Dáil debates

Tuesday, 18 June 2013

Ceisteanna - Questions - Priority Questions

Defence Forces Medicinal Products

2:10 pm

Photo of Pádraig Mac LochlainnPádraig Mac Lochlainn (Donegal North East, Sinn Fein)
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11. To ask the Minister for Defence his views on the facts raised on the Prime Time programme regarding the number of suicides associated with the use of Lariam; and if he will make a statement on the matter. [29111/13]

Photo of Alan ShatterAlan Shatter (Dublin South, Fine Gael)
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Malaria is a serious disease that kills approximately 1 million people per annum in sub-Saharan Africa alone. It is a serious threat to any military force operating in the area. The anti-malaria regime in place in the Defence Forces, including the use of Lariam, has worked. In the decade of deployment to sub-Saharan Africa by the Defence Forces, not a single member of the Defence Forces has died from malaria and there are only three documented cases of personnel contracting the disease.

The Irish Medicines Board, IMB, is the statutory body that regulates medicines available in Ireland. I am advised that the three anti-malarial medications licensed by the IMB, namely, Lariam, Malarone and Doxycycline, can all have significant side-effects. To assert that any one of these products is automatically a more effective or safer alternative to the others is a grossly misleading over-simplification. Each of the three drugs has been used by the Defence Forces, depending on individual circumstances, including the type of malaria in the destination, the duration of travel, etc. I am further advised that the Defence Forces are fully aware of the range of reported side-effects attaching to all anti-malarial medications. Protocols are in place to control the risk of side-effects in individuals.

Lariam is one of the most effective medications for protection against the type of malaria prevalent in sub-Saharan Africa. I have had the various allegations surrounding the use of Lariam investigated thoroughly and I have obtained the advice of leading medical experts who concur with the prescribing practices followed by the Defence Forces. I am advised that the allegation of a link between Lariam and suicide or suicide ideation has been examined. Of 156 non-service related deaths among members of the Defence Forces in the period from January 2000 to December 2010, 25 were apparently from self-inflicted injuries, although only one is recorded by a coroner as suicide. Of these 25 deaths, Lariam had never been prescribed in 16 cases. Of the remaining nine cases, given the limited period of time during which Lariam remains in the bloodstream, according to our expert advice, it is extremely unlikely that the product could have been a contributory factor in practically all of these cases. There is no evidence in any of the coroners' inquests linking any deaths to Lariam.

2:15 pm

Photo of Michael KittMichael Kitt (Galway East, Fianna Fail)
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I must interrupt the Minister.

Photo of Alan ShatterAlan Shatter (Dublin South, Fine Gael)
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Perhaps I might finish this sentence as it might be of assistance to the Deputy.

The death rate in the Defence Forces from self-inflicted injuries in the period 2000 to 2010, when lariam was being prescribed, was 0.24%. The death rate from self-inflicted injuries in the period 1989 to 1999, when Lariam was not being prescribed, was 0.32%, which is higher than the death rate in the period when lariam was being prescribed.

Additional information not given on the floor of the House

Lariam must remain in the formulary of medication prescribed by the medical corps for Defence Forces personnel on appropriate overseas missions, particularly those in sub-Saharan Africa, to ensure that our military personnel can have effective protection from the very serious risks posed by this highly dangerous disease.

Photo of Pádraig Mac LochlainnPádraig Mac Lochlainn (Donegal North East, Sinn Fein)
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Obviously, the Minister and his departmental officials are determined to defend the use of lariam and he has provided statistics which is fair enough. Why did the United States Government, which has one of the largest defence forces in the world, stop using lariam if everything the Minister has said about there being no concern over its use is accurate?

Photo of Alan ShatterAlan Shatter (Dublin South, Fine Gael)
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The answer is very simple. I understand the United States forces stopped using the medication owing to concerns about inadvertent prescribing to soldiers who should not take it. In this regard I am advised that the US authorities undertook mass administration of lariam for soldiers serving in areas subject to malaria without any individual screening of personnel. That is the difference between what the Defence Forces in this State do and what was occurring in the United States. The recommendation and protocols that apply here require the screening of each member of the Defence Forces with regard to the taking of lariam, to identify whether there are any contraindications that could give rise to an issue of concern.

Lariam is prescribed for a period of time prior to members of the Defence Forces going abroad on a mission in order to identify any reaction that might occur. The Defence Forces here do not mass prescribe, but follow all the instructions issued by the Irish Medicines Board in order to fully screen out personnel who may potentially have an adverse reaction to the medication. That is the crucial difference between us and the United States defence forces. In this context it is important to emphasise that this is about ensuring that members of our Defence Forces on UN missions do not contract malaria, which is crucial because one should never forget that malaria kills.

Photo of Pádraig Mac LochlainnPádraig Mac Lochlainn (Donegal North East, Sinn Fein)
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I understand the screening is for mental health issues that may be there and of course it would not be prescribed if that was the case. Mental health screening is very precarious. Many people do not acknowledge that they have mental health difficulties until a certain stage in their lives. That particular screening is fraught with difficulties.

Can the Minister confirm that the use of lariam is not cost related and is absolutely based on the best possible medical protection that can be given to members of the Defence Forces?

Photo of Alan ShatterAlan Shatter (Dublin South, Fine Gael)
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The decision to prescribe lariam is not based on cost but based on it being the appropriate medication to prescribe to provide protection against malaria for members of the Defence Forces going to particular regions. I remind the Deputy that the Irish Medicines Board is the statutory authority with responsibility for the quality, safety and efficacy of medicines for use in Ireland. That applies to all medicines and not just lariam. It does not have a special role simply with regard to the Defence Forces. For any prescription medicines that the Deputy, I or any other Member of this House might take, we are reliant on the best advices and expertise of the Irish Medicines Board.

Following approval and use of a medicine, the IMB monitors the type and frequency of any reported side effects. As product usage increases more information on safety profile becomes available. Further decisions and recommendations regarding its use are made by the IMB and its international counterparts. The Defence Forces comply fully with IMB guidelines on the prescription of medicines for members of the Defence Forces. Defence Forces policy is firstly to screen personnel for medical suitability and fitness to serve abroad.

Fitness to serve abroad is defined by medical classification code. Personnel who do not achieve the specific code are deemed to be medically unfit for overseas service. This automatically rules them out.

I assure the Deputy that this is an issue of which I was aware before I came into office, it is an issue about which I have regularly asked questions and it is one I am monitoring carefully. It is of great importance that our Defence Forces have the best possible medical information available to them and that we operate within that context and on the best advice of the Irish Medicines Board. This is what we will continue to do. In so far as any issue could arise, the Deputy can be assured I will ensure that any issue that does arise is fully addressed.