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: a failure to monitor adverse reactions either during pre-market evaluation or as part of post-approval surveillance.

HPB has been only able to account for a total of 25 adverse reaction reports.

Their 1997 list of adverse reactions fails to include the hundreds of often disabling adverse reactions suffered by Canadian soldiers in Africa between 1992 and 1995. The Forces could have provided several hundred such reports but were apparently never asked to do so. Even if such requests had been refused, the publicly available CF medical reports reveal a vast problem for the regulator. Such documents are likely to be as reliable as "unconfirmed newspaper" reports. HPB's job is to document adverse reactions rather than hiding from them.

The report of the Summary Investigation into Scott Smith's suicide included an amazing amount of detailed testimony showing wide spread adverse reaction to the drug as well as a signed statement from a CF medical doctor, expert in mefloquine issues. CF records reveal a 1995 acknowledgement of the reality of adverse reactions by the Deputy Chief of Defence Staff.

In addition there are now a significant number of publicly available CF medical reports outlining the adverse effects of mefloquine in Somalia. These reports detail "intolerable side-effects" involving "paranoia", "attempted suicide", "brain disorders", "hallucinations", "mood alteration", and "severe depression".

HPB's file of adverse reactions fails to record or show any awareness of these well documented events by CF doctors in the field. Nor does the record show the adverse effects that occurred prior to soldiers leaving or after they returned to Canada.