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Defence Forces Medicinal Products

Dáil Éireann Debate, Tuesday - 26 January 2016

Tuesday, 26 January 2016

Ceisteanna (52)

Clare Daly

Ceist:

52. Deputy Clare Daly asked the Minister for Defence further to Parliamentary Question No. 69 of 24 November 2015, if he is concerned that Lariam is a third-line drug for the US military in sub-Saharan Africa and is only issued for personnel who are unable to receive either of the other anti-malarial regimens; that its issue is accompanied by a wallet card containing current safety information from that country's Food and Drug Administration indicating the possibility that the neurological side effects may persist or become permanent; and, given this, why, as noted in his reply to Parliamentary Question No. 12 of 14 January 2015, the malaria chemoprophylactic agent of choice of the Irish Defence Forces for use in sub-Saharan Africa continues to be Lariam. [2952/16]

Amharc ar fhreagra

Freagraí ó Béal (17 píosaí cainte)

This follows on from a number of parliamentary questions from Deputies and the Minister's meeting with individuals in the campaign for action on Lariam. It is in light of the fact that the rest of the world is moving and rowing back on the use of Lariam. We know it has been completely abandoned in the UK, and in the United States it is only used in the defence forces as the third choice and only if the other options are not suitable - it is very much a last resort. Why, against all international best practice, does the Minister state that it is still the policy of the Irish Defence Forces to prescribe Lariam as the first drug of choice?

We do not prescribe Lariam as the first drug of choice. We look at a region and we take the best possible medical advice on the most appropriate drug for the region, depending on how long people will stay and the strain of malaria in the region. It is also not true to say that the UK and the US have abandoned Lariam. They have not.

I did not say that.

They do use Lariam, but only in certain circumstances. They have screening processes and information processing to ensure they do everything they can to manage the risk regarding the use of Lariam. We are trying to do the same. I had a very good meeting with the group advocating for a change in policy on the use of Lariam. As the Deputy would expect, it was a very emotive meeting as well as a very blunt one. The group has sent me in writing a series of questions.

I am having my Department and the Defence Forces look at those questions in detail to try to get responses to them. I have a working group, which is made up of international and Irish experts, to make recommendations to me as to the best course of action on Lariam. It would be irresponsible of me to make decisions in advance of getting that up-to-date report, which we had hoped to get by the end of January. The group has asked for more time and we will give them that, but - I have said this to the Deputy before and I hope she will take me at my word on it - I have an open mind about trying to do what is best. I am not going to make decisions about Lariam on the basis of court cases or anything like that. My only issue here is to do what is best for Irish soldiers who are serving in areas where malaria is a problem. There are, effectively, three malaria drugs, as far as I am aware. The medical advice that is available to me and to the Defence Forces will determine what drug is prescribed for the Defence Forces personnel going to different regions. If the expert group-----

I will come back to the Minister. I have to go back to Deputy Daly.

If the expert group recommends that we change policy, I will be first to make it happen.

I call Deputy Daly.

The problem is that best national and international practice - the Minister never quoted the source for his advice - would tell the Minister that Lariam should be a last resort. I did not say the Americans did not use it: I specifically said it was a last resort after the other two.

No, the Deputy said they had abandoned it.

I talked about Britain. We are talking about sub-Saharan Africa. That is where we are talking about. The Irish Defence Forces' policy is to prefer Lariam. I am only talking about sub-Saharan Africa. The United States army does not have that policy and it is not the case that Lariam is the most suitable drug for that area. That is the Minister's stated policy and it is against best practice. The people who met the Minister want to know why that is the policy, given that the manufacturers of Lariam themselves say that it should only be taken after very serious analysis of a person's predisposition or with a very clear warning. That is the only circumstance in which it is allowed in the rare examples in America. Why do we have a different view of that process in Ireland? We are exposing people to danger because it is not just about whether people have a predisposition or prior problems. The Minister cannot say with certainty that there has been an individual assessment of every member of the Defence Forces who was given Lariam and that is the only basis upon which the manufacturer says it should be given because of the undisputed dangers linked with that problem. I hear what the Minister is saying, that he does not have a fixed view, but we have been hearing that and meanwhile Lariam continues to be prescribed, albeit in smaller doses. I will come back to the Minister with a question on that.

We do not have large numbers of Defence Forces personnel in sub-Saharan Africa at the moment, but that is not the point. The point is that if the recommendation is that Lariam is the most appropriate drug for a region to which we are sending Defence Forces personnel, then of course there is a screening process. I have had long and detailed meetings with the Defence Forces and the Department of Defence on this issue to get an understanding of those screening processes in terms of ensuring that people are suitable for taking Lariam to protect themselves against malaria. That is as it is at the moment. If the expert working group we have asked to report to us on this comes back and makes suggestions, we will listen to them.

The so-called international best practice Deputy Daly is talking about does not reflect medical best practice on the basis of what we are currently making decisions on, given the advice I have and the Irish Defence Forces policy on the use of anti-malarial medication, which is in line with the current Health Products Regulatory Authority approved summary of product characteristics. That is basically a technical way of saying it is consistent with the medical advice related to those products. We will continue to try to do what is in the best interests of our Defence Forces personnel.

If the working group recommends something different, I will be the first to make the change immediately. However, I must wait until I get that report rather than making a change on the basis of what some other country somewhere else is doing.

I must call Deputy Clare Daly. I will come back to the Minister.

The reason we have a working group is to be able to make detailed recommendations on which we can act.

The Minister has acknowledged that the working group has not issued its findings and there has not been a change in policy. He might explain to me then how, in one of two parliamentary questions that I put to him recently, he told me that the overwhelming majority of personnel in sub-Saharan Africa were prescribed Lariam between 2010 and 2015 but when I asked the question specifically about 2015, I was told that 25% of Defence Forces personnel were not prescribed Lariam. That is clearly a differential. It means fewer personnel are being prescribed Lariam now than were in recent years in that region which I welcome. If the policy is unchanged, will the Minister explain the discrepancies in the number of personnel who were being prescribed the drug?

The Minister failed to answer how there can be an assurance that every personnel member had an individual assessment when the evidence that has been given to him in some instances would state the opposite, that their files were not assessed, they were not asked the appropriate questions and they were not given the proper warnings.

I can only answer from the evidence that I have seen, which is that the current screening process is a robust one and that individual soldiers, before they go, must fill out individual forms in relation to Lariam.

It was quite a different situation when we had many more troops in sub-Saharan Africa because we had troops on rotation, perhaps every six months. In recent years, we may well be sending troops for a shorter period. The numbers are much lower. For example, when I visited Mali last year and took anti-malarial medication, I was only there for two days and Lariam was not the appropriate drug. I had been to sub-Saharan Africa for a longer period and I took Lariam. Depending on how long a person stays, some drugs are taken daily while some are taken weekly. Therefore, one manages risk differently.

I will repeat this because of the meeting I had with families who feel that they have been seriously affected by Lariam. I take this issue most seriously and I have a lot of sympathy for those who are struggling.

I must go now to the next question. We are way over time. I call Deputy Troy for the next question.

We will make changes, but on the basis of expert advice.

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