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Health Minister urged to re-examine possible side effects of anti-malarial drug

Post by Trooper on Mon 21 Nov 2016, 06:21

Health Minister urged to re-examine possible side effects of anti-malarial drug

GLORIA GALLOWAY
OTTAWA — The Globe and Mail
Published Monday, Nov. 21, 2016 5:00AM EST
Last updated Monday, Nov. 21, 2016 5:44AM EST

Politicians of all stripes are asking the federal Health Minister to take another look at the potentially harmful effects of an anti-malarial drug that some veterans say permanently damaged their brains and contributed to the violence that erupted during the Somalia mission of the early 1990s.

At the same time, a proposed class-action lawsuit launched against the manufacturer of mefloquine and the Defence Department on behalf of veterans who say they still suffer repercussions from the pills they were forced to take on overseas deployments has been given new life as more former soldiers step forward to say they too were harmed.

The controversy around mefloquine, a drug marketed as Lariam that is still being offered to Canadian troops when they are sent to countries where malaria is prevalent, has been brewing since 1992 when a Somali teenager was beaten to death by Canadian soldiers. Veterans of the mission blame the drug for psychological damage that may have caused the aggressive behaviour.

The Commons Veterans Affairs committee, which is studying mental health and suicide prevention among former military personnel, wrote to Health Minister Jane Philpott last week to request that “the effects of the anti-Malaria drug mefloquine be examined in greater detail.”

The committee heard this fall from several veterans who told heart-wrenching stories about what they describe as the after-effects of the medicine including tinnitus, psychosis, paranoia and an inability to control their tempers. The testimony shocked some MPs and moved at least one to tears.

“I write to you in my capacity as chair in order to bring forward the concerns raised with regard to the historic and continuing use of mefloquine as an anti-malarial prophylaxis,” Liberal MP Neil Ellis wrote in the letter to Dr. Philpott.

Chief among the concerns raised at the committee hearings, wrote Mr. Ellis, were “neuropsychiatric reactions, questions over labelling and prescribing practices, paucity of empirical and peer-reviewed scientific evidence concerning neurotoxicity, and difficulties in finding potential treatment plans for those that may have persistent and lasting adverse symptomatology that could potentially be linked to the use of mefloquine.”

When asked for her response to the letter, Dr. Philpott’s staff turned the matter over to communications staff within the health department who said: “Health Canada continues to monitor the safety of mefloquine and will take action as necessary to make sure the benefits continue to outweigh its risks.”

It wasn’t until August of this year – three years after similar warnings were issued in the United States – that Health Canada posted a notice saying the drug can cause adverse neuropsychiatric reactions “that have been reported to continue many years after mefloquine has been stopped” and that “permanent vestibular damage has been seen in some cases.”

A group of veterans is now calling for an inquiry into what role the medication might have played in Somalia, and for the government to contact troops or veterans who were required to take mefloquine to determine if they suffered long-term consequences. They also want more research to develop better diagnosis and treatment of the effects.

Meanwhile, as in Britain, Australia and the United States, some Canadian veterans are turning to the courts.

A class-action lawsuit is being prepared on behalf of a veteran of the mission to Somalia where soldiers were ordered to take the drug as part of a clinical trial even though the Defence Department did not, as required, obtain their prior consent or monitor the outcomes and effects. The suit was actually launched some time ago but sat dormant until this summer when some of the veterans felt ready to tell their stories, said Wayne Stickland, a lawyer with Larmer Stickland in North Bay, Ont.

Mr. Stickland said the suit names the Department of National Defence and Hoffman-LaRoche, the drug’s manufacturer. The hope, he said, is to have the class-action certified in 2017. “It encompasses the deployment to Somalia and subsequent” missions, said Mr. Stickland. “So anybody who took mefloquine, either willingly or unwillingly – we say unwillingly – would be a potential class member.”

The Commons Veterans Affairs committee also heard from Brigadier-General Hugh MacKay, the military Surgeon-General, who said the long-term negative effects of mefloquine have not been proven by science – a position he reiterated last week in an interview with The Globe and Mail.

Different studies have arrived at different results.

A research paper released this month by the Armed Forces Surveillance Branch of the Defence Health agency in the United States that looked at the effects of the drug on thousands of U.S. soldiers who took it between 2008 and 2013 found that mefloquine was no more likely than the two main competing anti-malarials to cause neuropsychiatric issues.

But the incidence of both post-traumatic stress disorder and psychosis were significantly higher among non-deployed troops that took mefloquine than those who took atovaquone/proguanil (Malarone), a drug which is now more commonly used by Canadian troops.

Remington Nevin, a doctor and researcher at the Johns Hopkins University Bloomberg School of Public Health in Maryland who has studied the effects of mefloquine for nearly a decade, said there was a lot of “crude” data in the study that could be used to support both sides of the argument.

But, said Dr. Remington, the fact that non-deployed soldiers taking the drug were significantly more likely to get PTSD suggests there is something about mefloquine that can cause that to happen. “How,” he asked, “do you get diagnosed with post-traumatic stress disorder if you are not exposed to a trauma?”

http://www.theglobeandmail.com/news/politics/politicians-ask-for-review-of-side-effects-of-anti-malarial-drug/article32953965/
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Airborne Veterans call on the Feds to stop using anti-malaria drug

Post by Dannypaj on Tue 22 Nov 2016, 06:06

https://soundcloud.com/newstalk-580-cfra/listen-now-airborne-veterans-call-on-the-feds-to-stop-using-anti-malaria-drug

Listen to this as well, not sure if it was shared on CSAT.
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Tories call for ‘immediate action’ to study effects of anti-malarial drug

Post by Trooper on Tue 22 Nov 2016, 18:42

Tories call for ‘immediate action’ to study effects of anti-malarial drug

GLORIA GALLOWAY

OTTAWA — The Globe and Mail
Published Tuesday, Nov. 22, 2016 6:28PM EST
Last updated Tuesday, Nov. 22, 2016 6:28PM EST

Conservative MPs are calling upon the Liberal government to conduct a scientific study into the effects of an anti-malarial drug that some veterans say has left them with psychiatric problems and that they blame for the violence that erupted on the Somalia mission in the early 1990s.

The veterans affairs committee of the House of Commons, which has heard emotional testimony about mefloquine’s lasting effects, wrote to Health Minister Jane Philpott last week to point out the concerns that have been raised about the current and historical use of the drug. Conservatives on that committee issued a statement on Tuesday to emphasize what they say is the need for more research.

“We are very pleased that the committee reached a unanimous decision to write to the Minister of Health regarding this very serious issue. We were all deeply moved by veterans’ testimony at committee and their bravery in coming forward to share their stories,” Conservative MPs John Brassard, Cathay Wagantall and Robert Kitchen said in their statement.

“It is our hope that the Liberal government will take immediate action and conduct a true scientific study that examines this medication’s potential side effects and the impacts it may have had on our veterans, those currently serving in the Canadian Armed Forces, and members of the public,” they wrote.

Dr. Philpott’s staff forwarded questions about the committee’s letter to communications officials within Health Canada, who would say only that the government continues to monitor the safety of mefloquine and will take action as necessary to make sure the benefits continue to outweigh its risks.

The Conservatives are not the only ones who are urging more study of mefloquine.

“We’re about to send out troops to [Africa], and they will be required to take anti-malarial drugs,” said Irene Mathyssen, a New Democrat MP who is also on the veterans affairs committee. “I don’t understand why Health Canada can’t really take a close look at it and do the kind of responsible studying that the anecdotal information suggests should happen.”

A group of former soldiers has also been asking Ottawa to fund more thorough studies of mefloquine and to develop better techniques for distinguishing damage caused by the drug from the effects of post-traumatic stress disorder, which it mimics.

Health Canada updated the prescribing information for mefloquine in August to emphasize that certain side effects can persist for months or years after the drug is discontinued and may be permanent in some patients. Symptoms reported by some users include anxiety, paranoia, depression, hallucinations, psychotic behaviour and, in rare cases, thoughts of suicide.

Hugh MacKay, the military Surgeon-General, has said he does not believe there is enough scientific evidence that the drug – which is still offered to Canadian troops when they are deployed to countries where malaria is prevalent – can cause permanent damage to warrant investing additional money in research.

But General Jonathan Vance, the Chief of Defence Staff, has asked Dr. MacKay to conduct a review to determine how and when it should be used. That would entail looking at existing studies, as opposed to conducting new research.

Mefloquine is currently the option selected by about 5 per cent of Canadian troops who are prescribed anti-malarials. In the United States it is given to just 1 per cent of soldiers deploying to a region where malaria is a threat.

“Mefloquine has been ‘black boxed’ in the United States and is only used in extreme situations in the United Kingdom and Australia,” wrote the three Conservative MPs. “In light of the fact that the Liberals intend to deploy Canadian troops to Africa in the near future, we fully expect the government to take action and to align itself with our allies on this important issue.”

Two members of the Somalia mission were charged in the beating death of a 16-year-old Somali boy in 1993. The troops who took part in that peacekeeping deployment were required to take mefloquine as part of a poorly monitored clinical trial.

The drug was also handed out in Rwanda, Cambodia and Afghanistan.

A class-action lawsuit has now been launched against the defence department and pharmaceutical manufacturer Hoffmann-La Roche, on behalf of veterans who say their lives have been ruined by mefloquine. Some of the vets are also asking for the government to reach out to all of those former soldiers who have taken the drug to determine if they are experiencing long-term effects, and to conduct an inquiry into its use in Somalia.

But Defence Minister Harjit Singh told The Globe and Mail last week that he would leave the question of any inquiry up to medical experts. “As much as I would love to comment on any issue that pops up,” said Mr. Singh, “I have to rely on our experts who are there to make these types of decisions.”

http://www.theglobeandmail.com/news/politics/tories-call-for-immediate-action-to-study-effects-of-anti-malarial-drug/article32991408/
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Malaria drug's dark side-effects haunt Canadian vets

Post by Trooper on Tue 29 Nov 2016, 05:06

'Treated like lab rats': malaria drug's dark side-effects haunt Canadian vets

MP leading call for inquiry into adverse reactions suffered by soldiers administered mefloquine

By Steve Fischer, CBC News Posted: Nov 29, 2016 5:00 AM ET Last Updated: Nov 29, 2016 5:00 AM ET


Greg Janes served with the Canadian Airborne Regiment in Somalia in 1993. Soldiers there were administered weekly doses of the anti-malaria drug mefloquine, and began referring to the ritual as 'Psycho Tuesdays.'



Greg Janes was one of 900 members of the Canadian Airborne Regiment who went to Somalia in 1992 as part of a peacekeeping mission. As a medic, one of his jobs was to make sure everyone took the anti-malaria medication mefloquine.

Janes said soldiers were not asked for their consent before being administered the drug, even though it was considered experimental at the time.

'I don't remember anything about side-effects being mentioned.'

"It was never a question of having a choice to take it or not to take it. I don't remember anything about side-effects being mentioned," said Janes, who lives in Orlé​ans and now works as an Ottawa police officer.

The soldiers, including Janes, took weekly doses of the drug on Tuesdays, and soon began referring to the ritual as "Psycho Tuesdays," and to the nightmarish side effects they began suffering as "meflomares."

"It was a real thing because I don't know anybody who was on that particular medication who didn't have some instance of this occur," Janes said.

In addition to the nightmares, Janes said his symptoms included chronic

insomnia, hypervigilance, aggressiveness and "hair trigger" irritability.

Mission ended in scandal

The mission ended in scandal after two Canadian soldiers were charged with torturing and beating to death a Somali teenager. At an inquiry that followed, questions were raised about whether mefloquine may have played a role in the soldiers' violent crimes.

Many soldiers now say they started experiencing psychological problems soon after taking the drug in Somalia and that those problems persisted long after they returned to Canada.


Greg Janes, who served as a medic in Somalia and is now an Ottawa police officer, is seen here manning a vehicle-mounted gun in 1993.

Since his return to Canada in 1993, Janes said he's suffered from post-traumatic stress disorder, or PTSD, but he believes some of his psychological problems can be traced back to mefloquine.

"In my own personal experience, a quarter of a century, hundreds of hours of counselling, decades of medication, I still can't make the transition. I don't think that that's normal, and I'm not alone here."

Other veterans speak out

This fall the Standing Committee on Veterans Affairs held two days of hearings where MPs listened to a handful of veterans describe how they believe mefloquine has adversely affected them.

The committee has also received dozens of emails and phone calls in the past few weeks. As well as veterans who served in Somalia, soldiers who took mefloquine while stationed in Rwanda and Afghanistan have contacted the committee to say they, too, have suffered psychological problems as a result of taking the drug.

Conservative MP Cathay Wagantall is a member of the committee. She said veterans have similar stories of insomnia, anxiety, paranoia and depression.

"Mefloquine was given to them when they were in Somalia as an experimental drug. It wasn't licensed, yet there were protocols that were supposed to be followed to make sure they were screened, to make sure they should take it, and then followup throughout — and none of that happened. So no information went back to the drug company or Health Canada" Wagantall said.


Conservative MP Cathay Wagantall is a member of the Standing Committee on Veterans Affairs.

Health Canada, drug supplier issue warnings

In recent years Health Canada has advised people with pre-existing mental health issues including depression, general anxiety, schizophrenia and psychosis, as well as anyone with a history of convulsions, not to take the drug.

In August, AA Pharma, the drug's Canadian supplier, released a statement warning "psychiatric symptoms ranging from anxiety, paranoia and depression to hallucinations and psychotic behavior can occur with mefloquine use. Symptoms may occur early in the course of mefloquine use and on occasion, these symptoms have been reported to continue long after mefloquine has been stopped."

AA Pharma claims the incidence of serious adverse psychiatric reaction is just one in 11,000.

MP calls for comprehensive study

Wagantall disputes that figure, and said in the last month alone she's heard from more than a dozen veterans who've suffered serious reactions that could be linked to the drug. She's calling for a comprehensive study of all veterans who took the drug.

'I just hope they find the need to come forward and say, 'Look, we were treated like lab rats. You did an experiment on us and now you need to be honest about this whole thing.'"

"We want to find out who all these individuals are, track them, find out what has happened as far as side-effects for them ... and have it recognized that this needs to be treated specifically as a different type of injury, Wagantall said. "When you try to treat it as though it's PTSD, it causes all kids of other complications."

Janes blames the drug for a failed marriage and lost friendships, and said it has adversely affected his career, first as a solider and then a police officer. He's no longer on patrol, and has taken a desk job.

Janes said he decided to tell his story with the hope that it will inspire other veterans to reach out for help.

"I just hope they find the need to come forward and say, 'Look, we were treated like lab rats. You did an experiment on us and now you need to be honest about this whole thing.'"


'It was never a question of having a choice to take it or not to take it,' Greg Janes said of the weekly doses of mefloquine administered to soldiers.

http://www.cbc.ca/news/canada/ottawa/veteran-mefloquine-somalia-malaria-1.3869580
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Re: Mefloquine / Topics & Posted Articles

Post by tetech on Tue 29 Nov 2016, 15:17

Hi

Does anyone know what tours this medication was used on?

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Re: Mefloquine / Topics & Posted Articles

Post by johnny211 on Tue 29 Nov 2016, 16:03

tetech - Very good ?. I was also trying to find out when they first used it in the CF, but got nowhere. I did Damascus 79/80. Discussing this with a fellow Vet who was there at the same time, we both ended up in the MIR for a few days after taking some pills they gave us. But of crse its not in our needle books or docs. So when did this stuff start being in the system? Anyone know that? VVV...
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Re: Mefloquine / Topics & Posted Articles

Post by red510 on Tue 29 Nov 2016, 16:14

Was ordered to be taken during Op Toucan, East Timor 1999-2000.

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Re: Mefloquine / Topics & Posted Articles

Post by Trooper on Tue 29 Nov 2016, 19:41

As time passes, I'm sure we will learn more of where this Mefloquine was used in the Canadian Forces.

This issue is growing in volume with the medical experts getting more involved and Veterans fighting to bring it to light, so it won't be disappearing anytime soon.

Here is some info from an earlier post regarding Canada's use in Mefloquine;

The Canadian Armed forces use of Mefloquine, 1970's...1990's for Canada... in particular to the Canadian Airborne Regiment in 1993 for Somalia mission.

The file on mefloquine
Mefloquine developed by U.S. army and Roche in the 1970s to prevent malaria and treat it.

Used widely by travellers and armed forces for years.

Known side effects for some users include nightmares, depression, cognitive impairment, aggressive behaviour and paranoia.

Issued to Canadian Airborne Regiment in 1993 for Somalia mission.

In 2009, drug no longer on the preferred list in U.S. military

In 2013, U.S. military bans the use by special forces after the FDA issues strong warnings about side effects.

FDA continues to approve the drug as long as it is properly prescribed.

Still used by forces in the UK, Australia and Canada.

http://edmontonjournal.com/news/insight/new-push-for-ban-on-mefloquine
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Re: Mefloquine / Topics & Posted Articles

Post by johnny211 on Tue 29 Nov 2016, 21:26

Trooper - tks for that. I was sure it went back to the 70's too early 80's, but could not find any docs to support that. Has anyone else on here taken it back then?
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Travellers, doctors blame malaria drug for lasting psychiatric problems

Post by Trooper on Wed 30 Nov 2016, 06:29

Travellers, doctors blame malaria drug for lasting psychiatric problems

Jessica Konecny says mefloquine triggered severe bouts of anxiety and depression.

By Steve Fischer, CBC News Posted: Nov 30, 2016 5:30 AM ET Last Updated: Nov 30, 2016 5:30 AM ET


Jessica Konecny with the box of Lariam (Mefloqouine) pills she took while working in Ghana in 2004.

When Chatham, Ont., resident Jessica Konecny travelled to Ghana for a university work term 12 years ago, she was prescribed mefloquine — sold then under the brand name Lariam — to help prevent her from contracting malaria, endemic in that region of Africa.

Almost immediately, she began experiencing vivid nightmares.

"I had a dream about a spider. I was sleeping in a bug net so when I woke up, the spider was huge and it was on my net and my roommate had to turn on the lights and physically take me out of the net for me to believe that it wasn't happening."

Konecny was 22 at the time.

She says she had never experienced psychological problems before going to Africa, but soon became depressed, anxious and suspicious.


Jessica Konecny was 22 years old when she travelled to Ghana in 2004.

"I became so paranoid that I thought everyone was talking about me, and I had to go to the doctor … right away he said, 'What are you on?' And I said, 'Lariam,' and he said, 'Get off of it.'"

Soldiers blame drug for psychological problems

​Mefloquine had already come under scrutiny, with Canadian soldiers blaming the drug for psychological problems they experienced in Somalia in 1992-93. Others also reported having hallucinatory nightmares that felt like out-of-body experiences.

Konecny said the doctor who prescribed the drug for her did not tell her about any possible side effects. She chose mefloquine over other possible anti-malarial drugs because it was inexpensive and only needed to be taken once a week.

She stopped taking the pill after a two and a half months because of the psychological problems she experienced, but she says her mental health issues continued for the rest of her time in Ghana and after she returned to Canada.

"So right away when I came back the biggest ones were anxiety and depression...and then with the depression I stayed in bed a lot...I started seeing a psychiatrist here in Windsor and I was treated for anxiety and depression and also added on a mood disorder.

Travel doctor has heard complaints

Travel medicine clinic doctor Peter Teitelbaum said over the years he's prescribed thousands of doses of mefloquine for his clients in Ottawa. But more and more he now prescribes other anti-malaria medications.

"It didn't take very long to become apparent to me that mefloquine sometimes caused problems for people … I certainly had people coming back for a second or third trip who said I don't want to take that pill again.

"A very common thing was vivid dreams or nightmares, that was the most common complaint I heard," he said. He also had reports of insomnia and, in rarer cases, depression and paranoia.

Earlier this year Health Canada updated its information on the drug, warning patients to avoid it if they have ever experienced seizures or any psychiatric issues.

According to Dr. Barbara Raymond, with the Public Health Agency of Canada

Bad dreams, insomnia and sleep disturbances are not uncommon, according to Dr. Barbara Raymond, with the Public Health Agency of Canada, but she said "anything more serious, psychological psychiatric effects are considered to be rare. Less than one in ten thousand people would experience such an occurrence."

Official rate of adverse reaction to drug called into question

Doctors and patients question that rate, saying serious issues are likely more common.


Dr. Peter Teitelbaum runs the Riverside Travel Medicine Clinic in Ottawa. He now rarely prescribes mefloquine for travellers heading abroad.

Teitelbaum says Health Canada used a "passive reporting system," meaning the onus is on the doctor and patient to report any adverse effects.

He says without any system of registering or tracking patients, most people experiencing mental health issues will not take the time to file a report. ​

"It's not compulsory reporting and they're not going out and asking us," says Teitelbaum.

No plans to take drug off shelves

'..more stories are starting to come in, of people saying..that could very much explain what is happening to me.'
- Cathay Wagantall, Conservative MP

It's estimated about 30,000 people are prescribed mefloquine each year in Canada, down from twice that many a year in the early 2000s.

Health Minister Jane Philpott says there are no plans to take the drug off the shelves in Canada, but that her ministry will continue to monitor its use.


Jessica Konecny in Ghana in 2004.

"The department makes decisions addressing the efficacy of this medication and all other medications on the basis of scientific knowledge and as new information comes to light, they bring that information forward," she said.

Ironically, Jessica Konecny contracted malaria, after going off mefloquine while she was still in Ghana.

She says she became terribly sick at the time, but quickly recovered.

Given a choice, she said she'd rather get malaria than deal with the after-effects of the drug.

http://www.cbc.ca/news/canada/ottawa/mefloquine-depression-malaria-veterans-psychiatric-1.3872773
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Saskatchewan veteran speaks out about experience with anti-malarial drug mefloquine

Post by Trooper on Thu 01 Dec 2016, 13:43

December 1, 2016 1:36 pm

Saskatchewan veteran speaks out about experience with anti-malarial drug mefloquine

By Stu Gooden Global News


WATCH ABOVE: A Saskatchewan veteran is speaking out about his negative experience with the anti-malarial drug mefloquine. Stu Gooden speaks with Dave Bona, who says he hasn’t been the same after being given the drug.

A Saskatchewan veteran who served in the military is speaking out about his experience with the anti-malarial drug mefloquine.

Mefloquine is a drug prescribed to Canadian soldiers when deployed to zones known to have the malaria disease.

Dave Bona was administered the drug during the 1990s for two separate deployments to Somalia and Rwanda.

When he returned to Canada, he wasn’t the same.

“Why are they still issuing this drug? It makes no sense. It’s almost as if they actually don’t care about their soldiers,” Bona said.

“The only driving factor is cost. This is the cheapest drug out there.”

In 2013, a boxed warning was added to the label of the drug by the Food and Drug Administration, citing “neurologic and psychiatric side effects” associated with its use.

Dr. Remington Nevin, an anti-malarial medication expert based in Baltimore, Md., said during Bona’s deployment, soldiers weren’t properly briefed on the effects mefloquine had.

“It’s very disappointing that Canadian Forces soldiers received no warnings; no education at all about the important safety information that was necessary to follow,” he said.

“U.S. soldiers at least in theory, received a copy of the approved product insert describing under what conditions they should stop taking the drug, such as symptoms of anxiety, depression, and restlessness.”

“Canadian soldiers received no such warnings.”

Nevin added that the drug can cause brain damage, and has symptoms that may include insomnia, nightmares, depression, to even more severe side effects such as panic attacks, psychosis, and suicidal thoughts.

Dr. Andrew Currie, head of the Communicable Disease Control Program with the Canadian Armed Forces, denies that there is any evidence that links permanent brain damage to the drug.

“I think I echo those of us who provide care to our members, that it’s important that we understand the symptomatology and look out for the health of our members,” he said.

“When you read the scientific literature, and we’re talking about millions of doses of mefloquine, there’s nothing in the evidence that links permanent brain damage with use of mefloquine.”

Bona doesn’t understand how the military can continue giving the drug to its soldiers after the negative side effects he, and other veterans, experienced while on the drug.

He remembered that on the first day they were required to take mefloquine, everyone’s behaviour changed.

“It was like a horror show. The screaming, the yelling, guys getting up walking out of their tents; everyone was having the vivid dreams,” he recalled.

“As that tour progressed, who I was started to evaporate.”

He still suffers from symptoms. He believes the drug caused abdominal problems, vertigo, dizziness, and occasional episodes of “insane anger.”

“At times it’s like another person has dropped into our life,” his wife, Teresa Untereiner, said.

“It’s not Dave. His behaviour, his personality, changed.”

“Physiologically he changed as well too.”

http://globalnews.ca/news/3099642/saskatchewan-veteran-speaks-out-about-experience-with-mefloquine/
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Canadian Forces firm on risky anti-malaria drug ahead of Africa mission

Post by Trooper on Mon 05 Dec 2016, 06:37

Canadian Forces firm on risky anti-malaria drug ahead of Africa mission

GLORIA GALLOWAY
OTTAWA — The Globe and Mail
Published Monday, Dec. 05, 2016 5:00AM EST
Last updated Monday, Dec. 05, 2016 5:00AM EST

Val Reyes-Santiesteban is convinced she lost a military son to the neuropsychotic side effects of the anti-malarial drug mefloquine, and she fears some of the Canadian soldiers who are about to deploy to Africa could meet the same fate.

“It makes me sick. They’ve got to stop them from taking this drug,” Ms. Reyes-Santiesteban, of Welland, Ont., told The Globe and Mail. “Everyone in the government should take this pill once a week for a month and let them see what happens.”

Her son, Corporal Scott Smith, died of a self-inflicted gunshot wound on Christmas Day of 1994 in Rwanda, where he had been sent after taking part in the 1992 Somalia peacekeeping mission. Military doctors prescribed mefloquine for him on both deployments.

The army says he was “killed in action” even though his death, at the age of 23, was clearly suicide.

But, more than two decades later, as the government determines where its next peacekeeping mission in Africa will be, senior medical officials in the Canadian Forces say there is not enough scientific evidence to remove mefloquine as an option for troops who go to countries where malaria is a threat. They remain dubious of claims it can cause permanent damage, despite a Health Canada warning and veterans who say the medication ruined their lives.

Military brass said the same after allowing more than 1,000 Canadian Forces members in Somalia to be part of a poorly monitored clinical trial. Two of the soldiers on that mission were charged in the beating death of a Somali teen, and many others complained of alarming dreams, hallucinations and depression.

Even after doctors on the front lines implicated mefloquine in the troops’ violent behaviour, officers in Canada reassured the commission of inquiry into the Somalia affair that the drug could not cause the psychotic side effects being reported.

The current Liberal government has rejected calls from an all-party committee of the House of Commons and Somalia veterans for more research on mefloquine. And a previous Liberal government shut down the Somalia commission just before the issue of mefloquine was to be addressed.

As a result of recent media coverage, the chief of defence staff asked the military’s surgeon-general to take another look at the scientific literature about the drug. It is now prescribed to just a small fraction of Canadian troops.

The use of mefloquine in Somalia was unorthodox and possibly illegal. The drug had not been approved in Canada in 1992, but National Defence obtained it from Health Canada as part of a clinical trial in which military personnel were supposed to receive the informed consent of the users and to monitor the efficacy and the adverse reactions. They did neither.

The military chose mefloquine over other options because, unlike most anti-malarial drugs, it is taken once a week instead of daily and the Forces determined it was the best option for the Somalia theatre.

Ms. Reyes-Santiesteban does not doubt the drug killed her son.

As he was on his way to Rwanda in the fall of 1994, Cpl. Smith told a reporter for what is now called Canadian Shipper magazine that the malaria medication gave him hallucinations. A few months later, he was dead.

In the hours before he shot himself, Cpl. Smith took part in a convoy in which he was laughing and joking with his colleagues. Then he called his mother, his father and his best friend to wish them a Merry Christmas.

“He was coming home, we were going to have a late Christmas in February,” Ms. Reyes-Santiesteban said. “Nothing seemed to add up.”

Ms. Reyes-Santiesteban wrote to the military and politicians to demand they examine the role mefloquine may have played in the tragedy but, she said, she was never taken seriously.

That was also the response when Barry Armstrong, one of the military doctors who took part in the Somalia mission, expressed concerns about the drug’s effects on the troops.

In a post-deployment analysis he wrote for a 1993 conference, Dr. Armstrong said the failure of the United Nations forces in Somalia was “rather exceptional,” and “I believe that a simple reason may exist. Canadian and American troops may have been impaired by the use of mefloquine.”

Of the three military people who presented papers about the Somalia mission at the conference, “two of us had minor neuropsychiatric problems which occurred regularly in the 24 to 48 hours after our weekly mefloquine doses. If there are two of us, these reactions aren’t so rare.”

Greg Passey, a military doctor who was deployed to Rwanda in 1994, had similar concerns, and wanted to make them known to the Somalia inquiry. Despite a forces-wide communication that said any member of the military who had pertinent information should step forward, Dr. Passey said his decision to testify drew anger from senior officers.

Dr. Passey said one of his colleagues told him “the surgeon-general [then Major-General Wendy Clay] was very upset with me.” He said he decided to testify at the commission anyway, but it was shut down the week before his scheduled appearance.

Dr. Clay said in a telephone interview that she has no recollection of the incident, given that it took place nearly 20 years ago, and it would not have been her place to stop someone from testifying.

She was deputy surgeon-general during the Somalia mission and “certainly, at the time, you weighed the risks and the benefits and there seemed to be no doubt that mefloquine was an appropriate drug to give at that time,” Dr. Clay said. “Whether I would say the same thing now, I don’t know.”

Additional background material for the Somali inquiry includes a 1994 memo from Dr. Clay to the chief of defence staff saying she did not mean to “deny the perceptions of those who served in Somalia,” but the weight of scientific evidence suggests “that the probability of there being adverse effects severe enough to have an impact on the behaviour of our troops, and to constitute a contributing factor to the tragic events that occurred, is very low indeed.”

Some of the troops who believe they suffer long-lasting effects from the drug have started a class-action suit against the government and Hoffman-LaRoche, the drug’s manufacturer.

“The management of the soldiers’ mefloquine use was not at all what would constitute an approved trial,” Dr. Armstrong said in an e-mail. “Considering the dangers of mefloquine, its unapproved status in 1992 and the promise of our Charter of Rights and Freedoms, to guarantee Canadians’ rights to life, liberty and security of the person, I consider the military orders about taking mefloquine to be wrong.”

Early studies of mefloquine conducted by Hoffman-LaRoche put the risk of even mild side effects at about one in 10,000. Those statistics were recently quoted to The Globe and Mail by Brigadier-General Hugh MacKay, the current military surgeon-general.

But Hervey Blois, a medic on the Somalia mission, estimates that 300 or 400 troops who took part in that deployment were affected in one way or another.

“It was an extreme topic of conversation,” Mr. Blois said. The soldiers would say: “Holy cow, was I ever loopy the other night,” he said. “I would have some really vivid and real dreams. I got into a state of paranoia later on.”

A medical report from HMCS Preserver, a navy support ship stationed off the coast of Somalia at the time, said mefloquine was a problem. “Ten patients experienced nightmares with one patient having feelings of unease and paranoia,” it said. “One patient heard voices and talked to himself. All were switched to Doxycycline with no subsequent problems.”

In March, 1993, Clayton Matchee and Kyle Brown were charged in the beating death of Shidane Arone, a 16-year-old Somali. Mr. Brown was convicted of manslaughter and served a third of a five-year sentence. Mr. Matchee suffered brain damage when he tried to hang himself and was found unfit to stand trial.

When news of the crime hit the papers, an employee of the drug approvals branch of Health Canada walked into the office of Michele Brill-Edwards looking worried. Dr. Brill-Edwards was the senior physician at the department in the late 1980s, when Hoffman-LaRoche began the process of obtaining approval for mefloquine in Canada and, although she was no longer in that role, her former staff still came to her for advice.

“He said: ‘We allowed access under a clinical trial and all of this is going on and it clearly reflects possible mental derangement and we’re not getting any information back. We have no idea whether they are following the protocol that’s been set up and this is basically a big mess,’” Dr. Brill-Edwards said.

Several years later, Dr. Brill-Edwards decided to check the claim that just one in 10,000 people experience mefloquine’s side effects. She said she found those results were obtained from questionnaires handed to travellers on airplanes returning from Africa.

That is no way to collect data, she said, because those who had killed themselves or were in jail over a mefloquine-induced crime would not be counted, and people who had a psychotic episode abroad might be reluctant to divulge it on a card collected by a flight attendant. “If you think about it,” Dr. Brill-Edwards said, “it is the perfect way not to collect the experience of people who have had adverse effects of a mental nature.”

Health Canada, which still says “the benefits of mefloquine outweigh its risks when it is used as directed,” updated its warning labels in August. The department says mefloquine can cause adverse neuropsychiatric reactions that can persist after it is discontinued, and that permanent damage has been seen in some cases.

Nearly 1,000 British soldiers have required psychiatric treatment after taking the drug.

And the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency says that, due to the long half-life of mefloquine, adverse reactions may occur or persist up to several months after discontinuation, or become permanent.

Val Reyes-Santiesteban, who found her son riding a bicycle down a hallway of her home in the middle of the night while he was on leave from his deployment to Somalia, does not need more proof of mefloquine’s long-term psychiatric damage.

“I blame it now. I blamed it then,” she said. The government and the defence department “don’t admit fault. It’s not their job to admit fault. But I knew right away.”

http://www.theglobeandmail.com/news/politics/canadian-forces-firm-on-risky-anti-malaria-drug-ahead-of-africa-mission/article33202493/
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Is it time to re-open the Somalia probe?

Post by Trooper on Tue 06 Dec 2016, 06:20

Is it time to re-open the Somalia probe?

Given what we know now about mefloquine’s effects, the Liberals may have no option

Sheila Pratt Monday, December 5th, 2016

Veterans Affairs Minister Kent Hehr must be starting to recognize the can of worms that landed on this desk this fall.

To be fair, this particular bucket of problems didn’t start with Hehr, or with his government. It dates back to 1992, when 900 Canadian Airborne soldiers were given an experimental anti-malarial drug called mefloquine (sold under the brand name Lariam) under a flawed clinical trial run by the Department of National Defence and Health Canada.

More than twenty years later, some of those soldiers say they are still suffering from neuropsychiatric side effects from the drug, including uncontrollable anger, anxiety, hyper-aggression, paranoia, hallucinations and suicidal thoughts. Recent research shows the drug can cause permanent brain damage.

The veterans want an outreach program, more research into better treatment and acknowledgment by the government that the drug was improperly prescribed to those soldiers serving in Somalia given that it had not been licensed for use in Canada (the conclusion of a 1999 auditor general’s report).

In November, this newly formed group of veterans got a major boost when they got themselves inside the door of the Commons Standing Committee on Veterans Affairs. The all party-committee turned out to be sympathetic to their requests.

The veterans told the committee they’re convinced the psychiatric side effects of the drug played a role in the incident that led to the Airborne being disbanded — the 1992 beating death of a local teen at the hands of two Canadian soldiers during the ill-fated Somali mission. They want that episode reviewed.

The MPs on the committee took surprisingly quick action, voting unanimously to ask Health Canada to do more research into the drug’s side effects and stating that the committee is concerned about “the historic and continuing use of mefloquine.”

While pointing the finger at Health Canada may appear to take the heat off Hehr, the committee may have found the better target. For years, Health Canada failed to acknowledge the long-term side effects of the drug — among them, brain damage — despite the fact that Canada’s allies, including the U.S. and Britain, have confirmed those findings and have taken steps to restrict the drug’s use.

In July 2013, the U.S Food and Drug Administration upgraded its warning on the drug to its toughest level after its own study concluded that some of the drug’s side effects could be permanent.

Shortly after, the U.S. military banned the use of the drug among special forces such as Green Berets, and downgraded it to a drug of last resort for the rest of the armed forces.

European drug regulators did their own study and came to the same conclusion two years ago — which is why the U.K. armed forces now also consider mefloquine a drug of last resort.

For the Liberal government — for any government — reopening the Somali affair to look at the murder of Somali teenager Shidane Arone would be problematic. But the pressure to do so may grow.

Health Canada waited a long time — until August of this year, in fact — to approve a new label for mefloquine that would “add a more prominent warning on the labels to better emphasize its known risks,” as Health Canada put it. It did so quietly, by posting on its website the new wording on the drug label proposed by AA Pharma, the drug’s manufacturer in Canada.

“In a small number of patients it has been reported that dizziness or vertigo and loss of balance may continue for months or years after discontinuation of mefloquine, and in some cases vestibular damage may be permanent,” says the company’s drug monograph updated Aug. 4. Health Canada also said in an email that it considered both the FDA warning and the European studies in approving this change to the drug warnings.

None of this seems to have changed the government’s policy on the drug’s actual use.

“The benefits of mefloquine outweigh its risks when it is used as directed. The drug is an important tool in preventing and treating malaria, and provides effective protection against a strain of malaria that is resistant to another drug that is often used to treat malaria, namely, chloroquine,” Health Canada added.

Oddly enough, Kent Hehr was unaware of that change in the warnings this summer. He sent a letter to the veterans saying that “a review of the scientific literature has shown there are no long term side effects.” That was a few days after Health Canada posted the new warnings.

Seems the military didn’t get the message either. The army Surgeon General, Brigadier General Hugh MacKay, told the Veterans Affairs committee last month that the long-term negative side effects have not been proven by science.

Now that Health Canada has acknowledged that permanent side effects are possible, will that be enough to prompt the military to make changes to its policy on mefloquine usage? That’s the question the veterans are asking. They want to see mefloquine classified as a drug of last resort, as other countries have done.

More than 16,000 Canadian soldiers took mefloquine between January 2001 and 2012, mostly in Afghanistan.

In recent years, use of the drug by Canadian soldiers has dropped significantly, to about five per cent of soldiers going to tropical countries. That’s still much higher than in the U.S. military, where use of the drug is down to one per cent.

In the 1990s, Reform (later Conservative) MP John Cummins of British Columbia was the lone voice prodding successive federal governments on the mefloquine issue. Despite his efforts, governments took no action.

This time around, Saskatchewan Conservative MP Kathy Wagantall is taking up the torch. She’s been asking pointed questions in the House of Commons and putting pressure on the Trudeau government.

Saskatchewan is also the home province of Clayton Matchee, one of two soldiers involved in the beating death of that Somali teen. Matchee attempted suicide after the incident and, due to brain damage he sustained, he never went to trial. There’s already a move afoot to have Matchee’s case revisited to determine whether mefloquine toxicity played a role.

For the Liberal government — for any government — reopening the Somali affair to look at the murder of Somali teenager Shidane Arone would be problematic. But the pressure to do so may grow.

Some of the veterans initially had some hope the new Liberal government would recognize their cause and take some meaningful action. These days, they aren’t so sure anymore. Some have joined a class action lawsuit against Health Canada. That kind of legal action spells trouble for any government.

Mr. Hehr has some work to do.

https://ipolitics.ca/2016/12/05/is-it-time-to-re-open-the-somalia-probe/
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Germany bans drug linked to brain damage, ramps up pressure on Canada

Post by Trooper on Fri 09 Dec 2016, 10:20



Germany bans drug linked to brain damage, ramps up pressure on Canada

Mefloquine still used by Canadian Forces as anti-malarial, despite links to suicide and aggression

Sheila Pratt Friday, December 9th, 2016

The German defence ministry is in the process of banning the controversial anti-malarial drug mefloquine in its armed forces — a move that will leave Canada further out of step with its allies.

The German ministry took mefloquine off the list of medications prescribed for soldiers last week, said Agnieszka Brugger, a Green Party member of the German parliament who sits on the defence committee.

The ministry has not yet issued an official statement outlining its reasons for banning the drug for German soldiers, Brugger said in an email this week. But she’s pleased the ban her party pushed for is finally in place.

“Considering the neuropsychiatric side effects of this anti-malarial drug, that decision is a great first step,” said Brugger.

Mefloquine’s side effects include paranoia, anxiety, anger, hyper-aggression, nightmares and suicidal thoughts. The drug has been implicated in the violence committed by two Canadian soldiers who beat a Somali teen to death in a 1993 mission.

While use of the drug has decreased signficantly in the Canadian military, the defence department continues to use it as a frontline anti-malarial — unlike the U.S., Australia and United Kingdom, all of which have imposed tighter restrictions after research showed the drug can cause permanent side effects and brain damage.

Three years ago, Germany designated mefloquine a drug of last resort after both the U.S. Food and Drug Administration and the European Medicines Agency confirmed in separate studies that some of the side effects could be permanent and issued tougher warnings.

Going one step further last week, the ministry decided to drop the drug from the armed forces entirely. Manufacturer Roche is no longer marketing the drug in Germany.

The Green Party, which introduced a motion to the German Parliament requesting a ban on use of the drug in the armed forces, says it’s “unacceptable” to allow prescriptions of this potentially harmful medication.

“I am extremely glad that this decision (to ban the drug) was finally made and can only hope other forces will do the same,” said Brugger. “However we still have a lot of work to do.”

The Green Party is also asking the defence ministry to find out which soldiers took mefloquine and suffered side effects and to conduct more research, said Brugger, adding that the party has not received a response to those requests.

Brugger said the German defence ministry told her it cannot give an exact number of soldiers who took mefloquine as prescription records are not centralized.

Canadian veterans, including those from the former Canadian Airborne Regiment, say they are encouraged by Germany’s move and will continue to push Canada to take similar steps to restrict the drug, said John Dowe, co-founder of the International Mefloquine Veterans Alliance.

But the Canadian government continues “to deny commonly accepted facts understood (by) so many countries,” said Dowe, referring to recent comments by army Surgeon General Brigadier General Hugh MacKay.

MacKay told the House of Commons veterans affairs committee this fall that he did not think there was sound science behind the assertion that the drug has long-term side effects.

Health Canada tropical medicine expert Barbara Raymond also told the committee the evidence does not support the conclusion of long-term side effects.

DND’s refusal “ to acknowledge facts” set out by drug regulators is troubling and may be due to a fear of lawsuits, said Dowe.

Dr. Remington Nevin, a leading expert on mefloquine and its neuropsychiatric side effects, urged Canada to follow Germany’s example before it sends more soldiers to Africa on a peacekeeping mission.

“Canadian military officials remain years behind their European counterparts in their appreciation of the inherent dangers of mefloquine,” said Nevin, who also testified at the veterans affairs committee.

“European drug regulators have understood for a number of years that mefloquine is neurotoxic and may cause permanent brain injury leading to lasting psychiatric and neurologic effects.”

In August, Health Canada quietly approved new wording for mefloquine warnings proposed by manufactuer AA Pharma. The new wording makes clear side effects include “serious mental and nervous system” in some cases may be permanent.

The U.S. military, which developed the drug, also designated mefloquine a drug of last resort in 2013 and banned it for use among its special forces, such as the Green Berets.

Only one per cent of U.S soldiers use it. About five per cent of Canadian soldiers use it.

This fall, the U.K. defence ministry changed its prescribing policy and made mefloquine a drug of last resort following a parliamentary inquiry into the side effects. The defence ministry also apologized to soldiers wrongly prescribed the drug without individual assessments.

In Australia, mefloquine was deemed a “third line drug” in 2006 and in the past five years, only about 25 soldiers who cannot tolerate alternative drugs have been prescribed mefloquine, according to a defence ministry statement.

In Ireland, veterans are pushing to have the drug banned; the Irish military says there are no plans to withdraw mefloquine. Roche took the drug off the commerical market in July in Ireland.

More than 900 troops of the now defunct Canadian Airborne regiment were the first to take the drug in Canada under a flawed clinical trial in 1992. Another 16,000 soldiers in Afghanistan took the drug between 2001 and 2012.

Steven Nash was a junior officer in the Canadian Airborne, with 30 to 40 soldiers under his command in 1992-93 in Somalia. He noticed mefloquine’s side effects on some of his soldiers soon after arriving in the desert country.

Some of his soldiers who took the drug were plagued by bad dreams, sleeplessness and feelings of anxiety, and he feared they were in no shape to safely go out on patrol, Nash said in an interview.

“I used to call it the night of 1,000 dreams. I’d have arguments with my bosses and I’d say, ‘Could we not go out on patrol that night?’” he said. But his suggestion was rejected, he said, with “no sympathy from higher-ups.”

Nash compared the current mefloquine controversy with the unfortunate 1960s episode involving the testing of the defoliant Agent Orange by the U.S. military at CFB Gagetown in New Brunswick with Canada’s permission.

For years, the federal government resisted pressure from veterans who became ill from the contaminants in the chemical herbicide, tested at Gagetown in 1966 and 1967.

Finally, in 2007, the government set aside $100 million to compensate veterans made ill by the chemicals. By then, many of the soldiers involved in the episode had died, Nash noted.

http://ipolitics.ca/2016/12/09/germany-bans-drug-linked-to-brain-damage-ramps-up-pressure-on-canada/
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Re: Mefloquine / Topics & Posted Articles

Post by Dannypaj on Sat 10 Dec 2016, 07:15

Accordingly, the goal of the study is not to assess whether to recommend legislative or regulatory amendments to a specific benefit or service, but rather to examine whether existing benefits and services, as designed, can achieve their objectives, as perceived by the intended beneficiaries: veterans and their families
Not with a carrot over my head (NVC). Which benefits can be cancelled upon ministerial review.
Stop wasting money and help out the ones that protect and defend our land (and revert back to the Pension Act policies, i.e. instated by the Queen)
Make the lives of all veterans better.


Is there something I am missing?
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