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FDA Knew Army Sgt. Took Malaria Drug Known for Neurological Side Effects
Judicial Watch ^ | June 21, 2013

Posted on 06/21/2013 1:14:06 PM PDT by jazusamo

Judicial Watch has obtained new information indicating that the U.S. government is likely covering up a scandal involving an Army sergeant who apparently took a controversial anti-malaria drug—in contradiction to guidelines—before going on a rampage in Afghanistan.

The 39-year-old married father of two, Sergeant Robert Bales, was on his fourth deployment in a decade when he attacked and murdered 16 Afghan civilians (initial reports said it was 17) on March 11, 2012. Judicial Watch immediately launched an investigation and obtained documents from the Food and Drug Administration (FDA) that raised huge suspicions that Bales may have been given the anti-malaria drug, mefloquine hydrochloride, long known for its severe neurological side effects.

The Department of Defense (DOD) has refused to confirm or deny if Bales took mefloquine, but the FDA records obtained by JW indicate that he probably did because he was an otherwise “affable” man who became uncharacteristically psychotic and aggressive, a change common among those treated with mefloquine. The files detail more than 2,000 episodes of adverse reactions to mefloquine during a 15-year span, including 87 deaths associated with the drug. Of the deaths, 39 were recorded as suicides by the agency and a dozen as homicides.

This is why in 2009 the DOD removed mefloquine as the drug of choice in the treatment of malaria. Furthermore, the drug is specifically prohibited in the treatment of patients with head injuries, and in particular, a traumatic brain injury (TBI). It is also contraindicated for patients with post-traumatic stress disorder. Bales reportedly suffered a traumatic brain injury in Iraq in 2010. If so, DOD policy would have prohibited administration of the drug to Bales.

Now a report submitted to the Irish Medicines Board practically confirms that mefloquine was administered to Bales in contradiction to the guidelines because he had suffered a documented TBI. The document was made public by a longtime Army psychiatrist, Dr. Elspeth Cameron Ritchie, who retired in 2010 and heads the District of Columbia’s Department of Mental Health. In a national news magazine, Dr. Ritchie writes that important details have been redacted in the report and Bales isn’t mentioned by name, “but it’s unlikely there was another soldier with a traumatic brain injury in this time frame connected to 17 homicides (that was the original number; further investigation concluded 16 people had died).”

The document describes a negative side-effect to a medication and in this particular case details a “medically confirmed” event of homicide by a soldier taking mefloquine. It suggests that on March 29, 2012 the company that makes the drug, Roche, received a report that someone involved in the homicide of 17 civilians had been taking mefloquine. On April 11, Roche forwarded the document to the FDA, as it is required to do.

Dr. Ritchie is not surprised in fact, a week after Bale’s 2012 rampage the former veteran Army psychiatrist questioned whether the sergeant was on the anti-malaria drug, writing this in the same publication: “In the national quest to understand what motivated Army Staff Sergeant Robert Bales to leave his compound in the middle of the night, and allegedly gun down 16 men, women and children, there have been many motives already put forth. These include a “witches brew” of post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), marital problems, alcohol use, seeing a friend wounded, anger over frequent deployments, and not getting a promotion.”

She continues: “Yet none of these seem sufficient, especially given the reports of a sunny, affable man who had two small children. I would like to introduce a few other ideas, related to the concept that he might have had a brief psychotic episode. Psychosis means being out of touch with reality, having delusions or hallucinations, either because of medication or other brain insults.

“When I am examining a patient whose crimes seem out of character, which I do as a forensic psychiatrist, I always want to know if their behavior was due to a medical illness, medication, or illicit alcohol or drug use. One obvious question to consider is whether he was on mefloquine (Lariam), an anti-malarial medication. This medication has been increasingly associated with neuropsychiatric side effects, including depression, psychosis, and suicidal ideation.”

Earlier this month Sergeant Bales pled guilty, avoiding a trial that perhaps could have shed more light on what really happened. During his military court hearing, Bales said he couldn’t explain why he did it. “I’ve asked that question a million times since then, and there’s not a good reason in the world for why I did the horrible things I did,” he told the military judge. He is will probably spend the rest of his life in prison.

If, as the Irish Medicines Board report indicates, mefloquine was administered to Bales in contradiction to the guidelines, the Army certainly has some culpability in the massacre. Records obtained by JW reveal that, despite its directive to limit the use of mefloquine, the DOD is buying large quantities. Since 2010 the agency purchased 2,250,925 tablets of the drug at a cost of $5,487,130 over a period of 27 months, according to the records obtained by JW from the Defense Logistics Agency.


TOPICS: Foreign Affairs; News/Current Events
KEYWORDS: bales; fda; usarmy
If true the Army certainly has some culpability in this.
1 posted on 06/21/2013 1:14:07 PM PDT by jazusamo
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To: smoothsailing; Lancey Howard; Future Snake Eater

Ping!


2 posted on 06/21/2013 1:15:13 PM PDT by jazusamo ("Mercy to the guilty is cruelty to the innocent." -- Adam Smith)
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To: jazusamo

There was a Law and Order: SVU episode about this exact thing.


3 posted on 06/21/2013 1:15:48 PM PDT by autumnraine (America how long will you be so deaf and dumb to thoe tumbril wheels carrying you to the guillotine?)
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To: autumnraine
There was a Law and Order: SVU episode about this exact thing.

It was obviously "ripped from the headlines."

4 posted on 06/21/2013 1:18:53 PM PDT by E. Pluribus Unum (Religious faith in government is far crazier than religious faith in God.)
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To: jazusamo

I’ve taken mefloquine before. I can well believe the psychotic episodes. It is a bad drug.


5 posted on 06/21/2013 1:23:29 PM PDT by Jemian
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To: Jemian

Thanks, I’m totally unfamiliar with it other than what’s written here and it sounds bad.


6 posted on 06/21/2013 1:25:41 PM PDT by jazusamo ("Mercy to the guilty is cruelty to the innocent." -- Adam Smith)
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To: jazusamo
If true the Army certainly has some culpability in this.

More than a little bit I'd say.I once took a malaria drug (can't recall the name) that had serious side effects.IIRC I was also acting a bit strangely...having some anger when I'm not ordinarily the angry type.That anger didn't result in any serious problems...just some hurt feelings,a few dirty looks and a short talk with a couple of cops (who didn't arrest me or anything).When I came off of the drug I was back to normal.I shudder to think what might have happened if I was in a combat zone when I was taking it.

7 posted on 06/21/2013 1:26:44 PM PDT by Gay State Conservative (The Civil Servants Are No Longer Servants...Or Civil.)
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To: jazusamo
Back at the beginning of the Afghan campaign guys were coming home shooting up their family. Some blamed the malaria meds, others Jody. It was probably a combination of the two.
8 posted on 06/21/2013 1:26:54 PM PDT by Theoria
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To: jazusamo

Mefloquine can be very bad for some folks. I had a horrific reaction to the stuff while in the Congo. Flushed it down the toilet, and decided to take my chances with malaria. The regional medical officer at the embassy was surprised it had been issued to me at all. Direct quote: “Mefloquine? We don’t give that stuff to people who carry guns!”


9 posted on 06/21/2013 1:28:29 PM PDT by PowderMonkey (WILL WORK FOR AMMO)
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To: jazusamo

If the Army has “culpability”, then it seems to me that Bales should not be adjudged “guilty” of these charges and released from prison and sent for immediate treatment and follow-up. How can he be “guilty” if his actions were caused by this drug?


10 posted on 06/21/2013 1:29:08 PM PDT by miele man
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To: jazusamo

fourth deployment

NOT GUILTY.


11 posted on 06/21/2013 1:29:32 PM PDT by FES0844
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To: Gay State Conservative

Yes, more than a little is right.

As well as the Army keeping this under wraps, it really smells.


12 posted on 06/21/2013 1:30:25 PM PDT by jazusamo ("Mercy to the guilty is cruelty to the innocent." -- Adam Smith)
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To: miele man

I hear you and believe now that this is out we’ll hear more.


13 posted on 06/21/2013 1:32:48 PM PDT by jazusamo ("Mercy to the guilty is cruelty to the innocent." -- Adam Smith)
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To: jazusamo
a report submitted to the Irish Medicines Board practically confirms that mefloquine was administered to Bales in contradiction to the guidelines because he had suffered a documented TBI

If this turns out to be the case, the Army screwed up big time. Bales punishment should be determined with that in mind. I don't see any middle road, either he's guilty and deserves life in prison, or he's innocent and should be set free. How can he be partly responsible for the side effects of a drug the Army should never have given him? And with TBI, why in the hell was he sent back in to combat in the first place? This whole thing sucks.

14 posted on 06/21/2013 1:50:24 PM PDT by smoothsailing
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To: jazusamo

It’s true, as I can personally attest to the fact that anyone heading into that particular war zone is required by the Army to take daily doses of that particular anti-malarial drug. I stopped taking it after 3 days due to the crazy dreams in induced. I spoke to others who experienced the same crazy (violent)dreams and who also stopped taking the pills.


15 posted on 06/21/2013 1:57:34 PM PDT by semaj
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To: smoothsailing

Fully agree...I remember reading shortly after this happened (probably on a thread here) he’d suffered a TBI on a prior deployment.

I thought it strange then that he’d be deployed again but I can’t recall reading anything about being given the malaria drug.

I also was reading news articles here in WA state during his courts-martial and don’t recall any talk about having been given that drug.

Sounds to me like the Army and/or the DOD didn’t want that known.


16 posted on 06/21/2013 2:00:26 PM PDT by jazusamo ("Mercy to the guilty is cruelty to the innocent." -- Adam Smith)
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To: semaj

Thanks, SgtMaj.


17 posted on 06/21/2013 2:01:55 PM PDT by jazusamo ("Mercy to the guilty is cruelty to the innocent." -- Adam Smith)
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To: Theoria

“others Jody.”

Don’t hear that euphemism too often anymore.


18 posted on 06/21/2013 2:07:23 PM PDT by Boogieman
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To: semaj

Chantix does that to some,too. Difference is they tell you in their ads.


19 posted on 06/21/2013 2:12:00 PM PDT by TurboZamboni (Marx smelled bad & lived with his parents most his life.)
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To: jazusamo

Yup. Smells like we have a rat in the house. Did they use this poison in Nam?


20 posted on 06/21/2013 2:14:21 PM PDT by huldah1776
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To: semaj

It was the same stuff with the P-Tabs in the Gulf War. I took it for two days....realized that I was unable to focus at one hundred percent....to do mapping coordinates. At best...I was probably only sixty percent able to focus and do my job. I stopped the P-Tabs at the end of the 2nd day....just pretending to take the stuff from that point on. My OIC came up four days later....complaining that she couldn’t concentrate, and I just hinted that the P-Tabs were the issue.


21 posted on 06/21/2013 2:16:49 PM PDT by pepsionice
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To: jazusamo

No SgtMaj, just a lowly former sergeant of Marines. Semaj is my moniker backwards. I don’t have much of an imagination. LOL.


22 posted on 06/21/2013 2:21:07 PM PDT by semaj
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To: huldah1776

I just read it was developed in the 1970s at Walter Reed so it may have been tested on troops at the end of the war.


23 posted on 06/21/2013 2:26:54 PM PDT by jazusamo ("Mercy to the guilty is cruelty to the innocent." -- Adam Smith)
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To: semaj

Sorry for my mistake but a sergeant of Marines is about as good:)


24 posted on 06/21/2013 2:29:12 PM PDT by jazusamo ("Mercy to the guilty is cruelty to the innocent." -- Adam Smith)
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To: huldah1776

Walter Reed Army Institute.


25 posted on 06/21/2013 2:32:56 PM PDT by jazusamo ("Mercy to the guilty is cruelty to the innocent." -- Adam Smith)
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To: huldah1776
Did they use this poison in Nam?

We were given cloroquine/primaquine in Vietnam in the mid to late 60s.

26 posted on 06/21/2013 2:48:04 PM PDT by Ben Hecks
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To: jazusamo
"Sorry for my mistake but a sergeant of Marines is about as good:)"

No apology is necessary, stay well and Semper Fi.

27 posted on 06/21/2013 3:11:20 PM PDT by semaj
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To: Jemian

I stayed off of it completely. I heard way too many horror stories from my Soldiers who took it in the early Iraq days.


28 posted on 06/21/2013 3:14:34 PM PDT by Future Snake Eater (CrossFit.com)
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To: huldah1776

Out of curiosity, I decided to bite into one of the anti-malaria pills we had to take every Monday in Nam. BIG mistake. It had the foulest, nastiest, bitterest taste of anything I’ve ever had in my mouth. Tasted like battery acid that caused an involuntary puckering and which assaulted every nerve in my tongue and mouth and which took some minutes to clear out even after rinsing with water. I can still recall that nasty taste even now. It was a big pill as well. I stopped taking them after that.


29 posted on 06/21/2013 5:09:47 PM PDT by miele man
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To: jazusamo
If true the Army certainly has some culpability in this.

There are many things the military "leadership" is culpable for. Enlisted men and women are subjected to many medications that have questionable safety records because it is convenient for the military. When the Swine Flue hit in the '70s, and people were dieing from the vaccine, the military gave it's members a double dose (I was one of them). I had a sore arm and felt a little bad, but my roommate's arm hurt so bad he actually cried and then he shook so hard that I had to get out of the upper bunk and hit the floor to get some sleep.

30 posted on 06/22/2013 3:14:59 AM PDT by trebb (Where in the the hell has my country gone?)
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