Léim ar aghaidh chuig an bpríomhábhar
Gnáthamharc

Defence Forces Medicinal Products

Dáil Éireann Debate, Thursday - 8 October 2015

Thursday, 8 October 2015

Ceisteanna (2)

Seán Crowe

Ceist:

2. Deputy Seán Crowe asked the Minister for Defence if he is aware of a mounting body of evidence from experts that the use of Mefloquine or Lariam is linked with severe depression and other psychotic episodes and if he will consider suspending its use by the Defence Forces given that other safer options are potentially available. [34910/15]

Amharc ar fhreagra

Freagraí ó Béal (26 píosaí cainte)

The continued use of Lariam by the Defence Forces has been continually raised in this House with the Minister and his predecessors, now in opposition. Another question has also been tabled on it this morning. We are trying to find out why the Defence Forces continues to use this drug. Does the Minister know the number of people in the Defence Forces who claim this has triggered in them psychotic or severe depression? Other countries have stopped using this drug.

I thank Deputy Crowe for raising this issue, which has been raised regularly in the House. It has been debated in other parliaments in different parts of the world as well. The truth is that malaria is a very serious disease and is responsible for the deaths of hundreds of thousands of people every year. When we send our troops into conflict zones that are affected by malaria, we need to ensure we have the best medical treatment for those soldiers. I have stated repeatedly that I am not a qualified medical doctor. Politicians should not be making a decision on this matter except on the basis of the medical advice available. This has been my approach.

I am aware of the ongoing debate relating to the use of Lariam. The Deputy will be aware that the choice of medication for overseas deployment, including the use of Lariam, is a medical decision made by medical officers in the Defence Forces, having regard to the specific circumstances of the mission and the individual member of the Defence Forces concerned. The Defence Forces are aware of the range of reported side effects attaching to all anti-malarial medications. Significant precautions are taken by the Defence Forces medical officers in assessing the medical suitability of members of the Defence Forces to take any of the anti-malarial medications. It is the policy of the Defence Forces that personnel are individually screened for fitness for service overseas and medical suitability. A medical risk assessment for Lariam is carried out on an individual basis. The Defence Forces' policy in relation to the use of anti-malarial medication is in line with the current Health Products Regulatory Authority approved summary of product characteristics.

In January 2011, having regard to current and potential litigation, my Department established a working group to examine the use of Lariam and other anti-malarial drugs in the Defence Forces. The group produced its report to a former Minister for Defence in 2013. I am advised that the group investigated the allegations surrounding the use of Lariam and obtained the advice of leading medical experts, who concurred with the prescribing practices followed by the Defence Forces.

Additional information not given on the floor of the House

Since production of its report, members of the working group have continued to monitor developments in the area of malaria chemoprophylaxis. My Department has recently reconvened the malaria chemoprophylaxis working group. This group met in August and has engaged once again with experts, both nationally and internationally. The group expects to provide an updated report to me later this year.

By way of additional information, the Deputy may wish to note that Roche Products (Ireland) Limited, Roche, which distributes Lariam in Ireland, recently informed the Defence Forces that it is planning a discontinuation of Lariam from the Irish market with effect from 31 July 2016. I understand that Roche has indicated that its decision is based on a commercial assessment and takes into consideration medical needs, potential alternative treatments and prevention options. I understand that Roche has indicated that it is not aware of any withdrawal plans in other countries, particularly in the UK. It was indicated that in some European countries Lariam has however been withdrawn in the past due to low demand, malaria incidence and need for prevention. The implications arising from this decision by Roche are being considered in full by the Defence Forces medical branch.

I conclude by reminding the Deputy that malaria is a very serious disease killing approximately 1 million people per year in sub-Saharan Africa alone. It is a grave threat to any military force operating in the area. Anti-malarial medications must remain in the formulary of medications prescribed by the medical corps for Defence Forces personnel on appropriate overseas missions, to ensure that our military personnel can have effective protection from the very serious risks posed by this highly dangerous disease.

This sounds to me like a classic case of doctors differing and patients dying. If one looks at other militaries around the world, two years ago the US military declared the drug to be one of last resort. US Army Special Operations Command has banned its use. Defence Ministries in France, Germany, the Netherlands, Denmark and Canada have either banned its use or use it as a last resort only.

We would not knowingly put soldiers at risk if we could avoid it. It appears from the evidence coming from other jurisdictions that that is their conclusion as well. They have moved to some other drug. The producer, Roche, has also said there are potential side effects to this drug. Why is this happening? Is it because it is the cheapest drug? Is it because we have stockpiles of the drug? Families are suffering. They want to know what triggered this response in their loved ones, which is why we are trying to get to the core of the issue this morning.

I understand why the questions are being asked but we would not make any decisions on anti-malarial drugs which would unnecessarily put anyone at risk. The only priority is to make our troops as safe as possible when they are abroad. There is no simple solution here. There is no anti-malarial drug which is free of all side effects. They just do not exist.

There are alternatives to Lariam.

There are alternatives but each alternative has a complication.

The complications are not as serious though.

In all seriousness, there are lots of countries which still use Lariam. My Department has recently reconvened, on my instruction, the malaria working group. This group met in August and has engaged once again, because of the issues raised, with experts, both nationally and internationally. The group expects to provide an updated report to me later this year.

Roche Products (Ireland) Limited, which distributes Lariam in Ireland, recently informed the Defence Forces that it is planning to discontinue the supply of Lariam to the Irish market with effect from 31 July 2016. I understand this is simply a commercial decision but we will need to plan for the consequences of that decision. We are, and have been, considering alternatives to Lariam but there are no easy answers here. It is not as if one switches from Lariam to something that gives equally effective results with no side effects. Those drugs do not exist. We have to make a balanced decision in the interests of the safety of our troops and that is what we will do.

The key issue is the safety of the troops. We know from other countries that there have been huge psychotic disorders. We know from Roche that hallucinations, psychosis, suicide, suicidal thoughts and self-endangering behaviour have been reported and the drug may induce potentially serious neuropsychiatric disorders. The difficulty is that many people are asking why the Minister is adopting this position and if it is because of potential court cases. We always seem to adopt this approach of defending the State first and Joe Citizen second. That has been the pattern-----

That has nothing to do with it.

That has been the pattern with drug products and so on. The Minister defends the State rather than the individuals and the worry in respect of this is that there are many cases and will be court cases about this. There is no doubt about that.

If there are court cases, then of course they will go to court.

The Department of Defence will be paying that in the court.

Thank you, Deputy. The Deputy has made his point.

What the Deputy is trying to do is-----

What we are doing about this is wrong. The Minister tries to defend the State when he needs to own up to what is happening.

There are other Deputies waiting to ask questions.

What the Deputy is not referring to is the fact that 1 million people a year die of malaria. He is not referring to the fact that we send our troops into regions that have serious malaria issues. I need to protect them, to make sure they are not in those figures of people who die from malaria each year. There is a balance to be achieved here to make sure that when we make decisions to send troops to places like Mali, to other parts of North Africa and other parts of the world, where they are badly needed as peacekeepers, we protect them. We need to take the best medical advice available to us on those medical decisions. That is what we do. This has nothing to do with court cases in Ireland.

It is to do with dodgy drugs.

If there are court cases in Ireland we will deal with them. The only priority for me is making sure that when we make the serious decision to send troops abroad on peacekeeping missions, they are protected with the best medication we can give them for any diseases they may encounter in those areas.

Thank you, Minister.

That is the only issue and if that means moving away from Lariam because there is a better drug that can get better results, we will do that but it will be on medical advice, not on political point scoring.

Would the Minister please respect the Chair? Thank you.

Does the Ceann Comhairle want to change the order and take my Lariam question next?

The Deputy can proceed with Question No. 3.

We will come to it in a while.

Barr
Roinn