Dr David Healy… “Study 329 Trick, Treat or Treximet”…


http://davidhealy.org/study-329-trick-treat-or-treximet/

Study 329 Trick, Treat or Treximet

October, 31, 2016 | 21 Comments

The Paxil/Seroxat Study 329 Story In 2016: Project Censored : Downplayed stories illuminate larger patterns in inequality, spying, the environment and corporate influence ..


http://www.sfreporter.com/santafe/article-12640-project-censored.html

Crisis in Evidence-Based Medicine

The role of science in improving human health has been one of humanity’s greatest achievements, but the profit-oriented influence of the pharmaceutical industry has created a crisis situation. That research simply cannot be trusted. Burying truth for profit is a recurrent theme for Project Censored. The top story in 1981 concerned fraudulent testing from a single lab responsible for one-third of the toxicity and cancer testing of chemicals in America. But this problem is much more profound.

“Something has gone fundamentally wrong,” said Richard Horton, editor of The Lancet, commenting on a UK symposium on the reproducibility and reliability of biomedical research: “Much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness. … The apparent endemicity of bad research behavior is alarming.”

Horton’s conclusion echoed that of Marcia Angell, a former editor of the New England Journal of Medicine, who went public in 2009.

A classic case was Study 329 in 2001, which reported that paroxetine (Paxil in the United States and Seroxat in the United Kingdom) was safe and effective for treating depressed children and adolescents, leading doctors to prescribe Paxil to more than 2 million US children and adolescents by the end of 2002 before being called into question. The company responsible (now GlaxoSmithKline) agreed to pay $3 billion in 2012, the “largest healthcare fraud settlement in US history,” according to the US Department of Justice.

Nonetheless, the study has not been retracted or corrected, and “none of the authors have been disciplined,” Project Censored points out. This, despite a major reanalysis which “‘starkly’ contradicted the original report’s claims.” The reanalysis was seen as the first major success of a new open data initiative known as Restoring Invisible and Abandoned Trials.

While Project Censored noted one Washington Post story on the reanalysis, there was only passing mention of the open data movement. “Otherwise, the corporate press ignored the reassessment of the paroxetine study,” and beyond that, “Richard Horton’s Lancet editorial received no coverage in the US corporate press.”

Source: The Lancet 385, no. 9976, 2015; Cooper, Charlie, “Anti-Depressant was Given to Millions of Young People ‘After Trials Showed It was Dangerous,’” The Independent, 2015; Boseley, Sarah, “Seroxat Study Under-Reported Harmful Effects on Young People, Say Scientists,” The Guardian, 2015.

Interesting post about Seroxat from another blog


http://ocdguyuk.blogspot.ie/2015/11/seroxat-patient-information-leaflet.html

OCD Guy UK

About my thoughts and findings on OCD

Friday, 27 November 2015

Seroxat: Patient Information Leaflet Revision: Changes from August 2014 – March 2015

Seroxat

Patient Information Leaflet (PIL)

Revisions

Disclaimer

  • These are my own notes of changes I’ve noticed whilst eyeing up the leaflets. These are not definitive and I may have missed changes, misinterpreted a change or misspelled a word. Do not take what I’ve written as absolute. Please see your doctor or pharmacist if you have any concerns over the contents of your PIL.
  • For the definitive list of revisions or to enquire about the revisions if you have any concerns, please see your doctor or pharmacist.
  • Online information on revisions to Seroxat PIL can be found http://www.medicines.org.uk/emc/history/3185 but is very thin on what the changes are, hence why I do this blog post.

 Changes from PIL dated August 2014 

to PIL dated March 2015

——————————————————–
What’s been added
——————————————————–

Section 2: What you need to know before you take seroxat

Under “Important side effects seen with seroxat”:

“or neuroleptic malignant syndrome” added to sentence after “Other patients develop something called serotonin syndrome …”

“feeling very agitated or irritable, feeling hot, muscle stiffness” added to list belonging to sentence which says“… where they have some of all of the following symptoms”

Under “Other medicines and seroxat”

“Pravastatin, used to treat high cholesterol” added to list.

Section 4: Possible Side Effects

After “Allergic reactions to Seroxat” … “(shortness of breath)” has been added after the symptom “difficulty breathing”

After “Allergic reactions to Seroxat” the following symptoms have been added … “and feel weak or lightheaded resulting in collapse or loss of consciousness”

Section 4: Possible Side Effects

Under “Frequency Unknown” section, the following has been added “Some people have experienced aggression whilst taking seroxat”.

Under “Other possible side effects during treatment”, under “Uncommon side effects, likely to affects 1 in every 100 people”, the following has been added “If you are a diabetic patient you may notice a loss of control of your blood sugar levels whilst taking seroxat. Please speak to your doctor about adjusting the dosage of insulin or diabetes medications.”

Under “Other possible side effects during treatment”, under “Rare side effects, likely to affects 1 in every 1,000 people”, the following has been added “Menstrual period disorders (including heavy or irregular periods, bleeding between periods, and absence or delay of periods.”

Section 6: Contents of the pack and other information”

Under “Marketing Authorisation Holder and Manufacturer” there are now two manufacturers.

Previously it was just the manufacturer in Romania. Now the “Seroxat 20mg film-coated tablets” are made by manufacturer in Poland and the “Seroxat 10 and 30mg film-coated tablets” are made by the manufacturer in Romania.

——————————————————–
What’s been altered
——————————————————–

Section 4: Possible Side Effects

After “Very rare side effects, likely to affect up to 1 in every 10,000 people:” the first bullet point has had the title altered from “Allergic reactions to Seroxat” to “Allergic reactions, which may be severe to seroxat”

——————————————————–
What’s been removed
——————————————————–
NONE

The Elephant In The Room: Seroxat (Aropax/Paxil/Paroxetine) In The Adult Population…


ParoxetineWC

The past few days has seen a flurry of news articles about the restoration of GSK’s paroxetine study 329. This new interpretation of GSK’s infamous Seroxat study in adolescents has shown that the drug can be extremely harmful. It is estimated that up to two million American kids were prescribed the drug, and back in 2002, the head of the MHRA (at the time), Alastair Breckenridge, estimated that up to 7,000 or so, kids a year, were being prescribed Seroxat in the UK.

GSK’s spokesperson at the time, Alasdair Benbow, tried to play down the risks by comparing this suicide risk to a ‘small class of suicidal children” in an average school (how large he didn’t say, but I don’t know many primary schools with 7,000 kids). I am presuming Benbow was referring to the risk of Seroxat causing suicide in the general UK population (of those under-18 on Seroxat) with his ‘small class of suicidal children’ estimate?

If so, does this really make it anymore palatable, whether it was 30 suicidal kids or 40 suicidal kids, or 100? is the number of suicidal kids from Seroxat important? or is the fact that any kids were at risk at all just totally unacceptable? This Russian roulette style game of pill prescribing with Seroxat would hardly be a comfort to any parent who had a kid on Seroxat, how would they know if it was their child who would, or maybe would not, be- in Benbow’s ‘small class of suicidal children‘.

What would have been an acceptable number of suicidal children from Seroxat?

It seems to me that while Benbow was admitting there was a risk, he was trying to make out that it was a relatively small risk therefore not that significant in the grand scheme of Seroxat prescribing and childhood depression treatment. I’m sure the parents of any child who committed suicide on Seroxat would care little for Benbow’s analogy of a ‘small class of suicidal children’. Not to get too Freudian on Benbow, but the fact that he imagined the Seroxat suicide statistics in this way speaks volumes about the way companies like GSK think about risk/benefit ratios in the public who consume their drugs. We are merely statistics to them. The ‘small class of suicidal children’ was perhaps Benbows way of understanding collateral damage. It seems  that Benbow (with his psychiatrists cap on) was trying to reassure the public that it was only a ‘small class of suicidal children’ who would get these suicidal thoughts, or attempts.

So if it was a large class of suicidal children, would that have concerned Benbow at all?

Or how about a small school full of Seroxat suicides? would Benbow be alarmed by that?

Or how about a few small schools? Or a small town full of kids self harming and killing themselves on Seroxat?

Considering the amount of kids in the US who were prescribed it (two million), Benbow’s analogy doesn’t really stack up there. In fact, his analogy is a drop in the ocean when you guesstimate the numbers who were prescribed it globally (and people are still being prescribed it).

A recent Dutch article, refers to  (excuse the google translation)

“….Paroxetine, brand Seroxat is the most prescribed antidepressant among Dutch youths.

32 000 of the approximately 40.0000 young people between 18 and 25 years,

who last year suffered from depression were prescribed the drug, usually by a psychiatrist…”

The Dutch article doesn’t say how many under-18’s were prescribed Seroxat, but it does mention that up to 32,000 young people between the ages of 18 and 25 were prescribed it for depression. The article also doesn’t mention over 25’s, or the figures for Seroxat prescribing in that age group. So how many out of this 32,000 Dutch young adults will develop suicidal thoughts, self harm, aggression or akathisia from Seroxat?

Furthermore, if two million American kids were prescribed Seroxat (called Paxil over there) and up to 7,000 British kids were prescribed it in the UK, and 32,000 young adults in the Netherlands- how many Irish kids were prescribed it? How many Spanish kids? how many Australians? New Zealanders? South Africans? etc How many kids globally? how many people globally?

Seroxat is now off patent, but the chemical – Paroxetine- is sold globally under dozens of different generic brand names (as can be seen from the image above). Is GSK warning all of these kids of the suicidal side effects? Is GSK warning all of the regulators, doctors, etc globally about the risks in kids, and in young people? or in adults?

I doubt that that are.

So if Seroxat is proven to be so harmful for kids, and GSK also admit that there are further risks of suicidal ideation in the under 25’s and under 29’s, doesn’t that indicate that it’s probable that  Seroxat is a dangerous drug overall for people at any age?

In an article from 2004, the IMB (Irish Medicines Board) :

“…warned that the drug should not be used to treat anyone under the age of 18, as it appeared to increase the rate of self-harm and suicidal thoughts and behaviour in children and adolescents.

While the drug is only licensed in Ireland for use in people over the age of 18, doctors have the authority to prescribe it for younger patients if it is deemed appropriate. However this new warning will be directed at adults aged 18 – 29..”

There is a possibility of an increased risk of suicide-related behaviour in young adults aged 18 – 29. They should therefore be monitored carefully throughout treatment”, an IMB spokesperson told irishhealth.com.

When we add up the risks to under 29’s, and also the risks for all age groups, and we add this globally, what is the true extent of risks with Seroxat? how many adults are at risk? If it’s so harmful in children, then surely it’s the same in the adult populations.

I can only speak for myself, and I can honestly say that my experience of Seroxat at age 21 (3 years on the drug) was horrific beyond words. I don’t see how 21 is that much different to 18, or 17 in terms of how Seroxat would affect the body and mind. It did make me suicidal, aggressive, self harm, etc- just like the teenagers, I got the gamut of intolerable side effects. However, in the course of my blogging, and research, over the years, I have met many people over 29 who were prescribed Seroxat and it affected them in the same way. This is a drug which is toxic and dangerous no matter what age you are. GSK don’t talk about the loss of friends, self, family, income, prospects, relationships etc, or the trauma which it leaves people with. These are just as serious as the suicidal ideation that Seroxat induces. These are immeasurable, but they are very real.

In a recent post I illustrated the varied reaction from social media to the latest news about Seroxat harming kids. These reactions came from all walks of life, from all age groups, they were posted across continents, in real time on facebook and online news media. They tell of a drug causing people to shoot themselves, to lose friends, to miscarry babies, to lose their minds and their health. These stories tell of a drug which has destroyed people’s lives in so many different ways regardless of age. There are tens of thousands of Seroxat/Paxil horror stories online.

Seroxat is the mental health thalidomide. It’s not about a ‘small class of suicidal children’- it’s about mass poisoning on a global level with a dangerous, defective SSRI which never should have been licensed!

This horrible drug should be banned before anymore people get harmed.

People have been warning of the dangers for almost two decades now. See the Seroxat PIL for the litany of side effects added over the years.

Is it not time to pull this drug off the market?

From 2005:

Concerns over suicidal side effects for those taking paroxetine were first raised by the BBC’s Panorama programme in 2002.

Last year the Medicines and Healthcare products Regulatory Agency’s (MHRA) Committee on Safety of Medicines concluded that a modest increase in the risk of suicidal thoughts and self-harm for SSRIs could not be ruled out, but the benefits for adults outweighed the risks.

Safety review

The Norwegian researchers, whose study was triggered by a journalist from the Norwegian Broadcasting Corporation working on a medical information programme, analysed the results of 16 trials involving the drug.

The studies were presented to drug regulatory agencies in 1989, prior to the drug being licensed for use by doctors in the early 1990s.

In each, patients had either been given paroxetine or a placebo (dummy pill).

The researchers carried out a statistical analysis of all the results, taking into account the length of time patients were on the drugs.

The studies included 916 patients on paroxetine and 550 patients on placebo.

There were no actual suicides in any of the studies. However, there were seven suicide attempts in the group on paroxetine, and only one in the placebo group.

Writing in BMC Medicine, the team led by Dr Ivar Aursnes, said: “Patients and doctors should be warned that the increased suicidal activity observed in children and adolescents taking certain antidepressant drugs may well be present also in adults.

“We also conclude that the recommendation of restrictions in the use of paroxetine in children and adolescents conveyed by regulatory agencies lately should include usage in adults.”

Page_1



From The Atlantic Online 09/2015:

http://www.theatlantic.com/health/archive/2015/09/paxil-safety-bmj-depression-suicide/406105/

The Human Cost of a Misleading Drug-Safety Study

A reexamination of old data for Paxil found that the antidepressant is more dangerous than the authors let on. How much harm has been done in the 14 years since it was published?

Rodrigo Paredes /

David Dobbs 2:53 PM ET

Sara Bostock once sent me a picture of her and her daughter Cecily in happier times, and it’s a happy shot indeed: Mother and daughter, 40-something and 20-something, outdoors in the sun, looking radiant. With their beaming smiles—the same smile, really, for they look so alike—they appear thrilled to be mother and daughter.

One night in 2002, a couple years after that photo was taken, Sara woke in the night thinking she’d heard a bump in her kitchen. When she went to investigate, she found her 25-year-old daughter on the kitchen floor in a pool of blood. Next to Cecily on the floor was a large and bloody chef’s knife. In her chest were two knife wounds. One was shallow; the other was fatally deep.

Sara Bostock has always thought that her daughter was killed that night by an antidepressant called Paxil. Cecily, a bright, generally cheerful Stanford graduate, had been taking Paxil for two weeks. Five months before, she had become moderately depressed, and, as Sara would recall it, entered a psychiatric system newly enamored of chemical models of depression and chemical solutions. In search of the drug that would work well, doctors had put her on one after another that worked badly. Of these, Sara says, Paxil was the worst. It made Cecily more and more agitated, increasingly unlike herself. Finally she ended it in what Bostock has called a death “completely unexpected, out of character and violent.”

Cecily’s doctor was hardly alone in prescribing Paxil that year. A year before, in 2001, a much-publicized paper described a clinical trial that showed Paxil to be safe and effective in teenagers as well as adults. Study 329, as it became known, helped spur a huge increase in Paxil prescriptions. In 2002 alone, over 2 million prescriptions were written for children and teens, and many more for adults. (As a 25-year-old, Cecily Bostock was, from a neurophysiological perspective, on the cusp between adolescence and adulthood.) Did Cecily’s psychiatrist choose Paxil because of Study 329? It’s hard to believe the answer is not at least partly yes.

The study is now again in the news, as a new reanalysis of the its original data—including about 77,000 pages of formerly inaccessible patient records—shows that Paxil was neither effective nor safe. The reanalysis, published in the scientific journal BMJ, found that the study, underwritten by the drug’s maker, GlaxoSmithKline (or GSK), created a false picture of safety partly by misclassifying suicidal acts (such as taking 80 Tylenol) as less-alarming behavior or side effects. Other researchers who have looked at Study 329’s data have concluded likewise.

Virtually everyone involved in Study 329 has either declined to comment or insisted the study is sound.

Count this as shocking but unsurprising, for GSK has been admonished and fined many times since 2001, including once for $3 billion, for exaggerating Paxil’s safety and marketing it improperly for use in adolescents. Yet this BMJ study deals an especially sharp blow, for it’s only rarely that researchers are able to crack open the tightly sealed file cabinets of drugmakers and look at raw trial data. This illustrates why they want to do so: It appears to be a direct demonstration of how a company and researchers can misinterpret the data to make a bad drug look good.

Benedict Carey covers this story well in yesterday’s New York Times, though I disagree with his assertion that this reexamination of original data is something novel. Reexamining important data is part of science. It was delayed here, as it has been for most drug-trial studies, because drug companies are often allowed to keep their raw data secret. Even when outside researchers can get to the data —and it’s a wonder they managed to do so in this case—it’s both hard to find money for independent examination and hard to conduct that examination well. The BMJ study happened because of a special program called RIAT (for restoring invisible and abandoned trials) to spearhead such efforts.

Perhaps the most essential read, aside from the study itself, is the BMJ’s feature examining the study’s history. The article is deeply reported, sad, riveting, and damning. It condemns not just the company and the original study but an entire ecosystem of researchers, journals, and universities that have resisted the sort of correction the BMJ paper seems to offer. The most chilling part is that even though GlaxoSmithKline has been found to have acted questionably again and again in its promotion of Paxil, many of the institutions and researchers involved in the study and subsequent promotion of the product have remained unapologetic and are silent or unresponsive to efforts to have the original paper retracted or the record otherwise corrected.

At one point the article describes the increasing pressure put on Andrés Martin, a Yale professor and the current editor of the journal that published the 2001 study, to retract the paper. Martin has repeatedly stood his ground, stating in 2012, after GSK was fined $3 billion, that his inquiries had found “no basis for editorial action against the article.” Ivan Orasnky, the cofounder of the Retraction Watch blog, told the BMJ that Martin’s silence is straight from the “typical scientific playbook.” The universities whose researchers authored the original 2001 study, including Yale and Brown, have similarly refused to censure the paper or publish any open inquiries into its making. Virtually everyone involved in producing Study 329 has either declined to comment or insisted the original study is sound.

As Carey notes in his Times story, thousands of children, teens, and young adults attempted or committed suicide while on Paxil—but it’s impossible to know how many, if any, did so because of Paxil. This new BMJ paper makes it seem more likely than ever than some did. And of her daughter, Sara Bostock has no doubt.

When I first wrote about the controversies over use of SSRI’s in teens, a decade ago, a psychiatrist and journal editor critical of the practice told me, “If a drug company’s sales representative’s lips are moving, he’s lying.” It was meant as hyperbole—and it was damned good hyperbole. The current silence of the journals and institutions involved with Paxil’s long promotion reminds us that sealed lips can be just as deadly to the truth.

Jury Awards $1.5 Million in Seroxat (Paxil) Suicide Malpractice Suit


http://www.huffingtonpost.com/dr-peter-breggin/malpractice-suit-suicide_b_2194007.html

Dr. Peter Breggin

GET UPDATES FROM DR. PETER BREGGIN

Jury Awards $1.5 Million in Suicide Malpractice Suit

Posted: 11/27/2012 5:30 pm

Inquest At Irish Woman (Anna Byrne) Seroxat Suicide Returns Open Verdict


http://www.independent.ie/irish-news/i-love-you-annas-last-words-28903436.html

‘I love you’ – Anna’s last words

Gareth Naughton

THE heartbroken husband of a pregnant woman, found dead at the bottom of a hill, has spoken of their last phonecall – when they both said they loved each other.

Anna Byrne (35) from Beechdale in Dunboyne, Co Meath, and her unborn twin sons were killed in the fall at Howth summit in the early hours of March 8 this year.

The mother of two’s last known contact was at 11am the previous day when she spoke on the phone with her husband, Terry Byrne, and told him that she was going to the supermarket, an inquest has heard.

“At the end of the call, I told her to phone anytime if there was anything,” he told the court. “We told each other that we loved each other and she said ‘I’ll see ya later'”.

Mr Byrne was giving evidence at Dublin City Coroner’s Court, where an open verdict was returned at the inquest into his wife’s death.

Missing

He first became aware she was missing at 1.30pm when she failed to pick up their son from Montessori school.

Mr Byrne checked the supermarket and maternity hospitals and rang her friends.

At 3.30pm, gardai in Dunboyne were notified. Just after midnight a friend found Mrs Byrne’s car at Howth summit. Gardai found a note in the car.

A search-and-rescue operation followed but was called off at 3.30am. At 7.49am, something was spotted at the base of the cliff and rescue workers where lowered down to recover the body.

It was established that Mrs Byrne had been dead for eight to 10 hours, and a post-mortem examination gave the cause of death as multiple injuries due to a fall from a height.

Mrs Byrne had been taking the anti-depressant Seroxat for 10 years but had stopped during her pregnancy.

Master of the Rotunda Hospital, Dr Sam Coulter-Smith, said that Mrs Byrne did not indicate a history of depression when she registered the pregnancy, but that this information was contained in notes relating to her previous pregnancies. Mental health team notes are not contained in obstetric team notes for confidentiality reasons, he said.

She was due to deliver by caesarean section on March 29, he said. In mid-February she was noted to be “anxious”.

Six days before her death, Mrs Byrne and her husband attended an appointment with consultant psychiatrist at the Rotunda, Dr John Sheehan. She told him that she felt “part of her life was missing” because she had no daughter.

“She said that she planned the current pregnancy hoping for a baby daughter but found out at 20 weeks she was having twins and that they were both boys. She said that she was devastated,” he said.

Her mood was low, particularly in the evening, and she described a loss of interest and not feeling “maternal”.

She told him she felt overwhelmed by the prospect of having four boys but did not express any intention to take her own life, he said.

Mrs Byrne’s GP had started her on Sertraline – an anti-depressant regularly used during pregnancy – and Dr Sheehan doubled her dosage, prescribed an anti-histamine to help her sleep and advised her to seek a referral to a counsellor in her area.

She was suffering a recurrence of depression associated with an adjustment disorder to her twin pregnancy of boys, he said. Mrs Byrne presented a low risk given that she did not indicate that she was suicidal and had made future plans, he told the court.

Speaking from the body of the court, her father John Deeney asked why she had not been admitted to hospital for observation on foot of her anxiety.

Dr Sheehan said this was only done in severe cases of mental illness and admission would be to a psychiatric hospital.

Coroner Dr Brian Farrell said the note was a farewell letter and “particularly heart rending” but it was not dated. He also noted the difficult terrain that Mrs Byrne would have traversed to get to the area where she fell and her lack of suicidal ideation.

He said that although he was not saying that Mrs Byrne did not take her own life, the evidence heard in court did not satisfy the legal test for a verdict of suicide.

He returned an open verdict.

Dr Farrell will also write to the board of the Rotunda Hospital reflecting Mr Byrne’s concerns about sharing of mental health notes with the obstetrics team in cases such as his wife’s.

Irish Independent

– See more at: http://www.independent.ie/irish-news/i-love-you-annas-last-words-28903436.html#sthash.tALPWVzr.dpuf

Remembering Jamie Hoole (18) : One of the many “Seroxat-Suicides”


From 2008:

http://www.dailymail.co.uk/health/article-527837/Seroxat-makers-escape-prosecution-despite-failing-reveal-link-teenage-suicides-FOUR-years.html

Seroxat makers escape prosecution despite failing to reveal link to teenage suicides for FOUR years

By FIONA MACRAE

Last updated at 00:02 07 March 2008

jamie hooleSuicide: Jamie Hoole, who died aged 18 after taking Seroxat

Drug company bosses concealed information about the dangers of the anti-depressant Seroxat for five years while it was still being prescribed to children – yet they will escape prosecution over the cover-up.

Documents released yesterday as part of a four-year criminal investigation into GlaxoSmithKline show that the pharmaceutical giant had evidence that the drug didn’t work in children as early as 1998.

There were also suggestions the firm was aware of possible links to attempted suicides and suicidal thoughts.

But Glaxo did not alert Britain’s drugs’ watchdog to the problem until 2003, when the suicide link had become clear. The move led to an almost immediate ban on their use in under-18s.

Since it was first prescribed in Britain in 1990, the tablet, which makes GSK £1billion a year, has been associated with at least 50 suicides – both adult and child – in the UK alone.

Yesterday, the Medicines and Healthcare products Regulatory Agency hit out at Glaxo for withholding the information, and ministers promised to tighten the law.

But the watchdog came under fire itself over the failure to bring criminal proceedings against the firm for the cover up.

Ministers and officials insisted a prosecution was not realistically possible under the law as it stood at the time.

MHRA chief executive Professor Kent Woods said: “I remain concerned that GSK could and should have reported this information earlier than they did.

“All companies have a responsibility to patients and should report any adverse data signals to us as soon as they receive them.”

He said that although the law on disclosure of clinical data had been tightened in recent years, it would now be strengthened again.

In a letter to Glaxo, Professor Woods said: “Such a course of action should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards.

“I would have thought it self-evident that such information should be made available promptly to the regulator in order that action can be taken to public health.”

He added that Glaxo would not be prosecuted, as there was no realistic chance of a conviction under the legislation in place at the time.

However, the criticism may boost the case of British patients privately suing Glaxo after reacting badly when they tried to come off Seroxat.

Charles Medawar, of pharmaceutical watchdog Social Audit, said not just Glaxo but also the MHRA had “a great deal to apologise for”.

He said: “They say the decision not to prosecute was decided by the inadequacy of the law.

“My reaction is that before launching a million-pound investigation it might have been a good suggestion to check what the law actually says.”

Accusing the MHRA of a ‘naive and absurd’ level of trust in drug companies, he said: “The deviousness companies employ when promoting their drugs and minimising their side-effects is really quite extraordinary.”

Health Minister Dawn Primarolo said the Government would take “immediate steps” to strengthen the law, making it clear that drugs firms must disclose any information they had which could have a bearing on public health.

Glaxo denied it had withheld data, saying it “firmly believed” it had acted “properly and responsibly” and safety of its medicines was “paramount”.

It said there were no child suicides in any of the safety drug trials it carried out and it was only when the data from all nine trials was analysed together that any link with suicide emerged.

A spokesman added that Seroxat has never been licensed for use in under-18s in the UK and labelling stated that it was not recommended for children.

However, Seroxat, which is also known as paroxetine, was taken by an estimated 50,000 British children and teenagers before being banned for use in youngsters in 2003. Doctors are allowed to prescribe unlicensed drugs.

Prescribed to children as young as six, it was hailed by doctors as a “wonder drug”, capable of helping people overcome shyness.

However, it gradually became clear that the drug, which alters levels of mood-regulating chemicals in the brain, was not all it seemed.

As children taking it began to commit suicide, parents described how their sons and daughters suffered mood swings, nightmares and personality changes.

‘It was like giving him a loaded gun’

Jamie Hoole was just 18 when he was prescribed Seroxat for depression. Two months later, he killed himself.

His mother Jean Bambrough is convinced he would still be alive had it not been for Seroxat.

Miss Bambrough, 47, said: ‘It was like prescribing him a loaded gun.

“Jamie was depressed but I strongly believe he wouldn’t have done what he did if it wasn’t for Seroxat.”

The talented pianist and artist was given Seroxat after he lost his self-confidence and started to withdraw from everyday life. Initially, his depression seemed to lift.

Miss Bambrough, a personal assistant who split from Jamie’s father 20 years ago, said: “For the first few days, he was smiling and looked happy.

“But that didn’t last long. He became very agitated and couldn’t sleep. He was having really awful dreams.

“He couldn’t keep still and rocked backwards and forwards. He thought he was going mad.”

Jamie, a builder, then turned to self-harming, cutting his arms, legs and stomach with a knife.

Not long afterwards, his brother Daniel, then 13, came home from school to find him hanging from a belt in a bedroom of the family home in Northwood, North-West London.

An inquest into his death concluded it may have been “wholly or in part” linked to his use of the drug.

After the inquest in 2003 Miss Bambrough said: “All data on drugs should be made public before they are used on anyone – adults or children.”

Another Seroxat patient, Laura Davey, now in her 20s, was put on Seroxat because she was suffering from depression.

But instead of making her better the drug led to her self-harming.

She said: “As soon as I was put on Seroxat I started cutting myself every day. I was sitting in my bedroom with a compasses or a knife and I would slit my wrist so there would be blood.”

Read more: http://www.dailymail.co.uk/health/article-527837/Seroxat-makers-escape-prosecution-despite-failing-reveal-link-teenage-suicides-FOUR-years.html#ixzz2eVAC4AIl 
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Dr Peter Rost on Paxil/Seroxat : “Want To Kill Yourself”? (2006)


http://www.huffingtonpost.com/dr-peter-rost/want-to-kill-yourself_b_20880.html

Want to Kill Yourself?

The LAST thing you may want to do if you are young and want to kill yourself is to take a drug that will make you feel better. I’ll explain:

The antidepressant Paxil may raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the Food and Drug Administration warned today in a letter to doctors.

An analysis of trial data from nearly 15,000 patients treated with both Paxil and placebo (dummy pills) revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the FDA letter. And if Paxil has this problem, it also means that other new antidepressants in the same class may have the same problem.

Clearly, antidepressants used under careful medical supervision are still likely to outweigh the risks, but the FDA letter highlights a serious issue. When doctors and patients find out about a problem with a new drug it may already be too late. The fact that a drug is approved for use doesn’t mean that it is safe. And once a drug is on the market it takes almost as much bad data to get the drug off the market as it took to get it approved in the first place.

But there are lots of early warning signs. Increased suicidal thoughts for young people on antidepressants have been discussed for years. And now the FDA has the data to say that this was actually true.

But your doctor can’t wait until the FDA has enough data. It is your life and your physician has to make sure that he doesn’t take unnecessary risks with your life. One way to do this is to not use a new drug right away, but wait, until there is good data demonstrating the drug is safe. Unfortunately, many cowboy docs have a problem waiting.

Only a week ago it was revealed that Vioxx — a drug which used to be very popular for the treatment of pain and inflammation — could cause heart attack within the first two weeks of use.

A quarter of patients who suffered a heart attack while taking Vioxx did so within the first two weeks of their first Vioxx prescription.

Is this conclusive proof that Vioxx actually killed after only a couple of weeks? Of course not, but it is an indication that the problem with Vioxx may be even worse than what was initially thought.

In medicine, “Primum non nocere,” applies today more than ever before: “First do no harm.”

(Vioxx was voluntarily withdrawn from the market by Merck on September 30, 2004 after a study showed that it doubled patients’ risk of heart attacks and strokes after 18 months of use.)

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Additional information just arrived from AHRP:

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.ahrp.org/cms/

A faith-based belief system masquerading as science is collapsing under the weight of evidence that has, for so long been denied by drug manufacturers, by the FDA, and by psychiatry: the best selling, most profitable antidepressants pose an increased risk of suicide for children and adolescents, for “young adults”–in fact, no age group is exempt. [1]

1. GlaxoSmithKline (GSK) has submitted documents to the FDA and other regulatory agencies, contradicting its decade long denial that its antidepressant drug, paroxetine (Paxil / Seroxat) increased the risk of suicidal behavior in the company’s controlled clinical trials,. http://www.gsk.com/media/paroxetine_adult.htm

2. In a letter to healthcare professionals this week, GSK warned about the increased suicide risk stating:
“There is a possibility of an increased risk of suicide related behavior in young adults ages 18-29” — whether the drug is prescribed for depression or for other conditions not associated with suicide. http://www.gsk.com/media/paroxetine/adult_hcp_letter.pdf

3.GSK is the first of the SSRI drug manufacturers to acknowledge in the Paxil label that the drug may trigger more than “suicidal thoughts.” The drug increases the risk of “suicide attempts.” The Paxil CR label now includes the following warning:

“young adults, are at an increased risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.”

GSK added warnings acknowledging that patients on the drug may experience “persistently worse” depression, or may “experience emergent suicidality or symptoms that might be precursors to worsening depression or suicidality” and “these symptoms” may be “severe, abrupt in onset, or were not part of the patient’s presenting symptoms.”

The company advises doctors: “”Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication.”

When was the link between SSRI antidepressants to suicide first reported?

In 1990 by Dr. Martin Teicher warned that Prozac (the first SSRI antidepressant) could cause suicidal behavior: “At the present time we recommend that this drug be used cautiously and that the practitioner be attentive to the possible emergence of suicidal ideation, even in those patients without a previous history of suicidal thoughts or actions.” [2]

In 1991 Dr. Robert King reported that the same phenomenon happens in children. [3] Yet, for more than a decade, drug companies indignantly denied any suggestion of such a risk, attacking those who were able to see the risk and dare to disagree.

In 1991, the FDA convened an advisory committee whose financial ties to Eli Lilly, allowed them to equivocate enough for the FDA to conclude “there is no credible evidence” that Prozac increases the risk of suicide… This imprimatur became the watchword of the industry and the new antidepressants skyrocketed to a $17 billion dollar market.

But the human casualties who had been prescribed Paxil and other SSRIs mounted, and in October, 2002, the BBC-Panorama aired an investigative report whose after-effects still reverberate on both sides of the Atlantic, as well as in Australia. BBC not only introduced the public to victims of irresponsible prescribing of the drug, and GSK’s drug marketing tactics, making visible the collision between patients’ physical and mental well-being and corporate marketing tactics, but the program laid bare the indifference of regulatory agency officials to a serious threat to public health safety.

In May, 2003, a BBC follow-up report provided the opportunity for two expert psychiatrists to express their opposing views publicly. Dr. David Healy, psychopharmacologist, medical historian, and Director, North Wales Department of Psychological Medicine, cited evidence of a suicide risk, and Dr. Alastair Benbow, GSK’s Head of European Psychiatry, defended the drug and denied the risk. [4]

Dr. Healy: “The evidence is that roughly one person in sixty that goes on this drug makes a suicide attempt. Now you have to contrast that with the people going on placebo or sugar pill, and the rate there is one person in five hundred and fifty. That’s nine or ten times less. The risk on the drug is nine or ten times greater than the risk on sugar pill.”

Dr. Benbow: “We have been asked by the regulatory authorities to provide all our information related to suicides and I can tell you the data that we provide to them clearly shows no link between Seroxat and an increased risk of suicide – no link.”

BBC reporter asked Dr. Benbow if he was “absolutely confident” that Dr. Healy is wrong on this issue and will be shown to be wrong?”

Dr. Benbow replied: “Yes, absolutely. Not only that but Doctor Healy has made the same claims about a range of other medicines. He made the same claims about Prozac… [repeats]…he made the same claims about a range of other SSRIs. On every occasion he has been found to be wrong.”

In September, 2004, Alan Metz, GSK North American medical director told the Wall Street Journal: “Each time it has been looked at, there is no suggestion of an association with suicidal tendencies in adults, with relation to SSRIs.”

For more than a decade, they claimed that depression causes suicide, not the drugs. Since then, the backtracking of the naysayers has taken on an almost comedic air. In 2004, they acknowledged “suicidality” in kids, but not suicide, and certainly not adults. Now, GSK admits the drug is associated with increased risk of suicide attempts in adults, but only in young adults. Well, okay, the fine print states “the higher frequency observed in the younger adult population may extend beyond the age of 24.” But “it is difficult to conclude a causal relationship.”

No it’s not difficult to conclude a causal relationship. This double speak is reminiscent of comedian Steve Martin’s admission to smoking marijuana:

“I used to smoke marijuana. But I’ll tell you something: I would only smoke it in the late evening….. Oh, occasionally the early evening, but usually the late evening – or the mid-evening…… Just the early evening, midevening and late evening. Occasionally, early afternoon, early midafternoon, or perhaps the late-midafternoon. Oh, sometimes the early-mid-late-early morning. . . . But never at dusk..”

This week’s GSK acknowledgements put to rest the hackneyed defenses: “it’s the disease not the drug” and “no evidence of a drug-induced suicide risk in adults.”

The simple truth is this: these drugs can cause violent suicidal behavior and death: in kids and in adults, in depressed people and in nondepressed people. The data do not demonstrate that any segment of the population is not susceptible to this risk.

Industry’s denials were buttressed by the FDA.

Daniel Troy, FDA’s former chief counsel, intervened in judicial procedures on behalf of drug companies by invoking FDA authority which he falsely claimed pre-empts state laws protecting public health safety. In a 2002 Amicus Curiae brief, Troy wrote: “…had Pfizer given a warning as to a causal relation between Zoloft and suicide, FDA would have disapproved the warning. Indeed, based on its current scientific knowledge, FDA would still do so today.” [5]

Then, senior FDA officials tried to suppress a report by FDA’s own safety officer, Dr. Andrew Mosholder, whose pediatric SSRI data analysis confirmed a twofold suicidal risk. [6]

Only under intense pressure (in 2004) from parents whose children became suicidal after an SSRI was prescribed; and only after Congress applied pressure on the FDA were warnings of suicidality added to these drugs’ label. However, complaints by drug companies led the FDA to weaken the warnings, removing the following sentence from the label: “A causal role for antidepressants in inducing suicidality has been established in paediatric patients.”

Even as black box warnings were being crafted senior FDA officials denied the existence of evidence the drugs increase the risk of suicide. Dr. Robert Temple testified before a Congressional committee: “At the time … it was not an issue that was prominent in our thinking,” Temple testified. “We had never seen a signal for suicidality in the adult data.” [7] And Dr. Thomas Laughren said his agency had a database of about 40,000 adult patients involved in clinical trials and that “so far, we have seen no signal” indicating the drugs might increase suicide risk.”

GSK’s public admission that in fact, in some cases, young adults (18-24) who take Paxil (paroxetine) are at increased risk of suicide, is based on clinical trial data that GSK and the FDA have been sitting on since the early 1990’s. This acknowledgement of the evidence contradicts its repeated pronouncements and contradicts the sworn congressional testimony of these FDA officials.

Despite the acknowledged suicide risk, GSK attempts to persuade physicians (in the letter to healthcare professionals) to continue to prescribe their drug, offering the company’s faith-based “belief” in the drug’s benefit: “GSK continues to believe that the overall risk-benefit of paroxetine in the treatment of patients with MDD and other non-depressive disorders remains positive…”

http://www.gsk.com/media/paroxetine/adult_hcp_letter.pdf

But here again, the evidence does not support GSK’s claim of SSRI drug efficacy. A meta-analysis of the clinical trial evidence from short and long-term clinical trials by Professor Irving Kirsch and colleagues, showed that 83% of the effect of these drugs is duplicated by placebo. [8]

The question is: Should drugs be approved and marketed on the basis of what the drug company believes, or what the evidence shows?

The pharmaceutical industry is regulated because drugs have the potential to cause serious harm, and industry, with its obvious financial conflict of interest cannot be relied upon to serve the public interest. This is the reason we have an FDA–its mission is to protect us from harmful drugs that companies may want to market. How has this regulatory system been working?

For 15 years the FDA has stood firm in support of drug companies even as they misinformed physicians and the public with false assurances about the safety of these drugs, claiming that there is no evidence of a drug-related risk of suicide. FDA’s policy allowed drug companies to market SSRI’s aggressively by flooding the media with deceptive advertisements. The drugs became blockbusters and companies raked in billions of dollars in sales. All the while, both the industry and the FDA covered their eyes and ears to the human tragedies and the rising number of drug-related casualties.

GSK now reluctantly acknowledges the evidence linking the risk of suicide to its antidepressant, evidence whose existence GSK had denied for so long. That evidence is not new. Dr. Teicher, Dr. King, and all the physicians and lay people who recognized the red flags about these drugs’ hazards, and were courageous enough to speak out, were right all along. And the FDA was wrong all along. Even today, the FDA has not acknowledged the lethal risk that GSK has finally admitted. The evidence has been in FDA’s files for years. Thus, its failure to warn to protect the lives of children and adults is either due to their incompetence or their complicity with drug manufacturers. Either way, their inaction is a dismal failure and betrayal of the public trust.

Earlier this month, the GAO issued a report about its investigation of the FDA, concluding that the FDA is broken and unable to fix itself. [9] The GAO suggested that new legislation is needed to correct the corruption at the current FDA that today is costing people their lives. This latest installment in the book of FDA failures confirms the GAO report. The only question now is whether congress cares more about public health or the financial interests of the pharmaceutical industry.

References:

1. Juurlink, DN, Mamdani, MM, Kopp, A, Redelmeier, DA. The Risk of Suicide With Selective Serotonin Reuptake Inhibitors in the Elderly, The American Journal of Psychiatry (May 2006).

2. Teicher, M. H., Glod C., & Cole J. O. (1990). Emergence of intense suicidal preoccupation during fluoxetine treatment. American Journal of Psychiatry, 147, 207-210. See also case report by Creaney, W, Murray, I, and Healy, D. Antidepressant Induced Suicidal Ideation, Human Psychopharmacology, 1991, Vol. 6:329-332.

3. King, R. A., Riddle, M. A., Chappell, P. B., Hardin, M. T., Anderson, G. M., & Lombroso, P. (1991). Emergence of self-destructive phenomena in children and adolescents during fluoxetine treatment. Journal of the American Academy of Child and Adolescent Psychiatry, 30, 171-176.

4. BBC Panorama: Postcards from the Edge, 5/11/03
5. Daniel E. Troy, Chief Counsel Food and Drug Administration Amicus Brief, September 3, 2002 ; See also: Gary Young, FDA legal strategy would pre-empt tort suits National Law Journal March, 2004, vol. 128; Pg. 3 ww.law.com/jsp/nlj/PubArticleNLJ.jsp?id=1076428430132
See also, http://www.ahrp.org/infomail/05/09/30.php

6. Dr. Mosholder’s embargoed report and the accompanying FDA memos are posted on the AHRP website at: http://www.ahrp.org/risks/SSRImosholder/index.php

7. Anne C. Mulkern, Panel hammers FDA on antidepressant issue Kids’ suicide risk cited, Denver Post, September 24, 2004.

8.Irving Kirsch, Alan Scoboria, Thomas J. Moore, Antidepressants and Placebos: Secrets, Revelations, and Unanswered Questions, Prevention & Treatment, Volume 5, Article 33, posted July 15, 2002 http://journals.apa.org/prevention/volume5/pre0050033r.html

9. GAO Report http://www.ahrp.org/cms/content/view/148/28/

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

MHRA CEO Kent Woods Says of Seroxat:” We Have Never Said The Drug Is Safe”


http://www.mhra.gov.uk/home/groups/es-policy/documents/websiteresources/con017904.pdf

MHRA CEO Kent Woods Says of Seroxat:” We Have Never Said The Drug Is Safe” 

Back in 2008, during a meeting with Seroxat users group members, Kent Woods of the MHRA (the medicines regulator in the UK), stated (about Seroxat) that the MHRA have “never said the drug (Seroxat) is safe”.  (scroll down to page 18 of 41 of the PDF). This statement is astounding, considering that the MHRA exist in order to “Safe-Guard the Public Health” (or so their motto claims anyhow!). So, if they never said the drug is safe, but they have said it should not be prescribed to under-18’s because it is harmful, then does that mean that the risks of Seroxat outweigh the benefits? If the MHRA cannot even assess that Seroxat is safe, does that mean that they are willing to admit perhaps that it could be unsafe?

Or are they just conveniently sitting on the fence, as many thousands of people suffer because of this lethal prescription drug? 

The full transcript can be accessed through the link above- it makes for very interesting reading indeed- particularly in light of GSK’s recent 3 Billion dollar fine for fraud and unethical marketing. 

Remember – this meeting took place in 2008- just after the MHRA decided not to prosecute- after 4 years of investigating GSK–  they said that there was insufficiently robust laws at the time.

Yet- 4 years later- in 2012- the US government secures a 3 Billion dollar settlement with the same company- even though the company is not an American company- but a British one. It seems to me that GSK are practically untouchable in the UK- yet they have committed the same crimes on British shores. Shameful is an understatement…