Thursday, 21 June 2012

Ceisteanna (9, 10, 11, 12, 13, 14)

Aengus Ó Snodaigh

Ceist:

9Deputy Aengus Ó Snodaigh asked the Minister for Defence the number of Defence Force personnel who were discharged after taking Lariam. [30057/12]

Amharc ar fhreagra

Jonathan O'Brien

Ceist:

15Deputy Jonathan O’Brien asked the Minister for Defence the number of Defence Force personnel who were administered Lariam but were deemed unsuitable. [30056/12]

Amharc ar fhreagra

Joe Higgins

Ceist:

18Deputy Joe Higgins asked the Minister for Defence if he will explain the continued giving of anti-malaria drug, Lariam, to soldiers in the Defence Forces in view of the fact that the US army has discontinued its use and the numerous cases of neuropsychiatric side-effects including incidences of suicide. [29923/12]

Amharc ar fhreagra

Jonathan O'Brien

Ceist:

20Deputy Jonathan O’Brien asked the Minister for Defence the number of personnel in the Defence Forces who were administered Lariam and the years in which this took place. [30055/12]

Amharc ar fhreagra

Joe Higgins

Ceist:

22Deputy Joe Higgins asked the Minister for Defence if he will commit to carrying out a study to compare the incidences of suicide amongst Irish soldiers who were prescribed Lariam as opposed to those soldiers that have not received Lariam. [29924/12]

Amharc ar fhreagra

Clare Daly

Ceist:

25Deputy Clare Daly asked the Minister for Defence if he will end the army policy of prescribing Lariam for malaria; and if he will conduct an inquiry into suicide and negative health side effects related to its use. [29849/12]

Amharc ar fhreagra

Freagraí ó Béal (5 píosaí cainte) (Ceist ar Minister for Defence)

I propose to take Questions Nos. 9, 15, 18, 20, 22 and 25 together.

Malaria is a serious disease which can cause severe complications and death. It is estimated by the World Health Organisation that approximately 1 million people die every year from the disease in sub-Saharan Africa alone. It has long been recognised as a serious threat to any military force operating in a malarious area.

Lariam is a malaria chemoprophylactic agent first authorised for use in 1989 by the Irish Medicines Board, IMB, which is the statutory regulatory body charged with regulating the use of medicines in Ireland to ensure their quality, safety and efficacy. Research has shown that it is one of the most effective medications for protection against the type of malaria prevalent in sub-Saharan Africa. While certain risks associated with the use of the drug were highlighted in FDA drug safety newsletters in 1996 and 2003, the IMB remains of the view that the benefit-risk profile for the product was acceptable. The IMB continues to review the safety of this and all medicines on an ongoing basis and updates the product information as appropriate. Lariam remains the medication of choice for the Defence Forces for missions to sub-Saharan Africa and continues to be certified by the IMB.

In accordance with best international practice in prescribing Lariam, and taking account of the contraindications, warnings and side effects highlighted by the IMB, the Defence Forces screen all personnel for medical suitability. The screening system rules out staff with certain conditions, including depression, anxiety and neurodegenerative disorders, from overseas services. These are the conditions which, as has been indicated by the IMB and other regulatory bodies worldwide, are more likely to precipitate serious adverse reactions to Lariam. In addition, personnel who are found suitable for Lariam are obliged to commence their medication three to four weeks in advance of their travel. This precaution allows a slow build-up of the medication in the bloodstream and also permits assessment by the person of his or her individual reaction to the medication while still in Ireland. Personnel are screened both before and after deployments and all necessary actions are taken to ensure that those with contraindications to Lariam use are not prescribed the medication.

It should be noted that the primary area of operations for United States forces is currently Afghanistan. Neither the United States army nor the Irish Defence Forces recommend Lariam as a first-line malaria chemoprophylaxis for Afghanistan. Another factor to consider is that while the United States military engaged in mass prescribing, the Defence Forces, in accordance with the prescribing instructions, consider each individual case.

I am advised by the military authorities that three members of the Defence Forces displayed a serious symptomatology which may have been caused or contributed to by Lariam, although there is nothing conclusive in this regard. I am also advised that all three personnel made a full recovery and their cases were reported to the IMB. I am further advised by the director of the Defence Forces medical corps that he is unaware of any suicide by a member of the Defence Forces linked to Lariam.

No personnel have been discharged because they were below Defence Forces medical standards as a result of taking Lariam. I am informed that the number of personnel deemed unsuitable for Lariam due to contraindications cannot be quantified without an examination of every medical file, which would be impractical. Likewise, the number of personnel to whom Lariam was administered cannot be accurately established without an examination of every file. I have asked the military authorities to provide an estimate of this number based on the number of personnel who served on certain missions.

It is difficult to believe, in this computer era, that the number of personnel deployed in the sub-Saharan region who were administered Lariam cannot be quantified. Given the concerns that have been expressed by serving soldiers and ex-soldiers in regard to this medicine, those data should be compiled without delay. Will the Minister give a commitment, in advance of any future deployment in sub-Saharan Africa, that a review of the drug and its administration in the Defence Forces will be undertaken? Its use as an anti-malaria drug has been discontinued in the armed forces of many countries on the basis of its severe side effects, which include suicide and suicidal tendencies. The Minister indicated that three Defence Forces personnel have been identified as suffering side effects after taking the drug but that it is very difficult to say conclusively whether any staff committed suicide as a reaction to Lariam. That would indeed be difficult to quantify if the question of whether Lariam had been administered was not considered by the medical officer who conducted the examination of personnel who died through suicide.

The Irish Medicines Board determines the safety or otherwise of all medicines prescribed in this State. The board is appointed by the Minister for Health and its advisory committee on human medicines has a statutory role to provide advice in cases where it is proposed to refuse a licence for medicinal products on any grounds relating to safety, quality or efficacy. Following approval for use of a medicine, the IMB monitors the type and frequency of any reported side effects. As product usage increases, more information on the safety profile becomes available and further decisions and recommendations regarding its usage are made by the IMB and its international counterparts. The Defence Forces fully comply with IMB guidelines on the prescribing of medicines for members.

At present, no members of the Defence Forces are deployed in sub-Saharan Africa and there is no immediate plan for any such deployment. The fact remains that for certain types of malaria, Lariam is the treatment of choice. It is important that members of the Defence Forces who are deployed to areas where they are at risk of contracting the type of malaria for which Lariam is recommended as the appropriate treatment by the IMB, should have the drug available to them. The alternative, which I pointed out, is that in sub-Saharan Africa alone, there are 1 million deaths per annum arising from malaria, so this is not an issue of minor significance. I have no intention of sending nor wish to send members of the Defence Forces into harm's way in circumstances in which medicines are available to provide them with crucial protection. What was a failing in some defence forces elsewhere, including the United States defence forces, was that procedures were not in place whereby individual members of the defence forces were assessed as to the appropriateness of them being prescribed Lariam.

There are the contra-indications I mentioned. When a medical assessment is carried out and if there is an issue as to whether someone suffers from depression, may be taking medication for depression or has other difficulties which are contra-indications, it is very important that the member of the Defence Forces furnishes the medical doctor undertaking the assessment with the fullest information about his or her health. It is extremely dangerous should he or she not do so. That is the position.

I have no wish that anything would be done which would place at risk the health of members of the Defence Forces, nor could I stand over our posting members of the Defence Forces to an area of the world in which malaria is a serious risk without our relying on the best medical advice available to ensure they had whatever medical assistance was necessary.

One of the questions was about personnel who were administered Lariam but who were deemed unsuitable. There are people who might have depression and for whom the administration of Lariam might be deemed unsuitable. From my knowledge, few, if any, were deemed unsuitable for deployment based on the fact they would have to take Lariam and had some underlying ailment which might have reacted to it.

I have not only sought a review from this Minister but also raised the matter with the previous Minister for Defence. There are a number of cases of concern and that is why I raise the issue of Lariam. Given that we have the luxury of not having a deployment to sub-Saharan Africa in the near future, a review could take place on the use of Lariam and whether the alternatives would be more suitable. One of the alternatives needs to be administered more regularly and the belief is that is the reason it was rejected. Others said there was a cost implication.

I have asked the Minister and the previous Minister a range of questions about Lariam and to ensure the medical advice is not wrong. The Irish Medicines Board cannot act unless it has the information. The Defence Forces have not acted properly in regard to serving and former members of the Defence Forces who have raised a concern about Lariam. Can the Minister confirm that all such issues have been reported to the Irish Medicines Board by the Defence Forces?

I do not know on what basis the Deputy is alleging the Defence Forces have not acted properly in regard to this matter. It is important to look at the alternatives to Lariam. There are three other anti-malaria medications available, namely, Chloroquine, Malarone and Doxycycline. However, in the case of each of these products, there are specific reasons they are not suitable for use by the Defence Forces in sub-Saharan Africa and it is worthwhile setting out these reasons. Chloroquine is no longer in use because of the development of widespread resistance to it. Doxycycline must be taken in the absence of dairy products and it can also produce sun-sensitivity skin rashes in some individuals. This is particularly significant when used in sunny climates. For this reason, it is not recommended for first-line use by the Defence Forces in sub-Saharan Africa. Malarone is unsuitable for use as it is licensed for no more than 28 days continuous use in malarious areas by the Irish Medicines Board. In this context, this prophylactic agent is only suitable for use where the overseas deployment does not exceed 28 days.

These are among the reasons Lariam remains the anti-malaria chemoprophylactic agent of choice in areas where the predominant species of malaria is the virulentplasmodium falciparum. Lariam, therefore, is the agent of first choice on any sub-Saharan missions undertaken by the Defence Forces and that remains the position.

Doxycycline is the anti-malaria chemoprophylactic agent of choice in Afghanistan where the predominant species of malaria is the less virulentplasmodium vivax. Where Lariam is not required to be used, it is not used because it is not necessary to use it as a chemoprophylactic agent. In the context of sub-Saharan Africa, the alternatives do not offer our Defence Forces the protections to which they are entitled.

It is not practical to undertake a review of every file relating to every member of the Defence Forces who has taken Lariam since it was first utilised in the Defence Forces. The amount of resources and time it would take, in circumstances where there is not an indication that substantial numbers have been detrimentally affected by its use, cannot be justified. I have met some individuals who discussed with me their personal concerns as to the impact of Lariam on them. I am very conscious of these issues and their situation is not being ignored. As Minister, I must rely on the advice of the Irish Medicines Board but I will ensure what is necessary is undertaken in regard to any issue concerning the health of members of the Defence Forces.