Cases, cipramil (celexa) stories,, lundbeck, Our story., psychiatry, Random, Shanes story.

The Pharmaceutical Industry’s Influence in Irish Politics and Medicine.

Enda and James

The pharmaceutical industry has a long and tangled involvement within Irish politics. Besides politics, our medical ‘experts’ have built up their training and expertise while simultaneously having a fundamental collegial relationship with the pharmaceutical industry. Pharma politics may not be news to Americans, Latvians or our British neighbours – but as Ireland is my Country of birth, I claim poetic licence in focusing on my specific geographical area. Corruption within this industry has been widely publicised elsewhere but there seems to be a reticence within the Irish media to report on pharma wrongdoing or the objectivity of the psychiatric expert. My son, a young Irishman, died under the influence of 17 days of Citalopram (an SSRI antidepressant) – manufactured by Lundbeck, prescribed by a doctor, licensed by the Irish Medicine’s Board (henceforth IMB) and protected by the Irish College of Psychiatry (henceforth the College).

Despite much evidence to the contrary, our health Minister James Reilly has been quoted in the media as saying that “SSRIs aren’t addictive and treat depression effectively”. He also denied that GPs are systematically over-prescribing SSRIs.[1] He subsequently managed to ignore two medical experts (David Healy and Declan Gilsenan) who gave testimony in Leinster House that antidepressants were the leading cause of death within the mental health field and were in fact causing hundreds of Irish deaths each year. According to the Irish Pharmaceutical Healthcare Association there are approximately 120 pharmaceutical companies that have plants in Ireland – including 9 of the 10 largest pharmaceutical companies in the world.[2]

Last year the Irish Times reported that the Irish Government ‘came under pressure’ from the larger pharmaceutical firms over the Health Service Executives’ (HSE) decision not to approve new drugs for payment. There was an implied threat that this could ‘have implications for 25,000 jobs and future investment’ – so not surprisingly Enda Kenny and James Reilly backed down. The Times further reported that both had meetings with Abbott Laboratories and Eli Lilly, and further that Enda Kenny attended Eli Lilly’s board dinner at the Old Kinsale golf club in 2011. It is submitted that this relationship is much too close for comfort and therefore not conducive to having the Nation’s best interests at heart. Backing down under pressure from a bullying industry is never a good move, particularly when as a Nation we naturally assume that our Government is in control.

According to Dr David Healy who is regarded as the world leading expert on prescription drugs, antidepressants double the risk of suicide and violence, particularly upon starting, discontinuing and dosage change (up or down). He further stated that “antidepressants now come with black box warnings of suicide and in some jurisdictions such as Canada they come with warnings of violence also. Exactly the same mechanisms that lead to suicides lead to violence. In one case you have violence directed inward and in the other directed outwards. These mechanisms are akathisia, emotional blunting and psychosis.”[3]

The name ‘antidepressant’ itself is pure marketing genius by the pharmaceutical industry. Who would believe that these so-called magic pills can cause death, sometimes self-inflicted and extremely violent? In protecting the medical model, referring to antidepressant-induced suicide, the College stated “Anecdotal cases of suicide sometimes mistakenly attribute these tragic events to the treatment rather than the illness itself”.[4] This is a vastly differing stance compared to the IMB, the European Medicine’s Agency (EMA) and the Food and Drug Administration (FDA). The American regulator FDA slapped a black-box warning on all antidepressants, informing consumers of the increased risk of suicide.[5] The EMA followed suit requiring labelling changes to all antidepressants, again informing consumers of the increased risk of drug-induced suicidality.[6] The IMB is pretty limited in its capacity of protector of Irish citizens, deferring largely to the EMA. Interestingly, the IMB is almost fully funded by the pharmaceutical industry, so the public protector is funded by the very industry that it is supposed to be protecting the Irish people from. It should be noted that peter gøtzsche of the Nordic Cochrane Centre in Copenhagen recently stated that the IMB banned GlaxoSmithKline from claiming that Paroxetine (Seroxat/Paxil) corrects a chemical imbalance.[7] That depression is caused by a ‘chemical imbalance’ is a pharma invention used as a tool to sell antidepressant drugs. That the IMB made an executive decision and actually suppressed GSK or any other pharmaceutical company is the exception rather than the rule.

We don’t have to look too far to see Governmental and pharma influence within the medical industry. The ‘Sherif Sultan Saga’ is a prime example of the bullying and intimidation of a medical professional. Mr Sultan is a consultant in Galway who received an official warning and a gag order from the HSE for speaking out on the dangers of taking statin drugs.[8] This followed the publication of his paper ‘The ugly side of Statins’.[9] Mr Sultan said what David Healy has been saying for a long time, that he and his colleagues “are fed up with trial of organizations to cover up truth about the ugly side of statin because of invested interest and commercial sponsorship.” He also stated that “We are observing the revealing of the ‘utmost medical tragedy’ of all times. It is extraordinary that the healthcare industry has inadvertently induced life-threatening nutrient deficiency in millions of otherwise healthy people.”

Similar to the attempt at suppressing Sherif Sultan, the psychiatric Professors Patricia Casey, University College Dublin, and Ted Dinan, University College Cork, involved themselves not only in my son’s inquest but also with others where antidepressants were implicated. Both had long links to the same pharmaceutical companies who manufactured the implicated drug and both without exception defended the drugs, instead blaming the supposed underlying ‘illnesses’.[10] Both these professors are supposed experts in the psychiatric field and both fiercely defend antidepressants.[11] It is submitted that the objectivity of the expert opinion is paramount, particularly where the law is concerned. As the coronial system is the only Court of law where a deceased’s family can get answers, in cases of drug-induced death, bias or even a perception of bias should automatically render these ‘experts’ excluded from the legal process.

The health of the Irish nation will never be of utmost importance while our medical professionals, the IMB and the Irish Government have a vested interest in upholding the existing ‘pharma funded’ regime. While it seems my son was just a number in the collateral damage of the latter – I urge you to protect your family, start asking questions and stop trusting these dubious so-called professionals.


[7] Peter Gøtzsche ‘Deadly Medicines and Organised Crime’ P. 199

Newspaper and internet articles, Random

Vanessa’s Law – ‘Protecting Canadians from Unsafe Drugs’ (Bill C-17)

Terence young

Terence Young is a Canadian MP whose 15 year old daughter, Vanessa, died from a heart attack due to the heartburn medication Cisapride, marketed as Propulsid.

A month after Vanessa’s death the FDA released a statement stating that Propulsid was being pulled off the market due to the associated risk of serious cardiac arrhythmias and death; here. An Article by ‘Thomas L. Perry’ stated that Vanessa’s father was dumbfounded to read this Los Angeles Times exposé showing that the FDA and the manufacturer had known since 1993, 7 years before Vanessa’s death, that Prepulsid caused cardiac arrhythmias.

Yesterday (6th Dec 2013), the Canadian Minister for Health Rona Ambrose announced that the Canadian government is introducing new patient safety legislation, Vanessa’s Law, providing for the protection of its citizens from unsafe drugs.Vanessa Young Minister Ambrose stated “Today, we have introduced Vanessa’s Law, a law that would protect Canadians and help ensure that no drug that is unsafe is left on store shelves.” The proposed new legislation, if enacted, will enable the Canadian Government to sanction the pharmaceutical industry for selling unsafe products, proposing fines of up to $5 million per day and even imprisonment. It further provides that the Government can compel drug companies to do further testing, to revise their labels and recall dangerous drugs.

Terence Young stated “It is difficult to overstate the impact this bill will have for Canadians who take prescription and over the counter drugs. It represents a quantum leap forward in protecting vulnerable patients and reducing serious adverse drug reactions. It is absolutely necessary to reduce deaths and injuries caused by adverse drug reactions, seventy percent of which are preventable, and will serve Canadians extremely well.”

It remains to be seen whether this bill will be enacted. If so, the Canadian Government will be the first to put their citizens before the very powerful multi-billion dollar pharmaceutical industry. Either way, I foresee strong resistance to this bill, but maybe, just maybe, this is the first major bruise on Pharma’s Achilles’ heel.

In contrast to the latter, the UK Government recently debated the suicide link associated with Roche’s ‘Roaccutane’. Again, two parents had waited 10 years to get this debate to Westminster, this time on the Roaccutane-induced ‘suicide’ of their son following a few short weeks on Roche’s notorious acne drug. Roche pulled this drug off the US market in 2009, but it’s still available in the UK and Ireland. It has been stated that Roaccutane may have caused up to 20,000 deaths. The Westminster talk can be viewed here: approx 16.27 Mins. Caroline Nokes MP looked, to all intents and purposes, like she was sucking a Roaccutane-soaked lemon. I can only hope that the promise to keep talking to these parents was well-intentioned and not just Minister’s puff.

So, the Canadian and UK Government are at least discussing prescription drug induced deaths. The Irish Government are not!

Newspaper and internet articles, Random

The Sherif Sultan Saga

Mr ForgetfulThere’s been an interesting development today in the ‘Sherif Sultan’ Saga.

Remember, Mr Sultan is the consultant in Galway who received an official warning from the HSE for speaking out on the dangers of taking statin drugs? This followed the publication of his paper here-The ugly side of Statins. He said what David Healy has been saying for a long time, that he and his colleagues “are fed up with trial of organizations to cover up truth about the ugly side of statin because of invested interest and commercial sponsorship.”

The picture you may think is a random one, but no, it’s a reminder (no pun intended) that the FDA have recently added ‘memory loss’ to the ever growing list of serious statin adverse effects.

So Mr Sultan was slapped with a gagging order (aka ‘STFU’ order) by the HSE. Did he accept this lying down? No he didn’t! Was he willing to keep taking the paycheck and stop warning his patients that statins are dangerous and usually unnecessary? Nope! What he did say was “Odds are greater than 100 to 1 that if you’re taking a statin, you don’t really need it” and further “We are observing the revealing of the ‘utmost medical tragedy’ of all times. It is extraordinary that the healthcare industry has inadvertently induced life-threatening nutrient deficiency in millions of otherwise healthy people.” 

Thankfully the Irish Hospital Consultants Association (IHCA) have stepped in. Replying to the 2 senior executives, the IHCA have asked for the gagging order to be revoked. According to the Irish Independent, the reply states that there is “no provision in a hospital consultant’s contract to check with their employer the content of any comment they want to make to the public” and further that consultants have an “ethical, legal and moral obligation to advocate on behalf of their patients”.

Are we seeing the start of a revolt, an ethical army led by Mr Sultan? I sure hope so. The pharmaceutical influence in the ‘illness’ profession has reigned and dictated for long enough. It’s about time that someone stood up to Goliath. Will it be David again, or Sherif, or hopefully both? Who could have foreseen that the revolution would start in Ireland?

So the next time your doctor insists that you need that box of Pfizer pills or Lilly drug, ask him/her what he thinks of that surgeon in Galway who said “in Healthy patients with no cardiovascular history, statins have no proven benefit – in medical terms no scientific evidence for the use of statin in primary prevention.”

Our story., Random

Westminster Exposé

WestminsterSo myself and the poor long-suffering husband are just back from London, having attended a talk in the House of Commons given by Professor David Healy; ‘Antidepressants and The Politics of Health‘.

The meeting was chaired by MP Jim Dobbins who has previously aired concerns about the pharmaceutical industry and its close involvement within academia, such as the case with Professor David Nuttcase Nutt here. I don’t really have an issue with Professsor Nutt, other than with his false declaration to the Nation (on BBC radio) that ‘it’s impossible to kill yourself with an overdose of SSRI antidepressants‘. Dr Ciara Kelly said the same thing here on Irish radio. Very dangerous propaganda!

I challenged Prof Nutt on his statement (via Twitter) where he changed his story slightly and said ‘ALMOST impossibly’. Tell that to all the people who have died by an SSRI overdose of these ‘safe’ drugs Prof Nutt! Brian at ‘AntiDepAware‘ has a list of some SSRI victims here; Karen Gloster (2005), Barbara BerryDeborah Owens (2006), Rhian Evans (2007), Rodney Harrop (2008), Philip Bromley (2009), Belinda KellyMichael MillerNatalie CashinSusan Mealing (2010), Patrick Carroll (2011), Malcolm AverissRobert Lennon (2012) Donna ChaseMark Cain (2003), Christine ByrneDianne Pickersgill (2008) Dale Pashley (2007), Brian Elder (2010), Afsheen Khan (2011)

Anyway, I’m rambling off the point again this morning. Suffice to say,  as is usual, our trip did not always go as planned. We decided, as we were going to London for this talk, to bring the kids with us and maybe go to Legoland the following day. We had plenty of time as the flight was an early one and the talk wasn’t on until 2pm in Westminster. The Ryanair plane sounded decidedly dodgy, as if it was running on dirty fuel (haha, Tony will tell you I have a good mechanical ear) and unsurprisingly the pilot decided that we would have to change planes. This left us two hours behind schedule so the pressure was on, the kids were happily oblivious but the odds at arriving on time were stacked against us. In stepped my brother-in-law in his superman underpants in order to save the day and meet us in London Bridge. He took the kids to my sisters in Kent (where we were staying with 3 cousins, all girls and under the age of 3). This left us plenty of time to head to Westminster for the talk. Back on track.

There was nothing I could do about the frizzy hair at that stage but I thought I’d better change out of the tracksuit bottoms. I decided I would have to change into my ‘Westminster’ clothes in the toilet on the train. Yep, that sounds like a good idea you think? Thanks, I thought so too. The toilet doors were of the circular kind which we have here in Ireland too. There was a nice man sitting outside the toilet when I went in, who smiled at me and said hello; the English are so polite aren’t they? So I took the boots and tracksuit bottoms off and was standing in my underwear (thank God for small mercies) when the train jolted and I leaned backwards, for balance you understand. I leaned on the open-door button, which promptly left me standing in my knickers exposing myself to the poor man sitting outside. Frantic pressing on the buttons failed to close the doors for a lifetime of seconds, until the doors finally closed on the man’s shocked expression. I debated whether I could stay in the toilets until the man either got off or died from old age, whichever came first, but eventually braved the situation and departed from the toilet where I grinned at him in a stupid fashion. He couldn’t look me in the face and glanced quickly out the window. Oh well, nobody was arrested and Tony’s well used to my little accidents/incidences.

So having laughed our heads off all the way to Westminster, we finally made it with a half an hour to spare. After the talk was over, we retired to another room where a question and answer session took place. Jim Dobbins actually voiced what we all knew all along, that the pharmaceutical industry has the Government over a barrel and if the Govt were to sanction ‘industry’, they would threaten to take their business elsewhere, hence GSK et al having control in the UK. This is no doubt the case in Ireland where industries influence is palpable everywhere. If pharma can have such a huge influence over the UK Government, what chance do we have over here in our small country with a population of 4.5 million citizens and with a proven history of unscrupulously corrupt Ministers? You would have to wonder why Kathleen Lynch and James Reilly have done nothing about SSRI-induced deaths.

LegolandDavid Healy’s talk was brilliant as always. We also had the pleasure of meeting the lovely Brian of AntiDepAware and his equally gorgeous wife. We met with Bobby Fidd which is always a pleasure but who missed the chat afterwards having commandeered my poor husband to go outside for a smoke, and who subsequently both got lost.

The 3 gorgeous girlies under the age of 3 were hilarious, funny and little dotes. I don’t know how any household survives them, but I actually miss them already!

PS. The LegoLand experience was amazing and went without any major incident thankfully. All children accounted for, happy and alive, which is more than I can say for my eldest son’s involvement with Lundbeck pharmaceuticals and some uninformed Irish doctors.

Bob Fiddaman’s account of the meeting can be read here, while Brian’s can be read here.

Newspaper and internet articles, Random

Dr Sherif (Hippocrates) Sultan.

Hipp

Remember Hippocrates?

Primum non nocere  – “first, do no harm.”

An article in today’s Irish Independent entitled ‘HSE Gags Surgeon After Cholesterol Drug Claims’ has truly shocked me to the core. The article tells the sorry tale of a leading surgeon who is gagged for giving his informed opinion. The HSE is Irelands’ Health Service Executive. Its Code of Governance states:

“The Health Service Executive (HSE) was established under the Health Act 2004 as the single body with statutory responsibility for the management and delivery of health and personal social services in the Republic of Ireland. As outlined in the Health Act, 2004 the objective of the Executive is to use the resources available to it in the most beneficial, effective and efficient manner to improve, promote and protect the health and welfare of the public.”

Dr Sherif Sultan, a leading vascular surgeon at University College Hospital Galway, researched a number of statin studies and concluded that they may do more harm than good in healthy people. He found there was a lack of evidence to show they should be given to healthy people and therefore avoiding the risk of statins’ side effects. Commenting in the Independent, Dr Sultan said: “I have received an official warning from the HSE and have been instructed not to liaise directly with the press in my capacity as a HSE consultant.” Today is a bad day for human rights in Ireland. Surely the HSE is violating this man’s Constitutional right to ‘freedom of expression’, not to mention Irish Citizens right to ‘Bodily Integrity’?

Statins adverse effects can include increased risk of Diabetes, Impotence, Acute Renal Failure, Myalgia and Severe Memory Loss. Last year the FDA (US Medicines Regulator) added diabetes and memory loss warnings to all statins. So Dr Sultan is right to be concerned. It begs the question; is our Government running the HSE or is Big Pharma pulling the strings once again? He further stated that analysis by the ‘British Medical Journal’ showed the superiority of exercise over drug therapy. Imagine saying exercise was superior to a possibly dangerous drug? Put him in the stocks; seriously gag the man, he’s lost the plot!

Statins are the most prescribed medications drugs globally, meaning Dr Sultan is going up against a multi billion dollar industry. A quick search through David Healy’s RxISK website reveals, among other things: 6264 cases of Myalgia, 1879 deaths, 783 cases of Acute Renal failure, 908 cases of Depression and 653 cases of Memory impairment, all reported as an adverse effect of taking Pfizers’ Lipitor. It is common knowledge that the numbers of adverse effects is seriously under-reported and the above numbers are for just one of the Statin drugs.

Cardiologist Pat Nash of the ‘National University of Galway’ contradicted Dr Sultans position and was quick to ‘reassure patients that statins are safe’. 1879 deaths is not what I’d call safe Dr Nash. I’m sure his argument has nothing to do with the support that NUIG receives from Pfizer, Lilly, GlaxoSmithKline and MSD pharmaceuticals, or its research links with Lundbeck!

I wonder what our grandparents would have thought about doctors medicating healthy people, and that we were buying into it? I know what mine would have said. ‘Cyclafeetis!’ I think it is we who have lost the plot! Good on ye Dr Sultan.

Philippe Pinel 1745-1826 (Plagurised from RxISk.org): “there is an art in medicine in knowing when to treat but an even greater art in knowing when not to treat.”

Independent Article.

HSE Code Of Governance.

Statin Induced Amnesia; RxISK.org

Reported Adverse Effects.

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

Pharma advertising In Ireland

.

It takes a lot to shock me nowadays, but I admit to being shocked by an article in todays Irish Independent. It reported here that cheese advertisements will have to carry a health warning in order to limit intake under new restrictions on advertising to children. Cheese will carry a health warning as part of a bid to tackle childhood obesity; yet antidepressants are handed out like bloody smarties and your friendly GP will not give you a health warning on the doubling of suicide and violence risk? That makes no sense.

Under EU legislation, Ireland does not permit ‘direct to consumer’ (DTC) advertising for prescription products. This is unlike in the US and New Zealand where DTC advertising is permitted. In the case of a TV advertisement in the US, it must include a “major statement” for prescription drugs. A major statement must include a ‘spoken’ presentation of the drug’s most important risks. According to the Food and Drug Administration (FDA), this must be done in a way that is clear, conspicuous, and neutral.  In addition, they must include either every risk or provide enough sources (adequate provision) for the audience to obtain the drugs prescribing information.

EU advertising restrictions must mean that Irish broadcasting must be safer for the consumer, right? Actually, it doesn’t seem so. Last week I watched an Advert on TV3 regarding ‘Centrine Allergy’ which is an ‘over the counter’ antihistamine made by Rowex pharmaceuticals in County Cork. Considering there was no listed side-effects, this advert seemed to imply that Centrine Allergy is pretty harmless, so I looked up the patient  information leaflet (PIL). The possible adverse effects of taking this antihistamine include depression, hallucination, aggression, extreme fatigue, agitation, rapid heart beat, swelling, changes in liver function,weight increase, convulsions, confusion, difficulty in sleeping, difficulty focusing, blurred vision, unusual eye movements, fainting, tremor, tics, pain and/or difficulty passing water and memory loss.

It could be argued that this medication should not have OTC status considering the dangerous side-effects which can occur with consumption. Surely the advert should, at the very least, include the serious side effects above? What about the safety of the unborn baby? Surely pregnant women should be advised, that as Rowex admit to ‘limited experience’ within pregnancy, their advise is to ‘use with caution’, and further, that Centrine allergy should not be used during breast-feeding.

I sent off a complaint to TV3 and got a swift response the following day. The response included “The advertisement to which you refer is entirely in accordance with all relevant regulation. There is no requirement under regulation to include all the possible side-effects of a medicinal product in an advertisement” and “the advertisement clearly states through text at the bottom of the screen, that you should always read the label and to ask your pharmacist for further information. There was no attempt to mislead the public about the possible side effects of this medicine.” If this is the case, and there is no requirement to include all (or any) side effects with DTC pharma advertising, the regulations need further regulating! I sent my complaint and the TV3 reply on to the Broadcasting Authority of Ireland (BAI), so we’ll have to wait and see what happens next.

Centrine Allergy PIL here.

While I was trying to find the advertisement to record, I came across this one above, advocating for the ‘early diagnosis and treatment’ of Arthritis. It recommended sending off for a free information pack to ‘Arthritis Ireland’. Note the Pfizer logo on the bottom right. It seems their latest campaign to ‘raise awareness’ is in partnership with Pfizer, who just happen to be seeking EMA approval for their new Arthritis medication; now there’s a surprise! In Nov 2012 the FDA approved Pfizer’s Xeljanz (Tofacitinib) for patients with Arthritis. The EMA though rejected Pfizer’s initial application, concluding that the serious side-effects such as liver damage, certain cancers and gastro-intestinal perforations, meant that the ‘benefits did not outweigh the risks’. Pfizer was not to be deterred. Dr Yvonne Greenstreet, Pfizer’s senior vice-president of medicines development, stated “The re-examination process will enable us to seek to address the CHMP’s questions, and we will continue to work closely with the EMA with the goal of making this medication available to the appropriate patients in Europe.” Hmm; I get the feeling that ‘Arthritis Ireland’ is being used as a pawn by Pfizer in the EMA approval process. Only time will tell!

cipramil (celexa) stories,, lundbeck, Our story., psychiatry

LKMC Syndrome.

Lundbeck Killed My Child DisorderSo what’s happening this week in the depressing world of suicide and ‘mind altering drugs’?

The following was meant to be tongue in cheek but actually the subject is too serious and I miss my son too much to make light of this issue.

Did you hear there’s a new syndrome that’s just been confirmed? Yep, LKMS disorder aka ‘Lundbeck Killed My Son’ Disorder. I suppose if I was being fair, it should be called ‘LKMC’ aka ‘Lundbeck killed my Child’ Disorder. There are many of us affected by this virus, although thankfully it isn’t contagious.

It should be noted that LKMC disorder is a global problem, not just restricted to Ireland or the UK. In fact America, New Zealand and China are reporting an ever-increasing rate of suicide. I have previously shown that the unsuspecting Chinese are killing themselves at an alarming rate, most likely due to the relatively new ‘depression’ advertisements, pushed by dubious pharmaceutical companies including Lundbeck, here.

The latest news regarding the DSM-5 is that grief for more than 2 weeks, even after the death of a loved one, can be seen as a symptom of Major Depressive Disorder, here. Considering that Shane is dead almost four years and I can still blubber like a lunatic at the worst possible moments; that surely means I’m decidedly unwell. I wonder if a pill could cure the death of my son? Can they miraculously make him re-appear? Even your toddler’s ‘temper tantrums’ may be diagnosed as an illness under the new and ‘unimproved’ DSM-5 and therefore medicated accordingly.

This week researchers from Duke University reported that antidepressants, including Lundbeck’s Lexapro appears to help prevent a potentially serious stress-related heart condition. You can find the study in ‘The Journal of the American College of Cardiology’ here. I’d list the conflicts of interests but there isn’t enough room on the page. You can access them yourself by clicking the ‘Author Information’. Now you will have to pardon my stupidity here, but surely these researchers know that Lexapro causes heart-attacks and sudden death? The FDA sent out a warning letter to all practitioners advising of the risk of heart problem with Citalopram in August 2011. This was revised in March 2012 to include Escitalopram, which is no surprise as they’re basically the same drug (as found in a Brussel’s Court here).

Lundbeck whose patents (and patience) are running out, have been frantically scrambling around for their next block-buster drug. Vortioxetine aka Brintellix is their latest offering.  Data concerning Vortioxetine efficacy was presented at the 2013 American Psychiatric Association Annual Meeting (APA). 4 trial results were shown, 3 for and 1 against. It’s the 1 against that I would be interested in. Was there any deaths? There was certainly a death in one of the Citalopram trials. Are they going to publish all the Vortioxetine trials as GSK are supposed to be doing? Actually no, ignore that, GSK backtracked on that particular promise!

We will have to wait and see whether Vortioxetine will get a ‘licence to kill’ by the FDA and the EMA, and if so, whether it will add to the growing cases of LKMC disorder.

Newspaper and internet articles, psychiatry, Random

Two more young people dead; victims of a broken system?

Kieran and AlexandraSadly today’s newspapers report that a body recovered from the River Foyle has been identified as missing Dublin teenager Kieran McKeon. He was 18 years old.

Last March (13th) Kieran travelled to Derry with his friend Alexandra O’Brien (21) and checked into a nearby hotel. The following day some of Alexandra’s belongings were found on a bridge over the River Foyle. Following the recovery of her body, the PSNI also feared for Kieran’s safety. It was largely believed that they had both entered the water together from the Foyle Bridge. Tragically Kieran’s body was recovered on Thursday and identified today.

The Irish Times reported in March: “Alexandra and Kieran were both day patients at St John of God’s, which specialises in treating people with mental health problems. In their original missing-person description of Ms O’Brien, the PSNI described her as “vulnerable.”

Now, considering they were both patients of St John of God hospital, there is no doubt that they were medicated. The Irish ‘medical model’ did not save these two young people and in my humble opinion, probably caused or at least contributed to their deaths. Yes young people can be vulnerable. Yes people die by suicide without being medicated BUT young people are far more susceptible to the adverse-effects of psychiatric drugs. Were these young people or their families warned of the doubling of the suicide risk? Were they told that these drugs were not recommended for young people, or that the EU warning on these drugs was upped to under 25s because of the suicide risk? I have first hand experience of Irish Psychiatrists denying that these drugs can cause suicide. They are wrong! The US has a black-box warning on these drugs because of the serious repercussions, particularly in young people.

FDA confirms risks of antidepressants.

Baum Hedlund, A cure worse than the disease.

Here is a 1991 you-tube video on the dangers of SSRIs; listen to these people’s stories if you dare/care. Despite this FDA hearing, it was another 13 years (2004) before they finally put a black-box warning in place for Under 18s. It took another 3 years (2007) before the US upped the warning to Under 24s; the EU followed suit upping the suicide warning to U25s. Yet the EU and the Irish Medicines Board declined to put a black-box warning on the same drugs for fear that it would “stop people from taking drugs that were perfectly suited to them”. Never mind the poor people who lost their lives by taking them!

Sadly this still hasn’t stopped uninformed doctors from medicating young people. It still hasn’t stopped suicide awareness groups from accepting funding from the makers of drugs which cause suicide; you know who you are. Is it any wonder when there are psychiatrists, like Dr Moosajee Bhamjee on Newstalk radio, who said that the suicide warnings were only put in place because of ‘the media and other issues’. Then again, the person who could have acted on this is Minister Kathleen Lynch. Remember Professor Healy and Declan Gilsenan’s meeting with her? David Healy told her that these drugs are the leading cause of death within the mental health field. Dr Gilsenan told her he had serious concerns that these drugs were causing people to kill themselves. Has she done anything? Yet again, NO! Shame on her.

.

Newspaper and internet articles, psychiatry

Sundance Diagnostics, a genetic test pre-suicide

Sundance Diagnostics<- Click on the picture to go to the Sundance website.

.

Did you know that there could soon be a test which will enable doctors to establish whether a person will react badly to antidepressants? An American company, Sundance Diagnostics, is in the early stages of developing a Genetic test for Prescription Drug Side Effects. This test, if successful, will establish whether a person is at risk of Suicide and Violence before (not after) being prescribed an antidepressant.

This from their website:

“Sundance Diagnostics is working to develop the world’s first genetic safety tests to predict a patient’s risk of antidepressant-induced suicidal thinking or behavior. There is a strong need to make pharmaceutical drugs safer for patients—especially when those drugs have serious side effects and are being sold to millions of people. Sundance is using the most advanced genetic technologies to develop its safety tests to predict a patient’s risk. The goal is to save lives, improve treatment, increase patient confidence in treatment, and reduce the cost of treatment.”

CEO Kim Bechthold, referring to the fact that over 90% of school shooters were on psychiatric drugs, stated “The importance of genetic tests to curb the risk of suicide and risk of acts of violence has been heightened as governments and communities search for effective ways to halt tragic mass shootings.”

Maria has written a great article on the MIA website about this. Unbelievably, she mentioned that she was offered a blood test to assess any risk for her cat pre-operation but not a test for her 17 year-old son Toran who died by a Fluoxetine/Prozac induced suicide. I could argue forever that a ‘drug-induced suicide’ is not suicide but that’s for another day. In her article Maria debated whether this test would in fact give the impression that antidepressants actually work for some people and she didn’t want to give people false hope. She answers that one perfectly, as usual. My thoughts on that one slightly differ with others. If you or anyone else is on an antidepressant and feel that the drug is helping, whether it’s the placebo/smartie effect or not, why fix what’s not broken? It’s when the drugs don’t work and cause awful adverse-effects such as suicide and homicide, that I do have a big problem. Informed consent, which you don’t get in Ireland, is my problem. If a person is pre-warned of the possible adverse-effects as recommended by the Irish Human Rights Commission, at least that person will have some chance of survival. In Ireland, people do not get that chance. Considering that this test is being developed in America at huge expense and, if successful, will be used worldwide, what will Ireland’s excuse be? That there is no point ordering a test which will solve a problem that doesn’t exist?

What surprised me most was the comments under Maria’s article, where some people opined that this test might actually make things worse. I hadn’t actually thought about that, and while there are some valid and understandably differing opinions, if this test is successful, in my opinion the pros will definitely outweigh the cons. Or in psychiatric language, in this case (unlike with antidepressants), the benefits will definitely outweigh the risks!

Maria’s Article.

Sundance Press Release 3-11-13 A (3)

I, being a natural cynic, had a few questions which I needed to be clarified. I put them to Kim and her scientific advisor, Peter Tolias, Ph.D,…

.

I’ve been enquiring about suicide tests and read a lot about the STAR*D trial. What happened to the hints of a Pharmacogenetic marker from the STAR*D study that you initially referred to?

Dear Leonie,

This is Peter: The STAR*D study itself was the largest and most comprehensive study ever performed that studied drug-induced suicide risk, however, the technology that was available to be used at the time to examine markers only allowed them to study a small fraction of the human genome.  In spite of this, several new markers were identified that could ultimately be useful as a component of a broader genetic test.  These STAR*D markers, plus additional markers we hope to be discovered by Sundance, need to be confirmed in an independent study before a test is ready for the clinic.  Sundance intends to initiate a clinical trial for confirmation just as soon as the sequencing study is completed.

Your press release mentioned Whole Genome Screening (WGS) being an advance on Genome Wide Association Screening (GWAS). Will WGS really tell more than GWAS would?

This is Peter; Absolutely, because whole genome sequencing means identifying the complete sequence of a patient’s genome rather than a fraction of a percent identified by GWAS.  (10 million compared to 3 billion base pairs in the haploid genome (or 6 billion nucleotides), roughly 300 times the information)

How soon do you intend to have this genetic testing ready for distribution, months, years, decades?

Leonie, this is Kim again.  The sequencing portion of our work and the confirmatory study can take from 12 months to 18 months.  Sometimes a study actually has to be redone, resulting in more time.   If the sequencing is successful,  and if all else goes well, we could have a laboratory-developed test for physicians in 18 months in the U.S.  If we seek FDA approval, it will require at least another year.  FDA approval is not required in the United States however. For approval in Ireland, we will submit our initial confirmatory study results.  If the authorities require the type of studies that are required for FDA approval, it will take additional time.