Lariam Pulled From Sale in Ireland

RTE News are reporting today that the anti-malarial drug, Lariam (Mefloquine), has been withdrawn from sale in Ireland.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and a number of pending legal actions in Ireland is, according to manufacturer Roche, not the reason why it has been withdrawn.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.

Do the maths!

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Just sayin'

Bob Fiddaman.

Comic Relief and GSK Form Five-Year Partnership

It's one of those headlines that one would think is parody. You read it right folks, "Comic Relief and GSK Form Five-Year Partnership."

Comic Relief is, in essence, a charity founded in 1985 to try and tackle the famine in Ethiopia. It takes up much of the BBC broadcasting slots under the guise of Red Nose Day, beginning in the afternoon on CBBC, a channel aimed at children, and usually runs throughout the night and early hours of the morning. It's a pastiche of comedy clips featuring world renowned comedians from all over the globe. Their mission - to "bring about positive and lasting change in the lives of poor and disadvantaged people, which we believe requires investing in work that addresses people's immediate needs as well as tackling the root causes of poverty and injustice."

Earlier this year I reported on another children's charity, namely, "Save The Children". I wrote a number of emails to them as I was concerned that a charity, whose main focus was children, had entered into a partnership with a company who had knowingly put children at risk by covering up the suicide link caused by one of their products, Paxil. The series of emails, including responses from Save The Children, can be read here. In short, they told me that they were well aware of Glaxo's history but decided to press ahead with the partnership because, "these risks are outweighed by the benefits of the partnership in helping us achieve our ambitions for children."

GSK are no strangers to Comic Relief. In 2002 they donated $200,000 (Australian) to Comic Relief and announced a fund-raising program in which its drug sales people would visit doctors dressed as clowns. At the time, many accused Glaxo's fund-raising program as having some similarities to its advertising for one of Australia's top-selling anti-depressant drugs. That drug is called Aropax, better known as Seroxat in the UK and Paxil in the US and Canada. (Back story)

Your normal every-day average Brit would take their hats off to Glaxo, particularly with the announcement that they are going to inject £17 million, alongside Comic Relief's £5 million into a fund that will help fight malaria and "improve health" in five malaria endemic countries in sub-Saharan Africa and Asia. (See official GSK press release)

It's obvious that GSK will no longer promote Seroxat via smokescreens but the irony is that since 2002 GSK have paid out compensation to victims of Seroxat, including over 3,000 people who became addicted to Seroxat, over 800 women whose children were born with serious heart defects because of Seroxat, and also being found guilty of Seroxat causing, in part, the death of Donald Schell and his family members.

On the surface GSK's £17 million donation and 5 year partnership with Comic Relief seems generous, however, it should, I believe, carry a cautionary disclaimer.

Here's the reason why - Alastair Benbow: The Devil is in the Details

Nothing more needs to be said.


Bob Fiddaman.

Lariam Suicides - MHRA Respond

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.

The MHRA can be contacted via email here.


Bob Fiddaman.

MHRA Blind to the Facts Over Lariam

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

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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.


DAP'S

Bob Fiddaman.