On November 20, 1997 I recommended that your audit of the Department of Health's Health Protection Branch (HPB) include an audit of the decision-making and compliance with the requirements of the Food and Drug Act with regard to mefloquine's pre-market evaluation, mechanisms for monitoring adverse drug reactions and post-approval surveillance.

Today I want to bring to your attention HPB's troubling lack of awareness of a mefloquine-related suicide by a Canadian soldier on December 25, 1994. The Canadian Forces conducted a Summary Investigation and concluded that mefloquine was a contributing factor in the suicide. Yet HPB's only knowledge of a highly publicized suicide triggered by long term mefloquine use was "an unconfirmed newspaper report".

That Summary Investigation also revealed that a significant number of soldiers were having troubling reactions to the drug.

HPB claims to have mechanisms for monitoring adverse drug reactions and ensuring post-approval surveillance. With regard to mefloquine, these mechanisms are clearly not working. While HPB is to be congratulated for reading the newspapers, surely the media reports on Scott Smith's suicide and the assumed mefloquine role in his suicide ought to have triggered follow-up by the Branch. The newspaper report might have been the beginning of the matter but it ought not to have been the end of the matter. This is not the first time long term mefloquine use by Canadian has lead to suicide or attempted suicide.

HPB failed in its responsibility to monitor adverse reactions to mefloquine. HPB does not appear aware of the evidence and findings of the Summary Investigation into Scott Smith's suicide in Rwanda.