Seán Ó Fearghaíl (Kildare South, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I thank the Ceann Comhairle for accepting this issue. According to media reports yesterday, a study on the use of the controversial anti-malarial drug, Lariam, received by the Minister for Defence, Deputy Shatter, whom I welcome in the Chamber, is legally privileged and will not be published. The use of Lariam has been a topic of concern for some time, and not only under the current Government. It is vital that we answer these concerns.

Yesterday The Irish Times carried a story stating that the administration of the drug to Defence Forces personnel travelling to malarial countries will continue, notwithstanding revised safety information from the manufacturer Roche, stating that the drug can cause serious neuro-psychiatric disorders. Roche states that possible side effects include insomnia, anxiety and depression. The company also mentions that hallucinations, psychosis, suicide, suicidal thoughts and self-endangering behaviour have been reported. It states that adverse reactions can persist for several months after discontinuation of the drug.

It seems that soldiers on a mission to Chad in 2009 were told that if they failed to take Lariam and caught malaria through their own fault the Defence Forces would not be liable. It is also reported they were required to take the drug under supervision, were warned not to take any other anti-malarial medicine and were told that only Lariam is effective in Chad. Other drugs such as Malarone and Coartem are used by other countries, including the United States. Alternative anti-malarial drugs found in the possession of any soldier would be considered contraband and soldiers were told they could face disciplinary action if found with such drugs.

Some serving and former members of the Defence Forces have begun legal action against the State, complaining of side effects including depression and suicidal ideation. The report of the working group on malarial chemoprophylaxis, set up in 2009, examined the use of Lariam. The group reported to the Minister during the summer. A statement from the Department of Defence notes that the report was produced in the context of current and potential litigation, is legally privileged and would not be published.

I am astonished by this attitude. Surely the report should be published as a matter of course. Is it not in any case subject to discovery by any lawyers taking action in this matter? Does the fact it is not being published not give the impression there is something to hide on the part of the Department of Defence? Should a Government that claims to cherish transparency, which pats itself on the back on a regular basis about improvements in the Freedom of Information Act and other areas, not publish this report?

This particular controversy will not go away. The momentum demanding action and either an exposé or an explanation on the part of the Department is growing by the day. Whatever may have been said by different Ministers in the past, including those of my party who adopted a particular view on the matter, we cannot ignore the growing controversy. Apart from that controversy, the growing body of evidence seems to suggest that at least there are questions to answer. When we look at this drug as not only one of three possible medications that could be used, but also one in respect of which its own manufacturer has raised real and meaningful concerns, it is incumbent on he Department of Defence to address those concerns. In this instance, where I understand the Minister has a report, he should at least publish it.

Alan Shatter (Dublin South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank the Deputy for raising the issue. I am sorry he is making allegations that somebody has something to hide. I certainly have nothing to hide and I assume each of my predecessors who were Ministers for Defence for 14 years during the lifetime of the previous Government had nothing to hide. The document to which the Deputy refers, the instructions from 2009 published by the Defence Forces, were published when the Deputy's colleague, Deputy Willie O'Dea, was Minister for Defence. I have nothing to hide.

Arising from assertions which had been circulating regarding the prescribing and side effects of Lariam, my Department established a working group in January 2011 to examine the use of Lariam and other anti-malarial drugs in the Defence Forces. The group comprises representatives of the Defence Forces Medical Corps, Defence Forces personnel policy branch and Defence Forces human resources and litigation branch. It also includes representatives from the State Claims Agency and the Chief State Solicitor's Office.

The purpose of this group was to review issues arising in respect of the use of Lariam, having particular regard to current and potential litigation, to review and confirm the approach of the Defence Forces in regard to the use of malaria chemoprophylaxis in the Defence Forces and to ensure that the procedures in relation thereto continue to be appropriate and in accordance with best medical practice as promulgated by the relevant medical authorities. The work of the group informs the Defence organisation's process of ongoing risk assessment and mitigation in the context of a proactive risk management strategy.

The group reported back to me in June this year. While the report was produced, as the Deputy correctly noted, in the context of current and potential litigation and is, therefore, legally privileged, I can confirm that the group investigated all the various allegations surrounding the use of Lariam and that it obtained advice from leading medical experts. These experts concur with the practices followed by the Defence Forces in prescribing Lariam.

On my behalf, the State Claims Agency is currently handling 24 cases taken by members and former members of the Defence Forces who allege personal injury as a result of their consumption of mefloquine, or Lariam. High Court proceedings have been served in respect of nine of these cases.

It is important to draw to the attention of the Deputy and of the House that malaria is a serious disease that can cause serious complications and death.

It is estimated by the World Health Organization that approximately 1 million people die every year from malaria in sub-Saharan Africa alone. It has also long been recognised as being a serious threat to any military force operating in a malarious 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. Research has shown that lariam is one of the most effective medications for protection against the type of malaria prevalent in sub-Saharan Africa. It is authorised for use by the Irish Medicines Board, IMB, which is the statutory regulatory body charged with the regulation of the quality, safety and efficacy of medicines available in Ireland. I am advised that the decisions of the IMB are taken in consultation with European and other international bodies and that the IMB remains of the view that the benefit-risk profile for the product remains acceptable.

The choice of chemoprophylactic medication depends on a number of factors including the type of malaria in the destination, resistance to particular drugs, the profile of the traveller - in other words, contra-indications, underlying health conditions and purpose of travel - the duration of travel and adherence issues. This choice must always remain a medical decision to be made by medical officers in the Defence Forces on the basis of best medical practice, having regard to the specific circumstances of the mission and the individual member of the Defence Forces. It is not a matter for ministerial direction.

The Defence Forces are fully aware of the range of reported side effects attaching to all anti-malarial medications and significant precautions are taken by the medical corps in assessing the medical suitability of members of the Defence Forces to take lariam or any of the other anti-malarial medications. Lariam must remain in the formulary of medications 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.

There is not, as the Deputy put it, a growing controversy. It is a question of how this matter should be approached. My central concern is the safety and health of members of the Defence Forces and in that context we will continue to abide by the best advices of the Irish Medicines Board and ensure that we have in place the appropriate medical procedures to pre-screen members of the Defence Forces as to their suitability for the taking of lariam before they go on any mission abroad.

Seán Ó Fearghaíl (Kildare South, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I must first acknowledge that the procedure over the years in this country has been far better than it was in the United States of America where the drug was widely prescribed and that the screening adopted by the military authorities in this country is one that I acknowledge has been particularly effective. If the Minister believes there is not a growing controversy on the issue then he is once again denying reality and he is not aware of what is happening around him because it is a simple statement of fact.

The Minister indicated that the expert report concurs with the practices followed by the Defence Forces in prescribing lariam to date. Could he indicate whether the report recommends that the Department of Defence continues to prescribe lariam as heretofore? The report might well be accessible by way of discovery in the event of legal action being taken. A number of cases are before the courts currently. Given that in the event of legal action the report would have to be made available, why does the Minister not publish it now and let us see what it contains so as to clear up any concerns?

Alan Shatter (Dublin South, Fine Gael)
Link to this: Individually | In context | Oireachtas source

It is always legitimate that questions are asked but the fact that individuals raised concerns does not justify the Deputy being alarmist with regard to the use of lariam. As the Deputy well knows from responses to previous questions in the Dáil on the issue, which I addressed at great length, the difficulties that arose with the use of lariam by members of the United States army derived from the fact that there was no pre-screening and that all of the contra-indications, for example, if someone suffers from depression or other psychosomatic difficulty, were not screened out. There was a substantial problem in the American armed forces because they did not adopt the approach we adopt.

There is nothing in the report that indicates in any shape or form that the approach that has been taken heretofore should not be taken. I wish to be quite categoric on that. I reiterate that the choice of medication must always remain a medical decision to be made by medical officers in the Defence Forces on the basis of best medical practice, having regard to the specific circumstances of the mission and the individual member of the Defence Forces. It is not a matter for ministerial direction. The expert group investigated all the various allegations surrounding the use of lariam and obtained advice from leading medical experts. In the context of research, Lariam has been shown to be one of the most effective medications for protection against the type of malaria prevalent in sub-Saharan Africa. Other medications are available that are not suitable for sub-Saharan Africa. There are various types of malaria and we have an obligation to ensure that our forces have the protection that is appropriate to them. Malarone is another possible alternative but not all the alternatives are suitable for each location in which we deploy members of the Defence Forces.