Lariam

Madeleine Moon Excerpts

Thursday 27th October 2016 Westminster Hall

[Mrs Madeleine Moon (Bridgend) (Lab)]

I beg to move,

That this House has considered the Fourth Report from the Defence Committee of Session 2015-16, An acceptable risk? The use of Lariam for military personnel, HC 567, and the Government response, HC 648.

Before I turn to the overview of the report and the conclusions of the Select Committee on Defence, I want to put on record our thanks to those who gave us the impetus to investigate the issue and contributed their knowledge and their time. I apologise if I leave anyone out. Our thanks go to Trixie Foster and the retired Colonel Andrew Marriott for their persistence in raising the issue and co-ordinating a detailed submission; to defence correspondents who took the matter up; and to Forces TV whose work brought in more evidence. I thank the Library for its research and our Clerks, who do a magnificent job, as well as the witnesses who appeared at our three evidence sessions, including from the drug’s manufacturer, Roche.

I would also like to put on record my personal thanks to the Committee for agreeing to pursue the issue for the sake of the approximately 25% to 35% of personnel who have taken Lariam who have been directly affected. The Committee was determined to ensure that the Ministry of Defence would examine the damage to lives and the failure of the duty of care, and to make the necessary recommendations to protect our armed forces personnel in the future.

Lariam is one of several antimalarial drugs that the MOD uses to protect military personnel against malaria. None of the alternatives is without its problems, but Lariam has been the subject of concern for a long time. The inquiry set out to establish a clear picture of the impact of its use in the UK armed forces. I think it is fair to say that the Committee was shocked and surprised by what we found. I will leave others to go into details, as it is my role to give an overview of our principal conclusions and recommendations.

From the evidence we received from individuals and the statistics that the MOD provided, we were shocked that Lariam is still being used so often despite the well-known problems. We were told by the drug’s manufacturer that the MOD accounts for one fifth of all its UK sales. At a minimum, 17,368 personnel were prescribed the drug between 2007 and 2015. There may well be more, but one of our findings was the haphazard nature of MOD medical record keeping. Note to the Minister: it was particularly unhelpful when the MOD published its first 10-page statistical bulletin on Lariam on the day we took evidence from the Minister.

The MOD receives advice from the Advisory Committee on Malarial Prevention alongside the advice from the manufacturer. Roche is clear in its guidance that every individual who is prescribed Lariam should undergo an assessment with a medical professional to identify any contra-indications that might make them more susceptible to side effects. We questioned whether the ACMP’s advice was appropriate. It was clear to us that the general advice that it offered was not tailored to the specific needs and circumstances of the military. It fell short and put military personnel at risk. We concluded that the MOD should work with the ACMP to develop specific guidelines, similar to the US so-called “Yellow Book”.

[Douglas Chapman (Dunfermline and West Fife) (SNP)]

Is the hon. Lady now confident that the MOD will be able to deliver on the duty of care and the commitment to proper prescribing of Lariam, especially when a large number of troops are leaving at the same time?

[Mrs Moon]

If I am perfectly honest, no. I think that the medical care that is offered continues to fall short, but I hope that the Committee will be able to address the issue again in future and ask for further updates. Of course, we have the opportunity to hear from the Minister today what further progress has been made.

Alongside our findings about the ACMP, we looked at whether Lariam was appropriate to where personnel were sent and the work that they do. The Minister and the Surgeon General told us that geographical location was a consideration in prescribing Lariam. By contrast, other witnesses made it clear that there is nowhere where Lariam should be the preferred drug, particularly given that there is increasing resistance to it and there are alternatives available. Geography aside, and linked to our earlier concerns about the ACMP advice, we sought to clarify whether Lariam, given the known side effects, was appropriate at all in a military setting. A military deployment is a world away from a tourist sightseeing or sitting by a pool. The physical and mental strain of being deployed in stressful situations does not need to be exacerbated by the severe side effects that Lariam can induce.

Dr Nevin gave evidence of an alarming potential negative impact on military performance and operations. There were cases of service personnel experiencing

“episodes of panic resulting in abnormal behaviour”

and incidents of servicemen becoming confused and being found “wandering aimlessly”. There were incidents of tension and anger, episodes of severe mental and physical exhaustion and nausea, lapses of concentration and episodes of short-term memory loss, ill temper, dangerous driving, confusion and suicide ideation. That is a grim picture of medically induced problems for military personnel on deployment.

We explored whether other nations gave Lariam to their armed forces. Our research uncovered a mixed picture, but a tendency towards either no longer using Lariam at all or using it only as a drug of last resort. That all added weight to our recommendation that greater clarity is needed in determining when to use Lariam, and that attention should be paid to whether it is appropriate for military personnel.

At the heart of our inquiry was the question whether the MOD was fulfilling its duty of care by following the clear guidance on prescribing Lariam. Did every individual undergo the Roche-required individual medical assessment prior to deployment? Was it realistic to think that the MOD could ensure that that happened, particularly for a large-scale, short-notice deployment? Alarmingly, there was evidence that individual assessments were not happening. Lariam was included in pre-deployment kit; it was handed out on parade; or the MOD relied on an assessment of medical records only for prescription. We felt that that was a fundamental failure in duty of care. We concluded that, aside from the need to consider the practicalities of arranging assessments, prescribing Lariam should only ever be a last resort bounded by strict conditions. Linked to that, we uncovered concerns about non-reporting of contra-indications; military personnel appeared unwilling to admit to conditions such as a previous history of depression, because of fear of a negative impact on their career. That underlines even further the need for individual assessments.

Several witnesses reported that personnel were so concerned by the reputation of Lariam that they discarded their medication and were potentially left with no antimalarial protection at all. That came even from the very top. I believe Lord Dannatt has announced that he refused to take Lariam and would throw it away. We were deeply disturbed by that and recommended that the MOD should monitor compliance rates.

[Bob Stewart (Beckenham) (Con)]

I recall that evidence that came to us, as hearsay, from Lord Dannatt. It really shocks me that he was Chief of the General Staff and felt that way and did not take action. I think that the Committee felt that too.

[Mrs Moon]

We most certainly did; but that also shows the inertia in the Ministry of Defence. We heard from many personnel—either individually or as a Committee—at different ranks within the MOD. The matter was not something that was not known about, but it was not being tackled or recognised as a major problem for serving personnel.

Finally, and most tragically, we heard from many individuals who suffered severe long-term effects from taking Lariam. Long after leaving the military, they are still suffering such things as mental trauma, vivid dreams and suicide ideation. That is totally unacceptable. We sought to establish what support was on offer for them from the MOD as it became clear that arrangements were somewhat fragmented. We recommended the establishment of a single point of contact, which we felt was particularly important for veterans, some of whom have experienced mental health problems for years.

Having seen what happened in the previous debate, when the vice-chair of the Committee could not be called to speak owing to time restrictions, I shall now leave it to my colleagues to expand further on the report and evidence. We look forward to hearing from the Minister that further progress has been made.

--- Later in debate ---

[Johnny Mercer]

I thank my hon. Friend, loosely speaking, for raising that point. He gets to the crux of the problem. Essentially in the military, we go on medical advice. None of us are scientists or doctors. If we get into the real detail of the issue, it is on that point that we get to the nub of what has gone wrong.

[Mrs Moon]

Does the hon. Gentleman agree that the problem was that there was no medical advice? Often, a sergeant major would just walk down the ranks, saying, “Take these.” There was no assessment—nothing. It was just, “This is what we have in the stores. You take it.” There were no warnings about the side effects or about reporting them. That was, and remains, the failure.

[Johnny Mercer]

I absolutely agree that the single point of failure was that we had a drug that, like any drug—even paracetamol or Anadin—should be used within the guidelines set down by the manufacturer, but instead of people being given it carefully, in a medical fashion, with individual risk assessments as stipulated by Roche, Lariam was just handed out on parade. Clearly, that is not the way to do business. The hon. Lady is right. I am glad that we have identified that practice, and I believe that we have put a stop to it. That is a good thing to have come out of the report.

We now need to ensure that we look after those who come forward. There are conversations about compensation and things like that—I understand that that is the way of the world—but that is never the intent behind inquiries such as this. I am interested in looking after those who are going through the process. We must get those who come forward some sort of treatment. We must provide some point of contact that is not just known by me, other MPs and those within Main Building. Everybody should know where they can go to get help if they feel they have been affected, and we need to show them a clear pathway.

Ultimately, we need to pay people an interest and accept that something has gone wrong. There is a slight issue within the Department—I know that everybody, including the Minister, knows this—with accepting evidence of a problem. If I have seen that in my experience as a lowly Member of Parliament, I can only imagine what it is like for families who have an issue with the Ministry of Defence to come forward. I bring that point to people’s attention and ask that we never ignore evidence of problems. We all know what soldiers are like. They are fantastic people, although if they are not moaning, something is not right, but we need to be slightly smarter and understand what they are saying so that we can identify problems before they become as big a problem as Lariam.

--- Later in debate ---

[Fabian Hamilton]

My apologies for that. I obviously did not write my notes correctly. I am sorry if I misquoted the right hon. Gentleman.

As we discussed in the previous debate, we have a duty to ensure that people who put their lives on the line for the defence of this country, like hon. Members in this Chamber who have done so, do so in the knowledge that those who ask them to do it and who send them to dangerous places are looking after their interests.

We know that Lariam is the brand name of mefloquine and that it is used to treat malaria. It is most commonly administered as a prophylaxis, but the history of side effects, the evidence we have received and the evidence in the Defence Committee’s report make it clear that it is not necessarily the most appropriate prophylactic medication. I am glad we have made it clear that we do not blame the manufacturer, Roche, for the misuse of its drug. It is clearly an issue for the Army itself and we want the Army to get it right. That is why the Committee’s report was written in the first place. I myself have taken chloroquine and proguanil; I suffered some side effects, but nothing like those that have been recorded for Lariam.

We know that many countries’ military forces have used Lariam in the past, but that it is becoming increasingly uncommon because of its side effects. Some 17,000 British military personnel were prescribed Lariam between April 2007 and March 2015, and the reports of those side effects meant that many of them have discarded their Lariam tablets instead of using them. That makes them far more susceptible to malaria, which is extremely dangerous—as the hon. Member for Stafford said, it has killed 438,000 people in the last 12 months.

The summary of the Defence Committee report says:

“The evidence we received highlighted some severe examples of the possible side-effects of Lariam in a military setting. While they may be in the minority, we do not believe that the risk and severity of these side-effects are acceptable for our military personnel on operations overseas.”

When the Minister responds to the debate—I apologise that I will not be present to hear him—will he care to tell us about the handing out of Lariam to military personnel in future in the light of the report and the evidence contained within it?

In preparing for this debate, I sought the advice of a specialist—he has asked not to be named—who works at the London School of Hygiene & Tropical Medicine. His view was quite interesting. He made the point that Lariam is a cheaper medication than some antimalarials, and that it is very effective. That could be one reason why the MOD is maintaining its support for Lariam in the face of media controversy, the Defence Committee report and, of course, resistance from many military personnel. The specialist said that it is a good drug. He even gave it to his spouse when they went to west Africa a few years ago. He reported that she had had the most vivid and crazy dreams. Like most drugs, it is not good for some people, but it is good for others.

One thing in favour of Lariam is that it is administered once a week. Many other antimalarials are administered once a day. For someone in a military setting who is in a conflict situation, or who has been deployed in a remote area, it being a once-a-week drug will have a huge benefit for those administering it and those having to take it. A once-a-week dosage also increases the chances of compliance and of people actually taking the medication when they need to take it.

The specialist I mentioned noted that the number of tests on the effects of Lariam on Army personnel were small and were not done in an adequately controlled situation. I do not know whether my hon. Friend the Member for Bridgend would agree with that, given the evidence taken by the Select Committee, but there needs to be far more testing. There needs to be a much greater database of evidence to prove conclusively that so many people will not tolerate Lariam and that it should perhaps be replaced by other drugs, depending on geolocation and the individual assessment of military personnel.

[Mrs Moon]

Is my hon. Friend aware that there have been episodes in which serving personnel have murdered individuals, and in which they have deliberately carried out inappropriate acts, all because they were under the influence of Lariam? That is part of the record that the Committee looked at.

[Fabian Hamilton]

Yes, I was aware of that, but I am not aware of the details. I have heard anecdotal evidence, but it is important to hear about the actual cases and evidence.

I know that other Members wish to speak, and of course the Minister must respond, so I shall conclude. Paragraph 97 in the conclusion of the Defence Committee report states:

“The Ministry of Defence has a duty of care to protect military personnel on operations overseas. It includes ensuring that they are adequately inoculated against disease. This will never be without the risk of detrimental side-effects, and we understand that the MoD must balance those risks against the health of our Armed Forces. However, in the case of malaria, we conclude that the MoD’s current policy has got that balance wrong.”

I hope the Minister addresses that point in his response.

--- Later in debate ---

[The Parliamentary Under-Secretary of State for Defence (Mark Lancaster)]

It is a pleasure to serve under your chairmanship, Mr Rosindell.

We seem to have had something of a flurry of detailed questions towards the end of the debate, giving me little opportunity to address many of them in the nine minutes I have to respond to the debate. I will do my best, but at the start I simply commit to writing to any hon. Member whose question I do not manage to answer during that time.

Of course, I begin by taking this opportunity to thank the Defence Committee for its very thorough report on the use of mefloquine by service personnel, and I also thank the hon. Members who have spoken today, from the opening contribution by the hon. Member for Bridgend (Mrs Moon) onwards. I will address many of the points that were made as I go through, but on a specific point that she made, I absolutely regret the publication of the statistics on the day of the Committee hearing. However, she may not be aware that it is absolutely right that Ministers have no control over the collection or publication of statistics; it would be wrong if we did. So it was genuinely an unfortunate coincidence, and it would have been even worse if the statistics had been published the day afterwards.

I thank my hon. Friend the Member for Plymouth, Moor View (Johnny Mercer) for his passionate contribution, not least because every time he speaks in this House he seems to suggest that I should be promoted—so I thank him very much indeed. I also thank my hon. Friend the Member for Stafford (Jeremy Lefroy), who gave an incredibly incisive personal account; it really was very powerful. Of course, I also thank my right hon. Friend the Member for New Forest East (Dr Lewis), who asked a number of questions, which I will endeavour to answer during my response to the debate.

We had other good contributions from the hon. Members for Leeds North East (Fabian Hamilton), who has had to leave us, for Glasgow North (Patrick Grady), and for East Renfrewshire (Kirsten Oswald). I will endeavour to address all the points that they made in due course.

The Government have considered our conclusions carefully, and I will outline the positive steps that the Ministry of Defence is taking to address the Committee’s recommendations. Before I do so, I want to nail one issue that floated around towards the end of the debate—that Lariam is somehow the MOD’s drug of first choice, and that cost is a factor in its use. According to the “British National Formulary” of March 2015, Lariam, at £14.53 for an eight-week supply, is more expensive than Paludrine/Avloclor, less expensive than Malarone but more expensive than doxycycline. So cost is not a factor, and we would never prescribe on the basis of cost alone.

Equally, mefloquine currently constitutes only 1.2% of all the antimalarial tablets held by the MOD, and in terms of doses for a six-month deployment—of course, doses for different drugs are given at different rates—it accounts for just 14% of the stock. So 86% of our stock is not Lariam. That hardly represents a reliance on Lariam or evidence that it is being used as a drug of first choice.

[Mrs Moon]

I am delighted to hear about the low take-up of Lariam by the Ministry of Defence now. Does the Minister have the figures for what the take-up was in the past?

[Mark Lancaster]

Those figures give the current status, but I believe that the figures for the last eight years, which is as far as we go back, are similar. However, I am happy to write to the hon. Lady to give the exact figures. Of course, much of this debate is about how we move forward, as opposed to what we have done in the past, and I hope to demonstrate in my response over the next five and a half minutes that the steps we are taking are very positive.

It is important for me to state that we take the health and wellbeing of our personnel extremely seriously and acknowledge the duty of care to provide the best possible support to them. Malaria is a deadly disease, and we must protect our deployed personnel from it. The most effective way to do so is through the use of antimalarial drugs. However, as we have established, no antimalarial drug is 100% effective and risk-free. Indeed, all medications have the potential to cause side effects and adverse reactions in a small number of people. That is why the MOD needs to use a range of prevention drugs to protect our personnel and ensure that the treatment provided is the most effective for each individual. I should emphasise that despite tens of thousands of service personnel deploying to malaria-risk areas, no serviceman or woman has died from malaria resulting from an operational deployment since 1992, and cases of severe malaria are rare in the armed forces.

I turn to the two main recommendations of the Committee’s report. The first was that the MOD works with the Advisory Committee on Malaria Prevention to develop guidelines on mefloquine and other antimalarials, specifically regarding their use by military personnel. The MOD has always kept its malaria prevention policy under constant review, and I can confirm that a recently revised malaria prevention policy has been passed to the ACMP for its consideration.

The revised policy is based on three elements. In the first instance, at around the time when individuals complete initial training they will undergo a face-to-face consultation with a medical professional, to identify any adverse reactions to the five most commonly used antimalarial drugs. Secondly, after posting into a deployable role, armed forces personnel will undertake a generic face-to-face travel health risk assessment, again with a medical professional. Finally, once individuals are advised that they are likely to deploy, they will undertake a deployment-specific face-to-face travel health risk assessment.

The results of those assessments will be recorded in the patient’s electronic health record. Although the need for a risk assessment is not new—defence policy since 2004 has been clear on the requirement for such assessments—monitoring will now be better aided by an electronic records system. In answer to a question put by my right hon. Friend the Member for New Forest East, perhaps I can say that if the actions that he described need to be taken, in extremis, before an emergency deployment, they will be based on those three thorough, face-to-face, comprehensive interviews, as recorded in the electronic record.

On that point, I reiterate what I said when I gave evidence to the Committee. I recognise that anecdotal evidence submitted to the Committee suggests that, in a small number of cases, some people believe that their individual risk assessments did not take place in the past. I hope that the new system will prevent that situation from recurring. I encourage anyone who has concerns about the issue to come forward, in confidence, as there are established processes by which current and former members of the armed forces can be referred to medical staff to have such concerns investigated.

That leads me to the second main recommendation of the Committee’s report, namely that the MOD should establish a single point of contact for those who are worried about their experience of mefloquine. I am pleased to report that the mefloquine single point of contact has been set up and publicised widely through the chain of command, veterans’ organisations, military publications and GPs. As I sat here listening to the debate, I googled the advice about that single point of contact, and there it was on the gov.uk website. It was launched last month and is easily accessible. It is a confidential service for people to make contact by phone and email, and it is supported by other information on the Government website, as I have just said. Depending on their circumstances, individuals are directed to a range of information and services available to help them. That includes how service personnel and veterans can find out whether they have been prescribed mefloquine in the past. My right hon. Friend the Member for New Forest East has raised concerns about the quality of information being given on the helpline. I am more than happy to go and examine that, and I will write to the Committee with details as to exactly what advice is being given.

Again, I encourage anyone who is concerned about their experience of mefloquine and who has not yet gone to the single point of contact, including those who believe that their risk assessment did not take place, to contact the single point of contact or speak to their GP.

In addition to those two main recommendations, the MOD will conduct a prospective audit of returning travellers, to assess the impact of the new policy. That will be for any antimalarial drug that has been taken. The MOD will also continue to undertake post-deployment surveys, to enhance its understanding of compliance with the revised policy.

The Government informed the Committee that the MOD would undertake further research into the impact of the adverse effects of antimalarial drugs on the performance of military personnel. A research proposal is currently being considered by the MOD’s research ethics committee. The research will be in the form of a retrospective survey of soldiers deployed on exercise in Kenya who have been prescribed one of three antimalarial drugs. A questionnaire will seek information about risk assessments, individuals’ compliance with prescriptions, the incidence and prevalence of side effects of the drugs, and the impact of those side effects on functional effectiveness.

If there are any other questions, I will endeavour to write to hon. Members about them.

Question put and agreed to.

Resolved,

That this House has considered the Fourth Report from the Defence Committee of Session 2015-16, An acceptable risk? The use of Lariam for military personnel, HC 567, and the Government response, HC 648.