A Clinical Drug Trial Gone Wrong and the Unfinished Business of the Somalia Affair

As public awareness has grown in relation to the adverse health effects of the anti-malarial drug mefloquine in military veterans, much of the media attention has focused on a series of drug trials conducted by the Australian Defence Force in Bougainville and Timor Leste from 1998 to 2002. Although mefloquine is also known to have been widely used in the military forces of Canada, the United States, the United Kingdom and Ireland among others, what is less well known is that Canadian veterans were also subjected to a drug trial that seriously contravened numerous health regulations. This pre-license clinical trial involved the administration of mefloquine to 1,400 Canadian troops deployed to Somalia in 1992-1993 and played a significant role in a series of incidents that became known as the Somalia Affair.

During this drug trial many of the soldiers commonly experienced adverse psychiatric side effects of mefloquine. Two local Somali civilians were killed by members of the contingent, one of whom was shot and the other was captured then beaten to death, during episodes consistent with mefloquine intoxication. When photos of these incidents were released a public inquiry and criminal investigation were launched, resulting in one soldier attempting suicide, one being sentenced to five years in jail, and several others disciplined. The head of the Canadian military was forced to resign, as was his successor. The Minister for Defence also resigned. Most significantly of all, the entire Canadian Airborne Regiment was disbanded. Yet when the Somalia inquiry began to examine “the mefloquine issue” in 1996 it’s work was mysteriously “truncated” by the Liberal government:

THE MEFLOQUINE ISSUE

Mefloquine is a relatively new anti-malarial drug, first made generally available to the Canadian public in 1993. It is used both to prevent malaria (that is, as a prophylactic) and to treat malaria. Mefloquine is used in areas where the local strains of malaria have developed a resistance to other anti-malarial drugs. Somalia is one such place.

Some suggestion has been made to this Inquiry that mefloquine caused severe side effects, including abnormal and violent behaviour, among some Canadian Forces personnel in Somalia. We were not able to explore fully the possible impact of mefloquine. This would have required additional hearings dedicated specifically to the issue, which time did not permit. However, we report here our general findings about mefloquine and its possible impact on operations in Somalia.

It is clear that mefloquine caused some minor problems in Somalia, as might be expected from a review of the medical literature. We learned of several incidents of gastrointestinal upset, vivid dreams, nightmares referred to by soldiers as “meflomares”, and inability to sleep following the use of this drug. Side effects – or at least the minor side effects, and possibly also the major side effects – appeared to be most pronounced in the 24 to 48 hours after taking mefloquine.

If mefloquine did in fact cause or contribute to some of the misbehaviour that is the subject of this Inquiry, CF personnel who were influenced by the drug might be partly or totally excused for their behaviour. However, for reasons described more fully in Chapter 41, we are not able to reach a final conclusion on this issue. We can offer only general observations about the decision to prescribe mefloquine for personnel deployed to Somalia.

TRUNCATION OF THE INQUIRY AND THE UNFINISHED
MANDATE

Under the revised terms of reference given to us in the aftermath of the Federal Court of Canada decision characterizing as unlawful the Governments decision to curtail our Inquiry, we were instructed to report on the pre-deployment phase of the Somalia operation and were given discretion to report on all other matters in our original mandate to the extent that we deemed advisable. In compliance with this adjusted mandate, our report describes in detail all the many matters that we have been able to canvass in the time available. It also traces the outline of what we were originally asked to investigate but were unable to complete due to the truncation of our work.

There is an obvious public interest in discovering the answers to questions about the Somalia affair that remain unexplored.

Chapter 42 begins with an account of our efforts to gain the time needed to do justice to the Inquiry’s mandate. We go on to examine the Governments decision to truncate that mandate. We conclude with a review of the portions of the mandate that we were forced to abandon – the Inquiry’s unfinished business.

some of our work remains undone. We obviously could not address, in full detail, the overall post-deployment response of the chain of command to the problems encountered during the Somalia mission, and the behaviour of senior officers and officials for the purpose of assessing their personal accountability, because our hearings were brought to an end before the most important witnesses relevant to that issue and time period could be called.

… The Minister of National Defence at the time of the Government’s decision to truncate the Inquiry, Mr. Young, also asserted frequently and to our amazement, that all that needs to be known about “what happened” in Somalia is known. We continue to believe that important facts concerning the deployment and its aftermath are not yet known or remain obscure. We thought, because of its public statements, that the Government also believed that it was essential, and in the interests of the Canadian military and its renewal, to expose, understand, confront, and analyze the facts publicly and in an independent, non-partisan setting, as well as address all the important matters raised in the terms of reference. Obviously, we were mistaken, as the Government abandoned its earlier declared interest in holding to account senior leaders and officials who participated in the planning and execution of the mission and responded to the problems that arose. Once again, history repeats itself, in that only the lower ranks have been made to account for the marked failures of their leaders.

We fear that the implementation of hastily crafted and mostly cosmetic reforms, coupled with the abandonment of an interest in accountability or an implementation of reforms unrelated to specific facts and problems identified and assessed in a thorough, independent, and impartial process, will serve merely to postpone the day of reckoning that must surely come.

One of the few journalists to follow up on this use of mefloquine in Somalia was Peter Worthington, who wrote for the Edmonton Sun in January 1998:

Many believe mefloquine may have been responsible for some of the bizarre behavior of our troops in Somalia, since the drug was still in experimental stages in 1992 and not legally sold in Canada. W5 discovered that when the now-disbanded Airborne Regiment was sent to Somalia, Health Canada sanctioned the use of mefloquine (under the brand name Lariam, manufactured by Hoffman-La Roche) only on condition it was a controlled study with soldiers monitored and effects recorded.

None of this was done. As we now know, side-effects can lead to severe psycho-neurological problems. Dr. Michelle Brill-Edwards, a Health Canada drug regulator, quit in protest of possible dangerous psychiatric reactions – full-blown psychoses in cases, as well as hallucinations, nausea, nightmares, paranoia and suicidal impulses.

… Reform MP John Cummins is a vociferous critic of mefloquine, and speculates it could be responsible for Master Cpl. Clayton Matchee’s rampage when he beat a Somali prisoner to death in 1993. I’ve had soldiers, both serving and discharged, say their behavior was affected for a year or so after they had extended use of mefloquine in Somalia or Rwanda. Some are investigating a class action suit against the government.

Not given a choice, Canadian soldiers were ordered to take mefloquine in Somalia and Rwanda. One soldier, Scott Smith, who went from Somalia to Rwanda and was on mefloquine for most of a year, inexplicably committed suicide on Christmas Day, 1995.

… Getting back to Somalia, in October 1994 Hoffman-La Roche’s office in Mississauga formally notified DND it had received no response about shipments of mefloquine sent to the army in Petawawa, Ont., and the medical centre in Debert, N.S., in 1992. The understanding was that the military would be a “co-investigator” in a study that required them to “maintain logs of distribution,” complete with consent forms from soldiers.

Health Canada demanded an answer within 24 hours. DND responded that it did not consider troops to be part of a “safety monitoring study,” and no mefloquine consent forms were necessary for soldiers.

These documents weren’t given to the Somalia inquiry which, according to Cummins, wasn’t aware our soldiers were, in effect, guinea pigs for a drug at the time illegal in Canada.

What’s disquieting is that there seems no awareness in government circles that mefloquine, while effective against malaria, might indeed be dangerous, with unknown victims among our military.

The Auditor General of Canada did eventually investigate the conduct of this clinical trial, making a series of damning findings in its April 1999 report, summarised as follows:

National Defence participated in a clinical trial of an anti-malarial drug, but did not follow the study protocol when the drug was administered to Canadian Forces personnel deployed to Somalia. Despite a requirement in the protocol to do so, the Department did not obtain consent from the personnel who received the drug, did not systematically monitor for efficacy, and did not provide to the study sponsor records of the drug’s administration or reports of adverse reactions to the drug.

Once Health Canada approved the conditions for the clinical trial of the drug, it made no attempt to monitor the study to ensure that the trial was adhering to the protocol with its reporting requirements and procedures to protect patients’ well-being.

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Despite these findings, little or no action was taken to hold Department of National Defense or Health Canada medical officials to account. Now almost two decades later, with an extensive body research on mefloquine’s adverse neuropsychiatric effects now published, several of the key witnesses have again called for this matter to be properly addressed.

Among these is Dr Greg Passey, a former army psychiatrist who said in an interview earlier this year:

“I thought the military should be aware of — that the courts should be aware — that it has the potential to have an extreme effect on individual behaviour.

“I wrote a letter to the committee in January 1996 and stated my opinion that mefloquine had significant side-effects … of paranoia and aggression.”

“Unfortunately, the Liberal government shut down the inquiry the week before I was to testify. And that was the end of my involvement in the issue until now.”

Dr Passey had previously written to one of the affected Somalia veterans:

In regards to Kyle Brown, I still have a book about him and his time in the Airborne that I read in the 90s. Being a trauma therapist and reading about his upbringing and personality before being deployed to Somalia, there were a number of issues I would have liked to testify about at the Somalia Inquiry in regards to what appeared to be a dramatic change in his personality and behaviour. I would have testified that there was a high likelihood that the mefloquine altered his behaviour. I can’t remember now if any alcohol was involved but if it was, then even just a couple of beers (we were still allowed to drink on deployment back then) when coupled with the mefloquine could have had potentially disasterous effects on a person’s ability to curtail aggressive thoughts or behavior. I’m sorry I never got the chance to at least voice those concerns.

2013 interview with Dr Michele Brill Edwards about her experiences with Health Canada

Former Health Canada official Dr Michele Brill-Edwards, who resigned in protest over this issue, has also called for the government to properly recognise the harmful effects of mefloquine on these veterans:

The federal government should recognize the anti-malaria drug mefloquine was not used safely in a trial during the fateful Somalia mission and address veteran concerns, a former top Health Canada bureaucrat says.

The defence and health departments failed to do their due diligence when the drug was released under a clinical trial to 900 Canadian Airborne soldiers going to Somalia in 1992, Dr. Michele Brill Edwards says.

“We owe a duty to them to recognize mefloquine may have caused great harm,” Brill Edwards told The Journal in a rare interview on the subject.

“It’s high time we stopped pretending mefloquine was used safely.”

Most compellingly, John Dowe – an eye witness of the events in Somalia – described in an interview last year the psychotic behaviour of two of the soldiers involved in the killings, in addition to the overall conduct of the drug trial.

More recently, Mr Dowe has written about his determination to see the historical record of these events corrected to include the role played by mefloquine:

As a member of 2 Commando, The Canadian Airborne Regiment, I was one of the soldiers who witnessed the psychotic reaction of Master Corporal Matchee, and was ordered by him to remain and observe the carrying out of a standing, unlawful order. I carry with me the weight of that event to this day, and am haunted by it every day. In Brian Bergman and Luke Fisher’s piece titled appropriately enough ‘A night of Terror’ (Maclean’s, March 1994) the authors ominously wrote how ‘Canadians may never know the full story of what happened that March night of the 16th … they will almost certainly never understand why some members of Canada’s elite military force behaved so abominably.’

I believe I now understand why. Like the piece mentioned above, we in the Commando also called March 16th ‘Fright Night’. Then again, we called every Tuesday night that nickname – it was the weekday of issue for mefloquine. I have just recently connected with Trooper Brown and we have spoken at length. Prior, we had been separated after the incident for 21 years through his imprisonment, life, and other circumstances. Further, the psychologically dissociative symptoms from PTSD – and the lasting effects of mefloquine – conspired to prevent our meeting and subsequent discussion to break-down these events and grasp all the variables.

Time’s objective lens and new positive, supportive facts have also highlighted the need for further investigation. It is therefore my intention, with the full support and cooperation   of Mr Brown, to determine all causal factors involved in the play of actions of that frightful evening. Many families’ lives, military careers and no less than the full honour of a disbanded Canadian regiment, are owed a full account that your help – and the possible help of other supportive voices – will provide to this imperative. So we all can understand why … and heal.

A central component of the Trudeau Liberal Government’s recent election platform was this commitment to Canada’s veterans:

For a decade, Stephen Harper’s Conservatives have dishonoured us all by failing to uphold this sacred obligation. They have not been truthful to, or respectful of, our veterans …

A Liberal government will live up to our obligation to Canada’s veterans and their families. We will demonstrate the respect and appreciation for our veterans that Canadians rightly expect, and ensure that no veteran has to fight the government for the support and compensation they have earned.

The government’s commitment that “no veteran has to fight the government” has already proven hollow. Veterans Affairs Minister Kent Hehr has ignored repeated requests over the last six months from affected veterans to simply meet with them. A measure of the Trudeau government’s genuine commitment to Canada’s veterans will be the manner in which it addresses, or continues to ignore, this unfinished business from the Somalia Affair.


Related Stories

Sheila Pratt, Stop pretending mefloquine was used safely on soldiers: former top Canadian drug bureaucrat, Ottawa Citizen, 7 February 2016.

Sheila Pratt, Veterans anxious to hear from Hehr on mefloquine issue, Ottawa Citizen, 1 February 2016.

Sheila Pratt, New push for ban on mefloquine in the Canadian military, Ottawa Citizen, 29 January 2016.

Sheila Pratt, Life after Somalia: Kyle Brown, PTSD and the pastOttawa Citizen, 29 January 2016.

Peter O’Neil, Opposition MPs demand government act on dangerous anti-malaria drug, Vancouver Sun, 28 January 2016.

Peter O’Neil, B.C. military veteran calls for federal apology for controversial anti-malaria drug, Vancouver Sun, 27 January 2016.

Grant Lafleche, Put an end to mefloquine, The Standard, 24 December 2014.

Dave Lazzarino, The Canadian Airborne Regiment’s Somali Affair, 20 years later, The Edmonton Sun, 15 March 2013.

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About IMVAlliance.org

An international network of military veterans, families and friends affected by the health impacts of the neurotoxic antimalarial drug, mefloquine.
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One Response to A Clinical Drug Trial Gone Wrong and the Unfinished Business of the Somalia Affair

  1. Hervey Blois says:

    John Dowe, your unceasing drive and ability to connect this massive electronic social media conglomerate of website, FaceBook, and Twitter is no less than phenomenal.
    I am however, astounded at the ignorance of Minister of Veterans Affairs in his written statements to Dave Bona. In essence, he has “washed his hands” of any acknowledgement of wrongs done. Although perhaps true this is not directly a VAC issue, I would have thought he would have been more understanding and compassionate to the facts.
    Having said that, my hat is off to you for your continued efforts to this cause. I would furthermore like to extend a BZ to Claude Lalancette for his bold move in initiating the efforts that resulted in the formation of the Standing Committee on Veterans Affairs.
    In conjunction with Dr. Nevin, Dr. Ritchie, and Dr. Passey on 25 October 2016, this has created a hailstorm of activity in the Globe and Mail as well as other media concerns.
    The testimony of the witnesses on 27 October 2016, Including Claude Lalancette, John Dowe, David Bona, and Brandon Keets was ‘la piece de resistance’ of the joint effort of veterans across Canada to bring together these personal stories and deliverance of facts to the Canadian House of Commons.
    Almost ironically, the Somalia tour was dubbed Operation Deliverance. I highly doubt that anyone at that time would have though we would be working to deliver our own misfortunes to the Government of Canada.
    I would also like to thank the members of the ACVA for their questions and concerns throughout this process. There has already been positive action taken to this end. Even the Royal Canadian Legion has expressed written support.
    Job well done ladies and gentlemen, military and civilian alike. John, you are a true leader.

    Liked by 1 person

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