lundbeck, Newspaper and internet articles

Dodgy Professors and Even Dodgier Decisions.

Irish Times LariamOn the front page of today’s Sunday Times, an article by Mark Tighe reports that the army expert who advised the Irish Government on it’s practice of prescribing the dangerous drug Lariam, has previously received funding from Roche, the manufactures of Lariam.

So someone finally gets the conflict of interest here? Patricia Schlagenhauf stated that she is the ‘Malaria Prevention Advisor’ to the Irish Armed Forces. My previous blog on Lariam here.

Patricia Schlagenhauf
Patricia Schlagenhauf

Presumably Alan Shatter relied on Professor Schlagenhauf’s advice when he defended the use of the drug following a number of ‘suicides’ of Irish troops. He disputed its links to suicide, stating “There is no evidence in any of the coroners’ inquests linking any deaths to Lariam.” This is one of his decisions which I wholeheartedly disagree with. Why listen to the families, when the ‘pharma funded’ expert is telling you otherwise?

Okay, putting it into my perspective; following my son’s ‘death by Lundbeck’, why was Patricia Casey allowed to intervene in Shane’s inquest having had years of links to the same pharmaceutical company? Why did the medical council, following my complaint, feel the need to get an ‘independent‘ report from Oxford from someone who also has numerous links to Lundbeck? I have to give some credit to Professor Cowen, who was willing to communicate with me and answer my questions. He said he didn’t know the full circumstances but Professor Healy was in a better position to assess Shane’s case. You mean this assessment? The same report that the Medical Council were reluctant to accept from me? Isn’t e-mail wonderful!

Who’s running the show here? Nice to see this article today in the ‘Sunday Times’ albeit little comfort for the families of these young troops. There is a growing opinion that drug induced death can never and should never be called suicide. Millie Kieve of APRIL has been campaigning for a verdict of ‘Iatrogenic death’ following the death of her daughter.

Iatrogenic death: deaths induced inadvertently by a physician or surgeon or by medical treatment or diagnostic procedures.

Newspaper and internet articles, Random

Why would anyone defend the use of Lariam?

Sgt. Robert BalesRTE’s Prime-time (Irish National Broadcaster) tackled the issue of Lariam-induced suicides within the Irish army on May 23rd. The programme can be viewed here.

For those who are not aware of Lariam (aka Mefloquine), it is a highly controversial anti-malaria drug used within the defense forces when deployed overseas. The drug can cause many serious adverse effects and numerous families have blamed it for their loved one’s suicide. Interestingly, it comes 5th in the PLOS ONE ‘Prescription Drugs associated with violence’ study (after Champix and Seroxat). The US army stopped the use of Lariam following numerous suicides and severe psychiatric reactions associated with its use. Tragically, for all concerned, this drug has been implicated in the massacre of 17 Afghan citizens including children by Sgt. Robert Bales (pictured) on March 11, 2012. His wife said “I have no idea what happened, but he would not – he loves children. He would not do that.

A few weeks after the Prime-time programme (which included grieving families and their harrowing testimonies), I was disappointed to see the Minister for Defence, Alan Shatter, defending Lariam in the media. He defended the use of the drug, disputing its links to suicide and said “There is no evidence in any of the coroners’ inquests linking any deaths to Lariam.” He seemed to have completely undermined the Prime-time programme and it made no sense to me. Why would he do that?

Sorry but I have no answers to Minister Shatter’s involvement but I do have a very recent warning (8th July 2013) from Roche Pharmaceuticals which the Minister might find embarrassing. The link can be found here but Minister Shatter might find the excerpt below interesting.

Lariam

Minister Shatter said of the nine cases of lariam suicides” “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”. Irish Times June 19th. The following excerpt may help him a little bit with that one:

Lariam 1

Roche, who originally marketed Lariam, is no stranger to controversy, having also invented the notorious acne drug Accutane. This drug is also widely linked to suicide and following numerous lawsuits in 2009 Roche pulled the drug from the US market. The Irish Medicine’s Board still allow it though despite a high profile court case involving a courageous Irish father here. Roche’s corruption and intimidation tactics were subsequently captured in Doug Bremner’s ‘Before You Take That Pill’.

What I do find interesting is why Roche came out with the warning now. Was it pressure from the Prime-time documentary? Was it pressure from the pharma-funded Irish Medicine’s Board? I doubt it! But one thing is for sure, it was not out of the goodness of Roche’s pharma heart.

Lariam 2

.

Army reviews notorious drug after Afghan massacre

PLOS ONE ‘Prescription Drugs associated with violence’ 

US Army curbs Lariam

Newspaper and internet articles, Random

Is Lariam another cause of suicide?

Who asked this question and why?

The Dark Side Of Lariam – 60 Minutes – CBS News

Are the Irish Medicines Board doing their job or are they letting another dangerous medication slip through the net?

People have been saying for 30 years that antidepressants cause suicide and violence but what have the IMB done? Nothing! Looks like Lariam can cause the same side effects. Are they going to do the same with Lariam; DENY, DENY, DENY, or will they say that the warnings are sufficiently displayed on the patient information leaflet? The usual response is not good enough! The Dail is there to support the people, not to pass the buck to the Irish Medicines Board, who pass the buck to the EMA. (so why don’t we regulate our medicines through the European Medicines Agency?)

Side-effects of Lariam. (wikipedia)

Mefloquine is an orally administered antimalarial drug used prophylactically against and as a treatment for malaria. It also goes by the trade name Lariam (manufactured by F. Hoffmann–La Roche) or Mefaquin and by the chemical name mefloquine hydrochloride (formulated with HCl). Mefloquine was developed in the 1970s at the Walter Reed Army Institute of Research in the U.S. as a synthetic analogue of quinine.

Mefloquine may have severe and permanent adverse side effects. It is known to cause severe depression, anxiety, paranoia, aggression, nightmares, insomnia, seizures, birth defects, peripheral motor-sensory neuropathy, vestibular (balance) damage and  central nervous system problems. Central nervous system events occur in up to 25% of people taking Lariam, such as dizziness, headache, insomnia, and vivid dreams. A Te broadcast entitled “Contents Unknown” tells the story of an American who lost his memory while working in India as a result of mefloquine prophylaxis.

Dáil debates

Wednesday, 15 December 2010

Other Questions

Defence Forces Personnel

3:00 pm

Photo of Liz McManusLiz McManus (Wicklow, Labour) Link to this

Question 25: To ask the Minister for Defence the number of suicides there have been in the Defence Forces since Lariam was first used; and if he will make a statement on the matter. [47270/10]

Photo of Jan O'SullivanJan O’Sullivan (Limerick East, Labour) Link to this

Question 57: To ask the Minister for Defence the number of members of the Defence Forces who have committed suicide and had taken Lariam that have been reported to the Irish Medicines Board; and if he will make a statement on the matter. [47272/10]

Photo of Jan O'SullivanJan O’Sullivan (Limerick East, Labour) Link to this

Question 66: To ask the Minister for Defence the number of persons who have committed suicide in the Defence Forces since Lariam was first used that were either taking Lariam or had taken Lariam in the past and if in the past, the date on which they had their last Lariam dose;; and if he will make a statement on the matter. [47271/10]

Photo of Tony KilleenTony Killeen (Minister, Department of Defence; Clare, Fianna Fail) Link to this

I propose to take Questions Nos. 25, 57 and 66 together.

I am advised by the military authorities that the Defence Forces personnel management system does not capture data on the number of suicides in the Defence Forces during a specific period. In this context, the information requested regarding the number of suicide victims who were either taking Lariam or who had taken Lariam prior to committing suicide is not available.

Lariam is authorised for use by the Irish Medicines Board, which is the statutory regulatory body charged with regulating the use of medicines to ensure the quality, safety and efficacy of medicines available in Ireland. Lariam was first authorised for use by the Irish Medicines Board in 1989. The authorised product information provides details to ensure the safe and effective use of this medicinal product. While certain risks associated with the use of the drug were highlighted in drug safety newsletters in 1996 and 2003, the Irish Medicines Board remained of the view that the benefit-risk profile for the product remained acceptable. The Irish Medicines Board continues to review the safety of this and all medicines on an ongoing basis and updates the product information as appropriate.

In accordance with best practice in prescribing this medication and taking account of the contraindications, warnings and side effects highlighted by the Irish Medicines Board, the Defence Forces screen all personnel for medical suitability. The screening system automatically rules out personnel from overseas service with certain conditions such as depression, anxiety, neurodegenerative disorders and so on which, as has been indicated by the Irish Medicines Board, are more likely to precipitate serious adverse reactions to Lariam. Pregnant personnel also are excluded.

In the case of overseas missions to malarious areas, the medical screening involves an assessment of the individual’s suitability to be prescribed the selected anti-malarial agent in line with current Irish Medicines Board guidelines. This typically involves review of the individual’s previous experience, if any, with the medication. The individual’s medical history is also screened for those conditions which have been identified as precipitating serious side effects in association with the medication. In addition, blood tests are carried out to ensure that the liver is healthy, as liver disease is an accepted contraindication to the use of Lariam.

It is the policy of the Defence Forces Medical Corps that personnel who are found suitable for Lariam should commence their medication three to four weeks in advance of their travel. The purpose of this precaution is twofold. While it allows a slow build-up of the medication in the bloodstream, it also permits assessment by the person of his or her individual reaction to the medication while still in Ireland. During this probationary period, the individual can consult a medical officer on any adverse reaction, minor or major. Some minor reactions may be transient but if persistent or troublesome, the individual will be deemed to have sensitivity to the medication and will be found not medically suitable for the mission.

The Defence Forces take all necessary precautions in assessing the suitability of personnel before prescribing Lariam in accordance with the prescribing instructions and information provided by the Irish Medicines Board. Personnel are screened both before and after deployments and all necessary actions are taken to ensure that those with contraindications to Lariam use are deemed unsuitable for overseas service and are not prescribed the medication.

Photo of Brian O'SheaBrian O’Shea (Waterford, Labour) Link to this

To revert to the original question regarding suicides, may I take it there is no record of the number of serving or former members of the Defence Forces who have committed suicide? If such information is not available, it is difficult to assess what role or part Lariam could have played in this regard. What exactly is the position with regard to the deaths of serving members? Is it a military function to establish the cause of death or that of a civilian coroner? How do the Defence Forces deal with deaths within the service?

Photo of Tony KilleenTony Killeen (Minister, Department of Defence; Clare, Fianna Fail) Link to this

The Defence Forces personnel management system does not have a means to capture the data in this regard. My understanding is that the coroner decides what is the cause of death and obviously suicide sometimes is found to be the cause. However, all kinds of other outcomes are possible and frequently it is not entirely clear what was the cause. Moreover, it is a matter of enormous sensitivity to survivors and family members and is a very difficult issue with which to deal but my understanding is that it is a civil matter to be dealt with by the coroner and that the Defence Forces personnel management system does not have the capacity to accommodate the information.

Photo of Brian O'SheaBrian O’Shea (Waterford, Labour) Link to this

While I take it that this is the position, some Members have been receiving representations on concerns regarding Lariam toxicity pertaining to ongoing illness and suicide. Does the Minister not agree that, in respect of the personnel and families affected, an effort should be made to put together the necessary information in order that the entire subject of the use of Lariam in this regard can be more fully assessed?

Photo of Tony KilleenTony Killeen (Minister, Department of Defence; Clare, Fianna Fail) Link to this

I agree with the Deputy that it would be helpful to have the maximum level of information available and it is important to bear in mind that, in the first instance, responsibility rests with the Irish Medicines Board in respect of any medicines that are approved for use. The Deputy is correct in that the Defence Forces have particular reason to use this medication and have a large cohort of people who need to use it. A reasonable person would state that the precautions taken by administering three or four weeks beforehand, as well as ongoing assessment before travel and during the overseas trip, are very important. Moreover, one should bear in mind that the Defence Forces Medical Corps is available to personnel both in Ireland and to those who are deployed on overseas service. I have no reason to believe that members of the Defence Forces are reluctant to access the services available from the Medical Corps.

Photo of David StantonDavid Stanton (Cork East, Fine Gael) Link to this

I have three brief questions. First, have there been any reported adverse effects as a result of the use of Lariam? Second, can the Minister provide Members with figures regarding the number of suicides or attempted suicides in the Defence Forces in the recent past? Third, the Minister should comment on mental health issues in the Defence Forces.

Photo of Tony KilleenTony Killeen (Minister, Department of Defence; Clare, Fianna Fail) Link to this

As for adverse effects, my understanding is that the Medical Corps would notify the Irish Medicines Board of any effects and that an internal medical communications channel exists. In respect of figures for attempted suicide or suicides, this certainly is not captured by the personnel management system in any event. Moreover, I am not aware whether it is being captured in respect of any other group for that matter. What was the third question?

Photo of David StantonDavid Stanton (Cork East, Fine Gael) Link to this

It pertained to mental health issues. On the subject of adverse effects, is the Minister aware of any incidents in which a report was given by the Medical Corps to the Irish Medicines Board as he has indicated? Has any such report been given?

Photo of Tony KilleenTony Killeen (Minister, Department of Defence; Clare, Fianna Fail) Link to this

While I am not aware of any particular report, I understand that the Irish Medicines Board depends on two sources. In the first instance, it depends on international medical sources. In addition, I understand that access is available for sources in all the medical services within the country at every level to make information available. As far as I am aware, there is an obligation on people to make such information available and I understand it is made available. However, I am not aware of any particular cohort of people being subject to particular tests or of some kind of peer review being carried out. I am not aware whether this is the case within the Defence Forces and I certainly do not have such information to hand.

4:00 pm

Photo of Aengus Ó SnodaighAengus Ó Snodaigh (Dublin South Central, Sinn Fein) Link to this

In a previous answer to me in respect of similar questions, the Minister stated that “three members of the Defence Forces had been treated for serious symptoms which may have been caused or contributed to by Lariam”. He also noted there was a further cohort of seven personnel with less dramatic symptoms. The questions being debated pertain to suicide and there has been an obligation since 2003 on the Defence Forces to refer any adverse reaction to the Irish Medicines Board. In particular, the fact that suicide and suicide ideation was added to the safety literature in respect of Lariam in 2003 means the Defence Forces should be on high alert for any suicide. The mere fact that the victim was either taking or had taken Lariam in the past should have resulted in a suspected adverse drug reaction report to the Irish Medicines Board. My question is whether all such cases have been referred to the Irish Medicines Board. Moreover, if the Defence Forces have not compiled and are not compiling data on suicide, can the Minister instruct them to so do and to ensure that, in particular, cases in which Lariam had been taken are flagged to the Irish Medicines Board?

Is the Minister aware of the report of the Permanent Defence Force on suicide and turning the tide of suicide? Between 2001-06 there were 15 suicides of serving members. There is a question regarding whether Lariam has an effect among those who have left the Defence Forces.

Would the Minister agree to meet former members – I know there is a problem with meeting current serving members – of the Defence Forces who have highlighted issues regarding Lariam to see whether their concerns are based on fact? It would be helpful to the group that has now formed which is examining these issues. The US military and other militaries have stopped using Lariam specifically because there are concerns about suicide and other adverse effects.

Photo of Tony KilleenTony Killeen (Minister, Department of Defence; Clare, Fianna Fail) Link to this

The Deputy referred to ten cases, which he has previously referred to in parliamentary questions and which I have discussed with him, Deputies O’Shea and Stanton and others outside the House. In the case of the three people with serious symptomatology, it may have been caused or contributed to by Lariam. I am informed that there is nothing conclusive in this regard, which is not surprising. On the further cohort of seven, they have less dramatic symptoms and remain under review. Again, there is no conclusive evidence that the use of Lariam was a factor in any of the cases.

I am quite confident that the obligations to consult and provide information to the Irish Medicines Board are being complied with; I will check that. It is very difficult to access the figures on suicide. Whatever the local view may be at the time of a person’s death, ultimately the matter is decided in a coroner’s court and the information becomes available at some point in time. It is not always clear what the exact cause of death is in some instances. It is something which might make it very difficult for military authorities to gather the information.

I am prepared to examine this matter. The three Deputies and the group which was mentioned are obviously concerned about it. In so far as is possible, I will report to the Deputies on what seems to be practically possible.

In regard to a meeting, I tend to take the view that it is preferable to meet the representative associations of current serving members. I have also met the representative associations of retired people. It is a matter I will take up with the Deputy privately when I have considered it.