Hon. Allan Rock, P.C., M.P.
Minister of Health
House of Commons
Ottawa, Ontario
KIA 0A6

Dear Minister:

I was troubled to read in the February 9, 1998 edition of the Defence Policy Review a comment by Hoffmann-La Roche, the manufacturer of mefloquine.

Hoffmann-La Roche claimed that its Lariam Safety Monitoring Study conducted under the requirements of the Food and Drug Act for your department's pre-licensing review of the drug "was not a rigorous study."

The article goes on to say that Hoffmann-La Roche "made clear, from the company's point of view, that they had no problem with the way DND had handled the mefloquine issue." I am concerned that the company has publicly flouted its duty and the duty of its investigation to obey the Food and Drug Act when conducting studies of new drugs.

You will recall that your department made an urgent request of Hoffmann-La Roche on October 20, 1994 for information on how the Safety Monitoring Study had been conducted in regard to the Department of Defence's use of mefloquine.

It would be appreciated if you might review the appropriateness of the published comment by a Hoffmann-La Roche official that the Lariam Safety Monitoring Study "was not a rigorous study" and that in the company's view "that they had no problem with the way DND had handled the mefloquine issue."

Yours truly,

John Cummins, M.P.

Your audit of the Health Protection Branch and its handling of the mefloquine issue can help re-establish public confidence in the licensing of new drugs.

Yours sincerely,