John Cummins, M.P.
Delta-South Richmond
News Release

FOR IMMEDIATE RELEASE

 

May 6, 1998

 

Mr. Denis Desautels
Auditor General of Canada
240 Sparks Street
Ottawa, Ontario
K1A 0A6

Dear Auditor General:

Your office "aids accountability by conducting independent audits of federal government operations. These audits provide Members of Parliament with objective information to help them examine the government's activities and hold it to account."

You have indicated that in response to my request for an independent audit of the manner in which the Health Protection Branch (HPB) licensed mefloquine, particularly the part of the clinical trial known as the Safety Monitoring Study, that you have asked HPB officials to look into this matter and report back to your office with the results of their investigation.

As a result of an interview published in the Defence Policy Review (DPR) dated April 30, 1998 by an official of the Health Protection Branch, I have some concerns about a self-audit by HPB: "We undertook a review of the activities that took place in and around the approval of mefloquine, both for the safety monitoring study, as well as for the approval of the drug in general...We did find that given our responsibilities under the Food and Drug Act, and regulations that we did act in a way that was laid out in those regulations." DPR raised the issue with HPB because they were aware of the review you had requested. Self-serving audits and reviews of this sort do not enhance public confidence in the licensing of new drugs.

I am concerned that this department's audit of its own operations will not provide an independent assessment of the actions of HPB on mefloquine to determine compliance with the law. If HPB had properly audited the Safety Monitoring Study and the various reported adverse side-effects after licensing, I would not now be asking for an independent audit.

Yours sincerely,

John Cummins, M.P.

For more information, please contact:

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