Hon. John Reid, P.C.
Information Commissioner of Canada
112 Kent Street
Ottawa, Ontario
K1A 1H3

Dear Mr. Reid:

I submitted an information request, 98-A-469, on September 17, 1998 to the Department of Health for:

"copies of all documents (memos, briefings or notes) relating to results from the Lariam Safety Monitoring Study."

On April 19, 1999 the department provided me with a two page review of safety data for the Lariam Safety Monitoring Study, dated August 24, 1992. Nothing else has been received.

It is inconceivable that there is not further documentation as the Safety Monitoring Study was ongoing until 1993 and the safety data from the Study was integral to the licensing of Lariam (mefloquine). Licensing occurred in early 1993 and the drug was available for marketing within several months of licence approval. Once the drug was licensed the Safety Study would not have ended until all supplies ordered under the Study were either used up or returned to the manufacturer.

The August 24, 1992 document points to planned further discussions with the manufacturer to ensure the Safety Study operated within the requirements of the Food and Drug Act.

It would be appreciated if your office might follow-up with the Health Protection Branch so that we might receive the missing documents on the results of the Lariam Safety Monitoring Study.