RTE News are reporting today that the anti-malarial drug, Lariam (Mefloquine), has been withdrawn from sale in Ireland.
Side effects reported with Lariam include, but are not limited to, aggression, paranoia, suicidal thinking, completed suicide.
Lariam is no stranger to controversy and a number of pending legal actions in Ireland is, according to manufacturer Roche, not the reason why it has been withdrawn.
According to Roche, "Lariam was taken off sale following "a portfolio reassessment" by the company."
They add that "it remains available in 16 European countries."
Slightly worrying.
Back in August 2015 I wrote to the British drug regulator, the MHRA, regarding the number of associated completed suicides on Lariam, a figure I pulled from the MHRA database.
They told me...
"Of the nine UK spontaneous suspected ADR reports of suicide associated with mefloquine, I can confirm that three of the cases were followed up by the MHRA with either the reporting doctor or family member. Two cases were reported to us by pharmaceutical companies and so follow-up was conducted by the Marketing Authorisation Holder.
"The remaining four cases were received between 1998 and 2002 and as such were previously stored in our legacy ADR database. We do not hold records of follow up letters to cases from our legacy database and can confirm that we have no record of any further communications regarding these cases."
Remarkably, the MHRA continue to give the antidepressant, Seroxat, a clean bill of health despite it being reported that there have been 65 reports of completed suicide via the MHRA database. Lariam, to date, has 12 reports of completed suicide associated with its use.
Lariam (Mefloquine) Roche
12 reports of completed suicides (MHRA)
Seroxat (Paroxetine) GlaxoSmithKline
65 reports of completed suicide (MHRA)
Lariam removed from sale in Ireland.
Seroxat still prescribed in Ireland.
The current CEO of the MHRA is Dr Ian Hudson.
Before joining the MHRA Dr Hudson was the Head of World Safety at GlaxoSmithKline.
Back in September I wrote to the British drug regulator, the MHRA, under the terms of the Freedom of information act. The question I put to them was in regard to reported suicides associated with Lariam (mefloquine) reported on their database. Their Drug Analysis Print (DAP) had shown that there were 9 completed suicides associated with the drug. For those that don't know, Lariam, marketed and manufactured by Roche, is a drug used to treat the prevention of malaria and I wrote about it here back in August. It's used a lot by the military to treat soldiers who visit and train in countries that have a high risk of malaria. Worryingly, it wasn't just the completed suicides that concerned me. There were a number of other psychiatric events associated with this drug, namely;
18 reports of Abnormal behaviour.
24 reports of Affect lability (rapid shifts in outward emotional expressions; often associated with organic brain syndromes such as intoxication.)
61 reports of Agitation
304 reports of Anxiety
38 reports of Aggression
82 reports of Paranoia
11 reports of Personality change
67 reports of Confusional state
61 reports of Disorientation
19 reports of Delusion
341 reports of Depression
10 reports of Depersonalisation
14 reports of Dissociation
28 reports of Irritability
59 reports of Mood swings
15 reports of Mental disorder
11 reports of Mania
162 reports of Panic attack
119 reports of Abnormal dreams
146 reports of Nightmares
113 reports of Hallucinations
19 reports of Acute psychosis*
76 reports of Psychotic disorder
9 reports of Completed suicide
33 reports of Suicidal ideation
12 reports of Thinking abnormal
* Bizarrely, there has been one reported death of "acute psychosis" - This seems to have been omitted from the "completed suicide" category - unless, of course, the person died naturally?
The MHRA took approx one month to answer my question. Their full response is below.
They told me...
"Of the nine UK spontaneous suspected ADR reports of suicide associated with mefloquine, I can confirm that three of the cases were followed up by the MHRA with either the reporting doctor or family member. Two cases were reported to us by pharmaceutical companies and so follow-up was conducted by the Marketing Authorisation Holder.
"The remaining four cases were received between 1998 and 2002 and as such were previously stored in our legacy ADR database. We do not hold records of follow up letters to cases from our legacy database and can confirm that we have no record of any further communications regarding these cases."
The International Mefloquine Veterans' Alliance have taken an interest in my correspondence with the MHRA, their website makes claims that there have been denials by military officials, veterans’ affairs agencies, the ethically compromised medical establishment, the pharmaceutical industry and their lobbyists, which has resulted in no support for veterans and their families experiencing the debilitating, chronic health effects of mefloquine toxicity, some of which are listed above.
Hopefully, this somewhat blasé response from the MHRA will help those campaigning, or, as I strongly suggest, get those campaigning to write to the MHRA to ask them why the follow-up rate has been so poor regarding the reported suicides and other psychiatric adverse events associated with this drug.
Earlier today the BBC reported on the concerns surrounding an anti-malaria drug.
Lariam (mefloquine) is said to be causing concern regarding its side-effects, of which suicidal thinking and completed suicide are listed.
Worryingly, Lariam is handed out to soldiers who train or are in combat in countries where malaria is rife.
Surely, a pill taken to prevent malaria can't be that bad?
Think again.
I accessed the MHRA's Drug Analysis Prints (DAP's) earlier today - the results for Lariam were startling. Question is, why have the British drug regulator overlooked the glaringly obvious?
In all, there have been 19 reported fatalities regarding Lariam. Okay, not a great deal but when you look into the DAP's you will find that 9 of these 19 deaths have been death by suicide.
One thing the MHRA have always played down with antidepressant related suicide is that it could be the "illness" that caused the suicide and not the product. Fair enough, I guess but in the case of Lariam, the patients subjected to this particular drug do so because they wish to prevent something and not suppress or cure something.
Let's dig a little deeper.
Lariam was created by the military in the 1970's and manufactured by pharmaceutical company, Hoffman-La Roche.
Lariam Tablets contain the active ingredient mefloquine. They are used to treat malaria and to help prevent you from catching malaria.
Drug Analysis Print for Lariam (MHRA)
Total number of reactions 6713
Total number of ADR reports: 2282
Total number of fatal ADR reports: 19
Let's focus on the adverse reactions associated with 'psychiatric disorders.'
There here have been...
18 reports of Abnormal behaviour.
24 reports of Affect lability (rapid shifts in outward emotional expressions; often associated with organic brain syndromes such as intoxication.)
61 reports of Agitation
304 reports of Anxiety
38 reports of Aggression
82 reports of Paranoia
11 reports of Personality change
67 reports of Confusional state
61 reports of Disorientation
19 reports of Delusion
341 reports of Depression
10 reports of Depersonalisation
14 reports of Dissociation
28 reports of Irritability
59 reports of Mood swings
15 reports of Mental disorder
11 reports of Mania
162 reports of Panic attack
119 reports of Abnormal dreams
146 reports of Nightmares
113 reports of Hallucinations
19 reports of Acute psychosis*
76 reports of Psychotic disorder
9 reports of Completed suicide
33 reports of Suicidal ideation
12 reports of Thinking abnormal
* Bizarrely, there has been one reported death of "acute psychosis" - This seems to have been omitted from the "completed suicide" catagory - unless, of course, the person died naturally?
So, a whole heap of psychiatric disorders are being reported to the British drug regulator. They, as usual, log these reports and make them public to geeks like me.
What is worrying here is that Lariam is the standard drug used for British soldiers training or fighting wars in countries that has a presence of malaria.
So, just to spell it out for the limpless drug regulator.
A drug causing or apparently causing all of the above is given to men and women who, as part of their training and/or duty of combat, are given guns and live ammunition.
All of the above reports were spontaneous reports sent through the Yellow Card System, a system that the MHRA are proud of. How many, if any at all, have the MHRA investigated?
A question I put to them under the Freedom of Information Act.
Dear Sirs, According to the MHRA's DAP for the drug MEFLOQUINE there have been 19 reported fatalities associated. Whilst I understand that this does not mean the drug caused the fatalities I would, however like to draw your attention to the number of people that have died by suicide whilst taking MEFLOQUINE Your own figures suggest that, out of the 19 reported fatalities, 9 have been by completed suicide. This is significantly high for a drug used to treat malaria. Under the terms of the freedom of information act, I would like to know how many of these 9 reports the MHRA have investigated and what were the outcomes of these investigations. Furthermore, there have been 33 reports of suicide ideation, and 4 suicide attempts. The Psychiatric disorders reported for this particular drug are quite staggering. Again, Under the terms of the freedom of information act, I would like to know how many reports of Psychiatric disorders have been followed up by the MHRA. Sincerely, Bob Fiddaman
--
I am quite flabbergasted at these figures.
This, ladies and gentlemen, is the MHRA at work. They collect adverse reports (Yellow Cards) and file them. Aren't they supposed to protect the public from unsafe drugs?
How is a system that reports adverse reactions protecting the public? What are the MHRA doing regarding investigating the 9 suicides (possibly 10)?
It seems absurd that a drug given to healthy patients (soldiers) is still on the market when reports of it are possibly the cause of all of the above psychiatric disorders.
The MHRA have 20 working days to reply to my FOI request.
I will, of course, publish any reply they give to me. It's a matter of public interest.
Kat McCormick of the Utopia Research Institute has a great article up regarding Patrick McGorry's early intervention program and one of the choices of drugs McGorry may or may not use on children.
Risperdal seems to be a popular choice these days for children with apparent mental disorders, if McGorry & Co have their way, your child could be prescribed it...without actually having any disorder. That's the early intervention program for you folks. It can spot if your child may get a disorder in future years, a simple test drive in McGorry's DeLorean will let him and his team know if your child will fall foul in future years.
Risperdal has many side-effects, McCormick writes, in the main, about one of those - Man Boobs.
"We don't need no education,
We don't need no thought control." Pink Floyd - Another brick in the wall.
Former Australian of the year Patrick "DeLorean" McGorry has come back in time - to next week as it happens.
While he's speaking at the American Psychiatric Association annual conference blowing smoke about early psychosis, his British cohort British psychiatrist, Prof. Robin "Marty McFly" Murray, will be attending an "Infant Mental Health" Conference in Perth, W. Australia.
The infant mental health conference is part of the World Infant Mental Health Association whereby guest speakers talk about psychosis and things like cannabis increasing the risk of schizophrenia.
Murray and McGorry were co-authors of a psychosis study published last month. They claimed there are "brain structural abnormalities" in schizophrenics! They studied 102 people "at high risk of developing schizophrenia" (The DeLorean theory again) who were from the Personal Assessment and Crisis Evaluation Clinic [PACEC] in Melbourne, Australia. The clinic is operated from the Orygen Youth mental health centre... which just happens to be run by McGorry, in fact he is the Director of the centre.
Murray [Marty McFly] has received honorariums for speaking at meetings organised by most major producers of antipsychotic drugs, and his research group has received funding from Eli Lilly and Astra Zeneca.
So, what is the infant mental health conference all about? Well, according to the conference organizers, Sapmea, it's this:
The theme of the conference ‘Growing up solid: Integrating emotional and mental health throughout infancy, childhood and adolescence’ has never been more relevant. Mental health disorders cause the highest burden of disease in the 0-18 years age group, yet services to this group remain underfunded, fractured and piecemeal. The AAIMHI and RANZCP Faculty of Child Psychiatry are delighted to host a joint conference, reflecting our commitment to the integration of understanding and treatment of mental illness from infancy to adulthood.
This event is being promoted with artwork of the aboriginal type, it depicts a baby dreaming. Nice touch you guys.
The conference program sees an array of sessions that will take place, they range from eating disorders in infancy to Cannabis and Schizophrenia and management of psychosis. The AAIMHI & FCAP Conference – Preliminary Program can be downloaded HERE.
I've written about Paddy 'DeLorean' McGorry and his early intervention program numerous times on this blog, a program that he wants to go global. So, why is a British Professor [Sir Robin Murray] attending the event? Well he is a firm believer that cannabis can cause the onset of schizophrenia:
"It is one of ten prospective studies all pointing in this same direction. In short, it adds a further brick to the wall of evidence showing that use of traditional cannabis is a contributory cause of psychoses like schizophrenia."
So, why attend an event in Western Australia? Well, the event, it could be said, is going to target the indigenous population, known to enjoy a reefer or two. Hey, first let's rape their land, second we will tell them that what they have been doing for thousands of years can give them a mental disorder!
I am particularly stupefied with the following quote from Murray, taken from the BBC news on April 30 2007. Here he was speaking of cannabis use:
"Proving a long-term effect was extremely difficult, as it was not ethical or feasible to stimulate long-term psychosis in volunteers. If something has an active effect in inducing the symptoms of psychosis after one dose, then it would not be at all surprising if repeated use induced the chronic condition."
"HELLO, MCFLY... ANYBODY AT HOME?"
So, cannabis can cause psychosis but don't worry it can be treated with anti-psychotic medication - no problem with meds of that nature causing psychosis, right?
Don't get me wrong, I'm not a fan of cannabis, the UK has a huge problem, many teenagers can't seem to get enough of the bud and regular morning trips on public transport sees school kids puffing away whilst talking like a gangster from a hip hop music video...and that's just the white British kids!
You cannot treat one brain fuck up chemical with another brain fuck up chemical. Hey, let's treat alcoholism with...ummmm... alcohol, while we're at it.
PATIENT: "Doctor, I am drinking a bottle of Vodka a night"
DOCTOR: "Here, take this" [Doctor hands patient bottle of Whiskey]
Yes, there is a huge cannabis problem here in Blighty but there is an even bigger problem in binge drinking and sniffing of powder [of the white variety] We also have a problem much bigger than booze and cocaine, we have doctors prescribing brain altering chemicals to children, a regulator [MHRA] who bury their heads in the sand citing "We told doctor's it's not recommended for children." Oh, thank you MHRA, thank you so much for sending out letters. You really do care doncha!
As comedian Chris Rock once said, the government don't want you to take YOUR drugs, they want you to take THEIR drugs.
So, while editor in chief of The official journal of the International Early Psychosis Association (IEPA) [Patrick McGorry] is giving it some in the US at the American Psychiatric Association annual conference, Prof Robin Murray, who just happens to be on the editorial board of the "official journal of IEPA", will be 'giving it large' in Perth from May 12 to 14th 2011.
These people see a social problem and they pounce on it. Before you know it there will be drugs given to football hooligans or people who express their freedom by protesting.
McGorry was voted Australian of the year in 2010.
Murray was knighted in the 2011 New Year Honours for services to medicine.
You and me are from different tribes
Never learned to talk, so we learned to fight
Communication like water spilled
What we can't take in was lost or killed
We learned to live where we bore each child
Every step we took lost another mile
Came the day we were face to face
Didn't understand so our instincts raced
If we don't get together at all, we lose it
Get to the table and talk, we'll choose it
Forget what's been said before, confusing
Out of the heart of it all our future's born
If we don't look inside our souls, we could be gone
Forty thousand years underneath your belt
Now you have to pray where the white man knelt
You've been ridiculed because of what you felt
Tried to crucify you, but you fought like hell
The dreams that lead your every move
Full of stories you could never prove
If god is part of the written word
There are stories that your god ain't heard
If we don't get together at all, we lose it
Get to the table and talk, we'll choose it
Forget what's been said before, confusing
Out of the heart of it all our future's born
If we don't look inside our souls, we could be gone
J.Barnes/J.Neill/T.Brock
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING
