Calls for the Ministry of Defence to ban the use of the anti malarial drug Lariam (the UK marketing name of mefloquine) have recently received wide coverage in the media. The argument is that side effects are so severe that the risk to troops, who regularly take the medication for many months at a time, outweighs the potential benefit. In the meantime, more expensive alternatives should be used for protection against the parasite.
Lariam in the media
In March 2015 Radio 4’s documentary The Lariam Legacy , on which I was interviewed, talked about the lives disrupted and the careers allegedly wrecked by this drug. Several newspapers followed up the story, including The Independent, which has an honourable history on this subject. On 19 August the Today programme revealed that Johnny Mercer MP had demanded an enquiry and a ban, and on 21 August The Independent reported that the House of Commons select committee on defence was considering conducting its owninvestigation.
The “Lariam stories” I have heard from clients and witnesses lead me to be optimistic that the committee will decide to look at whether this drug should be given to troops at all. Certainly, there has been concern for a long time (see my most recent blog on our website). My hope is that it will also consider the question of how it has been administered, and whether there have been breaches of the Ministry of Defence’s obligations as both employer and healthcare provider.
In this blog I will deal with the issues of the MoD’s legal duty of care towards members of the armed forces, including the need to respect their entitlement to receive medical treatment only when they have given consent.
MoD’s press release
The MoD’s press release dated 20 August 2015 in response to the Today programme report includes the statement that “since 2013 mefloquine has only been prescribed after an individual risk assessment”. In the long version of the report my firm was quoted as having expressed concern that service personnel were being handed the drug without such an assessment, so it would seem that the MoD is responding to that question. In doing so, it unwittingly reveals that until 2013 there was no systematic requirement for individual assessments before this drug was administered to service personnel.
Duty of care towards service personnel
The release appears to confirm my suspicions that service personnel have been ordered to take a drug that can have serious side effects, permanent in some cases, without;
- Their consent,
- Consideration of any special reasons why an individual should not be given this drug
- Advice about side effects
- Advice on what to do if they experience problems
If this has been happening it would constitute not only an assault on their dignity as human beings, but also a failure of the MoD’s duty of care both as employer and as healthcare provider. It is on the basis of that suspicion that I have been investigating claims from a number of former members to the services. I am now able to advise my clients that their cases are that much more likely to succeed.
What is medical consent?
In the case of Montgomery v East Lanarkshire Health Board UKSC 11 the Supreme Court confirmed that a doctor should give a enough information about the risks and benefits of treatment for a reasonable patient to be able to make a decision. That means that the patient must be told about any material risks of having and – not having – the treatment, and about what alternatives there may be. If s/he is not given this information the doctor has not been given proper consent.
If there is no doctor involved in the process but there should be that does not, of course, absolve the healthcare provider of any breaches of the consent process.
Avoiding malaria; a medical necessity
Anyone with knowledge or experience of malaria knows that it is a serious and potentially fatal illness. No responsible doctor who is sending a patient to an area where malaria is endemic such as Sierra Leone, Kenya or Afghanistan would do so without providing full advice on effective preventative (“prophylactic”) drugs. An employer should consider refusing to allow personnel who do not take anti malarial drugs to deploy at all.
That is not, however, to say that the MoD is entitled to choose a drug and order all personnel to take it without providing for individual medical assessments, or to decide not to give advice on the consequences, side effects and any appropriate alternatives. This would be the case whatever drug we were discussing, whether it was for high blood pressure or an STD.
Individual assessment; a medical duty
Anti malarials are strong drugs. There can be very serious consequences if the wrong medication is given, or if the right prescription is given or taken in the wrong way. Avoiding a bad outcome is not something a patient can attempt without appropriate advice. This is not a question of applying the right kind of sun block or putting a plaster on a blister. So how should service personnel be advised, and what choices should they be given?
Lariam is an efficient prophylactic, and it saves lives. It is cheap, and only needs to be taken once a week. I am aware of no information currently in the public domain that makes it clear whether it is the cheapness, the theoretical convenience of a weekly dose or the effectiveness that has led to the MoD stockpiling more than 11,500 tablets, according to the Guardian.
There are other common anti malarial drugs, however, that are listed as being as effective as Lariam. They are more expensive. They need to be taken every day, which some say is easier to remember.
Which drug should be given in any case should be decided according to what drug suits the individual.
There are precautions that must be taken with all drugs, but those that are recommended both by Government agencies and by the manufacturers in relation to Lariam are more stringent than many. Since 1996, for example, the MHRA, then called the Medicines Control Agency, has been clear that nobody who has a history of a “neuropsychiatric disturbance”, including depression – which is relatively common – should take it.
“Neuropsychiatric disorder” would also include Post Traumatic Stress Disorder. In my team we act for many service men and women who have been diagnosed as suffering from PTSD, and many who should have been diagnosed far earlier, while serving. It follows that there are current or former personnel who have been prescribed Lariam but who should not, and who may have suffered from permanent effects as a result.
If the drug is handed out on parade to a soldier with a history of PTSD, depression, seizures or some other relevant disorder neither he nor the staff distributing the tablets will not know that s/he should under no circumstances take it.
Most drugs have side effects. In the case of Lariam, these are listed by the MHRA as including “depression and suicidal ideation, anxiety, panic, confusion, hallucinations, paranoid delusions and convulsions”. The manufacturer’s current guidance adds suicidal thought, self-endangering behaviour and severe anxiety, nightmares, feeling restless, unusual behaviour and confusion.
Indicators for seeking medical advice
- Suicidal ideation or thoughts
- Paranoid delusions
- Self-endangering behaviour
- Unusual behaviour
The patient should seek medical advice before the next dose is due if s/he experiences any of these. This is to minimise the possibility of getting malaria, because a different preventative can then be given. It also – and very importantly – means that s/he is taken off the medication that is causing the side effects, in the hope that they will prove to be temporary.
Again, when the drug has been handed out on parade by non-medical staff, service personnel will not have had these vital warnings. They will have continued to take Lariam to the end of the course. That means that a substantial number of members of the Army, Navy and RAF will at the very least have been subjected to several months of extremely unpleasant symptoms, and at worst have suffered permanent consequences.
The Radio 4 programme The Lariam Legacy highlighted evidence from a number of former members of the armed service that the drugs were routinely handed out with kit, along with water purification tablets and soap. Rarely was Lariam given by a medic. Some personnel who had experienced “Lariam dreams” or other symptoms such as untypical aggression or even seizures fund that these continued either long term or, in some cases permanently, even after they had stopped taking the medication. At Bolt Burdon Kemp we have been consulted by serving and retired personnel in this situation. We are in correspondence with the Ministry of Defence.
The duty of care
Service personnel are acutely aware that they have a duty to keep themselves healthy, both for their own sakes and for that of their comrades and their Service. It can obviously harm an operation or an exercise if the participants fall ill with malaria.
Service personnel can believe that doing their duty means they must take whatever they are given without arguing or having a right of choice. That is not right. They are entitled under the law to be treated as adults, with a choice about what treatment they should be given, and to expect that as much care should be taken not to harm them from both a medical and an operational perspective as if they were in the hands of their civilian doctors. With some treatments and conditions, indeed, military medics know more that the average civilian GP, and military personnel therefore should be able to expect the doctor to be more alert to potential problems.
It is true that they have an unusual relationship with their employer, the Ministry of Defence. The MoD provides their medical care. It also trains them and gives them the equipment they need to do the job. Because the soldier’s fitness and health are among the tools the MoD uses to protect us some of the decisions they take are very different to those of a civilian GP. Certain basic principles apply across the board, however, and that of consent is one of these.
The military’s basic duty of care towards service personnel is to take reasonable steps to avoid foreseeable injury. If it has failed to take those steps it will be liable to pay compensation for the injuries caused, and these would include those months of unnecessary suffering.