Newspaper and internet articles, psychiatry

Sundance Diagnostics, a genetic test pre-suicide

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

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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,…

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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.

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

Trudy Schoger; death by Cipralex

Yesterday ‘CBC NEWS’ Canada did a segment on Mike Schoger’s mum Trudy.

Trudy Schoger died from a heart attack a few hours after taking her first dose of Lundbeck’s Cipralex (AKA Lexapro). What people should be aware of is that this drug (as found by a Brussels Court) is the same as Celexa/Cipramil and the same drug that Shane was on. The recent warnings recommend a dose no higher than 40mg’s (20mg’s for the elderly) due to the risk of heart problems, including death. Tony spoke to a man last month in Dundrum who was still on a 60mg’s dose. Doctors differ, patients die!

Not only can this Lundbeck drug cause suicide, depression and aggression; it can also cause sudden death. According to a ‘Freedom of Information’ response that I received from the Irish Medicines Board, this drug has also been reported to have caused ‘intrauterine’ death, suicide and sudden death in Ireland.


Short Extract here…

An Ontario man whose mother died from a heart attack after taking a popular anti-depressant believes she would still be alive if she’d been warned about the drug’s known dangers.

“She deserved better,” said Mike Schoger, an engineer from the Chatham area, whose 75-year old mother Trudy died in December, just hours after taking her first dose of Cipralex.

“Health Canada knew there were issues for months [before fully warning the public],” said Schoger.

Trudy Schoger was on a diuretic, but otherwise healthy, when she was prescribed Cipralex for depression. The day she died, her son found her writhing in pain on her bed.

“She took the first dose and 45 minutes later she started getting pain in her shoulders and neck and chest,” said Schoger. Hours later, his mother lay dead in hospital and he was in shock.

“You could say my mom was one of my best friends,” said Shoger. “The last thing I would have expected is for something like this to happen.”

Citalopram and escitalopram safety update.

Citalopram and Escitalopram: Risk of sudden death and more allegations of Kickback and Bribes.

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

Hello Copenhagen.

Mit navn er Leonie, og min søns navn var Shane Clancy. Han dræbte sig selv og en anden ung mand den 6. august 2009. Han havde været på Cipramil i 17 dage.
Han havde ingen voldelig forhistorie, faktisk var der ikke skabt vold i ham, og jeg er overbevist om, at Cipramil fik ham til at begå udåden.
Juryen ved den efterfølgende undersøgelse kom frem til en åben dom (afslog en selvmords dom).
Professor David Healy, der udtalte sig som ekspert vidne under sagen, fastslog helt klart, at dette kan ske for en lille minoritet af mennesker, der kan få en frygtelig reaktion af antidepressiver.
Selv om problemet som sådan kan synes lille, bliver det stort, taget i betragtning at millioner af mennesker verden over behandles med disse præparater.
Efter retssagen om Shane udtalte Lundbeck (producenten af Cipramil) på irsk tv, RTE news, at deres middel ikke kunne være skyld i handlingen, og at der ikke var nogen beviser til støtte for vores klage, til trods for at de i deres produktresumé til lægerne skriver om risikoen for selvmord/drab ved indtagelse af præparatet!
Det irske psykiatri selskab gik i medierne for at underkende eksperternes meninger som spekulative.
Den irske Lægemiddelstyrelse udtalte, at indlægssedlen til patienterne gav tilstrækkelig advarsel, og at det ikke var nødvendigt med en black box advarsel i Irland, ligesom der er i Canada og USA.
Timothy Dinan, der var den mest højrøstede i tilbagevisningen af vores klage, er medlem af Det irske Psykiatri selskab, medlem af den irske Lægemiddelstyrelse og modtager honorarer (betaling) fra Lundbeck…så hvad siger det dig?
Er der tale om korruption?
Leonie

lundbeck, Shanes story.

Latest e-mail to Lundbeck.

To whom it concerns,

I have written to lundbeck Ireland and also lundbeck Canada on Aug 8th 2010 but am still awaiting reply. My name is Leonie and my son’s name was Shane Clancy. He was 22 before cipramil killed him but you know that already, just as you know the side effects of these drugs. Murder and suicide.

Let me just explain that I know what is going on at Lundbeck and I can also prove it. I have been in touch with John Virapen who worked for you in the Caribbean. His stories of bribing officials and doctors first class trips with all expenses paid to Denmark and corruption in general make for very interesting listening. You will not get away with murdering my son.

Leonie fennell

I would also be very interested to know if Shane’s death was logged as an adverse reaction!

Health Canada Endorsed Important Safety Information on CELEXA® (citalopram hydrobromide)

Lundbeck Canada Inc.
413 St. Jacques Street West
Suite FB-230
Montreal, QC H2Y 1N9

May 26, 2004

Subject: WARNING for SSRIs and other newer anti-depressants regarding the potential for behavioural and emotional changes, including risk of self-harm

Dear Health Care Professional,

Lundbeck Canada Inc., following discussions with Health Canada, would like to inform you of important safety information regarding the possibility that SSRIs (selective serotonin reuptake inhibitors) and other newer anti-depressants may be associated with behavioural and emotional changes, including risk of self-harm.

The Class warning incorporated in the product monograph of Celexa® (citalopram hydrobromide) is provided below.

POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM.

There are clinical trial and post-marketing reports with SSRIs and other newer anti-depressants, in both pediatrics and adults, of severe agitation-type adverse events coupled with self-harm or harm to others. The agitation-type events include: akathisia, agitation, disinhibition, emotional lability, hostility, aggression, depersonalization.

lundbeck, Our story.

Don’t forget my son paid for his medication (With his life!)

After a lot of persistance and quite a few phonecalls  I eventually spoke to Claus Braestrup who was the CEO OF Lundbeck Copenhagen until 2008 . I was hoping he would tell me whether he knew about the side effects or were they just burying their heads in the sand.  While he was polite to me and seemed nice enough, he just kept repeating the same sentence (I’m so sorry, I can’t help you). He advised me to contact Lundbeck Ireland which I did and also sent the same e-mail to Lundbeck Canada for good measure.

STILL AWAITING  REPLY.

E- mail below..

tocanadacustomerservice@lundbeck.com

dateSun, Aug 8, 2010 at 1:04 PM
Letter from Shane’s parents…
mailed-bygmail.com

Aug 8  2010
To whom it concerns,
Could someone answer my question?
My name is Leonie Fennell and my sons name was Shane Clancy. He was on celexa for three weeks when he killed himself and another young man.
He was very sad over a break-up with his girlfriend. He didn’t have a violent bone in his body. The jury at Shane’s inquest returned an open verdict (rejecting a suicide verdict).
Lundbeck made this statement on RTE..
Statement – Cipramil (citalopram)

15th April 2010 – In response to inaccuracies stated today at an Inquest held in the Wicklow Coroner’s Court, Lundbeck dispute the evidence given and claims made about Cipramil (citalopram).

It was stated at the Inquest that citalopram may have caused the behaviour and actions of Shane Clancy that resulted in his self-inflicted death, that of xxxx xxxx  and the wounding of two other people.

Extensive scientific studies have shown that there is no evidence linking citalopram to violent behaviour.

There are trials which show that citalopram has the potential to reduce, rather than provoke, irritability, aggression and violent behaviour.  In a trial of patients with schizophrenia, citalopram was shown to reduce aggressiveness in chronically violent patients.  In another trial of elderly patients, it was shown to reduce symptoms of agitation, restlessness and irritability.  In the treatment of patients with depression, significant improvement was reported for irritability and indirect aggression.

The data available on overdose with citalopram also shows no evidence of violent behaviour.   A paper published in 2009 by Hayes et al in the Journal of Emergency Medicine which retrospectively reviewed approximately 370 citalopram patients with overdose reported no aggressive or violent behaviour.

Depression is associated with an increased risk of suicide and this may be particularly evident in the early stages of treatment.   A review of all available data for citalopram (that from clinical trials and that collated after the medicine was made available) shows no increased risk of suicide.

Citalopram has been used in an estimated 130 million patients worldwide.
It  contradicts this statement made in Canada by Lundbeck,

As you can see in the Adult and Pediatrics: Additional data section..it clearly states self harm and harm to others as one of the side effects of these drugs!

http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2004/celexa_hpc-cps-eng.php
So my question is; how can two countries make completely opposite statements about the same drug?
Am I missing something here?
Leonie