloquine: its failure to account for 69,000 tablets shipped to the Canadian Forces in October 1992 under the Lariam Safety Monitoring Study.

How could HPB loose track of 69,000 mefloquine tablets that were ordered and shipped under a clinical study? That is enough to last 1000 men for more than a year. If the Study did not lose track of the tablets, how else can the fact that 69,000 tablets were missing and the regulator made no efforts to account for them either during their review of the Study's findings or during licensing?

Hoffmann-LaRoche consistently confirmed to HPB that the 69,000 tablets were ordered and shipped under the clinical study. Not only did Hoffmann-LaRoche inform HPB that the drugs were shipped under the Study, the company provided HPB with a copy of the order form which accompanied the shipment. That order form clearly states that the drug was for use under the "Lariam Safety Monitoring Study". The missing tablets were therefore always counted under the Study by those conducting the Study.

The Minister of Health has assured Parliament that Dr. Martin Tepper of the Canadian Forces "fulfilled his role as co-investigator for the Lariam SMS by submitting the required information related to the dispensing of mefloquine under the Lariam SMS within the CF to Hoffmann-La Roche and Health Canada. This information included a dispensing record for mefloquine and safety data (adverse events) on all travellers who received mefloquine within the Lariam SMS. Any serious adverse drug reactions (ADRs) were reportable immediately to both the Health Protection Branch and Hoffmann-La Roche."