Poison Pill: The Story of mefloquine From The Laboratory To The Courtroom

Part 3: Psycho Tuesday and Wacky Wednesday

In the May 8th, 1989 edition of the New York Times, an insignificant-looking article is reporting the FDA approval of the new anti-malaria drug, Lariam. It notes the drug’s developer, the Army Medical Research and Development Command, as well as Hoffmann-La Roche and the World Health Organization, both of whom collaborated on the project with the army.

It goes on to state further that malaria infects between 300-400 million people annually, and 3-5 million will die of the disease. American world travellers can now do so without fear of contracting malaria, thanks to the good people at Roche Pharmaceuticals, the WHO, and the United States Army.

A Warning Goes Unheeded

Then, in November, a letter was sent to the New England Journal of Medicine by three doctors from the Centres for Disease Control in Atlanta. It is the first appearance in the literature of mefloquine-induced psychosis as an adverse reaction. To quote the article:

The recent licensure of mefloquine in the United States has important implications for the protection of visitors to areas with chloroquine-resistant P. falciparum malaria. To clarify the absorption and metabolism of mefloquine, we conducted a pharmacokinetic study in healthy American adults. We found an unexpectedly high rate of adverse drug reactions.

 Three subjects (43 percent) had neurologic symptoms that were severe enough to impair normal functioning for 3 to 14 days. All reactions were transient and resolved spontaneously. Individual reactions varied greatly and did not correlate with blood mefloquine concentrations or pharmacokinetic variables (elimination half-life, peak concentration, and time of peak concentration; 

The level of the acid metabolite peaked at 14 days, long enough after the onset of adverse reactions to suggest that the symptoms resulted predominantly from the parent drug.

The high incidence of neurologic impairment after a therapeutic dose of mefloquine is a cause for concern, and it appears to be substantially higher than that found previously. In French travelers receiving mefloquine for malaria, the drug has been reported to cause severe neurologic toxicity, including seizures and psychosis.6 , 7 More information must be gathered to determine whether such reactions occur with the prophylactic use of mefloquine. Such side effects could dissuade the traveler from complying with the prophylactic regimen. It also must be determined whether psychomotor function is sufficiently impaired to pose a risk for persons using mefloquine.

Leslie C. Patchen, M.S.
Carlos C. Campbell, M.D., M.P.H.
Sharyon B. Williams, B.S.
Centers for Disease Control, Atlanta, GA 30333

It would be a bombshell revelation. Previous clinical trials had demonstrated very low rates of adverse events, and this report flew in the face of the findings from the other trials.

Another letter was sent to The Lancet in April 1990 by doctors from the Armed Forces Institute of Medical Sciences in Bangkok which read in part:

Neurological reactions, ranging from dizziness and inability to concentrate to psychotic reactions,” after mefloquine treatment and prophylaxis have raised the question of the risks of mefloquine prophylaxis. This is of special concern to doctors who have to recommend prophylaxis for those travelling to regions with multiply resistant Plasmodium falciparum. We report our experience with mefloquine prophylaxis in US soldiers training in Thailand for 6 weeks in 1988.

Armed Forces Institute of Medical Sciences, Bangkok 10400, Thailand JAMES D. ARTHUR G. DENNIS SHANKS PETER ECHEVERRIA

A pattern was beginning to emerge. In the first three years of the 1990s, hundreds, perhaps thousands of studies and trials were being conducted on mefloquine, testing it in various combinations and in various scenarios. It was typically performed well in these studies, and although there were reports of severe psychological effects, these were reported as being rare, and usually, another factor is thought to be involved such as drug or alcohol abuse.

But letters were starting to be seen in a myriad of medical journals, that were contradicting the positive results of the studies. They were all saying the same thing, which was that mefloquine was a dangerous drug to be avoided. Unfortunately, those warnings went unheard, or unheeded, and in 1993 it would lead to tragedy.


Somalia Civil War, 1992

In 1992, Somalia was a lawless failed state, ruled by warlords. In order to help establish order, the United Nations-sponsored a humanitarian effort that would also monitor a brokered cease-fire in the country. It was known as UNOSOM I, and would run until December of that year.

It was replaced by UNITAF, the United Task Force, which was not run under the auspices of the UN, but rather was a task force spearheaded by the U.S., with other countries, including Canada, participating. The Canadian contingent would consist of a battle group from the Canadian Airborne Regiment.

From the outset, the Canadian mission was plagued by controversy. The selection of the Airborne Regiment for this particular assignment was a matter of great discussion and debate, and the argument is still made today. Initially, the mission was intended to be strictly of a humanitarian and peace-keeping nature, but things began to become complicated when the mission would later allow for the troops to be fully armed, and they began to prepare for a combat mission. The continual changes to the rules of engagement would contribute to the stressful situation on the ground.

This made the Airborne Regiment an odd choice for this assignment. Typically, peace-keeping missions will involve unarmed troops, they carry their weapons but they are not loaded. The requirements involve observing a more defensive posture, such as setting up camp perimeters, conducting routine patrols, observing activity, as well as performing a number of humanitarian tasks in the surrounding area. These duties are part of being a soldier in an infantry regiment, like the Princess Patricia’s Canadian Light Infantry, who had a great deal of experience in conducting peace-keeping operations at the time.

The Airborne Regiment however was different. Meant to be the “tip of the spear” in combat operations, the Airborne Regiment consisted of the best of the best from all three Canadian infantry regiments. Like all elite military forces, they were a highly trained and motivated machine, whose sole purpose was to kill. It takes a certain mindset to do a job like that, and it gets drilled into these troops relentlessly. Many, including myself, felt and still feel that it wasn’t an appropriate choice and that it ran counter to conventional military doctrine and thinking.

Another controversy arose when it was discovered that the regiment had some serious issues with racism. It had been well established that racist and white supremacist elements existed within the regiment. In the portraits of Airborne members from that period, a Confederate flag can be seen hanging in the background beside the Canadian flag. The regiment was also known to have problems with discipline, and there were questions as to whether officers were exercising proper control over their troops.

Nevertheless, the regiment would be sent to Somalia in December, but before they left the men had to begin malaria prophylaxis. The drug they were given hadn’t been approved for use in Canada at the time, and so they were to be given the medication as part of a clinical drug trial. The drug was mefloquine.

Drug Mistrial

Establishing a Machine Gun Emplacement, 1993

The facts are laid out in an article in the Lancet, one of the oldest and most respected peer-reviewed medical journals in the world. An article in the May 1999 edition gives the details about how the military acquired the drug, and the impression that I am left with is that it did so through fraudulent means.

The medication had been given to the military by the sponsor of the study, presumably the manufacturer. In order to participate in the study, strict reporting protocols have to be adhered to. Detailed records would need to be kept, adverse reactions would need to be reported immediately, and symptoms thoroughly documented. The health records of the participants would also have to be checked to screen for potential problems, such as a history of depression or other mental illnesses.

What happened next could be summed up with an expression often used in the military. It was a cluster-fuck. There was no effort whatsoever to record anything, measure anything, observe anything, or report anything. The men were told that they were being given an anti-malarial drug, and were told what the potential side effects were as they appeared on the monograph. They were unaware of the fact that they were supposed to be taking part in a clinical trial, and had not been given the proper informed consent.

Speaking as someone who is not in the legal profession, common sense tells me that two crimes have been committed here. First, the military acted with a blatant disregard for the lives of these men that resulted in harm and is also culpable in the deaths of two Somali teenagers. Second, by obtaining the drugs for the study had never intended to perform the work required, they committed fraud by deception. I realize that there will never be any recriminations for this, but I figured I’d put it out there anyway.

It is clear from the evidence gathered to this point, that many of the soldiers who were in Somalia were suffering severe adverse reactions to mefloquine. There are accounts of men experiencing hallucinations, psychosis, severe depression, and other severe psychological symptoms. The symptoms were the worst on the day they received their weekly dosage of mefloquine. Depending upon the day of the week, these days were known among the men as either “Psycho Tuesday” or “Wacko Wednesday”.

It is evident that mefloquine played a major role in the events that took place in Somalia, in fact, I’d go so far as to say that two Somali teens would not have been killed, Master Corporal Clayton Matchee wouldn’t have attempted suicide, and Trooper Kyle Brown wouldn’t have spent time in prison. It is also likely that the Airborne Regiment wouldn’t have wound up being disbanded in disgrace.

Reopening the Somalia Inquiry

Somalia Commission Chairman, Justice Gilles Letourneau

The Somalia Commission of Inquiry ended in 1997, unfinished and incomplete. The overwhelming body of evidence about mefloquine needs to be added to the record, and the final report amended to reflect the new information.

Perhaps most importantly, this information must be considered when taking into account the miscarriage of justice that has occurred with regard to Clayton Matchee and Kyle Brown. They have carried the burden of the blame for what happened, and their names need to be cleared. Their actions were reprehensible, but in the absence of mefloquine they would not have occurred.

Since only the Prime Minister and cabinet are capable of doing so, I am calling upon them to re-sit the Commission and give Justice Letourneau a new mandate. Justice demands it, and so do a large number of veterans and the Canadians who support them, like me.


In part 4, Afghanistan, quinism, and lawsuits.

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