Interesting video on seroxat (paxil) that GSK seem very concerned about

Interesting video on seroxat (paxil) that GSK seem very concerned about

Joined: April 19th, 2005, 7:01 pm

April 4th, 2008, 1:35 am #1


Enough to spend money on lawyers letters to the person who made it.

To read about it, see this (just one of many) sources who discuss GSK's concern: 

<FONT color=#000066 size=4><STRONG>It's Groundhog Day for bullying by GlaxoSmithKline over Seroxat</STRONG></FONT>

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Joined: April 19th, 2005, 7:01 pm

April 4th, 2008, 1:47 am #2


Perhaps it wasn't such a good idea, Glaxo, to understimate the determination of people and try the 'Big Pharma threatens Individual Patient" tactic.

Anyway,&nbsp;a list of some people 'holding' the video in their blogs is&nbsp;copied over from here:

<STRONG>&nbsp;</STRONG><FONT color=#000066 size=4><STRONG>Has GlaxoSmithKline bitten off more than it can chew? - bloggers weigh in over intimidation</STRONG></FONT>

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..."

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Joined: April 19th, 2005, 7:01 pm

April 4th, 2008, 3:39 am #3

Enough to spend money on lawyers letters to the person who made it.

To read about it, see this (just one of many) sources who discuss GSK's concern:&nbsp;

<FONT color=#000066 size=4><STRONG>It's Groundhog Day for bullying by GlaxoSmithKline over Seroxat</STRONG></FONT>

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<A title="Permanent Link to Glaxo, An Angry Blogger And Free Speech" href="http://www.pharmalot.com/2008/04/glaxo-an-angry-blogger-and-free-speech/" rel=bookmark>Glaxo, An Angry Blogger And Free Speech</A>

<DIV class=entry>
<A title=paxil.jpg href="http://www.pharmalot.com/wp-content/uploads/2008/04/paxil.jpg"><IMG class="imageframe imgalignleft" height=102 alt=paxil.jpg src="http://www.pharmalot.com/wp-content/uploads/2008/04/paxil.jpg" width=76></A>Back in February, a UK resident named Bob Fiddaman posted a video on his site, which is known as Seroxat Sufferers. For those unaware, Seroxat is the trade name in the UK for the Paxil antidepressant and Fiddaman has regularly railed against the drugmaker over the pill and its various side effects, such as links to suicide and difficult withdrawal symptoms.

The four-minute video posted was, essentially, a pastiche that intersperses a photo of Alistair Benbow, Glaxo’s European head of psychiatry, with various written statements. Fiddaman juxtaposed statements from Glaxo and Benbow with conflicting statements from various documents to create a contrast that underscored charges that the drugmaker hid evidence from regulators, doctors and the public. Later, on his own site, Fiddaman also posted a remark that compared Benbow to a notorious dictator.

At that point, Glaxo’s attorneys wrote a letter demanding he remove the remark <EM>and</EM> the video because these implied Benbow had lied or was guilty of a cover-up and that it was all defamatory. Fiddaman apologized, removed the video and then posted the letter, but it continues to circulate. And a growing number of bloggers accuse Glaxo of stifling debate about a controversial drug that remains the subject of litigation.

“One is left wondering who has caused the greater offence, who owes the apology, and to whom that apology is owed,” wrote Aubrey Blumsohn on his Scientific Misconduct blog. “The scientific questions are overwhelming, and the intimidation of a questioning patient cannot be allowed to divert attention from the lack of any real answering.”

We contacted Glaxo and a spokeswoman wrote the drugmaker “accepts that the company and its products are subject to public debate. However, we cannot accept personal and baseless attacks on our employees.” In a conversation, she adds “the issue was the specific offensive reference to one Glaxo employee.” So is there a concerted effort to stifle blogs and the video? No, she says. Will Glaxo approach other sites to remove the video should it be posted. To her knowledge, she says, no such decision has been made.

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Joined: April 19th, 2005, 7:01 pm

April 4th, 2008, 11:25 am #4

Enough to spend money on lawyers letters to the person who made it.

To read about it, see this (just one of many) sources who discuss GSK's concern:&nbsp;

<FONT color=#000066 size=4><STRONG>It's Groundhog Day for bullying by GlaxoSmithKline over Seroxat</STRONG></FONT>

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<H1 class=article><FONT size=3>http://www.thisislondon.co.uk/news/article-23450129-details/Seroxat+makers+escape+prosecution+despite+failing+to+reveal+link+to+teenage+suicides+for+FOUR+years/article.do</FONT></H1>
<H1 class=article>"Seroxat makers escape prosecution despite failing to reveal link to teenage suicides for FOUR years </H1><STRONG>Last updated at 23:22pm on 07.03.08 </STRONG>



<DIV id=rhs><IMG height=388 alt="jamie hoole" src="http://img.dailymail.co.uk/i/pix/2008/03_01/hooleDM0603_228x388.jpg" width=228 border=1>
<P class=caption>Suicide: Jamie Hoole, who died aged 18 after taking Seroxat
</DIV><STRONG><FONT size=4>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. </FONT></STRONG>


Documents released yesterday as part of a four-year criminal investigation into GlaxoSmithKline show that <STRONG><FONT size=4>the pharmaceutical giant had evidence that the drug didn't work in children as early as 1998</FONT></STRONG>.

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

<STRONG><FONT size=4>But Glaxo did not alert Britain's drugs' watchdog to the problem until 2003</FONT></STRONG>, when the suicide link had become clear. The move led to an almost immediate ban on their use in under-18s...."

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http://www.newsdesk.se/view/pressrelease/gsk-statement-on-mhra-investigation-200368

GlaxoSmithKline AB
GSK statement on MHRA investigation
<STRONG>2008-03-06 14:08</STRONG>

“...The safe use of our medicines is paramount to everyone who works for GSK and the company is committed to ensuring that all appropriate information is made available to regulators, doctors and patients. We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18,” <FONT size=4><STRONG>said Dr Alastair Benbow, Medical Director for GSK Europe...</STRONG>."</FONT>

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Joined: April 19th, 2005, 7:01 pm

April 4th, 2008, 12:10 pm #5


<FONT size=4><EM>At that point GlaxoSmithKline were SmithKline Beecham</EM></FONT>

<FONT size=4><EM>http://www.socialaudit.org.uk/5111-009.htm</EM></FONT>
<FONT size=4><EM>
&nbsp;

"...For the record, our view is that <STRONG>the regulators themselves played a major part in creating the problems now being addressed</STRONG>. We believe that nothing short of a thorough overhaul of the drug safety monitoring system is essential and that comparable problems will arise in future unless and until that is done..."

&nbsp;
</EM></FONT>
<FONT size=4><EM>"...</EM><STRONG>Since 1997</STRONG><EM>, </EM><STRONG>Social Audit has repeatedly drawn the attention of the MCA/CSM to this fatal flaw in the trials it approved </STRONG>– </FONT>

<FONT size=4><EM>in particular in</EM><STRONG><EM> </EM>the trial they relied on to prove the claim of long-term efficacy of paroxetine</STRONG>. </FONT>

<FONT size=4><EM>This trial exemplifies </EM><STRONG>the problem</STRONG>: <STRONG>it was conducted jointly by a (then) CSM member and an employee of SmithKline Beecham<EM>.</EM></STRONG><EM> See the description of methods and critique of results in Medawar (1997) and in correspondence between Social Audit and the then Chairman of the CSM (</EM></FONT><FONT size=4><EM>Rawlins, 1998)</EM></FONT><FONT size=4><EM>..."</EM></FONT>

<EM><FONT size=4></FONT></EM>&nbsp;

<FONT size=4></FONT>&nbsp;

http://www.antidepressantsfacts.com/Bri ... d-1-12.htm
<FONT size=4>
The pre-school pill poppers
<FONT face=Geneva,Arial,sans-serif size=2>Sarah Boseley Health Correspondent</FONT>
<FONT face=Geneva,Arial,sans-serif size=2>Guardian</FONT>
<FONT face=Geneva,Arial,sans-serif size=2>Thursday February 24, <FONT size=5>2000</FONT></FONT><FONT size=5> </FONT>
</FONT>
<FONT size=4>"...One such small study by the drug safety research unit at Southampton university looked at the prescription of SSRIs - the Prozac breed of antidepressants - for children aged 12 and under in <STRONG>100 general practices. They found just 19 children on SSRIs (selective serotonin reuptake inhibitors</STRONG>) - <STRONG>but the average age of these children was six, and they ranged from one year-old to 12</STRONG>...."</FONT>

<FONT size=4></FONT>&nbsp;

<FONT size=4>http://www.guardian.co.uk/science/2003/ ... ciencenews</FONT>

<P class=byline>"&nbsp;Wednesday December 10 <STRONG><FONT size=5>2003 </FONT></STRONG>

<P class=history>"...Trials on children have not been carried out in all the drugs, but the completed studies show a worrying increase in suicidal behaviour among those on SSRIs compared with those given a placebo (sugar pill).

None of the drugs has a licence for use in children with depression in the UK, but GPs have prescribed more and more SSRIs for children.

<FONT size=4><STRONG>It is estimated that as many as 50,000 children on antidepressants in Britain..."</STRONG></FONT>

&nbsp;

"...The first major <STRONG><FONT size=4>Seroxat trial in children was finished by 1996, but the results were not published until 2001</FONT></STRONG>. Data was also gathered in 1996 after a trial of Lustral, manufactured by Pfizer, showing that <STRONG>9% of depressed children on the drug became suicidal</STRONG>.

Dr Healy, whose own researches led to the establishment of the SSRI review, said yesterday: <FONT size=4><STRONG>"They should have known by 1996 that there was a problem. GSK and Pfizer were asked to do this by the regulators so that we knew what the safety issues were</STRONG>...." </FONT>

<FONT size=4></FONT>&nbsp;
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Joined: April 19th, 2005, 7:01 pm

April 7th, 2008, 10:47 am #6

Enough to spend money on lawyers letters to the person who made it.

To read about it, see this (just one of many) sources who discuss GSK's concern:&nbsp;

<FONT color=#000066 size=4><STRONG>It's Groundhog Day for bullying by GlaxoSmithKline over Seroxat</STRONG></FONT>

<DIV class=post-body>
<DIV>
<EMBED src= width=425 height=355 type=application/x-shockwave-flash wmode="transparent"></DIV></DIV>
PR firm confidential notes to GSK re withdrawal / discontinuation issue
http://www.ssri-uksupport.com/files/GSKprFirmMemo.pdf

GSK memo to Reps, 'Not to be disclosed to Physicians'
http://www.ssri-uksupport.com/files/GSKtoReps.pdf

GSK memo to Reps with cartoon of Agitated Withdrawal Patient
http://www.ssri-uksupport.com/files/GSK ... ypaxil.pdf

GSK memo "Why Discontinuation is an Issue" and Cartoon of Moneybag
http://www.ssri-uksupport.com/files/GSKmoneybagmemo.pdf

GSK&nbsp; memo on how to make money with paxil for Social Anxiety Disorder
http://www.ssri-uksupport.com/files/GSK ... nguide.pdf

and

Court docs re GSK paxil data analysis suggesting that suicide risk was obscured for 15 years.
http://www.ssri-uksupport.com/GSKsuicid ... ildata.pdf

6th March 2008 - The MHRA write to GSK advising that despite their "withholding clinical trial data relating to safety in children and adolescents", and despite GSK 'nevertheless promoting the product for use in this age group', GOVERNMENT lawyers have 'decided not to pursue a prosecution of GSK'.
http://www.ssri-uksupport.com/files/MHRAtoGSK.pdf

Despite the horrors some children went through and despite the&nbsp;DEATHS of children who took a drug promoted by a company who withheld data which would have allowed physicians to have known that it was not safe for children, GOVERNMENT lawyers let GSK 'get away with it'.&nbsp; Unbelievable definition of legal "justice".

&nbsp;

Getting away with deaths of children and adolescents caused by fraud in science must be one hell of a thing to feel 'proud' about on all sides in this.&nbsp;GSK, MHRA, Government Lawyers.

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Joined: April 19th, 2005, 7:01 pm

April 7th, 2008, 12:40 pm #7


The most interesting of the documents above is the one marked:

"Court docs re GSK paxil data analysis suggesting that suicide risk was obscured for 15 years.
http://www.ssri-uksupport.com/GSKsuicid ... ildata.pdf "

Just as with other pdfs here, the same documents and memos can also be found at various other sites. And like the video in the first post of this thread, the more sites that hold evidence, the better.

Here's a few extracts from the pdf.&nbsp;&nbsp;&nbsp;If there are typos, thats due to my copy typing, not the original:


Page 31

...Thus, GlaxoSmithKline's own CEO [J-P Garnier] acknowledged that side effects should only be counted after the washout phase is complete and the official study has begun, when patients are randomly assigned to either be on placebo or the drug...

Page 32

...Completed studies that occured in the wash-out phase were counted as though they occurred in the placebo group...In other words GSK only disclosed half the problem - the improper suicide attempts counts and not the improper completed suicide counts - to the FDA....

Page 33

...If GSK had presented its new analysis of the correct data on suicide attemmpts the same way it had presented the inaccurate data for years, the correct data would have shown that Paxil increases the risk of suicide and suicide attempts more than eight-fold, as we have seen.&nbsp; But GSK's new way of presenting the data obscured the problem again....

...Note that GSK's admission that only one patient on placebo attempted suicide and the FIVE other suicide attempts previously counted against placebo had now been "excluded from the figures" only appears as a footnote to the table in the report.&nbsp; Note also that GSK continues to report patient-years exposure (PYE) calculations, which as we discussed earlier are inappropriate because the risk of Paxil-induced suicidality is not evenly distributed over time...

Page 34

...The 40 Paxil suicide attempts in 1991 would be the same in 2002, but the 6 placebo suicide attempts in 1991 would be down to 1 in 2002.&nbsp; The significant different would be instantly recognizable: a Paxil suicide attempt rate of 1.3% versus a placebo rate of 0.18", representing a statistically significant more than seven-fold increased risk of suicide attempts for patients on Paxil...

Page 35

...As we have seen in the combined suicidal behaviour Table 10 on page 13, the full tally is 45 Paxil suicides and suicide attempts to only one placebo suicide attempt.&nbsp; <STRONG>Had GSK compared the complete, correct counts, the data would have shown that Paxil causes a statistically significant, greater-than-eight-fold increased risk of suicidal behaviour for patients put on the drug.&nbsp; Instead, GSK's new way of presenting the data again obscured the problem.
</STRONG>...

Page 37

...The linchpin of Spitzer's case was a secret, internal GSK report dating to October 1998 saying the studies showed Paxil "failed" to be more effective than placebo pills in depressed children.&nbsp; The secret memorandum urged company executives to "effectively manage the dissemination of these data in order to minimize any potential negative commercial impact" that might "undermine the profile" of Paxil.&nbsp; In other words, the position paper raised concerns that the damaging information might affect Paxil's global sales, which approached $5 billion a year.&nbsp; How did the report propose to "effectively manage" the potentionally damaging results?&nbsp; By selectively publishing the few "positive data" that would appear to make Paxil look good.

To accomplish this goal, GSK turned to the psychiatrists who originally conducted the studies fof the company.&nbsp; Headed by <STRONG>Dr Martin Keller....a group of more than twenty leading academic psychiatrists published the selected Paxil data in the July 2001 issue of the Journal of the American Academy of Child and Adolescent Psychiatry</STRONG>.&nbsp; In stark contrast to the 1998 secret, internal GSK memo, Keller and his colleagues used highly selected pieces of positive data to glowingly conclude in 2001:&nbsp; "Paxil is generally well tolerated and effective for major depression in adolescents"...

...<STRONG>Kellers misleading 2001 report in the JAACAP was highly influential and widesly used to promote Paxil to children.</STRONG>&nbsp; After its publication, the use of antidepressants for children skyrocketed.&nbsp; But 2 years later, in June 2003, on the basis of the same data, the British introduced their virtual ban on Paxil for children...

End Extracts

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Joined: April 19th, 2005, 7:01 pm

April 7th, 2008, 12:47 pm #8

<EM>...As we have seen in the combined suicidal behaviour Table 10 on page 13, the full tally is 45 Paxil suicides and suicide attempts to only one placebo suicide attempt.&nbsp; </EM><STRONG><EM>Had GSK compared the complete, correct counts, the data would have shown that Paxil causes a statistically significant, greater-than-eight-fold increased risk of suicidal behaviour for patients put on the drug.&nbsp; Instead, GSK's new way of presenting the data again obscured the problem.
</EM></STRONG>
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Joined: April 19th, 2005, 7:01 pm

April 7th, 2008, 12:53 pm #9


and now GSK&nbsp;have gotten away with promoting their drug for children having obscured the danger to their lives - and some have been lost because of it -&nbsp;they get THEIR lawyers&nbsp;to&nbsp;threaten a patient in the UK.

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&nbsp;

&nbsp;

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April 7th, 2008, 3:00 pm #10

PR firm confidential notes to GSK re withdrawal / discontinuation issue
http://www.ssri-uksupport.com/files/GSKprFirmMemo.pdf

GSK memo to Reps, 'Not to be disclosed to Physicians'
http://www.ssri-uksupport.com/files/GSKtoReps.pdf

GSK memo to Reps with cartoon of Agitated Withdrawal Patient
http://www.ssri-uksupport.com/files/GSK ... ypaxil.pdf

GSK memo "Why Discontinuation is an Issue" and Cartoon of Moneybag
http://www.ssri-uksupport.com/files/GSKmoneybagmemo.pdf

GSK&nbsp; memo on how to make money with paxil for Social Anxiety Disorder
http://www.ssri-uksupport.com/files/GSK ... nguide.pdf

and

Court docs re GSK paxil data analysis suggesting that suicide risk was obscured for 15 years.
http://www.ssri-uksupport.com/GSKsuicid ... ildata.pdf

6th March 2008 - The MHRA write to GSK advising that despite their "withholding clinical trial data relating to safety in children and adolescents", and despite GSK 'nevertheless promoting the product for use in this age group', GOVERNMENT lawyers have 'decided not to pursue a prosecution of GSK'.
http://www.ssri-uksupport.com/files/MHRAtoGSK.pdf

Despite the horrors some children went through and despite the&nbsp;DEATHS of children who took a drug promoted by a company who withheld data which would have allowed physicians to have known that it was not safe for children, GOVERNMENT lawyers let GSK 'get away with it'.&nbsp; Unbelievable definition of legal "justice".

&nbsp;

Getting away with deaths of children and adolescents caused by fraud in science must be one hell of a thing to feel 'proud' about on all sides in this.&nbsp;GSK, MHRA, Government Lawyers.

&nbsp;
"The evidence however is clear, these medicines are NOT linked with suicide.&nbsp; These medicines are NOT linked with an increased rate of self harm"&nbsp; stated Dr Alistair Benbow.

http://www.youtube.com/watch?v=TozBgI5L ... re=related

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