Americans mislead Allies on use of anti-malaria drug, mefloquine or Lariam


Dr. Remington Nevin speaks out in the Sunday Business Post, in an article on the adverse problems affecting Irish soldiers who have been issued the anti-malaria drug mefloquine or Lariam. In his opinion, the U.S. has withheld vital information from its allies, who might have ceased issuing the drug to their troops had they been informed the Americans stopped dispensing it in 2009. BONNIE

 
Collateral damage
10 April 2011 By John Burke

When Tony Moore first noticed his hands beginning to swell, he wasn’t unduly concerned.

At the time He was one of 400 Irish soldiers on peacekeeping duty in Liberia, and he blamed the problem with his hands on the blistering heat in the troubled African nation.

Ten weeks later, in the autumn of 2004, Moore was back in Dublin, but the swelling hadn’t gone down. He went to St Brecin’s, the Irish Army hospital, and was told that the best could do was wait to see what happened next.

If anything, Moore says, his health got worse. On top of the physical symptoms, he began to feel mentally unwell.

‘‘I was feeling down in the dumps, and I couldn’t figure out why,” he says.

His dark moods turned to anxiety, and then to severe depression. It was a turn of events the Dubliner couldn’t have imagined when he joined the army in 1983.

By the time he retired in 2008, at the age of 41, he had served in the Lebanon, Somalia, Bosnia, Liberia and Chad.

He describes himself as someone who ‘‘always had bundles of energy going back over the years’’. But by the time he finally hung up his boots, he says he was both physically and mentally ‘‘floored’’.

Moore now believes that the critical changes in his body and mind occurred a fortnight into his trip to Liberia in 2004, within days of being given Lariam, a controversial anti-malaria drug which the U.S. army has recently stopped giving to its soldiers.

Lariam, the trade name for mefloquine, has been the main anti-malaria pill given to Irish soldiers serving overseas since the 2004 mission to Liberia.

Moore says that, since taking Lariam, his life has been dominated by bouts of severe depression and crippling tiredness borne from insomnia.

Dave O’Shea, another former Irish soldier, tells a similar story. From Limerick, O’Shea met Moore while he was searching for an explanation for the rapid physical and mental changes he had experienced shortly after coming home from the same tour of duty in Liberia.

‘‘Something strange began to happen to me while I was over there,” says O’Shea. ‘‘I went from always being a good sleeper to getting two hours’ sleep a night. That went on for six months; every night I would get out of bed and sit in the rec room, wide awake and exhausted.”

O’Shea began to feel mentally unwell as his stint in Liberia progressed; in one incident he jumped through a window following a row with a fellow soldier. ‘‘I don’t remember doing it,” he says. ‘‘I couldn’t explain any of my behaviour then, or for a long time afterwards.”

O’Shea was ultimately commended by his superiors for his soldiering in Liberia. Like Moore, he was given Lariam while on the mission.

In the two months after he returned to Ireland, O’Shea began to lose weight rapidly, and also developed acne and other skin problems. His memories of that time are hazy, but he says he began to display signs of aggressiveness that were out of character.

‘‘I’d done a lot of martial arts and bodybuilding, and I had worked on doors for years in my spare time, but I was always a talker – I was never one for any trouble,” he says. ‘‘Then suddenly I began to get into fights, and to lash out at people. It wasn’t my style at all; I was like a different person.”

On top of the insomnia and aggression, O’Shea’s moods swung wildly and unpredictably, as he says they still do. In an effort to improve his situation he cut out alcohol, but says the effect was negligible, and those closest to him began to complain that his behaviour was becoming unbearable.

By then, some years had passed since O’Shea had been given Lariam. While searching the internet for help with his moods, he came across a link to Mefloquine Ireland, a not-for-profit group which first established a presence here in 1999 as an off-shoot of similar groups in the US and Britain in the late 1990s.

In turn, both O’Shea and Tony Moore contacted Anthony Bryce, a former company director who was heavily involved in Mefloquine Ireland.

Moore and O’Shea were surprised at the number of soldiers who had served in Liberia or in Chad who had also contacted the group.

Bryce is engaged in a long-term legal action Against Roche, the company which manufacturers Lariam, as well as the doctor who prescribed the drug to him.

He is at pains to point out that he is not a medical professional, and does not advise anyone against taking Lariam. But he says that, in the 15 years since he first took the drug while he was on honeymoon with his wife Cathy in Kenya in 1996, life as he knew it has all but ended.

In that time, he says, he has suffered from chronic tiredness and insomnia, and has also experienced a symptom described by a number of patients who have taken Lariam – so-called suicide-ideation, or the detailed plotting of his own death.

Lariam remains an approved drug here and in the U.S.

The U.S. Federal Drug Administration’s (FDA) notes on the drug state that ‘‘rare instances of suicide in patients taking mefloquine have been reported, but no studies have demonstrated a statistical association between mefloquine use and suicide, suicidal ideas, suicide attempts or any other violent behaviour’’.

However, the FDA’s information note recommends against prescribing Lariam to patients with a history of psychiatric or alcohol problems, and states that side-effects may include anxiety, paranoia, depression, agitation, restlessness, mood changes, panic attacks, forgetfulness, hallucinations, aggression and psychotic behaviour.

For former soldiers like Moore, O’Shea and approximately 50 others who attended recent meetings of a support group, the key issue is the fact that it was the state which gave them Lariam.

They believe the prescribing of Lariam to Irish troops travelling abroad should be halted, and say that those who believe they have been affected by the drug should be screened and given access to remedial treatment, at the state’s expense.

Although the group now has a Facebook page up and running, O’Shea says it is largely closed off to new members.

Like many serving and ex-serving members of the defence forces who believe they have been affected by Lariam, he is fearful that the public will believe their complaints are motivated by financial gain.

‘‘We all know how the army deafness thing was seen – how it became a joke that diminished the army.

“We don’t want that, and we’re being very careful about that,” he says. ‘‘This isn’t like the deafness issue. It only relates to a very small number of people, a fraction of those who went overseas to Liberia and Chad, and who can show they have been affected by this after a full medical screening.”

The U.S. military remains the main expert on the use of Lariam, having played a role in the creation of the drug, and having the longest experience of giving it to its soldiers – it was first used towards the end of the Vietnam War.

U.S. army doctors have not only studied the drug’s side-effects inside out, but have also looked at the military administrative processes under which some soldiers who should never have been prescribed Lariam still ended up taking it.

A major study was published last February in the medical journal Pharmacoepidemiological Drug Safety (pharmacoepidemiology is the name given to the study of how large groups of people interact with specific drugs).

The study, entitled ‘Mefloquine [Lariam] prescriptions in the presence of contraindications: prevalence among U.S. military personnel deployed to Afghanistan during 2007’,was conducted by one of the leading U.S. medical experts on Lariam, army doctor Major Remington Nevin.

Nevin’s study began with the recognition that contraindications tomefloquine include a ‘‘history of certain prevalent neuropsychiatric disorders, which are thought to increase the risk of severe adverse events including anxiety, paranoia, depression, hallucinations, psychosis and possibly suicide’’.

The study looked at administrative policies in the U.S. military dating back to 2002 with the aim of determining if, and how, soldiers and their medical officers were subverting, intentionally or otherwise, the strict ban on Lariam being given to troops with a medical history of neuro-psychiatric problems.

It looked at 4,505 active duty U.S. military personnel who were prescribed Lariam in the lead-up to combat deployment in Afghanistan.

Of those personnel, a total of 9.6 per cent had contraindications tomefloquine use, and should not have been given the drug under any circumstances.

But Nevin’s analysis found that 13.8 per cent of those with contraindications were still being prescribed Lariam, despite the extra efforts made to pre-screen for the condition.

‘‘Despite the long-standing administrative policies meant to reduce such events, approximately one in seven individuals with neuro-psychiatric contraindications received a prescription for mefloquine prior to combat deployment . . . significantly increasing the risk of subsequent adverse events,” the study concluded.

Nevin conducted the study while based at The U.S. Army Africa Command, Combined Joint Task Force Horn of Africa, Camp Lemonier in Djibouti.

From Bayne-Jones Army Community Hospital at Fort Polkin Louisiana ,where he now works as a preventative medicine specialist, Nevin said there were ‘‘two basic issues at play’’ which were important to consider when prescribing Lariam to soldiers.

‘‘The first is that the risk of mefloquine adverse events is reduced, but not entirely eliminated, by screening out those with mental health disorders,” he says.

‘‘This is because the risk of mefloquine adverse events occurring is quite evenly distributed in the population. Inmost cases, when serious adverse events do occur they are preceded by a prodrome [early symptoms] of subtle mood changes which, if recognised and which result in discontinuation of the drug, can often prevent the worst reactions from occurring.”

In effect, according to Nevin – who was not speaking as an official spokesman for the U.S. army, but as a physician and expert in the use of anti-malarial drugs – those with a history of neuro-psychiatric problems might be less likely to blame the drug when they are overcome by sudden feelings of depression and anxiety.

‘‘Among those with histories of mental disorder, or who might be taking psychotropic medications, it seems plausible that these individuals will be less likely to attribute these symptoms to the drug if they occur, increasing the risk that they will continue taking the medication until a toxic encephalopathy [brain disease] develops,” he says.

‘‘It is for this reason that education is critical, so that the early warning signs of mefloquine encephalopathy can be properly recognized.

Unfortunately, many of the prodromal [early] symptoms – anxiety, restlessness, difficulty sleeping, vivid dreams and nightmares – are particularly common among even healthy soldiers deploying to combat, which is why Lariam is such a poor choice for military populations.”

Nevin says that, in the U.S. military in recent years, there has been an organizational bias in effect that has ‘‘favored the non-ascertainment of potentially disqualifying mental health conditions’’.

‘‘Given the quite significant manpower pressures that we have been under, it has been unfortunately the case that our systems and policies have not given priority to documenting the true prevalence of mental disorder and psychotropic drug use among our deploying personnel,” he says, citing the long-established problem the U.S. military has had with trying to encourage more troops to accept overseas assignment, as the numbers willing to do so has plummeted.

There has been no such problem with the Irish armed forces, where the relatively small overseas deployments – 400 to the upcoming deployment in Lebanon later this year – has meant that overseas duties are keenly sought by the troops.

However, the experience of the U.S. army highlights the problems that can occur when it comes to the screening process for Lariam.

‘‘Soldiers are tacitly discouraged from reporting such disqualifying conditions, and commanders are under tremendous pressure to ignore them or overrule medical recommendations not to deploy when they are identified.

‘‘This results in a lack of visibility of mental health symptoms and prior diagnoses at the time of pre-deployment mefloquine prescription,” says Nevin.

Seventeen soldiers are now ready to launch separate legal actions against the state arising from being given Lariam.

Preliminary work on the cases has been prepared by their solicitor, Pat McGonagle, who points to a large body of both military and medical expertise which raises major questions over the use of Lariam, and in particular the effect of prescribing it to a large group of soldiers being sent into combat, peacekeeping or peace-enforcement missions in malaria-infested zones.

McGonagle says this situation doesn’t have to drag on, nor does it have to become embedded in lengthy and costly litigation.

He says the soldiers only have a handful of demands; namely the cessation of the use of Lariam, and the provision of medical and physical treatment for their incapacities.

One of the main legal arguments, which the soldiers are expected to use in court, is that the Irish defence forces did not appropriately screen for disqualifying medical conditions prior to giving Lariam to troops who were sent to Liberia and Chad. Every soldier who serves in the army has a medical file known as an LA30.The full medical history of each soldier is contained in the file, and it includes full reference to all of the conditions which should normally disqualify someone from being prescribed Lariam.

Documents which are being prepared for the case show that in several cases, Lariam was prescribed to soldiers whose LA30s clearly showed that they should never have been given the drug.

It will be up to the court to decide the balance of liability in cases where soldiers failed to adequately self-report their previous medical history, but where the defence forces possessed all the information they needed to disqualify the soldiers from ever being given Lariam.

In the soldiers’ favour, the High Court has already established, in an unrelated legal action, that the state carries an especially high legal burden of care when it comes to protecting troops from illness or injury, given that soldiers work in a controlled environment where their choices are limited by the decisions of senior commanders about their choice of accommodation, transport, food and medicines.

The Department of Defence is actively preparing for a series of legal actions which it has been expecting for some time in connection with the prescription of Lariam to Irish troops.

The state’s weakness maybe the prescription of drugs to soldiers whose files showed a history of neuropsychosis but, in its defence, it is likely to claim that some soldiers effectively misled medics when they were verbally questioned prior to being given Lariam.

The Department of Defence told The Sunday Business Post that Lariam was prescribed as part of a ‘‘detailed screening and vaccination of personnel prior to deployment; the monitoring of personnel while abroad and the further screening and testing of personnel prior to, and following their return’’.

The department points out that Lariam is authorized for use by the Irish Medicines Board, which is the statutory body charged with regulating the use of medicines, and to ensure the quality, safety and efficacy of medicines available in Ireland.

A statement from the department went on to say that Lariam was ‘‘prescribed for areas where it is required and where it is deemed the most suitable and effective antimalarial prophylaxis for certain regions where Irish troops are deployed’’.

‘‘The Defence Forces Medical Corps continually review new research, information and/or advisories from the Irish Medical Board or other relevant bodies relating to medicines prescribed to our troops.

The malaria chemo-prophylaxis requirements for all missions, new and current, are reviewed on an ongoing basis, and the most appropriate medication is recommended by the Medical Corps,” it said.

The Sunday Business Post understands that senior army officers are reviewing the system of self-reporting for any disqualifying conditions which has been a key part of the current screening process.

But, if the army does decide to enhance its screening process, as is expected, from a legal point of view it may prove to be a case of closing the barn door after the horse has bolted.

Medically, it may not be the answer either – Nevin believes that any system relying on self-reporting is doomed from the start. ‘‘It is now a fairly well-established fact that self reporting of mental health concerns prior to [combat] deployment predictably results in invalid data,” he says.

‘‘So any system which solely relies on this to identify those who cannot take mefloquine is insufficient.”

Tony Moore says that many serving Irish soldiers are afraid to admit that they have got a disqualifying medical condition because they feel they will be banned from ever going on overseas duty.

‘‘There are young guys in the army now who are petrified that, if they admit to having problems, they’ll never get to serve overseas again,” he says.

Military sources have informed The Sunday Business Post that the Irish Army’s chief medical officer, Colonel Gerry Kerr, conducted a special review into the use of Lariam last summer on foot of the increasing activity of the group of ex-soldiers.

That review culminated in Kerr informing Army HQ that Lariam remained the most effective and safest anti-malarial drug, essentially guaranteeing its continued use for the time being.

Nevin said that he spoke directly to Kerr on the subject of the dangers of Lariam just five months ago when the pair met in Florida. The Sunday Business Post asked Kerr to participate in this article, but the Defence Forces press office did not respond to the request.

‘‘I spoke about this issue with the new chief of the Irish Defence Force medical corps, Dr. Kerr, in person when he was in Tampa this past December for a medical meeting.

‘‘He was just getting oriented to the controversy, and I shared with him my opinion that the U.S. army deserved, as I thought, at least some of the blame for how mefloquine had been misused in Ireland,” says Nevin.

‘‘For years after the U.S. army had developed the drug, we had vigorously advocated its use, while in retrospect overstating both its efficacy and safety.

‘‘When we quickly withdrew the drug from use in early 2009,we did so in a very obscure manner, without being fully open about our reasons for doing so and without widely announcing the dangers associated with its use that our senior leadership had been briefed on.

‘‘As a result, I believe many countries remained unaware of the drug’s dangers and continued its use unnecessarily. It is unfortunate that many of Ireland’s troubles with the drug might have been avoided had the U.S. been more proactive in announcing the reasons for our switch to safer alternatives.

‘‘It is my personal opinion that we let down our allies through our silence on this issue.”

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About Bonnie Toews and John Christiansen

Bonnie's Blog Posts invite our readers and free spirits everywhere to share life's adventures with us. I talk about writing my novels, reading books, chatting with other writers and John's and my journeys around the world. We welcome your anecdotes to our experiences and discussions.
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One Response to Americans mislead Allies on use of anti-malaria drug, mefloquine or Lariam

  1. Pingback: Americans mislead Allies on use of anti-malaria drug, mefloquine … - i Health Plus

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