Mefloquine, side-effect of

This problem has been around awhile so I’m not sure why some Canadians are still taking this drug to prevent malaria. Surely better, less toxic, solutions have been developed. Click here to learn more or read an excerpt below.

 

SAFETY PROTOCOL IGNORED

Second, on 20 April the Auditor General told Parliament that, contrary to their assertions, DND “did not follow the prescribed safety monitoring study protocol for mefloquine.” The military brass “ordered soldiers to take the drug without their consent and did not systematically monitor for adverse reactions or provide records to the manufacturer.”

He also noted that even though Health Canada had approved the terms of the clinical trial for the drug, “it made no attempt to ensure that the protocol, with its reporting requirements and procedures to protect patients’ well-being, was being followed.”

Speaking the truth seemed effortless for the Auditor General. He did not succumb to the power of the drug.

Third, on 6 May, the manager of Health Canada’s Office of Strategic Planning and Quality gave evidence before the Standing Committee on Health, contradicting the Auditor General and claiming that DND did submit adverse reactions reports on mefloquine. She further testified that her department received the adverse reaction reports a second time when the manufacturer made its application to licence the drug.”

The truth is DND never provided adverse reaction reports for either Somalia or Rwanda. Furthermore Health Canada approved the drug in April 1993 without reliable Canadian safety data.

Finally, on 18 November, Brigadier General Claude Auger, Surgeon General and Commander of the Canadian Forces Medical Group, in testimony before the Public Accounts Committee, reported that Canadian troops in Somalia were carefully monitored for mefloquine side-effects, suggesting a real commitment by DND to handle the drug with care: “The unit leaders, medical personnel, and paramedical personnel were informed and vigilant for mefloquine and stress-related side-effects.”

The truth is there was no monitoring for mefloquine side-effects even though such side-effects were rampant in Somalia. Brigadier General Auger’s statements were simply incorrect.

SPECIAL AUTHORIZATION?

Before the same Parliamentary Committee, the Surgeon General and officials from Health Canada claimed that DND had mistakenly believed that they had special authorization to use an unlicensed drug.

The truth is the drug was fraudulently acquired and Health Canada knew it. DND had ordered the drug from the manufacturer claiming it was for use under a clinical trial authorized by Health Canada. The military brass carefully noted on the order form that the drug was being purchased under the authority of the safety monitoring study.

The fact that the drug was fraudulently purchased was kept secret by both Health Canada and DND.

When in the fall of 1997 W5, a CTV news program, documented that the drug had been acquired under the safety monitoring study, bells started going off. Everyone knew that there had been widespread problems in Somalia with mefloquine. What had not been known was that the drug used in Somalia was unlicensed for use in Canada and had been fraudulently acquired. In addition, it had been assumed that perhaps DND had not really understood the potential psychiatric problems generated by the drug. It was now clear that they had been acutely aware since 1991 of the serious side-effects of the drug.

Once the program was aired, senior Defence staff immediately admitted to their Minister that they had “mislead” the Somalia Inquiry on the status of mefloquine and the clearly identified problems related to mefloquine use.

The military brass advised their Minister to lie if asked about mefloquine. In a memo dated 27 October 1997, under the heading “If Pressed on Illegality of Administering Mefloquine,” they advised the Minister to suggest that the drug used in Somalia was acquired in Europe rather than fraudulently in Canada. Shockingly, mefloquine was causing senior brass to advise their Minister to lie.

Even after being mislead about the illegal use of mefloquine the Inquiry still concluded that “mefloquine use could have been a factor in the abnormal behaviour of some troops in Somalia.” If DND had told the truth and admitted they had fraudulently acquired the drug and ignored the precautionary safety protocols required by the study, the Inquiry might have recognized the impact of the uncontrolled use of a mind- altering drug like mefloquine rather than concerning itself with silly allegations of racism and winter tents in the tropics.

LIES AND CONSPIRACIES

There were others who lied and conspired to hide the truth: the special branch of Health Canada that licences drugs and monitors side-effects, the Health Protection Branch (HPB) operated on a “don’t ask and don’t tell policy” regarding the illegal use of mefloquine by DND.

HPB had authorized the safety monitoring study. A document that I acquired under the Access to Information Act reveals that by mid-1992 HPB was well aware that the safety study was not being complied with and was not producing useful data. Nevertheless, in April 1993 it approved the drug for distribution in Canada without ever getting proper safety data.

In October 1994 when I raised the mefloquine issue in Parliament, mid-level officials at HPB drafted a letter to DND demanding answers. Initially HPB denied the letter ever existed. Eventually I received a copy. The letter advised the Surgeon General “that records of adverse reactions arising out of the mefloquine safety trial [were] not complete.” The letter reminded the Surgeon General of the requirements of the Food and Drug Act and the commitments to monitor and report side-effects agreed to when DND signed onto the safety monitoring study.

The letter was never sent. Senior Health officials chose to ignore the problem.

Scott Smith, a Canadian Airborne soldier in Rwanda, committed suicide on Christmas Day in 1994. One of the first communique’s back to Defence Headquarters from Rwanda revealed that Scott’s problems with mefloquine began in Somalia where he suffered hallucinations and other problems.

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