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John Cummins, M.P. Delta-South Richmond |
News Release |
FOR IMMEDIATE RELEASE
DATE: March 24, 1999
Parliamentary Question on Mefloquine
OTTAWA--"This parliamentary question on mefloquine and the government response to it should aid the Auditor General and others who are reviewing whether or not the Minister of Health carried out his statutory duty to protect the public from health hazards and frauds in the use of drugs. In the matter of mefloquine, the evidence overwhelmingly indicates that the Minister failed in this duty," said John Cummins, M.P. (Delta-South-Richmond).
The question has been printed on the Order Paper as Question 226. Under the Standing Orders of the House of Commons, the government is to answer the question within 45 days.
"With regard to the recording and reporting of adverse events related to the use of the antimalarial drug mefloquine by the manufacturer, the Health Protection Branch and the Canadian Forces:
a. did the Deputy Chief of Defence Staff in May of 1995 make a finding that mefloquine was a contributing factor in the suicide death of a Canadian soldier in Rwanda in December of 1994, and did a United Nations inquiry come to a similar conclusion;
b. what problems with the use of mefloquine did the January 21, 1993 CF medical services unit's post-op report of the relief phase of the Somalia mission record, and what actions were taken as a result of these findings;
c. what problems with the use of mefloquine did the April 1993 CF medical services unit's post deployment report on the Somalia mission record, and what actions were taken as a result of these findings;
d. what problems with the use of mefloquine did the October 1993 CF medical services unit report, "Medical Operations in Somalia, Surgical Section", record, and what actions were taken as a result of these findings;
e. what reporting procedures did the doctors of the CF medical services unit in Somalia employ to ensure that soldiers exhibiting what the product monograph refers to as signs of unexplained anxiety, depression, restlessness or confusion discontinued use of the drug as such signs were to be considered prodromal to a more serious event;
f. what special reporting procedures did the doctors of the CF medical services unit in Somalia employ on the day that mefloquine was administered, normally referred to by soldiers as psycho-Tuesday or Wednesday etc., to establish whether soldiers were exhibiting what the product monograph refers to as signs of unexplained anxiety, depression, restlessness or confusion;
g. did the doctors of the CF medical services unit report to the manufacturer on a regular basis adverse events suffered by soldiers under their care who had been administered mefloquine between December 1, 1992 and December 1, 1995, and were these adverse event reports made available to the Health Protection Branch by either doctors of the CF medical services unit or the manufacturer;
h. did the Health Protection Branch regularly receive from the manufacturer mefloquine (Lariam) adverse event reports, how soon after the adverse event occurred did the manufacturer normally report the event, and how many such events were reported by the manufacturer to the Health Protection Branch since 1990 ;
i. how many mefloquine related adverse events were reported to the Health Protection Branch by either doctors or their patients since 1990;
j. did the doctors of the CF medical services unit have a responsibility to report to either the manufacturer or the Health Protection Branch, suicide or suicide attempts by soldiers under their care who had been administered mefloquine (Lariam);
k. what were the findings of the August 24, 1992 "Review of the Safety Report Update for the Lariam Safety Monitoring Study" by the Infection and Immunology Division of the Health Protection Branch, as regards investigators failing to return their completed case record forms to the manufacturer, and did this indicate that the safety data from the Safety Monitoring Study was incomplete;
l. following the August 24, 1992 "Review of the Safety Report Update for the Lariam Safety Monitoring Study" by the Infection and Immunology Division of the Health Protection Branch, what remedial steps were requested of the manufacturer so as to ensure the manufacturer required the investigators to comply with the reporting requirements of Safety Monitoring Study; and
m. following the shipment of mefloquine by the manufacturer to CFB Petawawa ordered for the Somalia deployment, was the CF medical services unit informed or reminded in any manner on any occasion by the manufacturer of the CF's responsibility to comply with the requirements of the Lariam Safety Monitoring Study as to administering the drug, recording adverse events and reporting them to the manufacturer or the Health Protection Branch and if so when?"
The question can be found on the House of Commons web site at www.parl.gc.ca/36/1/parlbus/chambus/house/orderpaper/ordq-e.html or on my web page at www.reform.ca/cummins.
The supporting documents that provided the basis for this question are available on request.
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For more information, please contact:
John Cummins, M.P.
(613) 992-2957