Conclusions and recommendations
Introduction
1.We welcome the Minister’s apology to former and current Service personnel who believed that they were prescribed Lariam without the necessary individual risk assessments. This is a timely acknowledgement of the concerns raised about the use of Lariam. We look to the Minister to build on his opening statement by engaging positively with the recommendations we make in this Report. The prescription of a drug known to have ‘neuropsychiatric side effects and vestibular disorders’ without face-to-face interviews shows a lamentable weakness in the MoD’s Duty of Care towards service personnel. (Paragraph 5)
MoD use of Lariam
2.While the ACMP may be able to give general medical advice on the use of Lariam, it does not tailor its advice for use by the Armed Forces. We believe this to be a serious deficiency. Given the clear concerns about the use of Lariam for military personnel, this must be addressed as a matter of urgency. We recommend that the MoD, and its representative on the ACMP, work with the ACMP to develop guidelines on Lariam and other anti-malarials specific to their use by military personnel, along similar lines to the US Centers for Disease Control and Protection’s Yellow Book. (Paragraph 23)
3.The Government’s assertion that geographical deployment was part of the assessment for using Lariam has been disputed. For the sake of clarity we recommend that the MoD should set out which geographical areas, if any, it believes to have resistance to each anti-malarial drug which it uses, and any accompanying evidence it has to support its view. (Paragraph 27)
4.Publishing evidence pertinent to our inquiry on the day of a Ministerial oral evidence session, and without prior notice, is not an acceptable way to engage with the Committee. In its response to our Report, we shall expect a clear undertaking from the Ministry of Defence that this will not happen again. (Paragraph 29)
Individual risk assessments
5.The clear guidance from Roche is for individual risk assessments to be conducted before Lariam is prescribed. It is the MoD’s policy to adhere to that guidance, but the MoD appears to have interpreted the guidance to include the option of ‘desk-based’ risk assessments using patients’ medical records. We do not believe that to be an adequate alternative to face-to-face interviews. We therefore recommend that the MoD cease conducting risk assessments based solely on patients’ records and prescribe Lariam, if at all, only after detailed face-to-face individual risk assessments. Records of face-to-face assessments should be recorded in individual’s medical notes and a signature obtained confirming that risks have been explained and advice notes provided. (Paragraph 38)
6.We are concerned that the records held by the MoD are insufficient to give certainty that the policy of conducting individual risk assessments has been fully adhered to. While we understand that it would be more difficult to produce records before 2013, it should be a straightforward exercise to provide that detail for the past three years. We recommend that the Ministry of Defence conduct an audit of all prescriptions of Lariam since responsibility was moved to the Surgeon General. As part of that audit, we will expect the MoD to provide figures on the number of face-to-face assessments alongside the number of prescriptions based solely on patients’ records. (Paragraph 39)
7.It is not clear how the MoD would provide individual risk assessments prior to the prescription of Lariam in the event of a significant deployment. In its response to our Report, the MoD should set out how this would be done and an estimation of the time it would take to conduct face-to-face individual risk assessments at both company and battalion level. (Paragraph 43)
8.We further recommend that the MoD sets out a comparative assessment of the practicalities of prescribing Lariam with face-to-face interviews and prescribing other anti-malarial protections in the event of a large deployment at short notice. (Paragraph 44)
9.Whilst the extent of non-reporting of contra-indications is not clear, all of our witnesses acknowledged that there was a risk that some military personnel may hide symptoms in the belief that to do otherwise could jeopardise their careers. Doctors are well placed to spot this, but they cannot be guaranteed to do so in every case. This reinforces the need for detailed face-to-face individual risk assessments rather than implied risk assessments based on patients’ records. (Paragraph 50)
10.The anecdotal evidence we received suggesting that some military personnel preferred to throw away their Lariam rather than use it is deeply disturbing. If true, it is an indication that some in the Armed Forces have completely lost confidence in Lariam. In its response, we shall expect the Ministry of Defence to set out how it monitors compliance rates among military personnel who have been prescribed Lariam. (Paragraph 54)
11.In addition to the need for a face-to-face interview, we recommend that the MoD ensures that each individual, when made aware of the risks of Lariam, must be offered the option of receiving an alternative anti-malarial drug. (Paragraph 56)
The side-effects of Lariam
12.The risk of severe side-effects of using Lariam have been highlighted by both Roche and our witnesses. The evidence we have received has emphasised the specific risks that such side-effects can place on military personnel when deployed and the belief that the military environment has the potential to exacerbate those side-effects. While the majority of users will not experience them, we do not believe Lariam, and its risk profile, is compatible with the duties required of military personnel on operations. (Paragraph 73)
13.Strong anecdotal evidence suggests that a body of current and former Service personnel have been adversely affected by the use of Lariam. The MoD acknowledges its duty of care to support them, but the current arrangements for doing so appear to be inadequate. We recommend that the MoD establishes a single point of contact for all current and former Service personnel who have concerns about their experience of Lariam. This point of contact should be publicised widely though the Chain of Command, veterans organisations, the MoD website and military and forces magazines and publications. Discussions should also be held with the Department of Heath on possible ways of advising GPs of potential risks to veterans who may have been prescribed Lariam. (Paragraph 77)
Research undertaken on Lariam
14.There is a body of evidence which indicates that Lariam has a significant risk profile. This has been acknowledged by Roche in the guidance it issues with the drug. However, most of this research has focussed on the civilian population. We welcome the Government’s forthcoming audit of both Lariam and its alternatives but recommend that these audits are widened in scope to provide a more detailed understanding of the risks attached to the use of Lariam by military personnel. Such research should then be evaluated alongside research conducted by other nations’ militaries. (Paragraph 86)
Comparisons with the use of Lariam by other States
15.The Ministry of Defence asserts that its use of Lariam is not out of step with that of our allies. To support this, it has provided evidence on which of our allies offers Lariam as an anti-malarial drug. However, a number of our witnesses told us that our allies take a far more restrictive approach to the use of the drug. We recommend that the MoD updates its information on the use of Lariam by our allies to include the extent to which Lariam is used and under what circumstances it is prescribed. (Paragraph 96)
Conclusion
16.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. (Paragraph 97)
17.While it is clear to us that there are significant risks attached to the use of Lariam for military personnel, we accept that there are a very limited number of occasions when its prescription may be necessary. However, we conclude that the MoD should designate Lariam as a ‘drug of last resort’ and that prescribing it should be restricted by the following conditions:
- 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. (Paragraph 98)
18.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. Indeed, it is hard to see how they could ever be met except when the numbers to be individually assessed are few and far between. (Paragraph 99)
19.It is our firm conclusion that there is neither the need, nor any justification for continuing to issue this medication to Service personnel except when the three conditions listed above have been met. (Paragraph 100)
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19 May 2016