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John Cummins, M.P. Delta-South Richmond |
News Release |
FOR IMMEDIATE RELEASE
November 4, 1997
Adjournment Debate on Mefloquine
Mr. John Cummins (Delta-South Richmond): Mr. Speaker, Canadian troops in Somalia were administered the experimental drug mefloquine. Military doctors got the antimalarial drug because they agreed to participate in a prelicensing safety monitoring study. They ignored their commitment.
The Minister of Health was asked on October 20 if any action under the Food and Drug Act had been taken by his department against either the manufacturer who was responsible for supervising the Safety Monitoring Study or the surgeon general who acted illegally in prescribing the drug.
The Minister and his department are responsible for the administration of the Food and Drug Act. They ignored the fact that military doctors used an unlicensed drug that commonly has neuropsychiatric side effects. It is a drug the World Health Organization has expressed concerns about, and I quote from a World Health Organization document:
"Mefloquine is taken out of recommendations, based mainly on the concern about the neuropsychiatric side effects of mefloquine. Such side effects are relatively rare, but were considered a particular concern in military personnel."
The World Health Organization withdrew its support for the military use of the drug in April 1992, long before Canadian troops were sent to Africa. But this is not simply about whether the World Health Organization withdrew its support for the use of mefloquine by military personnel before soldiers were ordered to take it. It is about what the Department of Health did after learning the law had been broken.
The Minister did not explain what action his department took in 1993 when it learned of the problems in Somalia. The Minister did not explain why his department took part in a cover-up of the illegal use of mefloquine.
Officials in the Department of Health believed in 1993 there was a direct connection between the use of mefloquine and the death of Somali teenager Shidane Arone and the attempted suicide of Master Corporal Clayton Matchee.
The Minister's reply to my question on the response of his department to the illegal use of the unlicensed drug in 1992 and 1993 was to tell the House that the decision to illegally use mefloquine in Somalia was based on the best evidence available at the time.
Wrong. DND ignored the law and ignored critical evidence from reputable source which I would be happy to make available to the minister. Furthermore, the minister asked the House to await the outcome of continuing investigations before coming to any judgment.
Officials at the Department of Health told us on October 20 and 21 that no research is being undertaken by either the Department of Health or DND.
Can the minister tell this House whether his officials are mistaken or whether he was mistaken when he informed the House that there were continuing investigations?
A cover-up occurred at DND and in his own department in 1993 and 1994 as to the illegal prescription of mefloquine by the surgeon general and its possible connection to the attempted suicide in Somalia of Master Corporal Clayton Matchee in 1993 and the suicide of Corporal Scott Smith in Rwanda in 1994. These were Canadian soldiers who deserved better.
I hope this Minister is not trying to continue the cover-up of this illegal use of the unlicensed drug or to protect officials who had licensed mefloquine in 1993 at about the time the notorious events in Somalia became public.
The licensing was done based on an incomplete Safety Monitoring Study. Telling this House there is an investigation under way into mefloquine when his own officials deny any study is now under way does not help us get to the truth.
The Minister of Health did not acknowledge the drug was used illegally. Instead, the Minister said there was an ongoing investigation. Presumably he is talking about an investigation that has been ongoing since 1993. If so, even the Minister's infamous Airbus investigation did not take that long.
I would ask again whether the Minister can tell the House whether his officials are mistaken or whether he was mistaken when he informed the House there were continuing investigations. Furthermore, I would ask that he document for the House what action his department has taken with regard to the illegal use of mefloquine by the surgeon general and the failure by the manufacturer to carry out a proper Safety Monitoring Study.
Mr. Joseph Volpe (Parliamentary Secretary to Minister of Health): Mr. Speaker, I am pleased to respond to the hon. member regarding the antimalaria drug Lariam mefloquine and its availability to the Canadian Armed Forces in Somalia.
As he knows, Lariam has been and continues to be used and recognized worldwide as one of the most effective drugs for the prevention and treatment of a form of malaria resistant to most other antimalarial drugs. Estimated at over 2 million deaths each year, malaria is one of the world's greatest killers.
Prior to its marketing approval in 1993, Lariam was available to travelling Canadians through an open access clinical trial, referred to as a Safety Monitoring Study. The study provided Canadians with early access to a drug where few alternatives were available and monitored potential side effects of the drug in the interests of patient safety.
In 1994 Health Canada took immediate and affirmative action when media reported claims of several incidents where lariam may have been involved in Somalia. The Department of Health requested the sponsor to provide all information and adverse drug reaction reports as required under the Safety Monitoring Study.
According to Health Canada directives, researchers involved in clinical studies and attending physicians are bound to report without any exception any significant adverse reaction to drugs. The results of the monitoring study on drug safety, combined with recent information in scientific literature, confirm the prescribing information approved by Health Canada for Lariam.
The decision to use Lariam as a first choice therapy is a matter of responsibility for the patient. It is for the prescribing physician to decide in consultation with the patient whether a drug's potential benefits outweigh the risks.
I am sorry I could not answer.
Source: Hansard, November 4, 1997
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For more information, please contact:
John Cummins, M.P.
(613) 992-2957 or (604) 940-804