Sunday, January 18, 2009

Beware Antimalarial Drug, Mefloquine--still being issued to troops

In 1994, the president of my publishing company assigned me to cover the humanitarian relief effort following the Rwandan genocide. My article became a tribute to the overlooked logistics industry for its part in making such efforts the success they are, but I also stepped into the mire of the antimalaria drug scandal.

Cpl. Scott Smith, a peacekeeper I interviewed, later committed suicide on Christmas Eve, 1994, in Rwanda—two months before his tour of duty was up. He was coming home to a fantastic job, and in my interviews and regular talks with him, I was impressed with his upbeat, resourceful attitude. I have dealt with despondent people and know their skill for covering depression. Scott showed none of the signs, but he did talk about the terrible nightmares and diarrhea he was having especially on the days the troops took their weekly Mefloquine pill. He had endured these side effects in deployments to the Gulf War and Somalia as well. (You start taking the pill one week in advance of visiting a tropical area and for four weeks following your return.)

For this assignment, the cameraman and I were also issued Mefloquine (Lariam®). When flying on the armed forces transports delivering supplies to the refugee camps in Goma, Zaire, the pilots joked about not being on Mefloquine because “you can’t have pilots hallucinating in the air.”

According to a report from the National Defence Department in Ottawa for the Somalia Enquiry, “some Canadian Forces pilots and divers received another anti-malarial drug, Doxycycline, because Mefloquine was thought to cause dizziness and loss of fine motor control in some users. The post-deployment report of the HMCS Preserver, for example, stated that all aircrew on active flying duties used Doxycycline. The report also noted that several CF members who suffered adverse effects from taking Mefloquine were switched to Doxycycline.”

The peacekeepers described the designated day their companies took Mefloquine as Manic Monday, Loco Tuesday, Wacky Wednesday, Psycho Thursday or Freaky Friday. On these days, military stats show the rate of vehicle accidents rose. There are now medical papers available describing the dangers of mixing alcohol with Mefloquine, and Scott was naturally drinking on that Christmas Eve in celebration of his going home soon. He loved being in Rwanda and helping the people who were so appreciative of the Canadians who stayed behind and risked their lives to bring world attention to the genocide being executed in Rwanda at a rate much higher and more efficiently than any organized genocide previously committed, even by the Nazis.

I was only on Mefloquine nine weeks, but just that short time created a state of insomnia that began in Rwanda and lasted six months until sleep deprivation weakened my immune system and I collapsed with pneumonia. Then I was heavily drugged so I could sleep. Fourteen years later, I am lucky if I get five hours solid sleep per night, and for seven years, my thyroid had to be monitored because it showed strange scar-like damage. I constantly fluctuated between hyper- and hypothyroidism, so doctors were never sure what treatment course to take. Instead of doing the wrong thing, they decided to monitor it every three months. Somehow, on my own, my thyroid finally corrected itself and is now working normally. Was it Mefloquine? Others who have taken this drug have suffered serious damage to their livers, hearts and/or thyroids and haven’t healed themselves.

The military in the U.S., Britain, Canada and Australia have minimized the dangers of Mefloquine since the U.S. Army asked Roche Labs to create a shot that would prevent soldiers from being infected with one form of malaria they could not treat, and as a result those infected with it often died. Today, the number of troops suffering from the devastating adverse effects from taking Mefloquine far outweighs the danger of any of them dying from this form of malaria.Yet, U.S. and Canadian forces—probably British and Australian and all coalition forces too, but I don’t have confirmation of that—have issued Mefloquine in Iraq (but have since stopped) and continue to issue it in Afghanistan, despite reported evidence from the Gulf War, Angola relief effort, Somalia and Haiti UN Missions and Rwandan mission, plus other tropical deployments, that a significant number of troops are suffering from debilitating side effects, including suicides and/or aggressive violent behavior that has ended up in murder, usually of family members and, for sure, of spouses.

SOLDIERS FOR THE TRUTH talk about it on their web site. The Canadian National Defence Department finally issued a paper discussing the adverse effects in 1995, but the public didn’t know about it. CTV broadcaster, Christine Neilsen, produced an investigative report on W5 in October 1997. She took the plea of the suicide soldier’s mother seriously to investigate his death because she too had suffered adverse effects from taking Mefloquine on an assignment to Angola. She proved that the Canadian peacekeepers were being used as unwitting guinea pigs for the drug and suggested the true culprit in the Somalia scandal was Mefloquine, which affected the soldiers’ behavior and emotional states. Her research assistant uncovered the signed documents between Health Canada, the Department of National Defence and the drug company. Did the Canadian people rise up in revolt as a result of this scandalous treatment of our armed forces? No, Parliament barely uttered a peep.

We say we support our armed forces, but no one puts the brakes on issuing a drug that decimates our forces faster and more viciously than armed conflict. A British Medical Report sites the number as high as 1 in 10 people suffer adverse effects. They have been observing the results because, of all Western nations, a high proportion of British travelers visit tropical countries where malaria occurs. Canada admits that 1 in 1,000 can be adversely affected. Israel estimates 1 in 100,000. Whatever the ratio really is, it is TOO HIGH. We charge our armed forces with the job of saving our butts, but we don’t raise a finger to protect them from a drug company that has expanded its production of Mefloquine from the States to Pakistan under a different name, and this subsidiary has yet to place adequate warnings on its label to prescription users. NOT ACCEPTABLE.

USER BEWARE:
DOCTOR MICHELLE BRILL-EDWARDS, Canadian drug safety expert from transcript of radio interview with CBC’s Jennifer Westaway, August 26, 2002, 9:45 a.m., Reference NO. 226387-7:

BRILL-EDWARDS: “Well firstly, I should mention that there's a spectrum of what you could... as lay people understand this affects on the brain, or neuro-psychiatric side effects. Some of these are very common, every day problems that are not so severe, things like disturbed sleep, terrible dreams and so forth. But the more severe end of that spectrum of effects on the brain are actual psychosis, what we call acute psychosis, which, in lay terms, would be going crazy, someone who is out of touch with reality and whose actions can be bizarre. In particular, a big concern had been unexplained feelings of suicide and homicide.”

BRILL-EDWARDS: “Usually, there's a very strict order to not use this drug with alcohol. And the U.S. military has a good track record of trying to keep their military men dry in the field of battle. But once they return home, of course, then that restriction is off and alcohol may become a question. And we know that the drug lasts for a very long time in the body and this mixture may be lethal.”

BRILL-EDWARDS: “There is one study done by the military that was a carefully-done study that watched military men taking the drug in the field and they were seen weekly. And it's a very interesting point that in that study, two men had to be withdrawn from the study because of suicidal ideation.”

WESTAWAY: “What military was this?”

BRILL-EDWARDS: “This was the American military. And interestingly, of the 203 - I think it was - men in the study who had Mefloquine doses use in prophylaxis, two developed suicidal ideation. That would suggest that we're dealing with a serious psychiatric side-effect rate that is in the order of one in 100, not one in 12,000. . . . It changes the whole balance of whether and when this drug should be used in comparison with other drugs.”

For more information, you can visit BOWDENS MEDIA MONITORING LTD. online.

1 comment:

  1. IMPORTANT for EU (and in Parts also for the USA)! The German BfArM (comparable to the FDA in US) was the Rapporteur (Authority/Agency) who was responsible for the PSUR-WS Procedure Nr.: DE/H/0022/001 (Substance: Mefloquine). This Periodic Safety Update Report - Work Sharing (PSUR-WS) was implemented from 2006-2009 (3-Year PSUR). After a PSUR-WS is done, the responsible Agency (in this case the BfArM) has to carry out a new Core Safety Profile (CSP). In the Guidelines for this Drug Safety Procedure is written, that the whole Procedure had to be done within 110-135 Days. After that time a Final Assessement Report (FAR) and CSP had to carry out from the responsible P-RMS (Psur-Reference Member State). If further Information is required from the Manufacturer (within the Procedure), the Manufacturer have 14 Days to deliver this RFI (Request for Information). And now it comes: The BfArM (responsible as P-RMS for the Substance Mefloquine) had carry out the FAR/CSP for the PSUR-WS Nr.: DE/H/0022/001 in APRIL 2013. That was 4 Years !!! after the Data-Lock-Point (DLP) for this Procedure. Based on this new CSP also the FDA had carried out their "new" strengenthed Warnings (Block, Box, etc.) in JULY 2013. All other EU-Countries also then carried out the new CSP from BfArM. In Germany a "Dear Doctor Letter" came out in SEPTEMBER 2013. (Like you read before, the Manufacturer have normally 4 Month time to give out this Information to the Public. In this case (for Germany) it was more than 5 Months). Once again: All new warnings (WORLDWIDE) are based on the FAR/CSP from the BfArM dated 03.04.2013. 4 years!!! after the Drug Safety Procedure had normally to be done. For the USA: The Reason that ROCHE not continue the License in 2009 is, that they already knewed that a new CSP will carry out with new warnings after the PSUR-WS is done. In the "List of Substances under PSUR-WS" you can read that in 2009 there was an "Amended PAR" was carried out. Later (2011) you can read about a "Delay in the procedure" in this List. The whole PSUR-WS Procedure DE/H/PSUR/0022/001 stinks. The BfArM also wrote in Documents that they had recieved "confidential information" from the FDA for this PSUR-WS. Ask the FDA about this "confidential informations". Ask the FDA about the CSP/FAR from the BfArM from APRIL 2013 and ask the FDA why the P-RMS carried out this CSP/FAR after 4 Years the PSUR-WS had to be done already. You can ask the FDA also why they wait until the last Day to carry out this information on 29.07.2013 (remember: CSP came out 03. April 2013 and after that 4 Month time to give this to public would be 04.08.2013. The FDA carried it out on 29. July, but they knew about the new CSP already since APRIL 2013) For the EU: Same Questions to your Authorities and also the EMA. In a Document from the Irish Medicines Board you can also see that it took more than 1 Year after the BfArM ask for more Information (RFI) to the Manufacturer within this PSUR-WS (remember: the Manufacturer have 14 days to provide this information) that the Manufacturer give this Information. Related Documents and Screenshots can be found here: http://www.nebenwirkung-suizid.de/Documents/psur_ws_de_h_psur_0022_001.html (Documents are in English/ the german Text can be translated easy with google translate.) Thank you for your Attenton on this.

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