DEFENCE Minister Alan Shatter has been accused of a cover up over allegations arising from the controversial anti-malaria drug Lariam.
In a heated exchange in the Dáil on Oct 17, Fianna Fáil’s defence spokesperson Seán Ó Fearghaíl TD claimed the Minister’s decision not to publish a report on Lariam gave “the impression there is something to hide on the part of the Department of Defence”.
The Minister set up the Working Group on Malaria Chemoprophylaxis in 2011 to investigate claims made by former and serving members of the Defence Forces that they have suffered serious, long-term side-effects after being given Lariam (generic name mefloquine) while on United Nations duty in Africa.
“This controversy will not go away,” said Ó Fearghaíl. “The momentum demanding action and either an exposé or an explanation on the part of the Department is growing by the day.”
The momentum Ó Fearghaíl mentioned relates to the 24 cases being brought by former or serving Defence Forces personnel against the State for prescribing them Lariam.
Among the more serious and lasting side-effects allegedly associated with Lariam use include insomnia, restlessness, vertigo, dizziness, aggressive outbursts, memory loss, severe anxiety, depression, psychosis, and suicide ideation. Lariam has also been linked with causing permanent brain injury and suicide.
The minister claimed “legal privilege” arising from current and potential future litigation in refusing to publish the report, but assured Ó Fearghaíl there was nothing to hide: “There is not, as the deputy put it, a growing controversy.”
But evidence from elsewhere suggests Lariam is dogged by controversy. In 2007 — as seen in internal company records by this newspaper — Lariam’s manufacturer, the Swiss-based pharmaceutical giant Roche, began expressing reservations over its own product. “Lariam used to be the most important drug in the fight against malaria,” reads the transcript of Roche’s 2007 AGM in Basel.
“In the meantime, however, science had advanced; more effective anti-malarials with better side-effect profiles were now available, and these were generally used.”
That remark was made by Roche’s chairman, Dr Franz B Humer. T
oday Lariam makes up less than 3% of all anti-malaria prescriptions issued by Irish travel health experts; alternatives like Malarone and doxycycline are now favoured by doctors.
Since February 2009, the US army no longer issues Lariam to its Special Forces. This followed a spate of widely-reported suicides and murders by US troops who had taken the drug while on duty in Iraq and Afghanistan. In one case, the US army was reported to have investigated the use of Lariam in the aftermath of the murder of 16 villagers by a sergeant on duty with the Special Forces in Afghanistan. Dispensing the drug to US Special Forces is now classified a court-martialling offence. In June 2012, Dr Remington Nevin, a former US army major and one of the world’s leading experts on adverse reactions to anti-malarial medications at John Hopkins Bloomberg School of Public Health, testified before the US Senate on his research into Lariam. He said he feared that Lariam “may become the ‘Agent Orange’ of our generation: a toxic legacy that affects our troops, and our veterans ...
“We now understand the drug’s strong links to suicide and to acts of seemingly senseless and impulsive violence.”
Meanwhile, in July 2013, following a review of the drug’s risk/benefit profile, the US Food and Drug Administration (the FDA — the body responsible for licensing pharmaceuticals) made a major update to Lariam’s safety information by including a so-called “black box warning”. A black box warning is the strictest warning the FDA issues, indicating that a product carries significant risks of serious or life-threatening side-effects. The safety label for Lariam in the US now reads: “Neurologic side effects can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent.”
In the Dáil chamber, Shatter insisted Ó Fearghaíl was being “alarmist” in raising concerns about Lariam. In the Minister’s view, Lariam continues to be the best available drug to prescribe to Irish troops serving in malarial regions overseas.
“There is nothing in the report,” continued the Minister, “that indicates the approach that has been taken heretofore should not be taken. I wish to be quite categoric on that.”
Just how categoric the Irish Defence Forces have been regards their Lariam policy can be seen from instructions issued in official Defence Forces’ Medical Corps (DMC) documents seen by this newspaper.
A 2001 DMC letter circulated to the 221 Irish soldiers awaiting deployment to Eritrea in the Horn of Africa states: “Personnel in whom ... mefloquine is contraindicated ... will NOT be considered fit for deployment”. A contraindication is a medical term to describe a condition or factor that serves as a reason not to prescribe a patient a particular drug or treatment.
Meanwhile, a 2009 letter issued by an army medical officer to members of the 102nd Infantry Battalion awaiting deployment to Chad in central Africa instructs: “WARNING Do not take any other anti-malarial medicine as only Lariam is effective in Chad ... If you do not follow this instruction and catch malaria by your own fault the Defence Forces are not liable.”
However, Malarone and doxycycline are effective in Chad, according to the Centre for Disease Control in the US, the NHS in Britain, and the World Health Organisation.
“Other anti-malarial medicine, eg Malarone,” the medical officer further instructs, “will not be allowed in your possession and will be treated as contraband. Any personnel found not following this instruction will face disciplinary action.”
Yet this “Lariam-only” stance is out of step with many of our European counterparts. A 2011 survey by the European Organisation of Military Associations found that several European armies are much more likely to prescribe alternative anti-malarials, like Malarone and doxycycline.
The Danish and Norwegian armies exclusively use Malarone, while the Polish army uses Malarone for the first month, then doxycycline for the remainder of a mission. The Austrian army prescribes Malarone as a first choice drug, and only considers Lariam if a soldier shows contraindications to Malarone.
And following the July “black box” update by the FDA, the German army has now made Lariam a drug of “last resort”; it is only prescribed after a soldier rejects all other alternative medicines.
Speaking to the Irish Examiner, Ó Fearghaíl said he raised the Lariam issue in the Daíl again on Dec 12. And again, he was told the findings of the working group will remain secret. Ó Fearghaíl said he has taken Lariam in the past while on holidays, and has suffered no serious side-effects. But considering the evidence now available, “there is concern,” Ó Fearghaíl said, “and it is genuine”.
By persisting with the present Lariam policy in the Defence Forces, Ó Fearghaíl said Shatter was “out of touch”.
Concern, Oxfam and Médecins Sans Frontières (MSF), who routinely send staff from their Irish offices to malaria-endemic countries to carry out their overseas aid programmes, each said that they use all three main anti-malarial prophylaxes depending on an individual’s specific needs. A spokesperson for MSF said: “It depends which medication best suits the individual, as people can react differently to each”.
* This article was supported by the Mary Raftery Journalism Fund
Anthony’s story: “there should be no argument; the drug should be pulled”
Anthony Moore (47) is a former soldier who claims to have suffered physical and psychological side-effects, after being prescribed Lariam while on overseas duty with the Irish Army. Moore joined the Irish Navy in 1983, and served on UN missions in Lebanon, Somalia, Bosnia, Liberia, and Chad. His problems began after being given Lariam, while on tour in Liberia in 2005-06, and again, in Chad, in 2008.
“While in Liberia, I reported the swelling of the hands,” Moore said. “I thought it was the heat. But then it went from the swollen hands to pins and needles, shoulder pains, muscle spasms. I suffered a complete draining of the body, once coming back from Liberia for two years.
“When I went to Chad, I suffered with hallucinations. It went from hallucinations to depression, to mood swings and suicidal thoughts. Everything you can think of that is a side-effect of Lariam, I’ve gone through — except suicide. Sometimes, I would cry for no reason.
“My whole life has just been turned upside down. And my family suffers because of it. I could be grand one minute, and then burst out. I get claustrophobia. Every day you suffer with something different. This morning it was paranoia, it was hitting me. Day in, day out, I suffer with the spasms in the shoulders.”
Moore’s worst incident, since taking Lariam, occurred while at home chatting with his wife. “I went from grand one minute, jabbering away, to almost putting a knife through my wife. That got very, very scary. I got out of the kitchen straight away, broke down.
“I didn’t know where this was coming from, it was like someone put a bag over my head. I went blank. All I could see was grabbing a knife. It’s like Jekyll and Hyde. That was the fright of my life,” Moore said.
Moore left the army in 2009, and now runs a support group, called Action Lariam for Irish Soldiers, through Facebook, for former and serving Irish soldiers affected by the drug. Since founding the group, he has heard from hundreds of Irish soldiers who have had similar Lariam experiences to him. He hopes the group will help to highlight the dangers associated with Lariam.
“The first thing that should be done, there should be no argument, the drug should be pulled,” said Moore.
The second thing Moore would like is a rehabilitation programme for affected soldiers. “I’d like to see medical specialists made available to treat soldiers. To coach soldiers to get over, or at least cope with, their problems,” Moore said.
“And, also, that their problems can be explained to their families. My wife and my children understand what I’m going through now, but many families have been destroyed by Lariam, because people don’t understand what’s happening to them.”
Alan’s story: “I couldn’t go out ... I felt depressed, sad. My balance was gone”
After returning from a UN mission to Chad, in 2010, Alan Byrne (28) didn’t understand what was happening to him. Chad was his first overseas tour with the Irish Army, which he joined in 2007. Byrne was prescribed Lariam while in Chad.
“You trust the army, what they give you,” Bryne said. “I never questioned them. We went over, and, because it’s your first time overseas, you don’t know if the drug is having an effect on you, or if it’s the place. But I got really bad dreams; you’d think they were real. I’d wake up in a puddle of sweat. I’d get mood swings, snap at people — and that’s not like me. So, I just took it as the pressures of being overseas.”
On returning to Ireland, the ‘warzone’ continued for Byrne. “When I got home, I carried on the same; I felt the same as I did in Chad. I couldn’t sleep. Sleeping tablets wouldn’t help.”
Byrne struggled with insomnia, loss of balance, acute anxiety and depression, for months. It took its toll, and he could no longer cope.
“When I went back to the job in the barracks, I just couldn’t handle it. The worst; I wasn’t sleeping. I was getting one or two hours sleep a night. The first thing we do in the morning is go on a 10k run, or whatever, and I had physically no energy to do that.”
Byrne went to the Army Medical Officers, but felt he did not receive the appropriate medical treatment, just routine counselling and a prescription for anti-depressants. Byrne had learned about the side-effects associated with Lariam-use, but the army dismissed his concerns, he said.
“All I got was time off. So all I was doing was going home, sitting at home. But I was happier at home, because I felt like I couldn’t go out in public. I felt depressed, sad. My balance was gone; I’d be walking into walls at home. I felt anxious all the time. Like, even now I’m sweating.”
“Eventually, after about a year back, in 2011, I went the suicidal way. I got rushed to St James’ Hospital, got put on watch there for a few hours, until I calmed myself down. But, ever since then, I still have them tendencies to do it — like, I just feel like exploding.”
Like Anthony Moore, Byrne feels his life has been turned upside down by taking Lariam. Also like Moore, he feels the army wants to wash its hands of any responsibility for dispensing the drug. “The army goes on about loyalty — look out for your comrades, don’t leave anyone behind — but, as far as I can see, they don’t care about you. “As soon as I mentioned Lariam, I was pushed to the back of the pile. And there was nothing I could do to get back up.”
Byrne said: “If you asked me, ‘Is there one thing you’d like to change in your life?’ Yes, there is. I’d never have gone to Chad.”
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