John Cummins, M.P. Delta-South Richmond

News Release

FOR IMMEDIATE RELEASE
May 11, 1999

Mr. Joseph Volpe, M.P.
Chair of the Standing Committee on Health
House of Commons
Ottawa, Ontario
K1A 0A6

Dear Chair:

I very much appreciated the courtesy your Committee showed me on May 6th when it allowed me to address the Health Protection Branch's handling of the antimalarial drug mefloquine. Concerns about the misuse of the drug and its side effects have been a matter of public concern since 1994.

The evidence presented to the Committee from Jan Pound, Manager of Strategic Planning, Communications and Quality at the Health Protection Branch deserves careful scrutiny. Ms. Pound testified that "DND did submit [adverse reaction reports] to us and we did see them also when the manufacturer made the formal application for approval of this drug." It would be reassuring if Ms. Pound's testimony were consistent with the facts but it is not.

The Auditor General in his April 1999 report stated: "However, not until October 1994, when the use of the drug by Canadian soldiers in Somalia became an issue, did Health Canada ask the manufacturer for copies of the records on the 69,000 doses of mefloquine provided to National Defence in 1992. The manufacturer did not have any such records, although the study protocol called for them to be provided to the manufacturer every six months...When [National Defence] could not provide the information, Health Canada took no action."

That is to say, Health Canada never bothered to inquire about the missing adverse reaction reports from DND, required under the Safety Monitoring Study, until there were media reports on the problem in October 1994. This was nearly two years after the Department had licensed the drug.

Records indicate that the Department became aware the safety data was not being reported to it by the manufacturer in August 1992, prior to DND's purchase of the drug for Somalia, yet it never took action to require the manufacturer to produce the safety data. Instead it proceeded with the licensing without Canadian safety data and with meagre foreign data as much of it was held by the US Army and never turned over to the Health Protection Branch.

The Department failed to give any oversight to the pre-licensing safety study. The drug was licensed with little or no Canadian safety data contrary to what the Department told the Committee on May 6th. Furthermore after licensing the Department has shown a marked lack of concern and attention to the widely reported side-effects of the drug in Canada.

Following the release of the Auditor General's damming report on the failures of the Health Protection Branch and the highly questionable information provided to the Committee on May 6th by the Branch, I would ask that the Committee take the opportunity review the Department's handling of the Lariam Safety Monitoring Study, its licensing of the drug without adequate Canadian safety information, and its embarrassing lack of awareness of side-effects since licensing.

Such a review would shed light on whether the Health Protection Branch's failures at every stage of its handling of mefloquine is symptomatic of a larger problem at Health Canada.

Consideration of this request to undertake a review of the Health Protection Branch's handling of the antimalarial drug mefloquine would be most appreciated.

Yours truly,

cc. Committe Members

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For more information, please contact:

John Cummins, M.P.
(613) 992-2957