Everyone smiling, and waving.

Paxil, Seroxat- Paroxetine Generation. 

Brave New World 

GlaxoSmithKline- Meet the Dealer. 

Millions of people in this world of confusion

And the company and its doctors actively pushed the solution

Happy pills that turned men into killers.

And the company even tried to get a license to give it to children. 

The will to kill- and the days filled with rage.

Addiction

Suicide

Halucinations.

GSK- Prophets of despair.

Daily rising.

There’s more than me- that’s watching you 

]]> http://truthman30.wordpress.com/2013/05/14/seroxat-by-kirk-brandon/feed/ 0 truthman30 http://truthman30.wordpress.com/2013/05/11/ed-silverman-pharmalot/ http://truthman30.wordpress.com/2013/05/11/ed-silverman-pharmalot/#comments Sat, 11 May 2013 21:54:04 +0000 truthman30 http://truthman30.wordpress.com/?p=3935 ]]>

http://www.pharmalive.com/glaxo-and-transparency-one-panel-member-has-a-conflict

Irish broadcaster Pat Kenny regularly carts out the Irish Biological Psychiatrist Jim Lucey on his radio show. I’ve been listening (and reading between the lines) of his interviews. They can be listened to (and downloaded) on this link:

http://www.stpatrickshosp.ie/prof-jim-lucey-pat-kenny

One that is particularly interesting is “Does Depression Really Exist?”.

In this interview , Lucey admits that Psychiatric Diagnosis isn’t about addressing the cause, he says it’s about diagnosing the symptoms in order to label depression.

One listener asked a question, “would I be on Effexor for the rest of my life”? “I’m worried and I don’t know what to do”.

Lucey seems to think that if someone has 3 re-current depressions due to stopping treatment- which he calls re-lapses- that they should stay on medication.

What Jim Lucey doesn’t say is- SSRI medications – like Effexor- can cause a withdrawal syndrome which mimics and often increases symptoms of depression and anxiety- therefore how does a psychiatrist diagnose re-lapse and differentiate between re-lapse into depression and SSRI withdrawal induced depression?

While I don’t doubt Jim Lucey believes in the biological model of psychiatry – it amazes me how he fails to see the dangers of prescribing a one-size-fits-all model for depression. Not once does he offer other alternatives- such as changes in diet, exercise, alternative therapies, nutrition, psychotherapy etc.

He says recurring depression might need a mood-stabilizer such as lithium. Perhaps a recurring depression needs intensive talk-therapy- not merely chemical intervention?

What he doesn’t address is the cause of depression in the first place- many factors which he mentions- such as grief, life-changes, environmental factors etc- he brushes over these and sees the individual purely in terms of symptoms instead of focusing on the root-cause.

Until the root cause of the depression is dealt with- chemical band-aid psychiatric drugs will not aid an individual in overcoming their depression. I speak from experience..

Discussing Mental Health entirely in biological terms, and aiming to treat Mental Health solely in chemical treatments, is extremely limited and does a great disservice to sufferers of depression and anxiety. Chemical treatments have clearly failed the majority of mental health sufferers,  and perhaps it’s time that psychiatrists like Jim Lucey begin to see beyond the symptoms, the diagnosis and the ‘disease’, and into the essence of the individual.

The individual holds the key to their own recovery.

On RTE radio  on Monday at the end of a debate on autism, Pat Kenny’s resident psychiatrist Prof Jim Lucey said Dr Gilsenan’s views were “a classic example of a single dimemsional divide” that occurs in the suicide debate. Not sure exactly what that means, but he went on to say there is “no evidence” that anti-depressants cause suicide, and referred to an “anti-psychiatry movement”. Prof Lucey instead preferred to blame alcohol for a rise in suicide. I was under the impression that we Irish had always drunk copious amounts, so why all of a sudden is it driving us to suicide? Perhaps the issue of alcohol mixed with legally prescribed drugs would be a more valid argument. Coroners up and down the country have been commenting on the number of cases where legally prescribed drugs are a factor in deaths.

Jim Lucey says that there is no evidence that anti-depressants cause suicide. This is blatantly untrue. Perhaps Mr Lucey would like to take a look at the tens of thousands of stories of SSRI induced suicide, murder and aggression on SSRI Stories- http://ssristories.com/

or maybe he would open his mind and read about the coroners reports of SSRI induced suicides on this website:

http://antidepaware.co.uk/

It might shock, or surprise, some of my international readers to know that abortion is still illegal in Ireland- and there is a right-wing Christian conservative element in Irish society that wishes to keep it that way- forever.

Thousands of Irish women leave Irish shores for the UK each year in order to have an abortion- a right they are denied in their own country.

The abortion debate has been re-ignited in recent times in Ireland, mainly because of the death of savita halappanavar. Savita was denied an abortion in Ireland even though there was a threat to her life. Because of her death the abortion debate has been thrust back into the Irish political and socio-cultural arena, with many opinions about abortion bandied about in the media- and elsewhere- throughout Ireland for the past few months.

In the Irish abortion debate- as in most countries- there are effectively two camps of divided opinions- the ‘pro-life’ side and the ‘pro choice’ side. But what makes this debate in Ireland particularly interesting has been the involvement of psychiatrists in the debate. I personally think it should be a woman’s right to choose, no matter what the circumstances, but for the purpose of this post I would like to concentrate mainly on the abortion and suicide issues- as I think as you will see- the raising of this controversial taboo has also flagged massive holes in the logic, legitimacy and credibility of Irish psychiatry in general- not just in relation to abortion and the threat of suicide because of it- but also in relation to the entire practice of Psychiatry in Ireland as a whole.

Current legislation is now being drafted in Ireland in order to address the blatant incongruities in Irish abortion laws. One of the controversial elements of this legislation includes a risk assessment of a hypothetical suicidal pregnant woman by psychiatrists. In Ireland- as it stands- there is a so called ‘equal right to life of both mother and fetus’. But there is also a stipulation that in cases where there is a substantial threat to the life of the mother- an abortion can be performed.This is where the threat of suicide comes in- as suicide is surely a valid threat to the life of the mother? Not so – it seems- according to some Irish psychiatrists.

David Quinn, director of the Iona Institute, a religious advocacy group which opposes abortion, said the organisation was “very concerned” at what was contained in the heads of the Bill, particularly in relation to the provision on suicide which he said, if implemented, would see Irish law “crossing a moral Rubicon”.

“The suicide provision is the most worrying provision in it because, if and when this becomes law, for the first time in Ireland, it will provide for the direct killing of an unborn child where there is an alternative treatment,” he said.

Mr Quinn reiterated the organisation’s contention that suicide was not a cure for suicidal ideation, a viewpoint which he said had been supported by 113 Irish psychiatrists who last week signed a statement indicating their opposition to suicidality as grounds for an abortion.

He said the organisation would also be reviewing the part of the Bill which deals with conscientious objection as to what implications this had for Catholic hospitals.

Anti-abortion organisation the Life Institute accused Fine Gael of “caving in” to Labour on abortion. Spokeswoman Niamh Uí Bhriain said the smaller Coalition party represented “less than 10 per cent of the people now, according to polls, yet they are deciding for the whole country on this issue of life and death”.

She said the Government “had ignored all the medical evidence that confirmed abortion was not a treatment for suicide”.

“This Government asked medical experts to give evidence on this issue, and the evidence they heard demolished the case for legalising abortion on suicide grounds, but now they have roundly ignored the evidence and moved to allow unborn children to be deliberately killed for the first time in Ireland.”

Although pro-choice groups welcomed the publishing of the heads of the Bill, they also expressed concern at some of the elements therein.

The Abortion Rights Campaign welcomed the publication as a step toward securing access to safe and legal abortion in Ireland but added that it was “deeply disappointed” by several sections of the draft legislation.

Spokeswoman Cathie Doherty said the campaign was “extremely alarmed” by the inclusion of the assessment of three doctors for termination when a woman is at risk of suicide.

“Requiring three doctors to assess a suicidal pregnant woman is outrageous. This legislation will be redundant if the women affected will continue to travel to England rather than face interrogation by multiple doctors,” she said.

Possible penalty

The organisation also labelled a possible penalty of 14 years in prison for illegal abortion in Ireland as “nothing short of barbaric”.

“To threaten women facing this difficult decision with imprisonment is not only wrong in and of itself, but it may prevent women from disclosing information about previous abortion to their doctors, or seeking medical care in the event of complications from illegal abortion,” said another spokeswoman, Sarah Malone.

Sinead Kennedy of Action on X said the organisation was “very disappointed” by elements of the Bill, particularly around suicidal ideation. She criticised the requirement for a suicidal woman or girl to receive the unanimous consent of three medical practitioners before an abortion could take place in these circumstances, describing it as a “callous disregard for women’s lives”.

Ms Kennedy also criticised the Bill for distinguishing between medical and psychiatric emergencies. “Psychiatric emergencies are medical emergencies and any psychiatrist will tell you that,” she said.

Now if you notice the play on words here, by David Quinn of the ultra-conservative Catholic Iona institute- he is claiming- with the apparent backing of 113 Irish psychiatrists – that ‘abortion is not a treatment for suicide’. Whoever said that it was? It is the threat to the woman’s life by suicide that is the issue. Nobody- apart from right-wing Christian fundamentalists- has alluded to abortion being a treatment for mental illness or suicidality but completed suicide and suicidality may indeed be the result of the trauma of an unwanted pregnancy. It seems that the ‘pro-life’ brigade are not so much ‘pro-life’ but merely anti-abortion in all circumstances- even if that means that a woman would take her own life because she cannot get access to an abortion procedure.

Psychiatrists in Ireland have been telling us for decades that suicidal thoughts should be taken with the utmost seriousness, that they are a sign of mental illness, clinical depression etc, and that psychiatric intervention should be sought immediately – because – they told us- suicide is life threatening and they tell us- depression itself is life threatening because of the risk of suicide.

Yet- 113 Irish psychiatrists have basically just come out and said that suicidality should not be taken seriously if that suicidal individual happens to be a pregnant woman- and suicidality- according to Irish psychiatry – should be viewed with suspicion, contempt and skepticism when that pregnant woman is also seeking an abortion because of it. In other words- they know that they can’t assess whether someone is really suicidal or not.

For decades psychiatrists have been telling us that they are the experts on suicidality but now they seem to saying that they can’t predict suicide. If – as they now admit- they cannot predict suicide, can they be trusted to diagnose ‘mental illness’ at all?

This undermines the credibility of the entire practice of psychiatry because it is their so called ‘expertise’ in matters of suicidality, in particular suicidality and its relation to mental illness -which are exposed under the spotlight by this debate. In effect, their expertise in matters of mental distress are revealed to be -not so expert -after all.

Do you see the gaping holes in the logic here?

On the one hand Irish psychiatry have been saying for years that depression is a life threatening illness solely because of the risk of suicide inherent with depression. But on the other- they are now saying that up to three doctors have to assess the ‘suicide risk’ of a pregnant woman before she is effectively deemed authentically suicidal enough to have an abortion. Or at least convincing enough to warrant an abortion in order to protect her life.

This is not about ‘abortion as a treatment’ for suicidal pregnant women- it’s the so called ‘pro-life’ brigade who have inserted this baseless mantra into Irish media discourse- this is about Irish psychiatrists caught up in their own religious views clouding reality- it is also about psychiatry in Ireland being unwilling and blatantly ill-equipped for the position which for so long they have claimed legitimacy over:  the treatment of suicidality.

You can’t have it both ways.

Take for instance, the vociferous ‘pro-life’ opinion of Dr Patricia Casey, a member of the Iona Institute Catholic think-tank. Casey is a controversial Irish psychiatrist for many reasons which I won’t cover here but in the context of suicidality she says :

In practice, the risk of suicide, even in high-risk groups such as those with serious mental illness, is very low. And among pregnant women the risk of dying by suicide is lowest of all.

Casey states here that ‘the risk of suicide even in high risk groups such as those with serious mental illness is very low.’

That statement is completely at odds with what psychiatrists have been telling us for years- in particular in relation to the risk of suicide in depressed people. So all of a sudden- suicidality in serious mental illness is not really that much of a big deal?

She also says that the risk of dying by suicide is lowest of all in pregnant women. While this might be true- just because it’s a low risk- doesn’t mean it is zero risk. So effectively, Casey and her cohorts admit there is a risk – albeit low. Therefore what Irish psychiatry are really implying is- Irish women seeking abortions will lie about their suicidal states in order to get one and Irish psychiatrists don’t want to be involved in assessing or facilitating this process. Is this not insulting – not only to all women in Ireland? but does it not also demean the seriousness of suicidality itself? And furthermore does it not indicate the blatant hypocrisy of the Irish psychiatric profession, which for decades has claimed to be the only authority on ‘mental illness’, ‘suicide’, ‘depression’ etc?

Irish psychiatry have shot themselves in the foot once again. Abortion is a secular and civic debate, it is a human rights and personal rights issue. It is one of personal individual autonomy. Moral and religious persuasions should not influence professional and scientific opinions.

So hypothetically – if we be the devil’s advocate here- and take Irish psychiatry’s oxymoronic opinion that ‘abortion is not a treatment for suicidality’  then what do they suggest a distressed and pregnant Irish woman do if she is feeling suicidal? Presumably they will try to offer her psychiatric treatment? If so- what psychiatric treatment is available to a suicidal pregnant woman in Ireland. Well- according to Dr Moosajee Bhamjee- there is little or no ‘talk-therapy’ available in Ireland and the waiting lists for psychotherapy can be month’s long. Therefore- I presume that the ‘treatment’ available to a depressed and suicidal pregnant woman in Ireland would predominantly be SSRI drugs?

SSRI drugs are known to cause birth defects, they can also be addictive and cause severe side effects- which includes suicidal ideation, aggression, etc.

Is this really an adequate treatment for a woman who is already depressed, anxious, suicidal and traumatized by an unwanted pregnancy? Or will the panel of psychiatrists who are called upon to assess whether she is adequately suicidal enough, or at least convincingly suicidal enough -permit her to have a medical procedure which might save her life? Or faced with a draconian style inquisition of skeptical and intimidating psychiatrists- will, emotionally fragile and distressed, pregnant Irish women continue (as they have done for decades) to seek proper medical care elsewhere?

Only time will tell..

Personally I think Ireland needs to propel itself pronto into the 21st century.

The Catholic church has had a strangle-hold upon the monopoly of morals, how people live, their sexual persuasion, what they should believe, their marriage rights and their education for far too long.

Irish psychiatry has also had unquestionable authority upon the ‘mental and emotional’ health of Irish citizens for far to long too…

Despite the fact that both are utterly corrupt- and in the case of Irish Psychiatry – utterly devoid of compassion, logic and reason…

Ironically- the Irish psychiatrist Dr Veronica O’Keane seems to be the only one who sees sense.

Although I am not a fan of her opinion on SSRI drugs-  but when it comes to abortion and suicide -at least someone in Irish psychiatry seems to possess an iota of humanity and logic:

Professor of Psychiatry at Trinity College Dublin Veronica O’Keane has said psychiatrists are legitimately deemed best placed to assess suicide risk and if there was a mental illness in a woman it would be their role to treat that illness.

Speaking on RTÉ’s Today with Pat Kenny, Dr O’Keane said if there was the presence of mental illness it sometimes would make a doctor less likely to recommend an abortion.

She said situations are different, and she thought it was much easier to make a decision in the absence of mental illness.

“I think this legislation is primarily for women who are suicidal because they have an unwanted pregnancy and that is the only way of resolving their suicidal problems – is to have a termination,” she said.

Responding after the programme, Psychiatrist Prof Patricia Casey said that the legislation will allow for abortion in the case of women without mental illness, who simply do not wish to give birth to an unwanted baby.

Prof O’Keane also described as “an absolute farce” a survey by a “pro-life” group that claimed 120 psychiatrists who responded did not agree with proposed legislation to legislate for the X Case based on the suicide provision.

Prof Keane said it was a survey conducted by a statedly-biased group and it was done without the permission of the College of Psychiatry Ireland.

She said that those conducting the survey had not gone through the college’s procedures and the survey would not have passed through the college’s guidelines.

She said the survey did not represent psychiatrists.

Describing the survey as it stood as “incomprehensible, and garbled”, she said it did not make any sense.

Prof Casey threatened to leave the studio if she could not respond.

Prof Casey said that the reason they did not do the survey through the college was because they could not get the names of the college membership, in relation to a previous study.

So, she said, when this study was happening she said that “they could not get the numbers from them”.

In a statement following the programme, Prof Casey said: “This was not a College of Psychiatry survey, nor did it purport to be. It was a letter that was sent, asking consultant psychiatry colleagues if they agreed with a particular statement, relating to the involvement of psychiatrists in relation to the current abortion proposals.

“The issue of obtaining permission from the college does not apply. We received a 42% response rate, and it cannot be reasonably argued, by Prof O’Keane, that it was incomprehensive. The overwhelming majority agreed with the statement.

“The question of peer review does not arise.”

http://www.rte.ie/news/2013/0503/390162-fianna-fail-pregnancy/

For an interesting insight into the hypocrisies of the abortion/suicide debate – check out the podcast from RTE’s Pat Kenny here:

http://www.rte.ie/radio1/today-with-pat-kenny/podcasts/

http://www.tv3.ie/3player/show/41/62035/0/Tonight-with-Vincent-Browne

http://leoniefennell.wordpress.com/2013/05/04/patricia-casey-v-veronica-okeane/

Savita Halappanavar

Great post by Bob Fiddaman over at Seroxat Sufferers Blog (more on this later)..

Check it out..

http://fiddaman.blogspot.ie/2013/05/patient-information-or-litigation.html?spref=tw

Thursday, May 02, 2013

Patient Information or Litigation Disclaimer?

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I was browsing through some SSRi patient information leaflets [PILs] earlier and have come to the conclusion that the manufacturers warnings about this, that and the other are merely coded messages to the consumer.

Years ago, when SSRi’s first hit the market, there were few warnings of side-effects. Sure, back then we had dizziness, nausea, sweating etc but that’s standard for most, if not all, prescription medicines.

Today, after US litigation, patient reporting and, it has to be said, internet activism, the PILs take on a completely different look. They [the manufacturer] are telling us we can’t sue because we were told.

It’s almost as if pharmaceutical compliance departments had a eureka moment and turned really bad news into something that could be productive in the future. “Hey if we stick broad but vague warning labels on our drugs then we cover ourselves from future litigation… quick, get the number for that medical ghostwriting team we used back in 1998″

Let’s take a look at Seroxat for example. [NHS Information]

Motion to dismiss

1. Some people who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment. 

Very vague statement but one that would certainly be used by GlaxoSmithKline attorneys if they were ever faced with a lawsuit. “There is no case for your client as my client clearly stated in the patient information leaflet that Seroxat wasn’t for everyone.”

2. “If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide.

“If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible.”

Again, Glaxo attorneys could have a field day, “Your honour, we have reason to believe that the deceased did not contact their prescriber, yet my client clearly stated in the patient information leaflet for them to do so if they were feeling suicidal, therefore we argue that there is no merit in this case” 

 3. Seroxat is not suitable for everyone and some people should never use it.

“Your honour, if the deceased had killed themselves by touching an electrical fence despite there being a warning not to do so would my learned friends still be representing him in court?” 

4. Over time it is possible that Seroxat can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately.

“Your honour, the plaintiff may have become, over time, unsuitable for our client’s product, he may also have had an adverse reaction to my client’s product. At no time, leading up to his attempted suicide, did he contact his prescriber despite the fact that my client had advised this in the patient information leaflet.”

5. You should only take this medicine during pregnancy if your doctor thinks that you need it

“Your honour, whilst my client has every sympathy for the birth defects the child in this case was born with, it was not my client’s fault. My client never prescribed Seroxat to this young mother, it was her doctor.”

6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth

“Your honour, how many warnings did this mother need, was she illiterate, could she not read? My client refutes any responsibly with regard to the plaintiff’s son being born with septal heart defects. In fact, my client believes that it should be the plaintiff who should be facing prosecution for acting irresponsibly.”

 7. This medicine may decrease fertility in men.

“Your honour, he was warned.”

8. Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.

“Your honour, my client blames the plaintiff and both the doctor and midwife, they should have read the patient information leaflet.”

Judge’s summation - Sadly, it is with great regret that I am granting GlaxoSmithKline motion to dismiss on the grounds that they covered all bases for any future litigation by applying warnings to their patient information leaflet. I am, however, recommending that in future Glaxo elaborate on the warnings. My recommendations are underlined:

1. Some people, particularly those who are poor metabolizers, who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment. GlaxoSmithKline nor your prescriber cannot tell you if you are a poor metabolizer so, in essence, by administering Seroxat you are playing solo Russian roulette.

2. If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide. Changes such as an increase in depression, anxiety, an inability to sit still, a lack of empathy toward others, excruciating electric-like zaps in your head, horrific nightmares where the subject matter is death, homicide, suicide. Outbursts of anger, for no apparent reason, aimed at those you love. If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible. NHS Direct et al should then telephone a 24 hour hotline, manned by an independent body who have no financial ties to GlaxoSmithKline, and request a safe withdrawal protocol. The patient should be hospitalized, at GlaxoSmithKline’s expense, and monitored at regular intervals. Any item of clothing that could be used as an instrument for suicide must also be removed. GlaxoSmithKline’s CEO, Sir Andrew Witty, should be contacted, no matter what time of day or night it is. Sir Witty may then realise that bad things didn’t just happen to patients under JP Garnier’s watch, they are still happening and are not part of “an era”. Sir Witty can sit with the patient while he/she experiences thoughts of self-harm and/or suicide. Because of the logistics and vast number of people who suffer these kind of adverse reactions to Seroxat it is recommended that Sir Witty handpicks a team of GlaxoSmithKline executives to be on emergency call to tend to the needs of Seroxat induced suicide victims.

3. Seroxat is not suitable for everyone and some people should never use it. Some people cannot excrete Seroxat from their system quicker than others. This means that they build up toxic levels of the drug, in fact these people are overdosing on Seroxat without actually knowing it. This simple fact should be made crystal clear in future patient information leaflets. Sir Witty and his handpicked team of executives should disseminate this information to the public by word of mouth. Alternatively  a full page advertisement can be used in popular mainstream newspapers to warn this vulnerable patient population. “Toxic levels of Seroxat may lead to self harm and suicidal thoughts” should also be added to the patient information leaflet.

4. Over time it is possible that Seroxat can become unsuitable for some people, particularly those who are poor metabolizers, or they may become unsuitable for it, particularly those who are poor metabolizers, If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately. The Prescriber should then contact GlaxoSmithKline to file an adverse reaction report. In turn GlaxoSmithKline should investigate the adverse reaction and report back to the prescriber with a causality assessment. This will then help the prescriber decide, in future consultations with patients, if Seroxat is the drug for them.

5. You should only take this medicine during pregnancy if your doctor thinks that you need it – This whole sentence needs drastic change. A doctor does not have access to the rat pup studies that GlaxoSmithKline has and kept from the public. Expectant mothers should be made aware of the Sloot study whereby Seroxat and other SSRi’s were exposed to rat fetuses. Out of all the SSRi’s used in this study only one came out as a clear teratogen – Seroxat. Another example of a teratogen, in case consumers are not aware of the word, is the anti-nausea and sedative drug, Thalidomide.

6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth. The sort of ‘problems’ are:


Persistent Pulmonary Hypertension of the Newborn (PPHN) – 6 times increased risk
Anencephaly (fatal neural tube defect) – 2.5 times increased risk
Clubfoot – 5 times increased risk
Craniosynostosis (craniofacial defect) – 2.5 times increased risk
Omphalocele (abdominal wall defect) – nearly tripled risk
Gastroschisis (abdominal wall defect) – 30 percent increased risk
Pulmonary Atresia – 3 times increased risk
Spina Bifida – 60 percent increased risk
Diaphragmatic Hernia – 80 percent increased risk
Anal and Esophagal Atresia – 30 percent increased risk
Heart Defects – nearly doubled risk
Septal Defects, including Atrial and Ventricular (also known as “hole in the heart” defects)
Hypoplastic Left/Right Heart Syndromes
Malformed or blocked heart valves that will not close
Transposition of the Great Arteries
Tetralogy of Fallot
Mitral Valve
Heart murmur

Like packets of cigarettes I make the recommendation that GlaxoSmithKline add a photograph to the packaging of Seroxat. An example is below.

Spina Bifida – 60 percent increased risk when taking Seroxat [1]

7. This medicine may decrease fertility in men. Given recommendation 6 this may not be such a bad thing, particularly if the female partner is also digesting Seroxat. Sir Witty and his team of handpicked executives may wish to visit any male patient who has decreased fertility as a result of taking Seroxat and, if requested, help to fill out some adoption forms for the wannabe father. GlaxoSmithKline shall foot the bill for the whole adoption procedure, including lawyers fees and expenses for the child up to the age of 19.

8. Before you have your baby you should discuss breast-feeding with your doctor or midwife as Seroxat can find a way into your baby when he/she breast feeds. This can cause serious implications for the newborn child and may result in Seroxat overdose, addiction, agitation and in some instances death. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. They will also offer you the court transcripts from the Kilker Vs GlaxoSmithKline birth defect trial where GlaxoSmithKline were found guilty for manufacturing a drug [Seroxat] that caused Lyam Kilker to be born with heart defects. This will  help expectant mothers to make a fully informed decision and may deter them from breast feeding given that Seroxat can harm a baby whilst it is still in the womb so chances are the baby can be harmed if ingesting breast milk that is still in the mother’s system. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife and with the knowledge that your doctor or midwife actually know what they are talking about.

I make these recommendations with the knowledge that healthcare professionals and GlaxoSmithKline have the right to ignore them as do global medicine regulators and coroners. In fact, the word ‘recommendation’ means nothing. It just makes people like me seem as if I really care when in actual fact I’m just recommending what I think should be done but I know that the likelihood of any recommendations made simply means that nothing has to be adhered to. I’m a Judge and I have to be seen to be doing something. I use war as an example. World leaders got together to fight the might of Hitler. At some point it was only recommended that they intervene. They didn’t have to but because they did they stopped Hitler, some would suggest that those recommendations to intervene should have been carried out earlier, maybe more lives would have been saved. Thing is, those recommendations were listened to, they were put into place and we are a better world for it.

I would urge for GlaxoSmithKline’s CEO and handpicked executives to search their consciences but past litigation [in the US] has shown that these individuals blame everyone and everything but their product.

I would like to recommend that Seroxat is removed from the shelves but know I would face tough opposition from those who have been duped into believing that the benefits of this particular antidepressant outweigh the risks. The risks, all of them, should be printed out in clear laypersons terms, again, I can only recommend this. I do know that, after reviewing all the court documents in cases such as Seroxat induced suicide, Seroxat birth defects, Seroxat withdrawal/addiction, that I will never allow any family member of mine to take this drug. That’s my privilege as I am a Judge.

Glaxo’s motion to dismiss – Granted.

Rt Hon Judge I.M Pointless


**Footnote**

Later that year the Rt Hon Judge I.M Pointless granted the same motions to Eli Lilly, Wyeth, Pfizer, Forest Labs, Lundbeck and other SSRi manufacturers, including those manufacturers that make generic versions of SSRi medication. 

He also made similar recommendations.

[1] Birth Defects Cased By Seroxat [Birth Defect Resource]

Bob Fiddaman

“Irony is wasted on the stupid”  (Oscar Wilde)

Interesting to see Seroxat back in the news of late- this time though not because of its propensity to cause suicide, homicide, birth defects or withdrawal- but because apparently GSK are being accused of an illegal ‘pay to delay’ deal with their generic rivals going back to the early 2000′s.

What makes this interesting is the response from GSK CEO – Sir Andrew Witty- his comments about this latest accusation in relation to GSK’s notorious Seroxat drug are subtle but loaded…

You will notice that Andrew Witty fails to really deny that GSK did a ‘pay for delay deal’- but he implies that the headlines on this scandal have been ‘misleading‘. I think for a drug company which has consistently misled its patients, share-holders, regulators, governments and practically every stakeholder related to it for the past 20 years- to use the word ‘misleading’ in any context is an irony that Oscar Wilde would surely appreciate…

http://www.philly.com/philly/blogs/phillypharma/With-Supreme-Court-weighing-a-case-GSKs-Andrew-Witty-says-pay-to-delay-label-misleading-defends-such-settlements.html

With Supreme Court weighing a case, GSK’s

Andrew Witty says ‘pay-to-delay’ label

misleading, defends such settlements

David Sell

As drugmaker GlaxoSmithKline reported 25 percent lower, after-tax profits in the first quarter of 2013 compared to a year earlier, chief executive officer Andrew Witty said Wednesday that the company would reorganize its pharmaceutical operations, opening the potential of sale of older brands.

Glaxo is based in London, but has about 1300 employees in Philadelphia’s Navy Yard and more in other facilities in Pennsylvania and New Jersey.

Meanwhile, with UK authorities criticizing GSK for trying to delay the introduction of generic competitors nearly 10 years ago and the U.S. Supreme Court weighing a case, Witty defended the business practice.

The UK’s Office of Fair Trading alleged on April 19 that GSK had abused its dominant position in the UK to delay the introduction of generic medicine by paying off three generic drug companies. GSK said the allegations stemmed from activity between 2001 and 2004, that it was cooperating with the investigation, but thought it had acted within British law.

In many countries, patents on drugs give manufacturers exclusivity in the marketplace, allowing them to charge more for a drug.

In the United States, branded and generic companies have had made such deals for nearly 30 years, and they are called reverse payments or pay-to-delay deals. Basically, the generic company applies to the FDA for approval of a drug that it says is close to a copy of the branded product, but not so close as to infringe on the patent. The branded company sues, claiming patent infringement. Sometimes they settle the suit, with the generic drugmaker able to sell its version earlier than it would have if it waited for the patent to expire.

But sometimes those settlements are made with the branded company paying the generic company, and that prompted the U.S. Federal Trade Commission to object. The FTC argues that the growing number of deals involving payment restrict trade and hurt consumers and taxpayers.

The U.S. Supreme Court heard arguments on March 25 and will likely decide whether such deals are legitimate by the end of its term in June.

When asked by the Inquirer about the practice, Witty declined to discuss specific cases, but he defended the general practice.

“I push back at the description of ‘pay-to-delay’ as a label,” Witty said from London in a conference call with reporters. “It is a convenient label that people have chosen to use. But in many situations – and I’m talking generically here and not specifically about any particular case – there has been a settlement between the patent holder and a non-patent holder, which usually leads to the generic product being made available before the expiration date of the patent. What is achieved in that is the elimination of uncertainty for both sides.

“The patent holder has a patent. The challenger wants to challenge that patent. But neither side knows what the outcome of that [litigation] is going to be – other than it is going to be a difficult process and expensive. As a consequence, sometimes settlements make sense for parties concerned. But almost always, those settlements lead to the generic being made available earlier than waiting for the patent to expire. Within that, I think it is entirely reasonable that the patent holder should be able to come to settlement to take away the uncertainty. Presumably, the challenger would only enter into such a settlement if it also made sense for them, for the mirror image reason, ie., they don’t have certainty either. Every case is different and every challenge is different. But I would push back on this, I think, misleading label.”

As for the reorganization inside the pharmaceutical division of the company, Witty said GSK will shift about 50 “legacy” prescription medicines that are promoted lightly, if at all, into one category and that group’s finances would be reported separately starting in January of 2014. This group of products will be called “Established Products.”

Glaxo has a consumer segment that sells such things as toothpaste and denture products. But the other two pharmaceutical groups would be one that deals with products currently on the market and receiving promotional resources, with the second being products in the pipeline but not yet approved or launched. Glaxo has submitted six drugs for approval by the U.S. Food and Drug Administration and the European Medicines Agency.

Witty said the established products – such as Zantac, Imitrex and Zofran – amount to about $4.5 billion in revenue, and he was asked if it signaled an intent to sell those products.

“How it might play forward beyond that is an open question,” Witty said. “It is a sensible move for us to make sure we are maximizing value in the short run. But, of course, it opens optionality for the future. I would not give any guidance on how or when that might evolve, but it opens some optionality.”

Glaxo had $9.9 billion in sales in the first quarter, which was a drop from $10.1 billion in the same period in 2012.

The after-tax profit for the first quarter of 2013 was $1.57 billion, which compared to $2.1 billion for the same period in 2012. One factor in the difference in profit was that in January of 2012, GSK reported the $660 million sale of some of its over-the-counter brands to Prestige Brands Holdings, Inc.

Witty said Wednesday, as he has done in the past, that he has no plans for GSK to enter the generic drug market.

“There is absolutely no interest in going into the generics business,” Witty said. “That is a long-held view of mine and that view has not changed.”

A link to the quarterly financial report is here.

Here are some articles pertaining to how GSK have consistently been accused of ‘misleading’ the public..

GSK misled over Serevent data?

October 10, 2005
| PharmaTimes

GlaxoSmithKline is in the firing line again after a letter published in The Lancet accused the firm of misleading regulators over clinical data for its asthma compound, Serevent (salmeterol), which is also an active ingredient in its multi-billion dollar offering Advair (salmeterol/fluticasone). However, the news has been strongly combated in a responding article from the UK drug giant. Public Citizen, the US consumer group, said a 1996 trial – the Salmeterol Multicenter Asthma Research Trial – showed an increased risk of asthma death amongst patients taking GSK’s drug. These results have never been published, it says, despite interim results being presented to the US Food and Drug Administration in July 2003 at a review by the agency’s advisory committee. Final study data were submitted to the FDA on August 29, 2003, but included adverse event observations reported six months after the 28-day trial ended, which Public Citizen claims went against the trial’s protocol: “The inclusion of the post-study data reduced the apparent dangers of salmeterol with respect to four critical study outcomes, including asthma-related death.” The FDA questioned the results in 2004, and in July its advisory board recommended strengthening the warning labels for both Serevent and Advair to caution about the risk of asthma-related death [[14/07/05a]]. However, the agency has yet to make its final decision. “The behavior of GlaxoSmithKline in submitting these faulty data is deplorable,” said Peter Lurie, deputy director of Public Citizen’s Health Research Group and co-author of the letter. Without “greater transparency at the FDA, we will never know how often this kind of self-serving data analysis occurs.” However, in a hard-hitting response to Dr Lurie, the company said: “GSK has acted responsibly and transparently and communicated with a sense of urgency to ensure that healthcare professionals and patients had access to the results of SMART.” It argued that the protocol did specify both the collection of reported events during the 28-week study period and during a 6-month follow-up. The results, it stresses, were disseminated in a variety of means: the company said it issued two ‘Dear Healthcare Professional’ letters, posted notices on its website and that of the FDA, presented the results at a medical meeting in 2003, and included the information in its online clinical trial registry. However, GSK will likely be unhappy at being back in the spotlight again as it was questions over its antidepressant, Paxil/Seroxat (paroxetine), that led to the global move towards making clinical trial data – both positive and negative – publicly available [[03/06/04a]], [[17/06/04b]].

http://www.pharmatimes.com/mobile/05-10-10/GSK_misled_over_Serevent_data.aspx

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UK Funds: Glaxo Misled On Avandia Risks

Posted Sat, 09/15/2007 – 9:08am by Ed Silverman 0
jp-garnier.jpgJust one more example of investor dissatisfaction with JP Garnier. The North Yorkshire Pension Fund and the Avon Pension Fun, which together manage more than $6 billion in assets, are vying to be lead plaintiffs in a US class-action lawsuit filed against the drugmaker for misleading investors over the risks of its Avandia diabetes pill.

The lawsuit seeks unspecified damages related to a slide in the group’s share price that followed a study published in May in the New England Journal of Medicine claiming that Avandia raised the risk of heart attack by 42 per cent. The findings, denied by GSK, wiped about $18 billion off its market capitalisation.

The two UK funds claim they lost roughly $5 million. “We are joining [the lawsuit] because it is in our members’ interests to do so,” Neil Sellstrom, of the North Yorkshire fund, tells The Times of London.

The lawsuit alleges Glaxo “engaged in a scheme to deceive the market and a course of conduct that artificially inflated GSK’s stock price” and “failed to adequately disclose” important risk info. Glaxo is accused of “fraud” and “deceit.” A spokesman for GSK said that the company believed the lawsuit had no merit and would vigorously defend itself.

Glaxo investors are increasingly unhappy with the drugmaker’s share price and some are agitating for Garnier to sell off various pieces, such as the consumer healthcare business or vaccines research. For his part, the indefatigable Garner refuses to consider such moves and last week brushed aside the criticism.

Garnier, however, continues to suffer setbacks. At week’s end, the FDA further delayed approval of Entereg, an experimental constipation med that’s being developed by Glaxo’s partner, Adolor. The agency previously issued an approvable letter back in June, which itself was a disappointment.

http://www.pharmalive.com/uk-funds-glaxo-misled-avandia-risks

Professor says GSK knowingly mislead about Paxil safety

Jon Jueridini, a professor of psychiatry at the University of Adelaide in Australia, recently authored an article claiming that the pharmaceutical company GlaxoSmithKline seriously misrepresented safety and effectiveness data when publishing information about its antidepressant Paxil, also known as paroxetine. GSK was previously known as SmithKline Beecham, and is currently involved in ongoing Paxil litigation over birth defects.

In an article for the Website “The Conversation,” Jueridini details information that he came across while examining internal documents as an expert witness in a case against a pharmaceutical company.

Between 1993 and 1998, he writes, GSK paid $5 million for research into Paxil.

Researchers subsequently published the results in the Journal of the American Academy of Child & Adolescent Psychiatry in 2001, asserting that Paxil “is generally well tolerated and effective for major depression in adolescents.”

Jueridini characterizes this as a “serious misrepresentation of both the effectiveness and safety of the drug.” Children on Paxil did no better than those on placebo in the studies, Juerdini writes, but the company misrepresented or flat-out omitted any negative findings in the published results.

Other alarming information has since come to light concerning Paxil and other antidepressants classified as selective serotonin reuptake inhibitors, or SSRIs. In July of 2007, the New England Journal of Medicine published a study by the federal Centers for Disease Control and Prevention that showed babies born to mothers who took SSRIs such as Paxil, Prozac, and Zoloft during the second half of pregnancy had a significantly increased risk of being born with birth defects, including serious respiratory disorders.

See the article here: https://theconversation.edu.au/insight-into-how-pharma-manipulates-research-evidence-a-case-study-4071

Related posts:

GSK Paxil settlement has lessons for consumers
Study questions safety of antidepressants
GSK CEO addresses company’s fraud allegations
Paxil manufacturer paying record settlement for fraud
Book takes critical look at antidepressant marketing
Unpublished studies distort assessment of treatments
Article questions psychiatry’s reliance on drugs
Psychologist believes antidepressants overprescribed

http://www.lopezmchugh.com/2012/04/21/professor-says-gsk-knowingly-mislead-about-paxil-safety

An attorney for an upstate New York gun owner claims his client’s permit to own firearms was suspended by state police because he received a prescription for anti-anxiety medication.

The action, Tresmond said, resulted from the New York SAFE (Secure Ammunition and Firearms Enforcement) Act of 2013, signed into law on Jan. 15 in the wake of the Newtown, Conn., shootings, in which gunman Adam Lanza killed 20 children and six adults.

“It’s disconcerting to know that if your doctor prescribes you a psychotropic medication … that results in the state police trolling to pick up this information, and if you do have a gun license, it will be revoked,” Jim Tresmond, attorney and gun-rights advocate, told Buffalo news station WKBW.com.

Authorities have not confirmed that the man’s prescription for anti-anxiety medication was the cause for the suspension of his gun permit, though Tresmond said it was.

http://www.livescience.com/28617-prescription-meds-gun-control.html

The debate above shows the utter farce of Irish Psychiatry.
As usual, nobody who actually has experienced psychiatry- or as Pat Bracken calls them the ‘service users’- are represented on the show.

In the following video- a typical example of the patient/psychiatrist divide is illustrated by a woman who was forcibly drugged and Electro-Shocked.

The condescending manner of psychiatrists towards their ‘patients’ is clearly illustrated by Anne Jeffers here. Psychiatry is about power, nothing else.

Psychiatrists excuse their drug treatments away by claiming that they don’t have funding for talk-therapists, yet many consultant psychiatrists are paid hundreds of thousands a year- how about they take a cut in their wages and employ a psychologist and psychotherapist to work alongside them? They won’t do this because they want to keep their monopoly on the lucrative business of ‘mental health’- a business which uses human distress as fodder…

Lundbeck, The manufacturers of SSRI Cipramil are the main sponsors of the Irish association of Suicidology- Check out the document below and ask yourself- how lucrative is human distress for the pharmaceutical industry and psychiatrists in Ireland?

http://www.ias.ie/index.php?option=com_content&view=article&id=6%3Ainauguralaward&catid=2%3Anews&Itemid=2

http://isepp.wordpress.com/2012/04/03/mother-speaks-on-paxil-withdrawal-until-you-have-witnessed-it-you-can-not-even-imagine-what-it-is-like/

Mother speaks on Paxil withdrawal: “Until you have witnessed it, you cannot even imagine what it is like”

Posted on April 3, 2012 by isepp

3 Votes

Posted by Maria Mangicaro

Laurie Yorke, a NJ nurse, shares her family’s experience at one of the ISEPP (formerly ICSPP) conferences.

For more information on Paxil withdrawal please visit www.PaxilProgress.org

PaxilProgress is a peer-to-peer message board community for people to share their personal experiences with taking antidepressants, and allows others to ask questions, and to learn from each other, and make their own, more informed decisions.

The International Society for Ethical Psychology & Psychiatry is an independent organization which currently takes no monies from external sources.  Our annual conferences are a major outlet for cutting-edge information in mental health.

The ISEPP 2012 conference, “Alternatives to Biological Psychiatry II: Treatments That Work“, is scheduled for November 2-3 at the Airport Marriot Hotel in Philadelphia, Pennsylvania.

The Foundation for Excellence in Mental Health Care will be joining ISEPP at the conference and will be leading a strategy session on Satuday afternoon. We are also collaborating with MindFreedom International which will host a one-day event on Thursday, November 1 at the hotel and the The Philadelphia Society for Psychoanalytic Psychology (PSPP) which will be hosting an event on the afternoon of Sunday, Novmber 4, 2012 at the hotel.

One of the keynote speakers will be Dr. Grace Jackson, author of Rethinking Psychiatric Drugs: A Guide for Informed Consent and Drug-induced Dementia: a perfect crime.

Click here for registration information.

**THIS VIDEO DOES NOT PROVIDE MEDICAL ADVICE. The content is not intended to be a substitute for professional medical advice, diagnosis, or treat.  Abrupt stopping of psychiatric medications can be dangerous, please consult your physician to make any decisions about changes in psychiatric medications.

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One Response to Mother speaks on Paxil withdrawal: “Until you have witnessed it, you cannot even imagine what it is like”

Glenn says:

April 8, 2012 at 1:16 pm

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Looking for more information on effects of paxil withdraws after taking it for ten years and the doctor stops it all of a sudden. Any information will help. Thank you