Our story., Random

The non-pursuit of happiness.

Happy womanThe non-pursuit of happiness. “Happiness often sneaks in through a door you didn’t know you left open” John Barrymore.

There you have it, just when I least expect it, it creeps in (uninvited I might add) and smacks me round my gobsmacked gob!

Today was the usual run of the mill day; there I was, for once minding my own business, standing in the kitchen after collecting the kids from school, when it happened. Lucy was rabbiting on about planting her acorn tree in the garden, Henry was doing his usual worrying about his maths homework, when there it was; I realised I was happy, or maybe content is a better description. You could have knocked me down with a feather. Four years and one month since my lovely son died and I was just resigning myself to looking at my miserable face staring back at me from the bathroom mirror, when today my heart felt ‘not quite’ so heavy. Do you know how mind-numbingly boring it is being miserable?

I knew it was coming of course; I tried hard to ignore it, I’m not bloody ready, but lately the sadness was lifting whether I liked it or not. This, of course doesn’t mean that I won’t cry in Tescos or embarrass myself at the motor tax counter ever again, but the endless need to fight Lundbeck, the corrupt medical system and even more corrupt Irish psychiatry was being overridden by walks on the beach, feeding the ducks or teaching the kids how to ride a bike (a seemingly impossible task). It doesn’t make me less sad about the way my son died or the fact that he caused the death of an innocent young man, some things can never be unseen or unheard unfortunately, but I’ve resigned myself to it and understand the circumstances.

I certainly won’t be letting Lundbeck off anytime soon (actually not ever) as my son deserved so much better. I wonder sometimes if Ulf Wiinberg (CEO of1111 Lundbeck) sleeps well at night? Probably, but you can bet your bottom dollar that Shane’s face and all the other victim’s faces must make the odd appearance in the pharmaceutical cesspit that lurks in the furthest recesses of his mind. That reminds me, a new book by Peter Gøtzsche ‘Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare‘ has recently been published. Chapter two is freely available here and deals with SSRI induced suicide. If you can’t face reading the whole chapter, then pages 224-229 deal with Lundbeck corruption which you might find interesting.

Lundbeck’s latest symposium is happening soon in Monaco (November). I see that Professor Tim Dinan from UCC Cork is making an appearance, although the European Medicines Agency assured me that Professor Dinan will not receive any honorarium for his trip to Monaco or any of the other Lundbeck sponsored symposia that I brought to their attention; so no worries on the ‘independence’ of their scientific advisors there. Phew, that’s such a relief!

Anyway, getting back to my original point, somehow I feel that this shift in mood would make Shane the happiest of all. Now I think the ducks are waiting for me.

Newspaper and internet articles, Random

Pharma advertising In Ireland

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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, Newspaper and internet articles

Lundbeck’s Vortioxetine (Lu AA21004) Will the FDA and the EMA approve another ‘killer’ drug?

So Lundbeck are seeking approval for their latest offering Vortioxetine. This is the drug which Lundbeck director ‘Torsten Madsen’ is referring to in this video. He says ”Some of the studies that we conducted did not have the outcome that we had hoped for, so we speculate that, emm, the reason is due to a too low dosing of 21004″ (Or maybe it’s because it’s another of Lundbeck’s useless offerings!)

Lundbeck’s supposed ‘antidepressant’ patent is due to run out very soon, so they’re scrambling around for a new ‘billion dollar’ pill. Will you be the next guiney pig? Citalopram and Escitalopram (same product) have caused untold suffering and numerous deaths including suicide and homicides, so will the new offering be any different? How many people will die from this drug if it does happen to be approved by the regulators?

The Clinical Trials website include 5 ‘Vortioxetine’ clinical trials conducted in India, here. Lundbeck has already been found guilty of fraud and corruption in India. Nowone would have to consider, if Lundbeck are continuously using corrupt practices in India, as with the licencing of Deanxit here, how can their findings with LU AA21004 be relied upon? Who did they have to pay to get the right results this time?

Will the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) allow another killer drug to slip through the net?

Deanxit Fraud 

Lundbeck ethics

Brussles Court find Citalopram and Escitalopram to be the same product.

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

Lundbeck’s hall of shame.

Since Shane died in 2009 we have tried, and will continue to try, to warn the public that antidepressants can cause suicide and/or homicide. We have Professor Healy’s expert report which states that, in his opinion, Cipramil caused the events of 2009 (It’s attached to the side-bar on the right if anyone needs any information). During the last 2 years and 5 months, we have had to contend with denials and rebuttals from Lundbeck (surprise, surprise) and Ireland’s Psychiatric body, the College of Psychiatry of Ireland; Statements such as this one from Prof. T. Dinan…

Prof Timothy Dinan UCC said that he could say with“100 per cent certainty and without any fear of contradiction” that modern anti-depressants such as the drug Citalopram (sold as Cipramil) which Mr Clancy took do not cause people to commit murder. He added that there was no evidence either that the drugs cause patients to take their own lives.

Along with Prof. Patricia Casey who also rebutted our claims and denied the side-effects, Prof. Dinan has a long history of collaboration with lundbeck. He has lectured at meetings and served on advisory boards organised by companies promoting antipsychotic medications, including Eli Lilly, Janssen-Cilag, Pfizer and AstraZeneca, and contributed to the Lundbeck Mental health barometer report. He has lectured at meetings sponsored by or acted as an advisor to all companies who market a branded SSRI. He is a clinical trials subcommitee member with the Irish Medicines Board and is also a listed expert with the European Medicines Agency (EMA). His declared Conflict of interests do not mention much of the above though! Link.

Both of these Psychiatrists have attended Inquests where antidepressants have been an issue in the persons death. Is this a conflict of interest?

Link to more denials from Psychiatry Ireland.

Here is a small collection from SSri stories which involves suicide and/or Homicide while on Lundbeck’s drugs. Information relating to the individual stories and other antidepressants can also be found on this website. Ssri stories.

Lundbeck’s hall of shame.

Celexa School Shooting 2006 North Carolina, Teen Shoots at Two Students: Kills his Father: Celexa Found Among his Personal Effects

Celexa Murder 2009 Texas Postpartum: Mother, Previously Diagnosed as Schizophrenic, Mutilates Infant after One Day on Celexa

Celexa Murder-Suicide 2010  West Virginia Elderly Man Kills Wife & Himself

Celexa Suicide 2010 England Man of Strong Character Hangs Himself

Celexa Suicide 2010 England Former Mayor Hangs Self: Had Set Up Camera To Photograph Girls: No Alcohol

Celexa Suicide 2010 England 27 Year Old Commits Suicide

Celexa Suicide 2010 New Zealand 26 Year Old Kills Self: Celexa Increased his Anxiety

Celexa Violence/Death 2010 Iraq/Canada Soldier, 22 Years Old, Becomes Violent With Police: They Shoot Him Dead

Celexa Murder 2011 Florida 17 Year Old Kills His Parents

Celexa Suicide 2011 England Woman, 73, Kills Herself While on Celexa

Celexa Murder Attempt 2011 Massachusetts *Coed at Wellesley Found Not Guilty Due to Celexa Antidepressant Use: Stabbed Boyfriend 8 times

Celexa Murder-Suicide 2010-04-22 Ireland *Jury Finds Celexa Cause of Murder-Suicide: Two Physicians Testify: Foundation Demands Action

Celexa Murder & Arson 1999 Texas Mother Kills her Two Children

Celexa Suicide 2009 Illinois Man Kills Himself After 13 Days of an Abrupt Withdrawal

Celexa Murder Withdrawal 2009 Texas Postpartum: Mother Murders Baby

Celexa Suicide 2008 England Woman Mistakenly Believes She Has Cancer – A Side Effect of SSRIs-: Kills Herself

Celexa Suicide 2005 Canada 16 Year Old Girl: Coroner’s Inquest

Celexa Murder-Suicide 2006 Australia Man Kills Wife, Two Children and Self

Celexa Suicide 2008 England Coroner Blames Celexa For Man’s Suicide

Celexa Murder 2010 Oklahoma Man Kills Best Friend: Given Death Sentence Waives Appeals: Expert Testifies On Celexa

Celexa Suicide 2010 England Physician & Coroner Testify Celexa Contributed to Suicide of Woman: Pharma Dr. Agrees!

Celexa Murder-Attempt/Suicide 2011 Florida Autopsy of School Board Shooter Released: Celexa Found: Shooter Killed Himself

Lexapro…

Lexapro Murder-Suicide Attempt 2006 Pennsylvania Mother Attempts to Kill Children and Self

Lexapro Suicide Lexapro 2003 New York 17 Year Old Hangs Himself

Lexapro Suicide 2003 Virginia 18 Year Old Jumps to his Death

Lexapro Suicide 2004 Wisconsin 17 Year Old Girl Kills Self

Lexapro Road Rage Murder 2004 Massachusetts Man Deliberately Drives Into Tree: Kills Girlfriend

Lexapro Suicide 2005 Pennyslvania Woman Burns Herself to Death

Lexapro Murder 2005 Virginia Man Kills & Dismembers his Father: One Day Withdrawal

Lexapro Suicide 2005 Georgia 13 Year Old Hangs Himself

Lexapro Suicide 2006 Ohio Two Brothers Commit Suicide Within Months; Family Sues

Lexapro Suicide 2006 Utah 11 Year Old Girl Hangs Self; Family Sues

Lexapro Murder-Suicide Attempt 2005 New York Prominent Banker Shoots Son & Self

Lexapro Murder-Suicide 2007 Arizona Mother Kills her Two Year Old & Herself

Lexapro Suicide 2007 Florida Teen Jumps From 11th Floor Hotel Room

Lexapro Kidnapping/Stabbing 2004 Colorado Man Stabs Ex-Wife: Kidnaps Children

Lexapro Suicide 2007 Texas 18 Year Old Girl Kills Self: Lawsuit Could Be Decisive

Lexapro Suicide 2007 Florida Popular Meteorologist Commits Suicide

Lexapro Suicide 2007 Ireland Man Kills Self After 8 Days on Lexapro

Lexapro Suicide 2008 Missouri 14 Year Old Girl Commits Suicide While On Lexapro

Lexapro Murder 2007 Indiana Mother Murders Her Adopted Baby

Lexapro Suicide 2008 Washington 16 Year Old Girl Shoots Self: Lawsuit

Lexapro Murder-Suicide Attempt 2008 Ohio Man Attempts to Kill Wife: Succeeds in Killing Self

Lexapro Suicide 2008 Iraq/Texas Soldier Kills Self: He was Born & Raised in Oregon

Lexapro Murder 2008 Tennessee Husband Kills 18 Year Old Friend of Wife

Lexapro Suicide Attempt 2008 New Mexico Judge in Lawsuit Said Relative Attempted Suicide on Lexapro

Lexapro Murder 2009 Colorado Man Stabs Father, a Physician

Lexapro Suicide 2009 New York 14 Year Old Girl Commits Suicide: Fund for Funeral Expenses Announced

Lexapro Death 2004 Nebraska 28 Year Old Suicidal Man Killed by Police: 4 Day Lexapro Withdrawal

Lexapro Vehicular Manslaughter 2010 Idaho Man Has Four Car Crashes In One Day: No Alcohol Involved

Lexapro Mania/Bizarre Behavior 2010 Ohio 62 Year Old Man Becomes Manic and Insane on Lexapro: Tasered by Police: Dies

Lexapro Murder 2010 Louisiana Involuntary Intoxication is the Defense at Trial: No Alcohol Involved

Lexapro Murder 2010 California Woman Stabs Man To Death: Appeals Court

Lexapro Murder 2010 Texas 22 Year Old Kills 6 Month Old Baby: Appeals Court

Lexapro Vehicular Homicide 2010 New Jersey Woman Kills Pedestrian: Leaves Scene of Accident: No Alcohol Involved

Lexapro Murder 2011 Virginia Richmond Man Murders Co-Worker: Holds Family Hostage: Attempts Suicide

Lexapro Suicide 2011 New York Woman Jumps in Front of Train

Lexapro & Celexa Suicide 2008 Maine 24 Year Old Kills Himself

Lexapro Suicide 2004 Oregon 22 Year Old Given Med for back pain

Lexapro Murder 2007 Virginia Man Kills Girlfriend During Two Week Withdrawal from Lexapro

Lexapro Suicide 2009 Florida Young Man Was Taking Lexapro As Needed: On & Off the Drug

Lexapro Suicide 2010 Colorado 19 Year Old Woman Kills Herself

Lexapro Suicide 2011 Nevada Inmate Kills Self: Family Wants Answers

Lexapro Cyber Suicide Lexapro 2008 Florida 19 Year Old Kills Self in Front Of Webcam

Lexapro Murder 2008 Oklahoma 26 Year Old Murders 10 Year Old: Plans for Cannabilism

Lexapro School Threat/Lockdown 2008 California **Violent High School Student Shot to Death on Campus by Police

Newspaper and internet articles, Random

European Medicines Agency (EMA) in fraud investigation

Drug watchdog in fraud investigation
 
The Irish Medicines Board (IMB), who are primarily funded by the pharmaceutical industry, when asked why they won’t investigate ssri’s and the relation to suicide and homicide, will always pass the buck back to the EMA. There’s an interesting article today in the English Independent about the EMA and fraud.
 
Considering there has been issues before with the IMB and Conflicts of Interest, I wonder how many brown envelopes have been passed around between the IMB, the EMA, and the pharma industry. Just who is regulating the regulators?
 
Considering that there is one sentence in the EMA and IMB patient information leaflet to warn consumers that suicide ideation can actually be caused by ssri’s and there is a black box warning and about 5 pages of warnings in America’s FDA version, I’m sure I’m not alone in thinking that there is corruption going on at the highest level.
 
Jeremy Laurance  Monday 07 November 2011

The safety of medicines in the UK has been cast into doubt by a fraud inquiry at the European regulator responsible for licensing pharmaceutical drugs across the EU.

The European Medicines Agency, based in Canary Wharf, London, is under investigation over alleged conflicts of interest by the European Anti-Fraud Office (OLAF). If proven, the allegation would undermine confidence in the pharmaceutical industry which is already reeling from a series of disasters involving heavily publicised medicines, which later turned out to have deadly side effects.

The British multinational GlaxoSmithKline announced last week it would pay $3bn (£1.9bn) to settle US criminal and civil investigations into its sales practices, after the withdrawal of diabetes drug Avandia in 2010 due to an increased risk of heart attack.

The investigation into the European medical regulator relates to the scandal over the French diabetic drug, Mediator, which was withdrawn from the European market in 2009, a decade after initial signs that it could be responsible for fatal heart problems.

Mediator, made by French pharmaceutical firm, Servier, was on the market for 33 years and was prescribed as a weight loss drug taken by an estimated 5 million people in France and by many more in Italy and Spain. It is estimated it caused between 500 and 2,000 deaths, mainly from heart valve problems, before it was banned. Mediator was not marketed in the UK, but the fallout from the scandal has damaged confidence in the drug regulatory system.

The chief executive of the French regulator, the Health Products Safety Agency, resigned and the body which he headed was overhauled after a damning official report said it “failed in its duties.” The reformed regulator, renamed National Agency for the Safety of Medicines (ANSM), includes new measures to guarantee transparency and avoid conflicts of interest.

The investigation into the EMA was triggered by Michèle Rivasi, a French Member of the European Parliament for Europe Ecologie Les Verts, a green party. She has pointed out that 80 per cent of its budget comes from the pharmaceutical industry making independent oversight impossible.

The EMA was created in 1995 to harmonise drug regulation systems in the EU. It said last month it had “strengthened the rules on how it handles potential conflicts of interest of its staff and experts” after it was criticised by the agency’s Budgetry Control Committee.

Olaf told The Independent its investigation into the agency opened in July but could not give details “for reasons of judicial secrecy”. The EMA said it knew of the probe but had not seen the accusation. A spokesman added: “We have a robust process for dealing with conflicts of interest. It is transparent and there’s no attempt to hide anything.”

http://www.independent.co.uk/news/uk/crime/drug-watchdog-in-fraud-investigation-6258244.html

https://leoniefennell.wordpress.com/2011/06/11/doubts-cast-over-pat-omahony-conflict-of-interest-and-the-irish-medicines-board/

https://leoniefennell.wordpress.com/2011/08/07/the-irish-medicines-board-e27-million-funding-from-the-pharmaceutical-industry/

Newspaper and internet articles, psychiatry, Random

Conflict of interest in Ireland’s drug regulator, the IMB.

From The Sunday Times
 
November 8, 2009
 

Drug regulator ‘risks conflict of interest’

 

Gabrielle Monaghan

 
Ireland’s drug regulator has been accused of being too close to the pharmaceutical industry. An academic report has concluded that more than one-in-four senior personnel at the Irish Medicines Board (IMB) had “potential conflicts of interest”.
Orla O’Donovan, one of its authors, said public concern about the safety of drugs, such as swine-flu vaccines, could be alleviated if the IMB was more open about the relationship between its decision-makers and advisers and the drugs industry.
The report, published in Social Science & Medicine, showed a chairperson of one of the IMB’s advisory committees had taken part in research sponsored by the pharmaceutical industry and received industry honoraria and consultancy fees.

A former chief executive worked for a drug company before joining the IMB and left to work for another one.

Between 1996, when the agency was set up, and 2005, four members of the IMB’s senior management team had a background in the pharmaceutical industry and one of those also participated in research funded by drug companies, the research found. In total, five out of 19 senior people had links with the drug industry.

The IMB, a state body that charges pharmaceutical and medical devices companies for inspections of drugs, says no staff members have any drug company connections. It said advisory committees, which it does not regard as staff, do not make decisions.

The IMB said employees are not allowed to have any interest in the drug industry and are prohibited from working on products they have been involved with. “Products are licensed purely on the basis of their potential benefit to health,” an IMB spokeswoman said.

The study says the Irish Medicines Board Act of 1995, which set up the agency, is unclear about the “beneficial interest” committee members must declare, such as receiving honoraria from companies or serving on an advisory committee.

The study compares policies at the IMB with those of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency. It found all three operate on the assumption that potential conflicts of interest can be managed and are therefore not a problem.

O’Donovan gave the example of a 2002 IMB newsletter which announced that Professor Frank Hallinan, a former Schering-Plough employee, had resigned as chief executive and would be joining Wyeth Biopharma as director of quality. Pat O’Mahony, his successor, worked as a technical manager in the veterinary pharmaceutical industry in Ireland and the UK.

O’Donovan’s study showed that public access to information about potential conflicts of interest of senior IMB personnel and advisers is restricted.

 

Drugs regulator to publish declarations of interest 

The Irish Times – Tuesday, March 23, 2010

PAUL CULLEN

THE STATE’S drugs regulator is planning to provide public access for the first time to the declarations of interest of its staff, board and committee members in pharmaceutical companies.

The Irish Medicines Board, which licenses new drugs and medical devices, plans to bring its practices into line with the European Medicines Agency, which publishes such declarations online, The Irish Times understands.

The agency yesterday rejected claims in an academic journal that senior people working in or with the IMB face potential conflicts of interest as a result of past links to the pharmaceutical industry.

Orla O’Donovan of UCC’s department of applied social studies, writing in the journal Social Science Medicine, claimed the agency “manages” rather than prohibits potential conflicts of interest and restricts public access to information on the issue.

Writing in the same journal, Prof John Abraham of the University of Sussex described the lack of public access to the declaration of interests by committee members as “shocking” and “an unacceptable democratic deficit in modern Europe”.

IMB rules prohibit staff or their families from having any financial interest in the pharmaceutical industry and from working on products that they may have had an involvement with in previous employment. Members of advisory committees are asked to confirm at each meeting that they have no conflict with matters under discussion.

However, declarations of interest have not been publicly available up to now because they are deemed to contain personal information which is exempt from release under freedom of information legislation.

17/07/2011

It is now July 2011 and strangely enough there is no mention of any declarations of interest on the IMB website or anywhere else. I’m waiting with anticipation as THAT will be very interesting! It will also be much more interesting when the Irish doctors, professors and universities have to declare how much they receive from the pharmaceutical industry. Now that, will be worth waiting for!

Newspaper and internet articles, Random

Doubts cast over Pat O’Mahony, conflict of interest and the Irish Medicines Board.

Late last year Thomas Lonngren left as head of the European Medicines Agency after 10 years. Shortly afterwards he accepted a post with a pharma consulting firm, prompting questions about conflicts of interest.

Subject to approval, Guido Rasi, the current head of the Italian Medicines Agency, has been nominated to run the European Medicines Agency after a search process that has drawn fire from critics and the European Parliament.

It was controversy over Mr. Lonngren’s departure and his subsequent new position within the pharmaceutical industry that helped cast a shadow over the search process. Since Mr. Lonngren left the EMA, criticism has been mounting about him taking up a job with a pharma consultancy NDA directly after leaving the agency.

Our own head of the Irish Medicines Board Mr. Pat O’Mahony, had been considered a front-runner for Thomas Lonngren’s job, but he fell out of favor because he personally approved Lonngren’s consulting job without even mentioning the potential for conflicts.

When it emerged that Mr. O’Mahony had personally approved Lönngren’s move to NDA, and had raised no concerns about conflict of interest, doubts about his own judgement became an issue. Link

He was interviewed here in the “Irish pharmacist” which by the looks of it is just an advertising platform for pharmaceutical companies including lundbeck and escitalopram, which by the way, lundbeck got into big trouble for in the UK for false advertising, when lexapro/cipralex was found to be identical to cipramil, but hey, that’s another story! BMJ.

There is also an advertisment in here for chantix/champix, the smoking cessation drug, which has the worst drug safety record with more reported serious injuries than any other prescription drug even before Pat O’Mahony did this interview in 2009, but strangely no mention of it, but I doubt if pfizer would acknowledge the serious side effects… No that’s Pat O’Mahonys job!

Then again, concerns have arisen before with conflicts of interest and the IMB, and the fact that Pat O’Mahony worked as a technical manager in the veterinary pharmaceutical industry in Ireland and the UK. Link 

It seems that any investigation into citalopram is up to Pat O’Mahony, and the fact that I have informed the IMB of all the information, concerns over the licencing of cipramil, lundbeck admitting suicide/homicide, hidden and false advertising, coroner’s concerns with citalopram, an expert medical report ect, I honestly don’t know what the problem is, unless of course “conflict of interest” also means that Mr. O’Mahony doesn’t want to upset the pharmaceutical companies who make these antidepressants because you can be sure that lundbeck’s cipramil is not the only problem drug in this class!

Newspaper and internet articles

Thousands Suing over GSK’s Diabetes Drug prescribed in Ireland.

 

Rosiglitazone (Avandia /Avandamet) is a medicinal product which was authorised for use in Ireland in 2000 to treat type II diabetes, a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood. It was prescribed for use when other treatments had failed. Avandia was one of the most popular drugs taken by type II Diabetic patients but had serious side effects.

Studies by the New England Journal of Medicine had found that people who took the drug had a 43% increased risk of suffering a heart attack and a 64% increase in the risk of death from all cardiovascular causes.

In March 2007 the US FDA issued a public safety notice warning users of the increased risk of heart failure and strokes for people taking the drug and ordered the manufacturer to add a prominent “black box” warning to the drugs packaging to tell users about the increased risks of heart failure and cardiovascular disease. Since then there has been a spate of law suits filed against the manufacturer GlaxoSmithKline Plc who have agreed to pay $700 million dollars over the last 8 months to resolve about 12,000 compensation claims alleging the drug maker failed to warn consumers of its dangers.

Avandia was freely available in Ireland but was withdrawn in September 2010 after concerns were raised by the European Medicines Agency. At the time the Irish Medicines Board recommended to health care professionals that prescribers should not issue any new or repeat prescriptions and doctors were advised to review diabetic patients and switch them to alternative medications. There are an estimated 200,000 people suffering from type II diabetes in Ireland.

Liam Moloney, a medical lawyer, based in Naas, Co. Kildare said today, “This drug was widely prescribed in Ireland since 2000 for the treatment of Type 2 diabetes. This drug had very serious side affects and there are now thousands of claims for compensation pending in the UK and US from affected users. The manufacturer recently settled a wrongful death claim from the widow of a 49 year old man who suffered a heart attack and died after taking the drug for 15 months. Anyone who has taken this drug and has suffered any adverse effects such as cardio vascular problems should immediately seek medical and legal advice”

No surprises here with GSK and dodgy drugs, and no surprises with the Irish Medicines Board “Healthcare professional letter” making no decision for themselves, as per usual…Link

cipramil (celexa) stories,, lundbeck, Newspaper and internet articles

Simon Tiplady (36), and 3 days on citalopram.

 
 
This is a report of another young man who was prescribed Citalopram 3 days before he died by suicide. His name was Simon Tiplady and he was 36 years old.
.
Simon was a keen runner and had previously run the London Marathon for Arthritis Care. He went to his doctor on November 4th and was prescribed Citalopram. He killed himself on November 7th.
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At the inquest into Mr Tiplady’s death on November 7th, his wife Mrs Tiplady said “Simon was a wonderful man who loved his family. He was such a gentle man and liked to do a lot of charity work and fundraising.”
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.
 
So how could this man, a partner in a reasonably prosperous business, who by his wife’s account was just a worrier and got somewhat stressed when a job wasn’t going right, get some medication to help, and then kill himself 3 days later? Not exactly a happy pill was it? But hey, lundbeck got paid!
.
 
 
Was this man or his family informed of the possible suicidal and homicidal side-effects with this drug, particularly upon starting, discontinuing or dosage change with citalopram and all SSRIs? The coroner Paul Kelly recorded a verdict of self-suspension by ligature, after hearing he had been found hanging at a renovated property.
.
 
 
Lundbeck is a corrupt pharmaceutical company, so no surprises that they manufacture a dangerous drug and down-play the side effects, because of the profit they make. Last year the European Commission launched an investigation into Lundbeck’s dodgy activities. In another instance an e-mail was uncovered written by their vice-president, talking about their prospective acquisition of a drug for premature babies…”we can price these almost anywhere we want given the product profiles.” Lundbeck’s plan? Once they had the rights to the drug, Indocin IV, they would increase the price of each treatment course from $78 to $1,500. Link
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BUT, there are no excuses for the European Medicines Agency, the MHRA and the IMB not investigating Citalopram, when so many people kill themselves and other people on this supposedly anti-depressant.
.
 
I have requested that the Irish Medicines Board (IMB) investigate Citalopram but as yet they are not forthcoming, and until they do, there will be more and more unfortunate, unsuspecting victims!
.
 
Full article in “This is Grimsby” on Monday, April 27, 2009 Link.
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Random

Off-label prescribing for children in Europe.

 

Off-label, unauthorised Rxing (prescribing) in children “widespread” in Europe

Lynne Taylor  World News | January 27, 2011

(Excerpt)

“The prescribing of off-label and unauthorised medicines to children is still widespread in Europe, accounting for 45%-60% of total prescriptions in both inpatient and outpatient care, says a new report from the European Medicines Agency (EMA).”

This article goes further to say that the study notes that the therapeutic classes that are used most frequently off-label or without a marketing authorisation are among others.. contraceptives, antibiotics and ssri anti-depressants. 

There are reasons why ssri’s are not licenced for children. (The warnings have been upped to age 25 buts that’s another story) The E.U. has published these warnings/side effects for under 18’s taking ssri’s..

Age: Children (under 18)
Side Effects: Suicide Risk/Suicide Attempts/Suicide, Aggression, Violence, Hostility. 
IS THAT NOT ENOUGH OF A REASON NOT TO PRESCRIBE THESE DRUGS TO CHILDREN? ARE THE RISKS NOT SERIOUS ENOUGH?

 

 

 

It’s not just Americans who have to deal with the fall-out from off label prescribing, the side effects are the same for european children. But is it just American pharmaceutical companies that are fined for improper conduct?

 

 Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Why: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received a $313 million penalty.  The settlement also covered Forest’s off-label use of Celexa for children’s use.

 
 
 
 
Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Why: Allergan’s was fined $600 million by the Department of Justice. The settlement was broken into two parts: $375 million in fines and $225 milion in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy. 
 
Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Why:  J&J received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.
 
GlaxoSmithKline
With: U.S. Attorney’s office in Colorado
When: Jan. 29, 2009
Why: After seven years of off-label promotion on nine of its best-selling drugs, GlaxoSmithKline (GSK) was ordered to pay $400 million to the U.S. Attorney’s office in Colorado.
 
Pfizer
With: Department of Justice
When: Jan. 26, 2009
Why: Right after acquiring Wyeth, Pfizer dropped a bombshell in its fourth quarter earnings report; the company was charged $2.3 billion for off-label promotions of its COX-2 drugs.
 

 Novartis
With: U.S. Attorney’s office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Why: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.

 

 

 

 

 
 January 2009
 European UnionDrug Class: Newer Antidepressants, Older AntidepressantsAge: Children (under 18)
Side Effects: Suicide Risk/Suicide Attempts/Suicide
Summary: The Pharmacovigilance Working Party (a party that provides advice on the safety of medicinal products and on the investigation of adverse reactions associated with medicinal products authorized in the European Union) recommended an update to product labeling and all antidepressants patient information leaflets to include information on the increased risk of suicide for children to young adults.
Source: “Antidepressants and suicidal thoughts and behaviour,” Pharmacovigilance Working Party, January 2006.
 
August 19, 2005
European UnionDrug Class: Newer AntidepressantsDrug Name: Fluoxetine, Fluvoxamine, Sertraline, Paroxetine, Citalopram, Escitalopram, Atomoxetine, Duloxetine, Venlafaxine, Mianserin, Milnacipram, Reboxetine, Mirtazapine
Age: Children (under 18)
Side Effects: Suicide Risk/Suicide Attempts/Suicide, Aggression, Violence, Hostility
Summary: The Commission of the European Communities, representing 25 European countries, endorsed and issued the strongest warning yet against child antidepressant use as recommended by Europe’s Committee for Medicinal Products for Human Use (CHMP).
Clinical trials had shown that the drugs caused suicidal behavior including suicide attempts and suicidal ideation, aggression, hostility (predominantly aggression, oppositional behavior and anger) and/or related behavior.
Source: Commission of the European Communities Commission Decision concerning the placement on the market, under Article 21 of the Directive 2001/83/EC of the European Parliament and of the Council, Brussels 19-VIII-2005, C (2205) 3256.