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'MoD "DISREGARDED MALARIA DRUG PRECAUTIONS" SAY MPs'

By Ben Farmer, Defence Correspondent

Telegraph Online – 24 May 2016

The Ministry of Defence has shown “lamentable weakness” in its duty to protect soldiers, sailors and airmen, by ignoring stringent precautions for handing out a controversial anti-malarial drug, MPs have said. The Commons defence committee said there is "very strong anecdotal evidence" that manufacturer’s guidelines to cut Lariam’s harmful side-effects in some users had been “disregarded” by the armed forces.

Allegations that hundreds of former service personnel are suffering mental illness after they were prescribed the drug, also called mefloquine, have led to calls for military doctors to stop giving it. The committee called for the MoD to use the drug only as a last resort, when there was no alternative available.

While Lariam is not the main anti-malarial drug used by the armed forces, at least 17,368 personnel were prescribed it at least once between the start of April 2007 and the end of March 2015, according to official MoD figures.

A report by the committee said it had received strong anecdotal evidence that current and former service personnel had been adversely affected and that arrangements for supporting them were "inadequate". While the manufacturer, Roche, had issued "clear guidance" that individual risk assessments should be conducted before prescribing, the committee said the MoD appeared to have interpreted this to include "desk-based" assessments using medical records rather than face-to-face interviews.

It said it was "deeply disturbing" that some personnel apparently preferred to throw away the Lariam they had been prescribed and run the risk of contracting malaria, rather than take the drug.

"If true, it is an indication that some in the armed forces have completely lost confidence in Lariam,"

the committee said.

"Lariam is a drug whose own manufacturers have laid down stringent conditions which must be met if it is to be prescribed safely. We see no reason to disbelieve the very strong anecdotal evidence that such conditions have been ignored in dispensing it to large numbers of troops about to be deployed."

The committee chairman Julian Lewis said:

"It is our firm conclusion that there is neither the need, nor any justification for continuing to issue this medication to service personnel unless they can be individually assessed, in accordance with the manufacturers' requirements.

"And – most of the time – that is simply impossible, when a sudden, mass deployment of hundreds of troops is necessary.”

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MoD under fire for giving controversial anti-malarial drug Lariam to thousands of troops despite severe side effects including depression and hallucinations

• MoD criticised for giving controversial anti-malarial drug to British troops
• Senior MPs warn the drug – Lariam – should only be used as a last resort
• Side-effects of the anti-malarial drug include depression and hallucinations
• Lariam has already been banned from being given to US Special Forces

By Larisa Brown, Defence Reporter

Mail Online – 24 May 2016

British troops fighting overseas should only be prescribed the controversial anti-malarial drug Lariam as a last resort, senior MPs will warn today. In a damning report, the Ministry of Defence will be criticised for giving the drug – which is linked to side-effects including depression and hallucinations – to thousands of soldiers.

The Commons Defence Committee will say it believes the risk and severity of the side effects were unacceptable for military personnel on operations overseas. The drug should be effectively banned unless there are extraordinary circumstances in which soldiers cannot take any other alternatives, a group of cross-party MPs will say.

Its findings, published today, came as hundreds of former troops are expected to mount legal claims against the department after suffering mental health issues and psychological side-effects. Some ex-military personnel claimed they encountered hallucinations, severe depression, sleep deprivation and anxiety as a result of taking the drug.

Lariam was banned from being given to US Special Forces in 2013, but in the UK it remains one of the drugs of choice for military personnel in malarial areas. The MoD has a stockpile of more than 11,500 packs of the drug. MPs called for Lariam to be designated a 'drug of last resort' only to be issued where there was no alternative available.

At least 17,368 personnel were prescribed it at least once between the start of April 2007 and the end of March 2015, according to official MoD figures. The Committee said there was 'strong anecdotal evidence' that stringent conditions laid down by the manufacturers for issuing Lariam had been ignored by the armed forces.

Tory MP Julian Lewis, chair of the committee, said:

'It is our firm conclusion that there is neither the need, nor any justification for continuing to issue this medication to service personnel unless they can be individually assessed, in accordance with the manufacturers' requirements. And – most of the time – that is simply impossible, when a sudden, mass deployment of hundreds of troops is necessary.'

Kevin Timms, a lawyer at Irwin Mitchell leading dozens of cases against the MoD, welcomed the report, but added that the action came 'too late' for the many veterans who have had their lives ruined after suffering serious side effects. Another firm, Hilary Meredith Solicitors, has so far been contacted by over 450 former service personnel who were prescribed the drug and suffered side-effects. Partner Philippa Tuckman said Lariam had been associated with 'disturbing' side effects for years and should be banned all together.

The committee said it had received evidence that a body of current and former service personnel had been adversely affected by its use and that the arrangements for supporting them were 'inadequate'. While the manufacturer, Roche, had issued 'clear guidance' that individual risk assessments should be conducted before prescribing, the committee said the MoD appeared to have interpreted this to include 'desk-based' assessments using medical records rather than face-to-face interviews.

It said it was 'deeply disturbing' that some personnel apparently preferred to throw away the Lariam they had been prescribed and run the risk of contracting malaria, rather than take the drug.

'If true, it is an indication that some in the armed forces have completely lost confidence in Lariam,'

the committee said.

'Lariam is a drug whose own manufacturers have laid down stringent conditions which must be met if it is to be prescribed safely. We see no reason to disbelieve the very strong anecdotal evidence that such conditions have been ignored in dispensing it to large numbers of troops about to be deployed.'

The drug should be restricted to personnel who are unable to tolerate any of the alternatives, after a face-to-face interview and after they have been made aware of the alternatives, the committee said.

An MoD spokesman said:

'The vast majority of deployed personnel already receive alternatives to Lariam and, where it is used, we require it to be prescribed after an individual risk assessment. We have a duty to protect our personnel from malaria and we welcome the committee's conclusion that, in some cases, Lariam will be the most effective way of doing that.'

* * *

Lariam: “a drug of last resort”

Lariam is one of several anti-malarial drugs used by the MOD

By Andrew McHarg

UK Defence Journal – 24 May 2016

A report by the Defence Select committee published today has criticised the MOD’s use of the anti-malarial drug Lariam, opening the door for legal action by victims. The drug Mefloquine, sold under the brand name Lariam, has the potential to cause serious side effects such as anxiety, depression and has been linked to suicide attempts. The MOD has been criticised by the chair of the select committee, Dr Julian Lewis, for dispensing Lariam in “large numbers” with health warnings being “disregarded”.

Speaking to the BBC’s Today programme Maj Mick Wallace, who served in Kenya and was prescribed Lariam, believed the drug had led to his severe depression, saying

“I just didn’t feel right and it’s still going on”.

The risks associated with the drug are well known and circulated by the manufacturer, Roche, who stopped marketing Lariam in the US in 2009. A report from the government body responsible for regulating healthcare drugs in the UK, the MHRA, highlighted the dangers of the drug. The MHRA warning stated that Mefloquine containing drugs, such as Lariam, may cause:

Psychiatric symptoms associated with use of mefloquine such as nightmares, acute anxiety, depression, restlessness, or confusion should be regarded as potentially prodromal for a more serious event. Cases of suicide, suicidal thoughts, and self-endangering behaviour such as attempted suicide have been reported in association with use of mefloquine.

The law firm Hilary Meredith Solicitors reports that they have been contacted by 470 current and former service personnel who have suffered from mental health issues after taking the drug. Philippa Tuckman, a partner at the firm who also gave evidence to the enquiry, stated:

“I have long campaigned for the MoD to recognise that the casual way in which it has administered Lariam to service personnel over many years constitutes yet another breach of its legal duty of care towards our military personnel. Service personnel have a tendency to be so dedicated that they think only of the duty they owe; it doesn’t occur to them that it should go both ways. Sadly, the MoD will sometimes take advantage of that to get away with providing dramatically substandard care. That is not deliberate, but the catastrophic effect on the lives of our soldiers, sailors and airmen and women is the same as if it were.”

The report recommends Lariam is only prescribed as a “last resort” when other anti-malarial drugs are unsuitable for an individual and only after a face-to-face risk assessment has been carried out.

* * *

MPs say malaria drug Lariam should only be used by UK troops as 'last resort'

Report says medication, which can have severe psychological side-effects, should be prescribed only under certain conditions

By Richard Norton-Taylor and Jamie Grierson

Guardian Online – 24 May 2016

Lariam, an anti-malarial drug that can have severe psychological side-effects, should be prescribed to British troops only as a last resort in a very limited number of cases, MPs have said. The risks associated with the drug were deemed to be so great that military personnel threw them away rather than take them, the Commons defence committee heard. Roche, manufacturer of the drug, issues a “prescriber checklist” asking whether the patient has ever suffered neuropsychological conditions.

However, military personnel might hide any such conditions fearing that they could jeopardise their careers, a report released on Tuesday says. It adds that, though Roche has laid down stringent conditions that must be met if Lariam (also known as mefloquine) is to be prescribed safely there was

“very strong anecdotal evidence that such conditions have been ignored in dispensing it to large numbers of troops about to be deployed”.

The MPs continue:

“There is neither the need, nor any justification for continuing to issue this medication to service personnel except when the three conditions … above have been met.”

These are that the drug should be prescribed

“only to those who are unable to tolerate any of the available alternatives; only after a face-to-face individual risk assessment has been conducted; and only after the patient has been made aware of the alternatives and has been given the choice between Lariam and another suitable anti-malarial drug”.

Julian Lewis, chairman of the defence committee, said:

“It seems quite clear that not only is the MoD [Ministry of Defence] unable to follow the manufacturer’s guidelines for prescribing the drug in all instances, but a number of troops discard their Lariam rather than risk its potentially dangerous side-effects.”

Most of the time it was simply impossible to carry out individual assessments because

“a sudden, mass deployment of hundreds of troops is necessary”.

The law firm Hilary Meredith said it had been contacted by 470 former service personnel who were prescribed the drug and suffered from a range of mental health issues and psychological side-effects, including hallucinations, severe depression, sleep deprivation and anxiety.

Former army commando Grant Evatt, a director of the firm, said:

“Like thousands of other troops, I took anti-malarial drugs … we had no idea of the potential side-effects.”

Tuesday’s report says at least 17,368 British military personnel were prescribed Lariam at least once between 2007 and 2015, while 104,000 were prescribed different drugs. Chloroquine and proguanil travel packs account for 75% of MoD stocks of anti-malarial drugs. Though troops in other European countries are offered Lariam, malarone and doxycycline are preferred.

Vice Admiral Alasdair Walker, Surgeon General of the British Army, told BBC Radio 4’s Today programme the forces would continue to use Lariam despite the concerns raised.

“We have a duty to protect our personnel from malaria, we welcome the committee’s conclusion that in some cases Lariam will be an appropriate third-place drug,”

he said.

“Let me put things in perspective though, there are 190m cases of malaria a year, half a million people die from malaria and in the British military, despite the fact we send people to high-malaria areas, we’ve only had one death in 1992, so in the last 25 years we’ve had one death. So we are taking this seriously. All these drugs, unfortunately, like many other drugs for other conditions, have side-effects so for some people it’s not appropriate to take doxycycline or malarone and in these situations where they’re liable to be exposed to malaria, then we reserve the right to use mefloquine – Lariam – where appropriate with the recommendations that Roche, the drug company, make.”

Reminded that Roche recommends thorough interviews with prospective users of Lariam, the Vice- Admiral said:

“The policy I’m driving with all my primary care staff, the GPs that prescribe this, is to make sure there’s a proper risk assessment made of the people before they deploy and the informed consent to take the drug is there. The committee did say with certain circumstances, well-controlled, Lariam could be prescribed and we would not take that drug out of our armamentarium, it’s an effective anti-malarial.”