Several weeks ago I filed a post here on Battleland linking U.S. Army Staff Sergeant Robert Bales to possible use of the anti-malarial drug Lariam. He is the soldier who pled guilty last month to killing 16 Afghan civilians in March 2012. The post was based on a heavily-redacted report of adverse events, or negative side-effects, compiled by the drug’s manufacturer, Roche, and submitted to drug regulators.
My colleague, Dr. Remington Nevin, had received that initial report from the group Action Lariam for Irish Soldiers (firstname.lastname@example.org) as part of a larger release of files from the Irish Medicines Board. Knowing that Roche would have shared this report with international regulators, Dr. Nevin subsequently requested the corresponding FDA report through a Freedom of Information Act (FOIA) request, and recently received it.
The unredacted report indicates Roche received the original adverse event report from a pharmacist, which we did not know before.
The report says:
Initial Information for this Spontaneous case, AER number 1054403, was received on 29/Mar/2012 from a Pharmacist and concerns a patient of unknown demographics who was treated with Mefloquine Hydrochloride (Lariam) for an unknown indication. Medical history included TBI (Traumatic brain injury). No concurrent illnesses were reported. No concomitant medications or past drugs were reported. On an unknown date, the patient started Mefloquine Hydrochloride (dose, form and frequency not reported). On an unknown date the patient who was a soldier in the US Army developed homicidal behavior and led to Homicide killing 17 Afghanis. It was reported that this patient was administered Mefloquine in direct contradiction to US military rules that Mefloquine should not be given to soldiers who had suffered TBI (Traumatic brain injury) due to its propensity to cross blood brain barriers inciting psychotic, homicidal or suicidal behavior. The outcome of Homicide was not Reported. There was insufficient information regarding the therapy ongoing status of Mefloquine Hydrochloride. The reported did not provide the seriousness criteria of the event of Homicide and its causal relationship with Mefloquine Hydrochloride. The company assessed the event of Homicide as medically significant. No further information was available.
Several journalists contacted me after my earlier post. A recurring question has been: “Why didn’t Bales’ lawyer cite Lariam, if, as the document suggests, he were taking it?”
We do not have a good answer. We asked Bales’ lawyer that very question prior to that earlier post, but never got a response.
So what do we make of all this? Frankly I still do not know. Might this report simply be incorrect? Or did Bales accept a plea deal in exchange for not raising the Lariam issue?
I am not a big believer in government conspiracies. Rather what I have seen is that the right hand often does not coordinate with the left.
Mefloquine use has been previously linked to violent conduct, but never to such a notorious event. Given the enormous public-health and political implications that would come with confirmation of this report, this latest news makes more urgent the question of whether or not mefloquine helped fuel Bales’ massacre.
If his lawyers won’t answer that simple question, the U.S. military should.