Seroxat can be a killer - so says South Cumbria Coroner

SOUTH Cumbria coroner Ian Smith will contact drug authorities because he fears people are killing themselves after taking antidepressants.

Mr Smith is to write to the Committee on the Safety of Medicines – an independent advisory body on the quality and safety of medicines – following the inquest into the death of Nigel Woodburn.

Mr Woodburn drove into a tree just four days after being prescribed controversial antidepressants.

The retired bank manager, of Bardsea Green, was killed at the wheel of his car on June 16, minutes after confessing to his wife he’d had suicidal thoughts. He had been prescribed Citalopram after becoming depressed through ill health.

His heart-broken family said they were not aware of the suicide risks associated with antidepressants until the issue was highlighted at Mr Woodburn’s inquest this week.

Mr Smith told Tuesday’s inquest he knew of several other suspected suicides involving the same group of antidepressants, known as selective serotonin re-uptake inhibitors (SSRIs).

He said: “I have to say this is probably the fifth, if not sixth inquest I’ve heard within a period of three years when somebody either just going on to Citalopram or Seroxat, or coming off it, have killed themselves one way or another, totally out of the blue, totally without expectation, without a history of suicidal thoughts in the past.”

Mr Woodburn’s stepson, Gareth Salton, said: “I want people to understand the effects these drugs have.

“I want people to know it isn’t just something you read about in the national media.”

On the morning of his death, Mr Woodburn, 68, told his wife Rita he’d been thinking of killing himself.

“Even at that time I wasn’t unduly concerned,” she said.

“I didn’t think for a minute he was going to do anything silly.”

Mrs Woodburn went to ring her son, Gareth, and when she returned to the sitting room her husband had gone and the car was missing.

He travelled a short distance, in his pyjamas and dressing gown, along the A5087 coast road before crashing into a tree.

Collision investigator PC Philip Murray confirmed tyre tracks on the grass verge were consistent with rolling wheels, which indicates brakes weren’t applied.

Consultant histopathologist at Furness General Hospital, Dr Marek Witkowski, said the cause of death was a head injury.

Mr Woodburn had also suffered a ruptured aorta, which Dr Witkowski said raised questions about whether this caused the accident or happened upon impact.

Mr Smith said: “I think it is highly unlikely this man, who had just expressed for the first time in his life thoughts about suicide, should just by chance have had the ruptured aorta which caused the accident.”

Mr Smith returned a narrative verdict that Mr Woodburn died in a road vehicle collision.

He added: “I think what happened to Mr Woodburn was in part as a result of the drugs he was taking. There has been publicity about these drugs recently, particularly relating to younger adults, and it does seem to me it’s something that needs to highlighted.”

After the inquest, Mr Salton, 40, added: “I want people to know how awful these drugs are, and that when friends and family are put on these drugs to recognise what might happen, so they don’t go through the nine months of self-recrimination that this family has.”

Coroner’s officer Liz Gaskell stressed that anybody concerned about these antidepressants must consult their GP.

The missing nine pages - GlaxoSmithKline misses Sentator Grassley’s deadline and continues to hide evidence

Just how long does it take to write an email with a PDF attachment of nine missing pages?

Half an hour?

15 minutes?

No time at all if you have nothing to hide and want to be open and honest… shame that this obviously doesn’t apply to GlaxoSmithKline.

This from Charles Grassley’s letter to Glaxo on February 6 this year:

It is my understanding that 9 pages of Dr. Glenmullen’s report are not available
publicly. Accordingly, please respond to the following questions and request for
information. Please repeat each enumerated question and follow it with your response.

1. When did GSK first learn that Paxil was associated with an increased suicide
risk?

2. When did GSK first report to FDA that Paxil was associated with an increased
suicide risk?

3. When did GSK first notify patients and doctors that Paxil was associated with
an increased suicide risk? Please provide all pertinent documents and
communications.

4. Please provide the Committee with the complete, unredacted version of Dr.
Glenmullen’s report. Along with that report, please provide the appendix and
all documents that are referred to in the report, in the order that they are
referenced.

5. Please provide the Committee with the accompanying children and
adolescents report. Along with this report, please provide the appendix and all
documents that are noted in the report, in the order that they are referenced.

Thank you again for your continued assistance in this matter.

Because I understand that these documents are already available in electronic format, I would
appreciate receiving the documents and information requested by no later than February
14, 2008.

The deadline’s come and gone - what are you hiding from us Glaxo?

Read more here and here.

Stephen Kazmierczak - the Illinois gunman stopped taking Paxil (Seroxat)…?

… according to news channel ABC7 Chicago - full story here:

“Authorities have not figured out what motivated the man, described as a hardworking, award-winning former honor student by NIU faculty, to go on a shooting rampage that killed five students.

Kazmierczak, 27, was treated for mental illness nine years ago. He was considered volatile, according to a staff member who worked at the facility at the time, and violent if he stopped taking the antidepressant and anti-anxiety pills prescribed for him. Including Paxil, it was medication he was supposed to still be taking and apparently stopped a couple of weeks ago.”

So Paxil/Seroxat may have been involved in this tragedy, however we need to know the details - we need to know the truth.

Read more:

A brief history of school shootings

The Finland Massacre

SSRI stories

Antidepressants and violence

Nebraska shooting - antidepressant connection yet again?

Update: There is now confirmation that the anti-depressant NIU shooter Steven Kazmierczak went off of a few weeks ago was Prozac, but it’s not clear if he was on the original patented version made by Lilly or if he was on a generic. His ex-girlfriend told CNN that the drug made him feel like a “zombie.”

Stephen Kazmierczak - the Illinois gunman who ’stopped his medication’

Every time there is a school shooting in America, my first thought on hearing the news is…“I wonder if antidepressants are involved”.

We don’t know yet in the latest case in Illinois if antidepressants where involved, but we do know “Officials have said that the man who killed five students and injured many more before turning the gun on himself at Northern Illinois University had become erratic in the past two weeks after stopping his medication”.

I wonder what more we will find out?

For more on this story, see here.

For more on school shootings see here and  here.

Time to join up the dots?

What is GlaxoSmithKline still hiding from us - what is so important about the missing 9 pages?

Last week news broke in the New Scientist that Glaxo’s own researchers had been responsible for “an inappropriate analysis” of clinical trials that “obscured” suicide risks associated with Seroxat/Paxil for 15 years (see the court documents released last month).

Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.

An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it’s “virtually impossible” that GSK simply misunderstood the data.

Glenmullen’s report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public.

Read that last sentence again - “… the judge agreed to make parts of it public…”

What was released to the public was 83 pages of Dr Glemullen’ report - 9 pages have been withheld.

Over now to United States Senator Chuck Grassley, I think.

Senator Grassley has written to Mr. Christopher Viehbacher, President of GlaxoSmithKline (United States) asking for the missing nine pages. The full letter is here.

Part of it reads:

It is my understanding that 9 pages of Dr. Glenmullen’s report are not available publicly. Accordingly, please respond to the following questions and request for information. Please repeat each enumerated question and follow it with your response.

1. When did GSK first learn that Paxil was associated with an increased suicide risk?

2. When did GSK first report to FDA that Paxil was associated with an increased suicide risk?

3. When did GSK first notify patients and doctors that Paxil was associated with an increased suicide risk? Please provide all pertinent documents and communications.

4. Please provide the Committee with the complete, unredacted version of Dr. Glenmullen’s report. Along with that report, please provide the appendix and all documents that are referred to in the report, in the order that they are referenced.

5. Please provide the Committee with the accompanying children and adolescents report.

Now, I think at this point we should turn to Professor David Healy.

As an expert witness in the Schell/Tobin case, Professor Healy had been granted access to Glaxo’s archives and made shocking discoveries, so much so that on the 7 June 2000, he wrote to Dr June Raine of the UK’s Licensing body the MHRA.

“… All of their [GSK] healthy volunteer studies were supposed to have been made available to me but not all were. Of the ones that were missing there was trace correspondence left in once indicating that the investigator had never witnessed such a level of problems in a study with healthy volunteers. Another study was a single dose study which in a dose dependent fashion yielded a 75% rate of severe adverse events most of which involved the central nervous system. There were other disturbing indications from one of the other missing studies”.

“My testimony in this case also bore witness to sealed studies and other unreported data. It commented on the Montgomery Baldwin Study which yielded a projected rate of 45 suicide attempts in a group of recurrent brief depressive disordered patients on paroxetine per annum versus 12 on placebo. The figures were not statistically significant in great part one has to suggest because the company had terminated the study early. This termination and subsequent non-publication I would imagine the jury will have found and others will find significant.

In conclusion, Professor Healy wrote:

“I think what will also be clear is that SmithKline Beecham recognised the presence of withdrawal syndromes in their volunteers from the early to mid 1980s. That withdrawal syndromes occurred at a much higher rate than occur on benzodiazepines. Nevertheless they applied for and have received from you and other regulators a licence to claim that their drug is effective in the prophylaxis of depression and these claims have been based on designs which almost certainly are designs better suited to show the presence of a withdrawal syndrome than designs suited to demonstrate prophylaxis in depressive disorders. A great number of people have in recent years been told that when they begin to feel ill on discontinuing treatment that this is the recrudescence of their mood disorder rather than a discontinuation syndrome from their drug. I would imagine that a great many such people and others on their behalf will feel extraordinarily let down and angry when faced with the evidence that I’ve been faced with”.

Anyone see a pattern forming here?

Senator Grassley has given GlaxoSmithKline until February 14 to respond to his letter…

Seroxat increases suicidal thinking - it’s official - 2: Alastair Benbow weighs in

I am getting VERY confused by all this…

Just a few days ago, we had this news:

WARNINGS of the dangers of suicidal thoughts and behaviour are to be
included in the packages of anti-depressants in the UK. Warnings will be
carried in the patient information leaflet in the packets from October this
year (2008).

The direction was issued yesterday (Tuesday 5 February 200 by the Government’s
Medicines and Healthcare Products Regulatory Agency (MHRA).

So it’s official then - Seroxat/Paxil is linked to suicide.

But wait - in a Panorama interview in April 2003, GlaxoSmithKline’s own spokesman, the one and only Alastair Benbow told us (in no uncertain terms):

“The evidence, however, is clear, these [Seroxat/Paxil] medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm.”

And in ‘E-mails from the edge’ a Panorama programme broadcast in May 2003, Benbow once again defended Seroxat. He said “Whilst self-harm and suicidal thoughts are clearly a feature of depression, they have not been shown in carefully done studies to be a feature of treatment with these [Seroxat/Paxil] medicines.”

Now, remind me again Alastair - where did you put those “carefully done studies” that show Seroxat treatment is not associated with suicidal thoughts.

I think we would all like to see them - in fact, why didn’t you show them to the MHRA before it decided to add the new warnings to the patient information leaflet?

Seroxat increases suicidal thinking - it’s official - but what about addiction and withdrawal?

Seroxat increases suicidal thoughts - it’s official, or at least it will be official
from October this year. But only if you’re 25 years old or younger…

… if you’re older, even by a month or just a day, then you’re safe - so they
tell us and GlaxoSmithKline always tells us the truth, don’t you agree?

But no mention of withdrawal or addiction.

WARNINGS of the dangers of suicidal thoughts and behaviour are to be
included in the packages of anti-depressants in the UK. Warnings will be
carried in the patient information leaflet in the packets from October this
year.

The direction was issued yesterday (Tuesday) by the Government’s
Medicines and Healthcare Products Regulatory Agency. (MHRA)

A notice has been sent to drug manufacturers. It mentions a review by
the Food and Drugs Agency in America, which looked at bupropion,
citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine,
mirtazapine, nefazodone, paroxetine, sertraline and venlaxfaxine.

The review found no risk of higher sucidality in the general
population but said younger people were at higher risk and that there
were no differences in the risk between antidepressant classes.

A statement released by the MHRA says that the wording of warnings has
been agreed by the EU as has the time table for implementation.

The agreed wording reads:

“Thoughts of suicide and worsening of your depression or anxiety
disorder. If you are depressed and/or have anxiety disorders, you can
sometimes have thoughts of harming or killing yourself. These may be
increased when first starting antidepressants, since these medicines
all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

If you have previously had thoughts about killing or harming yourself.

If you are a young adult.

Information from clinical trials has shown an increased risk of
suicidal behaviour in young adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you
are depressed or have an anxiety disorder and ask them to read this
leaflet. You might ask them to tell you if they think your depression
or anxiety is getting worse or if they are worried about changes in
your behaviour.”

The news was greeted as a victory by anti-drugs campaigner, Janice
Simmons, a grandmother from Great Stukeley in Huntingdon.

Mrs Simmons told The Hunts Post on Tuesday: “I’ve won. This is the
result of eight years’ work. Warnings of suicidal thoughts and
behaviour will now be carried on all anti-depressants.”

Mrs Simmons, 57, began her campaign after she discovered that her
second husband, John had been prescribed Seroxat years before she met
him and since become addicted to anti-depressants. Her help-group -
the Seroxat User Group - has had tens of thousands of hits on its
website. Mrs Simmons has gathered information from across the world.
She has begun a dossier of case histories of tragic effects on people
who have been prescribed anti-depressants.

This year she had a meeting with the Prime Minister, Gordon Brown to
discuss the problem. However, she has always conceded that the drugs
can help some people.

One of the issues Mrs Simmons discussed with Gordon Brown was the
length of time (four years) that the MHRA has taken to investigate
allegations against the manufacturer of Seroxat, GlaxoSmithKline.

It is alleged that the drugs giant withheld information that Seroxat
could cause suicide in under 18s. The allegations have always been
denied and GSK has said that Seroxat was never licensed for children.

Too little too late is what I say

Anti-depressants and massacres - Fox news investigates

I believe that anti-depressants can cause extreme violence.

I have written on the subject before. All too often it seemed that the only other people in the world who would ever begin to entertain the possibility were people such as Micheal Moore and Dr Peter Breggin in the USA – and in England David Healy, Andrew Herxheimer and David B. Menkes, who co-authored a paper on the subject in 2006 - Antidepressants and Violence: Problems at the Interface of Medicine and Law.

Now maybe the rest of the world is slowly starting to catch up. The video below is from ‘Hannity’s America’ on Fox News and was aired a couple of days ago. It explores links between extreme examples of violent behavior among teens on anti-depressants:

I suggest you also watch The Drugging of our Children - this feature-length documentary examines the alarming growth in the prescription of powerful psychotropic drugs for adolescents and children. Leading experts, as well as Neil Bush, Michael Moore and Gary Null, provide insightful commentary about the growing trend to pathologize the behavior of children, and then require them to take mind-altering pharmaceutical drugs as a “cure.” The documentary recounts the national tragedy of Columbine and focuses on the largely unknown fact that teenage shooter Eric Harris was on the psychotropic drug Luvox at the time he and Dylan Klebold took the lives of 13 other students at their high school. Violence and aggression, precipitated by prescribed drug use, is also explored in an unprecedented discussion between Mark Taylor, the first shooting victim in the Columbine tragedy, and Cory Baadsgard, a teenager on Paxil and Effexor who, in another violent incident, took his teacher and 23 students hostage at gunpoint in his Washington high school.

If you want more information, then you can read follow up with these links:

Nebraska shooting - antidepressant connection yet again?

Lost in translation - were Anti-Depressants Involved In Finland School Massacre?

A brief history of school shootings

The Finland Massacre

SSRI storiesAntidepressants and violence

Join up the dots?

More on that youth suicide study

This from the Boston Globe article “Suicide rates as a public relations tool”

Alison Bass asks two questions that reporters suffering from shyness are afraid to ask:

1. “Why are some in the psychiatric community, despite lack of evidence, working to convince the American public that the FDA may have erred in putting the most serious kind of warning possible on the use of [SSRI antidepressants] in young people?”

Answer: The alarmist call by such ‘pillars of the psychiatric community’ as Dr. David Shaffer and Dr. J. John Mann of Columbia University, to rescind Black Box suicide warnings on antidepressant drug labels, may be viewed as protecting their investment in the antidepressant drug business. Both Dr. Shaffer and Dr. Mann–and an army of other academics who, like them, are ‘on the take’–can be counted upon by drug manufacturers to ring the fire alarm despite the lack of evidence of any fire.

In fact, Bass, points out, the authors of the AJP study overlooked the fact that prescription rates did not drop in the year when suicide rates among youth increased, (2003-2004). Since suicide rates for 2005 are not yet available from the Centers for Disease Control and Prevention, there is no evidence of a connection between variations in youth suicide rates and antidepressant prescription usage.

2: “Who stands to benefit from the latest alarm about an apparent upturn in youth suicide rates?”

Answer: The sharp drop in the sale of SSRIs since 2004 has put a big dent in their manufacturers’ bottom line. These companies have an enormous stake in reversing the current FDA warnings. That might explain why Pfizer (the maker of Zoloft) contributed $30,000 to cover the cost of collecting data for the American Journal of Psychiatry study, which was also funded by the National Institute of Mental Health.

“It’s also worth noting that the two lead authors of the paper have disclosed financial conflicts of interest: Columbia professor of psychiatry Dr. John Mann has been a paid consultant to at least two SSRI makers, Pfizer and GlaxoSmithKline (the maker of Paxil), and Robert Gibbons has served as an expert witness for Wyeth Pharmaceuticals (the maker of Effexor, another SSRI).”

More can be found here at the AHRP blog.

You MUST watch this video

The video contains TV clips about the controversy, snippets of an FDA meeting about the drugs, and interviews with now-familiar critics, including Harvard’s Joseph Glenmullen and David Healy of the University of Wales. The video opens and closes with a 911 call in which a New Jersey teen can be heard threatening to kill herself. This is not for the faint-hearted, and it’s likely to upset anyone who believes antidepressants can help people.

Watch it here.