Press Release

ISSUE

On 14 Oct 97, CTV-W5 reported that the military administered illegally mefloquine, an anti-malarial and experimental drug, to CF troops in Somalia in 1991-1993. CTV-W5 noted that while the CF had access to mefloquine through a safety monitoring study, they failed to follow the rules of seeking informed consent and monitoring the side-effects of the drug and reporting to the manufacturer.

PROPOSED RESPONSE

	Given operational requirements and the risk of contacting malaria outweighing the known potential side-effects of mefloquine, the use of mefloquine was, and remains today, the appropriate antimalarial drug to use.
	Knowing the side-effects of mefloquine, our troops received oral briefings on the risks of malaria and the need to take prescribed drugs, and were advised to report any significant problems to their medical unit.
	Canadian Forces deployed to Somalia in December 1992. Mefloquine was licensed by Health Canada shortly thereafter in January 1993 and it became available for sale in March 1993.
	In the case of Somalia, mefloquine was prescribed to our forces under the assumption, now seemingly false, that Health Canada and the drug manufacturer had agreed to its use outside the study by our troops.
	There was no intention to acquire or use mefloquine under false pretences.
	Mefloquine had been recommended for use by international experts and agencies, including the Centre for Disease Control in Atlanta, Georgia and the World Health Organization, as will as our own Health Canada Committee to Advise on Tropical Medicine and Travel (CATMAT).
	It is also the drug of choice of many other countries for their tourists and their armed forces. Other countries who used mefloquine include the United States and Britain.

IF PRESSED ON ILLEGALITY OF ADMINISTERING MEFLOQUINE

	Mefloquine was acquired legally. Under the National Defence Act, the Chief of Health Services is responsible to protect CF members from disease threats in deployment areas, and in discharging vaccines and medications which ensure the health and well-being of our troops.
	Mefloquine was licensed in Europe and could have been acquired outside Canada for use in Somalia. Although the regulators of the Canada Food and Drug Act do not have jurisdiction outside Canada, and thus would not apply in Somalia, it is usual practice for DND to seek approval from Health Canada for use of unlicensed products.

BACKGROUND

	Safety Monitoring Study: Under the terms of the Safety Monitoring Study, certain protocol procedures had to be followed including monitoring use and distribution of mefloquine and any possible side effects, as well as seeking informed consent from participating Canadian Forces members.
	In the case of Somalia, given operational requirements and that the significant risk of contracting malaria outweighed the possible side-effects of mefloquine, written informed consent was not sought. It was assumed that this decision had been agreed to by Health Canada and the drug manufacturer. Of note, before Somalia, such consent was sought as part of protocol procedures of the Study; in addition, it must be noted that oral briefings were nonetheless given to our troops going to Somalia on the risks of malaria vis a vis mefloquine.
	In sum, National Defence should have simply informed the manufacturer and Health Canada of its intent to proceed with the use of mefloquine outside the parameters of the Study.
	Side-effects: As with all drugs, mefloquine has side-effects, which are know to occur in up to 25% of people taking the drug. These side-effects are usually mild and diminish after several doses and include nausea, diarrhoea and abdominal pain, dizziness, and vivid dreams. Fewer than 1% of individuals need to be changed to an alternate medication. Serious (neuro-psychological) side-effects are rare, occurring only in 1 in 10,000 individuals.
	Other anti-malarial drugs are used by the CF, including chloroquine which is most frequently used anti-malarial used in the CF; mefloquine or doxycycline are used in areas where malaria is known to be resistant to chloroquine. Knowing the side-effects of mefloquine, pilots in Somalia were prescribed doxycycline. However, doxycycline can cause severe photosensitivity (exaggerated reaction to sunlight) - which is a serious side- effect in Africa.
	Whenever a medication is distributed to CF members, health care personnel will advise the member to report unexpected reactions or side-effects. CF members are informed of the side effects either in large group briefings as part of the Departure Assistance Group or on small scale by the pharmacist or medical officer on a one-to-one basis. The continued or repeated use of any medication after experiencing side-effects depends on many factors, including the severity and risks of previous and future side-effects, benefits expected from medication, and availability and risks of alternate medication. The usual practice is to switch members who experience intolerable side-effects to alternative medication whenever available.
	Post-Operation Follow-up: Though no specific post-operation follow-up was done for members prescribed mefloquine, a post deployment medical is conducted which includes a questionnaire and a physical examination; at this time returning members have the opportunity to report verbally or in writing the symptoms or side-effects they did, or continue to, experience.
	Mefloquine and Alcohol: Some of the side-effects of mefloquine, noted above, are comparable to, and may be enhanced by, alcohol. However, the Canadian Forces and the medical community have long recognized that drugs and alcohol should not be mixed; this is reflected in operational briefings and regulations.
	Somalia Commission of Inquiry - Mefloquine: The Commission examined the possibility that severe side effects caused by mefloquine, including abnormal and violent behaviour, may have had an impact on operations in Somalia. Noting that they were not able to explore fully the possible impact of mefloquine, the Commission's report states that they were not able to "reach a final conclusion on this issue" and that "DND's decision in 1992 to prescribe mefloquine for CF personnel deployed in Somalia appears to be consistent with the medical practice at the time." Finally, while stating that "mefloquine use could have been a factor in the abnormal behaviour of some troops in Somalia", the Commission concedes that "further investigation is warranted before any such conclusions about the role of mefloquine [in Somalia] can be drawn."
	In addition, evidence before the Somalia Inquiry indicates that all approvals had been obtained for the use of mefloquine. It must be noted that there was no intention to mislead the Commission. Until recently, it was believed that the Surgeon General Branch had informed Health Canada that the mefloquine was being dispensed without the consent of individuals -- even the directorate which authorized the use of mefloquine in Somalia was under this misconception. Those actions appear not to have taken place as no documents requesting or approving the change can be found. (emphasis added)